Department for Transport Great Minster House 33 Horseferry Road London SW1P 4DR Tel 0300 330 3000 Web site wwwdftgovuk xxxx xxxxx

xxxxxxx xxxxx xxx Our Ref F0009705 By email Your Ref

xxxxxxxxxxxx DATE 18 MARCH 2013

Dear xx xxxxx

Freedom of Information Act Request ndash F0009705

Thank you for your information request of 19 January 2013 which stated the following

Under the Freedom of Information act 2000 I request access to and copies of all documents including emails meeting reports minutes emails and official communications relating to discussions between the departments of Health and Transport regarding proposals to alter drug-driving regulations relating to people using ldquopain managementrdquo since January 2012 I would prefer to receive the information in electronic format to the enclosed email address However if it is more convenient I would be happy to receive the information in hard copy format If my request is denied in whole or part I ask that you justify all deletions by reference to specific exemptions of the act I will also expect you to release all segregable portions of otherwise exempt material

PLEASE NOTE IN PARTICULAR THAT I WILL NOT ACCEPT THE IMPOSITION OF QUALIFIED EXEMPTIONS ON A BLANKET BASIS I WILL REQUIRE AT THE VERY LEAST EVIDENCE THAT AN ATTEMPT HAS BEEN MADE TO MAKE A PARTIAL DISCLOSURE OF AVAILABLE INFORMATION IN A REDACTED DIGESTED OR EDITED FORM

Your request has been considered under the Freedom of Information Act 2000

Having completed the search I can confirm that the Department for Transport (DfT) does hold the information you requested but has decided that some information cannot be disclosed for the reasons given below The application of the public interest test in considering the factors in favour of disclosing information and withholding some of the information under Section 35 has been considered The reason for withholding some of the information is for the following reasons

It is in the public interest that decisions are based on the best advice available and a full consideration of all the options

Ministers and officials can conduct rigorous and candid risk assessments of their policies without there being premature disclosure which might close off discussion

1

The information that can be released is listed on page 5

Please note that the names and direct contacts details of departmental junior officials - that is staff below the senior civil service and some external stakeholders - have been withheld in reliance on the personal information exemption at section 40(2)amp(3) of the Freedom of Information Act 2000 (the full text of the exemption is attached at Annex A) These individuals are not in public facing roles and therefore have an expectation that their names and direct contacts details will not be put into the public domain To do so would be unfair and contravene the first data protection principle of fairness

The information being withheld falls under the exemption in Section 35 (the formulation or development of government policy) and Section 22 (information intended for future publication) of the Freedom of Information Act 2000

Copyright issues

Some of the information supplied to you continues to be protected by the Copyright Designs and Patents Act 1988 You are free to use it for your own purposes including for private study and non-commercial research and for any other purpose authorised by an exception in current copyright law Documents (except photographs) can be also used in the UK without requiring permission for the purposes of news reporting Any other re-use for example commercial publication would require the permission of the copyright holder

Most documents supplied by the Department for Transport will have been produced by government officials and will be Crown Copyright Most Crown Copyright information can be re-used under the Open Government Licence (httpwwwnationalarchivesgovukdocopen-government-licence) For information about OGL and about re-using Crown Copyright information please see The National Archives website - httpwwwnationalarchivesgovukinformation-managementuk-gov-licensing-frameworkhtm

Copyright in other documents may rest with a third party For information about obtaining permission from a third party see the Intellectual Property Officersquos website at wwwipogovuk

In keeping with the spirit and effect of the Freedom of Information Act all information is assumed to be releasable to the public unless exempt A copy of this response and the information provided may now be published on our website together with any related information that will provide a key to its wider context

If you are unhappy with the way the Department has handled your request or with the decisions made in relation to your request you may complain within two calendar months of the date of this letter by writing to the Departmentrsquos Information Rights Unit at

Zone D01 Ashdown House Sedlescombe Road North Hastings East Sussex TN37 7GA E-mail FOI-Advice-Team-DFTdftgsigovuk

Please see attached details of DfTrsquos complaints procedure and your right to complain to the Information Commissioner If you have any queries about this letter please contact

2

me Please remember to quote the reference number above in any future communications

Yours sincerely

xxxxx xxxxx

If you have any questions related to this response then please get in touch with the Department for Transportrsquos Press Officer xxxxxxx xxxxx on telephone 020 7944 xxxx

Press Office Department for Transport Great Minster House 33 Horseferry Road London SW1P 4DR Tel 020 7944 xxxx E-Mail xxxxxxxxxxdftgsigovuk

3

Your right to complain to DfT and the Information Commissioner

You have the right to complain within two calendar months of the date of this letter about the way in which your request for information was handled andor about the decision not to disclose all or part of the information requested In addition a complaint can be made that DfT has not complied with its FOI publication scheme

Your complaint will be acknowledged and you will be advised of a target date by which to expect a response Initially your complaint will be re-considered by the official who dealt with your request for information If after careful consideration that official decides that hisher decision was correct your complaint will automatically be referred to a senior independent official who will conduct a further review You will be advised of the outcome of your complaint and if a decision is taken to disclose information originally withheld this will be done as soon as possible

If you are not content with the outcome of the internal review you have the right to apply directly to the Information Commissioner for a decision The Information Commissioner can be contacted at

Information Commissionerrsquos Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF

4

Contents

30 January 2012 1412 ndash e-mail DH to DfT Page 6

27 June 2012 ndash Letter from Earl Attlee to Napp Pharmaceuticals Appendix A

29 November 2012 1422 ndash ppt presentation(attached separately)Appendix B

19 March 2012 1710 ndash e-mail DH to DfT 7Page 21 March 2012 1132 ndash e-mail DH to DfT 8Page 21 March 2012 1312 ndash e-mail DfT to DH Page 9

3 July 2012 1513 ndash e-mail DH to DfT Page 10 3 July 2012 1713 ndash e-mail DfT to DH Page 11 20 July 2012 ndash Note of meeting of Officials Working Group Page 12 17 August 2012 ndash Note of meeting of Officials Working Group Page 13 30 August 2012 1450 ndash e-mail DfT to DH Page 14 30 August 2012 1450 ndash Note of meeting with Napp Page 14 30 August 2012 1450 ndash Note of Napprsquos key concerns Page 21 30 August 2012 1450 ndash Note on controlled drugs with medical uses Page 28 13 September 2012 1603 ndash e-mail DfT to DH Page 29 17 October 2012 1108 ndash e-mail DfT to DH 30 Page 17 October 2012 1108 ndash Extract of briefing Page 30 29 November 2012 1422 ndash e-mail DfT to DH Page 31

19 December 2012 1412 ndash e-mail DH to DfT 32 Page 19 December 2012 1419 ndash e-mail DH to DfT 33 Page 19 December 2012 1419 ndash e-mail DH to DfT 33 Page 19 December 2012 1427 ndash e-mail DH to DfT 34 Page 19 December 2012 1519 ndash e-mail DH to DfT 34 Page 19 December 2012 1526 ndash e-mail DH to DfT 35 Page 19 December 2012 1529 ndash e-mail DH to DfT 35 Page 19 December 2012 1529 ndash Table of prescriptions Page 36 19 December 2012 1533 ndash e-mail DH to DfT 37 Page 19 December 2012 1536 ndash e-mail DH to DfT 37 Page 19 December 2012 1543 ndash e-mail DH to DfT 37 Page 19 December 2012 1549 ndash e-mail DH to DfT 38 Page 19 December 2012 1552 ndash e-mail DH to DfT 38 Page 19 December 2012 1607 ndash e-mail DH to DfT Page 39

5

From xxxxxxxxxxdhgsigovuk Sent 30 January 2012 1412 To DuncanPricedftgsigovuk Cc xxxxxxxdhgsigovuk xxxxxxxxxxxdhgsigovuk xxxxxxxdhgsigovuk MarkPruntydhgsigovuk JeremyMeanmhragsigovuk Subject DH comments DfT briefing for Mike PenningPM meeting on 1st Feb about Drug driving

Duncan

The following are the key comments from DH regarding the draft brief you sent in your email below

1 We agree there needs to be effective measures in place which means they need to be practical We need to be cautious about discussing legislation before having effective testing devices in place

2 We also need to ensure that sufficient time is given to explore this issue thoroughly to guard against implementing measures that may have unintended consequences

3 We believe it is essential that a pharmacist is included in the expert group Feel free to contact xxxx xxxxxxx who has been working in the xxxxx xxxxxxx xxxx xxx xxxxxx xxxxxx Xxx email address is xxxxxxxxxxxxbtinternetcom Do let me know if you dont have any luck in securing his input and Ill see if we can suggest an alternative pharmacist Xxxx is interested but we dont know whether his current work schedule will permit him to become involved with this work

4 xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxx

I hope these comments are helpful

Kind regards

xxxxxx xxxxxx xxxxxx xxxxxxx xxxxx Department of Health xxxx xxx Wellington House 133-155 Waterloo Road London SE1 8UG 0207 972 xxxx

6

Your right to complain to DfT and the Information Commissioner

You have the right to complain within two calendar months of the date of this letter about the way in which your request for information was handled andor about the decision not to disclose all or part of the information requested In addition a complaint can be made that DfT has not complied with its FOI publication scheme

Your complaint will be acknowledged and you will be advised of a target date by which to expect a response Initially your complaint will be re-considered by the official who dealt with your request for information If after careful consideration that official decides that hisher decision was correct your complaint will automatically be referred to a senior independent official who will conduct a further review You will be advised of the outcome of your complaint and if a decision is taken to disclose information originally withheld this will be done as soon as possible

If you are not content with the outcome of the internal review you have the right to apply directly to the Information Commissioner for a decision The Information Commissioner can be contacted at

Information Commissionerrsquos Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF

4

Contents

30 January 2012 1412 ndash e-mail DH to DfT Page 6

27 June 2012 ndash Letter from Earl Attlee to Napp Pharmaceuticals Appendix A

29 November 2012 1422 ndash ppt presentation(attached separately)Appendix B

19 March 2012 1710 ndash e-mail DH to DfT 7Page 21 March 2012 1132 ndash e-mail DH to DfT 8Page 21 March 2012 1312 ndash e-mail DfT to DH Page 9

3 July 2012 1513 ndash e-mail DH to DfT Page 10 3 July 2012 1713 ndash e-mail DfT to DH Page 11 20 July 2012 ndash Note of meeting of Officials Working Group Page 12 17 August 2012 ndash Note of meeting of Officials Working Group Page 13 30 August 2012 1450 ndash e-mail DfT to DH Page 14 30 August 2012 1450 ndash Note of meeting with Napp Page 14 30 August 2012 1450 ndash Note of Napprsquos key concerns Page 21 30 August 2012 1450 ndash Note on controlled drugs with medical uses Page 28 13 September 2012 1603 ndash e-mail DfT to DH Page 29 17 October 2012 1108 ndash e-mail DfT to DH 30 Page 17 October 2012 1108 ndash Extract of briefing Page 30 29 November 2012 1422 ndash e-mail DfT to DH Page 31

19 December 2012 1412 ndash e-mail DH to DfT 32 Page 19 December 2012 1419 ndash e-mail DH to DfT 33 Page 19 December 2012 1419 ndash e-mail DH to DfT 33 Page 19 December 2012 1427 ndash e-mail DH to DfT 34 Page 19 December 2012 1519 ndash e-mail DH to DfT 34 Page 19 December 2012 1526 ndash e-mail DH to DfT 35 Page 19 December 2012 1529 ndash e-mail DH to DfT 35 Page 19 December 2012 1529 ndash Table of prescriptions Page 36 19 December 2012 1533 ndash e-mail DH to DfT 37 Page 19 December 2012 1536 ndash e-mail DH to DfT 37 Page 19 December 2012 1543 ndash e-mail DH to DfT 37 Page 19 December 2012 1549 ndash e-mail DH to DfT 38 Page 19 December 2012 1552 ndash e-mail DH to DfT 38 Page 19 December 2012 1607 ndash e-mail DH to DfT Page 39

5

From xxxxxxxxxxdhgsigovuk Sent 30 January 2012 1412 To DuncanPricedftgsigovuk Cc xxxxxxxdhgsigovuk xxxxxxxxxxxdhgsigovuk xxxxxxxdhgsigovuk MarkPruntydhgsigovuk JeremyMeanmhragsigovuk Subject DH comments DfT briefing for Mike PenningPM meeting on 1st Feb about Drug driving

Duncan

The following are the key comments from DH regarding the draft brief you sent in your email below

1 We agree there needs to be effective measures in place which means they need to be practical We need to be cautious about discussing legislation before having effective testing devices in place

2 We also need to ensure that sufficient time is given to explore this issue thoroughly to guard against implementing measures that may have unintended consequences

3 We believe it is essential that a pharmacist is included in the expert group Feel free to contact xxxx xxxxxxx who has been working in the xxxxx xxxxxxx xxxx xxx xxxxxx xxxxxx Xxx email address is xxxxxxxxxxxxbtinternetcom Do let me know if you dont have any luck in securing his input and Ill see if we can suggest an alternative pharmacist Xxxx is interested but we dont know whether his current work schedule will permit him to become involved with this work

4 xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxx

I hope these comments are helpful

Kind regards

xxxxxx xxxxxx xxxxxx xxxxxxx xxxxx Department of Health xxxx xxx Wellington House 133-155 Waterloo Road London SE1 8UG 0207 972 xxxx

6

Contents

30 January 2012 1412 ndash e-mail DH to DfT Page 6

27 June 2012 ndash Letter from Earl Attlee to Napp Pharmaceuticals Appendix A

29 November 2012 1422 ndash ppt presentation(attached separately)Appendix B

19 March 2012 1710 ndash e-mail DH to DfT 7Page 21 March 2012 1132 ndash e-mail DH to DfT 8Page 21 March 2012 1312 ndash e-mail DfT to DH Page 9

3 July 2012 1513 ndash e-mail DH to DfT Page 10 3 July 2012 1713 ndash e-mail DfT to DH Page 11 20 July 2012 ndash Note of meeting of Officials Working Group Page 12 17 August 2012 ndash Note of meeting of Officials Working Group Page 13 30 August 2012 1450 ndash e-mail DfT to DH Page 14 30 August 2012 1450 ndash Note of meeting with Napp Page 14 30 August 2012 1450 ndash Note of Napprsquos key concerns Page 21 30 August 2012 1450 ndash Note on controlled drugs with medical uses Page 28 13 September 2012 1603 ndash e-mail DfT to DH Page 29 17 October 2012 1108 ndash e-mail DfT to DH 30 Page 17 October 2012 1108 ndash Extract of briefing Page 30 29 November 2012 1422 ndash e-mail DfT to DH Page 31

19 December 2012 1412 ndash e-mail DH to DfT 32 Page 19 December 2012 1419 ndash e-mail DH to DfT 33 Page 19 December 2012 1419 ndash e-mail DH to DfT 33 Page 19 December 2012 1427 ndash e-mail DH to DfT 34 Page 19 December 2012 1519 ndash e-mail DH to DfT 34 Page 19 December 2012 1526 ndash e-mail DH to DfT 35 Page 19 December 2012 1529 ndash e-mail DH to DfT 35 Page 19 December 2012 1529 ndash Table of prescriptions Page 36 19 December 2012 1533 ndash e-mail DH to DfT 37 Page 19 December 2012 1536 ndash e-mail DH to DfT 37 Page 19 December 2012 1543 ndash e-mail DH to DfT 37 Page 19 December 2012 1549 ndash e-mail DH to DfT 38 Page 19 December 2012 1552 ndash e-mail DH to DfT 38 Page 19 December 2012 1607 ndash e-mail DH to DfT Page 39

5

From xxxxxxxxxxdhgsigovuk Sent 30 January 2012 1412 To DuncanPricedftgsigovuk Cc xxxxxxxdhgsigovuk xxxxxxxxxxxdhgsigovuk xxxxxxxdhgsigovuk MarkPruntydhgsigovuk JeremyMeanmhragsigovuk Subject DH comments DfT briefing for Mike PenningPM meeting on 1st Feb about Drug driving

Duncan

The following are the key comments from DH regarding the draft brief you sent in your email below

1 We agree there needs to be effective measures in place which means they need to be practical We need to be cautious about discussing legislation before having effective testing devices in place

2 We also need to ensure that sufficient time is given to explore this issue thoroughly to guard against implementing measures that may have unintended consequences

3 We believe it is essential that a pharmacist is included in the expert group Feel free to contact xxxx xxxxxxx who has been working in the xxxxx xxxxxxx xxxx xxx xxxxxx xxxxxx Xxx email address is xxxxxxxxxxxxbtinternetcom Do let me know if you dont have any luck in securing his input and Ill see if we can suggest an alternative pharmacist Xxxx is interested but we dont know whether his current work schedule will permit him to become involved with this work

4 xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxx

I hope these comments are helpful

Kind regards

xxxxxx xxxxxx xxxxxx xxxxxxx xxxxx Department of Health xxxx xxx Wellington House 133-155 Waterloo Road London SE1 8UG 0207 972 xxxx

6

From xxxxxxxxxxdhgsigovuk Sent 30 January 2012 1412 To DuncanPricedftgsigovuk Cc xxxxxxxdhgsigovuk xxxxxxxxxxxdhgsigovuk xxxxxxxdhgsigovuk MarkPruntydhgsigovuk JeremyMeanmhragsigovuk Subject DH comments DfT briefing for Mike PenningPM meeting on 1st Feb about Drug driving

Duncan

The following are the key comments from DH regarding the draft brief you sent in your email below

1 We agree there needs to be effective measures in place which means they need to be practical We need to be cautious about discussing legislation before having effective testing devices in place

2 We also need to ensure that sufficient time is given to explore this issue thoroughly to guard against implementing measures that may have unintended consequences

3 We believe it is essential that a pharmacist is included in the expert group Feel free to contact xxxx xxxxxxx who has been working in the xxxxx xxxxxxx xxxx xxx xxxxxx xxxxxx Xxx email address is xxxxxxxxxxxxbtinternetcom Do let me know if you dont have any luck in securing his input and Ill see if we can suggest an alternative pharmacist Xxxx is interested but we dont know whether his current work schedule will permit him to become involved with this work

4 xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxx

I hope these comments are helpful

Kind regards

xxxxxx xxxxxx xxxxxx xxxxxxx xxxxx Department of Health xxxx xxx Wellington House 133-155 Waterloo Road London SE1 8UG 0207 972 xxxx

6

From xxxxxxxxxxxxdhgsigovuk Sent 19 March 2012 1710 To Duncan Pricedftgsigovuk Cc xxxxxxxxdhgsigovuk xxxxxxxxxxxxxdhgsigovuk xxxxxxxdhgsigovuk MarkPruntydhgsigovuk JeremyMeanmhragsigovuk xxxxxxxxxxxdhgsigovuk xxxxxxxxxxxxxdhgsigovuk xxxxxxxxxxdhgsigovuk xxxxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxxjusticegsigovuk xxxxxxxxxxxjusticegsigovuk xxxxxxxxxxxxxjusticegsigovuk DuncanPricedftgsigovuk xxxxxxxxxxxxxdftgsigovuk PatriciaHayesdftgsigovuk xxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxxxhomeofficegsigovuk Subject xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx

Xxxxxxx

Thank you for your email I understand xxxx xxxxxxxxx discussed this with you over the phone I have also previously sent emails setting out the Department of Healths views to Duncan Price who is copied into this email

xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxx

xxxx xxxxx xxxx with our second point in relation to the sentence in paragraph 2 which Ive pasted below This point is essential as it covers both medicines prescribed or supplied for medical purposes the latter including medicines bought over the counter on the advice of a pharmacist

the offence would contain a statutory defence where the drug or drugs in question have been prescribed or supplied for medical purposes and have been taken in accordance with the directions given

Many thanks

xxxxxxx xxxxxx xxxxxx xxxxxx xxxxx Department of Health xxxx xxx Wellington House 133-155 Waterloo Road London SE1 8UG 0207 972 xxxx

7

From xxxxxxxxxxxxdhgsigovuk Sent 21 March 2012 1132 To xxxxxxxxxxxxxxxxxxxxxxdftgsigovuk Cc xxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxjusticegsigovuk DuncanPricedftgsigovuk xxxxxxxxxxxscotlandofficegsigovuk xxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxdhgsigovuk xxxxxxxxxxxxxjusticegsigovuk xxxxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxdftgsigovuk PatriciaHayesdftgsigovuk xxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxxxjusticegsigovuk MarkPruntydhgsigovuk xxxxxxxxdhgsigovuk xxxxxxxdhgsigovuk xxxxxxxxxxxxxxdhgsigovuk JeremyMeanmhragsigovuk Subject xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx

Dear xxxxxxx

xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx

xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx

Similarly if you are going down this approach you need an accurate description of controlled drugs in the Annex The statement on page 3 that they can only legally be obtained on prescription by a medical practitioner is wrong Codeine for example is available in over-the-counter medicines and a lot of dispensing of methadone in drug treatment services is not necessarily prescribed by a doctor - it could for example be by a nurse

xxxx

xxxx xxxxxxxxx xxxxx xxxxxxxxxx xxxxxxxx Department of Health xx xxxxxx Wellington House 133-155 Waterloo Road London SE1 8UG (0)20 7972 xxxx

8

From xxxxxxxxxxxdftgsigovuk Sent 21 March 2012 1312 To xxxxxxxxxxxxndhgsigovuk Cc xxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxjusticegsigovuk DuncanPricedftgsigovuk xxxxxxxxxxxxscotlandofficegsigovuk xxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxdhgsigovuk xxxxxxxxxxxxdhgsigovuk JeremyMeanmhragsigovuk xxxxxxxxxxxxxjusticegsigovuk xxxxxxxxxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxxxxdftgsigovuk MarkPruntydhgsigovuk xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxdhgsigovuk xxxxxxxxxxxxxjusticegsigovuk Subject xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx

xxxx

Many thanks

1 We are seeking to give effect to North recommendations which is why the proposal refers to controlled drugs Recommendations 12 and 13 and also page 12 of the North Report states ldquoThe third stage involves the introduction of a new specific offence of driving with certain controlled drugs in the blood at or above levels at which those are deemed to be impairingrdquo

2 The creation of the new offence will simply make enforcement easier in respect of certain drugs The existing impairment offence (section 4 RTA) will continue to be used to deal with other drugs An extract from page 13 of the North Report is helpful in explaining the limits of the new offence

ldquoThis stage three regime would provide a means of tackling the major part of our drug driving problem but it would not deal with the vast majority of prescribed and over-the-counter medicines nor would it deal with all controlled drugs or new social drugs and legal substances taken for their impairing effects including so-called lsquolegal highsrsquo It would therefore be necessary to maintain the existing offence of driving while impaired by drugs as a lsquocatch-allrsquo to cover these other substances and instances There should be no statutory defence of having taken a drug in accordance with medical advice in relation to that existing offence just as there is not at presentrdquo

3 Pages 133 ndash 134 of North report (and reflected in the diagram on page 134) attempts to define controlled drugs as those that are not available over the counter without prescription We will consider further what is meant by ldquocontrolled drugsrdquo and will clarify the definition as required

I hope this addresses your concerns

Regards xxxxx xxxxxxx Road User Licensing Insurance and Safety Extension - xxxx

9

From xxxxxxxxxxxdhgsigovuk Sent 03072012 1535 To xxxxxxxxxxxxxxxxxxxdftgsigovuk Cc DuncanPricedftgsigovuk Subject Fw Drug driving - Involving our Senior Medical Officer

xxxxxxxx

I was hoping to discuss this with you over the phone but I understand you are at a meeting till 430pm I am leaving early today so I will have to call you tomorrow However in the mean time Ill put some of my thoughts down in this email to get the ball rolling

As xxx points out in xxx email Mark and xxx come at this policy from two different angles It would be helpful to have Mark on board as an observer as it will help us consider our clinical guidance relating to people in drug treatment and also to raise any additional issues the panel might want to consider relating to this particular client group But Mark will not be bringing the same issues to the table as xxx

xxx can bring the pharmacists perspective to the table I note the Chair refers to pharmacokinetics as already represented However we are referring to something different Pharmacokinetics is about the actions of drugs in the body over time We are talking addressing issues relating to pharmacists who have responsibility for dispensing medication and expertise in the safe and effective use of medication - a different issue altogether I think the language confuses these matters sometimes Pharmacists are the front line if you like where we all get our medication from so it is vital that issues from this side are raised and discussed This is not represented in the panel Many of the contributions we provided to recent DfT documents were put together with this angle in mind It is why xxx attends the policy group as xxx brings the pharmacy aspects to group discussions I hope this provides some further detail for us to discuss tomorrow

Kind regards

xxxxxx xxxxxx xxxxxx xxxxxxx xxxxx Department of Health xxxx xxx Wellington House 133-155 Waterloo Road London SE1 8UG 0207 972 xxxx

10

From xxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 03072012 1732 To MarkPruntydhgsigovuk xxxxxxxxxxxxdhgsigovuk Cc DuncanPricedftgsigovuk Subject RE Drug driving - Involving our Senior Medical Officer

Dear Mark

I think xxx is very happy for you to join this group and would in fact value your expertise more than that of xx xxxxxx xxxxxxx xxx has spoken to xxx and has agreed for xxx to join the panel simply to accommodate DoHrsquos wishes xxx has not seen that xxx would make a valuable addition to the panel and felt that xxx was indeed slightly confused about why xxx should be involved

Now that DoH colleague have put forward your name xxx would like to get you on board The membership and ToR of the panel are in the public domain so it is problematic to keep adding new members

As xxx xxxxxxxx has not formally been included in the panel we feel that it would be easiest to speak to xxx xxxxxxxx and explain to xxx why we can no longer accommodate xxx Instead you could join the panel as an observer

To pick up on xxxxxx points below the focus of the new law is controlled drugs that are illicit and there is a statutory defence for those taking controlled drugs in line with directions see below

(3) It is a defence for a person (ldquoDrdquo) charged with an offence under this section to show thatmdash

(a) the specified controlled drug had been prescribed or supplied to D for medical or dental purposes

(b) D took the drug in accordance with any directions given by the person by whom the drug was prescribed or supplied and with any accompanying instructions (so far as consistent with any such directions) given by the manufacturer or distributor of the drug and

Thanks xxxxxxxx

xxxxxxx xxxxxxxxxxxxx Roads Strategic Projects Roads Directorate Domestic 020 7944 xxxx

11

Working Group on Drug Driving ndash note of 20 July 2012 meeting

Attendees Duncan Price (DfT) Xxxxxxx xxxxxxxxxxxxx (DfT) Xxxx xxxxxxxxxxxx (DoH) Xxx xxxx (DoH) Xxxxxxx xxxxx (HO) xxxxxxxxxxxxxxxxx (HO) xxxxxx xxxx (MoJ)

Duncan Price provided an update on the Lords Committee stage and summarised the amendments tabled Key issues were controlled drugs used for clinical purposes and concerns about zero-tolerance levels A Hansard link had been circulated Duncan Price xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxx The report stage was likely to be around 7 November

Duncan Price informed the group that the drug driving panelrsquos xxxx xxx xxxxx would be briefing interested members of the House of Lords on 24 October about the panelrsquos work Xxxx xxxxxxxxx asked to be invited to that briefing

Duncan Price set out the high level timeline for the introduction of the new offence The Bill would go to the Commons either before or after Christmas The specification for mobile drug screening devices would be informed by the expert panelrsquos recommendations for the types of drugs and limits to be covered by the offence The type approval process for those devices could then run in parallel with the public consultation on the draft regulations The new offence could then commence in around the middle of 2014

It was agreed that work on the next stage impact assessment would be taking forward in close collaboration with the MoJ Home Office and DoH

12

Working Group on Drug Driving ndash draft note of 17 August 2012 meeting

Attendees Xxxx xxxxxxxxxxx (DoH) Xxx xxxx (DoH) Xxxxxx xxxxxx (HO) Xxxxxxxx xxxxxxxx (HO) Xxxxxxxxxx xxxx (HO) Xxxxx xxxxxx (MoJ for xxxxxx xxxx) Duncan Price (DfT) Xxxxxxx xxxxxxxxxxxx (DfT) Xxxxxxx xxxxx (DfT)

Duncan Price explained that the CPS and ACPO were being consulted about a possible change in the legislation to accept blood only evidential samples and not urine (which was not reliable to detect all drugs) or saliva or sweat Saliva and sweat if included would have to be as a theoretical future option until effective testing could be established (HO and DH agreed to approach contacts in Australia Belgium and US for data)

The Explanatory Note has now had comments from DfT legal Duncan Price will send out a redrafted version to the group for further comments

Discussions were still ongoing as to whether it would be possible to specify measurable levels in blood for all the controlled drugs of interest or whether provision should be made to enable levels to be specified in metabolites (provided these can be specifically related back to a controlled drug) Likewise consideration was being given for variable limits (dependent on alcohol levels) (Note the expert panelrsquos meeting of 21st August suggested a specified limit in a metabolite (itself not a controlled drug) might be appropriate in respect of cocaine rather than the drug itself)

Duncan Price suggested that the amendments made at Lords Committee stage related to medicinal uses of drugs would be problematic He was continuing to consider whether and how the panelrsquos emerging conclusions or policy assurances would be relevant to concerns expressed including in the NAPP briefing paper He had also met with representatives of NAPP and they had put some experts in touch with the expert panelrsquos chair

DfT will provide an update on drug driving to the 11th October ACMD Council meeting Jeremy Mean will need to advise when the MHRA could be updated

The group suggested an update should be provided for the 7 November Inter-ministerial group on drugs

Duncan Price also promised to send the group a first draft of ldquoEnforcement Procedures against Drink Drivers and Other Offenders ndash A Consultation Documentrdquo (Proposed Changes in Legislation for Testing Procedures for Drink and Drug Driving and in Other Transport Sectors and for Remedial Training for Road Traffic Offenders) This document covers the legislative changes contained in the Governmentrsquos response to the North review (other than the new drug driving offence)

[Post meeting note this document was sent on 21 August with initial comments requested by 31 August]

13

From DuncanPricedftgsigovuk Sent 30082012 1450 To xxxxxxxxxxxdhgsigovuk Cc xxxxxxxxxxxxxxxxxdftgsigovuk Subject Fw Meeting with Napp Pharmaceuticals

xxxxxxx

I attach in respect to briefing for Ann Miltonrsquos planned meeting with NAPP on 23rd October the following

- a note of NAPPrsquos key concerns (as they drafted them) plus my response - a letter Earl Atlee to NAPP - the draft sent to Lord Henleyrsquos office for signature to Lord Luce about similar issues - the note of the meeting NAPP had with me (it is NAPPrsquos note with my comments) - an internal note about controlled drugs for medical uses

The notes we did on the amendments made at Committee stage for Ministers cover some of the NAPP issues but I havenrsquot enclosed them as I have sent quite a lot already ndash but yoursquore welcome to a copy if you want one

Duncan Price Tel 020 7944 2241 Department for Transport

Note of the Meeting

Napp Pharmaceuticals and Department for Transport Meeting on Drug Driving 31 July 2012

Attendees Duncan Price Deputy Director Road User Licensing Insurance amp Safety (DP) Xxx xxxxxxxx Department for Transport Xxxxxx xxxxx Napp Pharmaceuticals Xxxxxx xxxxxxxxxxxxx Napp Pharmaceuticals Xxx xxxxxx Napp Pharmaceuticals Xxxx xxxxxx Ranelagh International Xxxxxxx xxxxxx Ranelagh International (RB)

Xxx began the meeting by providing a brief background on Napp xx noted that the company has been in Cambridge for thirty years and is well-known for its range of pain medications and in particular strong opioids Napp has helped to revolutionise the management of cancer and chronic pain through the development of various slow release and round the clock formulations Now the company is also moving into respiratory medicine and other areas It employs approximately 1100 people and is fifteenth in terms of GP prescription sales Xxx noted that Napp is interested in drug driving because of the impact legislation may have on patients

14

DP said that he is leading on drug driving policy and that the legislation currently going through Parliament is one of three pieces of work the Department is taking forward together The current proposals are enabling legislation which will allow the Government to determine the details critical to the new offence once the Expert Panel has published its recommendations DP suggested that the Expert Panelrsquos interim advice would be available in October

Xx noted that Napp is fully in support of the legislation and what it is trying to achieve but there are a few unintended consequences that it may cause for both manufacturers and patients Xx raised concerns about the impact on legitimate patients on a stable dose of medication that may be affected by legislation designed to target those who abuse illegal and legal drugs Xx added that Napp is in contact with a number of clinicians and other experts who would be happy to feed in to this policy development

Xx raised the issue of patients who are unimpaired being criminalised and facing a significant burden of proof if the proposed legislation is passed As the legislation is currently proposed there is a defence for patients taking prescription medication but the burden is first with them to prove that they have taken their medication is accordance with all instructions including from manufacturers There is a significant onus on patients to show they are not impaired despite what police say The defence is really only available once the driver is in court

Xx then compared the proposed legislation to the drink driving laws and highlighted the differences to drug driving legislation and the issue of strict liability Could the legislation be more focussed on its intended aim and tailor the list of controlled substances to those known to be abused as opposed to a catch all approach There needs to be protection for patients but at the moment the legislation appears to be trying to do both

Xx also noted the importance of ensuring that this is a policeable offence In the Governmentrsquos response to the North Review there was discussion of the Australian approach to drug driving Police found the impairment side of legislation hard to prove so they have instead just used the strict liability approach to prosecute drivers based on detection of a controlled substance

DP noted that all of the issues raised by xx are important What is being discussed in Parliament at the moment is enabling legislation which is setting out the framework The detail will become clearer once the interim advice from the Expert Panel has been received which is due in October The Department has already started to give some assurances in certain areas for example a zero tolerance approach for cannabis has been ruled out They will be able to home in as more advice is received from the Panel although it is not possible to pin the Panel down until it has reported DP added that there will be informed discussions with peers in late October before the legislation goes to Report Stage

Xx asked if the Panelrsquos advice will have any influence on the current draft Bill Xx asked if it would be worth making the primary legislation more focussed for example on substances known to be abused which would allow for strict liability The problem for patients would then become irrelevant as they would not be the focus of the legislation Xx also noted the problem that will arise from including heroin on the list of controlled substances Heroin metabolises into morphine in the blood as do some over-the-counter medications which makes it hard to distinguish between the different drug types This will lead to unintended consequences for patients

15

DP stated that he understood this argument but noted that the legislation is intended to be fit for purpose to allow for the whole range of potential decisions the Panel could make The decision might be made to change the substances on the controlled list although nothing so far has led him to think something should change The current list links back to the range included in the Misuse of Drugs Act The advice on the drugs will feed into the consultation and the subsequent affirmative procedure

DP added that because of the enabling nature of the current legislation there are some problems for example legal highs are not included on the list of controlled substances at the moment Due to the nature of the legislative procedure it can take a while to identify a problem and then legislate to give police powers They expect legal highs can become controlled drugs if they have protracted and serious consequences in a quicker time than the duration of the regulation-making process for drug driving There are powers to apply the legislation to all controlled drugs but they will need to go through it controlled drug by controlled drug in order to determine specific limits etc The Government envisages a mixed economy of the new and the existing offence

DP said that heroin is one drug of significant interest as it is known to be prevalent and associated with road safety risks The Panel are looking at opiates as a group of drugs and it will be for the Panel to decide how it can be detected He noted that they will need to consider all potential effects before setting any levels DP said that he knows that this is an area of importance for Napp as their patients will have a tolerance which is highly relevant to these considerations He would expect the Panel to look at that The Department wants the Panel to look at the opiate family so they do not only consider heroin

Xx said that the higher level of metabolites is an issue but these patients will be unimpaired where as a heroin user trying to get high is very different In terms of the defence the burden of proof lies on the shoulders of the patient Has the Department considered eliminating the impairment element and introducing an exemption for patients

DP responded that they have been considering all areas when looking at the medical defence Drink heroin and medically prescribed opiates have some similarities and also some important differences With alcohol some people who are over the limit will say they are unimpaired but the risks do increase as blood alcohol levels increase This can be the same with drugs

Xx noted that when a patient is on a steady dose of medication the pain they would be under if they were to stop taking their medication could be more impairing

DP said that he recognises the differences to drink driving Heroin users and medication users have different tolerances to ordinary people and the lsquodrink driving analogy is limitedrsquo Drinking has social benefits and it is a choice for people

Xx added that Napp sees that there is a desire to make drug like drink driving something that society will not tolerate but patients have to take their medication There is existing legislation against impairment for those who are irresponsible when taking their medication At the moment patients are being brought down to the lowest common denominator of those who abuse drugs This minority is causing problems for everyone else

16

Xxx noted that unlike with drink driving where increased alcohol leads to increased impairment there is not increased impairment with a high but stable dose of prescription medication Xx added that he believes there is a Swedish study which has investigated levels of impairment in patients

DP stated that although the opiate family is being considered together at the moment if it is not possible to distinguish between heroin and other opiates then it is open for the Department to decide whether or not to include morphine in the legislation They could decide that the disbenefits of including it would outweigh the benefits

He noted that the reason medications remain included is that there are problems with abuse for example with Benzodiazepines which are known to cause road safety problems Just because a controlled drug can be prescribed does not mean it will be removed from the legislation There will be a differentiation between a medical level at which someone must not drive and where they should not drive

Xx noted that Napp wants to work with the Government so that morphine can be included in the list of controlled substances By introducing an exemption or at least taking the burden of proof off the patient this could be done

DP said that the offence has a wide remit and there is a defence where they would like to include taking medication in accordance with medical advice There is a strong burden of proof on the prosecution to put evidence to the courts

Xx noted that the patient has to substantiate the proof first Xx added that patients already have a poor quality of life and this puts them under more stress Xxx said that pain is costing the country pound13bn a year and the Government has only recently decided to deem pain a long term condition and to work to help people have a good quality of life This seems like a backward step Doctors have been campaigning for years to get pain recognised and this is therefore a concern for them too as it may interfere with their choice of treatments

Xx said that with a few tweaks to the legislation the burden of proof could be placed on the prosecution For example by adding the word lsquoknowinglyrsquo to protect patients who were unaware of any advice against driving This would reassure them that a prescription will mean that they are protected Xx added that xxx has already had patient groups coming to her who are concerned that they are going to have to fight again

Xx noted that there is the issue of the lsquoknock onrsquo impact of one case highlighted by the media which could lead to patients becoming more cautious about taking their medication

DP said that he thought the Panel was unlikely to recommend low threshold levels He said that they have looked at the amendments tabled and they had material prepared for the Committee Stage of the legislation which was not needed and will be used to inform the informal discussion among peers in October He added that he feels the burden of proof leans towards the prosecution Once the prescription is presented it is down to the prosecution to prove beyond reasonable doubt that the medication was not taken properly For example one way would be if they can show that the blood level of a drug was in excess of the level prescribed

17

Xx raised concerns that cautious drivers may be wrongly pulled over by police and that it will be difficult for them to prove that they were unimpaired DP said that there are a swathe of issues about how far along the process people will be taken The balance is broadly right in the defence and if a case did go to court it would be resolved in the right way

DP noted that he is aware of the problems with testing procedures and that it is a genuinely difficult area Xx added that there are also concerns about those involved in a car crash and the insurance implications for a patient if they are the innocent party but test positively for drugs

DP said that is the situation already with the existing law and that there is currently a big drop off of cases before they reach the courts let alone conviction This is partly why the new offence is needed to target illegal drug users This issue is already there Xx acknowledged this but noted that the risk for patients would be heightened and that legislation designed to give police powers to stop drug abusers from driving should not spill over to impact on patients and make them worry about driving

Xx noted xxxx xxxxx xxxxx recent lsquoFit for Workrsquo report which showed that the main problem for the workforce is low back pain therefore many more people could be forced to stop work if they felt that by taking their medication it could mean that they are not deemed fit to drive

It was also noted that in the first stages of pain patients will seek pharmacist advice and use low doses of codeine to manage their pain There are 8m Osteoarthritis sufferers in the UK and over 70 report that they are in constant pain They typically start with over-the-counter medication including NSAIDS and codeine such as Nurofen Plus They will not have a prescription so how will they fare under the legislation

DP stated that this is partly an issue for the Panel He said he hoped that there is a good swathe of people on the Panel and asked if there is anything that Napp would like to submit to them Xx said there would be and that xxx would liaise with him on behalf of NAPP and feed in any information that would be considered helpful

Xxx noted that there are some concerns about the lack of medicalpainpatient representation on the Panel and that if these groups could feed in to the Panel that would help alleviate some concerns

DP said that the Panel is bringing in materials from other experts and that subject to his clearing it with the Chair they would be very keen to see papers etc The Panel would like to see as much research as possible Although they do not meet on policy there have been a number of issues related to the science of opioids that are of interest Xx asked if it would be helpful to also send the Panel a paper from Napp on where they believe legislation contains areas of risk and burden for patients to make the Panel aware of not only where the legislation can work but also where it could go wrong Xx asked if a pain expert could feed that in DP said case studies on the impact on patients would be helpful but there should be a focus on the science The legal aspects will not concern the Panel They should be happy to receive papers although he will have to talk to the Chair about having any experts appear in front of the Panel Xx assured DP that this would be done if the Chair was in agreement

18

Xx asked for some detail on the practical process of the Panelrsquos work Is the October report interim or final

DP said that it will be an interim report as there may be more work to do afterwards but that it is hoped and expected that the report will cover all the major drug types in the terms of reference They will use the findings across Government and then the decision will be made to move to the consultation The findings will also be communicated to the Committee on the Misuse of Drugs and the MRHA Secretariat representatives from both have been at Panel meetings

The secondary legislation will be in effect from early 2014 The plan is to consult on it in early 2013 and then progress through affirmative procedure in the later part of 2013 It will allow for the possible subsequent inclusion of other drugs

Xx asked about the development of testing devices and their specificity DP said that he is not a technical authority about the machines but does have information on the approval process A decision will be made at the end of the year on those currently going through police stations There will also be the beginning of the process to develop the second generation of roadside testing but the specifications cannot be finalised until the Panel reports These will be threshold detectors not just presentabsent detectors They will cover something related to heroin Legislation has been drafted so that police can undertake multiple preliminary tests as all drugs cannot be tested for at the same time The technology is important as an offence without it would not have the impact hoped for

DP added that other countries have a zero tolerance approach with presentabsent tests but that they want a threshold approach here He said that the legislation is linked to road safety it is not intended to change the law on possession use of drugs It is about public safety The existing penalty regime is not suitable for a zero tolerance approach At the moment crossing the limit means a 12 month driving ban and other consequences which is different to abroad The reason the drink drive limit has not been reduced is because the Government does not want to create a two tier system where the lower limit becomes seen as only equivalent to being given a speeding ticket The penalty for drug driving needs to allow for a more proportionate approach to enforcement At the moment if you are well versed in the law you have a good chance of evading conviction They want to change the balance and do not want to lower the penalty in comparison to drink driving He added that problems with some detection equipment abroad would not be acceptable in the UK legal system especially evidential saliva sampling The technology appears not there yet

DP noted that the Department is also looking at appropriate policy statements to make about the legislation The press has already focussed on areas where the new offence wonrsquot be an impact Xxx said that policy statements would help those patients who are already concerned

DP asked if Napprsquos patients receive unequivocal advice that they can drive Xx said not necessarily The issue is patients do not read advice and if they did they would not necessarily fully understand it It comes down to what the Doctor says but this legislation could then put them in a difficult position too Xx noted that the advice to patients in leaflets for medication regardless of whether they are prescription only medicines or over the counter would have a statement that would alert the patient to potential drowsiness or tiredness and advise that if this symptom was experienced patients should not drive or operate machinery This would be the same advice that clinicians would give to patients

19

about their medication unless as with certain drugs the DVLA should be notified and patients specifically informed that they must not drive whilst taking this medication The onus is on the patient to determine if they have this side effect and to what extent they are impaired DP noted that there is a difference between advice that a patient cannot drive and being told not to drive if they feel drowsy Xxx added that patients on a stable dose will be unsure if they can continue to work have a good quality of life etc and this will lead them to question whether or not to take their medication

DP stated that the Government can provide the context on what they think directions are but this will still be interpreted by a court Xx said publishing that information would provide comfort to patients who are concerned DP said this would be discussed with peers as well

Xx asked who will be invited to the informal discussion with peers and MPs DP said it would be just members of the House of Lords and Commons They will be able to meet with the Panel and other Government experts Xx noted that this would be useful for peers as those Napp has spoken to have had answers to initial questions but there are still areas where they would like some clarification DP noted that he and the Lords Spokesperson met with interested peers in advance of the Committee Stage It is easier to provide more factual clarification informally than on the floor of the House and Spokespeople will value the chance to make some progress before the Report Stage

Xx confirmed that Napp would put together some helpful information for DP to pass on to the Panel and will bring in some experts to feed in to that Xx added that Napp would be happy to feed in to any policy statements etc DP said he would be happy to clarify any issues in writing Xx said Napp would put together a list of questions for DP for this Xx said xxx would involve patient groups here too

Xx asked if there has been any input in the policy from the Department for Health DP said that a quadrilateral working group from Transport Justice Home and Health are working on the policy They have met between Panel meetings to see what is said and if there are any issues to put to the Panel

Xx asked if there is anything else Napp can do DP said that the more specific Napp can be about concerns evidence on the effect of treatments on impairment etc that would be helpful The policy is very much at the evidence gathering stage at the moment

Xx reiterated Napprsquos concerns regarding the Panel membership

DP said that at some point he expected tough decisions will be made about the balance of the proscons of the policy issues No solution will tick every box

Xx said that policy statements will be key to giving the police and the CPS guidance on who they are targeting as well as what lsquodirectionsrsquo mean to allay the fears of patients and clinicians DP said he hoped they would be able to allay fears He added that there is no advantage for the police to have lots of people in stations and being processed who are not impaired There is a realistic policy possibility that heroin will have to be set aside Just because the Panel is looking at it does not mean there is a commitment that it will be in the new offence They know that there may be no test to distinguish between different types of opiates

20

Xxx passed on two emails which he explained were from xx xxxxxxx xxxxxxx and xx xxxxxx xxxxxxxxn representing the views of CPPC and RCGP respectively Both Doctors expressed their concerns for patients and offered to contribute to discussions on the proposed legislation

A Note of Napprsquos Key Concerns

Napp Pharmaceuticals Meeting with Department for Transport 31 July 2012

Note I have added in bold italicised text some DfT responses to the questions in your original note which is otherwise as you sent me ndash Duncan Price 2882012

A Statement of support for drug driving legislation to stop people from driving while under the

influence of illegal drugs

Napp is concerned about the unintended consequences of the legislation on patients taking

long‐term medication for chronic pain Napp wants to work with the Government to find a

solution

1) Impact on Patients

2) Criminalisation of Patients

3) Different to Drink Driving Law

4) Policeable Offence

B Outline of Concerns

1) Impact on Patients

Evidence shows that patients on a stable dose of opioid analgesics are not necessarily

impaired but under the proposed system patients may be inaccurately identified as taking

impairing drugs and face prosecution

Patients well established on a stable dose of an opioid analgesic may have levels of

metabolites in their system well above any threshold used for roadside and police station

testing This means they could face serious charges despite driving unimpaired

There are concerns for patients such as those with Osteoarthritis the majority of who use

over the counter medications to manage their pain

Concern that patients will stop taking their medication so that they can drive This may

make their driving more impaired as a result of the pain that they will be under

Questions

Has there been consideration of how to distinguish between opiates that are used legally

for medicinal purposes and those used illegally (Napp would be happy to share clinical

knowledge of opioids that may be helpful to the panel and to any other interested parties

in Government)

The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

21

The panel is considering natural and synthetic opioids Its terms of reference include that it should establish the likelihood of whether concentrations of drugs broadly equivalent in their impairment effects to blood alcohol concentrations of 20 50 and 80mg100ml would be exceeded This will include a consideration of prescribed or otherwise legally obtained drugs which are known to impair driving

The panel will advise the Government which will then itself consider what specified limits to propose and then consult about I can assure you that in doing so it will consider how screening equipment and evidential blood specimens would distinguish between opiates used for legitimate medical purposes and those used illicitly

I am grateful for the offer of sharing clinical knowledge you made when we met I know the panel has since considered some of the evidence your experts have provided and some of its members have met an expert you recommended and one of your legal advisors

Has there been consideration of just introducing a list of restricted drugs known to be used

recreationally as with the Australian model

The list of restricted drugs used in some states in Australia does include THC (the active ingredient of cannabis) which does have some limited medical uses here The Governmentrsquos prime targets for this legislation are controlled drugs often or exclusively used illicitly including those included in the Australian legislation (THC amphetamines and MDMA)

At this stage we are awaiting advice from the panel but the Governmentrsquos position is that it should develop a new offence with the potential to include a number of categories of drug including benzodiazepines and opiates The abuse including the use of high quantities of methadone and some benzodiazepines (which can be prescribed) appears (alongside heroin) to be a significant contributor to the public safety problems this legislation is addressing

Many of the drugs specifically identified in the panelrsquos terms of reference are used exclusively or predominantly illicitly ndash for example amphetamine-types cannabinoids cocaine and hallucinogens

There is a reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

22

We are therefore using the definition of lsquocontrolled drugrsquo in the Misuse of Drugs Act 1971 within the new offence although which controlled drugs will be determined when regulations are brought forward

What consideration have you given to the issue of patients who drive unimpaired but will

still face prosecution if tested as levels of metabolites in their system may be above any

prescribed limit

This is being considered in both the terms of reference for the technical panelrsquos advice about the setting of specified limits (to keep patients out of the scope of the offence) and the inclusion of the medical defence within the offence

The panel has also been asked to consider the degree of variability in impairment effects across the population including for habitual drug users

In the terms of reference for the panel we have also specifically included the following from the North review (paragraph 743)

ldquoSome drugs which may be proscribed for driving might also be used legitimately in accordance with medical advice (for example morphine may be prescribed for chronic pain or diazepam (a benzodiazepine) may be prescribed for anxiety) Indeed the Review recognises that in some circumstances it may be more dangerous for a person to drive having not taken their medically prescribed drug than driving without having taken it Drugs have different effects on different people and levels at which they are prescribed are likely to reflect this It would clearly be wrong to put in jeopardy of prosecution those who are properly and safely taking medically prescribed drugs and driving in accordance with medical advice for whom despite the presence of a proscribed drug there is no evidence of any driving impairmentrdquo

I should also emphasise that the content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

2) Criminalisation of Patients

Statutory defence is included in the current legislation for those who have taken

prescription medication in accordance with prescribersupplier instructions and any

accompanying instructions from the manufacturer BUT

Only applicable after patient has been arrested further tested and their case has

progressed ndash this will cause innocent patients significant stress and

inconvenience

The defence puts the burden of proof on patients to prove that they acted in

accordance with all medical advice when the burden should be on the

prosecution to prove that they didnrsquot

23

Innocent patients may face criminalisation based on a technicality in legislation

that is not intended to target them

Questions

Is an exemption feasible (If not what is going to be done to ensure that patients are

protected)

I do not consider an exemption from the offence for all controlled drugs that can possibly be supplied or used for medical reasons is feasible Many controlled drugs for example cannabis have some medicinal uses

It is perfectly feasible for decisions about which controlled drugs would be specified for the new offence to be influenced by the reasons for whether their use is often always seldom or never for medical reasons Indeed such distinctions would be vital if this legislation were being introduced to enforce further against the illegal supply or use of controlled drugs

Whether that is the right approach to decision-making related to driving with controlled drugs in the body where there are levels associated with elevated risks to public safety is however questionable This legislation is being introduced to address road safety problems and the expert panelrsquos terms of reference are focussed on providing advice about the risks of driving after taking controlled drugs

It is to no-onesrsquo benefit for patients who are innocent of the offence to be arrested and tested There are several protections in place to reduce these risks Firstly police do not have random testing powers for drink and drug driving Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving

under the influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would result in disproportionate and large numbers of patients having evidential blood tests but then being not guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

24

It is important to note that the prosecution for a case where a defence has been raised that a patient had taken a controlled drug in accordance with medical advice must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code Test about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

It is important now and it will be important with the new offence in place that medical advice does not suggest to patients that they drive when doing so would present a significant risk to themselves and the public To do so risks patients being involved in road traffic incidents and also committing the existing offence of driving whilst impaired due to drugs

3) Different to Drink Driving Law

There have been calls for a strict liability approach to drug driving as exists for drink

driving Napp believes this would not be a suitable approach for drug driving based on the

current draft Bill

Alcohol does not have any medical necessity people do not need to consume

alcohol to ensure that a chronic condition does not prevent them from

functioning on a daily basis

Prescription medications that patients may take to treat chronic pain are a

medical necessity and are essential to ensuring that they are able to function on a

daily basis

A strict liability approach could lead to patients not taking essential medication in

order to be able to drive without fear of prosecution

Alternatively patients may choose not to drive at all which could have a serious

impact on their ability to work and go about their daily lives

Questions Is an exemption feasible (If not what is going to be done to ensure that patients are protected)

There are some useful analogies with drink driving law For example prior to the introduction of the specific drink driving offence the law in relation to drink drivers was difficult to enforce The specific offence there has contributed to major improvements in public safety

I do accept one of the differences with some controlled drugs is that some people take them for medicinal not recreational purposes This is not the case for all controlled drugs This may well affect what is included in the regulations for the offence

25

When we met I did say that it is conceivable for even as prevalent a recreational drug as heroin to not be included in the regulations for the offence This might be if it transpired that a limit relevant to heroin had to be set in a metabolite itself used in or a metabolite of a medically prescribed drug If such a limit also then had the effect of criminalising driving with medically supplied controlled drugs when that did not present an elevated risk to public safety I can see it would be a limit we might well not implement However I await the advice of the expert panel to see what it recommends related to heroin and whether (and how) that might affect other opiates

4) Policeable Offence

It is argued that drivers wonrsquot be stopped by police unless they appear impaired BUT

Plans are to test all those involved in a traffic accident for drugs including

innocent parties An innocent unimpaired patient involved in a crash through no

fault of their own could then face serious charges

Impairment is subjective and police may be suspicious of someonersquos driving for a

number of reasons such as driving too cautiously This apparently lsquoimpairedrsquo

driving may be due to various factors unrelated to the driverrsquos use of prescribed

medication but if they are stopped by police they may find themselves facing

serious and unjust charges

The existing impairment offence will remain so police will still be able to catch

those who do drive while impaired by prescription medication

Questions How close is the Home Office to approval of a drug testing device for use in police stations Can you provide any details

The laboratory testing phases of the type approval process is under way and the process is due to be completed at the end of this year

Is the Home Office still aiming for a 2014 approval of a drug testing device for portable use

It is still aiming for 2014 for these devices and we are planning the timing of that process together with the work on the new offence

Since the Governmentrsquos response to the North Review in June 2010 has the drug driving data quality improved

Yes we have received more information from Coroners recently and we also have had the conclusions of the European DRUID research

C Solutions

Napp believes that the best way to protect patients is by introducing an exemption for

those who can demonstrate that they are taking prescription medication

Existing legislation against driving while impaired would allow police to charge

anyone who did drive while under the influence of impairing prescription

medication

26

This would put the burden of proof on prosecutors saving innocent patients

considerable stress inconvenience and wasted CPS and police time

The Department considers that the statutory defence affords appropriate protection to patients who drive after taking prescription medication

The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

D Other Points for Consideration

Napp is keen to support this legislation in its efforts to stop users of illegal drugs

from driving and wishes to support policy development to ensure that patients are

protected Napp would be keen to provide any further information or other

means of assistance that could be of help here

Napp would like to submit written andor oral evidence to the Expert Panelrsquos

inquiry

Napp is concerned about the lack of pain expertise and patient representatives on

the Expert panel

Lord Henley mentioned that a seminar might be held after the summer recess to

discuss the issues arising from this legislation further Napp would be keen to

receive any further information on this

I hope this has been covered satisfactorily in the discussion we had on 31st July and since then

I do consider the legislation has strong safeguards in place for patients The Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

I hope I have addressed at least some of your concerns I should be happy to discuss the issues further

Duncan Price 2882012

27

Note on controlled drugs with medical uses

(i) The reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

(ii) Circumstances in which drug testing can be administered Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under the

influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

(iii) The medical defence The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

(iv) Drugs to be covered by the new offence and any specified limits to be based on expert advice The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

(v) Other controls The content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

(vi) Prosecutions to be in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

(vii) In light of the above the Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

28

From DuncanPricedftgsigovuk Sent 13092012 1603 To xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Cc xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Subject RE NRAS - Crime and Courts Bill clauses on drug driving

Xxxxxx

Below is my draft response to this letter Irsquoll send it when I have your comments about it

Dear xx xxxxxxx

Xxxxxx xxxxxxxx has forwarded your email of 28th August to me I am the lead policy official for the legislative clause about drug impaired driving in the Crime and Courts Bill

I am aware of concerns about innocent motorists taking prescribed medications being stopped tested being taken to police stations having blood samples taken and possibly going to court before being exonerated This is not the intention of the legislation and I can assure you we are mindful of this concern as we progress the legislation and respond to advice from an expert panel about the details

There are several protections in place to reduce the risk of large numbers of innocent motorists being arrested and taken to police stations

Firstly motorists cannot be stopped randomly for drug tests Testing can only be administered in three circumstances ndash namely where a driver has committed a moving traffic offence

a driver has been involved in a road traffic accident and or

there is reason for a police officer to suspect that a person has been driving under the influence of drink or drugs

This means that in practice drivers taking prescribed medicines would not be stopped and required to undergo drug testing without there being real cause for concern Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would be likely to result in disproportionate and large numbers of people prescribed drugs having evidential blood tests but then not being found guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

Fourthly it is important to emphasise that the prosecution for a case where the medical defence has been raised must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code for Crown Prosecutors which contains a requirement about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

Finally in the context of the clause before parliament the content of the regulations (specifying which controlled drugs should be covered by the new offence and the limits to be specified for them) will be the subject of public consultation Before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of

29

Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

I hope that this letter serves to allay concerns about possible unintended consequences for people taking prescription medicines

Duncan Price Tel 020 7944 xxxx Department for Transport

From JessicaMatthewdftgsigovuk Sent 17 October 2012 1108 To xxxxxxxxxxxxadhgsigovuk Cc xxxxxxxxxxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxxxxxdhgsigovuk xxxxxxxxdhgsigovuk Subject Re Department of Health attendance at the Lords briefing for the drug driving legislation

Xxxxxxxx is out of the office today but wersquoll send over the time and venue tomorrow and share the briefing with you Irsquod be happy to brief Dr Prunty beforehand ndash perhaps over the phone

Wersquore planning on a reasonably open debate about the legislation We wonrsquot have got policy clearance on the amendments to the legislation but wersquore inclined to say that the Government is minded to or is considering x y or z

Happy to discuss

Jessica Matthew Deputy Director Road User Licensing Insurance and Safety Tel 020 7944 xxxx Zone 321 Great Minster House 76 Marsham Street London SW1P 4DR

Extract of Briefing shared with DH from the above e-mail

How will you make sure that people taking medication in accordance with their prescription arenrsquot arrested and taken to court as a result of this legislation

The medical defence in the provisions provides substantial and appropriate protection for people taking medically prescribed or supplied controlled drugs It places an evidential burden on a person accused of committing the offence So the accused must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court It is then for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on

It is unlikely that a person taking medication in accordance with their prescription would be taken to court for a number of reasons

30

1 Motorists cannot be stopped randomly for drug tests They can only be tested where They have committed a moving traffic offence They have been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under

the influence of drink or drugs

2 The drugs to be included in the legislation and their limits will be set in regulations The content of the regulations will be the subject of public consultation and an affirmative resolution This will provide an opportunity for any concerns with the proposed specified limits to be raised and carefully considered

3 The expert panel is bearing in mind the normal therapeutic ranges and expected drug concentrations in blood when setting limits for those drugs that may also be used for medicinal purposes This means that only patients on unusually high doses of medication might have a positive screening and proceed to evidential blood test

4 Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any cases before they reach the court Indeed there is a Code for Crown Prosecutors which contains a requirement that prosecutions are in the public interest

From xxxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 29 November 2012 1422 To xxxxxxxdhgsigovuk xxxxxxxxxpsncorguk xxxxxxxxxxxxxtheccaorguk xxxxxxxxxxnpacouk xxxxxxxxxxxxrpharmscom xxxxxxxxxxxsaddactionorguk xxxxxroadsafecom xxxxxxxxxxxxxxxxxxsdrconsortiumorg xxxm-allianceorguk xxxxxxxxxxxturning-pointcouk xxxxxxxxROSPAcom xxxxxxxxxxxxxxxxtheAAcom xxxxxxxxxacpopnnpoliceuk adminactionaddictionorguk xxxxxxxxxageukorguk xxxxxxxxxxxbrakeorguk xxxxxxxxbmaorguk xxxxxxxxxxxbritishpainsocietyorg xxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxcpsgsigovuk xxxxxxxxdrugscopeorguk xxxxxxxxxiamorguk xxxxxxxxxxxxxxlawsocietyorguk xxxxxxxxxxxliberty-human-rightsorguk xxxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxxpactsorguk xxxxxxxxxxparliamentuk xxxxxxxxxxxxRACFoundationorg xxxxxxxxxxdurhamgovuk xxxxxxxxxxxxxxxxPolicyConnectorguk xxxxxxxxxxxxxxpsncorguk xxxxxxxxxxxxxdvlagsigovuk Xxxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxhomeofficegsigovuk xxxxxxxxnpacouk xxxxxxxxxxxxdhgsigovuk xxxxxxxxxdrugscopeorguk Cc xxxxxxxxxxxxxxxxxxxdftgsigovuk JessicaMatthewdftgsigovuk xxxxxxxxxxxxxxxxxxdftgsigovuk Subject Drug driving seminar presentation

Dear all

Many thanks to those of you who were able to attend our Drug Driving Stakeholder Seminar last week

We hope you found as useful as we did

Please find attached a copy of the presentation as promised

Kind regards

Xxxxxx xxxxxxx

31

From xxxxxxxxxxxxdhgsigovuk Sent 21 March 2012 1132 To xxxxxxxxxxxxxxxxxxxxxxdftgsigovuk Cc xxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxjusticegsigovuk DuncanPricedftgsigovuk xxxxxxxxxxxscotlandofficegsigovuk xxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxdhgsigovuk xxxxxxxxxxxxxjusticegsigovuk xxxxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxdftgsigovuk PatriciaHayesdftgsigovuk xxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxxxjusticegsigovuk MarkPruntydhgsigovuk xxxxxxxxdhgsigovuk xxxxxxxdhgsigovuk xxxxxxxxxxxxxxdhgsigovuk JeremyMeanmhragsigovuk Subject xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx

Dear xxxxxxx

xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx

xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx

Similarly if you are going down this approach you need an accurate description of controlled drugs in the Annex The statement on page 3 that they can only legally be obtained on prescription by a medical practitioner is wrong Codeine for example is available in over-the-counter medicines and a lot of dispensing of methadone in drug treatment services is not necessarily prescribed by a doctor - it could for example be by a nurse

xxxx

xxxx xxxxxxxxx xxxxx xxxxxxxxxx xxxxxxxx Department of Health xx xxxxxx Wellington House 133-155 Waterloo Road London SE1 8UG (0)20 7972 xxxx

8

From xxxxxxxxxxxdftgsigovuk Sent 21 March 2012 1312 To xxxxxxxxxxxxndhgsigovuk Cc xxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxjusticegsigovuk DuncanPricedftgsigovuk xxxxxxxxxxxxscotlandofficegsigovuk xxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxdhgsigovuk xxxxxxxxxxxxdhgsigovuk JeremyMeanmhragsigovuk xxxxxxxxxxxxxjusticegsigovuk xxxxxxxxxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxxxxdftgsigovuk MarkPruntydhgsigovuk xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxdhgsigovuk xxxxxxxxxxxxxjusticegsigovuk Subject xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx

xxxx

Many thanks

1 We are seeking to give effect to North recommendations which is why the proposal refers to controlled drugs Recommendations 12 and 13 and also page 12 of the North Report states ldquoThe third stage involves the introduction of a new specific offence of driving with certain controlled drugs in the blood at or above levels at which those are deemed to be impairingrdquo

2 The creation of the new offence will simply make enforcement easier in respect of certain drugs The existing impairment offence (section 4 RTA) will continue to be used to deal with other drugs An extract from page 13 of the North Report is helpful in explaining the limits of the new offence

ldquoThis stage three regime would provide a means of tackling the major part of our drug driving problem but it would not deal with the vast majority of prescribed and over-the-counter medicines nor would it deal with all controlled drugs or new social drugs and legal substances taken for their impairing effects including so-called lsquolegal highsrsquo It would therefore be necessary to maintain the existing offence of driving while impaired by drugs as a lsquocatch-allrsquo to cover these other substances and instances There should be no statutory defence of having taken a drug in accordance with medical advice in relation to that existing offence just as there is not at presentrdquo

3 Pages 133 ndash 134 of North report (and reflected in the diagram on page 134) attempts to define controlled drugs as those that are not available over the counter without prescription We will consider further what is meant by ldquocontrolled drugsrdquo and will clarify the definition as required

I hope this addresses your concerns

Regards xxxxx xxxxxxx Road User Licensing Insurance and Safety Extension - xxxx

9

From xxxxxxxxxxxdhgsigovuk Sent 03072012 1535 To xxxxxxxxxxxxxxxxxxxdftgsigovuk Cc DuncanPricedftgsigovuk Subject Fw Drug driving - Involving our Senior Medical Officer

xxxxxxxx

I was hoping to discuss this with you over the phone but I understand you are at a meeting till 430pm I am leaving early today so I will have to call you tomorrow However in the mean time Ill put some of my thoughts down in this email to get the ball rolling

As xxx points out in xxx email Mark and xxx come at this policy from two different angles It would be helpful to have Mark on board as an observer as it will help us consider our clinical guidance relating to people in drug treatment and also to raise any additional issues the panel might want to consider relating to this particular client group But Mark will not be bringing the same issues to the table as xxx

xxx can bring the pharmacists perspective to the table I note the Chair refers to pharmacokinetics as already represented However we are referring to something different Pharmacokinetics is about the actions of drugs in the body over time We are talking addressing issues relating to pharmacists who have responsibility for dispensing medication and expertise in the safe and effective use of medication - a different issue altogether I think the language confuses these matters sometimes Pharmacists are the front line if you like where we all get our medication from so it is vital that issues from this side are raised and discussed This is not represented in the panel Many of the contributions we provided to recent DfT documents were put together with this angle in mind It is why xxx attends the policy group as xxx brings the pharmacy aspects to group discussions I hope this provides some further detail for us to discuss tomorrow

Kind regards

xxxxxx xxxxxx xxxxxx xxxxxxx xxxxx Department of Health xxxx xxx Wellington House 133-155 Waterloo Road London SE1 8UG 0207 972 xxxx

10

From xxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 03072012 1732 To MarkPruntydhgsigovuk xxxxxxxxxxxxdhgsigovuk Cc DuncanPricedftgsigovuk Subject RE Drug driving - Involving our Senior Medical Officer

Dear Mark

I think xxx is very happy for you to join this group and would in fact value your expertise more than that of xx xxxxxx xxxxxxx xxx has spoken to xxx and has agreed for xxx to join the panel simply to accommodate DoHrsquos wishes xxx has not seen that xxx would make a valuable addition to the panel and felt that xxx was indeed slightly confused about why xxx should be involved

Now that DoH colleague have put forward your name xxx would like to get you on board The membership and ToR of the panel are in the public domain so it is problematic to keep adding new members

As xxx xxxxxxxx has not formally been included in the panel we feel that it would be easiest to speak to xxx xxxxxxxx and explain to xxx why we can no longer accommodate xxx Instead you could join the panel as an observer

To pick up on xxxxxx points below the focus of the new law is controlled drugs that are illicit and there is a statutory defence for those taking controlled drugs in line with directions see below

(3) It is a defence for a person (ldquoDrdquo) charged with an offence under this section to show thatmdash

(a) the specified controlled drug had been prescribed or supplied to D for medical or dental purposes

(b) D took the drug in accordance with any directions given by the person by whom the drug was prescribed or supplied and with any accompanying instructions (so far as consistent with any such directions) given by the manufacturer or distributor of the drug and

Thanks xxxxxxxx

xxxxxxx xxxxxxxxxxxxx Roads Strategic Projects Roads Directorate Domestic 020 7944 xxxx

11

Working Group on Drug Driving ndash note of 20 July 2012 meeting

Attendees Duncan Price (DfT) Xxxxxxx xxxxxxxxxxxxx (DfT) Xxxx xxxxxxxxxxxx (DoH) Xxx xxxx (DoH) Xxxxxxx xxxxx (HO) xxxxxxxxxxxxxxxxx (HO) xxxxxx xxxx (MoJ)

Duncan Price provided an update on the Lords Committee stage and summarised the amendments tabled Key issues were controlled drugs used for clinical purposes and concerns about zero-tolerance levels A Hansard link had been circulated Duncan Price xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxx The report stage was likely to be around 7 November

Duncan Price informed the group that the drug driving panelrsquos xxxx xxx xxxxx would be briefing interested members of the House of Lords on 24 October about the panelrsquos work Xxxx xxxxxxxxx asked to be invited to that briefing

Duncan Price set out the high level timeline for the introduction of the new offence The Bill would go to the Commons either before or after Christmas The specification for mobile drug screening devices would be informed by the expert panelrsquos recommendations for the types of drugs and limits to be covered by the offence The type approval process for those devices could then run in parallel with the public consultation on the draft regulations The new offence could then commence in around the middle of 2014

It was agreed that work on the next stage impact assessment would be taking forward in close collaboration with the MoJ Home Office and DoH

12

Working Group on Drug Driving ndash draft note of 17 August 2012 meeting

Attendees Xxxx xxxxxxxxxxx (DoH) Xxx xxxx (DoH) Xxxxxx xxxxxx (HO) Xxxxxxxx xxxxxxxx (HO) Xxxxxxxxxx xxxx (HO) Xxxxx xxxxxx (MoJ for xxxxxx xxxx) Duncan Price (DfT) Xxxxxxx xxxxxxxxxxxx (DfT) Xxxxxxx xxxxx (DfT)

Duncan Price explained that the CPS and ACPO were being consulted about a possible change in the legislation to accept blood only evidential samples and not urine (which was not reliable to detect all drugs) or saliva or sweat Saliva and sweat if included would have to be as a theoretical future option until effective testing could be established (HO and DH agreed to approach contacts in Australia Belgium and US for data)

The Explanatory Note has now had comments from DfT legal Duncan Price will send out a redrafted version to the group for further comments

Discussions were still ongoing as to whether it would be possible to specify measurable levels in blood for all the controlled drugs of interest or whether provision should be made to enable levels to be specified in metabolites (provided these can be specifically related back to a controlled drug) Likewise consideration was being given for variable limits (dependent on alcohol levels) (Note the expert panelrsquos meeting of 21st August suggested a specified limit in a metabolite (itself not a controlled drug) might be appropriate in respect of cocaine rather than the drug itself)

Duncan Price suggested that the amendments made at Lords Committee stage related to medicinal uses of drugs would be problematic He was continuing to consider whether and how the panelrsquos emerging conclusions or policy assurances would be relevant to concerns expressed including in the NAPP briefing paper He had also met with representatives of NAPP and they had put some experts in touch with the expert panelrsquos chair

DfT will provide an update on drug driving to the 11th October ACMD Council meeting Jeremy Mean will need to advise when the MHRA could be updated

The group suggested an update should be provided for the 7 November Inter-ministerial group on drugs

Duncan Price also promised to send the group a first draft of ldquoEnforcement Procedures against Drink Drivers and Other Offenders ndash A Consultation Documentrdquo (Proposed Changes in Legislation for Testing Procedures for Drink and Drug Driving and in Other Transport Sectors and for Remedial Training for Road Traffic Offenders) This document covers the legislative changes contained in the Governmentrsquos response to the North review (other than the new drug driving offence)

[Post meeting note this document was sent on 21 August with initial comments requested by 31 August]

13

From DuncanPricedftgsigovuk Sent 30082012 1450 To xxxxxxxxxxxdhgsigovuk Cc xxxxxxxxxxxxxxxxxdftgsigovuk Subject Fw Meeting with Napp Pharmaceuticals

xxxxxxx

I attach in respect to briefing for Ann Miltonrsquos planned meeting with NAPP on 23rd October the following

- a note of NAPPrsquos key concerns (as they drafted them) plus my response - a letter Earl Atlee to NAPP - the draft sent to Lord Henleyrsquos office for signature to Lord Luce about similar issues - the note of the meeting NAPP had with me (it is NAPPrsquos note with my comments) - an internal note about controlled drugs for medical uses

The notes we did on the amendments made at Committee stage for Ministers cover some of the NAPP issues but I havenrsquot enclosed them as I have sent quite a lot already ndash but yoursquore welcome to a copy if you want one

Duncan Price Tel 020 7944 2241 Department for Transport

Note of the Meeting

Napp Pharmaceuticals and Department for Transport Meeting on Drug Driving 31 July 2012

Attendees Duncan Price Deputy Director Road User Licensing Insurance amp Safety (DP) Xxx xxxxxxxx Department for Transport Xxxxxx xxxxx Napp Pharmaceuticals Xxxxxx xxxxxxxxxxxxx Napp Pharmaceuticals Xxx xxxxxx Napp Pharmaceuticals Xxxx xxxxxx Ranelagh International Xxxxxxx xxxxxx Ranelagh International (RB)

Xxx began the meeting by providing a brief background on Napp xx noted that the company has been in Cambridge for thirty years and is well-known for its range of pain medications and in particular strong opioids Napp has helped to revolutionise the management of cancer and chronic pain through the development of various slow release and round the clock formulations Now the company is also moving into respiratory medicine and other areas It employs approximately 1100 people and is fifteenth in terms of GP prescription sales Xxx noted that Napp is interested in drug driving because of the impact legislation may have on patients

14

DP said that he is leading on drug driving policy and that the legislation currently going through Parliament is one of three pieces of work the Department is taking forward together The current proposals are enabling legislation which will allow the Government to determine the details critical to the new offence once the Expert Panel has published its recommendations DP suggested that the Expert Panelrsquos interim advice would be available in October

Xx noted that Napp is fully in support of the legislation and what it is trying to achieve but there are a few unintended consequences that it may cause for both manufacturers and patients Xx raised concerns about the impact on legitimate patients on a stable dose of medication that may be affected by legislation designed to target those who abuse illegal and legal drugs Xx added that Napp is in contact with a number of clinicians and other experts who would be happy to feed in to this policy development

Xx raised the issue of patients who are unimpaired being criminalised and facing a significant burden of proof if the proposed legislation is passed As the legislation is currently proposed there is a defence for patients taking prescription medication but the burden is first with them to prove that they have taken their medication is accordance with all instructions including from manufacturers There is a significant onus on patients to show they are not impaired despite what police say The defence is really only available once the driver is in court

Xx then compared the proposed legislation to the drink driving laws and highlighted the differences to drug driving legislation and the issue of strict liability Could the legislation be more focussed on its intended aim and tailor the list of controlled substances to those known to be abused as opposed to a catch all approach There needs to be protection for patients but at the moment the legislation appears to be trying to do both

Xx also noted the importance of ensuring that this is a policeable offence In the Governmentrsquos response to the North Review there was discussion of the Australian approach to drug driving Police found the impairment side of legislation hard to prove so they have instead just used the strict liability approach to prosecute drivers based on detection of a controlled substance

DP noted that all of the issues raised by xx are important What is being discussed in Parliament at the moment is enabling legislation which is setting out the framework The detail will become clearer once the interim advice from the Expert Panel has been received which is due in October The Department has already started to give some assurances in certain areas for example a zero tolerance approach for cannabis has been ruled out They will be able to home in as more advice is received from the Panel although it is not possible to pin the Panel down until it has reported DP added that there will be informed discussions with peers in late October before the legislation goes to Report Stage

Xx asked if the Panelrsquos advice will have any influence on the current draft Bill Xx asked if it would be worth making the primary legislation more focussed for example on substances known to be abused which would allow for strict liability The problem for patients would then become irrelevant as they would not be the focus of the legislation Xx also noted the problem that will arise from including heroin on the list of controlled substances Heroin metabolises into morphine in the blood as do some over-the-counter medications which makes it hard to distinguish between the different drug types This will lead to unintended consequences for patients

15

DP stated that he understood this argument but noted that the legislation is intended to be fit for purpose to allow for the whole range of potential decisions the Panel could make The decision might be made to change the substances on the controlled list although nothing so far has led him to think something should change The current list links back to the range included in the Misuse of Drugs Act The advice on the drugs will feed into the consultation and the subsequent affirmative procedure

DP added that because of the enabling nature of the current legislation there are some problems for example legal highs are not included on the list of controlled substances at the moment Due to the nature of the legislative procedure it can take a while to identify a problem and then legislate to give police powers They expect legal highs can become controlled drugs if they have protracted and serious consequences in a quicker time than the duration of the regulation-making process for drug driving There are powers to apply the legislation to all controlled drugs but they will need to go through it controlled drug by controlled drug in order to determine specific limits etc The Government envisages a mixed economy of the new and the existing offence

DP said that heroin is one drug of significant interest as it is known to be prevalent and associated with road safety risks The Panel are looking at opiates as a group of drugs and it will be for the Panel to decide how it can be detected He noted that they will need to consider all potential effects before setting any levels DP said that he knows that this is an area of importance for Napp as their patients will have a tolerance which is highly relevant to these considerations He would expect the Panel to look at that The Department wants the Panel to look at the opiate family so they do not only consider heroin

Xx said that the higher level of metabolites is an issue but these patients will be unimpaired where as a heroin user trying to get high is very different In terms of the defence the burden of proof lies on the shoulders of the patient Has the Department considered eliminating the impairment element and introducing an exemption for patients

DP responded that they have been considering all areas when looking at the medical defence Drink heroin and medically prescribed opiates have some similarities and also some important differences With alcohol some people who are over the limit will say they are unimpaired but the risks do increase as blood alcohol levels increase This can be the same with drugs

Xx noted that when a patient is on a steady dose of medication the pain they would be under if they were to stop taking their medication could be more impairing

DP said that he recognises the differences to drink driving Heroin users and medication users have different tolerances to ordinary people and the lsquodrink driving analogy is limitedrsquo Drinking has social benefits and it is a choice for people

Xx added that Napp sees that there is a desire to make drug like drink driving something that society will not tolerate but patients have to take their medication There is existing legislation against impairment for those who are irresponsible when taking their medication At the moment patients are being brought down to the lowest common denominator of those who abuse drugs This minority is causing problems for everyone else

16

Xxx noted that unlike with drink driving where increased alcohol leads to increased impairment there is not increased impairment with a high but stable dose of prescription medication Xx added that he believes there is a Swedish study which has investigated levels of impairment in patients

DP stated that although the opiate family is being considered together at the moment if it is not possible to distinguish between heroin and other opiates then it is open for the Department to decide whether or not to include morphine in the legislation They could decide that the disbenefits of including it would outweigh the benefits

He noted that the reason medications remain included is that there are problems with abuse for example with Benzodiazepines which are known to cause road safety problems Just because a controlled drug can be prescribed does not mean it will be removed from the legislation There will be a differentiation between a medical level at which someone must not drive and where they should not drive

Xx noted that Napp wants to work with the Government so that morphine can be included in the list of controlled substances By introducing an exemption or at least taking the burden of proof off the patient this could be done

DP said that the offence has a wide remit and there is a defence where they would like to include taking medication in accordance with medical advice There is a strong burden of proof on the prosecution to put evidence to the courts

Xx noted that the patient has to substantiate the proof first Xx added that patients already have a poor quality of life and this puts them under more stress Xxx said that pain is costing the country pound13bn a year and the Government has only recently decided to deem pain a long term condition and to work to help people have a good quality of life This seems like a backward step Doctors have been campaigning for years to get pain recognised and this is therefore a concern for them too as it may interfere with their choice of treatments

Xx said that with a few tweaks to the legislation the burden of proof could be placed on the prosecution For example by adding the word lsquoknowinglyrsquo to protect patients who were unaware of any advice against driving This would reassure them that a prescription will mean that they are protected Xx added that xxx has already had patient groups coming to her who are concerned that they are going to have to fight again

Xx noted that there is the issue of the lsquoknock onrsquo impact of one case highlighted by the media which could lead to patients becoming more cautious about taking their medication

DP said that he thought the Panel was unlikely to recommend low threshold levels He said that they have looked at the amendments tabled and they had material prepared for the Committee Stage of the legislation which was not needed and will be used to inform the informal discussion among peers in October He added that he feels the burden of proof leans towards the prosecution Once the prescription is presented it is down to the prosecution to prove beyond reasonable doubt that the medication was not taken properly For example one way would be if they can show that the blood level of a drug was in excess of the level prescribed

17

Xx raised concerns that cautious drivers may be wrongly pulled over by police and that it will be difficult for them to prove that they were unimpaired DP said that there are a swathe of issues about how far along the process people will be taken The balance is broadly right in the defence and if a case did go to court it would be resolved in the right way

DP noted that he is aware of the problems with testing procedures and that it is a genuinely difficult area Xx added that there are also concerns about those involved in a car crash and the insurance implications for a patient if they are the innocent party but test positively for drugs

DP said that is the situation already with the existing law and that there is currently a big drop off of cases before they reach the courts let alone conviction This is partly why the new offence is needed to target illegal drug users This issue is already there Xx acknowledged this but noted that the risk for patients would be heightened and that legislation designed to give police powers to stop drug abusers from driving should not spill over to impact on patients and make them worry about driving

Xx noted xxxx xxxxx xxxxx recent lsquoFit for Workrsquo report which showed that the main problem for the workforce is low back pain therefore many more people could be forced to stop work if they felt that by taking their medication it could mean that they are not deemed fit to drive

It was also noted that in the first stages of pain patients will seek pharmacist advice and use low doses of codeine to manage their pain There are 8m Osteoarthritis sufferers in the UK and over 70 report that they are in constant pain They typically start with over-the-counter medication including NSAIDS and codeine such as Nurofen Plus They will not have a prescription so how will they fare under the legislation

DP stated that this is partly an issue for the Panel He said he hoped that there is a good swathe of people on the Panel and asked if there is anything that Napp would like to submit to them Xx said there would be and that xxx would liaise with him on behalf of NAPP and feed in any information that would be considered helpful

Xxx noted that there are some concerns about the lack of medicalpainpatient representation on the Panel and that if these groups could feed in to the Panel that would help alleviate some concerns

DP said that the Panel is bringing in materials from other experts and that subject to his clearing it with the Chair they would be very keen to see papers etc The Panel would like to see as much research as possible Although they do not meet on policy there have been a number of issues related to the science of opioids that are of interest Xx asked if it would be helpful to also send the Panel a paper from Napp on where they believe legislation contains areas of risk and burden for patients to make the Panel aware of not only where the legislation can work but also where it could go wrong Xx asked if a pain expert could feed that in DP said case studies on the impact on patients would be helpful but there should be a focus on the science The legal aspects will not concern the Panel They should be happy to receive papers although he will have to talk to the Chair about having any experts appear in front of the Panel Xx assured DP that this would be done if the Chair was in agreement

18

Xx asked for some detail on the practical process of the Panelrsquos work Is the October report interim or final

DP said that it will be an interim report as there may be more work to do afterwards but that it is hoped and expected that the report will cover all the major drug types in the terms of reference They will use the findings across Government and then the decision will be made to move to the consultation The findings will also be communicated to the Committee on the Misuse of Drugs and the MRHA Secretariat representatives from both have been at Panel meetings

The secondary legislation will be in effect from early 2014 The plan is to consult on it in early 2013 and then progress through affirmative procedure in the later part of 2013 It will allow for the possible subsequent inclusion of other drugs

Xx asked about the development of testing devices and their specificity DP said that he is not a technical authority about the machines but does have information on the approval process A decision will be made at the end of the year on those currently going through police stations There will also be the beginning of the process to develop the second generation of roadside testing but the specifications cannot be finalised until the Panel reports These will be threshold detectors not just presentabsent detectors They will cover something related to heroin Legislation has been drafted so that police can undertake multiple preliminary tests as all drugs cannot be tested for at the same time The technology is important as an offence without it would not have the impact hoped for

DP added that other countries have a zero tolerance approach with presentabsent tests but that they want a threshold approach here He said that the legislation is linked to road safety it is not intended to change the law on possession use of drugs It is about public safety The existing penalty regime is not suitable for a zero tolerance approach At the moment crossing the limit means a 12 month driving ban and other consequences which is different to abroad The reason the drink drive limit has not been reduced is because the Government does not want to create a two tier system where the lower limit becomes seen as only equivalent to being given a speeding ticket The penalty for drug driving needs to allow for a more proportionate approach to enforcement At the moment if you are well versed in the law you have a good chance of evading conviction They want to change the balance and do not want to lower the penalty in comparison to drink driving He added that problems with some detection equipment abroad would not be acceptable in the UK legal system especially evidential saliva sampling The technology appears not there yet

DP noted that the Department is also looking at appropriate policy statements to make about the legislation The press has already focussed on areas where the new offence wonrsquot be an impact Xxx said that policy statements would help those patients who are already concerned

DP asked if Napprsquos patients receive unequivocal advice that they can drive Xx said not necessarily The issue is patients do not read advice and if they did they would not necessarily fully understand it It comes down to what the Doctor says but this legislation could then put them in a difficult position too Xx noted that the advice to patients in leaflets for medication regardless of whether they are prescription only medicines or over the counter would have a statement that would alert the patient to potential drowsiness or tiredness and advise that if this symptom was experienced patients should not drive or operate machinery This would be the same advice that clinicians would give to patients

19

about their medication unless as with certain drugs the DVLA should be notified and patients specifically informed that they must not drive whilst taking this medication The onus is on the patient to determine if they have this side effect and to what extent they are impaired DP noted that there is a difference between advice that a patient cannot drive and being told not to drive if they feel drowsy Xxx added that patients on a stable dose will be unsure if they can continue to work have a good quality of life etc and this will lead them to question whether or not to take their medication

DP stated that the Government can provide the context on what they think directions are but this will still be interpreted by a court Xx said publishing that information would provide comfort to patients who are concerned DP said this would be discussed with peers as well

Xx asked who will be invited to the informal discussion with peers and MPs DP said it would be just members of the House of Lords and Commons They will be able to meet with the Panel and other Government experts Xx noted that this would be useful for peers as those Napp has spoken to have had answers to initial questions but there are still areas where they would like some clarification DP noted that he and the Lords Spokesperson met with interested peers in advance of the Committee Stage It is easier to provide more factual clarification informally than on the floor of the House and Spokespeople will value the chance to make some progress before the Report Stage

Xx confirmed that Napp would put together some helpful information for DP to pass on to the Panel and will bring in some experts to feed in to that Xx added that Napp would be happy to feed in to any policy statements etc DP said he would be happy to clarify any issues in writing Xx said Napp would put together a list of questions for DP for this Xx said xxx would involve patient groups here too

Xx asked if there has been any input in the policy from the Department for Health DP said that a quadrilateral working group from Transport Justice Home and Health are working on the policy They have met between Panel meetings to see what is said and if there are any issues to put to the Panel

Xx asked if there is anything else Napp can do DP said that the more specific Napp can be about concerns evidence on the effect of treatments on impairment etc that would be helpful The policy is very much at the evidence gathering stage at the moment

Xx reiterated Napprsquos concerns regarding the Panel membership

DP said that at some point he expected tough decisions will be made about the balance of the proscons of the policy issues No solution will tick every box

Xx said that policy statements will be key to giving the police and the CPS guidance on who they are targeting as well as what lsquodirectionsrsquo mean to allay the fears of patients and clinicians DP said he hoped they would be able to allay fears He added that there is no advantage for the police to have lots of people in stations and being processed who are not impaired There is a realistic policy possibility that heroin will have to be set aside Just because the Panel is looking at it does not mean there is a commitment that it will be in the new offence They know that there may be no test to distinguish between different types of opiates

20

Xxx passed on two emails which he explained were from xx xxxxxxx xxxxxxx and xx xxxxxx xxxxxxxxn representing the views of CPPC and RCGP respectively Both Doctors expressed their concerns for patients and offered to contribute to discussions on the proposed legislation

A Note of Napprsquos Key Concerns

Napp Pharmaceuticals Meeting with Department for Transport 31 July 2012

Note I have added in bold italicised text some DfT responses to the questions in your original note which is otherwise as you sent me ndash Duncan Price 2882012

A Statement of support for drug driving legislation to stop people from driving while under the

influence of illegal drugs

Napp is concerned about the unintended consequences of the legislation on patients taking

long‐term medication for chronic pain Napp wants to work with the Government to find a

solution

1) Impact on Patients

2) Criminalisation of Patients

3) Different to Drink Driving Law

4) Policeable Offence

B Outline of Concerns

1) Impact on Patients

Evidence shows that patients on a stable dose of opioid analgesics are not necessarily

impaired but under the proposed system patients may be inaccurately identified as taking

impairing drugs and face prosecution

Patients well established on a stable dose of an opioid analgesic may have levels of

metabolites in their system well above any threshold used for roadside and police station

testing This means they could face serious charges despite driving unimpaired

There are concerns for patients such as those with Osteoarthritis the majority of who use

over the counter medications to manage their pain

Concern that patients will stop taking their medication so that they can drive This may

make their driving more impaired as a result of the pain that they will be under

Questions

Has there been consideration of how to distinguish between opiates that are used legally

for medicinal purposes and those used illegally (Napp would be happy to share clinical

knowledge of opioids that may be helpful to the panel and to any other interested parties

in Government)

The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

21

The panel is considering natural and synthetic opioids Its terms of reference include that it should establish the likelihood of whether concentrations of drugs broadly equivalent in their impairment effects to blood alcohol concentrations of 20 50 and 80mg100ml would be exceeded This will include a consideration of prescribed or otherwise legally obtained drugs which are known to impair driving

The panel will advise the Government which will then itself consider what specified limits to propose and then consult about I can assure you that in doing so it will consider how screening equipment and evidential blood specimens would distinguish between opiates used for legitimate medical purposes and those used illicitly

I am grateful for the offer of sharing clinical knowledge you made when we met I know the panel has since considered some of the evidence your experts have provided and some of its members have met an expert you recommended and one of your legal advisors

Has there been consideration of just introducing a list of restricted drugs known to be used

recreationally as with the Australian model

The list of restricted drugs used in some states in Australia does include THC (the active ingredient of cannabis) which does have some limited medical uses here The Governmentrsquos prime targets for this legislation are controlled drugs often or exclusively used illicitly including those included in the Australian legislation (THC amphetamines and MDMA)

At this stage we are awaiting advice from the panel but the Governmentrsquos position is that it should develop a new offence with the potential to include a number of categories of drug including benzodiazepines and opiates The abuse including the use of high quantities of methadone and some benzodiazepines (which can be prescribed) appears (alongside heroin) to be a significant contributor to the public safety problems this legislation is addressing

Many of the drugs specifically identified in the panelrsquos terms of reference are used exclusively or predominantly illicitly ndash for example amphetamine-types cannabinoids cocaine and hallucinogens

There is a reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

22

We are therefore using the definition of lsquocontrolled drugrsquo in the Misuse of Drugs Act 1971 within the new offence although which controlled drugs will be determined when regulations are brought forward

What consideration have you given to the issue of patients who drive unimpaired but will

still face prosecution if tested as levels of metabolites in their system may be above any

prescribed limit

This is being considered in both the terms of reference for the technical panelrsquos advice about the setting of specified limits (to keep patients out of the scope of the offence) and the inclusion of the medical defence within the offence

The panel has also been asked to consider the degree of variability in impairment effects across the population including for habitual drug users

In the terms of reference for the panel we have also specifically included the following from the North review (paragraph 743)

ldquoSome drugs which may be proscribed for driving might also be used legitimately in accordance with medical advice (for example morphine may be prescribed for chronic pain or diazepam (a benzodiazepine) may be prescribed for anxiety) Indeed the Review recognises that in some circumstances it may be more dangerous for a person to drive having not taken their medically prescribed drug than driving without having taken it Drugs have different effects on different people and levels at which they are prescribed are likely to reflect this It would clearly be wrong to put in jeopardy of prosecution those who are properly and safely taking medically prescribed drugs and driving in accordance with medical advice for whom despite the presence of a proscribed drug there is no evidence of any driving impairmentrdquo

I should also emphasise that the content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

2) Criminalisation of Patients

Statutory defence is included in the current legislation for those who have taken

prescription medication in accordance with prescribersupplier instructions and any

accompanying instructions from the manufacturer BUT

Only applicable after patient has been arrested further tested and their case has

progressed ndash this will cause innocent patients significant stress and

inconvenience

The defence puts the burden of proof on patients to prove that they acted in

accordance with all medical advice when the burden should be on the

prosecution to prove that they didnrsquot

23

Innocent patients may face criminalisation based on a technicality in legislation

that is not intended to target them

Questions

Is an exemption feasible (If not what is going to be done to ensure that patients are

protected)

I do not consider an exemption from the offence for all controlled drugs that can possibly be supplied or used for medical reasons is feasible Many controlled drugs for example cannabis have some medicinal uses

It is perfectly feasible for decisions about which controlled drugs would be specified for the new offence to be influenced by the reasons for whether their use is often always seldom or never for medical reasons Indeed such distinctions would be vital if this legislation were being introduced to enforce further against the illegal supply or use of controlled drugs

Whether that is the right approach to decision-making related to driving with controlled drugs in the body where there are levels associated with elevated risks to public safety is however questionable This legislation is being introduced to address road safety problems and the expert panelrsquos terms of reference are focussed on providing advice about the risks of driving after taking controlled drugs

It is to no-onesrsquo benefit for patients who are innocent of the offence to be arrested and tested There are several protections in place to reduce these risks Firstly police do not have random testing powers for drink and drug driving Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving

under the influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would result in disproportionate and large numbers of patients having evidential blood tests but then being not guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

24

It is important to note that the prosecution for a case where a defence has been raised that a patient had taken a controlled drug in accordance with medical advice must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code Test about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

It is important now and it will be important with the new offence in place that medical advice does not suggest to patients that they drive when doing so would present a significant risk to themselves and the public To do so risks patients being involved in road traffic incidents and also committing the existing offence of driving whilst impaired due to drugs

3) Different to Drink Driving Law

There have been calls for a strict liability approach to drug driving as exists for drink

driving Napp believes this would not be a suitable approach for drug driving based on the

current draft Bill

Alcohol does not have any medical necessity people do not need to consume

alcohol to ensure that a chronic condition does not prevent them from

functioning on a daily basis

Prescription medications that patients may take to treat chronic pain are a

medical necessity and are essential to ensuring that they are able to function on a

daily basis

A strict liability approach could lead to patients not taking essential medication in

order to be able to drive without fear of prosecution

Alternatively patients may choose not to drive at all which could have a serious

impact on their ability to work and go about their daily lives

Questions Is an exemption feasible (If not what is going to be done to ensure that patients are protected)

There are some useful analogies with drink driving law For example prior to the introduction of the specific drink driving offence the law in relation to drink drivers was difficult to enforce The specific offence there has contributed to major improvements in public safety

I do accept one of the differences with some controlled drugs is that some people take them for medicinal not recreational purposes This is not the case for all controlled drugs This may well affect what is included in the regulations for the offence

25

When we met I did say that it is conceivable for even as prevalent a recreational drug as heroin to not be included in the regulations for the offence This might be if it transpired that a limit relevant to heroin had to be set in a metabolite itself used in or a metabolite of a medically prescribed drug If such a limit also then had the effect of criminalising driving with medically supplied controlled drugs when that did not present an elevated risk to public safety I can see it would be a limit we might well not implement However I await the advice of the expert panel to see what it recommends related to heroin and whether (and how) that might affect other opiates

4) Policeable Offence

It is argued that drivers wonrsquot be stopped by police unless they appear impaired BUT

Plans are to test all those involved in a traffic accident for drugs including

innocent parties An innocent unimpaired patient involved in a crash through no

fault of their own could then face serious charges

Impairment is subjective and police may be suspicious of someonersquos driving for a

number of reasons such as driving too cautiously This apparently lsquoimpairedrsquo

driving may be due to various factors unrelated to the driverrsquos use of prescribed

medication but if they are stopped by police they may find themselves facing

serious and unjust charges

The existing impairment offence will remain so police will still be able to catch

those who do drive while impaired by prescription medication

Questions How close is the Home Office to approval of a drug testing device for use in police stations Can you provide any details

The laboratory testing phases of the type approval process is under way and the process is due to be completed at the end of this year

Is the Home Office still aiming for a 2014 approval of a drug testing device for portable use

It is still aiming for 2014 for these devices and we are planning the timing of that process together with the work on the new offence

Since the Governmentrsquos response to the North Review in June 2010 has the drug driving data quality improved

Yes we have received more information from Coroners recently and we also have had the conclusions of the European DRUID research

C Solutions

Napp believes that the best way to protect patients is by introducing an exemption for

those who can demonstrate that they are taking prescription medication

Existing legislation against driving while impaired would allow police to charge

anyone who did drive while under the influence of impairing prescription

medication

26

This would put the burden of proof on prosecutors saving innocent patients

considerable stress inconvenience and wasted CPS and police time

The Department considers that the statutory defence affords appropriate protection to patients who drive after taking prescription medication

The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

D Other Points for Consideration

Napp is keen to support this legislation in its efforts to stop users of illegal drugs

from driving and wishes to support policy development to ensure that patients are

protected Napp would be keen to provide any further information or other

means of assistance that could be of help here

Napp would like to submit written andor oral evidence to the Expert Panelrsquos

inquiry

Napp is concerned about the lack of pain expertise and patient representatives on

the Expert panel

Lord Henley mentioned that a seminar might be held after the summer recess to

discuss the issues arising from this legislation further Napp would be keen to

receive any further information on this

I hope this has been covered satisfactorily in the discussion we had on 31st July and since then

I do consider the legislation has strong safeguards in place for patients The Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

I hope I have addressed at least some of your concerns I should be happy to discuss the issues further

Duncan Price 2882012

27

Note on controlled drugs with medical uses

(i) The reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

(ii) Circumstances in which drug testing can be administered Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under the

influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

(iii) The medical defence The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

(iv) Drugs to be covered by the new offence and any specified limits to be based on expert advice The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

(v) Other controls The content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

(vi) Prosecutions to be in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

(vii) In light of the above the Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

28

From DuncanPricedftgsigovuk Sent 13092012 1603 To xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Cc xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Subject RE NRAS - Crime and Courts Bill clauses on drug driving

Xxxxxx

Below is my draft response to this letter Irsquoll send it when I have your comments about it

Dear xx xxxxxxx

Xxxxxx xxxxxxxx has forwarded your email of 28th August to me I am the lead policy official for the legislative clause about drug impaired driving in the Crime and Courts Bill

I am aware of concerns about innocent motorists taking prescribed medications being stopped tested being taken to police stations having blood samples taken and possibly going to court before being exonerated This is not the intention of the legislation and I can assure you we are mindful of this concern as we progress the legislation and respond to advice from an expert panel about the details

There are several protections in place to reduce the risk of large numbers of innocent motorists being arrested and taken to police stations

Firstly motorists cannot be stopped randomly for drug tests Testing can only be administered in three circumstances ndash namely where a driver has committed a moving traffic offence

a driver has been involved in a road traffic accident and or

there is reason for a police officer to suspect that a person has been driving under the influence of drink or drugs

This means that in practice drivers taking prescribed medicines would not be stopped and required to undergo drug testing without there being real cause for concern Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would be likely to result in disproportionate and large numbers of people prescribed drugs having evidential blood tests but then not being found guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

Fourthly it is important to emphasise that the prosecution for a case where the medical defence has been raised must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code for Crown Prosecutors which contains a requirement about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

Finally in the context of the clause before parliament the content of the regulations (specifying which controlled drugs should be covered by the new offence and the limits to be specified for them) will be the subject of public consultation Before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of

29

Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

I hope that this letter serves to allay concerns about possible unintended consequences for people taking prescription medicines

Duncan Price Tel 020 7944 xxxx Department for Transport

From JessicaMatthewdftgsigovuk Sent 17 October 2012 1108 To xxxxxxxxxxxxadhgsigovuk Cc xxxxxxxxxxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxxxxxdhgsigovuk xxxxxxxxdhgsigovuk Subject Re Department of Health attendance at the Lords briefing for the drug driving legislation

Xxxxxxxx is out of the office today but wersquoll send over the time and venue tomorrow and share the briefing with you Irsquod be happy to brief Dr Prunty beforehand ndash perhaps over the phone

Wersquore planning on a reasonably open debate about the legislation We wonrsquot have got policy clearance on the amendments to the legislation but wersquore inclined to say that the Government is minded to or is considering x y or z

Happy to discuss

Jessica Matthew Deputy Director Road User Licensing Insurance and Safety Tel 020 7944 xxxx Zone 321 Great Minster House 76 Marsham Street London SW1P 4DR

Extract of Briefing shared with DH from the above e-mail

How will you make sure that people taking medication in accordance with their prescription arenrsquot arrested and taken to court as a result of this legislation

The medical defence in the provisions provides substantial and appropriate protection for people taking medically prescribed or supplied controlled drugs It places an evidential burden on a person accused of committing the offence So the accused must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court It is then for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on

It is unlikely that a person taking medication in accordance with their prescription would be taken to court for a number of reasons

30

1 Motorists cannot be stopped randomly for drug tests They can only be tested where They have committed a moving traffic offence They have been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under

the influence of drink or drugs

2 The drugs to be included in the legislation and their limits will be set in regulations The content of the regulations will be the subject of public consultation and an affirmative resolution This will provide an opportunity for any concerns with the proposed specified limits to be raised and carefully considered

3 The expert panel is bearing in mind the normal therapeutic ranges and expected drug concentrations in blood when setting limits for those drugs that may also be used for medicinal purposes This means that only patients on unusually high doses of medication might have a positive screening and proceed to evidential blood test

4 Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any cases before they reach the court Indeed there is a Code for Crown Prosecutors which contains a requirement that prosecutions are in the public interest

From xxxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 29 November 2012 1422 To xxxxxxxdhgsigovuk xxxxxxxxxpsncorguk xxxxxxxxxxxxxtheccaorguk xxxxxxxxxxnpacouk xxxxxxxxxxxxrpharmscom xxxxxxxxxxxsaddactionorguk xxxxxroadsafecom xxxxxxxxxxxxxxxxxxsdrconsortiumorg xxxm-allianceorguk xxxxxxxxxxxturning-pointcouk xxxxxxxxROSPAcom xxxxxxxxxxxxxxxxtheAAcom xxxxxxxxxacpopnnpoliceuk adminactionaddictionorguk xxxxxxxxxageukorguk xxxxxxxxxxxbrakeorguk xxxxxxxxbmaorguk xxxxxxxxxxxbritishpainsocietyorg xxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxcpsgsigovuk xxxxxxxxdrugscopeorguk xxxxxxxxxiamorguk xxxxxxxxxxxxxxlawsocietyorguk xxxxxxxxxxxliberty-human-rightsorguk xxxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxxpactsorguk xxxxxxxxxxparliamentuk xxxxxxxxxxxxRACFoundationorg xxxxxxxxxxdurhamgovuk xxxxxxxxxxxxxxxxPolicyConnectorguk xxxxxxxxxxxxxxpsncorguk xxxxxxxxxxxxxdvlagsigovuk Xxxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxhomeofficegsigovuk xxxxxxxxnpacouk xxxxxxxxxxxxdhgsigovuk xxxxxxxxxdrugscopeorguk Cc xxxxxxxxxxxxxxxxxxxdftgsigovuk JessicaMatthewdftgsigovuk xxxxxxxxxxxxxxxxxxdftgsigovuk Subject Drug driving seminar presentation

Dear all

Many thanks to those of you who were able to attend our Drug Driving Stakeholder Seminar last week

We hope you found as useful as we did

Please find attached a copy of the presentation as promised

Kind regards

Xxxxxx xxxxxxx

31

From xxxxxxxxxxxdftgsigovuk Sent 21 March 2012 1312 To xxxxxxxxxxxxndhgsigovuk Cc xxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxjusticegsigovuk DuncanPricedftgsigovuk xxxxxxxxxxxxscotlandofficegsigovuk xxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxdhgsigovuk xxxxxxxxxxxxdhgsigovuk JeremyMeanmhragsigovuk xxxxxxxxxxxxxjusticegsigovuk xxxxxxxxxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxxxxdftgsigovuk MarkPruntydhgsigovuk xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxdhgsigovuk xxxxxxxxxxxxxjusticegsigovuk Subject xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx

xxxx

Many thanks

1 We are seeking to give effect to North recommendations which is why the proposal refers to controlled drugs Recommendations 12 and 13 and also page 12 of the North Report states ldquoThe third stage involves the introduction of a new specific offence of driving with certain controlled drugs in the blood at or above levels at which those are deemed to be impairingrdquo

2 The creation of the new offence will simply make enforcement easier in respect of certain drugs The existing impairment offence (section 4 RTA) will continue to be used to deal with other drugs An extract from page 13 of the North Report is helpful in explaining the limits of the new offence

ldquoThis stage three regime would provide a means of tackling the major part of our drug driving problem but it would not deal with the vast majority of prescribed and over-the-counter medicines nor would it deal with all controlled drugs or new social drugs and legal substances taken for their impairing effects including so-called lsquolegal highsrsquo It would therefore be necessary to maintain the existing offence of driving while impaired by drugs as a lsquocatch-allrsquo to cover these other substances and instances There should be no statutory defence of having taken a drug in accordance with medical advice in relation to that existing offence just as there is not at presentrdquo

3 Pages 133 ndash 134 of North report (and reflected in the diagram on page 134) attempts to define controlled drugs as those that are not available over the counter without prescription We will consider further what is meant by ldquocontrolled drugsrdquo and will clarify the definition as required

I hope this addresses your concerns

Regards xxxxx xxxxxxx Road User Licensing Insurance and Safety Extension - xxxx

9

From xxxxxxxxxxxdhgsigovuk Sent 03072012 1535 To xxxxxxxxxxxxxxxxxxxdftgsigovuk Cc DuncanPricedftgsigovuk Subject Fw Drug driving - Involving our Senior Medical Officer

xxxxxxxx

I was hoping to discuss this with you over the phone but I understand you are at a meeting till 430pm I am leaving early today so I will have to call you tomorrow However in the mean time Ill put some of my thoughts down in this email to get the ball rolling

As xxx points out in xxx email Mark and xxx come at this policy from two different angles It would be helpful to have Mark on board as an observer as it will help us consider our clinical guidance relating to people in drug treatment and also to raise any additional issues the panel might want to consider relating to this particular client group But Mark will not be bringing the same issues to the table as xxx

xxx can bring the pharmacists perspective to the table I note the Chair refers to pharmacokinetics as already represented However we are referring to something different Pharmacokinetics is about the actions of drugs in the body over time We are talking addressing issues relating to pharmacists who have responsibility for dispensing medication and expertise in the safe and effective use of medication - a different issue altogether I think the language confuses these matters sometimes Pharmacists are the front line if you like where we all get our medication from so it is vital that issues from this side are raised and discussed This is not represented in the panel Many of the contributions we provided to recent DfT documents were put together with this angle in mind It is why xxx attends the policy group as xxx brings the pharmacy aspects to group discussions I hope this provides some further detail for us to discuss tomorrow

Kind regards

xxxxxx xxxxxx xxxxxx xxxxxxx xxxxx Department of Health xxxx xxx Wellington House 133-155 Waterloo Road London SE1 8UG 0207 972 xxxx

10

From xxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 03072012 1732 To MarkPruntydhgsigovuk xxxxxxxxxxxxdhgsigovuk Cc DuncanPricedftgsigovuk Subject RE Drug driving - Involving our Senior Medical Officer

Dear Mark

I think xxx is very happy for you to join this group and would in fact value your expertise more than that of xx xxxxxx xxxxxxx xxx has spoken to xxx and has agreed for xxx to join the panel simply to accommodate DoHrsquos wishes xxx has not seen that xxx would make a valuable addition to the panel and felt that xxx was indeed slightly confused about why xxx should be involved

Now that DoH colleague have put forward your name xxx would like to get you on board The membership and ToR of the panel are in the public domain so it is problematic to keep adding new members

As xxx xxxxxxxx has not formally been included in the panel we feel that it would be easiest to speak to xxx xxxxxxxx and explain to xxx why we can no longer accommodate xxx Instead you could join the panel as an observer

To pick up on xxxxxx points below the focus of the new law is controlled drugs that are illicit and there is a statutory defence for those taking controlled drugs in line with directions see below

(3) It is a defence for a person (ldquoDrdquo) charged with an offence under this section to show thatmdash

(a) the specified controlled drug had been prescribed or supplied to D for medical or dental purposes

(b) D took the drug in accordance with any directions given by the person by whom the drug was prescribed or supplied and with any accompanying instructions (so far as consistent with any such directions) given by the manufacturer or distributor of the drug and

Thanks xxxxxxxx

xxxxxxx xxxxxxxxxxxxx Roads Strategic Projects Roads Directorate Domestic 020 7944 xxxx

11

Working Group on Drug Driving ndash note of 20 July 2012 meeting

Attendees Duncan Price (DfT) Xxxxxxx xxxxxxxxxxxxx (DfT) Xxxx xxxxxxxxxxxx (DoH) Xxx xxxx (DoH) Xxxxxxx xxxxx (HO) xxxxxxxxxxxxxxxxx (HO) xxxxxx xxxx (MoJ)

Duncan Price provided an update on the Lords Committee stage and summarised the amendments tabled Key issues were controlled drugs used for clinical purposes and concerns about zero-tolerance levels A Hansard link had been circulated Duncan Price xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxx The report stage was likely to be around 7 November

Duncan Price informed the group that the drug driving panelrsquos xxxx xxx xxxxx would be briefing interested members of the House of Lords on 24 October about the panelrsquos work Xxxx xxxxxxxxx asked to be invited to that briefing

Duncan Price set out the high level timeline for the introduction of the new offence The Bill would go to the Commons either before or after Christmas The specification for mobile drug screening devices would be informed by the expert panelrsquos recommendations for the types of drugs and limits to be covered by the offence The type approval process for those devices could then run in parallel with the public consultation on the draft regulations The new offence could then commence in around the middle of 2014

It was agreed that work on the next stage impact assessment would be taking forward in close collaboration with the MoJ Home Office and DoH

12

Working Group on Drug Driving ndash draft note of 17 August 2012 meeting

Attendees Xxxx xxxxxxxxxxx (DoH) Xxx xxxx (DoH) Xxxxxx xxxxxx (HO) Xxxxxxxx xxxxxxxx (HO) Xxxxxxxxxx xxxx (HO) Xxxxx xxxxxx (MoJ for xxxxxx xxxx) Duncan Price (DfT) Xxxxxxx xxxxxxxxxxxx (DfT) Xxxxxxx xxxxx (DfT)

Duncan Price explained that the CPS and ACPO were being consulted about a possible change in the legislation to accept blood only evidential samples and not urine (which was not reliable to detect all drugs) or saliva or sweat Saliva and sweat if included would have to be as a theoretical future option until effective testing could be established (HO and DH agreed to approach contacts in Australia Belgium and US for data)

The Explanatory Note has now had comments from DfT legal Duncan Price will send out a redrafted version to the group for further comments

Discussions were still ongoing as to whether it would be possible to specify measurable levels in blood for all the controlled drugs of interest or whether provision should be made to enable levels to be specified in metabolites (provided these can be specifically related back to a controlled drug) Likewise consideration was being given for variable limits (dependent on alcohol levels) (Note the expert panelrsquos meeting of 21st August suggested a specified limit in a metabolite (itself not a controlled drug) might be appropriate in respect of cocaine rather than the drug itself)

Duncan Price suggested that the amendments made at Lords Committee stage related to medicinal uses of drugs would be problematic He was continuing to consider whether and how the panelrsquos emerging conclusions or policy assurances would be relevant to concerns expressed including in the NAPP briefing paper He had also met with representatives of NAPP and they had put some experts in touch with the expert panelrsquos chair

DfT will provide an update on drug driving to the 11th October ACMD Council meeting Jeremy Mean will need to advise when the MHRA could be updated

The group suggested an update should be provided for the 7 November Inter-ministerial group on drugs

Duncan Price also promised to send the group a first draft of ldquoEnforcement Procedures against Drink Drivers and Other Offenders ndash A Consultation Documentrdquo (Proposed Changes in Legislation for Testing Procedures for Drink and Drug Driving and in Other Transport Sectors and for Remedial Training for Road Traffic Offenders) This document covers the legislative changes contained in the Governmentrsquos response to the North review (other than the new drug driving offence)

[Post meeting note this document was sent on 21 August with initial comments requested by 31 August]

13

From DuncanPricedftgsigovuk Sent 30082012 1450 To xxxxxxxxxxxdhgsigovuk Cc xxxxxxxxxxxxxxxxxdftgsigovuk Subject Fw Meeting with Napp Pharmaceuticals

xxxxxxx

I attach in respect to briefing for Ann Miltonrsquos planned meeting with NAPP on 23rd October the following

- a note of NAPPrsquos key concerns (as they drafted them) plus my response - a letter Earl Atlee to NAPP - the draft sent to Lord Henleyrsquos office for signature to Lord Luce about similar issues - the note of the meeting NAPP had with me (it is NAPPrsquos note with my comments) - an internal note about controlled drugs for medical uses

The notes we did on the amendments made at Committee stage for Ministers cover some of the NAPP issues but I havenrsquot enclosed them as I have sent quite a lot already ndash but yoursquore welcome to a copy if you want one

Duncan Price Tel 020 7944 2241 Department for Transport

Note of the Meeting

Napp Pharmaceuticals and Department for Transport Meeting on Drug Driving 31 July 2012

Attendees Duncan Price Deputy Director Road User Licensing Insurance amp Safety (DP) Xxx xxxxxxxx Department for Transport Xxxxxx xxxxx Napp Pharmaceuticals Xxxxxx xxxxxxxxxxxxx Napp Pharmaceuticals Xxx xxxxxx Napp Pharmaceuticals Xxxx xxxxxx Ranelagh International Xxxxxxx xxxxxx Ranelagh International (RB)

Xxx began the meeting by providing a brief background on Napp xx noted that the company has been in Cambridge for thirty years and is well-known for its range of pain medications and in particular strong opioids Napp has helped to revolutionise the management of cancer and chronic pain through the development of various slow release and round the clock formulations Now the company is also moving into respiratory medicine and other areas It employs approximately 1100 people and is fifteenth in terms of GP prescription sales Xxx noted that Napp is interested in drug driving because of the impact legislation may have on patients

14

DP said that he is leading on drug driving policy and that the legislation currently going through Parliament is one of three pieces of work the Department is taking forward together The current proposals are enabling legislation which will allow the Government to determine the details critical to the new offence once the Expert Panel has published its recommendations DP suggested that the Expert Panelrsquos interim advice would be available in October

Xx noted that Napp is fully in support of the legislation and what it is trying to achieve but there are a few unintended consequences that it may cause for both manufacturers and patients Xx raised concerns about the impact on legitimate patients on a stable dose of medication that may be affected by legislation designed to target those who abuse illegal and legal drugs Xx added that Napp is in contact with a number of clinicians and other experts who would be happy to feed in to this policy development

Xx raised the issue of patients who are unimpaired being criminalised and facing a significant burden of proof if the proposed legislation is passed As the legislation is currently proposed there is a defence for patients taking prescription medication but the burden is first with them to prove that they have taken their medication is accordance with all instructions including from manufacturers There is a significant onus on patients to show they are not impaired despite what police say The defence is really only available once the driver is in court

Xx then compared the proposed legislation to the drink driving laws and highlighted the differences to drug driving legislation and the issue of strict liability Could the legislation be more focussed on its intended aim and tailor the list of controlled substances to those known to be abused as opposed to a catch all approach There needs to be protection for patients but at the moment the legislation appears to be trying to do both

Xx also noted the importance of ensuring that this is a policeable offence In the Governmentrsquos response to the North Review there was discussion of the Australian approach to drug driving Police found the impairment side of legislation hard to prove so they have instead just used the strict liability approach to prosecute drivers based on detection of a controlled substance

DP noted that all of the issues raised by xx are important What is being discussed in Parliament at the moment is enabling legislation which is setting out the framework The detail will become clearer once the interim advice from the Expert Panel has been received which is due in October The Department has already started to give some assurances in certain areas for example a zero tolerance approach for cannabis has been ruled out They will be able to home in as more advice is received from the Panel although it is not possible to pin the Panel down until it has reported DP added that there will be informed discussions with peers in late October before the legislation goes to Report Stage

Xx asked if the Panelrsquos advice will have any influence on the current draft Bill Xx asked if it would be worth making the primary legislation more focussed for example on substances known to be abused which would allow for strict liability The problem for patients would then become irrelevant as they would not be the focus of the legislation Xx also noted the problem that will arise from including heroin on the list of controlled substances Heroin metabolises into morphine in the blood as do some over-the-counter medications which makes it hard to distinguish between the different drug types This will lead to unintended consequences for patients

15

DP stated that he understood this argument but noted that the legislation is intended to be fit for purpose to allow for the whole range of potential decisions the Panel could make The decision might be made to change the substances on the controlled list although nothing so far has led him to think something should change The current list links back to the range included in the Misuse of Drugs Act The advice on the drugs will feed into the consultation and the subsequent affirmative procedure

DP added that because of the enabling nature of the current legislation there are some problems for example legal highs are not included on the list of controlled substances at the moment Due to the nature of the legislative procedure it can take a while to identify a problem and then legislate to give police powers They expect legal highs can become controlled drugs if they have protracted and serious consequences in a quicker time than the duration of the regulation-making process for drug driving There are powers to apply the legislation to all controlled drugs but they will need to go through it controlled drug by controlled drug in order to determine specific limits etc The Government envisages a mixed economy of the new and the existing offence

DP said that heroin is one drug of significant interest as it is known to be prevalent and associated with road safety risks The Panel are looking at opiates as a group of drugs and it will be for the Panel to decide how it can be detected He noted that they will need to consider all potential effects before setting any levels DP said that he knows that this is an area of importance for Napp as their patients will have a tolerance which is highly relevant to these considerations He would expect the Panel to look at that The Department wants the Panel to look at the opiate family so they do not only consider heroin

Xx said that the higher level of metabolites is an issue but these patients will be unimpaired where as a heroin user trying to get high is very different In terms of the defence the burden of proof lies on the shoulders of the patient Has the Department considered eliminating the impairment element and introducing an exemption for patients

DP responded that they have been considering all areas when looking at the medical defence Drink heroin and medically prescribed opiates have some similarities and also some important differences With alcohol some people who are over the limit will say they are unimpaired but the risks do increase as blood alcohol levels increase This can be the same with drugs

Xx noted that when a patient is on a steady dose of medication the pain they would be under if they were to stop taking their medication could be more impairing

DP said that he recognises the differences to drink driving Heroin users and medication users have different tolerances to ordinary people and the lsquodrink driving analogy is limitedrsquo Drinking has social benefits and it is a choice for people

Xx added that Napp sees that there is a desire to make drug like drink driving something that society will not tolerate but patients have to take their medication There is existing legislation against impairment for those who are irresponsible when taking their medication At the moment patients are being brought down to the lowest common denominator of those who abuse drugs This minority is causing problems for everyone else

16

Xxx noted that unlike with drink driving where increased alcohol leads to increased impairment there is not increased impairment with a high but stable dose of prescription medication Xx added that he believes there is a Swedish study which has investigated levels of impairment in patients

DP stated that although the opiate family is being considered together at the moment if it is not possible to distinguish between heroin and other opiates then it is open for the Department to decide whether or not to include morphine in the legislation They could decide that the disbenefits of including it would outweigh the benefits

He noted that the reason medications remain included is that there are problems with abuse for example with Benzodiazepines which are known to cause road safety problems Just because a controlled drug can be prescribed does not mean it will be removed from the legislation There will be a differentiation between a medical level at which someone must not drive and where they should not drive

Xx noted that Napp wants to work with the Government so that morphine can be included in the list of controlled substances By introducing an exemption or at least taking the burden of proof off the patient this could be done

DP said that the offence has a wide remit and there is a defence where they would like to include taking medication in accordance with medical advice There is a strong burden of proof on the prosecution to put evidence to the courts

Xx noted that the patient has to substantiate the proof first Xx added that patients already have a poor quality of life and this puts them under more stress Xxx said that pain is costing the country pound13bn a year and the Government has only recently decided to deem pain a long term condition and to work to help people have a good quality of life This seems like a backward step Doctors have been campaigning for years to get pain recognised and this is therefore a concern for them too as it may interfere with their choice of treatments

Xx said that with a few tweaks to the legislation the burden of proof could be placed on the prosecution For example by adding the word lsquoknowinglyrsquo to protect patients who were unaware of any advice against driving This would reassure them that a prescription will mean that they are protected Xx added that xxx has already had patient groups coming to her who are concerned that they are going to have to fight again

Xx noted that there is the issue of the lsquoknock onrsquo impact of one case highlighted by the media which could lead to patients becoming more cautious about taking their medication

DP said that he thought the Panel was unlikely to recommend low threshold levels He said that they have looked at the amendments tabled and they had material prepared for the Committee Stage of the legislation which was not needed and will be used to inform the informal discussion among peers in October He added that he feels the burden of proof leans towards the prosecution Once the prescription is presented it is down to the prosecution to prove beyond reasonable doubt that the medication was not taken properly For example one way would be if they can show that the blood level of a drug was in excess of the level prescribed

17

Xx raised concerns that cautious drivers may be wrongly pulled over by police and that it will be difficult for them to prove that they were unimpaired DP said that there are a swathe of issues about how far along the process people will be taken The balance is broadly right in the defence and if a case did go to court it would be resolved in the right way

DP noted that he is aware of the problems with testing procedures and that it is a genuinely difficult area Xx added that there are also concerns about those involved in a car crash and the insurance implications for a patient if they are the innocent party but test positively for drugs

DP said that is the situation already with the existing law and that there is currently a big drop off of cases before they reach the courts let alone conviction This is partly why the new offence is needed to target illegal drug users This issue is already there Xx acknowledged this but noted that the risk for patients would be heightened and that legislation designed to give police powers to stop drug abusers from driving should not spill over to impact on patients and make them worry about driving

Xx noted xxxx xxxxx xxxxx recent lsquoFit for Workrsquo report which showed that the main problem for the workforce is low back pain therefore many more people could be forced to stop work if they felt that by taking their medication it could mean that they are not deemed fit to drive

It was also noted that in the first stages of pain patients will seek pharmacist advice and use low doses of codeine to manage their pain There are 8m Osteoarthritis sufferers in the UK and over 70 report that they are in constant pain They typically start with over-the-counter medication including NSAIDS and codeine such as Nurofen Plus They will not have a prescription so how will they fare under the legislation

DP stated that this is partly an issue for the Panel He said he hoped that there is a good swathe of people on the Panel and asked if there is anything that Napp would like to submit to them Xx said there would be and that xxx would liaise with him on behalf of NAPP and feed in any information that would be considered helpful

Xxx noted that there are some concerns about the lack of medicalpainpatient representation on the Panel and that if these groups could feed in to the Panel that would help alleviate some concerns

DP said that the Panel is bringing in materials from other experts and that subject to his clearing it with the Chair they would be very keen to see papers etc The Panel would like to see as much research as possible Although they do not meet on policy there have been a number of issues related to the science of opioids that are of interest Xx asked if it would be helpful to also send the Panel a paper from Napp on where they believe legislation contains areas of risk and burden for patients to make the Panel aware of not only where the legislation can work but also where it could go wrong Xx asked if a pain expert could feed that in DP said case studies on the impact on patients would be helpful but there should be a focus on the science The legal aspects will not concern the Panel They should be happy to receive papers although he will have to talk to the Chair about having any experts appear in front of the Panel Xx assured DP that this would be done if the Chair was in agreement

18

Xx asked for some detail on the practical process of the Panelrsquos work Is the October report interim or final

DP said that it will be an interim report as there may be more work to do afterwards but that it is hoped and expected that the report will cover all the major drug types in the terms of reference They will use the findings across Government and then the decision will be made to move to the consultation The findings will also be communicated to the Committee on the Misuse of Drugs and the MRHA Secretariat representatives from both have been at Panel meetings

The secondary legislation will be in effect from early 2014 The plan is to consult on it in early 2013 and then progress through affirmative procedure in the later part of 2013 It will allow for the possible subsequent inclusion of other drugs

Xx asked about the development of testing devices and their specificity DP said that he is not a technical authority about the machines but does have information on the approval process A decision will be made at the end of the year on those currently going through police stations There will also be the beginning of the process to develop the second generation of roadside testing but the specifications cannot be finalised until the Panel reports These will be threshold detectors not just presentabsent detectors They will cover something related to heroin Legislation has been drafted so that police can undertake multiple preliminary tests as all drugs cannot be tested for at the same time The technology is important as an offence without it would not have the impact hoped for

DP added that other countries have a zero tolerance approach with presentabsent tests but that they want a threshold approach here He said that the legislation is linked to road safety it is not intended to change the law on possession use of drugs It is about public safety The existing penalty regime is not suitable for a zero tolerance approach At the moment crossing the limit means a 12 month driving ban and other consequences which is different to abroad The reason the drink drive limit has not been reduced is because the Government does not want to create a two tier system where the lower limit becomes seen as only equivalent to being given a speeding ticket The penalty for drug driving needs to allow for a more proportionate approach to enforcement At the moment if you are well versed in the law you have a good chance of evading conviction They want to change the balance and do not want to lower the penalty in comparison to drink driving He added that problems with some detection equipment abroad would not be acceptable in the UK legal system especially evidential saliva sampling The technology appears not there yet

DP noted that the Department is also looking at appropriate policy statements to make about the legislation The press has already focussed on areas where the new offence wonrsquot be an impact Xxx said that policy statements would help those patients who are already concerned

DP asked if Napprsquos patients receive unequivocal advice that they can drive Xx said not necessarily The issue is patients do not read advice and if they did they would not necessarily fully understand it It comes down to what the Doctor says but this legislation could then put them in a difficult position too Xx noted that the advice to patients in leaflets for medication regardless of whether they are prescription only medicines or over the counter would have a statement that would alert the patient to potential drowsiness or tiredness and advise that if this symptom was experienced patients should not drive or operate machinery This would be the same advice that clinicians would give to patients

19

about their medication unless as with certain drugs the DVLA should be notified and patients specifically informed that they must not drive whilst taking this medication The onus is on the patient to determine if they have this side effect and to what extent they are impaired DP noted that there is a difference between advice that a patient cannot drive and being told not to drive if they feel drowsy Xxx added that patients on a stable dose will be unsure if they can continue to work have a good quality of life etc and this will lead them to question whether or not to take their medication

DP stated that the Government can provide the context on what they think directions are but this will still be interpreted by a court Xx said publishing that information would provide comfort to patients who are concerned DP said this would be discussed with peers as well

Xx asked who will be invited to the informal discussion with peers and MPs DP said it would be just members of the House of Lords and Commons They will be able to meet with the Panel and other Government experts Xx noted that this would be useful for peers as those Napp has spoken to have had answers to initial questions but there are still areas where they would like some clarification DP noted that he and the Lords Spokesperson met with interested peers in advance of the Committee Stage It is easier to provide more factual clarification informally than on the floor of the House and Spokespeople will value the chance to make some progress before the Report Stage

Xx confirmed that Napp would put together some helpful information for DP to pass on to the Panel and will bring in some experts to feed in to that Xx added that Napp would be happy to feed in to any policy statements etc DP said he would be happy to clarify any issues in writing Xx said Napp would put together a list of questions for DP for this Xx said xxx would involve patient groups here too

Xx asked if there has been any input in the policy from the Department for Health DP said that a quadrilateral working group from Transport Justice Home and Health are working on the policy They have met between Panel meetings to see what is said and if there are any issues to put to the Panel

Xx asked if there is anything else Napp can do DP said that the more specific Napp can be about concerns evidence on the effect of treatments on impairment etc that would be helpful The policy is very much at the evidence gathering stage at the moment

Xx reiterated Napprsquos concerns regarding the Panel membership

DP said that at some point he expected tough decisions will be made about the balance of the proscons of the policy issues No solution will tick every box

Xx said that policy statements will be key to giving the police and the CPS guidance on who they are targeting as well as what lsquodirectionsrsquo mean to allay the fears of patients and clinicians DP said he hoped they would be able to allay fears He added that there is no advantage for the police to have lots of people in stations and being processed who are not impaired There is a realistic policy possibility that heroin will have to be set aside Just because the Panel is looking at it does not mean there is a commitment that it will be in the new offence They know that there may be no test to distinguish between different types of opiates

20

Xxx passed on two emails which he explained were from xx xxxxxxx xxxxxxx and xx xxxxxx xxxxxxxxn representing the views of CPPC and RCGP respectively Both Doctors expressed their concerns for patients and offered to contribute to discussions on the proposed legislation

A Note of Napprsquos Key Concerns

Napp Pharmaceuticals Meeting with Department for Transport 31 July 2012

Note I have added in bold italicised text some DfT responses to the questions in your original note which is otherwise as you sent me ndash Duncan Price 2882012

A Statement of support for drug driving legislation to stop people from driving while under the

influence of illegal drugs

Napp is concerned about the unintended consequences of the legislation on patients taking

long‐term medication for chronic pain Napp wants to work with the Government to find a

solution

1) Impact on Patients

2) Criminalisation of Patients

3) Different to Drink Driving Law

4) Policeable Offence

B Outline of Concerns

1) Impact on Patients

Evidence shows that patients on a stable dose of opioid analgesics are not necessarily

impaired but under the proposed system patients may be inaccurately identified as taking

impairing drugs and face prosecution

Patients well established on a stable dose of an opioid analgesic may have levels of

metabolites in their system well above any threshold used for roadside and police station

testing This means they could face serious charges despite driving unimpaired

There are concerns for patients such as those with Osteoarthritis the majority of who use

over the counter medications to manage their pain

Concern that patients will stop taking their medication so that they can drive This may

make their driving more impaired as a result of the pain that they will be under

Questions

Has there been consideration of how to distinguish between opiates that are used legally

for medicinal purposes and those used illegally (Napp would be happy to share clinical

knowledge of opioids that may be helpful to the panel and to any other interested parties

in Government)

The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

21

The panel is considering natural and synthetic opioids Its terms of reference include that it should establish the likelihood of whether concentrations of drugs broadly equivalent in their impairment effects to blood alcohol concentrations of 20 50 and 80mg100ml would be exceeded This will include a consideration of prescribed or otherwise legally obtained drugs which are known to impair driving

The panel will advise the Government which will then itself consider what specified limits to propose and then consult about I can assure you that in doing so it will consider how screening equipment and evidential blood specimens would distinguish between opiates used for legitimate medical purposes and those used illicitly

I am grateful for the offer of sharing clinical knowledge you made when we met I know the panel has since considered some of the evidence your experts have provided and some of its members have met an expert you recommended and one of your legal advisors

Has there been consideration of just introducing a list of restricted drugs known to be used

recreationally as with the Australian model

The list of restricted drugs used in some states in Australia does include THC (the active ingredient of cannabis) which does have some limited medical uses here The Governmentrsquos prime targets for this legislation are controlled drugs often or exclusively used illicitly including those included in the Australian legislation (THC amphetamines and MDMA)

At this stage we are awaiting advice from the panel but the Governmentrsquos position is that it should develop a new offence with the potential to include a number of categories of drug including benzodiazepines and opiates The abuse including the use of high quantities of methadone and some benzodiazepines (which can be prescribed) appears (alongside heroin) to be a significant contributor to the public safety problems this legislation is addressing

Many of the drugs specifically identified in the panelrsquos terms of reference are used exclusively or predominantly illicitly ndash for example amphetamine-types cannabinoids cocaine and hallucinogens

There is a reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

22

We are therefore using the definition of lsquocontrolled drugrsquo in the Misuse of Drugs Act 1971 within the new offence although which controlled drugs will be determined when regulations are brought forward

What consideration have you given to the issue of patients who drive unimpaired but will

still face prosecution if tested as levels of metabolites in their system may be above any

prescribed limit

This is being considered in both the terms of reference for the technical panelrsquos advice about the setting of specified limits (to keep patients out of the scope of the offence) and the inclusion of the medical defence within the offence

The panel has also been asked to consider the degree of variability in impairment effects across the population including for habitual drug users

In the terms of reference for the panel we have also specifically included the following from the North review (paragraph 743)

ldquoSome drugs which may be proscribed for driving might also be used legitimately in accordance with medical advice (for example morphine may be prescribed for chronic pain or diazepam (a benzodiazepine) may be prescribed for anxiety) Indeed the Review recognises that in some circumstances it may be more dangerous for a person to drive having not taken their medically prescribed drug than driving without having taken it Drugs have different effects on different people and levels at which they are prescribed are likely to reflect this It would clearly be wrong to put in jeopardy of prosecution those who are properly and safely taking medically prescribed drugs and driving in accordance with medical advice for whom despite the presence of a proscribed drug there is no evidence of any driving impairmentrdquo

I should also emphasise that the content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

2) Criminalisation of Patients

Statutory defence is included in the current legislation for those who have taken

prescription medication in accordance with prescribersupplier instructions and any

accompanying instructions from the manufacturer BUT

Only applicable after patient has been arrested further tested and their case has

progressed ndash this will cause innocent patients significant stress and

inconvenience

The defence puts the burden of proof on patients to prove that they acted in

accordance with all medical advice when the burden should be on the

prosecution to prove that they didnrsquot

23

Innocent patients may face criminalisation based on a technicality in legislation

that is not intended to target them

Questions

Is an exemption feasible (If not what is going to be done to ensure that patients are

protected)

I do not consider an exemption from the offence for all controlled drugs that can possibly be supplied or used for medical reasons is feasible Many controlled drugs for example cannabis have some medicinal uses

It is perfectly feasible for decisions about which controlled drugs would be specified for the new offence to be influenced by the reasons for whether their use is often always seldom or never for medical reasons Indeed such distinctions would be vital if this legislation were being introduced to enforce further against the illegal supply or use of controlled drugs

Whether that is the right approach to decision-making related to driving with controlled drugs in the body where there are levels associated with elevated risks to public safety is however questionable This legislation is being introduced to address road safety problems and the expert panelrsquos terms of reference are focussed on providing advice about the risks of driving after taking controlled drugs

It is to no-onesrsquo benefit for patients who are innocent of the offence to be arrested and tested There are several protections in place to reduce these risks Firstly police do not have random testing powers for drink and drug driving Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving

under the influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would result in disproportionate and large numbers of patients having evidential blood tests but then being not guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

24

It is important to note that the prosecution for a case where a defence has been raised that a patient had taken a controlled drug in accordance with medical advice must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code Test about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

It is important now and it will be important with the new offence in place that medical advice does not suggest to patients that they drive when doing so would present a significant risk to themselves and the public To do so risks patients being involved in road traffic incidents and also committing the existing offence of driving whilst impaired due to drugs

3) Different to Drink Driving Law

There have been calls for a strict liability approach to drug driving as exists for drink

driving Napp believes this would not be a suitable approach for drug driving based on the

current draft Bill

Alcohol does not have any medical necessity people do not need to consume

alcohol to ensure that a chronic condition does not prevent them from

functioning on a daily basis

Prescription medications that patients may take to treat chronic pain are a

medical necessity and are essential to ensuring that they are able to function on a

daily basis

A strict liability approach could lead to patients not taking essential medication in

order to be able to drive without fear of prosecution

Alternatively patients may choose not to drive at all which could have a serious

impact on their ability to work and go about their daily lives

Questions Is an exemption feasible (If not what is going to be done to ensure that patients are protected)

There are some useful analogies with drink driving law For example prior to the introduction of the specific drink driving offence the law in relation to drink drivers was difficult to enforce The specific offence there has contributed to major improvements in public safety

I do accept one of the differences with some controlled drugs is that some people take them for medicinal not recreational purposes This is not the case for all controlled drugs This may well affect what is included in the regulations for the offence

25

When we met I did say that it is conceivable for even as prevalent a recreational drug as heroin to not be included in the regulations for the offence This might be if it transpired that a limit relevant to heroin had to be set in a metabolite itself used in or a metabolite of a medically prescribed drug If such a limit also then had the effect of criminalising driving with medically supplied controlled drugs when that did not present an elevated risk to public safety I can see it would be a limit we might well not implement However I await the advice of the expert panel to see what it recommends related to heroin and whether (and how) that might affect other opiates

4) Policeable Offence

It is argued that drivers wonrsquot be stopped by police unless they appear impaired BUT

Plans are to test all those involved in a traffic accident for drugs including

innocent parties An innocent unimpaired patient involved in a crash through no

fault of their own could then face serious charges

Impairment is subjective and police may be suspicious of someonersquos driving for a

number of reasons such as driving too cautiously This apparently lsquoimpairedrsquo

driving may be due to various factors unrelated to the driverrsquos use of prescribed

medication but if they are stopped by police they may find themselves facing

serious and unjust charges

The existing impairment offence will remain so police will still be able to catch

those who do drive while impaired by prescription medication

Questions How close is the Home Office to approval of a drug testing device for use in police stations Can you provide any details

The laboratory testing phases of the type approval process is under way and the process is due to be completed at the end of this year

Is the Home Office still aiming for a 2014 approval of a drug testing device for portable use

It is still aiming for 2014 for these devices and we are planning the timing of that process together with the work on the new offence

Since the Governmentrsquos response to the North Review in June 2010 has the drug driving data quality improved

Yes we have received more information from Coroners recently and we also have had the conclusions of the European DRUID research

C Solutions

Napp believes that the best way to protect patients is by introducing an exemption for

those who can demonstrate that they are taking prescription medication

Existing legislation against driving while impaired would allow police to charge

anyone who did drive while under the influence of impairing prescription

medication

26

This would put the burden of proof on prosecutors saving innocent patients

considerable stress inconvenience and wasted CPS and police time

The Department considers that the statutory defence affords appropriate protection to patients who drive after taking prescription medication

The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

D Other Points for Consideration

Napp is keen to support this legislation in its efforts to stop users of illegal drugs

from driving and wishes to support policy development to ensure that patients are

protected Napp would be keen to provide any further information or other

means of assistance that could be of help here

Napp would like to submit written andor oral evidence to the Expert Panelrsquos

inquiry

Napp is concerned about the lack of pain expertise and patient representatives on

the Expert panel

Lord Henley mentioned that a seminar might be held after the summer recess to

discuss the issues arising from this legislation further Napp would be keen to

receive any further information on this

I hope this has been covered satisfactorily in the discussion we had on 31st July and since then

I do consider the legislation has strong safeguards in place for patients The Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

I hope I have addressed at least some of your concerns I should be happy to discuss the issues further

Duncan Price 2882012

27

Note on controlled drugs with medical uses

(i) The reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

(ii) Circumstances in which drug testing can be administered Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under the

influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

(iii) The medical defence The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

(iv) Drugs to be covered by the new offence and any specified limits to be based on expert advice The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

(v) Other controls The content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

(vi) Prosecutions to be in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

(vii) In light of the above the Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

28

From DuncanPricedftgsigovuk Sent 13092012 1603 To xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Cc xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Subject RE NRAS - Crime and Courts Bill clauses on drug driving

Xxxxxx

Below is my draft response to this letter Irsquoll send it when I have your comments about it

Dear xx xxxxxxx

Xxxxxx xxxxxxxx has forwarded your email of 28th August to me I am the lead policy official for the legislative clause about drug impaired driving in the Crime and Courts Bill

I am aware of concerns about innocent motorists taking prescribed medications being stopped tested being taken to police stations having blood samples taken and possibly going to court before being exonerated This is not the intention of the legislation and I can assure you we are mindful of this concern as we progress the legislation and respond to advice from an expert panel about the details

There are several protections in place to reduce the risk of large numbers of innocent motorists being arrested and taken to police stations

Firstly motorists cannot be stopped randomly for drug tests Testing can only be administered in three circumstances ndash namely where a driver has committed a moving traffic offence

a driver has been involved in a road traffic accident and or

there is reason for a police officer to suspect that a person has been driving under the influence of drink or drugs

This means that in practice drivers taking prescribed medicines would not be stopped and required to undergo drug testing without there being real cause for concern Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would be likely to result in disproportionate and large numbers of people prescribed drugs having evidential blood tests but then not being found guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

Fourthly it is important to emphasise that the prosecution for a case where the medical defence has been raised must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code for Crown Prosecutors which contains a requirement about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

Finally in the context of the clause before parliament the content of the regulations (specifying which controlled drugs should be covered by the new offence and the limits to be specified for them) will be the subject of public consultation Before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of

29

Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

I hope that this letter serves to allay concerns about possible unintended consequences for people taking prescription medicines

Duncan Price Tel 020 7944 xxxx Department for Transport

From JessicaMatthewdftgsigovuk Sent 17 October 2012 1108 To xxxxxxxxxxxxadhgsigovuk Cc xxxxxxxxxxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxxxxxdhgsigovuk xxxxxxxxdhgsigovuk Subject Re Department of Health attendance at the Lords briefing for the drug driving legislation

Xxxxxxxx is out of the office today but wersquoll send over the time and venue tomorrow and share the briefing with you Irsquod be happy to brief Dr Prunty beforehand ndash perhaps over the phone

Wersquore planning on a reasonably open debate about the legislation We wonrsquot have got policy clearance on the amendments to the legislation but wersquore inclined to say that the Government is minded to or is considering x y or z

Happy to discuss

Jessica Matthew Deputy Director Road User Licensing Insurance and Safety Tel 020 7944 xxxx Zone 321 Great Minster House 76 Marsham Street London SW1P 4DR

Extract of Briefing shared with DH from the above e-mail

How will you make sure that people taking medication in accordance with their prescription arenrsquot arrested and taken to court as a result of this legislation

The medical defence in the provisions provides substantial and appropriate protection for people taking medically prescribed or supplied controlled drugs It places an evidential burden on a person accused of committing the offence So the accused must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court It is then for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on

It is unlikely that a person taking medication in accordance with their prescription would be taken to court for a number of reasons

30

1 Motorists cannot be stopped randomly for drug tests They can only be tested where They have committed a moving traffic offence They have been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under

the influence of drink or drugs

2 The drugs to be included in the legislation and their limits will be set in regulations The content of the regulations will be the subject of public consultation and an affirmative resolution This will provide an opportunity for any concerns with the proposed specified limits to be raised and carefully considered

3 The expert panel is bearing in mind the normal therapeutic ranges and expected drug concentrations in blood when setting limits for those drugs that may also be used for medicinal purposes This means that only patients on unusually high doses of medication might have a positive screening and proceed to evidential blood test

4 Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any cases before they reach the court Indeed there is a Code for Crown Prosecutors which contains a requirement that prosecutions are in the public interest

From xxxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 29 November 2012 1422 To xxxxxxxdhgsigovuk xxxxxxxxxpsncorguk xxxxxxxxxxxxxtheccaorguk xxxxxxxxxxnpacouk xxxxxxxxxxxxrpharmscom xxxxxxxxxxxsaddactionorguk xxxxxroadsafecom xxxxxxxxxxxxxxxxxxsdrconsortiumorg xxxm-allianceorguk xxxxxxxxxxxturning-pointcouk xxxxxxxxROSPAcom xxxxxxxxxxxxxxxxtheAAcom xxxxxxxxxacpopnnpoliceuk adminactionaddictionorguk xxxxxxxxxageukorguk xxxxxxxxxxxbrakeorguk xxxxxxxxbmaorguk xxxxxxxxxxxbritishpainsocietyorg xxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxcpsgsigovuk xxxxxxxxdrugscopeorguk xxxxxxxxxiamorguk xxxxxxxxxxxxxxlawsocietyorguk xxxxxxxxxxxliberty-human-rightsorguk xxxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxxpactsorguk xxxxxxxxxxparliamentuk xxxxxxxxxxxxRACFoundationorg xxxxxxxxxxdurhamgovuk xxxxxxxxxxxxxxxxPolicyConnectorguk xxxxxxxxxxxxxxpsncorguk xxxxxxxxxxxxxdvlagsigovuk Xxxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxhomeofficegsigovuk xxxxxxxxnpacouk xxxxxxxxxxxxdhgsigovuk xxxxxxxxxdrugscopeorguk Cc xxxxxxxxxxxxxxxxxxxdftgsigovuk JessicaMatthewdftgsigovuk xxxxxxxxxxxxxxxxxxdftgsigovuk Subject Drug driving seminar presentation

Dear all

Many thanks to those of you who were able to attend our Drug Driving Stakeholder Seminar last week

We hope you found as useful as we did

Please find attached a copy of the presentation as promised

Kind regards

Xxxxxx xxxxxxx

31

From xxxxxxxxxxxdhgsigovuk Sent 03072012 1535 To xxxxxxxxxxxxxxxxxxxdftgsigovuk Cc DuncanPricedftgsigovuk Subject Fw Drug driving - Involving our Senior Medical Officer

xxxxxxxx

I was hoping to discuss this with you over the phone but I understand you are at a meeting till 430pm I am leaving early today so I will have to call you tomorrow However in the mean time Ill put some of my thoughts down in this email to get the ball rolling

As xxx points out in xxx email Mark and xxx come at this policy from two different angles It would be helpful to have Mark on board as an observer as it will help us consider our clinical guidance relating to people in drug treatment and also to raise any additional issues the panel might want to consider relating to this particular client group But Mark will not be bringing the same issues to the table as xxx

xxx can bring the pharmacists perspective to the table I note the Chair refers to pharmacokinetics as already represented However we are referring to something different Pharmacokinetics is about the actions of drugs in the body over time We are talking addressing issues relating to pharmacists who have responsibility for dispensing medication and expertise in the safe and effective use of medication - a different issue altogether I think the language confuses these matters sometimes Pharmacists are the front line if you like where we all get our medication from so it is vital that issues from this side are raised and discussed This is not represented in the panel Many of the contributions we provided to recent DfT documents were put together with this angle in mind It is why xxx attends the policy group as xxx brings the pharmacy aspects to group discussions I hope this provides some further detail for us to discuss tomorrow

Kind regards

xxxxxx xxxxxx xxxxxx xxxxxxx xxxxx Department of Health xxxx xxx Wellington House 133-155 Waterloo Road London SE1 8UG 0207 972 xxxx

10

From xxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 03072012 1732 To MarkPruntydhgsigovuk xxxxxxxxxxxxdhgsigovuk Cc DuncanPricedftgsigovuk Subject RE Drug driving - Involving our Senior Medical Officer

Dear Mark

I think xxx is very happy for you to join this group and would in fact value your expertise more than that of xx xxxxxx xxxxxxx xxx has spoken to xxx and has agreed for xxx to join the panel simply to accommodate DoHrsquos wishes xxx has not seen that xxx would make a valuable addition to the panel and felt that xxx was indeed slightly confused about why xxx should be involved

Now that DoH colleague have put forward your name xxx would like to get you on board The membership and ToR of the panel are in the public domain so it is problematic to keep adding new members

As xxx xxxxxxxx has not formally been included in the panel we feel that it would be easiest to speak to xxx xxxxxxxx and explain to xxx why we can no longer accommodate xxx Instead you could join the panel as an observer

To pick up on xxxxxx points below the focus of the new law is controlled drugs that are illicit and there is a statutory defence for those taking controlled drugs in line with directions see below

(3) It is a defence for a person (ldquoDrdquo) charged with an offence under this section to show thatmdash

(a) the specified controlled drug had been prescribed or supplied to D for medical or dental purposes

(b) D took the drug in accordance with any directions given by the person by whom the drug was prescribed or supplied and with any accompanying instructions (so far as consistent with any such directions) given by the manufacturer or distributor of the drug and

Thanks xxxxxxxx

xxxxxxx xxxxxxxxxxxxx Roads Strategic Projects Roads Directorate Domestic 020 7944 xxxx

11

Working Group on Drug Driving ndash note of 20 July 2012 meeting

Attendees Duncan Price (DfT) Xxxxxxx xxxxxxxxxxxxx (DfT) Xxxx xxxxxxxxxxxx (DoH) Xxx xxxx (DoH) Xxxxxxx xxxxx (HO) xxxxxxxxxxxxxxxxx (HO) xxxxxx xxxx (MoJ)

Duncan Price provided an update on the Lords Committee stage and summarised the amendments tabled Key issues were controlled drugs used for clinical purposes and concerns about zero-tolerance levels A Hansard link had been circulated Duncan Price xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxx The report stage was likely to be around 7 November

Duncan Price informed the group that the drug driving panelrsquos xxxx xxx xxxxx would be briefing interested members of the House of Lords on 24 October about the panelrsquos work Xxxx xxxxxxxxx asked to be invited to that briefing

Duncan Price set out the high level timeline for the introduction of the new offence The Bill would go to the Commons either before or after Christmas The specification for mobile drug screening devices would be informed by the expert panelrsquos recommendations for the types of drugs and limits to be covered by the offence The type approval process for those devices could then run in parallel with the public consultation on the draft regulations The new offence could then commence in around the middle of 2014

It was agreed that work on the next stage impact assessment would be taking forward in close collaboration with the MoJ Home Office and DoH

12

Working Group on Drug Driving ndash draft note of 17 August 2012 meeting

Attendees Xxxx xxxxxxxxxxx (DoH) Xxx xxxx (DoH) Xxxxxx xxxxxx (HO) Xxxxxxxx xxxxxxxx (HO) Xxxxxxxxxx xxxx (HO) Xxxxx xxxxxx (MoJ for xxxxxx xxxx) Duncan Price (DfT) Xxxxxxx xxxxxxxxxxxx (DfT) Xxxxxxx xxxxx (DfT)

Duncan Price explained that the CPS and ACPO were being consulted about a possible change in the legislation to accept blood only evidential samples and not urine (which was not reliable to detect all drugs) or saliva or sweat Saliva and sweat if included would have to be as a theoretical future option until effective testing could be established (HO and DH agreed to approach contacts in Australia Belgium and US for data)

The Explanatory Note has now had comments from DfT legal Duncan Price will send out a redrafted version to the group for further comments

Discussions were still ongoing as to whether it would be possible to specify measurable levels in blood for all the controlled drugs of interest or whether provision should be made to enable levels to be specified in metabolites (provided these can be specifically related back to a controlled drug) Likewise consideration was being given for variable limits (dependent on alcohol levels) (Note the expert panelrsquos meeting of 21st August suggested a specified limit in a metabolite (itself not a controlled drug) might be appropriate in respect of cocaine rather than the drug itself)

Duncan Price suggested that the amendments made at Lords Committee stage related to medicinal uses of drugs would be problematic He was continuing to consider whether and how the panelrsquos emerging conclusions or policy assurances would be relevant to concerns expressed including in the NAPP briefing paper He had also met with representatives of NAPP and they had put some experts in touch with the expert panelrsquos chair

DfT will provide an update on drug driving to the 11th October ACMD Council meeting Jeremy Mean will need to advise when the MHRA could be updated

The group suggested an update should be provided for the 7 November Inter-ministerial group on drugs

Duncan Price also promised to send the group a first draft of ldquoEnforcement Procedures against Drink Drivers and Other Offenders ndash A Consultation Documentrdquo (Proposed Changes in Legislation for Testing Procedures for Drink and Drug Driving and in Other Transport Sectors and for Remedial Training for Road Traffic Offenders) This document covers the legislative changes contained in the Governmentrsquos response to the North review (other than the new drug driving offence)

[Post meeting note this document was sent on 21 August with initial comments requested by 31 August]

13

From DuncanPricedftgsigovuk Sent 30082012 1450 To xxxxxxxxxxxdhgsigovuk Cc xxxxxxxxxxxxxxxxxdftgsigovuk Subject Fw Meeting with Napp Pharmaceuticals

xxxxxxx

I attach in respect to briefing for Ann Miltonrsquos planned meeting with NAPP on 23rd October the following

- a note of NAPPrsquos key concerns (as they drafted them) plus my response - a letter Earl Atlee to NAPP - the draft sent to Lord Henleyrsquos office for signature to Lord Luce about similar issues - the note of the meeting NAPP had with me (it is NAPPrsquos note with my comments) - an internal note about controlled drugs for medical uses

The notes we did on the amendments made at Committee stage for Ministers cover some of the NAPP issues but I havenrsquot enclosed them as I have sent quite a lot already ndash but yoursquore welcome to a copy if you want one

Duncan Price Tel 020 7944 2241 Department for Transport

Note of the Meeting

Napp Pharmaceuticals and Department for Transport Meeting on Drug Driving 31 July 2012

Attendees Duncan Price Deputy Director Road User Licensing Insurance amp Safety (DP) Xxx xxxxxxxx Department for Transport Xxxxxx xxxxx Napp Pharmaceuticals Xxxxxx xxxxxxxxxxxxx Napp Pharmaceuticals Xxx xxxxxx Napp Pharmaceuticals Xxxx xxxxxx Ranelagh International Xxxxxxx xxxxxx Ranelagh International (RB)

Xxx began the meeting by providing a brief background on Napp xx noted that the company has been in Cambridge for thirty years and is well-known for its range of pain medications and in particular strong opioids Napp has helped to revolutionise the management of cancer and chronic pain through the development of various slow release and round the clock formulations Now the company is also moving into respiratory medicine and other areas It employs approximately 1100 people and is fifteenth in terms of GP prescription sales Xxx noted that Napp is interested in drug driving because of the impact legislation may have on patients

14

DP said that he is leading on drug driving policy and that the legislation currently going through Parliament is one of three pieces of work the Department is taking forward together The current proposals are enabling legislation which will allow the Government to determine the details critical to the new offence once the Expert Panel has published its recommendations DP suggested that the Expert Panelrsquos interim advice would be available in October

Xx noted that Napp is fully in support of the legislation and what it is trying to achieve but there are a few unintended consequences that it may cause for both manufacturers and patients Xx raised concerns about the impact on legitimate patients on a stable dose of medication that may be affected by legislation designed to target those who abuse illegal and legal drugs Xx added that Napp is in contact with a number of clinicians and other experts who would be happy to feed in to this policy development

Xx raised the issue of patients who are unimpaired being criminalised and facing a significant burden of proof if the proposed legislation is passed As the legislation is currently proposed there is a defence for patients taking prescription medication but the burden is first with them to prove that they have taken their medication is accordance with all instructions including from manufacturers There is a significant onus on patients to show they are not impaired despite what police say The defence is really only available once the driver is in court

Xx then compared the proposed legislation to the drink driving laws and highlighted the differences to drug driving legislation and the issue of strict liability Could the legislation be more focussed on its intended aim and tailor the list of controlled substances to those known to be abused as opposed to a catch all approach There needs to be protection for patients but at the moment the legislation appears to be trying to do both

Xx also noted the importance of ensuring that this is a policeable offence In the Governmentrsquos response to the North Review there was discussion of the Australian approach to drug driving Police found the impairment side of legislation hard to prove so they have instead just used the strict liability approach to prosecute drivers based on detection of a controlled substance

DP noted that all of the issues raised by xx are important What is being discussed in Parliament at the moment is enabling legislation which is setting out the framework The detail will become clearer once the interim advice from the Expert Panel has been received which is due in October The Department has already started to give some assurances in certain areas for example a zero tolerance approach for cannabis has been ruled out They will be able to home in as more advice is received from the Panel although it is not possible to pin the Panel down until it has reported DP added that there will be informed discussions with peers in late October before the legislation goes to Report Stage

Xx asked if the Panelrsquos advice will have any influence on the current draft Bill Xx asked if it would be worth making the primary legislation more focussed for example on substances known to be abused which would allow for strict liability The problem for patients would then become irrelevant as they would not be the focus of the legislation Xx also noted the problem that will arise from including heroin on the list of controlled substances Heroin metabolises into morphine in the blood as do some over-the-counter medications which makes it hard to distinguish between the different drug types This will lead to unintended consequences for patients

15

DP stated that he understood this argument but noted that the legislation is intended to be fit for purpose to allow for the whole range of potential decisions the Panel could make The decision might be made to change the substances on the controlled list although nothing so far has led him to think something should change The current list links back to the range included in the Misuse of Drugs Act The advice on the drugs will feed into the consultation and the subsequent affirmative procedure

DP added that because of the enabling nature of the current legislation there are some problems for example legal highs are not included on the list of controlled substances at the moment Due to the nature of the legislative procedure it can take a while to identify a problem and then legislate to give police powers They expect legal highs can become controlled drugs if they have protracted and serious consequences in a quicker time than the duration of the regulation-making process for drug driving There are powers to apply the legislation to all controlled drugs but they will need to go through it controlled drug by controlled drug in order to determine specific limits etc The Government envisages a mixed economy of the new and the existing offence

DP said that heroin is one drug of significant interest as it is known to be prevalent and associated with road safety risks The Panel are looking at opiates as a group of drugs and it will be for the Panel to decide how it can be detected He noted that they will need to consider all potential effects before setting any levels DP said that he knows that this is an area of importance for Napp as their patients will have a tolerance which is highly relevant to these considerations He would expect the Panel to look at that The Department wants the Panel to look at the opiate family so they do not only consider heroin

Xx said that the higher level of metabolites is an issue but these patients will be unimpaired where as a heroin user trying to get high is very different In terms of the defence the burden of proof lies on the shoulders of the patient Has the Department considered eliminating the impairment element and introducing an exemption for patients

DP responded that they have been considering all areas when looking at the medical defence Drink heroin and medically prescribed opiates have some similarities and also some important differences With alcohol some people who are over the limit will say they are unimpaired but the risks do increase as blood alcohol levels increase This can be the same with drugs

Xx noted that when a patient is on a steady dose of medication the pain they would be under if they were to stop taking their medication could be more impairing

DP said that he recognises the differences to drink driving Heroin users and medication users have different tolerances to ordinary people and the lsquodrink driving analogy is limitedrsquo Drinking has social benefits and it is a choice for people

Xx added that Napp sees that there is a desire to make drug like drink driving something that society will not tolerate but patients have to take their medication There is existing legislation against impairment for those who are irresponsible when taking their medication At the moment patients are being brought down to the lowest common denominator of those who abuse drugs This minority is causing problems for everyone else

16

Xxx noted that unlike with drink driving where increased alcohol leads to increased impairment there is not increased impairment with a high but stable dose of prescription medication Xx added that he believes there is a Swedish study which has investigated levels of impairment in patients

DP stated that although the opiate family is being considered together at the moment if it is not possible to distinguish between heroin and other opiates then it is open for the Department to decide whether or not to include morphine in the legislation They could decide that the disbenefits of including it would outweigh the benefits

He noted that the reason medications remain included is that there are problems with abuse for example with Benzodiazepines which are known to cause road safety problems Just because a controlled drug can be prescribed does not mean it will be removed from the legislation There will be a differentiation between a medical level at which someone must not drive and where they should not drive

Xx noted that Napp wants to work with the Government so that morphine can be included in the list of controlled substances By introducing an exemption or at least taking the burden of proof off the patient this could be done

DP said that the offence has a wide remit and there is a defence where they would like to include taking medication in accordance with medical advice There is a strong burden of proof on the prosecution to put evidence to the courts

Xx noted that the patient has to substantiate the proof first Xx added that patients already have a poor quality of life and this puts them under more stress Xxx said that pain is costing the country pound13bn a year and the Government has only recently decided to deem pain a long term condition and to work to help people have a good quality of life This seems like a backward step Doctors have been campaigning for years to get pain recognised and this is therefore a concern for them too as it may interfere with their choice of treatments

Xx said that with a few tweaks to the legislation the burden of proof could be placed on the prosecution For example by adding the word lsquoknowinglyrsquo to protect patients who were unaware of any advice against driving This would reassure them that a prescription will mean that they are protected Xx added that xxx has already had patient groups coming to her who are concerned that they are going to have to fight again

Xx noted that there is the issue of the lsquoknock onrsquo impact of one case highlighted by the media which could lead to patients becoming more cautious about taking their medication

DP said that he thought the Panel was unlikely to recommend low threshold levels He said that they have looked at the amendments tabled and they had material prepared for the Committee Stage of the legislation which was not needed and will be used to inform the informal discussion among peers in October He added that he feels the burden of proof leans towards the prosecution Once the prescription is presented it is down to the prosecution to prove beyond reasonable doubt that the medication was not taken properly For example one way would be if they can show that the blood level of a drug was in excess of the level prescribed

17

Xx raised concerns that cautious drivers may be wrongly pulled over by police and that it will be difficult for them to prove that they were unimpaired DP said that there are a swathe of issues about how far along the process people will be taken The balance is broadly right in the defence and if a case did go to court it would be resolved in the right way

DP noted that he is aware of the problems with testing procedures and that it is a genuinely difficult area Xx added that there are also concerns about those involved in a car crash and the insurance implications for a patient if they are the innocent party but test positively for drugs

DP said that is the situation already with the existing law and that there is currently a big drop off of cases before they reach the courts let alone conviction This is partly why the new offence is needed to target illegal drug users This issue is already there Xx acknowledged this but noted that the risk for patients would be heightened and that legislation designed to give police powers to stop drug abusers from driving should not spill over to impact on patients and make them worry about driving

Xx noted xxxx xxxxx xxxxx recent lsquoFit for Workrsquo report which showed that the main problem for the workforce is low back pain therefore many more people could be forced to stop work if they felt that by taking their medication it could mean that they are not deemed fit to drive

It was also noted that in the first stages of pain patients will seek pharmacist advice and use low doses of codeine to manage their pain There are 8m Osteoarthritis sufferers in the UK and over 70 report that they are in constant pain They typically start with over-the-counter medication including NSAIDS and codeine such as Nurofen Plus They will not have a prescription so how will they fare under the legislation

DP stated that this is partly an issue for the Panel He said he hoped that there is a good swathe of people on the Panel and asked if there is anything that Napp would like to submit to them Xx said there would be and that xxx would liaise with him on behalf of NAPP and feed in any information that would be considered helpful

Xxx noted that there are some concerns about the lack of medicalpainpatient representation on the Panel and that if these groups could feed in to the Panel that would help alleviate some concerns

DP said that the Panel is bringing in materials from other experts and that subject to his clearing it with the Chair they would be very keen to see papers etc The Panel would like to see as much research as possible Although they do not meet on policy there have been a number of issues related to the science of opioids that are of interest Xx asked if it would be helpful to also send the Panel a paper from Napp on where they believe legislation contains areas of risk and burden for patients to make the Panel aware of not only where the legislation can work but also where it could go wrong Xx asked if a pain expert could feed that in DP said case studies on the impact on patients would be helpful but there should be a focus on the science The legal aspects will not concern the Panel They should be happy to receive papers although he will have to talk to the Chair about having any experts appear in front of the Panel Xx assured DP that this would be done if the Chair was in agreement

18

Xx asked for some detail on the practical process of the Panelrsquos work Is the October report interim or final

DP said that it will be an interim report as there may be more work to do afterwards but that it is hoped and expected that the report will cover all the major drug types in the terms of reference They will use the findings across Government and then the decision will be made to move to the consultation The findings will also be communicated to the Committee on the Misuse of Drugs and the MRHA Secretariat representatives from both have been at Panel meetings

The secondary legislation will be in effect from early 2014 The plan is to consult on it in early 2013 and then progress through affirmative procedure in the later part of 2013 It will allow for the possible subsequent inclusion of other drugs

Xx asked about the development of testing devices and their specificity DP said that he is not a technical authority about the machines but does have information on the approval process A decision will be made at the end of the year on those currently going through police stations There will also be the beginning of the process to develop the second generation of roadside testing but the specifications cannot be finalised until the Panel reports These will be threshold detectors not just presentabsent detectors They will cover something related to heroin Legislation has been drafted so that police can undertake multiple preliminary tests as all drugs cannot be tested for at the same time The technology is important as an offence without it would not have the impact hoped for

DP added that other countries have a zero tolerance approach with presentabsent tests but that they want a threshold approach here He said that the legislation is linked to road safety it is not intended to change the law on possession use of drugs It is about public safety The existing penalty regime is not suitable for a zero tolerance approach At the moment crossing the limit means a 12 month driving ban and other consequences which is different to abroad The reason the drink drive limit has not been reduced is because the Government does not want to create a two tier system where the lower limit becomes seen as only equivalent to being given a speeding ticket The penalty for drug driving needs to allow for a more proportionate approach to enforcement At the moment if you are well versed in the law you have a good chance of evading conviction They want to change the balance and do not want to lower the penalty in comparison to drink driving He added that problems with some detection equipment abroad would not be acceptable in the UK legal system especially evidential saliva sampling The technology appears not there yet

DP noted that the Department is also looking at appropriate policy statements to make about the legislation The press has already focussed on areas where the new offence wonrsquot be an impact Xxx said that policy statements would help those patients who are already concerned

DP asked if Napprsquos patients receive unequivocal advice that they can drive Xx said not necessarily The issue is patients do not read advice and if they did they would not necessarily fully understand it It comes down to what the Doctor says but this legislation could then put them in a difficult position too Xx noted that the advice to patients in leaflets for medication regardless of whether they are prescription only medicines or over the counter would have a statement that would alert the patient to potential drowsiness or tiredness and advise that if this symptom was experienced patients should not drive or operate machinery This would be the same advice that clinicians would give to patients

19

about their medication unless as with certain drugs the DVLA should be notified and patients specifically informed that they must not drive whilst taking this medication The onus is on the patient to determine if they have this side effect and to what extent they are impaired DP noted that there is a difference between advice that a patient cannot drive and being told not to drive if they feel drowsy Xxx added that patients on a stable dose will be unsure if they can continue to work have a good quality of life etc and this will lead them to question whether or not to take their medication

DP stated that the Government can provide the context on what they think directions are but this will still be interpreted by a court Xx said publishing that information would provide comfort to patients who are concerned DP said this would be discussed with peers as well

Xx asked who will be invited to the informal discussion with peers and MPs DP said it would be just members of the House of Lords and Commons They will be able to meet with the Panel and other Government experts Xx noted that this would be useful for peers as those Napp has spoken to have had answers to initial questions but there are still areas where they would like some clarification DP noted that he and the Lords Spokesperson met with interested peers in advance of the Committee Stage It is easier to provide more factual clarification informally than on the floor of the House and Spokespeople will value the chance to make some progress before the Report Stage

Xx confirmed that Napp would put together some helpful information for DP to pass on to the Panel and will bring in some experts to feed in to that Xx added that Napp would be happy to feed in to any policy statements etc DP said he would be happy to clarify any issues in writing Xx said Napp would put together a list of questions for DP for this Xx said xxx would involve patient groups here too

Xx asked if there has been any input in the policy from the Department for Health DP said that a quadrilateral working group from Transport Justice Home and Health are working on the policy They have met between Panel meetings to see what is said and if there are any issues to put to the Panel

Xx asked if there is anything else Napp can do DP said that the more specific Napp can be about concerns evidence on the effect of treatments on impairment etc that would be helpful The policy is very much at the evidence gathering stage at the moment

Xx reiterated Napprsquos concerns regarding the Panel membership

DP said that at some point he expected tough decisions will be made about the balance of the proscons of the policy issues No solution will tick every box

Xx said that policy statements will be key to giving the police and the CPS guidance on who they are targeting as well as what lsquodirectionsrsquo mean to allay the fears of patients and clinicians DP said he hoped they would be able to allay fears He added that there is no advantage for the police to have lots of people in stations and being processed who are not impaired There is a realistic policy possibility that heroin will have to be set aside Just because the Panel is looking at it does not mean there is a commitment that it will be in the new offence They know that there may be no test to distinguish between different types of opiates

20

Xxx passed on two emails which he explained were from xx xxxxxxx xxxxxxx and xx xxxxxx xxxxxxxxn representing the views of CPPC and RCGP respectively Both Doctors expressed their concerns for patients and offered to contribute to discussions on the proposed legislation

A Note of Napprsquos Key Concerns

Napp Pharmaceuticals Meeting with Department for Transport 31 July 2012

Note I have added in bold italicised text some DfT responses to the questions in your original note which is otherwise as you sent me ndash Duncan Price 2882012

A Statement of support for drug driving legislation to stop people from driving while under the

influence of illegal drugs

Napp is concerned about the unintended consequences of the legislation on patients taking

long‐term medication for chronic pain Napp wants to work with the Government to find a

solution

1) Impact on Patients

2) Criminalisation of Patients

3) Different to Drink Driving Law

4) Policeable Offence

B Outline of Concerns

1) Impact on Patients

Evidence shows that patients on a stable dose of opioid analgesics are not necessarily

impaired but under the proposed system patients may be inaccurately identified as taking

impairing drugs and face prosecution

Patients well established on a stable dose of an opioid analgesic may have levels of

metabolites in their system well above any threshold used for roadside and police station

testing This means they could face serious charges despite driving unimpaired

There are concerns for patients such as those with Osteoarthritis the majority of who use

over the counter medications to manage their pain

Concern that patients will stop taking their medication so that they can drive This may

make their driving more impaired as a result of the pain that they will be under

Questions

Has there been consideration of how to distinguish between opiates that are used legally

for medicinal purposes and those used illegally (Napp would be happy to share clinical

knowledge of opioids that may be helpful to the panel and to any other interested parties

in Government)

The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

21

The panel is considering natural and synthetic opioids Its terms of reference include that it should establish the likelihood of whether concentrations of drugs broadly equivalent in their impairment effects to blood alcohol concentrations of 20 50 and 80mg100ml would be exceeded This will include a consideration of prescribed or otherwise legally obtained drugs which are known to impair driving

The panel will advise the Government which will then itself consider what specified limits to propose and then consult about I can assure you that in doing so it will consider how screening equipment and evidential blood specimens would distinguish between opiates used for legitimate medical purposes and those used illicitly

I am grateful for the offer of sharing clinical knowledge you made when we met I know the panel has since considered some of the evidence your experts have provided and some of its members have met an expert you recommended and one of your legal advisors

Has there been consideration of just introducing a list of restricted drugs known to be used

recreationally as with the Australian model

The list of restricted drugs used in some states in Australia does include THC (the active ingredient of cannabis) which does have some limited medical uses here The Governmentrsquos prime targets for this legislation are controlled drugs often or exclusively used illicitly including those included in the Australian legislation (THC amphetamines and MDMA)

At this stage we are awaiting advice from the panel but the Governmentrsquos position is that it should develop a new offence with the potential to include a number of categories of drug including benzodiazepines and opiates The abuse including the use of high quantities of methadone and some benzodiazepines (which can be prescribed) appears (alongside heroin) to be a significant contributor to the public safety problems this legislation is addressing

Many of the drugs specifically identified in the panelrsquos terms of reference are used exclusively or predominantly illicitly ndash for example amphetamine-types cannabinoids cocaine and hallucinogens

There is a reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

22

We are therefore using the definition of lsquocontrolled drugrsquo in the Misuse of Drugs Act 1971 within the new offence although which controlled drugs will be determined when regulations are brought forward

What consideration have you given to the issue of patients who drive unimpaired but will

still face prosecution if tested as levels of metabolites in their system may be above any

prescribed limit

This is being considered in both the terms of reference for the technical panelrsquos advice about the setting of specified limits (to keep patients out of the scope of the offence) and the inclusion of the medical defence within the offence

The panel has also been asked to consider the degree of variability in impairment effects across the population including for habitual drug users

In the terms of reference for the panel we have also specifically included the following from the North review (paragraph 743)

ldquoSome drugs which may be proscribed for driving might also be used legitimately in accordance with medical advice (for example morphine may be prescribed for chronic pain or diazepam (a benzodiazepine) may be prescribed for anxiety) Indeed the Review recognises that in some circumstances it may be more dangerous for a person to drive having not taken their medically prescribed drug than driving without having taken it Drugs have different effects on different people and levels at which they are prescribed are likely to reflect this It would clearly be wrong to put in jeopardy of prosecution those who are properly and safely taking medically prescribed drugs and driving in accordance with medical advice for whom despite the presence of a proscribed drug there is no evidence of any driving impairmentrdquo

I should also emphasise that the content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

2) Criminalisation of Patients

Statutory defence is included in the current legislation for those who have taken

prescription medication in accordance with prescribersupplier instructions and any

accompanying instructions from the manufacturer BUT

Only applicable after patient has been arrested further tested and their case has

progressed ndash this will cause innocent patients significant stress and

inconvenience

The defence puts the burden of proof on patients to prove that they acted in

accordance with all medical advice when the burden should be on the

prosecution to prove that they didnrsquot

23

Innocent patients may face criminalisation based on a technicality in legislation

that is not intended to target them

Questions

Is an exemption feasible (If not what is going to be done to ensure that patients are

protected)

I do not consider an exemption from the offence for all controlled drugs that can possibly be supplied or used for medical reasons is feasible Many controlled drugs for example cannabis have some medicinal uses

It is perfectly feasible for decisions about which controlled drugs would be specified for the new offence to be influenced by the reasons for whether their use is often always seldom or never for medical reasons Indeed such distinctions would be vital if this legislation were being introduced to enforce further against the illegal supply or use of controlled drugs

Whether that is the right approach to decision-making related to driving with controlled drugs in the body where there are levels associated with elevated risks to public safety is however questionable This legislation is being introduced to address road safety problems and the expert panelrsquos terms of reference are focussed on providing advice about the risks of driving after taking controlled drugs

It is to no-onesrsquo benefit for patients who are innocent of the offence to be arrested and tested There are several protections in place to reduce these risks Firstly police do not have random testing powers for drink and drug driving Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving

under the influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would result in disproportionate and large numbers of patients having evidential blood tests but then being not guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

24

It is important to note that the prosecution for a case where a defence has been raised that a patient had taken a controlled drug in accordance with medical advice must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code Test about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

It is important now and it will be important with the new offence in place that medical advice does not suggest to patients that they drive when doing so would present a significant risk to themselves and the public To do so risks patients being involved in road traffic incidents and also committing the existing offence of driving whilst impaired due to drugs

3) Different to Drink Driving Law

There have been calls for a strict liability approach to drug driving as exists for drink

driving Napp believes this would not be a suitable approach for drug driving based on the

current draft Bill

Alcohol does not have any medical necessity people do not need to consume

alcohol to ensure that a chronic condition does not prevent them from

functioning on a daily basis

Prescription medications that patients may take to treat chronic pain are a

medical necessity and are essential to ensuring that they are able to function on a

daily basis

A strict liability approach could lead to patients not taking essential medication in

order to be able to drive without fear of prosecution

Alternatively patients may choose not to drive at all which could have a serious

impact on their ability to work and go about their daily lives

Questions Is an exemption feasible (If not what is going to be done to ensure that patients are protected)

There are some useful analogies with drink driving law For example prior to the introduction of the specific drink driving offence the law in relation to drink drivers was difficult to enforce The specific offence there has contributed to major improvements in public safety

I do accept one of the differences with some controlled drugs is that some people take them for medicinal not recreational purposes This is not the case for all controlled drugs This may well affect what is included in the regulations for the offence

25

When we met I did say that it is conceivable for even as prevalent a recreational drug as heroin to not be included in the regulations for the offence This might be if it transpired that a limit relevant to heroin had to be set in a metabolite itself used in or a metabolite of a medically prescribed drug If such a limit also then had the effect of criminalising driving with medically supplied controlled drugs when that did not present an elevated risk to public safety I can see it would be a limit we might well not implement However I await the advice of the expert panel to see what it recommends related to heroin and whether (and how) that might affect other opiates

4) Policeable Offence

It is argued that drivers wonrsquot be stopped by police unless they appear impaired BUT

Plans are to test all those involved in a traffic accident for drugs including

innocent parties An innocent unimpaired patient involved in a crash through no

fault of their own could then face serious charges

Impairment is subjective and police may be suspicious of someonersquos driving for a

number of reasons such as driving too cautiously This apparently lsquoimpairedrsquo

driving may be due to various factors unrelated to the driverrsquos use of prescribed

medication but if they are stopped by police they may find themselves facing

serious and unjust charges

The existing impairment offence will remain so police will still be able to catch

those who do drive while impaired by prescription medication

Questions How close is the Home Office to approval of a drug testing device for use in police stations Can you provide any details

The laboratory testing phases of the type approval process is under way and the process is due to be completed at the end of this year

Is the Home Office still aiming for a 2014 approval of a drug testing device for portable use

It is still aiming for 2014 for these devices and we are planning the timing of that process together with the work on the new offence

Since the Governmentrsquos response to the North Review in June 2010 has the drug driving data quality improved

Yes we have received more information from Coroners recently and we also have had the conclusions of the European DRUID research

C Solutions

Napp believes that the best way to protect patients is by introducing an exemption for

those who can demonstrate that they are taking prescription medication

Existing legislation against driving while impaired would allow police to charge

anyone who did drive while under the influence of impairing prescription

medication

26

This would put the burden of proof on prosecutors saving innocent patients

considerable stress inconvenience and wasted CPS and police time

The Department considers that the statutory defence affords appropriate protection to patients who drive after taking prescription medication

The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

D Other Points for Consideration

Napp is keen to support this legislation in its efforts to stop users of illegal drugs

from driving and wishes to support policy development to ensure that patients are

protected Napp would be keen to provide any further information or other

means of assistance that could be of help here

Napp would like to submit written andor oral evidence to the Expert Panelrsquos

inquiry

Napp is concerned about the lack of pain expertise and patient representatives on

the Expert panel

Lord Henley mentioned that a seminar might be held after the summer recess to

discuss the issues arising from this legislation further Napp would be keen to

receive any further information on this

I hope this has been covered satisfactorily in the discussion we had on 31st July and since then

I do consider the legislation has strong safeguards in place for patients The Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

I hope I have addressed at least some of your concerns I should be happy to discuss the issues further

Duncan Price 2882012

27

Note on controlled drugs with medical uses

(i) The reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

(ii) Circumstances in which drug testing can be administered Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under the

influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

(iii) The medical defence The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

(iv) Drugs to be covered by the new offence and any specified limits to be based on expert advice The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

(v) Other controls The content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

(vi) Prosecutions to be in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

(vii) In light of the above the Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

28

From DuncanPricedftgsigovuk Sent 13092012 1603 To xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Cc xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Subject RE NRAS - Crime and Courts Bill clauses on drug driving

Xxxxxx

Below is my draft response to this letter Irsquoll send it when I have your comments about it

Dear xx xxxxxxx

Xxxxxx xxxxxxxx has forwarded your email of 28th August to me I am the lead policy official for the legislative clause about drug impaired driving in the Crime and Courts Bill

I am aware of concerns about innocent motorists taking prescribed medications being stopped tested being taken to police stations having blood samples taken and possibly going to court before being exonerated This is not the intention of the legislation and I can assure you we are mindful of this concern as we progress the legislation and respond to advice from an expert panel about the details

There are several protections in place to reduce the risk of large numbers of innocent motorists being arrested and taken to police stations

Firstly motorists cannot be stopped randomly for drug tests Testing can only be administered in three circumstances ndash namely where a driver has committed a moving traffic offence

a driver has been involved in a road traffic accident and or

there is reason for a police officer to suspect that a person has been driving under the influence of drink or drugs

This means that in practice drivers taking prescribed medicines would not be stopped and required to undergo drug testing without there being real cause for concern Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would be likely to result in disproportionate and large numbers of people prescribed drugs having evidential blood tests but then not being found guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

Fourthly it is important to emphasise that the prosecution for a case where the medical defence has been raised must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code for Crown Prosecutors which contains a requirement about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

Finally in the context of the clause before parliament the content of the regulations (specifying which controlled drugs should be covered by the new offence and the limits to be specified for them) will be the subject of public consultation Before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of

29

Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

I hope that this letter serves to allay concerns about possible unintended consequences for people taking prescription medicines

Duncan Price Tel 020 7944 xxxx Department for Transport

From JessicaMatthewdftgsigovuk Sent 17 October 2012 1108 To xxxxxxxxxxxxadhgsigovuk Cc xxxxxxxxxxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxxxxxdhgsigovuk xxxxxxxxdhgsigovuk Subject Re Department of Health attendance at the Lords briefing for the drug driving legislation

Xxxxxxxx is out of the office today but wersquoll send over the time and venue tomorrow and share the briefing with you Irsquod be happy to brief Dr Prunty beforehand ndash perhaps over the phone

Wersquore planning on a reasonably open debate about the legislation We wonrsquot have got policy clearance on the amendments to the legislation but wersquore inclined to say that the Government is minded to or is considering x y or z

Happy to discuss

Jessica Matthew Deputy Director Road User Licensing Insurance and Safety Tel 020 7944 xxxx Zone 321 Great Minster House 76 Marsham Street London SW1P 4DR

Extract of Briefing shared with DH from the above e-mail

How will you make sure that people taking medication in accordance with their prescription arenrsquot arrested and taken to court as a result of this legislation

The medical defence in the provisions provides substantial and appropriate protection for people taking medically prescribed or supplied controlled drugs It places an evidential burden on a person accused of committing the offence So the accused must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court It is then for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on

It is unlikely that a person taking medication in accordance with their prescription would be taken to court for a number of reasons

30

1 Motorists cannot be stopped randomly for drug tests They can only be tested where They have committed a moving traffic offence They have been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under

the influence of drink or drugs

2 The drugs to be included in the legislation and their limits will be set in regulations The content of the regulations will be the subject of public consultation and an affirmative resolution This will provide an opportunity for any concerns with the proposed specified limits to be raised and carefully considered

3 The expert panel is bearing in mind the normal therapeutic ranges and expected drug concentrations in blood when setting limits for those drugs that may also be used for medicinal purposes This means that only patients on unusually high doses of medication might have a positive screening and proceed to evidential blood test

4 Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any cases before they reach the court Indeed there is a Code for Crown Prosecutors which contains a requirement that prosecutions are in the public interest

From xxxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 29 November 2012 1422 To xxxxxxxdhgsigovuk xxxxxxxxxpsncorguk xxxxxxxxxxxxxtheccaorguk xxxxxxxxxxnpacouk xxxxxxxxxxxxrpharmscom xxxxxxxxxxxsaddactionorguk xxxxxroadsafecom xxxxxxxxxxxxxxxxxxsdrconsortiumorg xxxm-allianceorguk xxxxxxxxxxxturning-pointcouk xxxxxxxxROSPAcom xxxxxxxxxxxxxxxxtheAAcom xxxxxxxxxacpopnnpoliceuk adminactionaddictionorguk xxxxxxxxxageukorguk xxxxxxxxxxxbrakeorguk xxxxxxxxbmaorguk xxxxxxxxxxxbritishpainsocietyorg xxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxcpsgsigovuk xxxxxxxxdrugscopeorguk xxxxxxxxxiamorguk xxxxxxxxxxxxxxlawsocietyorguk xxxxxxxxxxxliberty-human-rightsorguk xxxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxxpactsorguk xxxxxxxxxxparliamentuk xxxxxxxxxxxxRACFoundationorg xxxxxxxxxxdurhamgovuk xxxxxxxxxxxxxxxxPolicyConnectorguk xxxxxxxxxxxxxxpsncorguk xxxxxxxxxxxxxdvlagsigovuk Xxxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxhomeofficegsigovuk xxxxxxxxnpacouk xxxxxxxxxxxxdhgsigovuk xxxxxxxxxdrugscopeorguk Cc xxxxxxxxxxxxxxxxxxxdftgsigovuk JessicaMatthewdftgsigovuk xxxxxxxxxxxxxxxxxxdftgsigovuk Subject Drug driving seminar presentation

Dear all

Many thanks to those of you who were able to attend our Drug Driving Stakeholder Seminar last week

We hope you found as useful as we did

Please find attached a copy of the presentation as promised

Kind regards

Xxxxxx xxxxxxx

31

From xxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 03072012 1732 To MarkPruntydhgsigovuk xxxxxxxxxxxxdhgsigovuk Cc DuncanPricedftgsigovuk Subject RE Drug driving - Involving our Senior Medical Officer

Dear Mark

I think xxx is very happy for you to join this group and would in fact value your expertise more than that of xx xxxxxx xxxxxxx xxx has spoken to xxx and has agreed for xxx to join the panel simply to accommodate DoHrsquos wishes xxx has not seen that xxx would make a valuable addition to the panel and felt that xxx was indeed slightly confused about why xxx should be involved

Now that DoH colleague have put forward your name xxx would like to get you on board The membership and ToR of the panel are in the public domain so it is problematic to keep adding new members

As xxx xxxxxxxx has not formally been included in the panel we feel that it would be easiest to speak to xxx xxxxxxxx and explain to xxx why we can no longer accommodate xxx Instead you could join the panel as an observer

To pick up on xxxxxx points below the focus of the new law is controlled drugs that are illicit and there is a statutory defence for those taking controlled drugs in line with directions see below

(3) It is a defence for a person (ldquoDrdquo) charged with an offence under this section to show thatmdash

(a) the specified controlled drug had been prescribed or supplied to D for medical or dental purposes

(b) D took the drug in accordance with any directions given by the person by whom the drug was prescribed or supplied and with any accompanying instructions (so far as consistent with any such directions) given by the manufacturer or distributor of the drug and

Thanks xxxxxxxx

xxxxxxx xxxxxxxxxxxxx Roads Strategic Projects Roads Directorate Domestic 020 7944 xxxx

11

Working Group on Drug Driving ndash note of 20 July 2012 meeting

Attendees Duncan Price (DfT) Xxxxxxx xxxxxxxxxxxxx (DfT) Xxxx xxxxxxxxxxxx (DoH) Xxx xxxx (DoH) Xxxxxxx xxxxx (HO) xxxxxxxxxxxxxxxxx (HO) xxxxxx xxxx (MoJ)

Duncan Price provided an update on the Lords Committee stage and summarised the amendments tabled Key issues were controlled drugs used for clinical purposes and concerns about zero-tolerance levels A Hansard link had been circulated Duncan Price xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxx The report stage was likely to be around 7 November

Duncan Price informed the group that the drug driving panelrsquos xxxx xxx xxxxx would be briefing interested members of the House of Lords on 24 October about the panelrsquos work Xxxx xxxxxxxxx asked to be invited to that briefing

Duncan Price set out the high level timeline for the introduction of the new offence The Bill would go to the Commons either before or after Christmas The specification for mobile drug screening devices would be informed by the expert panelrsquos recommendations for the types of drugs and limits to be covered by the offence The type approval process for those devices could then run in parallel with the public consultation on the draft regulations The new offence could then commence in around the middle of 2014

It was agreed that work on the next stage impact assessment would be taking forward in close collaboration with the MoJ Home Office and DoH

12

Working Group on Drug Driving ndash draft note of 17 August 2012 meeting

Attendees Xxxx xxxxxxxxxxx (DoH) Xxx xxxx (DoH) Xxxxxx xxxxxx (HO) Xxxxxxxx xxxxxxxx (HO) Xxxxxxxxxx xxxx (HO) Xxxxx xxxxxx (MoJ for xxxxxx xxxx) Duncan Price (DfT) Xxxxxxx xxxxxxxxxxxx (DfT) Xxxxxxx xxxxx (DfT)

Duncan Price explained that the CPS and ACPO were being consulted about a possible change in the legislation to accept blood only evidential samples and not urine (which was not reliable to detect all drugs) or saliva or sweat Saliva and sweat if included would have to be as a theoretical future option until effective testing could be established (HO and DH agreed to approach contacts in Australia Belgium and US for data)

The Explanatory Note has now had comments from DfT legal Duncan Price will send out a redrafted version to the group for further comments

Discussions were still ongoing as to whether it would be possible to specify measurable levels in blood for all the controlled drugs of interest or whether provision should be made to enable levels to be specified in metabolites (provided these can be specifically related back to a controlled drug) Likewise consideration was being given for variable limits (dependent on alcohol levels) (Note the expert panelrsquos meeting of 21st August suggested a specified limit in a metabolite (itself not a controlled drug) might be appropriate in respect of cocaine rather than the drug itself)

Duncan Price suggested that the amendments made at Lords Committee stage related to medicinal uses of drugs would be problematic He was continuing to consider whether and how the panelrsquos emerging conclusions or policy assurances would be relevant to concerns expressed including in the NAPP briefing paper He had also met with representatives of NAPP and they had put some experts in touch with the expert panelrsquos chair

DfT will provide an update on drug driving to the 11th October ACMD Council meeting Jeremy Mean will need to advise when the MHRA could be updated

The group suggested an update should be provided for the 7 November Inter-ministerial group on drugs

Duncan Price also promised to send the group a first draft of ldquoEnforcement Procedures against Drink Drivers and Other Offenders ndash A Consultation Documentrdquo (Proposed Changes in Legislation for Testing Procedures for Drink and Drug Driving and in Other Transport Sectors and for Remedial Training for Road Traffic Offenders) This document covers the legislative changes contained in the Governmentrsquos response to the North review (other than the new drug driving offence)

[Post meeting note this document was sent on 21 August with initial comments requested by 31 August]

13

From DuncanPricedftgsigovuk Sent 30082012 1450 To xxxxxxxxxxxdhgsigovuk Cc xxxxxxxxxxxxxxxxxdftgsigovuk Subject Fw Meeting with Napp Pharmaceuticals

xxxxxxx

I attach in respect to briefing for Ann Miltonrsquos planned meeting with NAPP on 23rd October the following

- a note of NAPPrsquos key concerns (as they drafted them) plus my response - a letter Earl Atlee to NAPP - the draft sent to Lord Henleyrsquos office for signature to Lord Luce about similar issues - the note of the meeting NAPP had with me (it is NAPPrsquos note with my comments) - an internal note about controlled drugs for medical uses

The notes we did on the amendments made at Committee stage for Ministers cover some of the NAPP issues but I havenrsquot enclosed them as I have sent quite a lot already ndash but yoursquore welcome to a copy if you want one

Duncan Price Tel 020 7944 2241 Department for Transport

Note of the Meeting

Napp Pharmaceuticals and Department for Transport Meeting on Drug Driving 31 July 2012

Attendees Duncan Price Deputy Director Road User Licensing Insurance amp Safety (DP) Xxx xxxxxxxx Department for Transport Xxxxxx xxxxx Napp Pharmaceuticals Xxxxxx xxxxxxxxxxxxx Napp Pharmaceuticals Xxx xxxxxx Napp Pharmaceuticals Xxxx xxxxxx Ranelagh International Xxxxxxx xxxxxx Ranelagh International (RB)

Xxx began the meeting by providing a brief background on Napp xx noted that the company has been in Cambridge for thirty years and is well-known for its range of pain medications and in particular strong opioids Napp has helped to revolutionise the management of cancer and chronic pain through the development of various slow release and round the clock formulations Now the company is also moving into respiratory medicine and other areas It employs approximately 1100 people and is fifteenth in terms of GP prescription sales Xxx noted that Napp is interested in drug driving because of the impact legislation may have on patients

14

DP said that he is leading on drug driving policy and that the legislation currently going through Parliament is one of three pieces of work the Department is taking forward together The current proposals are enabling legislation which will allow the Government to determine the details critical to the new offence once the Expert Panel has published its recommendations DP suggested that the Expert Panelrsquos interim advice would be available in October

Xx noted that Napp is fully in support of the legislation and what it is trying to achieve but there are a few unintended consequences that it may cause for both manufacturers and patients Xx raised concerns about the impact on legitimate patients on a stable dose of medication that may be affected by legislation designed to target those who abuse illegal and legal drugs Xx added that Napp is in contact with a number of clinicians and other experts who would be happy to feed in to this policy development

Xx raised the issue of patients who are unimpaired being criminalised and facing a significant burden of proof if the proposed legislation is passed As the legislation is currently proposed there is a defence for patients taking prescription medication but the burden is first with them to prove that they have taken their medication is accordance with all instructions including from manufacturers There is a significant onus on patients to show they are not impaired despite what police say The defence is really only available once the driver is in court

Xx then compared the proposed legislation to the drink driving laws and highlighted the differences to drug driving legislation and the issue of strict liability Could the legislation be more focussed on its intended aim and tailor the list of controlled substances to those known to be abused as opposed to a catch all approach There needs to be protection for patients but at the moment the legislation appears to be trying to do both

Xx also noted the importance of ensuring that this is a policeable offence In the Governmentrsquos response to the North Review there was discussion of the Australian approach to drug driving Police found the impairment side of legislation hard to prove so they have instead just used the strict liability approach to prosecute drivers based on detection of a controlled substance

DP noted that all of the issues raised by xx are important What is being discussed in Parliament at the moment is enabling legislation which is setting out the framework The detail will become clearer once the interim advice from the Expert Panel has been received which is due in October The Department has already started to give some assurances in certain areas for example a zero tolerance approach for cannabis has been ruled out They will be able to home in as more advice is received from the Panel although it is not possible to pin the Panel down until it has reported DP added that there will be informed discussions with peers in late October before the legislation goes to Report Stage

Xx asked if the Panelrsquos advice will have any influence on the current draft Bill Xx asked if it would be worth making the primary legislation more focussed for example on substances known to be abused which would allow for strict liability The problem for patients would then become irrelevant as they would not be the focus of the legislation Xx also noted the problem that will arise from including heroin on the list of controlled substances Heroin metabolises into morphine in the blood as do some over-the-counter medications which makes it hard to distinguish between the different drug types This will lead to unintended consequences for patients

15

DP stated that he understood this argument but noted that the legislation is intended to be fit for purpose to allow for the whole range of potential decisions the Panel could make The decision might be made to change the substances on the controlled list although nothing so far has led him to think something should change The current list links back to the range included in the Misuse of Drugs Act The advice on the drugs will feed into the consultation and the subsequent affirmative procedure

DP added that because of the enabling nature of the current legislation there are some problems for example legal highs are not included on the list of controlled substances at the moment Due to the nature of the legislative procedure it can take a while to identify a problem and then legislate to give police powers They expect legal highs can become controlled drugs if they have protracted and serious consequences in a quicker time than the duration of the regulation-making process for drug driving There are powers to apply the legislation to all controlled drugs but they will need to go through it controlled drug by controlled drug in order to determine specific limits etc The Government envisages a mixed economy of the new and the existing offence

DP said that heroin is one drug of significant interest as it is known to be prevalent and associated with road safety risks The Panel are looking at opiates as a group of drugs and it will be for the Panel to decide how it can be detected He noted that they will need to consider all potential effects before setting any levels DP said that he knows that this is an area of importance for Napp as their patients will have a tolerance which is highly relevant to these considerations He would expect the Panel to look at that The Department wants the Panel to look at the opiate family so they do not only consider heroin

Xx said that the higher level of metabolites is an issue but these patients will be unimpaired where as a heroin user trying to get high is very different In terms of the defence the burden of proof lies on the shoulders of the patient Has the Department considered eliminating the impairment element and introducing an exemption for patients

DP responded that they have been considering all areas when looking at the medical defence Drink heroin and medically prescribed opiates have some similarities and also some important differences With alcohol some people who are over the limit will say they are unimpaired but the risks do increase as blood alcohol levels increase This can be the same with drugs

Xx noted that when a patient is on a steady dose of medication the pain they would be under if they were to stop taking their medication could be more impairing

DP said that he recognises the differences to drink driving Heroin users and medication users have different tolerances to ordinary people and the lsquodrink driving analogy is limitedrsquo Drinking has social benefits and it is a choice for people

Xx added that Napp sees that there is a desire to make drug like drink driving something that society will not tolerate but patients have to take their medication There is existing legislation against impairment for those who are irresponsible when taking their medication At the moment patients are being brought down to the lowest common denominator of those who abuse drugs This minority is causing problems for everyone else

16

Xxx noted that unlike with drink driving where increased alcohol leads to increased impairment there is not increased impairment with a high but stable dose of prescription medication Xx added that he believes there is a Swedish study which has investigated levels of impairment in patients

DP stated that although the opiate family is being considered together at the moment if it is not possible to distinguish between heroin and other opiates then it is open for the Department to decide whether or not to include morphine in the legislation They could decide that the disbenefits of including it would outweigh the benefits

He noted that the reason medications remain included is that there are problems with abuse for example with Benzodiazepines which are known to cause road safety problems Just because a controlled drug can be prescribed does not mean it will be removed from the legislation There will be a differentiation between a medical level at which someone must not drive and where they should not drive

Xx noted that Napp wants to work with the Government so that morphine can be included in the list of controlled substances By introducing an exemption or at least taking the burden of proof off the patient this could be done

DP said that the offence has a wide remit and there is a defence where they would like to include taking medication in accordance with medical advice There is a strong burden of proof on the prosecution to put evidence to the courts

Xx noted that the patient has to substantiate the proof first Xx added that patients already have a poor quality of life and this puts them under more stress Xxx said that pain is costing the country pound13bn a year and the Government has only recently decided to deem pain a long term condition and to work to help people have a good quality of life This seems like a backward step Doctors have been campaigning for years to get pain recognised and this is therefore a concern for them too as it may interfere with their choice of treatments

Xx said that with a few tweaks to the legislation the burden of proof could be placed on the prosecution For example by adding the word lsquoknowinglyrsquo to protect patients who were unaware of any advice against driving This would reassure them that a prescription will mean that they are protected Xx added that xxx has already had patient groups coming to her who are concerned that they are going to have to fight again

Xx noted that there is the issue of the lsquoknock onrsquo impact of one case highlighted by the media which could lead to patients becoming more cautious about taking their medication

DP said that he thought the Panel was unlikely to recommend low threshold levels He said that they have looked at the amendments tabled and they had material prepared for the Committee Stage of the legislation which was not needed and will be used to inform the informal discussion among peers in October He added that he feels the burden of proof leans towards the prosecution Once the prescription is presented it is down to the prosecution to prove beyond reasonable doubt that the medication was not taken properly For example one way would be if they can show that the blood level of a drug was in excess of the level prescribed

17

Xx raised concerns that cautious drivers may be wrongly pulled over by police and that it will be difficult for them to prove that they were unimpaired DP said that there are a swathe of issues about how far along the process people will be taken The balance is broadly right in the defence and if a case did go to court it would be resolved in the right way

DP noted that he is aware of the problems with testing procedures and that it is a genuinely difficult area Xx added that there are also concerns about those involved in a car crash and the insurance implications for a patient if they are the innocent party but test positively for drugs

DP said that is the situation already with the existing law and that there is currently a big drop off of cases before they reach the courts let alone conviction This is partly why the new offence is needed to target illegal drug users This issue is already there Xx acknowledged this but noted that the risk for patients would be heightened and that legislation designed to give police powers to stop drug abusers from driving should not spill over to impact on patients and make them worry about driving

Xx noted xxxx xxxxx xxxxx recent lsquoFit for Workrsquo report which showed that the main problem for the workforce is low back pain therefore many more people could be forced to stop work if they felt that by taking their medication it could mean that they are not deemed fit to drive

It was also noted that in the first stages of pain patients will seek pharmacist advice and use low doses of codeine to manage their pain There are 8m Osteoarthritis sufferers in the UK and over 70 report that they are in constant pain They typically start with over-the-counter medication including NSAIDS and codeine such as Nurofen Plus They will not have a prescription so how will they fare under the legislation

DP stated that this is partly an issue for the Panel He said he hoped that there is a good swathe of people on the Panel and asked if there is anything that Napp would like to submit to them Xx said there would be and that xxx would liaise with him on behalf of NAPP and feed in any information that would be considered helpful

Xxx noted that there are some concerns about the lack of medicalpainpatient representation on the Panel and that if these groups could feed in to the Panel that would help alleviate some concerns

DP said that the Panel is bringing in materials from other experts and that subject to his clearing it with the Chair they would be very keen to see papers etc The Panel would like to see as much research as possible Although they do not meet on policy there have been a number of issues related to the science of opioids that are of interest Xx asked if it would be helpful to also send the Panel a paper from Napp on where they believe legislation contains areas of risk and burden for patients to make the Panel aware of not only where the legislation can work but also where it could go wrong Xx asked if a pain expert could feed that in DP said case studies on the impact on patients would be helpful but there should be a focus on the science The legal aspects will not concern the Panel They should be happy to receive papers although he will have to talk to the Chair about having any experts appear in front of the Panel Xx assured DP that this would be done if the Chair was in agreement

18

Xx asked for some detail on the practical process of the Panelrsquos work Is the October report interim or final

DP said that it will be an interim report as there may be more work to do afterwards but that it is hoped and expected that the report will cover all the major drug types in the terms of reference They will use the findings across Government and then the decision will be made to move to the consultation The findings will also be communicated to the Committee on the Misuse of Drugs and the MRHA Secretariat representatives from both have been at Panel meetings

The secondary legislation will be in effect from early 2014 The plan is to consult on it in early 2013 and then progress through affirmative procedure in the later part of 2013 It will allow for the possible subsequent inclusion of other drugs

Xx asked about the development of testing devices and their specificity DP said that he is not a technical authority about the machines but does have information on the approval process A decision will be made at the end of the year on those currently going through police stations There will also be the beginning of the process to develop the second generation of roadside testing but the specifications cannot be finalised until the Panel reports These will be threshold detectors not just presentabsent detectors They will cover something related to heroin Legislation has been drafted so that police can undertake multiple preliminary tests as all drugs cannot be tested for at the same time The technology is important as an offence without it would not have the impact hoped for

DP added that other countries have a zero tolerance approach with presentabsent tests but that they want a threshold approach here He said that the legislation is linked to road safety it is not intended to change the law on possession use of drugs It is about public safety The existing penalty regime is not suitable for a zero tolerance approach At the moment crossing the limit means a 12 month driving ban and other consequences which is different to abroad The reason the drink drive limit has not been reduced is because the Government does not want to create a two tier system where the lower limit becomes seen as only equivalent to being given a speeding ticket The penalty for drug driving needs to allow for a more proportionate approach to enforcement At the moment if you are well versed in the law you have a good chance of evading conviction They want to change the balance and do not want to lower the penalty in comparison to drink driving He added that problems with some detection equipment abroad would not be acceptable in the UK legal system especially evidential saliva sampling The technology appears not there yet

DP noted that the Department is also looking at appropriate policy statements to make about the legislation The press has already focussed on areas where the new offence wonrsquot be an impact Xxx said that policy statements would help those patients who are already concerned

DP asked if Napprsquos patients receive unequivocal advice that they can drive Xx said not necessarily The issue is patients do not read advice and if they did they would not necessarily fully understand it It comes down to what the Doctor says but this legislation could then put them in a difficult position too Xx noted that the advice to patients in leaflets for medication regardless of whether they are prescription only medicines or over the counter would have a statement that would alert the patient to potential drowsiness or tiredness and advise that if this symptom was experienced patients should not drive or operate machinery This would be the same advice that clinicians would give to patients

19

about their medication unless as with certain drugs the DVLA should be notified and patients specifically informed that they must not drive whilst taking this medication The onus is on the patient to determine if they have this side effect and to what extent they are impaired DP noted that there is a difference between advice that a patient cannot drive and being told not to drive if they feel drowsy Xxx added that patients on a stable dose will be unsure if they can continue to work have a good quality of life etc and this will lead them to question whether or not to take their medication

DP stated that the Government can provide the context on what they think directions are but this will still be interpreted by a court Xx said publishing that information would provide comfort to patients who are concerned DP said this would be discussed with peers as well

Xx asked who will be invited to the informal discussion with peers and MPs DP said it would be just members of the House of Lords and Commons They will be able to meet with the Panel and other Government experts Xx noted that this would be useful for peers as those Napp has spoken to have had answers to initial questions but there are still areas where they would like some clarification DP noted that he and the Lords Spokesperson met with interested peers in advance of the Committee Stage It is easier to provide more factual clarification informally than on the floor of the House and Spokespeople will value the chance to make some progress before the Report Stage

Xx confirmed that Napp would put together some helpful information for DP to pass on to the Panel and will bring in some experts to feed in to that Xx added that Napp would be happy to feed in to any policy statements etc DP said he would be happy to clarify any issues in writing Xx said Napp would put together a list of questions for DP for this Xx said xxx would involve patient groups here too

Xx asked if there has been any input in the policy from the Department for Health DP said that a quadrilateral working group from Transport Justice Home and Health are working on the policy They have met between Panel meetings to see what is said and if there are any issues to put to the Panel

Xx asked if there is anything else Napp can do DP said that the more specific Napp can be about concerns evidence on the effect of treatments on impairment etc that would be helpful The policy is very much at the evidence gathering stage at the moment

Xx reiterated Napprsquos concerns regarding the Panel membership

DP said that at some point he expected tough decisions will be made about the balance of the proscons of the policy issues No solution will tick every box

Xx said that policy statements will be key to giving the police and the CPS guidance on who they are targeting as well as what lsquodirectionsrsquo mean to allay the fears of patients and clinicians DP said he hoped they would be able to allay fears He added that there is no advantage for the police to have lots of people in stations and being processed who are not impaired There is a realistic policy possibility that heroin will have to be set aside Just because the Panel is looking at it does not mean there is a commitment that it will be in the new offence They know that there may be no test to distinguish between different types of opiates

20

Xxx passed on two emails which he explained were from xx xxxxxxx xxxxxxx and xx xxxxxx xxxxxxxxn representing the views of CPPC and RCGP respectively Both Doctors expressed their concerns for patients and offered to contribute to discussions on the proposed legislation

A Note of Napprsquos Key Concerns

Napp Pharmaceuticals Meeting with Department for Transport 31 July 2012

Note I have added in bold italicised text some DfT responses to the questions in your original note which is otherwise as you sent me ndash Duncan Price 2882012

A Statement of support for drug driving legislation to stop people from driving while under the

influence of illegal drugs

Napp is concerned about the unintended consequences of the legislation on patients taking

long‐term medication for chronic pain Napp wants to work with the Government to find a

solution

1) Impact on Patients

2) Criminalisation of Patients

3) Different to Drink Driving Law

4) Policeable Offence

B Outline of Concerns

1) Impact on Patients

Evidence shows that patients on a stable dose of opioid analgesics are not necessarily

impaired but under the proposed system patients may be inaccurately identified as taking

impairing drugs and face prosecution

Patients well established on a stable dose of an opioid analgesic may have levels of

metabolites in their system well above any threshold used for roadside and police station

testing This means they could face serious charges despite driving unimpaired

There are concerns for patients such as those with Osteoarthritis the majority of who use

over the counter medications to manage their pain

Concern that patients will stop taking their medication so that they can drive This may

make their driving more impaired as a result of the pain that they will be under

Questions

Has there been consideration of how to distinguish between opiates that are used legally

for medicinal purposes and those used illegally (Napp would be happy to share clinical

knowledge of opioids that may be helpful to the panel and to any other interested parties

in Government)

The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

21

The panel is considering natural and synthetic opioids Its terms of reference include that it should establish the likelihood of whether concentrations of drugs broadly equivalent in their impairment effects to blood alcohol concentrations of 20 50 and 80mg100ml would be exceeded This will include a consideration of prescribed or otherwise legally obtained drugs which are known to impair driving

The panel will advise the Government which will then itself consider what specified limits to propose and then consult about I can assure you that in doing so it will consider how screening equipment and evidential blood specimens would distinguish between opiates used for legitimate medical purposes and those used illicitly

I am grateful for the offer of sharing clinical knowledge you made when we met I know the panel has since considered some of the evidence your experts have provided and some of its members have met an expert you recommended and one of your legal advisors

Has there been consideration of just introducing a list of restricted drugs known to be used

recreationally as with the Australian model

The list of restricted drugs used in some states in Australia does include THC (the active ingredient of cannabis) which does have some limited medical uses here The Governmentrsquos prime targets for this legislation are controlled drugs often or exclusively used illicitly including those included in the Australian legislation (THC amphetamines and MDMA)

At this stage we are awaiting advice from the panel but the Governmentrsquos position is that it should develop a new offence with the potential to include a number of categories of drug including benzodiazepines and opiates The abuse including the use of high quantities of methadone and some benzodiazepines (which can be prescribed) appears (alongside heroin) to be a significant contributor to the public safety problems this legislation is addressing

Many of the drugs specifically identified in the panelrsquos terms of reference are used exclusively or predominantly illicitly ndash for example amphetamine-types cannabinoids cocaine and hallucinogens

There is a reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

22

We are therefore using the definition of lsquocontrolled drugrsquo in the Misuse of Drugs Act 1971 within the new offence although which controlled drugs will be determined when regulations are brought forward

What consideration have you given to the issue of patients who drive unimpaired but will

still face prosecution if tested as levels of metabolites in their system may be above any

prescribed limit

This is being considered in both the terms of reference for the technical panelrsquos advice about the setting of specified limits (to keep patients out of the scope of the offence) and the inclusion of the medical defence within the offence

The panel has also been asked to consider the degree of variability in impairment effects across the population including for habitual drug users

In the terms of reference for the panel we have also specifically included the following from the North review (paragraph 743)

ldquoSome drugs which may be proscribed for driving might also be used legitimately in accordance with medical advice (for example morphine may be prescribed for chronic pain or diazepam (a benzodiazepine) may be prescribed for anxiety) Indeed the Review recognises that in some circumstances it may be more dangerous for a person to drive having not taken their medically prescribed drug than driving without having taken it Drugs have different effects on different people and levels at which they are prescribed are likely to reflect this It would clearly be wrong to put in jeopardy of prosecution those who are properly and safely taking medically prescribed drugs and driving in accordance with medical advice for whom despite the presence of a proscribed drug there is no evidence of any driving impairmentrdquo

I should also emphasise that the content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

2) Criminalisation of Patients

Statutory defence is included in the current legislation for those who have taken

prescription medication in accordance with prescribersupplier instructions and any

accompanying instructions from the manufacturer BUT

Only applicable after patient has been arrested further tested and their case has

progressed ndash this will cause innocent patients significant stress and

inconvenience

The defence puts the burden of proof on patients to prove that they acted in

accordance with all medical advice when the burden should be on the

prosecution to prove that they didnrsquot

23

Innocent patients may face criminalisation based on a technicality in legislation

that is not intended to target them

Questions

Is an exemption feasible (If not what is going to be done to ensure that patients are

protected)

I do not consider an exemption from the offence for all controlled drugs that can possibly be supplied or used for medical reasons is feasible Many controlled drugs for example cannabis have some medicinal uses

It is perfectly feasible for decisions about which controlled drugs would be specified for the new offence to be influenced by the reasons for whether their use is often always seldom or never for medical reasons Indeed such distinctions would be vital if this legislation were being introduced to enforce further against the illegal supply or use of controlled drugs

Whether that is the right approach to decision-making related to driving with controlled drugs in the body where there are levels associated with elevated risks to public safety is however questionable This legislation is being introduced to address road safety problems and the expert panelrsquos terms of reference are focussed on providing advice about the risks of driving after taking controlled drugs

It is to no-onesrsquo benefit for patients who are innocent of the offence to be arrested and tested There are several protections in place to reduce these risks Firstly police do not have random testing powers for drink and drug driving Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving

under the influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would result in disproportionate and large numbers of patients having evidential blood tests but then being not guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

24

It is important to note that the prosecution for a case where a defence has been raised that a patient had taken a controlled drug in accordance with medical advice must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code Test about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

It is important now and it will be important with the new offence in place that medical advice does not suggest to patients that they drive when doing so would present a significant risk to themselves and the public To do so risks patients being involved in road traffic incidents and also committing the existing offence of driving whilst impaired due to drugs

3) Different to Drink Driving Law

There have been calls for a strict liability approach to drug driving as exists for drink

driving Napp believes this would not be a suitable approach for drug driving based on the

current draft Bill

Alcohol does not have any medical necessity people do not need to consume

alcohol to ensure that a chronic condition does not prevent them from

functioning on a daily basis

Prescription medications that patients may take to treat chronic pain are a

medical necessity and are essential to ensuring that they are able to function on a

daily basis

A strict liability approach could lead to patients not taking essential medication in

order to be able to drive without fear of prosecution

Alternatively patients may choose not to drive at all which could have a serious

impact on their ability to work and go about their daily lives

Questions Is an exemption feasible (If not what is going to be done to ensure that patients are protected)

There are some useful analogies with drink driving law For example prior to the introduction of the specific drink driving offence the law in relation to drink drivers was difficult to enforce The specific offence there has contributed to major improvements in public safety

I do accept one of the differences with some controlled drugs is that some people take them for medicinal not recreational purposes This is not the case for all controlled drugs This may well affect what is included in the regulations for the offence

25

When we met I did say that it is conceivable for even as prevalent a recreational drug as heroin to not be included in the regulations for the offence This might be if it transpired that a limit relevant to heroin had to be set in a metabolite itself used in or a metabolite of a medically prescribed drug If such a limit also then had the effect of criminalising driving with medically supplied controlled drugs when that did not present an elevated risk to public safety I can see it would be a limit we might well not implement However I await the advice of the expert panel to see what it recommends related to heroin and whether (and how) that might affect other opiates

4) Policeable Offence

It is argued that drivers wonrsquot be stopped by police unless they appear impaired BUT

Plans are to test all those involved in a traffic accident for drugs including

innocent parties An innocent unimpaired patient involved in a crash through no

fault of their own could then face serious charges

Impairment is subjective and police may be suspicious of someonersquos driving for a

number of reasons such as driving too cautiously This apparently lsquoimpairedrsquo

driving may be due to various factors unrelated to the driverrsquos use of prescribed

medication but if they are stopped by police they may find themselves facing

serious and unjust charges

The existing impairment offence will remain so police will still be able to catch

those who do drive while impaired by prescription medication

Questions How close is the Home Office to approval of a drug testing device for use in police stations Can you provide any details

The laboratory testing phases of the type approval process is under way and the process is due to be completed at the end of this year

Is the Home Office still aiming for a 2014 approval of a drug testing device for portable use

It is still aiming for 2014 for these devices and we are planning the timing of that process together with the work on the new offence

Since the Governmentrsquos response to the North Review in June 2010 has the drug driving data quality improved

Yes we have received more information from Coroners recently and we also have had the conclusions of the European DRUID research

C Solutions

Napp believes that the best way to protect patients is by introducing an exemption for

those who can demonstrate that they are taking prescription medication

Existing legislation against driving while impaired would allow police to charge

anyone who did drive while under the influence of impairing prescription

medication

26

This would put the burden of proof on prosecutors saving innocent patients

considerable stress inconvenience and wasted CPS and police time

The Department considers that the statutory defence affords appropriate protection to patients who drive after taking prescription medication

The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

D Other Points for Consideration

Napp is keen to support this legislation in its efforts to stop users of illegal drugs

from driving and wishes to support policy development to ensure that patients are

protected Napp would be keen to provide any further information or other

means of assistance that could be of help here

Napp would like to submit written andor oral evidence to the Expert Panelrsquos

inquiry

Napp is concerned about the lack of pain expertise and patient representatives on

the Expert panel

Lord Henley mentioned that a seminar might be held after the summer recess to

discuss the issues arising from this legislation further Napp would be keen to

receive any further information on this

I hope this has been covered satisfactorily in the discussion we had on 31st July and since then

I do consider the legislation has strong safeguards in place for patients The Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

I hope I have addressed at least some of your concerns I should be happy to discuss the issues further

Duncan Price 2882012

27

Note on controlled drugs with medical uses

(i) The reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

(ii) Circumstances in which drug testing can be administered Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under the

influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

(iii) The medical defence The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

(iv) Drugs to be covered by the new offence and any specified limits to be based on expert advice The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

(v) Other controls The content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

(vi) Prosecutions to be in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

(vii) In light of the above the Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

28

From DuncanPricedftgsigovuk Sent 13092012 1603 To xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Cc xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Subject RE NRAS - Crime and Courts Bill clauses on drug driving

Xxxxxx

Below is my draft response to this letter Irsquoll send it when I have your comments about it

Dear xx xxxxxxx

Xxxxxx xxxxxxxx has forwarded your email of 28th August to me I am the lead policy official for the legislative clause about drug impaired driving in the Crime and Courts Bill

I am aware of concerns about innocent motorists taking prescribed medications being stopped tested being taken to police stations having blood samples taken and possibly going to court before being exonerated This is not the intention of the legislation and I can assure you we are mindful of this concern as we progress the legislation and respond to advice from an expert panel about the details

There are several protections in place to reduce the risk of large numbers of innocent motorists being arrested and taken to police stations

Firstly motorists cannot be stopped randomly for drug tests Testing can only be administered in three circumstances ndash namely where a driver has committed a moving traffic offence

a driver has been involved in a road traffic accident and or

there is reason for a police officer to suspect that a person has been driving under the influence of drink or drugs

This means that in practice drivers taking prescribed medicines would not be stopped and required to undergo drug testing without there being real cause for concern Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would be likely to result in disproportionate and large numbers of people prescribed drugs having evidential blood tests but then not being found guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

Fourthly it is important to emphasise that the prosecution for a case where the medical defence has been raised must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code for Crown Prosecutors which contains a requirement about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

Finally in the context of the clause before parliament the content of the regulations (specifying which controlled drugs should be covered by the new offence and the limits to be specified for them) will be the subject of public consultation Before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of

29

Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

I hope that this letter serves to allay concerns about possible unintended consequences for people taking prescription medicines

Duncan Price Tel 020 7944 xxxx Department for Transport

From JessicaMatthewdftgsigovuk Sent 17 October 2012 1108 To xxxxxxxxxxxxadhgsigovuk Cc xxxxxxxxxxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxxxxxdhgsigovuk xxxxxxxxdhgsigovuk Subject Re Department of Health attendance at the Lords briefing for the drug driving legislation

Xxxxxxxx is out of the office today but wersquoll send over the time and venue tomorrow and share the briefing with you Irsquod be happy to brief Dr Prunty beforehand ndash perhaps over the phone

Wersquore planning on a reasonably open debate about the legislation We wonrsquot have got policy clearance on the amendments to the legislation but wersquore inclined to say that the Government is minded to or is considering x y or z

Happy to discuss

Jessica Matthew Deputy Director Road User Licensing Insurance and Safety Tel 020 7944 xxxx Zone 321 Great Minster House 76 Marsham Street London SW1P 4DR

Extract of Briefing shared with DH from the above e-mail

How will you make sure that people taking medication in accordance with their prescription arenrsquot arrested and taken to court as a result of this legislation

The medical defence in the provisions provides substantial and appropriate protection for people taking medically prescribed or supplied controlled drugs It places an evidential burden on a person accused of committing the offence So the accused must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court It is then for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on

It is unlikely that a person taking medication in accordance with their prescription would be taken to court for a number of reasons

30

1 Motorists cannot be stopped randomly for drug tests They can only be tested where They have committed a moving traffic offence They have been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under

the influence of drink or drugs

2 The drugs to be included in the legislation and their limits will be set in regulations The content of the regulations will be the subject of public consultation and an affirmative resolution This will provide an opportunity for any concerns with the proposed specified limits to be raised and carefully considered

3 The expert panel is bearing in mind the normal therapeutic ranges and expected drug concentrations in blood when setting limits for those drugs that may also be used for medicinal purposes This means that only patients on unusually high doses of medication might have a positive screening and proceed to evidential blood test

4 Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any cases before they reach the court Indeed there is a Code for Crown Prosecutors which contains a requirement that prosecutions are in the public interest

From xxxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 29 November 2012 1422 To xxxxxxxdhgsigovuk xxxxxxxxxpsncorguk xxxxxxxxxxxxxtheccaorguk xxxxxxxxxxnpacouk xxxxxxxxxxxxrpharmscom xxxxxxxxxxxsaddactionorguk xxxxxroadsafecom xxxxxxxxxxxxxxxxxxsdrconsortiumorg xxxm-allianceorguk xxxxxxxxxxxturning-pointcouk xxxxxxxxROSPAcom xxxxxxxxxxxxxxxxtheAAcom xxxxxxxxxacpopnnpoliceuk adminactionaddictionorguk xxxxxxxxxageukorguk xxxxxxxxxxxbrakeorguk xxxxxxxxbmaorguk xxxxxxxxxxxbritishpainsocietyorg xxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxcpsgsigovuk xxxxxxxxdrugscopeorguk xxxxxxxxxiamorguk xxxxxxxxxxxxxxlawsocietyorguk xxxxxxxxxxxliberty-human-rightsorguk xxxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxxpactsorguk xxxxxxxxxxparliamentuk xxxxxxxxxxxxRACFoundationorg xxxxxxxxxxdurhamgovuk xxxxxxxxxxxxxxxxPolicyConnectorguk xxxxxxxxxxxxxxpsncorguk xxxxxxxxxxxxxdvlagsigovuk Xxxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxhomeofficegsigovuk xxxxxxxxnpacouk xxxxxxxxxxxxdhgsigovuk xxxxxxxxxdrugscopeorguk Cc xxxxxxxxxxxxxxxxxxxdftgsigovuk JessicaMatthewdftgsigovuk xxxxxxxxxxxxxxxxxxdftgsigovuk Subject Drug driving seminar presentation

Dear all

Many thanks to those of you who were able to attend our Drug Driving Stakeholder Seminar last week

We hope you found as useful as we did

Please find attached a copy of the presentation as promised

Kind regards

Xxxxxx xxxxxxx

31

Working Group on Drug Driving ndash note of 20 July 2012 meeting

Attendees Duncan Price (DfT) Xxxxxxx xxxxxxxxxxxxx (DfT) Xxxx xxxxxxxxxxxx (DoH) Xxx xxxx (DoH) Xxxxxxx xxxxx (HO) xxxxxxxxxxxxxxxxx (HO) xxxxxx xxxx (MoJ)

Duncan Price provided an update on the Lords Committee stage and summarised the amendments tabled Key issues were controlled drugs used for clinical purposes and concerns about zero-tolerance levels A Hansard link had been circulated Duncan Price xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxx The report stage was likely to be around 7 November

Duncan Price informed the group that the drug driving panelrsquos xxxx xxx xxxxx would be briefing interested members of the House of Lords on 24 October about the panelrsquos work Xxxx xxxxxxxxx asked to be invited to that briefing

Duncan Price set out the high level timeline for the introduction of the new offence The Bill would go to the Commons either before or after Christmas The specification for mobile drug screening devices would be informed by the expert panelrsquos recommendations for the types of drugs and limits to be covered by the offence The type approval process for those devices could then run in parallel with the public consultation on the draft regulations The new offence could then commence in around the middle of 2014

It was agreed that work on the next stage impact assessment would be taking forward in close collaboration with the MoJ Home Office and DoH

12

Working Group on Drug Driving ndash draft note of 17 August 2012 meeting

Attendees Xxxx xxxxxxxxxxx (DoH) Xxx xxxx (DoH) Xxxxxx xxxxxx (HO) Xxxxxxxx xxxxxxxx (HO) Xxxxxxxxxx xxxx (HO) Xxxxx xxxxxx (MoJ for xxxxxx xxxx) Duncan Price (DfT) Xxxxxxx xxxxxxxxxxxx (DfT) Xxxxxxx xxxxx (DfT)

Duncan Price explained that the CPS and ACPO were being consulted about a possible change in the legislation to accept blood only evidential samples and not urine (which was not reliable to detect all drugs) or saliva or sweat Saliva and sweat if included would have to be as a theoretical future option until effective testing could be established (HO and DH agreed to approach contacts in Australia Belgium and US for data)

The Explanatory Note has now had comments from DfT legal Duncan Price will send out a redrafted version to the group for further comments

Discussions were still ongoing as to whether it would be possible to specify measurable levels in blood for all the controlled drugs of interest or whether provision should be made to enable levels to be specified in metabolites (provided these can be specifically related back to a controlled drug) Likewise consideration was being given for variable limits (dependent on alcohol levels) (Note the expert panelrsquos meeting of 21st August suggested a specified limit in a metabolite (itself not a controlled drug) might be appropriate in respect of cocaine rather than the drug itself)

Duncan Price suggested that the amendments made at Lords Committee stage related to medicinal uses of drugs would be problematic He was continuing to consider whether and how the panelrsquos emerging conclusions or policy assurances would be relevant to concerns expressed including in the NAPP briefing paper He had also met with representatives of NAPP and they had put some experts in touch with the expert panelrsquos chair

DfT will provide an update on drug driving to the 11th October ACMD Council meeting Jeremy Mean will need to advise when the MHRA could be updated

The group suggested an update should be provided for the 7 November Inter-ministerial group on drugs

Duncan Price also promised to send the group a first draft of ldquoEnforcement Procedures against Drink Drivers and Other Offenders ndash A Consultation Documentrdquo (Proposed Changes in Legislation for Testing Procedures for Drink and Drug Driving and in Other Transport Sectors and for Remedial Training for Road Traffic Offenders) This document covers the legislative changes contained in the Governmentrsquos response to the North review (other than the new drug driving offence)

[Post meeting note this document was sent on 21 August with initial comments requested by 31 August]

13

From DuncanPricedftgsigovuk Sent 30082012 1450 To xxxxxxxxxxxdhgsigovuk Cc xxxxxxxxxxxxxxxxxdftgsigovuk Subject Fw Meeting with Napp Pharmaceuticals

xxxxxxx

I attach in respect to briefing for Ann Miltonrsquos planned meeting with NAPP on 23rd October the following

- a note of NAPPrsquos key concerns (as they drafted them) plus my response - a letter Earl Atlee to NAPP - the draft sent to Lord Henleyrsquos office for signature to Lord Luce about similar issues - the note of the meeting NAPP had with me (it is NAPPrsquos note with my comments) - an internal note about controlled drugs for medical uses

The notes we did on the amendments made at Committee stage for Ministers cover some of the NAPP issues but I havenrsquot enclosed them as I have sent quite a lot already ndash but yoursquore welcome to a copy if you want one

Duncan Price Tel 020 7944 2241 Department for Transport

Note of the Meeting

Napp Pharmaceuticals and Department for Transport Meeting on Drug Driving 31 July 2012

Attendees Duncan Price Deputy Director Road User Licensing Insurance amp Safety (DP) Xxx xxxxxxxx Department for Transport Xxxxxx xxxxx Napp Pharmaceuticals Xxxxxx xxxxxxxxxxxxx Napp Pharmaceuticals Xxx xxxxxx Napp Pharmaceuticals Xxxx xxxxxx Ranelagh International Xxxxxxx xxxxxx Ranelagh International (RB)

Xxx began the meeting by providing a brief background on Napp xx noted that the company has been in Cambridge for thirty years and is well-known for its range of pain medications and in particular strong opioids Napp has helped to revolutionise the management of cancer and chronic pain through the development of various slow release and round the clock formulations Now the company is also moving into respiratory medicine and other areas It employs approximately 1100 people and is fifteenth in terms of GP prescription sales Xxx noted that Napp is interested in drug driving because of the impact legislation may have on patients

14

DP said that he is leading on drug driving policy and that the legislation currently going through Parliament is one of three pieces of work the Department is taking forward together The current proposals are enabling legislation which will allow the Government to determine the details critical to the new offence once the Expert Panel has published its recommendations DP suggested that the Expert Panelrsquos interim advice would be available in October

Xx noted that Napp is fully in support of the legislation and what it is trying to achieve but there are a few unintended consequences that it may cause for both manufacturers and patients Xx raised concerns about the impact on legitimate patients on a stable dose of medication that may be affected by legislation designed to target those who abuse illegal and legal drugs Xx added that Napp is in contact with a number of clinicians and other experts who would be happy to feed in to this policy development

Xx raised the issue of patients who are unimpaired being criminalised and facing a significant burden of proof if the proposed legislation is passed As the legislation is currently proposed there is a defence for patients taking prescription medication but the burden is first with them to prove that they have taken their medication is accordance with all instructions including from manufacturers There is a significant onus on patients to show they are not impaired despite what police say The defence is really only available once the driver is in court

Xx then compared the proposed legislation to the drink driving laws and highlighted the differences to drug driving legislation and the issue of strict liability Could the legislation be more focussed on its intended aim and tailor the list of controlled substances to those known to be abused as opposed to a catch all approach There needs to be protection for patients but at the moment the legislation appears to be trying to do both

Xx also noted the importance of ensuring that this is a policeable offence In the Governmentrsquos response to the North Review there was discussion of the Australian approach to drug driving Police found the impairment side of legislation hard to prove so they have instead just used the strict liability approach to prosecute drivers based on detection of a controlled substance

DP noted that all of the issues raised by xx are important What is being discussed in Parliament at the moment is enabling legislation which is setting out the framework The detail will become clearer once the interim advice from the Expert Panel has been received which is due in October The Department has already started to give some assurances in certain areas for example a zero tolerance approach for cannabis has been ruled out They will be able to home in as more advice is received from the Panel although it is not possible to pin the Panel down until it has reported DP added that there will be informed discussions with peers in late October before the legislation goes to Report Stage

Xx asked if the Panelrsquos advice will have any influence on the current draft Bill Xx asked if it would be worth making the primary legislation more focussed for example on substances known to be abused which would allow for strict liability The problem for patients would then become irrelevant as they would not be the focus of the legislation Xx also noted the problem that will arise from including heroin on the list of controlled substances Heroin metabolises into morphine in the blood as do some over-the-counter medications which makes it hard to distinguish between the different drug types This will lead to unintended consequences for patients

15

DP stated that he understood this argument but noted that the legislation is intended to be fit for purpose to allow for the whole range of potential decisions the Panel could make The decision might be made to change the substances on the controlled list although nothing so far has led him to think something should change The current list links back to the range included in the Misuse of Drugs Act The advice on the drugs will feed into the consultation and the subsequent affirmative procedure

DP added that because of the enabling nature of the current legislation there are some problems for example legal highs are not included on the list of controlled substances at the moment Due to the nature of the legislative procedure it can take a while to identify a problem and then legislate to give police powers They expect legal highs can become controlled drugs if they have protracted and serious consequences in a quicker time than the duration of the regulation-making process for drug driving There are powers to apply the legislation to all controlled drugs but they will need to go through it controlled drug by controlled drug in order to determine specific limits etc The Government envisages a mixed economy of the new and the existing offence

DP said that heroin is one drug of significant interest as it is known to be prevalent and associated with road safety risks The Panel are looking at opiates as a group of drugs and it will be for the Panel to decide how it can be detected He noted that they will need to consider all potential effects before setting any levels DP said that he knows that this is an area of importance for Napp as their patients will have a tolerance which is highly relevant to these considerations He would expect the Panel to look at that The Department wants the Panel to look at the opiate family so they do not only consider heroin

Xx said that the higher level of metabolites is an issue but these patients will be unimpaired where as a heroin user trying to get high is very different In terms of the defence the burden of proof lies on the shoulders of the patient Has the Department considered eliminating the impairment element and introducing an exemption for patients

DP responded that they have been considering all areas when looking at the medical defence Drink heroin and medically prescribed opiates have some similarities and also some important differences With alcohol some people who are over the limit will say they are unimpaired but the risks do increase as blood alcohol levels increase This can be the same with drugs

Xx noted that when a patient is on a steady dose of medication the pain they would be under if they were to stop taking their medication could be more impairing

DP said that he recognises the differences to drink driving Heroin users and medication users have different tolerances to ordinary people and the lsquodrink driving analogy is limitedrsquo Drinking has social benefits and it is a choice for people

Xx added that Napp sees that there is a desire to make drug like drink driving something that society will not tolerate but patients have to take their medication There is existing legislation against impairment for those who are irresponsible when taking their medication At the moment patients are being brought down to the lowest common denominator of those who abuse drugs This minority is causing problems for everyone else

16

Xxx noted that unlike with drink driving where increased alcohol leads to increased impairment there is not increased impairment with a high but stable dose of prescription medication Xx added that he believes there is a Swedish study which has investigated levels of impairment in patients

DP stated that although the opiate family is being considered together at the moment if it is not possible to distinguish between heroin and other opiates then it is open for the Department to decide whether or not to include morphine in the legislation They could decide that the disbenefits of including it would outweigh the benefits

He noted that the reason medications remain included is that there are problems with abuse for example with Benzodiazepines which are known to cause road safety problems Just because a controlled drug can be prescribed does not mean it will be removed from the legislation There will be a differentiation between a medical level at which someone must not drive and where they should not drive

Xx noted that Napp wants to work with the Government so that morphine can be included in the list of controlled substances By introducing an exemption or at least taking the burden of proof off the patient this could be done

DP said that the offence has a wide remit and there is a defence where they would like to include taking medication in accordance with medical advice There is a strong burden of proof on the prosecution to put evidence to the courts

Xx noted that the patient has to substantiate the proof first Xx added that patients already have a poor quality of life and this puts them under more stress Xxx said that pain is costing the country pound13bn a year and the Government has only recently decided to deem pain a long term condition and to work to help people have a good quality of life This seems like a backward step Doctors have been campaigning for years to get pain recognised and this is therefore a concern for them too as it may interfere with their choice of treatments

Xx said that with a few tweaks to the legislation the burden of proof could be placed on the prosecution For example by adding the word lsquoknowinglyrsquo to protect patients who were unaware of any advice against driving This would reassure them that a prescription will mean that they are protected Xx added that xxx has already had patient groups coming to her who are concerned that they are going to have to fight again

Xx noted that there is the issue of the lsquoknock onrsquo impact of one case highlighted by the media which could lead to patients becoming more cautious about taking their medication

DP said that he thought the Panel was unlikely to recommend low threshold levels He said that they have looked at the amendments tabled and they had material prepared for the Committee Stage of the legislation which was not needed and will be used to inform the informal discussion among peers in October He added that he feels the burden of proof leans towards the prosecution Once the prescription is presented it is down to the prosecution to prove beyond reasonable doubt that the medication was not taken properly For example one way would be if they can show that the blood level of a drug was in excess of the level prescribed

17

Xx raised concerns that cautious drivers may be wrongly pulled over by police and that it will be difficult for them to prove that they were unimpaired DP said that there are a swathe of issues about how far along the process people will be taken The balance is broadly right in the defence and if a case did go to court it would be resolved in the right way

DP noted that he is aware of the problems with testing procedures and that it is a genuinely difficult area Xx added that there are also concerns about those involved in a car crash and the insurance implications for a patient if they are the innocent party but test positively for drugs

DP said that is the situation already with the existing law and that there is currently a big drop off of cases before they reach the courts let alone conviction This is partly why the new offence is needed to target illegal drug users This issue is already there Xx acknowledged this but noted that the risk for patients would be heightened and that legislation designed to give police powers to stop drug abusers from driving should not spill over to impact on patients and make them worry about driving

Xx noted xxxx xxxxx xxxxx recent lsquoFit for Workrsquo report which showed that the main problem for the workforce is low back pain therefore many more people could be forced to stop work if they felt that by taking their medication it could mean that they are not deemed fit to drive

It was also noted that in the first stages of pain patients will seek pharmacist advice and use low doses of codeine to manage their pain There are 8m Osteoarthritis sufferers in the UK and over 70 report that they are in constant pain They typically start with over-the-counter medication including NSAIDS and codeine such as Nurofen Plus They will not have a prescription so how will they fare under the legislation

DP stated that this is partly an issue for the Panel He said he hoped that there is a good swathe of people on the Panel and asked if there is anything that Napp would like to submit to them Xx said there would be and that xxx would liaise with him on behalf of NAPP and feed in any information that would be considered helpful

Xxx noted that there are some concerns about the lack of medicalpainpatient representation on the Panel and that if these groups could feed in to the Panel that would help alleviate some concerns

DP said that the Panel is bringing in materials from other experts and that subject to his clearing it with the Chair they would be very keen to see papers etc The Panel would like to see as much research as possible Although they do not meet on policy there have been a number of issues related to the science of opioids that are of interest Xx asked if it would be helpful to also send the Panel a paper from Napp on where they believe legislation contains areas of risk and burden for patients to make the Panel aware of not only where the legislation can work but also where it could go wrong Xx asked if a pain expert could feed that in DP said case studies on the impact on patients would be helpful but there should be a focus on the science The legal aspects will not concern the Panel They should be happy to receive papers although he will have to talk to the Chair about having any experts appear in front of the Panel Xx assured DP that this would be done if the Chair was in agreement

18

Xx asked for some detail on the practical process of the Panelrsquos work Is the October report interim or final

DP said that it will be an interim report as there may be more work to do afterwards but that it is hoped and expected that the report will cover all the major drug types in the terms of reference They will use the findings across Government and then the decision will be made to move to the consultation The findings will also be communicated to the Committee on the Misuse of Drugs and the MRHA Secretariat representatives from both have been at Panel meetings

The secondary legislation will be in effect from early 2014 The plan is to consult on it in early 2013 and then progress through affirmative procedure in the later part of 2013 It will allow for the possible subsequent inclusion of other drugs

Xx asked about the development of testing devices and their specificity DP said that he is not a technical authority about the machines but does have information on the approval process A decision will be made at the end of the year on those currently going through police stations There will also be the beginning of the process to develop the second generation of roadside testing but the specifications cannot be finalised until the Panel reports These will be threshold detectors not just presentabsent detectors They will cover something related to heroin Legislation has been drafted so that police can undertake multiple preliminary tests as all drugs cannot be tested for at the same time The technology is important as an offence without it would not have the impact hoped for

DP added that other countries have a zero tolerance approach with presentabsent tests but that they want a threshold approach here He said that the legislation is linked to road safety it is not intended to change the law on possession use of drugs It is about public safety The existing penalty regime is not suitable for a zero tolerance approach At the moment crossing the limit means a 12 month driving ban and other consequences which is different to abroad The reason the drink drive limit has not been reduced is because the Government does not want to create a two tier system where the lower limit becomes seen as only equivalent to being given a speeding ticket The penalty for drug driving needs to allow for a more proportionate approach to enforcement At the moment if you are well versed in the law you have a good chance of evading conviction They want to change the balance and do not want to lower the penalty in comparison to drink driving He added that problems with some detection equipment abroad would not be acceptable in the UK legal system especially evidential saliva sampling The technology appears not there yet

DP noted that the Department is also looking at appropriate policy statements to make about the legislation The press has already focussed on areas where the new offence wonrsquot be an impact Xxx said that policy statements would help those patients who are already concerned

DP asked if Napprsquos patients receive unequivocal advice that they can drive Xx said not necessarily The issue is patients do not read advice and if they did they would not necessarily fully understand it It comes down to what the Doctor says but this legislation could then put them in a difficult position too Xx noted that the advice to patients in leaflets for medication regardless of whether they are prescription only medicines or over the counter would have a statement that would alert the patient to potential drowsiness or tiredness and advise that if this symptom was experienced patients should not drive or operate machinery This would be the same advice that clinicians would give to patients

19

about their medication unless as with certain drugs the DVLA should be notified and patients specifically informed that they must not drive whilst taking this medication The onus is on the patient to determine if they have this side effect and to what extent they are impaired DP noted that there is a difference between advice that a patient cannot drive and being told not to drive if they feel drowsy Xxx added that patients on a stable dose will be unsure if they can continue to work have a good quality of life etc and this will lead them to question whether or not to take their medication

DP stated that the Government can provide the context on what they think directions are but this will still be interpreted by a court Xx said publishing that information would provide comfort to patients who are concerned DP said this would be discussed with peers as well

Xx asked who will be invited to the informal discussion with peers and MPs DP said it would be just members of the House of Lords and Commons They will be able to meet with the Panel and other Government experts Xx noted that this would be useful for peers as those Napp has spoken to have had answers to initial questions but there are still areas where they would like some clarification DP noted that he and the Lords Spokesperson met with interested peers in advance of the Committee Stage It is easier to provide more factual clarification informally than on the floor of the House and Spokespeople will value the chance to make some progress before the Report Stage

Xx confirmed that Napp would put together some helpful information for DP to pass on to the Panel and will bring in some experts to feed in to that Xx added that Napp would be happy to feed in to any policy statements etc DP said he would be happy to clarify any issues in writing Xx said Napp would put together a list of questions for DP for this Xx said xxx would involve patient groups here too

Xx asked if there has been any input in the policy from the Department for Health DP said that a quadrilateral working group from Transport Justice Home and Health are working on the policy They have met between Panel meetings to see what is said and if there are any issues to put to the Panel

Xx asked if there is anything else Napp can do DP said that the more specific Napp can be about concerns evidence on the effect of treatments on impairment etc that would be helpful The policy is very much at the evidence gathering stage at the moment

Xx reiterated Napprsquos concerns regarding the Panel membership

DP said that at some point he expected tough decisions will be made about the balance of the proscons of the policy issues No solution will tick every box

Xx said that policy statements will be key to giving the police and the CPS guidance on who they are targeting as well as what lsquodirectionsrsquo mean to allay the fears of patients and clinicians DP said he hoped they would be able to allay fears He added that there is no advantage for the police to have lots of people in stations and being processed who are not impaired There is a realistic policy possibility that heroin will have to be set aside Just because the Panel is looking at it does not mean there is a commitment that it will be in the new offence They know that there may be no test to distinguish between different types of opiates

20

Xxx passed on two emails which he explained were from xx xxxxxxx xxxxxxx and xx xxxxxx xxxxxxxxn representing the views of CPPC and RCGP respectively Both Doctors expressed their concerns for patients and offered to contribute to discussions on the proposed legislation

A Note of Napprsquos Key Concerns

Napp Pharmaceuticals Meeting with Department for Transport 31 July 2012

Note I have added in bold italicised text some DfT responses to the questions in your original note which is otherwise as you sent me ndash Duncan Price 2882012

A Statement of support for drug driving legislation to stop people from driving while under the

influence of illegal drugs

Napp is concerned about the unintended consequences of the legislation on patients taking

long‐term medication for chronic pain Napp wants to work with the Government to find a

solution

1) Impact on Patients

2) Criminalisation of Patients

3) Different to Drink Driving Law

4) Policeable Offence

B Outline of Concerns

1) Impact on Patients

Evidence shows that patients on a stable dose of opioid analgesics are not necessarily

impaired but under the proposed system patients may be inaccurately identified as taking

impairing drugs and face prosecution

Patients well established on a stable dose of an opioid analgesic may have levels of

metabolites in their system well above any threshold used for roadside and police station

testing This means they could face serious charges despite driving unimpaired

There are concerns for patients such as those with Osteoarthritis the majority of who use

over the counter medications to manage their pain

Concern that patients will stop taking their medication so that they can drive This may

make their driving more impaired as a result of the pain that they will be under

Questions

Has there been consideration of how to distinguish between opiates that are used legally

for medicinal purposes and those used illegally (Napp would be happy to share clinical

knowledge of opioids that may be helpful to the panel and to any other interested parties

in Government)

The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

21

The panel is considering natural and synthetic opioids Its terms of reference include that it should establish the likelihood of whether concentrations of drugs broadly equivalent in their impairment effects to blood alcohol concentrations of 20 50 and 80mg100ml would be exceeded This will include a consideration of prescribed or otherwise legally obtained drugs which are known to impair driving

The panel will advise the Government which will then itself consider what specified limits to propose and then consult about I can assure you that in doing so it will consider how screening equipment and evidential blood specimens would distinguish between opiates used for legitimate medical purposes and those used illicitly

I am grateful for the offer of sharing clinical knowledge you made when we met I know the panel has since considered some of the evidence your experts have provided and some of its members have met an expert you recommended and one of your legal advisors

Has there been consideration of just introducing a list of restricted drugs known to be used

recreationally as with the Australian model

The list of restricted drugs used in some states in Australia does include THC (the active ingredient of cannabis) which does have some limited medical uses here The Governmentrsquos prime targets for this legislation are controlled drugs often or exclusively used illicitly including those included in the Australian legislation (THC amphetamines and MDMA)

At this stage we are awaiting advice from the panel but the Governmentrsquos position is that it should develop a new offence with the potential to include a number of categories of drug including benzodiazepines and opiates The abuse including the use of high quantities of methadone and some benzodiazepines (which can be prescribed) appears (alongside heroin) to be a significant contributor to the public safety problems this legislation is addressing

Many of the drugs specifically identified in the panelrsquos terms of reference are used exclusively or predominantly illicitly ndash for example amphetamine-types cannabinoids cocaine and hallucinogens

There is a reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

22

We are therefore using the definition of lsquocontrolled drugrsquo in the Misuse of Drugs Act 1971 within the new offence although which controlled drugs will be determined when regulations are brought forward

What consideration have you given to the issue of patients who drive unimpaired but will

still face prosecution if tested as levels of metabolites in their system may be above any

prescribed limit

This is being considered in both the terms of reference for the technical panelrsquos advice about the setting of specified limits (to keep patients out of the scope of the offence) and the inclusion of the medical defence within the offence

The panel has also been asked to consider the degree of variability in impairment effects across the population including for habitual drug users

In the terms of reference for the panel we have also specifically included the following from the North review (paragraph 743)

ldquoSome drugs which may be proscribed for driving might also be used legitimately in accordance with medical advice (for example morphine may be prescribed for chronic pain or diazepam (a benzodiazepine) may be prescribed for anxiety) Indeed the Review recognises that in some circumstances it may be more dangerous for a person to drive having not taken their medically prescribed drug than driving without having taken it Drugs have different effects on different people and levels at which they are prescribed are likely to reflect this It would clearly be wrong to put in jeopardy of prosecution those who are properly and safely taking medically prescribed drugs and driving in accordance with medical advice for whom despite the presence of a proscribed drug there is no evidence of any driving impairmentrdquo

I should also emphasise that the content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

2) Criminalisation of Patients

Statutory defence is included in the current legislation for those who have taken

prescription medication in accordance with prescribersupplier instructions and any

accompanying instructions from the manufacturer BUT

Only applicable after patient has been arrested further tested and their case has

progressed ndash this will cause innocent patients significant stress and

inconvenience

The defence puts the burden of proof on patients to prove that they acted in

accordance with all medical advice when the burden should be on the

prosecution to prove that they didnrsquot

23

Innocent patients may face criminalisation based on a technicality in legislation

that is not intended to target them

Questions

Is an exemption feasible (If not what is going to be done to ensure that patients are

protected)

I do not consider an exemption from the offence for all controlled drugs that can possibly be supplied or used for medical reasons is feasible Many controlled drugs for example cannabis have some medicinal uses

It is perfectly feasible for decisions about which controlled drugs would be specified for the new offence to be influenced by the reasons for whether their use is often always seldom or never for medical reasons Indeed such distinctions would be vital if this legislation were being introduced to enforce further against the illegal supply or use of controlled drugs

Whether that is the right approach to decision-making related to driving with controlled drugs in the body where there are levels associated with elevated risks to public safety is however questionable This legislation is being introduced to address road safety problems and the expert panelrsquos terms of reference are focussed on providing advice about the risks of driving after taking controlled drugs

It is to no-onesrsquo benefit for patients who are innocent of the offence to be arrested and tested There are several protections in place to reduce these risks Firstly police do not have random testing powers for drink and drug driving Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving

under the influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would result in disproportionate and large numbers of patients having evidential blood tests but then being not guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

24

It is important to note that the prosecution for a case where a defence has been raised that a patient had taken a controlled drug in accordance with medical advice must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code Test about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

It is important now and it will be important with the new offence in place that medical advice does not suggest to patients that they drive when doing so would present a significant risk to themselves and the public To do so risks patients being involved in road traffic incidents and also committing the existing offence of driving whilst impaired due to drugs

3) Different to Drink Driving Law

There have been calls for a strict liability approach to drug driving as exists for drink

driving Napp believes this would not be a suitable approach for drug driving based on the

current draft Bill

Alcohol does not have any medical necessity people do not need to consume

alcohol to ensure that a chronic condition does not prevent them from

functioning on a daily basis

Prescription medications that patients may take to treat chronic pain are a

medical necessity and are essential to ensuring that they are able to function on a

daily basis

A strict liability approach could lead to patients not taking essential medication in

order to be able to drive without fear of prosecution

Alternatively patients may choose not to drive at all which could have a serious

impact on their ability to work and go about their daily lives

Questions Is an exemption feasible (If not what is going to be done to ensure that patients are protected)

There are some useful analogies with drink driving law For example prior to the introduction of the specific drink driving offence the law in relation to drink drivers was difficult to enforce The specific offence there has contributed to major improvements in public safety

I do accept one of the differences with some controlled drugs is that some people take them for medicinal not recreational purposes This is not the case for all controlled drugs This may well affect what is included in the regulations for the offence

25

When we met I did say that it is conceivable for even as prevalent a recreational drug as heroin to not be included in the regulations for the offence This might be if it transpired that a limit relevant to heroin had to be set in a metabolite itself used in or a metabolite of a medically prescribed drug If such a limit also then had the effect of criminalising driving with medically supplied controlled drugs when that did not present an elevated risk to public safety I can see it would be a limit we might well not implement However I await the advice of the expert panel to see what it recommends related to heroin and whether (and how) that might affect other opiates

4) Policeable Offence

It is argued that drivers wonrsquot be stopped by police unless they appear impaired BUT

Plans are to test all those involved in a traffic accident for drugs including

innocent parties An innocent unimpaired patient involved in a crash through no

fault of their own could then face serious charges

Impairment is subjective and police may be suspicious of someonersquos driving for a

number of reasons such as driving too cautiously This apparently lsquoimpairedrsquo

driving may be due to various factors unrelated to the driverrsquos use of prescribed

medication but if they are stopped by police they may find themselves facing

serious and unjust charges

The existing impairment offence will remain so police will still be able to catch

those who do drive while impaired by prescription medication

Questions How close is the Home Office to approval of a drug testing device for use in police stations Can you provide any details

The laboratory testing phases of the type approval process is under way and the process is due to be completed at the end of this year

Is the Home Office still aiming for a 2014 approval of a drug testing device for portable use

It is still aiming for 2014 for these devices and we are planning the timing of that process together with the work on the new offence

Since the Governmentrsquos response to the North Review in June 2010 has the drug driving data quality improved

Yes we have received more information from Coroners recently and we also have had the conclusions of the European DRUID research

C Solutions

Napp believes that the best way to protect patients is by introducing an exemption for

those who can demonstrate that they are taking prescription medication

Existing legislation against driving while impaired would allow police to charge

anyone who did drive while under the influence of impairing prescription

medication

26

This would put the burden of proof on prosecutors saving innocent patients

considerable stress inconvenience and wasted CPS and police time

The Department considers that the statutory defence affords appropriate protection to patients who drive after taking prescription medication

The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

D Other Points for Consideration

Napp is keen to support this legislation in its efforts to stop users of illegal drugs

from driving and wishes to support policy development to ensure that patients are

protected Napp would be keen to provide any further information or other

means of assistance that could be of help here

Napp would like to submit written andor oral evidence to the Expert Panelrsquos

inquiry

Napp is concerned about the lack of pain expertise and patient representatives on

the Expert panel

Lord Henley mentioned that a seminar might be held after the summer recess to

discuss the issues arising from this legislation further Napp would be keen to

receive any further information on this

I hope this has been covered satisfactorily in the discussion we had on 31st July and since then

I do consider the legislation has strong safeguards in place for patients The Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

I hope I have addressed at least some of your concerns I should be happy to discuss the issues further

Duncan Price 2882012

27

Note on controlled drugs with medical uses

(i) The reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

(ii) Circumstances in which drug testing can be administered Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under the

influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

(iii) The medical defence The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

(iv) Drugs to be covered by the new offence and any specified limits to be based on expert advice The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

(v) Other controls The content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

(vi) Prosecutions to be in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

(vii) In light of the above the Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

28

From DuncanPricedftgsigovuk Sent 13092012 1603 To xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Cc xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Subject RE NRAS - Crime and Courts Bill clauses on drug driving

Xxxxxx

Below is my draft response to this letter Irsquoll send it when I have your comments about it

Dear xx xxxxxxx

Xxxxxx xxxxxxxx has forwarded your email of 28th August to me I am the lead policy official for the legislative clause about drug impaired driving in the Crime and Courts Bill

I am aware of concerns about innocent motorists taking prescribed medications being stopped tested being taken to police stations having blood samples taken and possibly going to court before being exonerated This is not the intention of the legislation and I can assure you we are mindful of this concern as we progress the legislation and respond to advice from an expert panel about the details

There are several protections in place to reduce the risk of large numbers of innocent motorists being arrested and taken to police stations

Firstly motorists cannot be stopped randomly for drug tests Testing can only be administered in three circumstances ndash namely where a driver has committed a moving traffic offence

a driver has been involved in a road traffic accident and or

there is reason for a police officer to suspect that a person has been driving under the influence of drink or drugs

This means that in practice drivers taking prescribed medicines would not be stopped and required to undergo drug testing without there being real cause for concern Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would be likely to result in disproportionate and large numbers of people prescribed drugs having evidential blood tests but then not being found guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

Fourthly it is important to emphasise that the prosecution for a case where the medical defence has been raised must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code for Crown Prosecutors which contains a requirement about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

Finally in the context of the clause before parliament the content of the regulations (specifying which controlled drugs should be covered by the new offence and the limits to be specified for them) will be the subject of public consultation Before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of

29

Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

I hope that this letter serves to allay concerns about possible unintended consequences for people taking prescription medicines

Duncan Price Tel 020 7944 xxxx Department for Transport

From JessicaMatthewdftgsigovuk Sent 17 October 2012 1108 To xxxxxxxxxxxxadhgsigovuk Cc xxxxxxxxxxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxxxxxdhgsigovuk xxxxxxxxdhgsigovuk Subject Re Department of Health attendance at the Lords briefing for the drug driving legislation

Xxxxxxxx is out of the office today but wersquoll send over the time and venue tomorrow and share the briefing with you Irsquod be happy to brief Dr Prunty beforehand ndash perhaps over the phone

Wersquore planning on a reasonably open debate about the legislation We wonrsquot have got policy clearance on the amendments to the legislation but wersquore inclined to say that the Government is minded to or is considering x y or z

Happy to discuss

Jessica Matthew Deputy Director Road User Licensing Insurance and Safety Tel 020 7944 xxxx Zone 321 Great Minster House 76 Marsham Street London SW1P 4DR

Extract of Briefing shared with DH from the above e-mail

How will you make sure that people taking medication in accordance with their prescription arenrsquot arrested and taken to court as a result of this legislation

The medical defence in the provisions provides substantial and appropriate protection for people taking medically prescribed or supplied controlled drugs It places an evidential burden on a person accused of committing the offence So the accused must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court It is then for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on

It is unlikely that a person taking medication in accordance with their prescription would be taken to court for a number of reasons

30

1 Motorists cannot be stopped randomly for drug tests They can only be tested where They have committed a moving traffic offence They have been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under

the influence of drink or drugs

2 The drugs to be included in the legislation and their limits will be set in regulations The content of the regulations will be the subject of public consultation and an affirmative resolution This will provide an opportunity for any concerns with the proposed specified limits to be raised and carefully considered

3 The expert panel is bearing in mind the normal therapeutic ranges and expected drug concentrations in blood when setting limits for those drugs that may also be used for medicinal purposes This means that only patients on unusually high doses of medication might have a positive screening and proceed to evidential blood test

4 Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any cases before they reach the court Indeed there is a Code for Crown Prosecutors which contains a requirement that prosecutions are in the public interest

From xxxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 29 November 2012 1422 To xxxxxxxdhgsigovuk xxxxxxxxxpsncorguk xxxxxxxxxxxxxtheccaorguk xxxxxxxxxxnpacouk xxxxxxxxxxxxrpharmscom xxxxxxxxxxxsaddactionorguk xxxxxroadsafecom xxxxxxxxxxxxxxxxxxsdrconsortiumorg xxxm-allianceorguk xxxxxxxxxxxturning-pointcouk xxxxxxxxROSPAcom xxxxxxxxxxxxxxxxtheAAcom xxxxxxxxxacpopnnpoliceuk adminactionaddictionorguk xxxxxxxxxageukorguk xxxxxxxxxxxbrakeorguk xxxxxxxxbmaorguk xxxxxxxxxxxbritishpainsocietyorg xxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxcpsgsigovuk xxxxxxxxdrugscopeorguk xxxxxxxxxiamorguk xxxxxxxxxxxxxxlawsocietyorguk xxxxxxxxxxxliberty-human-rightsorguk xxxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxxpactsorguk xxxxxxxxxxparliamentuk xxxxxxxxxxxxRACFoundationorg xxxxxxxxxxdurhamgovuk xxxxxxxxxxxxxxxxPolicyConnectorguk xxxxxxxxxxxxxxpsncorguk xxxxxxxxxxxxxdvlagsigovuk Xxxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxhomeofficegsigovuk xxxxxxxxnpacouk xxxxxxxxxxxxdhgsigovuk xxxxxxxxxdrugscopeorguk Cc xxxxxxxxxxxxxxxxxxxdftgsigovuk JessicaMatthewdftgsigovuk xxxxxxxxxxxxxxxxxxdftgsigovuk Subject Drug driving seminar presentation

Dear all

Many thanks to those of you who were able to attend our Drug Driving Stakeholder Seminar last week

We hope you found as useful as we did

Please find attached a copy of the presentation as promised

Kind regards

Xxxxxx xxxxxxx

31

Working Group on Drug Driving ndash draft note of 17 August 2012 meeting

Attendees Xxxx xxxxxxxxxxx (DoH) Xxx xxxx (DoH) Xxxxxx xxxxxx (HO) Xxxxxxxx xxxxxxxx (HO) Xxxxxxxxxx xxxx (HO) Xxxxx xxxxxx (MoJ for xxxxxx xxxx) Duncan Price (DfT) Xxxxxxx xxxxxxxxxxxx (DfT) Xxxxxxx xxxxx (DfT)

Duncan Price explained that the CPS and ACPO were being consulted about a possible change in the legislation to accept blood only evidential samples and not urine (which was not reliable to detect all drugs) or saliva or sweat Saliva and sweat if included would have to be as a theoretical future option until effective testing could be established (HO and DH agreed to approach contacts in Australia Belgium and US for data)

The Explanatory Note has now had comments from DfT legal Duncan Price will send out a redrafted version to the group for further comments

Discussions were still ongoing as to whether it would be possible to specify measurable levels in blood for all the controlled drugs of interest or whether provision should be made to enable levels to be specified in metabolites (provided these can be specifically related back to a controlled drug) Likewise consideration was being given for variable limits (dependent on alcohol levels) (Note the expert panelrsquos meeting of 21st August suggested a specified limit in a metabolite (itself not a controlled drug) might be appropriate in respect of cocaine rather than the drug itself)

Duncan Price suggested that the amendments made at Lords Committee stage related to medicinal uses of drugs would be problematic He was continuing to consider whether and how the panelrsquos emerging conclusions or policy assurances would be relevant to concerns expressed including in the NAPP briefing paper He had also met with representatives of NAPP and they had put some experts in touch with the expert panelrsquos chair

DfT will provide an update on drug driving to the 11th October ACMD Council meeting Jeremy Mean will need to advise when the MHRA could be updated

The group suggested an update should be provided for the 7 November Inter-ministerial group on drugs

Duncan Price also promised to send the group a first draft of ldquoEnforcement Procedures against Drink Drivers and Other Offenders ndash A Consultation Documentrdquo (Proposed Changes in Legislation for Testing Procedures for Drink and Drug Driving and in Other Transport Sectors and for Remedial Training for Road Traffic Offenders) This document covers the legislative changes contained in the Governmentrsquos response to the North review (other than the new drug driving offence)

[Post meeting note this document was sent on 21 August with initial comments requested by 31 August]

13

From DuncanPricedftgsigovuk Sent 30082012 1450 To xxxxxxxxxxxdhgsigovuk Cc xxxxxxxxxxxxxxxxxdftgsigovuk Subject Fw Meeting with Napp Pharmaceuticals

xxxxxxx

I attach in respect to briefing for Ann Miltonrsquos planned meeting with NAPP on 23rd October the following

- a note of NAPPrsquos key concerns (as they drafted them) plus my response - a letter Earl Atlee to NAPP - the draft sent to Lord Henleyrsquos office for signature to Lord Luce about similar issues - the note of the meeting NAPP had with me (it is NAPPrsquos note with my comments) - an internal note about controlled drugs for medical uses

The notes we did on the amendments made at Committee stage for Ministers cover some of the NAPP issues but I havenrsquot enclosed them as I have sent quite a lot already ndash but yoursquore welcome to a copy if you want one

Duncan Price Tel 020 7944 2241 Department for Transport

Note of the Meeting

Napp Pharmaceuticals and Department for Transport Meeting on Drug Driving 31 July 2012

Attendees Duncan Price Deputy Director Road User Licensing Insurance amp Safety (DP) Xxx xxxxxxxx Department for Transport Xxxxxx xxxxx Napp Pharmaceuticals Xxxxxx xxxxxxxxxxxxx Napp Pharmaceuticals Xxx xxxxxx Napp Pharmaceuticals Xxxx xxxxxx Ranelagh International Xxxxxxx xxxxxx Ranelagh International (RB)

Xxx began the meeting by providing a brief background on Napp xx noted that the company has been in Cambridge for thirty years and is well-known for its range of pain medications and in particular strong opioids Napp has helped to revolutionise the management of cancer and chronic pain through the development of various slow release and round the clock formulations Now the company is also moving into respiratory medicine and other areas It employs approximately 1100 people and is fifteenth in terms of GP prescription sales Xxx noted that Napp is interested in drug driving because of the impact legislation may have on patients

14

DP said that he is leading on drug driving policy and that the legislation currently going through Parliament is one of three pieces of work the Department is taking forward together The current proposals are enabling legislation which will allow the Government to determine the details critical to the new offence once the Expert Panel has published its recommendations DP suggested that the Expert Panelrsquos interim advice would be available in October

Xx noted that Napp is fully in support of the legislation and what it is trying to achieve but there are a few unintended consequences that it may cause for both manufacturers and patients Xx raised concerns about the impact on legitimate patients on a stable dose of medication that may be affected by legislation designed to target those who abuse illegal and legal drugs Xx added that Napp is in contact with a number of clinicians and other experts who would be happy to feed in to this policy development

Xx raised the issue of patients who are unimpaired being criminalised and facing a significant burden of proof if the proposed legislation is passed As the legislation is currently proposed there is a defence for patients taking prescription medication but the burden is first with them to prove that they have taken their medication is accordance with all instructions including from manufacturers There is a significant onus on patients to show they are not impaired despite what police say The defence is really only available once the driver is in court

Xx then compared the proposed legislation to the drink driving laws and highlighted the differences to drug driving legislation and the issue of strict liability Could the legislation be more focussed on its intended aim and tailor the list of controlled substances to those known to be abused as opposed to a catch all approach There needs to be protection for patients but at the moment the legislation appears to be trying to do both

Xx also noted the importance of ensuring that this is a policeable offence In the Governmentrsquos response to the North Review there was discussion of the Australian approach to drug driving Police found the impairment side of legislation hard to prove so they have instead just used the strict liability approach to prosecute drivers based on detection of a controlled substance

DP noted that all of the issues raised by xx are important What is being discussed in Parliament at the moment is enabling legislation which is setting out the framework The detail will become clearer once the interim advice from the Expert Panel has been received which is due in October The Department has already started to give some assurances in certain areas for example a zero tolerance approach for cannabis has been ruled out They will be able to home in as more advice is received from the Panel although it is not possible to pin the Panel down until it has reported DP added that there will be informed discussions with peers in late October before the legislation goes to Report Stage

Xx asked if the Panelrsquos advice will have any influence on the current draft Bill Xx asked if it would be worth making the primary legislation more focussed for example on substances known to be abused which would allow for strict liability The problem for patients would then become irrelevant as they would not be the focus of the legislation Xx also noted the problem that will arise from including heroin on the list of controlled substances Heroin metabolises into morphine in the blood as do some over-the-counter medications which makes it hard to distinguish between the different drug types This will lead to unintended consequences for patients

15

DP stated that he understood this argument but noted that the legislation is intended to be fit for purpose to allow for the whole range of potential decisions the Panel could make The decision might be made to change the substances on the controlled list although nothing so far has led him to think something should change The current list links back to the range included in the Misuse of Drugs Act The advice on the drugs will feed into the consultation and the subsequent affirmative procedure

DP added that because of the enabling nature of the current legislation there are some problems for example legal highs are not included on the list of controlled substances at the moment Due to the nature of the legislative procedure it can take a while to identify a problem and then legislate to give police powers They expect legal highs can become controlled drugs if they have protracted and serious consequences in a quicker time than the duration of the regulation-making process for drug driving There are powers to apply the legislation to all controlled drugs but they will need to go through it controlled drug by controlled drug in order to determine specific limits etc The Government envisages a mixed economy of the new and the existing offence

DP said that heroin is one drug of significant interest as it is known to be prevalent and associated with road safety risks The Panel are looking at opiates as a group of drugs and it will be for the Panel to decide how it can be detected He noted that they will need to consider all potential effects before setting any levels DP said that he knows that this is an area of importance for Napp as their patients will have a tolerance which is highly relevant to these considerations He would expect the Panel to look at that The Department wants the Panel to look at the opiate family so they do not only consider heroin

Xx said that the higher level of metabolites is an issue but these patients will be unimpaired where as a heroin user trying to get high is very different In terms of the defence the burden of proof lies on the shoulders of the patient Has the Department considered eliminating the impairment element and introducing an exemption for patients

DP responded that they have been considering all areas when looking at the medical defence Drink heroin and medically prescribed opiates have some similarities and also some important differences With alcohol some people who are over the limit will say they are unimpaired but the risks do increase as blood alcohol levels increase This can be the same with drugs

Xx noted that when a patient is on a steady dose of medication the pain they would be under if they were to stop taking their medication could be more impairing

DP said that he recognises the differences to drink driving Heroin users and medication users have different tolerances to ordinary people and the lsquodrink driving analogy is limitedrsquo Drinking has social benefits and it is a choice for people

Xx added that Napp sees that there is a desire to make drug like drink driving something that society will not tolerate but patients have to take their medication There is existing legislation against impairment for those who are irresponsible when taking their medication At the moment patients are being brought down to the lowest common denominator of those who abuse drugs This minority is causing problems for everyone else

16

Xxx noted that unlike with drink driving where increased alcohol leads to increased impairment there is not increased impairment with a high but stable dose of prescription medication Xx added that he believes there is a Swedish study which has investigated levels of impairment in patients

DP stated that although the opiate family is being considered together at the moment if it is not possible to distinguish between heroin and other opiates then it is open for the Department to decide whether or not to include morphine in the legislation They could decide that the disbenefits of including it would outweigh the benefits

He noted that the reason medications remain included is that there are problems with abuse for example with Benzodiazepines which are known to cause road safety problems Just because a controlled drug can be prescribed does not mean it will be removed from the legislation There will be a differentiation between a medical level at which someone must not drive and where they should not drive

Xx noted that Napp wants to work with the Government so that morphine can be included in the list of controlled substances By introducing an exemption or at least taking the burden of proof off the patient this could be done

DP said that the offence has a wide remit and there is a defence where they would like to include taking medication in accordance with medical advice There is a strong burden of proof on the prosecution to put evidence to the courts

Xx noted that the patient has to substantiate the proof first Xx added that patients already have a poor quality of life and this puts them under more stress Xxx said that pain is costing the country pound13bn a year and the Government has only recently decided to deem pain a long term condition and to work to help people have a good quality of life This seems like a backward step Doctors have been campaigning for years to get pain recognised and this is therefore a concern for them too as it may interfere with their choice of treatments

Xx said that with a few tweaks to the legislation the burden of proof could be placed on the prosecution For example by adding the word lsquoknowinglyrsquo to protect patients who were unaware of any advice against driving This would reassure them that a prescription will mean that they are protected Xx added that xxx has already had patient groups coming to her who are concerned that they are going to have to fight again

Xx noted that there is the issue of the lsquoknock onrsquo impact of one case highlighted by the media which could lead to patients becoming more cautious about taking their medication

DP said that he thought the Panel was unlikely to recommend low threshold levels He said that they have looked at the amendments tabled and they had material prepared for the Committee Stage of the legislation which was not needed and will be used to inform the informal discussion among peers in October He added that he feels the burden of proof leans towards the prosecution Once the prescription is presented it is down to the prosecution to prove beyond reasonable doubt that the medication was not taken properly For example one way would be if they can show that the blood level of a drug was in excess of the level prescribed

17

Xx raised concerns that cautious drivers may be wrongly pulled over by police and that it will be difficult for them to prove that they were unimpaired DP said that there are a swathe of issues about how far along the process people will be taken The balance is broadly right in the defence and if a case did go to court it would be resolved in the right way

DP noted that he is aware of the problems with testing procedures and that it is a genuinely difficult area Xx added that there are also concerns about those involved in a car crash and the insurance implications for a patient if they are the innocent party but test positively for drugs

DP said that is the situation already with the existing law and that there is currently a big drop off of cases before they reach the courts let alone conviction This is partly why the new offence is needed to target illegal drug users This issue is already there Xx acknowledged this but noted that the risk for patients would be heightened and that legislation designed to give police powers to stop drug abusers from driving should not spill over to impact on patients and make them worry about driving

Xx noted xxxx xxxxx xxxxx recent lsquoFit for Workrsquo report which showed that the main problem for the workforce is low back pain therefore many more people could be forced to stop work if they felt that by taking their medication it could mean that they are not deemed fit to drive

It was also noted that in the first stages of pain patients will seek pharmacist advice and use low doses of codeine to manage their pain There are 8m Osteoarthritis sufferers in the UK and over 70 report that they are in constant pain They typically start with over-the-counter medication including NSAIDS and codeine such as Nurofen Plus They will not have a prescription so how will they fare under the legislation

DP stated that this is partly an issue for the Panel He said he hoped that there is a good swathe of people on the Panel and asked if there is anything that Napp would like to submit to them Xx said there would be and that xxx would liaise with him on behalf of NAPP and feed in any information that would be considered helpful

Xxx noted that there are some concerns about the lack of medicalpainpatient representation on the Panel and that if these groups could feed in to the Panel that would help alleviate some concerns

DP said that the Panel is bringing in materials from other experts and that subject to his clearing it with the Chair they would be very keen to see papers etc The Panel would like to see as much research as possible Although they do not meet on policy there have been a number of issues related to the science of opioids that are of interest Xx asked if it would be helpful to also send the Panel a paper from Napp on where they believe legislation contains areas of risk and burden for patients to make the Panel aware of not only where the legislation can work but also where it could go wrong Xx asked if a pain expert could feed that in DP said case studies on the impact on patients would be helpful but there should be a focus on the science The legal aspects will not concern the Panel They should be happy to receive papers although he will have to talk to the Chair about having any experts appear in front of the Panel Xx assured DP that this would be done if the Chair was in agreement

18

Xx asked for some detail on the practical process of the Panelrsquos work Is the October report interim or final

DP said that it will be an interim report as there may be more work to do afterwards but that it is hoped and expected that the report will cover all the major drug types in the terms of reference They will use the findings across Government and then the decision will be made to move to the consultation The findings will also be communicated to the Committee on the Misuse of Drugs and the MRHA Secretariat representatives from both have been at Panel meetings

The secondary legislation will be in effect from early 2014 The plan is to consult on it in early 2013 and then progress through affirmative procedure in the later part of 2013 It will allow for the possible subsequent inclusion of other drugs

Xx asked about the development of testing devices and their specificity DP said that he is not a technical authority about the machines but does have information on the approval process A decision will be made at the end of the year on those currently going through police stations There will also be the beginning of the process to develop the second generation of roadside testing but the specifications cannot be finalised until the Panel reports These will be threshold detectors not just presentabsent detectors They will cover something related to heroin Legislation has been drafted so that police can undertake multiple preliminary tests as all drugs cannot be tested for at the same time The technology is important as an offence without it would not have the impact hoped for

DP added that other countries have a zero tolerance approach with presentabsent tests but that they want a threshold approach here He said that the legislation is linked to road safety it is not intended to change the law on possession use of drugs It is about public safety The existing penalty regime is not suitable for a zero tolerance approach At the moment crossing the limit means a 12 month driving ban and other consequences which is different to abroad The reason the drink drive limit has not been reduced is because the Government does not want to create a two tier system where the lower limit becomes seen as only equivalent to being given a speeding ticket The penalty for drug driving needs to allow for a more proportionate approach to enforcement At the moment if you are well versed in the law you have a good chance of evading conviction They want to change the balance and do not want to lower the penalty in comparison to drink driving He added that problems with some detection equipment abroad would not be acceptable in the UK legal system especially evidential saliva sampling The technology appears not there yet

DP noted that the Department is also looking at appropriate policy statements to make about the legislation The press has already focussed on areas where the new offence wonrsquot be an impact Xxx said that policy statements would help those patients who are already concerned

DP asked if Napprsquos patients receive unequivocal advice that they can drive Xx said not necessarily The issue is patients do not read advice and if they did they would not necessarily fully understand it It comes down to what the Doctor says but this legislation could then put them in a difficult position too Xx noted that the advice to patients in leaflets for medication regardless of whether they are prescription only medicines or over the counter would have a statement that would alert the patient to potential drowsiness or tiredness and advise that if this symptom was experienced patients should not drive or operate machinery This would be the same advice that clinicians would give to patients

19

about their medication unless as with certain drugs the DVLA should be notified and patients specifically informed that they must not drive whilst taking this medication The onus is on the patient to determine if they have this side effect and to what extent they are impaired DP noted that there is a difference between advice that a patient cannot drive and being told not to drive if they feel drowsy Xxx added that patients on a stable dose will be unsure if they can continue to work have a good quality of life etc and this will lead them to question whether or not to take their medication

DP stated that the Government can provide the context on what they think directions are but this will still be interpreted by a court Xx said publishing that information would provide comfort to patients who are concerned DP said this would be discussed with peers as well

Xx asked who will be invited to the informal discussion with peers and MPs DP said it would be just members of the House of Lords and Commons They will be able to meet with the Panel and other Government experts Xx noted that this would be useful for peers as those Napp has spoken to have had answers to initial questions but there are still areas where they would like some clarification DP noted that he and the Lords Spokesperson met with interested peers in advance of the Committee Stage It is easier to provide more factual clarification informally than on the floor of the House and Spokespeople will value the chance to make some progress before the Report Stage

Xx confirmed that Napp would put together some helpful information for DP to pass on to the Panel and will bring in some experts to feed in to that Xx added that Napp would be happy to feed in to any policy statements etc DP said he would be happy to clarify any issues in writing Xx said Napp would put together a list of questions for DP for this Xx said xxx would involve patient groups here too

Xx asked if there has been any input in the policy from the Department for Health DP said that a quadrilateral working group from Transport Justice Home and Health are working on the policy They have met between Panel meetings to see what is said and if there are any issues to put to the Panel

Xx asked if there is anything else Napp can do DP said that the more specific Napp can be about concerns evidence on the effect of treatments on impairment etc that would be helpful The policy is very much at the evidence gathering stage at the moment

Xx reiterated Napprsquos concerns regarding the Panel membership

DP said that at some point he expected tough decisions will be made about the balance of the proscons of the policy issues No solution will tick every box

Xx said that policy statements will be key to giving the police and the CPS guidance on who they are targeting as well as what lsquodirectionsrsquo mean to allay the fears of patients and clinicians DP said he hoped they would be able to allay fears He added that there is no advantage for the police to have lots of people in stations and being processed who are not impaired There is a realistic policy possibility that heroin will have to be set aside Just because the Panel is looking at it does not mean there is a commitment that it will be in the new offence They know that there may be no test to distinguish between different types of opiates

20

Xxx passed on two emails which he explained were from xx xxxxxxx xxxxxxx and xx xxxxxx xxxxxxxxn representing the views of CPPC and RCGP respectively Both Doctors expressed their concerns for patients and offered to contribute to discussions on the proposed legislation

A Note of Napprsquos Key Concerns

Napp Pharmaceuticals Meeting with Department for Transport 31 July 2012

Note I have added in bold italicised text some DfT responses to the questions in your original note which is otherwise as you sent me ndash Duncan Price 2882012

A Statement of support for drug driving legislation to stop people from driving while under the

influence of illegal drugs

Napp is concerned about the unintended consequences of the legislation on patients taking

long‐term medication for chronic pain Napp wants to work with the Government to find a

solution

1) Impact on Patients

2) Criminalisation of Patients

3) Different to Drink Driving Law

4) Policeable Offence

B Outline of Concerns

1) Impact on Patients

Evidence shows that patients on a stable dose of opioid analgesics are not necessarily

impaired but under the proposed system patients may be inaccurately identified as taking

impairing drugs and face prosecution

Patients well established on a stable dose of an opioid analgesic may have levels of

metabolites in their system well above any threshold used for roadside and police station

testing This means they could face serious charges despite driving unimpaired

There are concerns for patients such as those with Osteoarthritis the majority of who use

over the counter medications to manage their pain

Concern that patients will stop taking their medication so that they can drive This may

make their driving more impaired as a result of the pain that they will be under

Questions

Has there been consideration of how to distinguish between opiates that are used legally

for medicinal purposes and those used illegally (Napp would be happy to share clinical

knowledge of opioids that may be helpful to the panel and to any other interested parties

in Government)

The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

21

The panel is considering natural and synthetic opioids Its terms of reference include that it should establish the likelihood of whether concentrations of drugs broadly equivalent in their impairment effects to blood alcohol concentrations of 20 50 and 80mg100ml would be exceeded This will include a consideration of prescribed or otherwise legally obtained drugs which are known to impair driving

The panel will advise the Government which will then itself consider what specified limits to propose and then consult about I can assure you that in doing so it will consider how screening equipment and evidential blood specimens would distinguish between opiates used for legitimate medical purposes and those used illicitly

I am grateful for the offer of sharing clinical knowledge you made when we met I know the panel has since considered some of the evidence your experts have provided and some of its members have met an expert you recommended and one of your legal advisors

Has there been consideration of just introducing a list of restricted drugs known to be used

recreationally as with the Australian model

The list of restricted drugs used in some states in Australia does include THC (the active ingredient of cannabis) which does have some limited medical uses here The Governmentrsquos prime targets for this legislation are controlled drugs often or exclusively used illicitly including those included in the Australian legislation (THC amphetamines and MDMA)

At this stage we are awaiting advice from the panel but the Governmentrsquos position is that it should develop a new offence with the potential to include a number of categories of drug including benzodiazepines and opiates The abuse including the use of high quantities of methadone and some benzodiazepines (which can be prescribed) appears (alongside heroin) to be a significant contributor to the public safety problems this legislation is addressing

Many of the drugs specifically identified in the panelrsquos terms of reference are used exclusively or predominantly illicitly ndash for example amphetamine-types cannabinoids cocaine and hallucinogens

There is a reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

22

We are therefore using the definition of lsquocontrolled drugrsquo in the Misuse of Drugs Act 1971 within the new offence although which controlled drugs will be determined when regulations are brought forward

What consideration have you given to the issue of patients who drive unimpaired but will

still face prosecution if tested as levels of metabolites in their system may be above any

prescribed limit

This is being considered in both the terms of reference for the technical panelrsquos advice about the setting of specified limits (to keep patients out of the scope of the offence) and the inclusion of the medical defence within the offence

The panel has also been asked to consider the degree of variability in impairment effects across the population including for habitual drug users

In the terms of reference for the panel we have also specifically included the following from the North review (paragraph 743)

ldquoSome drugs which may be proscribed for driving might also be used legitimately in accordance with medical advice (for example morphine may be prescribed for chronic pain or diazepam (a benzodiazepine) may be prescribed for anxiety) Indeed the Review recognises that in some circumstances it may be more dangerous for a person to drive having not taken their medically prescribed drug than driving without having taken it Drugs have different effects on different people and levels at which they are prescribed are likely to reflect this It would clearly be wrong to put in jeopardy of prosecution those who are properly and safely taking medically prescribed drugs and driving in accordance with medical advice for whom despite the presence of a proscribed drug there is no evidence of any driving impairmentrdquo

I should also emphasise that the content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

2) Criminalisation of Patients

Statutory defence is included in the current legislation for those who have taken

prescription medication in accordance with prescribersupplier instructions and any

accompanying instructions from the manufacturer BUT

Only applicable after patient has been arrested further tested and their case has

progressed ndash this will cause innocent patients significant stress and

inconvenience

The defence puts the burden of proof on patients to prove that they acted in

accordance with all medical advice when the burden should be on the

prosecution to prove that they didnrsquot

23

Innocent patients may face criminalisation based on a technicality in legislation

that is not intended to target them

Questions

Is an exemption feasible (If not what is going to be done to ensure that patients are

protected)

I do not consider an exemption from the offence for all controlled drugs that can possibly be supplied or used for medical reasons is feasible Many controlled drugs for example cannabis have some medicinal uses

It is perfectly feasible for decisions about which controlled drugs would be specified for the new offence to be influenced by the reasons for whether their use is often always seldom or never for medical reasons Indeed such distinctions would be vital if this legislation were being introduced to enforce further against the illegal supply or use of controlled drugs

Whether that is the right approach to decision-making related to driving with controlled drugs in the body where there are levels associated with elevated risks to public safety is however questionable This legislation is being introduced to address road safety problems and the expert panelrsquos terms of reference are focussed on providing advice about the risks of driving after taking controlled drugs

It is to no-onesrsquo benefit for patients who are innocent of the offence to be arrested and tested There are several protections in place to reduce these risks Firstly police do not have random testing powers for drink and drug driving Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving

under the influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would result in disproportionate and large numbers of patients having evidential blood tests but then being not guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

24

It is important to note that the prosecution for a case where a defence has been raised that a patient had taken a controlled drug in accordance with medical advice must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code Test about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

It is important now and it will be important with the new offence in place that medical advice does not suggest to patients that they drive when doing so would present a significant risk to themselves and the public To do so risks patients being involved in road traffic incidents and also committing the existing offence of driving whilst impaired due to drugs

3) Different to Drink Driving Law

There have been calls for a strict liability approach to drug driving as exists for drink

driving Napp believes this would not be a suitable approach for drug driving based on the

current draft Bill

Alcohol does not have any medical necessity people do not need to consume

alcohol to ensure that a chronic condition does not prevent them from

functioning on a daily basis

Prescription medications that patients may take to treat chronic pain are a

medical necessity and are essential to ensuring that they are able to function on a

daily basis

A strict liability approach could lead to patients not taking essential medication in

order to be able to drive without fear of prosecution

Alternatively patients may choose not to drive at all which could have a serious

impact on their ability to work and go about their daily lives

Questions Is an exemption feasible (If not what is going to be done to ensure that patients are protected)

There are some useful analogies with drink driving law For example prior to the introduction of the specific drink driving offence the law in relation to drink drivers was difficult to enforce The specific offence there has contributed to major improvements in public safety

I do accept one of the differences with some controlled drugs is that some people take them for medicinal not recreational purposes This is not the case for all controlled drugs This may well affect what is included in the regulations for the offence

25

When we met I did say that it is conceivable for even as prevalent a recreational drug as heroin to not be included in the regulations for the offence This might be if it transpired that a limit relevant to heroin had to be set in a metabolite itself used in or a metabolite of a medically prescribed drug If such a limit also then had the effect of criminalising driving with medically supplied controlled drugs when that did not present an elevated risk to public safety I can see it would be a limit we might well not implement However I await the advice of the expert panel to see what it recommends related to heroin and whether (and how) that might affect other opiates

4) Policeable Offence

It is argued that drivers wonrsquot be stopped by police unless they appear impaired BUT

Plans are to test all those involved in a traffic accident for drugs including

innocent parties An innocent unimpaired patient involved in a crash through no

fault of their own could then face serious charges

Impairment is subjective and police may be suspicious of someonersquos driving for a

number of reasons such as driving too cautiously This apparently lsquoimpairedrsquo

driving may be due to various factors unrelated to the driverrsquos use of prescribed

medication but if they are stopped by police they may find themselves facing

serious and unjust charges

The existing impairment offence will remain so police will still be able to catch

those who do drive while impaired by prescription medication

Questions How close is the Home Office to approval of a drug testing device for use in police stations Can you provide any details

The laboratory testing phases of the type approval process is under way and the process is due to be completed at the end of this year

Is the Home Office still aiming for a 2014 approval of a drug testing device for portable use

It is still aiming for 2014 for these devices and we are planning the timing of that process together with the work on the new offence

Since the Governmentrsquos response to the North Review in June 2010 has the drug driving data quality improved

Yes we have received more information from Coroners recently and we also have had the conclusions of the European DRUID research

C Solutions

Napp believes that the best way to protect patients is by introducing an exemption for

those who can demonstrate that they are taking prescription medication

Existing legislation against driving while impaired would allow police to charge

anyone who did drive while under the influence of impairing prescription

medication

26

This would put the burden of proof on prosecutors saving innocent patients

considerable stress inconvenience and wasted CPS and police time

The Department considers that the statutory defence affords appropriate protection to patients who drive after taking prescription medication

The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

D Other Points for Consideration

Napp is keen to support this legislation in its efforts to stop users of illegal drugs

from driving and wishes to support policy development to ensure that patients are

protected Napp would be keen to provide any further information or other

means of assistance that could be of help here

Napp would like to submit written andor oral evidence to the Expert Panelrsquos

inquiry

Napp is concerned about the lack of pain expertise and patient representatives on

the Expert panel

Lord Henley mentioned that a seminar might be held after the summer recess to

discuss the issues arising from this legislation further Napp would be keen to

receive any further information on this

I hope this has been covered satisfactorily in the discussion we had on 31st July and since then

I do consider the legislation has strong safeguards in place for patients The Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

I hope I have addressed at least some of your concerns I should be happy to discuss the issues further

Duncan Price 2882012

27

Note on controlled drugs with medical uses

(i) The reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

(ii) Circumstances in which drug testing can be administered Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under the

influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

(iii) The medical defence The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

(iv) Drugs to be covered by the new offence and any specified limits to be based on expert advice The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

(v) Other controls The content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

(vi) Prosecutions to be in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

(vii) In light of the above the Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

28

From DuncanPricedftgsigovuk Sent 13092012 1603 To xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Cc xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Subject RE NRAS - Crime and Courts Bill clauses on drug driving

Xxxxxx

Below is my draft response to this letter Irsquoll send it when I have your comments about it

Dear xx xxxxxxx

Xxxxxx xxxxxxxx has forwarded your email of 28th August to me I am the lead policy official for the legislative clause about drug impaired driving in the Crime and Courts Bill

I am aware of concerns about innocent motorists taking prescribed medications being stopped tested being taken to police stations having blood samples taken and possibly going to court before being exonerated This is not the intention of the legislation and I can assure you we are mindful of this concern as we progress the legislation and respond to advice from an expert panel about the details

There are several protections in place to reduce the risk of large numbers of innocent motorists being arrested and taken to police stations

Firstly motorists cannot be stopped randomly for drug tests Testing can only be administered in three circumstances ndash namely where a driver has committed a moving traffic offence

a driver has been involved in a road traffic accident and or

there is reason for a police officer to suspect that a person has been driving under the influence of drink or drugs

This means that in practice drivers taking prescribed medicines would not be stopped and required to undergo drug testing without there being real cause for concern Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would be likely to result in disproportionate and large numbers of people prescribed drugs having evidential blood tests but then not being found guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

Fourthly it is important to emphasise that the prosecution for a case where the medical defence has been raised must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code for Crown Prosecutors which contains a requirement about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

Finally in the context of the clause before parliament the content of the regulations (specifying which controlled drugs should be covered by the new offence and the limits to be specified for them) will be the subject of public consultation Before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of

29

Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

I hope that this letter serves to allay concerns about possible unintended consequences for people taking prescription medicines

Duncan Price Tel 020 7944 xxxx Department for Transport

From JessicaMatthewdftgsigovuk Sent 17 October 2012 1108 To xxxxxxxxxxxxadhgsigovuk Cc xxxxxxxxxxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxxxxxdhgsigovuk xxxxxxxxdhgsigovuk Subject Re Department of Health attendance at the Lords briefing for the drug driving legislation

Xxxxxxxx is out of the office today but wersquoll send over the time and venue tomorrow and share the briefing with you Irsquod be happy to brief Dr Prunty beforehand ndash perhaps over the phone

Wersquore planning on a reasonably open debate about the legislation We wonrsquot have got policy clearance on the amendments to the legislation but wersquore inclined to say that the Government is minded to or is considering x y or z

Happy to discuss

Jessica Matthew Deputy Director Road User Licensing Insurance and Safety Tel 020 7944 xxxx Zone 321 Great Minster House 76 Marsham Street London SW1P 4DR

Extract of Briefing shared with DH from the above e-mail

How will you make sure that people taking medication in accordance with their prescription arenrsquot arrested and taken to court as a result of this legislation

The medical defence in the provisions provides substantial and appropriate protection for people taking medically prescribed or supplied controlled drugs It places an evidential burden on a person accused of committing the offence So the accused must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court It is then for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on

It is unlikely that a person taking medication in accordance with their prescription would be taken to court for a number of reasons

30

1 Motorists cannot be stopped randomly for drug tests They can only be tested where They have committed a moving traffic offence They have been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under

the influence of drink or drugs

2 The drugs to be included in the legislation and their limits will be set in regulations The content of the regulations will be the subject of public consultation and an affirmative resolution This will provide an opportunity for any concerns with the proposed specified limits to be raised and carefully considered

3 The expert panel is bearing in mind the normal therapeutic ranges and expected drug concentrations in blood when setting limits for those drugs that may also be used for medicinal purposes This means that only patients on unusually high doses of medication might have a positive screening and proceed to evidential blood test

4 Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any cases before they reach the court Indeed there is a Code for Crown Prosecutors which contains a requirement that prosecutions are in the public interest

From xxxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 29 November 2012 1422 To xxxxxxxdhgsigovuk xxxxxxxxxpsncorguk xxxxxxxxxxxxxtheccaorguk xxxxxxxxxxnpacouk xxxxxxxxxxxxrpharmscom xxxxxxxxxxxsaddactionorguk xxxxxroadsafecom xxxxxxxxxxxxxxxxxxsdrconsortiumorg xxxm-allianceorguk xxxxxxxxxxxturning-pointcouk xxxxxxxxROSPAcom xxxxxxxxxxxxxxxxtheAAcom xxxxxxxxxacpopnnpoliceuk adminactionaddictionorguk xxxxxxxxxageukorguk xxxxxxxxxxxbrakeorguk xxxxxxxxbmaorguk xxxxxxxxxxxbritishpainsocietyorg xxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxcpsgsigovuk xxxxxxxxdrugscopeorguk xxxxxxxxxiamorguk xxxxxxxxxxxxxxlawsocietyorguk xxxxxxxxxxxliberty-human-rightsorguk xxxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxxpactsorguk xxxxxxxxxxparliamentuk xxxxxxxxxxxxRACFoundationorg xxxxxxxxxxdurhamgovuk xxxxxxxxxxxxxxxxPolicyConnectorguk xxxxxxxxxxxxxxpsncorguk xxxxxxxxxxxxxdvlagsigovuk Xxxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxhomeofficegsigovuk xxxxxxxxnpacouk xxxxxxxxxxxxdhgsigovuk xxxxxxxxxdrugscopeorguk Cc xxxxxxxxxxxxxxxxxxxdftgsigovuk JessicaMatthewdftgsigovuk xxxxxxxxxxxxxxxxxxdftgsigovuk Subject Drug driving seminar presentation

Dear all

Many thanks to those of you who were able to attend our Drug Driving Stakeholder Seminar last week

We hope you found as useful as we did

Please find attached a copy of the presentation as promised

Kind regards

Xxxxxx xxxxxxx

31

From DuncanPricedftgsigovuk Sent 30082012 1450 To xxxxxxxxxxxdhgsigovuk Cc xxxxxxxxxxxxxxxxxdftgsigovuk Subject Fw Meeting with Napp Pharmaceuticals

xxxxxxx

I attach in respect to briefing for Ann Miltonrsquos planned meeting with NAPP on 23rd October the following

- a note of NAPPrsquos key concerns (as they drafted them) plus my response - a letter Earl Atlee to NAPP - the draft sent to Lord Henleyrsquos office for signature to Lord Luce about similar issues - the note of the meeting NAPP had with me (it is NAPPrsquos note with my comments) - an internal note about controlled drugs for medical uses

The notes we did on the amendments made at Committee stage for Ministers cover some of the NAPP issues but I havenrsquot enclosed them as I have sent quite a lot already ndash but yoursquore welcome to a copy if you want one

Duncan Price Tel 020 7944 2241 Department for Transport

Note of the Meeting

Napp Pharmaceuticals and Department for Transport Meeting on Drug Driving 31 July 2012

Attendees Duncan Price Deputy Director Road User Licensing Insurance amp Safety (DP) Xxx xxxxxxxx Department for Transport Xxxxxx xxxxx Napp Pharmaceuticals Xxxxxx xxxxxxxxxxxxx Napp Pharmaceuticals Xxx xxxxxx Napp Pharmaceuticals Xxxx xxxxxx Ranelagh International Xxxxxxx xxxxxx Ranelagh International (RB)

Xxx began the meeting by providing a brief background on Napp xx noted that the company has been in Cambridge for thirty years and is well-known for its range of pain medications and in particular strong opioids Napp has helped to revolutionise the management of cancer and chronic pain through the development of various slow release and round the clock formulations Now the company is also moving into respiratory medicine and other areas It employs approximately 1100 people and is fifteenth in terms of GP prescription sales Xxx noted that Napp is interested in drug driving because of the impact legislation may have on patients

14

DP said that he is leading on drug driving policy and that the legislation currently going through Parliament is one of three pieces of work the Department is taking forward together The current proposals are enabling legislation which will allow the Government to determine the details critical to the new offence once the Expert Panel has published its recommendations DP suggested that the Expert Panelrsquos interim advice would be available in October

Xx noted that Napp is fully in support of the legislation and what it is trying to achieve but there are a few unintended consequences that it may cause for both manufacturers and patients Xx raised concerns about the impact on legitimate patients on a stable dose of medication that may be affected by legislation designed to target those who abuse illegal and legal drugs Xx added that Napp is in contact with a number of clinicians and other experts who would be happy to feed in to this policy development

Xx raised the issue of patients who are unimpaired being criminalised and facing a significant burden of proof if the proposed legislation is passed As the legislation is currently proposed there is a defence for patients taking prescription medication but the burden is first with them to prove that they have taken their medication is accordance with all instructions including from manufacturers There is a significant onus on patients to show they are not impaired despite what police say The defence is really only available once the driver is in court

Xx then compared the proposed legislation to the drink driving laws and highlighted the differences to drug driving legislation and the issue of strict liability Could the legislation be more focussed on its intended aim and tailor the list of controlled substances to those known to be abused as opposed to a catch all approach There needs to be protection for patients but at the moment the legislation appears to be trying to do both

Xx also noted the importance of ensuring that this is a policeable offence In the Governmentrsquos response to the North Review there was discussion of the Australian approach to drug driving Police found the impairment side of legislation hard to prove so they have instead just used the strict liability approach to prosecute drivers based on detection of a controlled substance

DP noted that all of the issues raised by xx are important What is being discussed in Parliament at the moment is enabling legislation which is setting out the framework The detail will become clearer once the interim advice from the Expert Panel has been received which is due in October The Department has already started to give some assurances in certain areas for example a zero tolerance approach for cannabis has been ruled out They will be able to home in as more advice is received from the Panel although it is not possible to pin the Panel down until it has reported DP added that there will be informed discussions with peers in late October before the legislation goes to Report Stage

Xx asked if the Panelrsquos advice will have any influence on the current draft Bill Xx asked if it would be worth making the primary legislation more focussed for example on substances known to be abused which would allow for strict liability The problem for patients would then become irrelevant as they would not be the focus of the legislation Xx also noted the problem that will arise from including heroin on the list of controlled substances Heroin metabolises into morphine in the blood as do some over-the-counter medications which makes it hard to distinguish between the different drug types This will lead to unintended consequences for patients

15

DP stated that he understood this argument but noted that the legislation is intended to be fit for purpose to allow for the whole range of potential decisions the Panel could make The decision might be made to change the substances on the controlled list although nothing so far has led him to think something should change The current list links back to the range included in the Misuse of Drugs Act The advice on the drugs will feed into the consultation and the subsequent affirmative procedure

DP added that because of the enabling nature of the current legislation there are some problems for example legal highs are not included on the list of controlled substances at the moment Due to the nature of the legislative procedure it can take a while to identify a problem and then legislate to give police powers They expect legal highs can become controlled drugs if they have protracted and serious consequences in a quicker time than the duration of the regulation-making process for drug driving There are powers to apply the legislation to all controlled drugs but they will need to go through it controlled drug by controlled drug in order to determine specific limits etc The Government envisages a mixed economy of the new and the existing offence

DP said that heroin is one drug of significant interest as it is known to be prevalent and associated with road safety risks The Panel are looking at opiates as a group of drugs and it will be for the Panel to decide how it can be detected He noted that they will need to consider all potential effects before setting any levels DP said that he knows that this is an area of importance for Napp as their patients will have a tolerance which is highly relevant to these considerations He would expect the Panel to look at that The Department wants the Panel to look at the opiate family so they do not only consider heroin

Xx said that the higher level of metabolites is an issue but these patients will be unimpaired where as a heroin user trying to get high is very different In terms of the defence the burden of proof lies on the shoulders of the patient Has the Department considered eliminating the impairment element and introducing an exemption for patients

DP responded that they have been considering all areas when looking at the medical defence Drink heroin and medically prescribed opiates have some similarities and also some important differences With alcohol some people who are over the limit will say they are unimpaired but the risks do increase as blood alcohol levels increase This can be the same with drugs

Xx noted that when a patient is on a steady dose of medication the pain they would be under if they were to stop taking their medication could be more impairing

DP said that he recognises the differences to drink driving Heroin users and medication users have different tolerances to ordinary people and the lsquodrink driving analogy is limitedrsquo Drinking has social benefits and it is a choice for people

Xx added that Napp sees that there is a desire to make drug like drink driving something that society will not tolerate but patients have to take their medication There is existing legislation against impairment for those who are irresponsible when taking their medication At the moment patients are being brought down to the lowest common denominator of those who abuse drugs This minority is causing problems for everyone else

16

Xxx noted that unlike with drink driving where increased alcohol leads to increased impairment there is not increased impairment with a high but stable dose of prescription medication Xx added that he believes there is a Swedish study which has investigated levels of impairment in patients

DP stated that although the opiate family is being considered together at the moment if it is not possible to distinguish between heroin and other opiates then it is open for the Department to decide whether or not to include morphine in the legislation They could decide that the disbenefits of including it would outweigh the benefits

He noted that the reason medications remain included is that there are problems with abuse for example with Benzodiazepines which are known to cause road safety problems Just because a controlled drug can be prescribed does not mean it will be removed from the legislation There will be a differentiation between a medical level at which someone must not drive and where they should not drive

Xx noted that Napp wants to work with the Government so that morphine can be included in the list of controlled substances By introducing an exemption or at least taking the burden of proof off the patient this could be done

DP said that the offence has a wide remit and there is a defence where they would like to include taking medication in accordance with medical advice There is a strong burden of proof on the prosecution to put evidence to the courts

Xx noted that the patient has to substantiate the proof first Xx added that patients already have a poor quality of life and this puts them under more stress Xxx said that pain is costing the country pound13bn a year and the Government has only recently decided to deem pain a long term condition and to work to help people have a good quality of life This seems like a backward step Doctors have been campaigning for years to get pain recognised and this is therefore a concern for them too as it may interfere with their choice of treatments

Xx said that with a few tweaks to the legislation the burden of proof could be placed on the prosecution For example by adding the word lsquoknowinglyrsquo to protect patients who were unaware of any advice against driving This would reassure them that a prescription will mean that they are protected Xx added that xxx has already had patient groups coming to her who are concerned that they are going to have to fight again

Xx noted that there is the issue of the lsquoknock onrsquo impact of one case highlighted by the media which could lead to patients becoming more cautious about taking their medication

DP said that he thought the Panel was unlikely to recommend low threshold levels He said that they have looked at the amendments tabled and they had material prepared for the Committee Stage of the legislation which was not needed and will be used to inform the informal discussion among peers in October He added that he feels the burden of proof leans towards the prosecution Once the prescription is presented it is down to the prosecution to prove beyond reasonable doubt that the medication was not taken properly For example one way would be if they can show that the blood level of a drug was in excess of the level prescribed

17

Xx raised concerns that cautious drivers may be wrongly pulled over by police and that it will be difficult for them to prove that they were unimpaired DP said that there are a swathe of issues about how far along the process people will be taken The balance is broadly right in the defence and if a case did go to court it would be resolved in the right way

DP noted that he is aware of the problems with testing procedures and that it is a genuinely difficult area Xx added that there are also concerns about those involved in a car crash and the insurance implications for a patient if they are the innocent party but test positively for drugs

DP said that is the situation already with the existing law and that there is currently a big drop off of cases before they reach the courts let alone conviction This is partly why the new offence is needed to target illegal drug users This issue is already there Xx acknowledged this but noted that the risk for patients would be heightened and that legislation designed to give police powers to stop drug abusers from driving should not spill over to impact on patients and make them worry about driving

Xx noted xxxx xxxxx xxxxx recent lsquoFit for Workrsquo report which showed that the main problem for the workforce is low back pain therefore many more people could be forced to stop work if they felt that by taking their medication it could mean that they are not deemed fit to drive

It was also noted that in the first stages of pain patients will seek pharmacist advice and use low doses of codeine to manage their pain There are 8m Osteoarthritis sufferers in the UK and over 70 report that they are in constant pain They typically start with over-the-counter medication including NSAIDS and codeine such as Nurofen Plus They will not have a prescription so how will they fare under the legislation

DP stated that this is partly an issue for the Panel He said he hoped that there is a good swathe of people on the Panel and asked if there is anything that Napp would like to submit to them Xx said there would be and that xxx would liaise with him on behalf of NAPP and feed in any information that would be considered helpful

Xxx noted that there are some concerns about the lack of medicalpainpatient representation on the Panel and that if these groups could feed in to the Panel that would help alleviate some concerns

DP said that the Panel is bringing in materials from other experts and that subject to his clearing it with the Chair they would be very keen to see papers etc The Panel would like to see as much research as possible Although they do not meet on policy there have been a number of issues related to the science of opioids that are of interest Xx asked if it would be helpful to also send the Panel a paper from Napp on where they believe legislation contains areas of risk and burden for patients to make the Panel aware of not only where the legislation can work but also where it could go wrong Xx asked if a pain expert could feed that in DP said case studies on the impact on patients would be helpful but there should be a focus on the science The legal aspects will not concern the Panel They should be happy to receive papers although he will have to talk to the Chair about having any experts appear in front of the Panel Xx assured DP that this would be done if the Chair was in agreement

18

Xx asked for some detail on the practical process of the Panelrsquos work Is the October report interim or final

DP said that it will be an interim report as there may be more work to do afterwards but that it is hoped and expected that the report will cover all the major drug types in the terms of reference They will use the findings across Government and then the decision will be made to move to the consultation The findings will also be communicated to the Committee on the Misuse of Drugs and the MRHA Secretariat representatives from both have been at Panel meetings

The secondary legislation will be in effect from early 2014 The plan is to consult on it in early 2013 and then progress through affirmative procedure in the later part of 2013 It will allow for the possible subsequent inclusion of other drugs

Xx asked about the development of testing devices and their specificity DP said that he is not a technical authority about the machines but does have information on the approval process A decision will be made at the end of the year on those currently going through police stations There will also be the beginning of the process to develop the second generation of roadside testing but the specifications cannot be finalised until the Panel reports These will be threshold detectors not just presentabsent detectors They will cover something related to heroin Legislation has been drafted so that police can undertake multiple preliminary tests as all drugs cannot be tested for at the same time The technology is important as an offence without it would not have the impact hoped for

DP added that other countries have a zero tolerance approach with presentabsent tests but that they want a threshold approach here He said that the legislation is linked to road safety it is not intended to change the law on possession use of drugs It is about public safety The existing penalty regime is not suitable for a zero tolerance approach At the moment crossing the limit means a 12 month driving ban and other consequences which is different to abroad The reason the drink drive limit has not been reduced is because the Government does not want to create a two tier system where the lower limit becomes seen as only equivalent to being given a speeding ticket The penalty for drug driving needs to allow for a more proportionate approach to enforcement At the moment if you are well versed in the law you have a good chance of evading conviction They want to change the balance and do not want to lower the penalty in comparison to drink driving He added that problems with some detection equipment abroad would not be acceptable in the UK legal system especially evidential saliva sampling The technology appears not there yet

DP noted that the Department is also looking at appropriate policy statements to make about the legislation The press has already focussed on areas where the new offence wonrsquot be an impact Xxx said that policy statements would help those patients who are already concerned

DP asked if Napprsquos patients receive unequivocal advice that they can drive Xx said not necessarily The issue is patients do not read advice and if they did they would not necessarily fully understand it It comes down to what the Doctor says but this legislation could then put them in a difficult position too Xx noted that the advice to patients in leaflets for medication regardless of whether they are prescription only medicines or over the counter would have a statement that would alert the patient to potential drowsiness or tiredness and advise that if this symptom was experienced patients should not drive or operate machinery This would be the same advice that clinicians would give to patients

19

about their medication unless as with certain drugs the DVLA should be notified and patients specifically informed that they must not drive whilst taking this medication The onus is on the patient to determine if they have this side effect and to what extent they are impaired DP noted that there is a difference between advice that a patient cannot drive and being told not to drive if they feel drowsy Xxx added that patients on a stable dose will be unsure if they can continue to work have a good quality of life etc and this will lead them to question whether or not to take their medication

DP stated that the Government can provide the context on what they think directions are but this will still be interpreted by a court Xx said publishing that information would provide comfort to patients who are concerned DP said this would be discussed with peers as well

Xx asked who will be invited to the informal discussion with peers and MPs DP said it would be just members of the House of Lords and Commons They will be able to meet with the Panel and other Government experts Xx noted that this would be useful for peers as those Napp has spoken to have had answers to initial questions but there are still areas where they would like some clarification DP noted that he and the Lords Spokesperson met with interested peers in advance of the Committee Stage It is easier to provide more factual clarification informally than on the floor of the House and Spokespeople will value the chance to make some progress before the Report Stage

Xx confirmed that Napp would put together some helpful information for DP to pass on to the Panel and will bring in some experts to feed in to that Xx added that Napp would be happy to feed in to any policy statements etc DP said he would be happy to clarify any issues in writing Xx said Napp would put together a list of questions for DP for this Xx said xxx would involve patient groups here too

Xx asked if there has been any input in the policy from the Department for Health DP said that a quadrilateral working group from Transport Justice Home and Health are working on the policy They have met between Panel meetings to see what is said and if there are any issues to put to the Panel

Xx asked if there is anything else Napp can do DP said that the more specific Napp can be about concerns evidence on the effect of treatments on impairment etc that would be helpful The policy is very much at the evidence gathering stage at the moment

Xx reiterated Napprsquos concerns regarding the Panel membership

DP said that at some point he expected tough decisions will be made about the balance of the proscons of the policy issues No solution will tick every box

Xx said that policy statements will be key to giving the police and the CPS guidance on who they are targeting as well as what lsquodirectionsrsquo mean to allay the fears of patients and clinicians DP said he hoped they would be able to allay fears He added that there is no advantage for the police to have lots of people in stations and being processed who are not impaired There is a realistic policy possibility that heroin will have to be set aside Just because the Panel is looking at it does not mean there is a commitment that it will be in the new offence They know that there may be no test to distinguish between different types of opiates

20

Xxx passed on two emails which he explained were from xx xxxxxxx xxxxxxx and xx xxxxxx xxxxxxxxn representing the views of CPPC and RCGP respectively Both Doctors expressed their concerns for patients and offered to contribute to discussions on the proposed legislation

A Note of Napprsquos Key Concerns

Napp Pharmaceuticals Meeting with Department for Transport 31 July 2012

Note I have added in bold italicised text some DfT responses to the questions in your original note which is otherwise as you sent me ndash Duncan Price 2882012

A Statement of support for drug driving legislation to stop people from driving while under the

influence of illegal drugs

Napp is concerned about the unintended consequences of the legislation on patients taking

long‐term medication for chronic pain Napp wants to work with the Government to find a

solution

1) Impact on Patients

2) Criminalisation of Patients

3) Different to Drink Driving Law

4) Policeable Offence

B Outline of Concerns

1) Impact on Patients

Evidence shows that patients on a stable dose of opioid analgesics are not necessarily

impaired but under the proposed system patients may be inaccurately identified as taking

impairing drugs and face prosecution

Patients well established on a stable dose of an opioid analgesic may have levels of

metabolites in their system well above any threshold used for roadside and police station

testing This means they could face serious charges despite driving unimpaired

There are concerns for patients such as those with Osteoarthritis the majority of who use

over the counter medications to manage their pain

Concern that patients will stop taking their medication so that they can drive This may

make their driving more impaired as a result of the pain that they will be under

Questions

Has there been consideration of how to distinguish between opiates that are used legally

for medicinal purposes and those used illegally (Napp would be happy to share clinical

knowledge of opioids that may be helpful to the panel and to any other interested parties

in Government)

The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

21

The panel is considering natural and synthetic opioids Its terms of reference include that it should establish the likelihood of whether concentrations of drugs broadly equivalent in their impairment effects to blood alcohol concentrations of 20 50 and 80mg100ml would be exceeded This will include a consideration of prescribed or otherwise legally obtained drugs which are known to impair driving

The panel will advise the Government which will then itself consider what specified limits to propose and then consult about I can assure you that in doing so it will consider how screening equipment and evidential blood specimens would distinguish between opiates used for legitimate medical purposes and those used illicitly

I am grateful for the offer of sharing clinical knowledge you made when we met I know the panel has since considered some of the evidence your experts have provided and some of its members have met an expert you recommended and one of your legal advisors

Has there been consideration of just introducing a list of restricted drugs known to be used

recreationally as with the Australian model

The list of restricted drugs used in some states in Australia does include THC (the active ingredient of cannabis) which does have some limited medical uses here The Governmentrsquos prime targets for this legislation are controlled drugs often or exclusively used illicitly including those included in the Australian legislation (THC amphetamines and MDMA)

At this stage we are awaiting advice from the panel but the Governmentrsquos position is that it should develop a new offence with the potential to include a number of categories of drug including benzodiazepines and opiates The abuse including the use of high quantities of methadone and some benzodiazepines (which can be prescribed) appears (alongside heroin) to be a significant contributor to the public safety problems this legislation is addressing

Many of the drugs specifically identified in the panelrsquos terms of reference are used exclusively or predominantly illicitly ndash for example amphetamine-types cannabinoids cocaine and hallucinogens

There is a reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

22

We are therefore using the definition of lsquocontrolled drugrsquo in the Misuse of Drugs Act 1971 within the new offence although which controlled drugs will be determined when regulations are brought forward

What consideration have you given to the issue of patients who drive unimpaired but will

still face prosecution if tested as levels of metabolites in their system may be above any

prescribed limit

This is being considered in both the terms of reference for the technical panelrsquos advice about the setting of specified limits (to keep patients out of the scope of the offence) and the inclusion of the medical defence within the offence

The panel has also been asked to consider the degree of variability in impairment effects across the population including for habitual drug users

In the terms of reference for the panel we have also specifically included the following from the North review (paragraph 743)

ldquoSome drugs which may be proscribed for driving might also be used legitimately in accordance with medical advice (for example morphine may be prescribed for chronic pain or diazepam (a benzodiazepine) may be prescribed for anxiety) Indeed the Review recognises that in some circumstances it may be more dangerous for a person to drive having not taken their medically prescribed drug than driving without having taken it Drugs have different effects on different people and levels at which they are prescribed are likely to reflect this It would clearly be wrong to put in jeopardy of prosecution those who are properly and safely taking medically prescribed drugs and driving in accordance with medical advice for whom despite the presence of a proscribed drug there is no evidence of any driving impairmentrdquo

I should also emphasise that the content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

2) Criminalisation of Patients

Statutory defence is included in the current legislation for those who have taken

prescription medication in accordance with prescribersupplier instructions and any

accompanying instructions from the manufacturer BUT

Only applicable after patient has been arrested further tested and their case has

progressed ndash this will cause innocent patients significant stress and

inconvenience

The defence puts the burden of proof on patients to prove that they acted in

accordance with all medical advice when the burden should be on the

prosecution to prove that they didnrsquot

23

Innocent patients may face criminalisation based on a technicality in legislation

that is not intended to target them

Questions

Is an exemption feasible (If not what is going to be done to ensure that patients are

protected)

I do not consider an exemption from the offence for all controlled drugs that can possibly be supplied or used for medical reasons is feasible Many controlled drugs for example cannabis have some medicinal uses

It is perfectly feasible for decisions about which controlled drugs would be specified for the new offence to be influenced by the reasons for whether their use is often always seldom or never for medical reasons Indeed such distinctions would be vital if this legislation were being introduced to enforce further against the illegal supply or use of controlled drugs

Whether that is the right approach to decision-making related to driving with controlled drugs in the body where there are levels associated with elevated risks to public safety is however questionable This legislation is being introduced to address road safety problems and the expert panelrsquos terms of reference are focussed on providing advice about the risks of driving after taking controlled drugs

It is to no-onesrsquo benefit for patients who are innocent of the offence to be arrested and tested There are several protections in place to reduce these risks Firstly police do not have random testing powers for drink and drug driving Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving

under the influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would result in disproportionate and large numbers of patients having evidential blood tests but then being not guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

24

It is important to note that the prosecution for a case where a defence has been raised that a patient had taken a controlled drug in accordance with medical advice must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code Test about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

It is important now and it will be important with the new offence in place that medical advice does not suggest to patients that they drive when doing so would present a significant risk to themselves and the public To do so risks patients being involved in road traffic incidents and also committing the existing offence of driving whilst impaired due to drugs

3) Different to Drink Driving Law

There have been calls for a strict liability approach to drug driving as exists for drink

driving Napp believes this would not be a suitable approach for drug driving based on the

current draft Bill

Alcohol does not have any medical necessity people do not need to consume

alcohol to ensure that a chronic condition does not prevent them from

functioning on a daily basis

Prescription medications that patients may take to treat chronic pain are a

medical necessity and are essential to ensuring that they are able to function on a

daily basis

A strict liability approach could lead to patients not taking essential medication in

order to be able to drive without fear of prosecution

Alternatively patients may choose not to drive at all which could have a serious

impact on their ability to work and go about their daily lives

Questions Is an exemption feasible (If not what is going to be done to ensure that patients are protected)

There are some useful analogies with drink driving law For example prior to the introduction of the specific drink driving offence the law in relation to drink drivers was difficult to enforce The specific offence there has contributed to major improvements in public safety

I do accept one of the differences with some controlled drugs is that some people take them for medicinal not recreational purposes This is not the case for all controlled drugs This may well affect what is included in the regulations for the offence

25

When we met I did say that it is conceivable for even as prevalent a recreational drug as heroin to not be included in the regulations for the offence This might be if it transpired that a limit relevant to heroin had to be set in a metabolite itself used in or a metabolite of a medically prescribed drug If such a limit also then had the effect of criminalising driving with medically supplied controlled drugs when that did not present an elevated risk to public safety I can see it would be a limit we might well not implement However I await the advice of the expert panel to see what it recommends related to heroin and whether (and how) that might affect other opiates

4) Policeable Offence

It is argued that drivers wonrsquot be stopped by police unless they appear impaired BUT

Plans are to test all those involved in a traffic accident for drugs including

innocent parties An innocent unimpaired patient involved in a crash through no

fault of their own could then face serious charges

Impairment is subjective and police may be suspicious of someonersquos driving for a

number of reasons such as driving too cautiously This apparently lsquoimpairedrsquo

driving may be due to various factors unrelated to the driverrsquos use of prescribed

medication but if they are stopped by police they may find themselves facing

serious and unjust charges

The existing impairment offence will remain so police will still be able to catch

those who do drive while impaired by prescription medication

Questions How close is the Home Office to approval of a drug testing device for use in police stations Can you provide any details

The laboratory testing phases of the type approval process is under way and the process is due to be completed at the end of this year

Is the Home Office still aiming for a 2014 approval of a drug testing device for portable use

It is still aiming for 2014 for these devices and we are planning the timing of that process together with the work on the new offence

Since the Governmentrsquos response to the North Review in June 2010 has the drug driving data quality improved

Yes we have received more information from Coroners recently and we also have had the conclusions of the European DRUID research

C Solutions

Napp believes that the best way to protect patients is by introducing an exemption for

those who can demonstrate that they are taking prescription medication

Existing legislation against driving while impaired would allow police to charge

anyone who did drive while under the influence of impairing prescription

medication

26

This would put the burden of proof on prosecutors saving innocent patients

considerable stress inconvenience and wasted CPS and police time

The Department considers that the statutory defence affords appropriate protection to patients who drive after taking prescription medication

The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

D Other Points for Consideration

Napp is keen to support this legislation in its efforts to stop users of illegal drugs

from driving and wishes to support policy development to ensure that patients are

protected Napp would be keen to provide any further information or other

means of assistance that could be of help here

Napp would like to submit written andor oral evidence to the Expert Panelrsquos

inquiry

Napp is concerned about the lack of pain expertise and patient representatives on

the Expert panel

Lord Henley mentioned that a seminar might be held after the summer recess to

discuss the issues arising from this legislation further Napp would be keen to

receive any further information on this

I hope this has been covered satisfactorily in the discussion we had on 31st July and since then

I do consider the legislation has strong safeguards in place for patients The Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

I hope I have addressed at least some of your concerns I should be happy to discuss the issues further

Duncan Price 2882012

27

Note on controlled drugs with medical uses

(i) The reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

(ii) Circumstances in which drug testing can be administered Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under the

influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

(iii) The medical defence The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

(iv) Drugs to be covered by the new offence and any specified limits to be based on expert advice The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

(v) Other controls The content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

(vi) Prosecutions to be in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

(vii) In light of the above the Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

28

From DuncanPricedftgsigovuk Sent 13092012 1603 To xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Cc xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Subject RE NRAS - Crime and Courts Bill clauses on drug driving

Xxxxxx

Below is my draft response to this letter Irsquoll send it when I have your comments about it

Dear xx xxxxxxx

Xxxxxx xxxxxxxx has forwarded your email of 28th August to me I am the lead policy official for the legislative clause about drug impaired driving in the Crime and Courts Bill

I am aware of concerns about innocent motorists taking prescribed medications being stopped tested being taken to police stations having blood samples taken and possibly going to court before being exonerated This is not the intention of the legislation and I can assure you we are mindful of this concern as we progress the legislation and respond to advice from an expert panel about the details

There are several protections in place to reduce the risk of large numbers of innocent motorists being arrested and taken to police stations

Firstly motorists cannot be stopped randomly for drug tests Testing can only be administered in three circumstances ndash namely where a driver has committed a moving traffic offence

a driver has been involved in a road traffic accident and or

there is reason for a police officer to suspect that a person has been driving under the influence of drink or drugs

This means that in practice drivers taking prescribed medicines would not be stopped and required to undergo drug testing without there being real cause for concern Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would be likely to result in disproportionate and large numbers of people prescribed drugs having evidential blood tests but then not being found guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

Fourthly it is important to emphasise that the prosecution for a case where the medical defence has been raised must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code for Crown Prosecutors which contains a requirement about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

Finally in the context of the clause before parliament the content of the regulations (specifying which controlled drugs should be covered by the new offence and the limits to be specified for them) will be the subject of public consultation Before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of

29

Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

I hope that this letter serves to allay concerns about possible unintended consequences for people taking prescription medicines

Duncan Price Tel 020 7944 xxxx Department for Transport

From JessicaMatthewdftgsigovuk Sent 17 October 2012 1108 To xxxxxxxxxxxxadhgsigovuk Cc xxxxxxxxxxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxxxxxdhgsigovuk xxxxxxxxdhgsigovuk Subject Re Department of Health attendance at the Lords briefing for the drug driving legislation

Xxxxxxxx is out of the office today but wersquoll send over the time and venue tomorrow and share the briefing with you Irsquod be happy to brief Dr Prunty beforehand ndash perhaps over the phone

Wersquore planning on a reasonably open debate about the legislation We wonrsquot have got policy clearance on the amendments to the legislation but wersquore inclined to say that the Government is minded to or is considering x y or z

Happy to discuss

Jessica Matthew Deputy Director Road User Licensing Insurance and Safety Tel 020 7944 xxxx Zone 321 Great Minster House 76 Marsham Street London SW1P 4DR

Extract of Briefing shared with DH from the above e-mail

How will you make sure that people taking medication in accordance with their prescription arenrsquot arrested and taken to court as a result of this legislation

The medical defence in the provisions provides substantial and appropriate protection for people taking medically prescribed or supplied controlled drugs It places an evidential burden on a person accused of committing the offence So the accused must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court It is then for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on

It is unlikely that a person taking medication in accordance with their prescription would be taken to court for a number of reasons

30

1 Motorists cannot be stopped randomly for drug tests They can only be tested where They have committed a moving traffic offence They have been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under

the influence of drink or drugs

2 The drugs to be included in the legislation and their limits will be set in regulations The content of the regulations will be the subject of public consultation and an affirmative resolution This will provide an opportunity for any concerns with the proposed specified limits to be raised and carefully considered

3 The expert panel is bearing in mind the normal therapeutic ranges and expected drug concentrations in blood when setting limits for those drugs that may also be used for medicinal purposes This means that only patients on unusually high doses of medication might have a positive screening and proceed to evidential blood test

4 Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any cases before they reach the court Indeed there is a Code for Crown Prosecutors which contains a requirement that prosecutions are in the public interest

From xxxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 29 November 2012 1422 To xxxxxxxdhgsigovuk xxxxxxxxxpsncorguk xxxxxxxxxxxxxtheccaorguk xxxxxxxxxxnpacouk xxxxxxxxxxxxrpharmscom xxxxxxxxxxxsaddactionorguk xxxxxroadsafecom xxxxxxxxxxxxxxxxxxsdrconsortiumorg xxxm-allianceorguk xxxxxxxxxxxturning-pointcouk xxxxxxxxROSPAcom xxxxxxxxxxxxxxxxtheAAcom xxxxxxxxxacpopnnpoliceuk adminactionaddictionorguk xxxxxxxxxageukorguk xxxxxxxxxxxbrakeorguk xxxxxxxxbmaorguk xxxxxxxxxxxbritishpainsocietyorg xxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxcpsgsigovuk xxxxxxxxdrugscopeorguk xxxxxxxxxiamorguk xxxxxxxxxxxxxxlawsocietyorguk xxxxxxxxxxxliberty-human-rightsorguk xxxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxxpactsorguk xxxxxxxxxxparliamentuk xxxxxxxxxxxxRACFoundationorg xxxxxxxxxxdurhamgovuk xxxxxxxxxxxxxxxxPolicyConnectorguk xxxxxxxxxxxxxxpsncorguk xxxxxxxxxxxxxdvlagsigovuk Xxxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxhomeofficegsigovuk xxxxxxxxnpacouk xxxxxxxxxxxxdhgsigovuk xxxxxxxxxdrugscopeorguk Cc xxxxxxxxxxxxxxxxxxxdftgsigovuk JessicaMatthewdftgsigovuk xxxxxxxxxxxxxxxxxxdftgsigovuk Subject Drug driving seminar presentation

Dear all

Many thanks to those of you who were able to attend our Drug Driving Stakeholder Seminar last week

We hope you found as useful as we did

Please find attached a copy of the presentation as promised

Kind regards

Xxxxxx xxxxxxx

31

DP said that he is leading on drug driving policy and that the legislation currently going through Parliament is one of three pieces of work the Department is taking forward together The current proposals are enabling legislation which will allow the Government to determine the details critical to the new offence once the Expert Panel has published its recommendations DP suggested that the Expert Panelrsquos interim advice would be available in October

Xx noted that Napp is fully in support of the legislation and what it is trying to achieve but there are a few unintended consequences that it may cause for both manufacturers and patients Xx raised concerns about the impact on legitimate patients on a stable dose of medication that may be affected by legislation designed to target those who abuse illegal and legal drugs Xx added that Napp is in contact with a number of clinicians and other experts who would be happy to feed in to this policy development

Xx raised the issue of patients who are unimpaired being criminalised and facing a significant burden of proof if the proposed legislation is passed As the legislation is currently proposed there is a defence for patients taking prescription medication but the burden is first with them to prove that they have taken their medication is accordance with all instructions including from manufacturers There is a significant onus on patients to show they are not impaired despite what police say The defence is really only available once the driver is in court

Xx then compared the proposed legislation to the drink driving laws and highlighted the differences to drug driving legislation and the issue of strict liability Could the legislation be more focussed on its intended aim and tailor the list of controlled substances to those known to be abused as opposed to a catch all approach There needs to be protection for patients but at the moment the legislation appears to be trying to do both

Xx also noted the importance of ensuring that this is a policeable offence In the Governmentrsquos response to the North Review there was discussion of the Australian approach to drug driving Police found the impairment side of legislation hard to prove so they have instead just used the strict liability approach to prosecute drivers based on detection of a controlled substance

DP noted that all of the issues raised by xx are important What is being discussed in Parliament at the moment is enabling legislation which is setting out the framework The detail will become clearer once the interim advice from the Expert Panel has been received which is due in October The Department has already started to give some assurances in certain areas for example a zero tolerance approach for cannabis has been ruled out They will be able to home in as more advice is received from the Panel although it is not possible to pin the Panel down until it has reported DP added that there will be informed discussions with peers in late October before the legislation goes to Report Stage

Xx asked if the Panelrsquos advice will have any influence on the current draft Bill Xx asked if it would be worth making the primary legislation more focussed for example on substances known to be abused which would allow for strict liability The problem for patients would then become irrelevant as they would not be the focus of the legislation Xx also noted the problem that will arise from including heroin on the list of controlled substances Heroin metabolises into morphine in the blood as do some over-the-counter medications which makes it hard to distinguish between the different drug types This will lead to unintended consequences for patients

15

DP stated that he understood this argument but noted that the legislation is intended to be fit for purpose to allow for the whole range of potential decisions the Panel could make The decision might be made to change the substances on the controlled list although nothing so far has led him to think something should change The current list links back to the range included in the Misuse of Drugs Act The advice on the drugs will feed into the consultation and the subsequent affirmative procedure

DP added that because of the enabling nature of the current legislation there are some problems for example legal highs are not included on the list of controlled substances at the moment Due to the nature of the legislative procedure it can take a while to identify a problem and then legislate to give police powers They expect legal highs can become controlled drugs if they have protracted and serious consequences in a quicker time than the duration of the regulation-making process for drug driving There are powers to apply the legislation to all controlled drugs but they will need to go through it controlled drug by controlled drug in order to determine specific limits etc The Government envisages a mixed economy of the new and the existing offence

DP said that heroin is one drug of significant interest as it is known to be prevalent and associated with road safety risks The Panel are looking at opiates as a group of drugs and it will be for the Panel to decide how it can be detected He noted that they will need to consider all potential effects before setting any levels DP said that he knows that this is an area of importance for Napp as their patients will have a tolerance which is highly relevant to these considerations He would expect the Panel to look at that The Department wants the Panel to look at the opiate family so they do not only consider heroin

Xx said that the higher level of metabolites is an issue but these patients will be unimpaired where as a heroin user trying to get high is very different In terms of the defence the burden of proof lies on the shoulders of the patient Has the Department considered eliminating the impairment element and introducing an exemption for patients

DP responded that they have been considering all areas when looking at the medical defence Drink heroin and medically prescribed opiates have some similarities and also some important differences With alcohol some people who are over the limit will say they are unimpaired but the risks do increase as blood alcohol levels increase This can be the same with drugs

Xx noted that when a patient is on a steady dose of medication the pain they would be under if they were to stop taking their medication could be more impairing

DP said that he recognises the differences to drink driving Heroin users and medication users have different tolerances to ordinary people and the lsquodrink driving analogy is limitedrsquo Drinking has social benefits and it is a choice for people

Xx added that Napp sees that there is a desire to make drug like drink driving something that society will not tolerate but patients have to take their medication There is existing legislation against impairment for those who are irresponsible when taking their medication At the moment patients are being brought down to the lowest common denominator of those who abuse drugs This minority is causing problems for everyone else

16

Xxx noted that unlike with drink driving where increased alcohol leads to increased impairment there is not increased impairment with a high but stable dose of prescription medication Xx added that he believes there is a Swedish study which has investigated levels of impairment in patients

DP stated that although the opiate family is being considered together at the moment if it is not possible to distinguish between heroin and other opiates then it is open for the Department to decide whether or not to include morphine in the legislation They could decide that the disbenefits of including it would outweigh the benefits

He noted that the reason medications remain included is that there are problems with abuse for example with Benzodiazepines which are known to cause road safety problems Just because a controlled drug can be prescribed does not mean it will be removed from the legislation There will be a differentiation between a medical level at which someone must not drive and where they should not drive

Xx noted that Napp wants to work with the Government so that morphine can be included in the list of controlled substances By introducing an exemption or at least taking the burden of proof off the patient this could be done

DP said that the offence has a wide remit and there is a defence where they would like to include taking medication in accordance with medical advice There is a strong burden of proof on the prosecution to put evidence to the courts

Xx noted that the patient has to substantiate the proof first Xx added that patients already have a poor quality of life and this puts them under more stress Xxx said that pain is costing the country pound13bn a year and the Government has only recently decided to deem pain a long term condition and to work to help people have a good quality of life This seems like a backward step Doctors have been campaigning for years to get pain recognised and this is therefore a concern for them too as it may interfere with their choice of treatments

Xx said that with a few tweaks to the legislation the burden of proof could be placed on the prosecution For example by adding the word lsquoknowinglyrsquo to protect patients who were unaware of any advice against driving This would reassure them that a prescription will mean that they are protected Xx added that xxx has already had patient groups coming to her who are concerned that they are going to have to fight again

Xx noted that there is the issue of the lsquoknock onrsquo impact of one case highlighted by the media which could lead to patients becoming more cautious about taking their medication

DP said that he thought the Panel was unlikely to recommend low threshold levels He said that they have looked at the amendments tabled and they had material prepared for the Committee Stage of the legislation which was not needed and will be used to inform the informal discussion among peers in October He added that he feels the burden of proof leans towards the prosecution Once the prescription is presented it is down to the prosecution to prove beyond reasonable doubt that the medication was not taken properly For example one way would be if they can show that the blood level of a drug was in excess of the level prescribed

17

Xx raised concerns that cautious drivers may be wrongly pulled over by police and that it will be difficult for them to prove that they were unimpaired DP said that there are a swathe of issues about how far along the process people will be taken The balance is broadly right in the defence and if a case did go to court it would be resolved in the right way

DP noted that he is aware of the problems with testing procedures and that it is a genuinely difficult area Xx added that there are also concerns about those involved in a car crash and the insurance implications for a patient if they are the innocent party but test positively for drugs

DP said that is the situation already with the existing law and that there is currently a big drop off of cases before they reach the courts let alone conviction This is partly why the new offence is needed to target illegal drug users This issue is already there Xx acknowledged this but noted that the risk for patients would be heightened and that legislation designed to give police powers to stop drug abusers from driving should not spill over to impact on patients and make them worry about driving

Xx noted xxxx xxxxx xxxxx recent lsquoFit for Workrsquo report which showed that the main problem for the workforce is low back pain therefore many more people could be forced to stop work if they felt that by taking their medication it could mean that they are not deemed fit to drive

It was also noted that in the first stages of pain patients will seek pharmacist advice and use low doses of codeine to manage their pain There are 8m Osteoarthritis sufferers in the UK and over 70 report that they are in constant pain They typically start with over-the-counter medication including NSAIDS and codeine such as Nurofen Plus They will not have a prescription so how will they fare under the legislation

DP stated that this is partly an issue for the Panel He said he hoped that there is a good swathe of people on the Panel and asked if there is anything that Napp would like to submit to them Xx said there would be and that xxx would liaise with him on behalf of NAPP and feed in any information that would be considered helpful

Xxx noted that there are some concerns about the lack of medicalpainpatient representation on the Panel and that if these groups could feed in to the Panel that would help alleviate some concerns

DP said that the Panel is bringing in materials from other experts and that subject to his clearing it with the Chair they would be very keen to see papers etc The Panel would like to see as much research as possible Although they do not meet on policy there have been a number of issues related to the science of opioids that are of interest Xx asked if it would be helpful to also send the Panel a paper from Napp on where they believe legislation contains areas of risk and burden for patients to make the Panel aware of not only where the legislation can work but also where it could go wrong Xx asked if a pain expert could feed that in DP said case studies on the impact on patients would be helpful but there should be a focus on the science The legal aspects will not concern the Panel They should be happy to receive papers although he will have to talk to the Chair about having any experts appear in front of the Panel Xx assured DP that this would be done if the Chair was in agreement

18

Xx asked for some detail on the practical process of the Panelrsquos work Is the October report interim or final

DP said that it will be an interim report as there may be more work to do afterwards but that it is hoped and expected that the report will cover all the major drug types in the terms of reference They will use the findings across Government and then the decision will be made to move to the consultation The findings will also be communicated to the Committee on the Misuse of Drugs and the MRHA Secretariat representatives from both have been at Panel meetings

The secondary legislation will be in effect from early 2014 The plan is to consult on it in early 2013 and then progress through affirmative procedure in the later part of 2013 It will allow for the possible subsequent inclusion of other drugs

Xx asked about the development of testing devices and their specificity DP said that he is not a technical authority about the machines but does have information on the approval process A decision will be made at the end of the year on those currently going through police stations There will also be the beginning of the process to develop the second generation of roadside testing but the specifications cannot be finalised until the Panel reports These will be threshold detectors not just presentabsent detectors They will cover something related to heroin Legislation has been drafted so that police can undertake multiple preliminary tests as all drugs cannot be tested for at the same time The technology is important as an offence without it would not have the impact hoped for

DP added that other countries have a zero tolerance approach with presentabsent tests but that they want a threshold approach here He said that the legislation is linked to road safety it is not intended to change the law on possession use of drugs It is about public safety The existing penalty regime is not suitable for a zero tolerance approach At the moment crossing the limit means a 12 month driving ban and other consequences which is different to abroad The reason the drink drive limit has not been reduced is because the Government does not want to create a two tier system where the lower limit becomes seen as only equivalent to being given a speeding ticket The penalty for drug driving needs to allow for a more proportionate approach to enforcement At the moment if you are well versed in the law you have a good chance of evading conviction They want to change the balance and do not want to lower the penalty in comparison to drink driving He added that problems with some detection equipment abroad would not be acceptable in the UK legal system especially evidential saliva sampling The technology appears not there yet

DP noted that the Department is also looking at appropriate policy statements to make about the legislation The press has already focussed on areas where the new offence wonrsquot be an impact Xxx said that policy statements would help those patients who are already concerned

DP asked if Napprsquos patients receive unequivocal advice that they can drive Xx said not necessarily The issue is patients do not read advice and if they did they would not necessarily fully understand it It comes down to what the Doctor says but this legislation could then put them in a difficult position too Xx noted that the advice to patients in leaflets for medication regardless of whether they are prescription only medicines or over the counter would have a statement that would alert the patient to potential drowsiness or tiredness and advise that if this symptom was experienced patients should not drive or operate machinery This would be the same advice that clinicians would give to patients

19

about their medication unless as with certain drugs the DVLA should be notified and patients specifically informed that they must not drive whilst taking this medication The onus is on the patient to determine if they have this side effect and to what extent they are impaired DP noted that there is a difference between advice that a patient cannot drive and being told not to drive if they feel drowsy Xxx added that patients on a stable dose will be unsure if they can continue to work have a good quality of life etc and this will lead them to question whether or not to take their medication

DP stated that the Government can provide the context on what they think directions are but this will still be interpreted by a court Xx said publishing that information would provide comfort to patients who are concerned DP said this would be discussed with peers as well

Xx asked who will be invited to the informal discussion with peers and MPs DP said it would be just members of the House of Lords and Commons They will be able to meet with the Panel and other Government experts Xx noted that this would be useful for peers as those Napp has spoken to have had answers to initial questions but there are still areas where they would like some clarification DP noted that he and the Lords Spokesperson met with interested peers in advance of the Committee Stage It is easier to provide more factual clarification informally than on the floor of the House and Spokespeople will value the chance to make some progress before the Report Stage

Xx confirmed that Napp would put together some helpful information for DP to pass on to the Panel and will bring in some experts to feed in to that Xx added that Napp would be happy to feed in to any policy statements etc DP said he would be happy to clarify any issues in writing Xx said Napp would put together a list of questions for DP for this Xx said xxx would involve patient groups here too

Xx asked if there has been any input in the policy from the Department for Health DP said that a quadrilateral working group from Transport Justice Home and Health are working on the policy They have met between Panel meetings to see what is said and if there are any issues to put to the Panel

Xx asked if there is anything else Napp can do DP said that the more specific Napp can be about concerns evidence on the effect of treatments on impairment etc that would be helpful The policy is very much at the evidence gathering stage at the moment

Xx reiterated Napprsquos concerns regarding the Panel membership

DP said that at some point he expected tough decisions will be made about the balance of the proscons of the policy issues No solution will tick every box

Xx said that policy statements will be key to giving the police and the CPS guidance on who they are targeting as well as what lsquodirectionsrsquo mean to allay the fears of patients and clinicians DP said he hoped they would be able to allay fears He added that there is no advantage for the police to have lots of people in stations and being processed who are not impaired There is a realistic policy possibility that heroin will have to be set aside Just because the Panel is looking at it does not mean there is a commitment that it will be in the new offence They know that there may be no test to distinguish between different types of opiates

20

Xxx passed on two emails which he explained were from xx xxxxxxx xxxxxxx and xx xxxxxx xxxxxxxxn representing the views of CPPC and RCGP respectively Both Doctors expressed their concerns for patients and offered to contribute to discussions on the proposed legislation

A Note of Napprsquos Key Concerns

Napp Pharmaceuticals Meeting with Department for Transport 31 July 2012

Note I have added in bold italicised text some DfT responses to the questions in your original note which is otherwise as you sent me ndash Duncan Price 2882012

A Statement of support for drug driving legislation to stop people from driving while under the

influence of illegal drugs

Napp is concerned about the unintended consequences of the legislation on patients taking

long‐term medication for chronic pain Napp wants to work with the Government to find a

solution

1) Impact on Patients

2) Criminalisation of Patients

3) Different to Drink Driving Law

4) Policeable Offence

B Outline of Concerns

1) Impact on Patients

Evidence shows that patients on a stable dose of opioid analgesics are not necessarily

impaired but under the proposed system patients may be inaccurately identified as taking

impairing drugs and face prosecution

Patients well established on a stable dose of an opioid analgesic may have levels of

metabolites in their system well above any threshold used for roadside and police station

testing This means they could face serious charges despite driving unimpaired

There are concerns for patients such as those with Osteoarthritis the majority of who use

over the counter medications to manage their pain

Concern that patients will stop taking their medication so that they can drive This may

make their driving more impaired as a result of the pain that they will be under

Questions

Has there been consideration of how to distinguish between opiates that are used legally

for medicinal purposes and those used illegally (Napp would be happy to share clinical

knowledge of opioids that may be helpful to the panel and to any other interested parties

in Government)

The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

21

The panel is considering natural and synthetic opioids Its terms of reference include that it should establish the likelihood of whether concentrations of drugs broadly equivalent in their impairment effects to blood alcohol concentrations of 20 50 and 80mg100ml would be exceeded This will include a consideration of prescribed or otherwise legally obtained drugs which are known to impair driving

The panel will advise the Government which will then itself consider what specified limits to propose and then consult about I can assure you that in doing so it will consider how screening equipment and evidential blood specimens would distinguish between opiates used for legitimate medical purposes and those used illicitly

I am grateful for the offer of sharing clinical knowledge you made when we met I know the panel has since considered some of the evidence your experts have provided and some of its members have met an expert you recommended and one of your legal advisors

Has there been consideration of just introducing a list of restricted drugs known to be used

recreationally as with the Australian model

The list of restricted drugs used in some states in Australia does include THC (the active ingredient of cannabis) which does have some limited medical uses here The Governmentrsquos prime targets for this legislation are controlled drugs often or exclusively used illicitly including those included in the Australian legislation (THC amphetamines and MDMA)

At this stage we are awaiting advice from the panel but the Governmentrsquos position is that it should develop a new offence with the potential to include a number of categories of drug including benzodiazepines and opiates The abuse including the use of high quantities of methadone and some benzodiazepines (which can be prescribed) appears (alongside heroin) to be a significant contributor to the public safety problems this legislation is addressing

Many of the drugs specifically identified in the panelrsquos terms of reference are used exclusively or predominantly illicitly ndash for example amphetamine-types cannabinoids cocaine and hallucinogens

There is a reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

22

We are therefore using the definition of lsquocontrolled drugrsquo in the Misuse of Drugs Act 1971 within the new offence although which controlled drugs will be determined when regulations are brought forward

What consideration have you given to the issue of patients who drive unimpaired but will

still face prosecution if tested as levels of metabolites in their system may be above any

prescribed limit

This is being considered in both the terms of reference for the technical panelrsquos advice about the setting of specified limits (to keep patients out of the scope of the offence) and the inclusion of the medical defence within the offence

The panel has also been asked to consider the degree of variability in impairment effects across the population including for habitual drug users

In the terms of reference for the panel we have also specifically included the following from the North review (paragraph 743)

ldquoSome drugs which may be proscribed for driving might also be used legitimately in accordance with medical advice (for example morphine may be prescribed for chronic pain or diazepam (a benzodiazepine) may be prescribed for anxiety) Indeed the Review recognises that in some circumstances it may be more dangerous for a person to drive having not taken their medically prescribed drug than driving without having taken it Drugs have different effects on different people and levels at which they are prescribed are likely to reflect this It would clearly be wrong to put in jeopardy of prosecution those who are properly and safely taking medically prescribed drugs and driving in accordance with medical advice for whom despite the presence of a proscribed drug there is no evidence of any driving impairmentrdquo

I should also emphasise that the content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

2) Criminalisation of Patients

Statutory defence is included in the current legislation for those who have taken

prescription medication in accordance with prescribersupplier instructions and any

accompanying instructions from the manufacturer BUT

Only applicable after patient has been arrested further tested and their case has

progressed ndash this will cause innocent patients significant stress and

inconvenience

The defence puts the burden of proof on patients to prove that they acted in

accordance with all medical advice when the burden should be on the

prosecution to prove that they didnrsquot

23

Innocent patients may face criminalisation based on a technicality in legislation

that is not intended to target them

Questions

Is an exemption feasible (If not what is going to be done to ensure that patients are

protected)

I do not consider an exemption from the offence for all controlled drugs that can possibly be supplied or used for medical reasons is feasible Many controlled drugs for example cannabis have some medicinal uses

It is perfectly feasible for decisions about which controlled drugs would be specified for the new offence to be influenced by the reasons for whether their use is often always seldom or never for medical reasons Indeed such distinctions would be vital if this legislation were being introduced to enforce further against the illegal supply or use of controlled drugs

Whether that is the right approach to decision-making related to driving with controlled drugs in the body where there are levels associated with elevated risks to public safety is however questionable This legislation is being introduced to address road safety problems and the expert panelrsquos terms of reference are focussed on providing advice about the risks of driving after taking controlled drugs

It is to no-onesrsquo benefit for patients who are innocent of the offence to be arrested and tested There are several protections in place to reduce these risks Firstly police do not have random testing powers for drink and drug driving Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving

under the influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would result in disproportionate and large numbers of patients having evidential blood tests but then being not guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

24

It is important to note that the prosecution for a case where a defence has been raised that a patient had taken a controlled drug in accordance with medical advice must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code Test about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

It is important now and it will be important with the new offence in place that medical advice does not suggest to patients that they drive when doing so would present a significant risk to themselves and the public To do so risks patients being involved in road traffic incidents and also committing the existing offence of driving whilst impaired due to drugs

3) Different to Drink Driving Law

There have been calls for a strict liability approach to drug driving as exists for drink

driving Napp believes this would not be a suitable approach for drug driving based on the

current draft Bill

Alcohol does not have any medical necessity people do not need to consume

alcohol to ensure that a chronic condition does not prevent them from

functioning on a daily basis

Prescription medications that patients may take to treat chronic pain are a

medical necessity and are essential to ensuring that they are able to function on a

daily basis

A strict liability approach could lead to patients not taking essential medication in

order to be able to drive without fear of prosecution

Alternatively patients may choose not to drive at all which could have a serious

impact on their ability to work and go about their daily lives

Questions Is an exemption feasible (If not what is going to be done to ensure that patients are protected)

There are some useful analogies with drink driving law For example prior to the introduction of the specific drink driving offence the law in relation to drink drivers was difficult to enforce The specific offence there has contributed to major improvements in public safety

I do accept one of the differences with some controlled drugs is that some people take them for medicinal not recreational purposes This is not the case for all controlled drugs This may well affect what is included in the regulations for the offence

25

When we met I did say that it is conceivable for even as prevalent a recreational drug as heroin to not be included in the regulations for the offence This might be if it transpired that a limit relevant to heroin had to be set in a metabolite itself used in or a metabolite of a medically prescribed drug If such a limit also then had the effect of criminalising driving with medically supplied controlled drugs when that did not present an elevated risk to public safety I can see it would be a limit we might well not implement However I await the advice of the expert panel to see what it recommends related to heroin and whether (and how) that might affect other opiates

4) Policeable Offence

It is argued that drivers wonrsquot be stopped by police unless they appear impaired BUT

Plans are to test all those involved in a traffic accident for drugs including

innocent parties An innocent unimpaired patient involved in a crash through no

fault of their own could then face serious charges

Impairment is subjective and police may be suspicious of someonersquos driving for a

number of reasons such as driving too cautiously This apparently lsquoimpairedrsquo

driving may be due to various factors unrelated to the driverrsquos use of prescribed

medication but if they are stopped by police they may find themselves facing

serious and unjust charges

The existing impairment offence will remain so police will still be able to catch

those who do drive while impaired by prescription medication

Questions How close is the Home Office to approval of a drug testing device for use in police stations Can you provide any details

The laboratory testing phases of the type approval process is under way and the process is due to be completed at the end of this year

Is the Home Office still aiming for a 2014 approval of a drug testing device for portable use

It is still aiming for 2014 for these devices and we are planning the timing of that process together with the work on the new offence

Since the Governmentrsquos response to the North Review in June 2010 has the drug driving data quality improved

Yes we have received more information from Coroners recently and we also have had the conclusions of the European DRUID research

C Solutions

Napp believes that the best way to protect patients is by introducing an exemption for

those who can demonstrate that they are taking prescription medication

Existing legislation against driving while impaired would allow police to charge

anyone who did drive while under the influence of impairing prescription

medication

26

This would put the burden of proof on prosecutors saving innocent patients

considerable stress inconvenience and wasted CPS and police time

The Department considers that the statutory defence affords appropriate protection to patients who drive after taking prescription medication

The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

D Other Points for Consideration

Napp is keen to support this legislation in its efforts to stop users of illegal drugs

from driving and wishes to support policy development to ensure that patients are

protected Napp would be keen to provide any further information or other

means of assistance that could be of help here

Napp would like to submit written andor oral evidence to the Expert Panelrsquos

inquiry

Napp is concerned about the lack of pain expertise and patient representatives on

the Expert panel

Lord Henley mentioned that a seminar might be held after the summer recess to

discuss the issues arising from this legislation further Napp would be keen to

receive any further information on this

I hope this has been covered satisfactorily in the discussion we had on 31st July and since then

I do consider the legislation has strong safeguards in place for patients The Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

I hope I have addressed at least some of your concerns I should be happy to discuss the issues further

Duncan Price 2882012

27

Note on controlled drugs with medical uses

(i) The reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

(ii) Circumstances in which drug testing can be administered Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under the

influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

(iii) The medical defence The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

(iv) Drugs to be covered by the new offence and any specified limits to be based on expert advice The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

(v) Other controls The content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

(vi) Prosecutions to be in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

(vii) In light of the above the Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

28

From DuncanPricedftgsigovuk Sent 13092012 1603 To xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Cc xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Subject RE NRAS - Crime and Courts Bill clauses on drug driving

Xxxxxx

Below is my draft response to this letter Irsquoll send it when I have your comments about it

Dear xx xxxxxxx

Xxxxxx xxxxxxxx has forwarded your email of 28th August to me I am the lead policy official for the legislative clause about drug impaired driving in the Crime and Courts Bill

I am aware of concerns about innocent motorists taking prescribed medications being stopped tested being taken to police stations having blood samples taken and possibly going to court before being exonerated This is not the intention of the legislation and I can assure you we are mindful of this concern as we progress the legislation and respond to advice from an expert panel about the details

There are several protections in place to reduce the risk of large numbers of innocent motorists being arrested and taken to police stations

Firstly motorists cannot be stopped randomly for drug tests Testing can only be administered in three circumstances ndash namely where a driver has committed a moving traffic offence

a driver has been involved in a road traffic accident and or

there is reason for a police officer to suspect that a person has been driving under the influence of drink or drugs

This means that in practice drivers taking prescribed medicines would not be stopped and required to undergo drug testing without there being real cause for concern Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would be likely to result in disproportionate and large numbers of people prescribed drugs having evidential blood tests but then not being found guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

Fourthly it is important to emphasise that the prosecution for a case where the medical defence has been raised must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code for Crown Prosecutors which contains a requirement about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

Finally in the context of the clause before parliament the content of the regulations (specifying which controlled drugs should be covered by the new offence and the limits to be specified for them) will be the subject of public consultation Before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of

29

Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

I hope that this letter serves to allay concerns about possible unintended consequences for people taking prescription medicines

Duncan Price Tel 020 7944 xxxx Department for Transport

From JessicaMatthewdftgsigovuk Sent 17 October 2012 1108 To xxxxxxxxxxxxadhgsigovuk Cc xxxxxxxxxxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxxxxxdhgsigovuk xxxxxxxxdhgsigovuk Subject Re Department of Health attendance at the Lords briefing for the drug driving legislation

Xxxxxxxx is out of the office today but wersquoll send over the time and venue tomorrow and share the briefing with you Irsquod be happy to brief Dr Prunty beforehand ndash perhaps over the phone

Wersquore planning on a reasonably open debate about the legislation We wonrsquot have got policy clearance on the amendments to the legislation but wersquore inclined to say that the Government is minded to or is considering x y or z

Happy to discuss

Jessica Matthew Deputy Director Road User Licensing Insurance and Safety Tel 020 7944 xxxx Zone 321 Great Minster House 76 Marsham Street London SW1P 4DR

Extract of Briefing shared with DH from the above e-mail

How will you make sure that people taking medication in accordance with their prescription arenrsquot arrested and taken to court as a result of this legislation

The medical defence in the provisions provides substantial and appropriate protection for people taking medically prescribed or supplied controlled drugs It places an evidential burden on a person accused of committing the offence So the accused must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court It is then for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on

It is unlikely that a person taking medication in accordance with their prescription would be taken to court for a number of reasons

30

1 Motorists cannot be stopped randomly for drug tests They can only be tested where They have committed a moving traffic offence They have been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under

the influence of drink or drugs

2 The drugs to be included in the legislation and their limits will be set in regulations The content of the regulations will be the subject of public consultation and an affirmative resolution This will provide an opportunity for any concerns with the proposed specified limits to be raised and carefully considered

3 The expert panel is bearing in mind the normal therapeutic ranges and expected drug concentrations in blood when setting limits for those drugs that may also be used for medicinal purposes This means that only patients on unusually high doses of medication might have a positive screening and proceed to evidential blood test

4 Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any cases before they reach the court Indeed there is a Code for Crown Prosecutors which contains a requirement that prosecutions are in the public interest

From xxxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 29 November 2012 1422 To xxxxxxxdhgsigovuk xxxxxxxxxpsncorguk xxxxxxxxxxxxxtheccaorguk xxxxxxxxxxnpacouk xxxxxxxxxxxxrpharmscom xxxxxxxxxxxsaddactionorguk xxxxxroadsafecom xxxxxxxxxxxxxxxxxxsdrconsortiumorg xxxm-allianceorguk xxxxxxxxxxxturning-pointcouk xxxxxxxxROSPAcom xxxxxxxxxxxxxxxxtheAAcom xxxxxxxxxacpopnnpoliceuk adminactionaddictionorguk xxxxxxxxxageukorguk xxxxxxxxxxxbrakeorguk xxxxxxxxbmaorguk xxxxxxxxxxxbritishpainsocietyorg xxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxcpsgsigovuk xxxxxxxxdrugscopeorguk xxxxxxxxxiamorguk xxxxxxxxxxxxxxlawsocietyorguk xxxxxxxxxxxliberty-human-rightsorguk xxxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxxpactsorguk xxxxxxxxxxparliamentuk xxxxxxxxxxxxRACFoundationorg xxxxxxxxxxdurhamgovuk xxxxxxxxxxxxxxxxPolicyConnectorguk xxxxxxxxxxxxxxpsncorguk xxxxxxxxxxxxxdvlagsigovuk Xxxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxhomeofficegsigovuk xxxxxxxxnpacouk xxxxxxxxxxxxdhgsigovuk xxxxxxxxxdrugscopeorguk Cc xxxxxxxxxxxxxxxxxxxdftgsigovuk JessicaMatthewdftgsigovuk xxxxxxxxxxxxxxxxxxdftgsigovuk Subject Drug driving seminar presentation

Dear all

Many thanks to those of you who were able to attend our Drug Driving Stakeholder Seminar last week

We hope you found as useful as we did

Please find attached a copy of the presentation as promised

Kind regards

Xxxxxx xxxxxxx

31

DP stated that he understood this argument but noted that the legislation is intended to be fit for purpose to allow for the whole range of potential decisions the Panel could make The decision might be made to change the substances on the controlled list although nothing so far has led him to think something should change The current list links back to the range included in the Misuse of Drugs Act The advice on the drugs will feed into the consultation and the subsequent affirmative procedure

DP added that because of the enabling nature of the current legislation there are some problems for example legal highs are not included on the list of controlled substances at the moment Due to the nature of the legislative procedure it can take a while to identify a problem and then legislate to give police powers They expect legal highs can become controlled drugs if they have protracted and serious consequences in a quicker time than the duration of the regulation-making process for drug driving There are powers to apply the legislation to all controlled drugs but they will need to go through it controlled drug by controlled drug in order to determine specific limits etc The Government envisages a mixed economy of the new and the existing offence

DP said that heroin is one drug of significant interest as it is known to be prevalent and associated with road safety risks The Panel are looking at opiates as a group of drugs and it will be for the Panel to decide how it can be detected He noted that they will need to consider all potential effects before setting any levels DP said that he knows that this is an area of importance for Napp as their patients will have a tolerance which is highly relevant to these considerations He would expect the Panel to look at that The Department wants the Panel to look at the opiate family so they do not only consider heroin

Xx said that the higher level of metabolites is an issue but these patients will be unimpaired where as a heroin user trying to get high is very different In terms of the defence the burden of proof lies on the shoulders of the patient Has the Department considered eliminating the impairment element and introducing an exemption for patients

DP responded that they have been considering all areas when looking at the medical defence Drink heroin and medically prescribed opiates have some similarities and also some important differences With alcohol some people who are over the limit will say they are unimpaired but the risks do increase as blood alcohol levels increase This can be the same with drugs

Xx noted that when a patient is on a steady dose of medication the pain they would be under if they were to stop taking their medication could be more impairing

DP said that he recognises the differences to drink driving Heroin users and medication users have different tolerances to ordinary people and the lsquodrink driving analogy is limitedrsquo Drinking has social benefits and it is a choice for people

Xx added that Napp sees that there is a desire to make drug like drink driving something that society will not tolerate but patients have to take their medication There is existing legislation against impairment for those who are irresponsible when taking their medication At the moment patients are being brought down to the lowest common denominator of those who abuse drugs This minority is causing problems for everyone else

16

Xxx noted that unlike with drink driving where increased alcohol leads to increased impairment there is not increased impairment with a high but stable dose of prescription medication Xx added that he believes there is a Swedish study which has investigated levels of impairment in patients

DP stated that although the opiate family is being considered together at the moment if it is not possible to distinguish between heroin and other opiates then it is open for the Department to decide whether or not to include morphine in the legislation They could decide that the disbenefits of including it would outweigh the benefits

He noted that the reason medications remain included is that there are problems with abuse for example with Benzodiazepines which are known to cause road safety problems Just because a controlled drug can be prescribed does not mean it will be removed from the legislation There will be a differentiation between a medical level at which someone must not drive and where they should not drive

Xx noted that Napp wants to work with the Government so that morphine can be included in the list of controlled substances By introducing an exemption or at least taking the burden of proof off the patient this could be done

DP said that the offence has a wide remit and there is a defence where they would like to include taking medication in accordance with medical advice There is a strong burden of proof on the prosecution to put evidence to the courts

Xx noted that the patient has to substantiate the proof first Xx added that patients already have a poor quality of life and this puts them under more stress Xxx said that pain is costing the country pound13bn a year and the Government has only recently decided to deem pain a long term condition and to work to help people have a good quality of life This seems like a backward step Doctors have been campaigning for years to get pain recognised and this is therefore a concern for them too as it may interfere with their choice of treatments

Xx said that with a few tweaks to the legislation the burden of proof could be placed on the prosecution For example by adding the word lsquoknowinglyrsquo to protect patients who were unaware of any advice against driving This would reassure them that a prescription will mean that they are protected Xx added that xxx has already had patient groups coming to her who are concerned that they are going to have to fight again

Xx noted that there is the issue of the lsquoknock onrsquo impact of one case highlighted by the media which could lead to patients becoming more cautious about taking their medication

DP said that he thought the Panel was unlikely to recommend low threshold levels He said that they have looked at the amendments tabled and they had material prepared for the Committee Stage of the legislation which was not needed and will be used to inform the informal discussion among peers in October He added that he feels the burden of proof leans towards the prosecution Once the prescription is presented it is down to the prosecution to prove beyond reasonable doubt that the medication was not taken properly For example one way would be if they can show that the blood level of a drug was in excess of the level prescribed

17

Xx raised concerns that cautious drivers may be wrongly pulled over by police and that it will be difficult for them to prove that they were unimpaired DP said that there are a swathe of issues about how far along the process people will be taken The balance is broadly right in the defence and if a case did go to court it would be resolved in the right way

DP noted that he is aware of the problems with testing procedures and that it is a genuinely difficult area Xx added that there are also concerns about those involved in a car crash and the insurance implications for a patient if they are the innocent party but test positively for drugs

DP said that is the situation already with the existing law and that there is currently a big drop off of cases before they reach the courts let alone conviction This is partly why the new offence is needed to target illegal drug users This issue is already there Xx acknowledged this but noted that the risk for patients would be heightened and that legislation designed to give police powers to stop drug abusers from driving should not spill over to impact on patients and make them worry about driving

Xx noted xxxx xxxxx xxxxx recent lsquoFit for Workrsquo report which showed that the main problem for the workforce is low back pain therefore many more people could be forced to stop work if they felt that by taking their medication it could mean that they are not deemed fit to drive

It was also noted that in the first stages of pain patients will seek pharmacist advice and use low doses of codeine to manage their pain There are 8m Osteoarthritis sufferers in the UK and over 70 report that they are in constant pain They typically start with over-the-counter medication including NSAIDS and codeine such as Nurofen Plus They will not have a prescription so how will they fare under the legislation

DP stated that this is partly an issue for the Panel He said he hoped that there is a good swathe of people on the Panel and asked if there is anything that Napp would like to submit to them Xx said there would be and that xxx would liaise with him on behalf of NAPP and feed in any information that would be considered helpful

Xxx noted that there are some concerns about the lack of medicalpainpatient representation on the Panel and that if these groups could feed in to the Panel that would help alleviate some concerns

DP said that the Panel is bringing in materials from other experts and that subject to his clearing it with the Chair they would be very keen to see papers etc The Panel would like to see as much research as possible Although they do not meet on policy there have been a number of issues related to the science of opioids that are of interest Xx asked if it would be helpful to also send the Panel a paper from Napp on where they believe legislation contains areas of risk and burden for patients to make the Panel aware of not only where the legislation can work but also where it could go wrong Xx asked if a pain expert could feed that in DP said case studies on the impact on patients would be helpful but there should be a focus on the science The legal aspects will not concern the Panel They should be happy to receive papers although he will have to talk to the Chair about having any experts appear in front of the Panel Xx assured DP that this would be done if the Chair was in agreement

18

Xx asked for some detail on the practical process of the Panelrsquos work Is the October report interim or final

DP said that it will be an interim report as there may be more work to do afterwards but that it is hoped and expected that the report will cover all the major drug types in the terms of reference They will use the findings across Government and then the decision will be made to move to the consultation The findings will also be communicated to the Committee on the Misuse of Drugs and the MRHA Secretariat representatives from both have been at Panel meetings

The secondary legislation will be in effect from early 2014 The plan is to consult on it in early 2013 and then progress through affirmative procedure in the later part of 2013 It will allow for the possible subsequent inclusion of other drugs

Xx asked about the development of testing devices and their specificity DP said that he is not a technical authority about the machines but does have information on the approval process A decision will be made at the end of the year on those currently going through police stations There will also be the beginning of the process to develop the second generation of roadside testing but the specifications cannot be finalised until the Panel reports These will be threshold detectors not just presentabsent detectors They will cover something related to heroin Legislation has been drafted so that police can undertake multiple preliminary tests as all drugs cannot be tested for at the same time The technology is important as an offence without it would not have the impact hoped for

DP added that other countries have a zero tolerance approach with presentabsent tests but that they want a threshold approach here He said that the legislation is linked to road safety it is not intended to change the law on possession use of drugs It is about public safety The existing penalty regime is not suitable for a zero tolerance approach At the moment crossing the limit means a 12 month driving ban and other consequences which is different to abroad The reason the drink drive limit has not been reduced is because the Government does not want to create a two tier system where the lower limit becomes seen as only equivalent to being given a speeding ticket The penalty for drug driving needs to allow for a more proportionate approach to enforcement At the moment if you are well versed in the law you have a good chance of evading conviction They want to change the balance and do not want to lower the penalty in comparison to drink driving He added that problems with some detection equipment abroad would not be acceptable in the UK legal system especially evidential saliva sampling The technology appears not there yet

DP noted that the Department is also looking at appropriate policy statements to make about the legislation The press has already focussed on areas where the new offence wonrsquot be an impact Xxx said that policy statements would help those patients who are already concerned

DP asked if Napprsquos patients receive unequivocal advice that they can drive Xx said not necessarily The issue is patients do not read advice and if they did they would not necessarily fully understand it It comes down to what the Doctor says but this legislation could then put them in a difficult position too Xx noted that the advice to patients in leaflets for medication regardless of whether they are prescription only medicines or over the counter would have a statement that would alert the patient to potential drowsiness or tiredness and advise that if this symptom was experienced patients should not drive or operate machinery This would be the same advice that clinicians would give to patients

19

about their medication unless as with certain drugs the DVLA should be notified and patients specifically informed that they must not drive whilst taking this medication The onus is on the patient to determine if they have this side effect and to what extent they are impaired DP noted that there is a difference between advice that a patient cannot drive and being told not to drive if they feel drowsy Xxx added that patients on a stable dose will be unsure if they can continue to work have a good quality of life etc and this will lead them to question whether or not to take their medication

DP stated that the Government can provide the context on what they think directions are but this will still be interpreted by a court Xx said publishing that information would provide comfort to patients who are concerned DP said this would be discussed with peers as well

Xx asked who will be invited to the informal discussion with peers and MPs DP said it would be just members of the House of Lords and Commons They will be able to meet with the Panel and other Government experts Xx noted that this would be useful for peers as those Napp has spoken to have had answers to initial questions but there are still areas where they would like some clarification DP noted that he and the Lords Spokesperson met with interested peers in advance of the Committee Stage It is easier to provide more factual clarification informally than on the floor of the House and Spokespeople will value the chance to make some progress before the Report Stage

Xx confirmed that Napp would put together some helpful information for DP to pass on to the Panel and will bring in some experts to feed in to that Xx added that Napp would be happy to feed in to any policy statements etc DP said he would be happy to clarify any issues in writing Xx said Napp would put together a list of questions for DP for this Xx said xxx would involve patient groups here too

Xx asked if there has been any input in the policy from the Department for Health DP said that a quadrilateral working group from Transport Justice Home and Health are working on the policy They have met between Panel meetings to see what is said and if there are any issues to put to the Panel

Xx asked if there is anything else Napp can do DP said that the more specific Napp can be about concerns evidence on the effect of treatments on impairment etc that would be helpful The policy is very much at the evidence gathering stage at the moment

Xx reiterated Napprsquos concerns regarding the Panel membership

DP said that at some point he expected tough decisions will be made about the balance of the proscons of the policy issues No solution will tick every box

Xx said that policy statements will be key to giving the police and the CPS guidance on who they are targeting as well as what lsquodirectionsrsquo mean to allay the fears of patients and clinicians DP said he hoped they would be able to allay fears He added that there is no advantage for the police to have lots of people in stations and being processed who are not impaired There is a realistic policy possibility that heroin will have to be set aside Just because the Panel is looking at it does not mean there is a commitment that it will be in the new offence They know that there may be no test to distinguish between different types of opiates

20

Xxx passed on two emails which he explained were from xx xxxxxxx xxxxxxx and xx xxxxxx xxxxxxxxn representing the views of CPPC and RCGP respectively Both Doctors expressed their concerns for patients and offered to contribute to discussions on the proposed legislation

A Note of Napprsquos Key Concerns

Napp Pharmaceuticals Meeting with Department for Transport 31 July 2012

Note I have added in bold italicised text some DfT responses to the questions in your original note which is otherwise as you sent me ndash Duncan Price 2882012

A Statement of support for drug driving legislation to stop people from driving while under the

influence of illegal drugs

Napp is concerned about the unintended consequences of the legislation on patients taking

long‐term medication for chronic pain Napp wants to work with the Government to find a

solution

1) Impact on Patients

2) Criminalisation of Patients

3) Different to Drink Driving Law

4) Policeable Offence

B Outline of Concerns

1) Impact on Patients

Evidence shows that patients on a stable dose of opioid analgesics are not necessarily

impaired but under the proposed system patients may be inaccurately identified as taking

impairing drugs and face prosecution

Patients well established on a stable dose of an opioid analgesic may have levels of

metabolites in their system well above any threshold used for roadside and police station

testing This means they could face serious charges despite driving unimpaired

There are concerns for patients such as those with Osteoarthritis the majority of who use

over the counter medications to manage their pain

Concern that patients will stop taking their medication so that they can drive This may

make their driving more impaired as a result of the pain that they will be under

Questions

Has there been consideration of how to distinguish between opiates that are used legally

for medicinal purposes and those used illegally (Napp would be happy to share clinical

knowledge of opioids that may be helpful to the panel and to any other interested parties

in Government)

The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

21

The panel is considering natural and synthetic opioids Its terms of reference include that it should establish the likelihood of whether concentrations of drugs broadly equivalent in their impairment effects to blood alcohol concentrations of 20 50 and 80mg100ml would be exceeded This will include a consideration of prescribed or otherwise legally obtained drugs which are known to impair driving

The panel will advise the Government which will then itself consider what specified limits to propose and then consult about I can assure you that in doing so it will consider how screening equipment and evidential blood specimens would distinguish between opiates used for legitimate medical purposes and those used illicitly

I am grateful for the offer of sharing clinical knowledge you made when we met I know the panel has since considered some of the evidence your experts have provided and some of its members have met an expert you recommended and one of your legal advisors

Has there been consideration of just introducing a list of restricted drugs known to be used

recreationally as with the Australian model

The list of restricted drugs used in some states in Australia does include THC (the active ingredient of cannabis) which does have some limited medical uses here The Governmentrsquos prime targets for this legislation are controlled drugs often or exclusively used illicitly including those included in the Australian legislation (THC amphetamines and MDMA)

At this stage we are awaiting advice from the panel but the Governmentrsquos position is that it should develop a new offence with the potential to include a number of categories of drug including benzodiazepines and opiates The abuse including the use of high quantities of methadone and some benzodiazepines (which can be prescribed) appears (alongside heroin) to be a significant contributor to the public safety problems this legislation is addressing

Many of the drugs specifically identified in the panelrsquos terms of reference are used exclusively or predominantly illicitly ndash for example amphetamine-types cannabinoids cocaine and hallucinogens

There is a reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

22

We are therefore using the definition of lsquocontrolled drugrsquo in the Misuse of Drugs Act 1971 within the new offence although which controlled drugs will be determined when regulations are brought forward

What consideration have you given to the issue of patients who drive unimpaired but will

still face prosecution if tested as levels of metabolites in their system may be above any

prescribed limit

This is being considered in both the terms of reference for the technical panelrsquos advice about the setting of specified limits (to keep patients out of the scope of the offence) and the inclusion of the medical defence within the offence

The panel has also been asked to consider the degree of variability in impairment effects across the population including for habitual drug users

In the terms of reference for the panel we have also specifically included the following from the North review (paragraph 743)

ldquoSome drugs which may be proscribed for driving might also be used legitimately in accordance with medical advice (for example morphine may be prescribed for chronic pain or diazepam (a benzodiazepine) may be prescribed for anxiety) Indeed the Review recognises that in some circumstances it may be more dangerous for a person to drive having not taken their medically prescribed drug than driving without having taken it Drugs have different effects on different people and levels at which they are prescribed are likely to reflect this It would clearly be wrong to put in jeopardy of prosecution those who are properly and safely taking medically prescribed drugs and driving in accordance with medical advice for whom despite the presence of a proscribed drug there is no evidence of any driving impairmentrdquo

I should also emphasise that the content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

2) Criminalisation of Patients

Statutory defence is included in the current legislation for those who have taken

prescription medication in accordance with prescribersupplier instructions and any

accompanying instructions from the manufacturer BUT

Only applicable after patient has been arrested further tested and their case has

progressed ndash this will cause innocent patients significant stress and

inconvenience

The defence puts the burden of proof on patients to prove that they acted in

accordance with all medical advice when the burden should be on the

prosecution to prove that they didnrsquot

23

Innocent patients may face criminalisation based on a technicality in legislation

that is not intended to target them

Questions

Is an exemption feasible (If not what is going to be done to ensure that patients are

protected)

I do not consider an exemption from the offence for all controlled drugs that can possibly be supplied or used for medical reasons is feasible Many controlled drugs for example cannabis have some medicinal uses

It is perfectly feasible for decisions about which controlled drugs would be specified for the new offence to be influenced by the reasons for whether their use is often always seldom or never for medical reasons Indeed such distinctions would be vital if this legislation were being introduced to enforce further against the illegal supply or use of controlled drugs

Whether that is the right approach to decision-making related to driving with controlled drugs in the body where there are levels associated with elevated risks to public safety is however questionable This legislation is being introduced to address road safety problems and the expert panelrsquos terms of reference are focussed on providing advice about the risks of driving after taking controlled drugs

It is to no-onesrsquo benefit for patients who are innocent of the offence to be arrested and tested There are several protections in place to reduce these risks Firstly police do not have random testing powers for drink and drug driving Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving

under the influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would result in disproportionate and large numbers of patients having evidential blood tests but then being not guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

24

It is important to note that the prosecution for a case where a defence has been raised that a patient had taken a controlled drug in accordance with medical advice must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code Test about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

It is important now and it will be important with the new offence in place that medical advice does not suggest to patients that they drive when doing so would present a significant risk to themselves and the public To do so risks patients being involved in road traffic incidents and also committing the existing offence of driving whilst impaired due to drugs

3) Different to Drink Driving Law

There have been calls for a strict liability approach to drug driving as exists for drink

driving Napp believes this would not be a suitable approach for drug driving based on the

current draft Bill

Alcohol does not have any medical necessity people do not need to consume

alcohol to ensure that a chronic condition does not prevent them from

functioning on a daily basis

Prescription medications that patients may take to treat chronic pain are a

medical necessity and are essential to ensuring that they are able to function on a

daily basis

A strict liability approach could lead to patients not taking essential medication in

order to be able to drive without fear of prosecution

Alternatively patients may choose not to drive at all which could have a serious

impact on their ability to work and go about their daily lives

Questions Is an exemption feasible (If not what is going to be done to ensure that patients are protected)

There are some useful analogies with drink driving law For example prior to the introduction of the specific drink driving offence the law in relation to drink drivers was difficult to enforce The specific offence there has contributed to major improvements in public safety

I do accept one of the differences with some controlled drugs is that some people take them for medicinal not recreational purposes This is not the case for all controlled drugs This may well affect what is included in the regulations for the offence

25

When we met I did say that it is conceivable for even as prevalent a recreational drug as heroin to not be included in the regulations for the offence This might be if it transpired that a limit relevant to heroin had to be set in a metabolite itself used in or a metabolite of a medically prescribed drug If such a limit also then had the effect of criminalising driving with medically supplied controlled drugs when that did not present an elevated risk to public safety I can see it would be a limit we might well not implement However I await the advice of the expert panel to see what it recommends related to heroin and whether (and how) that might affect other opiates

4) Policeable Offence

It is argued that drivers wonrsquot be stopped by police unless they appear impaired BUT

Plans are to test all those involved in a traffic accident for drugs including

innocent parties An innocent unimpaired patient involved in a crash through no

fault of their own could then face serious charges

Impairment is subjective and police may be suspicious of someonersquos driving for a

number of reasons such as driving too cautiously This apparently lsquoimpairedrsquo

driving may be due to various factors unrelated to the driverrsquos use of prescribed

medication but if they are stopped by police they may find themselves facing

serious and unjust charges

The existing impairment offence will remain so police will still be able to catch

those who do drive while impaired by prescription medication

Questions How close is the Home Office to approval of a drug testing device for use in police stations Can you provide any details

The laboratory testing phases of the type approval process is under way and the process is due to be completed at the end of this year

Is the Home Office still aiming for a 2014 approval of a drug testing device for portable use

It is still aiming for 2014 for these devices and we are planning the timing of that process together with the work on the new offence

Since the Governmentrsquos response to the North Review in June 2010 has the drug driving data quality improved

Yes we have received more information from Coroners recently and we also have had the conclusions of the European DRUID research

C Solutions

Napp believes that the best way to protect patients is by introducing an exemption for

those who can demonstrate that they are taking prescription medication

Existing legislation against driving while impaired would allow police to charge

anyone who did drive while under the influence of impairing prescription

medication

26

This would put the burden of proof on prosecutors saving innocent patients

considerable stress inconvenience and wasted CPS and police time

The Department considers that the statutory defence affords appropriate protection to patients who drive after taking prescription medication

The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

D Other Points for Consideration

Napp is keen to support this legislation in its efforts to stop users of illegal drugs

from driving and wishes to support policy development to ensure that patients are

protected Napp would be keen to provide any further information or other

means of assistance that could be of help here

Napp would like to submit written andor oral evidence to the Expert Panelrsquos

inquiry

Napp is concerned about the lack of pain expertise and patient representatives on

the Expert panel

Lord Henley mentioned that a seminar might be held after the summer recess to

discuss the issues arising from this legislation further Napp would be keen to

receive any further information on this

I hope this has been covered satisfactorily in the discussion we had on 31st July and since then

I do consider the legislation has strong safeguards in place for patients The Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

I hope I have addressed at least some of your concerns I should be happy to discuss the issues further

Duncan Price 2882012

27

Note on controlled drugs with medical uses

(i) The reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

(ii) Circumstances in which drug testing can be administered Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under the

influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

(iii) The medical defence The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

(iv) Drugs to be covered by the new offence and any specified limits to be based on expert advice The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

(v) Other controls The content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

(vi) Prosecutions to be in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

(vii) In light of the above the Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

28

From DuncanPricedftgsigovuk Sent 13092012 1603 To xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Cc xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Subject RE NRAS - Crime and Courts Bill clauses on drug driving

Xxxxxx

Below is my draft response to this letter Irsquoll send it when I have your comments about it

Dear xx xxxxxxx

Xxxxxx xxxxxxxx has forwarded your email of 28th August to me I am the lead policy official for the legislative clause about drug impaired driving in the Crime and Courts Bill

I am aware of concerns about innocent motorists taking prescribed medications being stopped tested being taken to police stations having blood samples taken and possibly going to court before being exonerated This is not the intention of the legislation and I can assure you we are mindful of this concern as we progress the legislation and respond to advice from an expert panel about the details

There are several protections in place to reduce the risk of large numbers of innocent motorists being arrested and taken to police stations

Firstly motorists cannot be stopped randomly for drug tests Testing can only be administered in three circumstances ndash namely where a driver has committed a moving traffic offence

a driver has been involved in a road traffic accident and or

there is reason for a police officer to suspect that a person has been driving under the influence of drink or drugs

This means that in practice drivers taking prescribed medicines would not be stopped and required to undergo drug testing without there being real cause for concern Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would be likely to result in disproportionate and large numbers of people prescribed drugs having evidential blood tests but then not being found guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

Fourthly it is important to emphasise that the prosecution for a case where the medical defence has been raised must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code for Crown Prosecutors which contains a requirement about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

Finally in the context of the clause before parliament the content of the regulations (specifying which controlled drugs should be covered by the new offence and the limits to be specified for them) will be the subject of public consultation Before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of

29

Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

I hope that this letter serves to allay concerns about possible unintended consequences for people taking prescription medicines

Duncan Price Tel 020 7944 xxxx Department for Transport

From JessicaMatthewdftgsigovuk Sent 17 October 2012 1108 To xxxxxxxxxxxxadhgsigovuk Cc xxxxxxxxxxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxxxxxdhgsigovuk xxxxxxxxdhgsigovuk Subject Re Department of Health attendance at the Lords briefing for the drug driving legislation

Xxxxxxxx is out of the office today but wersquoll send over the time and venue tomorrow and share the briefing with you Irsquod be happy to brief Dr Prunty beforehand ndash perhaps over the phone

Wersquore planning on a reasonably open debate about the legislation We wonrsquot have got policy clearance on the amendments to the legislation but wersquore inclined to say that the Government is minded to or is considering x y or z

Happy to discuss

Jessica Matthew Deputy Director Road User Licensing Insurance and Safety Tel 020 7944 xxxx Zone 321 Great Minster House 76 Marsham Street London SW1P 4DR

Extract of Briefing shared with DH from the above e-mail

How will you make sure that people taking medication in accordance with their prescription arenrsquot arrested and taken to court as a result of this legislation

The medical defence in the provisions provides substantial and appropriate protection for people taking medically prescribed or supplied controlled drugs It places an evidential burden on a person accused of committing the offence So the accused must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court It is then for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on

It is unlikely that a person taking medication in accordance with their prescription would be taken to court for a number of reasons

30

1 Motorists cannot be stopped randomly for drug tests They can only be tested where They have committed a moving traffic offence They have been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under

the influence of drink or drugs

2 The drugs to be included in the legislation and their limits will be set in regulations The content of the regulations will be the subject of public consultation and an affirmative resolution This will provide an opportunity for any concerns with the proposed specified limits to be raised and carefully considered

3 The expert panel is bearing in mind the normal therapeutic ranges and expected drug concentrations in blood when setting limits for those drugs that may also be used for medicinal purposes This means that only patients on unusually high doses of medication might have a positive screening and proceed to evidential blood test

4 Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any cases before they reach the court Indeed there is a Code for Crown Prosecutors which contains a requirement that prosecutions are in the public interest

From xxxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 29 November 2012 1422 To xxxxxxxdhgsigovuk xxxxxxxxxpsncorguk xxxxxxxxxxxxxtheccaorguk xxxxxxxxxxnpacouk xxxxxxxxxxxxrpharmscom xxxxxxxxxxxsaddactionorguk xxxxxroadsafecom xxxxxxxxxxxxxxxxxxsdrconsortiumorg xxxm-allianceorguk xxxxxxxxxxxturning-pointcouk xxxxxxxxROSPAcom xxxxxxxxxxxxxxxxtheAAcom xxxxxxxxxacpopnnpoliceuk adminactionaddictionorguk xxxxxxxxxageukorguk xxxxxxxxxxxbrakeorguk xxxxxxxxbmaorguk xxxxxxxxxxxbritishpainsocietyorg xxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxcpsgsigovuk xxxxxxxxdrugscopeorguk xxxxxxxxxiamorguk xxxxxxxxxxxxxxlawsocietyorguk xxxxxxxxxxxliberty-human-rightsorguk xxxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxxpactsorguk xxxxxxxxxxparliamentuk xxxxxxxxxxxxRACFoundationorg xxxxxxxxxxdurhamgovuk xxxxxxxxxxxxxxxxPolicyConnectorguk xxxxxxxxxxxxxxpsncorguk xxxxxxxxxxxxxdvlagsigovuk Xxxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxhomeofficegsigovuk xxxxxxxxnpacouk xxxxxxxxxxxxdhgsigovuk xxxxxxxxxdrugscopeorguk Cc xxxxxxxxxxxxxxxxxxxdftgsigovuk JessicaMatthewdftgsigovuk xxxxxxxxxxxxxxxxxxdftgsigovuk Subject Drug driving seminar presentation

Dear all

Many thanks to those of you who were able to attend our Drug Driving Stakeholder Seminar last week

We hope you found as useful as we did

Please find attached a copy of the presentation as promised

Kind regards

Xxxxxx xxxxxxx

31

Xxx noted that unlike with drink driving where increased alcohol leads to increased impairment there is not increased impairment with a high but stable dose of prescription medication Xx added that he believes there is a Swedish study which has investigated levels of impairment in patients

DP stated that although the opiate family is being considered together at the moment if it is not possible to distinguish between heroin and other opiates then it is open for the Department to decide whether or not to include morphine in the legislation They could decide that the disbenefits of including it would outweigh the benefits

He noted that the reason medications remain included is that there are problems with abuse for example with Benzodiazepines which are known to cause road safety problems Just because a controlled drug can be prescribed does not mean it will be removed from the legislation There will be a differentiation between a medical level at which someone must not drive and where they should not drive

Xx noted that Napp wants to work with the Government so that morphine can be included in the list of controlled substances By introducing an exemption or at least taking the burden of proof off the patient this could be done

DP said that the offence has a wide remit and there is a defence where they would like to include taking medication in accordance with medical advice There is a strong burden of proof on the prosecution to put evidence to the courts

Xx noted that the patient has to substantiate the proof first Xx added that patients already have a poor quality of life and this puts them under more stress Xxx said that pain is costing the country pound13bn a year and the Government has only recently decided to deem pain a long term condition and to work to help people have a good quality of life This seems like a backward step Doctors have been campaigning for years to get pain recognised and this is therefore a concern for them too as it may interfere with their choice of treatments

Xx said that with a few tweaks to the legislation the burden of proof could be placed on the prosecution For example by adding the word lsquoknowinglyrsquo to protect patients who were unaware of any advice against driving This would reassure them that a prescription will mean that they are protected Xx added that xxx has already had patient groups coming to her who are concerned that they are going to have to fight again

Xx noted that there is the issue of the lsquoknock onrsquo impact of one case highlighted by the media which could lead to patients becoming more cautious about taking their medication

DP said that he thought the Panel was unlikely to recommend low threshold levels He said that they have looked at the amendments tabled and they had material prepared for the Committee Stage of the legislation which was not needed and will be used to inform the informal discussion among peers in October He added that he feels the burden of proof leans towards the prosecution Once the prescription is presented it is down to the prosecution to prove beyond reasonable doubt that the medication was not taken properly For example one way would be if they can show that the blood level of a drug was in excess of the level prescribed

17

Xx raised concerns that cautious drivers may be wrongly pulled over by police and that it will be difficult for them to prove that they were unimpaired DP said that there are a swathe of issues about how far along the process people will be taken The balance is broadly right in the defence and if a case did go to court it would be resolved in the right way

DP noted that he is aware of the problems with testing procedures and that it is a genuinely difficult area Xx added that there are also concerns about those involved in a car crash and the insurance implications for a patient if they are the innocent party but test positively for drugs

DP said that is the situation already with the existing law and that there is currently a big drop off of cases before they reach the courts let alone conviction This is partly why the new offence is needed to target illegal drug users This issue is already there Xx acknowledged this but noted that the risk for patients would be heightened and that legislation designed to give police powers to stop drug abusers from driving should not spill over to impact on patients and make them worry about driving

Xx noted xxxx xxxxx xxxxx recent lsquoFit for Workrsquo report which showed that the main problem for the workforce is low back pain therefore many more people could be forced to stop work if they felt that by taking their medication it could mean that they are not deemed fit to drive

It was also noted that in the first stages of pain patients will seek pharmacist advice and use low doses of codeine to manage their pain There are 8m Osteoarthritis sufferers in the UK and over 70 report that they are in constant pain They typically start with over-the-counter medication including NSAIDS and codeine such as Nurofen Plus They will not have a prescription so how will they fare under the legislation

DP stated that this is partly an issue for the Panel He said he hoped that there is a good swathe of people on the Panel and asked if there is anything that Napp would like to submit to them Xx said there would be and that xxx would liaise with him on behalf of NAPP and feed in any information that would be considered helpful

Xxx noted that there are some concerns about the lack of medicalpainpatient representation on the Panel and that if these groups could feed in to the Panel that would help alleviate some concerns

DP said that the Panel is bringing in materials from other experts and that subject to his clearing it with the Chair they would be very keen to see papers etc The Panel would like to see as much research as possible Although they do not meet on policy there have been a number of issues related to the science of opioids that are of interest Xx asked if it would be helpful to also send the Panel a paper from Napp on where they believe legislation contains areas of risk and burden for patients to make the Panel aware of not only where the legislation can work but also where it could go wrong Xx asked if a pain expert could feed that in DP said case studies on the impact on patients would be helpful but there should be a focus on the science The legal aspects will not concern the Panel They should be happy to receive papers although he will have to talk to the Chair about having any experts appear in front of the Panel Xx assured DP that this would be done if the Chair was in agreement

18

Xx asked for some detail on the practical process of the Panelrsquos work Is the October report interim or final

DP said that it will be an interim report as there may be more work to do afterwards but that it is hoped and expected that the report will cover all the major drug types in the terms of reference They will use the findings across Government and then the decision will be made to move to the consultation The findings will also be communicated to the Committee on the Misuse of Drugs and the MRHA Secretariat representatives from both have been at Panel meetings

The secondary legislation will be in effect from early 2014 The plan is to consult on it in early 2013 and then progress through affirmative procedure in the later part of 2013 It will allow for the possible subsequent inclusion of other drugs

Xx asked about the development of testing devices and their specificity DP said that he is not a technical authority about the machines but does have information on the approval process A decision will be made at the end of the year on those currently going through police stations There will also be the beginning of the process to develop the second generation of roadside testing but the specifications cannot be finalised until the Panel reports These will be threshold detectors not just presentabsent detectors They will cover something related to heroin Legislation has been drafted so that police can undertake multiple preliminary tests as all drugs cannot be tested for at the same time The technology is important as an offence without it would not have the impact hoped for

DP added that other countries have a zero tolerance approach with presentabsent tests but that they want a threshold approach here He said that the legislation is linked to road safety it is not intended to change the law on possession use of drugs It is about public safety The existing penalty regime is not suitable for a zero tolerance approach At the moment crossing the limit means a 12 month driving ban and other consequences which is different to abroad The reason the drink drive limit has not been reduced is because the Government does not want to create a two tier system where the lower limit becomes seen as only equivalent to being given a speeding ticket The penalty for drug driving needs to allow for a more proportionate approach to enforcement At the moment if you are well versed in the law you have a good chance of evading conviction They want to change the balance and do not want to lower the penalty in comparison to drink driving He added that problems with some detection equipment abroad would not be acceptable in the UK legal system especially evidential saliva sampling The technology appears not there yet

DP noted that the Department is also looking at appropriate policy statements to make about the legislation The press has already focussed on areas where the new offence wonrsquot be an impact Xxx said that policy statements would help those patients who are already concerned

DP asked if Napprsquos patients receive unequivocal advice that they can drive Xx said not necessarily The issue is patients do not read advice and if they did they would not necessarily fully understand it It comes down to what the Doctor says but this legislation could then put them in a difficult position too Xx noted that the advice to patients in leaflets for medication regardless of whether they are prescription only medicines or over the counter would have a statement that would alert the patient to potential drowsiness or tiredness and advise that if this symptom was experienced patients should not drive or operate machinery This would be the same advice that clinicians would give to patients

19

about their medication unless as with certain drugs the DVLA should be notified and patients specifically informed that they must not drive whilst taking this medication The onus is on the patient to determine if they have this side effect and to what extent they are impaired DP noted that there is a difference between advice that a patient cannot drive and being told not to drive if they feel drowsy Xxx added that patients on a stable dose will be unsure if they can continue to work have a good quality of life etc and this will lead them to question whether or not to take their medication

DP stated that the Government can provide the context on what they think directions are but this will still be interpreted by a court Xx said publishing that information would provide comfort to patients who are concerned DP said this would be discussed with peers as well

Xx asked who will be invited to the informal discussion with peers and MPs DP said it would be just members of the House of Lords and Commons They will be able to meet with the Panel and other Government experts Xx noted that this would be useful for peers as those Napp has spoken to have had answers to initial questions but there are still areas where they would like some clarification DP noted that he and the Lords Spokesperson met with interested peers in advance of the Committee Stage It is easier to provide more factual clarification informally than on the floor of the House and Spokespeople will value the chance to make some progress before the Report Stage

Xx confirmed that Napp would put together some helpful information for DP to pass on to the Panel and will bring in some experts to feed in to that Xx added that Napp would be happy to feed in to any policy statements etc DP said he would be happy to clarify any issues in writing Xx said Napp would put together a list of questions for DP for this Xx said xxx would involve patient groups here too

Xx asked if there has been any input in the policy from the Department for Health DP said that a quadrilateral working group from Transport Justice Home and Health are working on the policy They have met between Panel meetings to see what is said and if there are any issues to put to the Panel

Xx asked if there is anything else Napp can do DP said that the more specific Napp can be about concerns evidence on the effect of treatments on impairment etc that would be helpful The policy is very much at the evidence gathering stage at the moment

Xx reiterated Napprsquos concerns regarding the Panel membership

DP said that at some point he expected tough decisions will be made about the balance of the proscons of the policy issues No solution will tick every box

Xx said that policy statements will be key to giving the police and the CPS guidance on who they are targeting as well as what lsquodirectionsrsquo mean to allay the fears of patients and clinicians DP said he hoped they would be able to allay fears He added that there is no advantage for the police to have lots of people in stations and being processed who are not impaired There is a realistic policy possibility that heroin will have to be set aside Just because the Panel is looking at it does not mean there is a commitment that it will be in the new offence They know that there may be no test to distinguish between different types of opiates

20

Xxx passed on two emails which he explained were from xx xxxxxxx xxxxxxx and xx xxxxxx xxxxxxxxn representing the views of CPPC and RCGP respectively Both Doctors expressed their concerns for patients and offered to contribute to discussions on the proposed legislation

A Note of Napprsquos Key Concerns

Napp Pharmaceuticals Meeting with Department for Transport 31 July 2012

Note I have added in bold italicised text some DfT responses to the questions in your original note which is otherwise as you sent me ndash Duncan Price 2882012

A Statement of support for drug driving legislation to stop people from driving while under the

influence of illegal drugs

Napp is concerned about the unintended consequences of the legislation on patients taking

long‐term medication for chronic pain Napp wants to work with the Government to find a

solution

1) Impact on Patients

2) Criminalisation of Patients

3) Different to Drink Driving Law

4) Policeable Offence

B Outline of Concerns

1) Impact on Patients

Evidence shows that patients on a stable dose of opioid analgesics are not necessarily

impaired but under the proposed system patients may be inaccurately identified as taking

impairing drugs and face prosecution

Patients well established on a stable dose of an opioid analgesic may have levels of

metabolites in their system well above any threshold used for roadside and police station

testing This means they could face serious charges despite driving unimpaired

There are concerns for patients such as those with Osteoarthritis the majority of who use

over the counter medications to manage their pain

Concern that patients will stop taking their medication so that they can drive This may

make their driving more impaired as a result of the pain that they will be under

Questions

Has there been consideration of how to distinguish between opiates that are used legally

for medicinal purposes and those used illegally (Napp would be happy to share clinical

knowledge of opioids that may be helpful to the panel and to any other interested parties

in Government)

The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

21

The panel is considering natural and synthetic opioids Its terms of reference include that it should establish the likelihood of whether concentrations of drugs broadly equivalent in their impairment effects to blood alcohol concentrations of 20 50 and 80mg100ml would be exceeded This will include a consideration of prescribed or otherwise legally obtained drugs which are known to impair driving

The panel will advise the Government which will then itself consider what specified limits to propose and then consult about I can assure you that in doing so it will consider how screening equipment and evidential blood specimens would distinguish between opiates used for legitimate medical purposes and those used illicitly

I am grateful for the offer of sharing clinical knowledge you made when we met I know the panel has since considered some of the evidence your experts have provided and some of its members have met an expert you recommended and one of your legal advisors

Has there been consideration of just introducing a list of restricted drugs known to be used

recreationally as with the Australian model

The list of restricted drugs used in some states in Australia does include THC (the active ingredient of cannabis) which does have some limited medical uses here The Governmentrsquos prime targets for this legislation are controlled drugs often or exclusively used illicitly including those included in the Australian legislation (THC amphetamines and MDMA)

At this stage we are awaiting advice from the panel but the Governmentrsquos position is that it should develop a new offence with the potential to include a number of categories of drug including benzodiazepines and opiates The abuse including the use of high quantities of methadone and some benzodiazepines (which can be prescribed) appears (alongside heroin) to be a significant contributor to the public safety problems this legislation is addressing

Many of the drugs specifically identified in the panelrsquos terms of reference are used exclusively or predominantly illicitly ndash for example amphetamine-types cannabinoids cocaine and hallucinogens

There is a reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

22

We are therefore using the definition of lsquocontrolled drugrsquo in the Misuse of Drugs Act 1971 within the new offence although which controlled drugs will be determined when regulations are brought forward

What consideration have you given to the issue of patients who drive unimpaired but will

still face prosecution if tested as levels of metabolites in their system may be above any

prescribed limit

This is being considered in both the terms of reference for the technical panelrsquos advice about the setting of specified limits (to keep patients out of the scope of the offence) and the inclusion of the medical defence within the offence

The panel has also been asked to consider the degree of variability in impairment effects across the population including for habitual drug users

In the terms of reference for the panel we have also specifically included the following from the North review (paragraph 743)

ldquoSome drugs which may be proscribed for driving might also be used legitimately in accordance with medical advice (for example morphine may be prescribed for chronic pain or diazepam (a benzodiazepine) may be prescribed for anxiety) Indeed the Review recognises that in some circumstances it may be more dangerous for a person to drive having not taken their medically prescribed drug than driving without having taken it Drugs have different effects on different people and levels at which they are prescribed are likely to reflect this It would clearly be wrong to put in jeopardy of prosecution those who are properly and safely taking medically prescribed drugs and driving in accordance with medical advice for whom despite the presence of a proscribed drug there is no evidence of any driving impairmentrdquo

I should also emphasise that the content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

2) Criminalisation of Patients

Statutory defence is included in the current legislation for those who have taken

prescription medication in accordance with prescribersupplier instructions and any

accompanying instructions from the manufacturer BUT

Only applicable after patient has been arrested further tested and their case has

progressed ndash this will cause innocent patients significant stress and

inconvenience

The defence puts the burden of proof on patients to prove that they acted in

accordance with all medical advice when the burden should be on the

prosecution to prove that they didnrsquot

23

Innocent patients may face criminalisation based on a technicality in legislation

that is not intended to target them

Questions

Is an exemption feasible (If not what is going to be done to ensure that patients are

protected)

I do not consider an exemption from the offence for all controlled drugs that can possibly be supplied or used for medical reasons is feasible Many controlled drugs for example cannabis have some medicinal uses

It is perfectly feasible for decisions about which controlled drugs would be specified for the new offence to be influenced by the reasons for whether their use is often always seldom or never for medical reasons Indeed such distinctions would be vital if this legislation were being introduced to enforce further against the illegal supply or use of controlled drugs

Whether that is the right approach to decision-making related to driving with controlled drugs in the body where there are levels associated with elevated risks to public safety is however questionable This legislation is being introduced to address road safety problems and the expert panelrsquos terms of reference are focussed on providing advice about the risks of driving after taking controlled drugs

It is to no-onesrsquo benefit for patients who are innocent of the offence to be arrested and tested There are several protections in place to reduce these risks Firstly police do not have random testing powers for drink and drug driving Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving

under the influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would result in disproportionate and large numbers of patients having evidential blood tests but then being not guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

24

It is important to note that the prosecution for a case where a defence has been raised that a patient had taken a controlled drug in accordance with medical advice must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code Test about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

It is important now and it will be important with the new offence in place that medical advice does not suggest to patients that they drive when doing so would present a significant risk to themselves and the public To do so risks patients being involved in road traffic incidents and also committing the existing offence of driving whilst impaired due to drugs

3) Different to Drink Driving Law

There have been calls for a strict liability approach to drug driving as exists for drink

driving Napp believes this would not be a suitable approach for drug driving based on the

current draft Bill

Alcohol does not have any medical necessity people do not need to consume

alcohol to ensure that a chronic condition does not prevent them from

functioning on a daily basis

Prescription medications that patients may take to treat chronic pain are a

medical necessity and are essential to ensuring that they are able to function on a

daily basis

A strict liability approach could lead to patients not taking essential medication in

order to be able to drive without fear of prosecution

Alternatively patients may choose not to drive at all which could have a serious

impact on their ability to work and go about their daily lives

Questions Is an exemption feasible (If not what is going to be done to ensure that patients are protected)

There are some useful analogies with drink driving law For example prior to the introduction of the specific drink driving offence the law in relation to drink drivers was difficult to enforce The specific offence there has contributed to major improvements in public safety

I do accept one of the differences with some controlled drugs is that some people take them for medicinal not recreational purposes This is not the case for all controlled drugs This may well affect what is included in the regulations for the offence

25

When we met I did say that it is conceivable for even as prevalent a recreational drug as heroin to not be included in the regulations for the offence This might be if it transpired that a limit relevant to heroin had to be set in a metabolite itself used in or a metabolite of a medically prescribed drug If such a limit also then had the effect of criminalising driving with medically supplied controlled drugs when that did not present an elevated risk to public safety I can see it would be a limit we might well not implement However I await the advice of the expert panel to see what it recommends related to heroin and whether (and how) that might affect other opiates

4) Policeable Offence

It is argued that drivers wonrsquot be stopped by police unless they appear impaired BUT

Plans are to test all those involved in a traffic accident for drugs including

innocent parties An innocent unimpaired patient involved in a crash through no

fault of their own could then face serious charges

Impairment is subjective and police may be suspicious of someonersquos driving for a

number of reasons such as driving too cautiously This apparently lsquoimpairedrsquo

driving may be due to various factors unrelated to the driverrsquos use of prescribed

medication but if they are stopped by police they may find themselves facing

serious and unjust charges

The existing impairment offence will remain so police will still be able to catch

those who do drive while impaired by prescription medication

Questions How close is the Home Office to approval of a drug testing device for use in police stations Can you provide any details

The laboratory testing phases of the type approval process is under way and the process is due to be completed at the end of this year

Is the Home Office still aiming for a 2014 approval of a drug testing device for portable use

It is still aiming for 2014 for these devices and we are planning the timing of that process together with the work on the new offence

Since the Governmentrsquos response to the North Review in June 2010 has the drug driving data quality improved

Yes we have received more information from Coroners recently and we also have had the conclusions of the European DRUID research

C Solutions

Napp believes that the best way to protect patients is by introducing an exemption for

those who can demonstrate that they are taking prescription medication

Existing legislation against driving while impaired would allow police to charge

anyone who did drive while under the influence of impairing prescription

medication

26

This would put the burden of proof on prosecutors saving innocent patients

considerable stress inconvenience and wasted CPS and police time

The Department considers that the statutory defence affords appropriate protection to patients who drive after taking prescription medication

The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

D Other Points for Consideration

Napp is keen to support this legislation in its efforts to stop users of illegal drugs

from driving and wishes to support policy development to ensure that patients are

protected Napp would be keen to provide any further information or other

means of assistance that could be of help here

Napp would like to submit written andor oral evidence to the Expert Panelrsquos

inquiry

Napp is concerned about the lack of pain expertise and patient representatives on

the Expert panel

Lord Henley mentioned that a seminar might be held after the summer recess to

discuss the issues arising from this legislation further Napp would be keen to

receive any further information on this

I hope this has been covered satisfactorily in the discussion we had on 31st July and since then

I do consider the legislation has strong safeguards in place for patients The Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

I hope I have addressed at least some of your concerns I should be happy to discuss the issues further

Duncan Price 2882012

27

Note on controlled drugs with medical uses

(i) The reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

(ii) Circumstances in which drug testing can be administered Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under the

influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

(iii) The medical defence The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

(iv) Drugs to be covered by the new offence and any specified limits to be based on expert advice The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

(v) Other controls The content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

(vi) Prosecutions to be in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

(vii) In light of the above the Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

28

From DuncanPricedftgsigovuk Sent 13092012 1603 To xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Cc xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Subject RE NRAS - Crime and Courts Bill clauses on drug driving

Xxxxxx

Below is my draft response to this letter Irsquoll send it when I have your comments about it

Dear xx xxxxxxx

Xxxxxx xxxxxxxx has forwarded your email of 28th August to me I am the lead policy official for the legislative clause about drug impaired driving in the Crime and Courts Bill

I am aware of concerns about innocent motorists taking prescribed medications being stopped tested being taken to police stations having blood samples taken and possibly going to court before being exonerated This is not the intention of the legislation and I can assure you we are mindful of this concern as we progress the legislation and respond to advice from an expert panel about the details

There are several protections in place to reduce the risk of large numbers of innocent motorists being arrested and taken to police stations

Firstly motorists cannot be stopped randomly for drug tests Testing can only be administered in three circumstances ndash namely where a driver has committed a moving traffic offence

a driver has been involved in a road traffic accident and or

there is reason for a police officer to suspect that a person has been driving under the influence of drink or drugs

This means that in practice drivers taking prescribed medicines would not be stopped and required to undergo drug testing without there being real cause for concern Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would be likely to result in disproportionate and large numbers of people prescribed drugs having evidential blood tests but then not being found guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

Fourthly it is important to emphasise that the prosecution for a case where the medical defence has been raised must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code for Crown Prosecutors which contains a requirement about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

Finally in the context of the clause before parliament the content of the regulations (specifying which controlled drugs should be covered by the new offence and the limits to be specified for them) will be the subject of public consultation Before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of

29

Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

I hope that this letter serves to allay concerns about possible unintended consequences for people taking prescription medicines

Duncan Price Tel 020 7944 xxxx Department for Transport

From JessicaMatthewdftgsigovuk Sent 17 October 2012 1108 To xxxxxxxxxxxxadhgsigovuk Cc xxxxxxxxxxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxxxxxdhgsigovuk xxxxxxxxdhgsigovuk Subject Re Department of Health attendance at the Lords briefing for the drug driving legislation

Xxxxxxxx is out of the office today but wersquoll send over the time and venue tomorrow and share the briefing with you Irsquod be happy to brief Dr Prunty beforehand ndash perhaps over the phone

Wersquore planning on a reasonably open debate about the legislation We wonrsquot have got policy clearance on the amendments to the legislation but wersquore inclined to say that the Government is minded to or is considering x y or z

Happy to discuss

Jessica Matthew Deputy Director Road User Licensing Insurance and Safety Tel 020 7944 xxxx Zone 321 Great Minster House 76 Marsham Street London SW1P 4DR

Extract of Briefing shared with DH from the above e-mail

How will you make sure that people taking medication in accordance with their prescription arenrsquot arrested and taken to court as a result of this legislation

The medical defence in the provisions provides substantial and appropriate protection for people taking medically prescribed or supplied controlled drugs It places an evidential burden on a person accused of committing the offence So the accused must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court It is then for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on

It is unlikely that a person taking medication in accordance with their prescription would be taken to court for a number of reasons

30

1 Motorists cannot be stopped randomly for drug tests They can only be tested where They have committed a moving traffic offence They have been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under

the influence of drink or drugs

2 The drugs to be included in the legislation and their limits will be set in regulations The content of the regulations will be the subject of public consultation and an affirmative resolution This will provide an opportunity for any concerns with the proposed specified limits to be raised and carefully considered

3 The expert panel is bearing in mind the normal therapeutic ranges and expected drug concentrations in blood when setting limits for those drugs that may also be used for medicinal purposes This means that only patients on unusually high doses of medication might have a positive screening and proceed to evidential blood test

4 Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any cases before they reach the court Indeed there is a Code for Crown Prosecutors which contains a requirement that prosecutions are in the public interest

From xxxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 29 November 2012 1422 To xxxxxxxdhgsigovuk xxxxxxxxxpsncorguk xxxxxxxxxxxxxtheccaorguk xxxxxxxxxxnpacouk xxxxxxxxxxxxrpharmscom xxxxxxxxxxxsaddactionorguk xxxxxroadsafecom xxxxxxxxxxxxxxxxxxsdrconsortiumorg xxxm-allianceorguk xxxxxxxxxxxturning-pointcouk xxxxxxxxROSPAcom xxxxxxxxxxxxxxxxtheAAcom xxxxxxxxxacpopnnpoliceuk adminactionaddictionorguk xxxxxxxxxageukorguk xxxxxxxxxxxbrakeorguk xxxxxxxxbmaorguk xxxxxxxxxxxbritishpainsocietyorg xxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxcpsgsigovuk xxxxxxxxdrugscopeorguk xxxxxxxxxiamorguk xxxxxxxxxxxxxxlawsocietyorguk xxxxxxxxxxxliberty-human-rightsorguk xxxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxxpactsorguk xxxxxxxxxxparliamentuk xxxxxxxxxxxxRACFoundationorg xxxxxxxxxxdurhamgovuk xxxxxxxxxxxxxxxxPolicyConnectorguk xxxxxxxxxxxxxxpsncorguk xxxxxxxxxxxxxdvlagsigovuk Xxxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxhomeofficegsigovuk xxxxxxxxnpacouk xxxxxxxxxxxxdhgsigovuk xxxxxxxxxdrugscopeorguk Cc xxxxxxxxxxxxxxxxxxxdftgsigovuk JessicaMatthewdftgsigovuk xxxxxxxxxxxxxxxxxxdftgsigovuk Subject Drug driving seminar presentation

Dear all

Many thanks to those of you who were able to attend our Drug Driving Stakeholder Seminar last week

We hope you found as useful as we did

Please find attached a copy of the presentation as promised

Kind regards

Xxxxxx xxxxxxx

31

Xx raised concerns that cautious drivers may be wrongly pulled over by police and that it will be difficult for them to prove that they were unimpaired DP said that there are a swathe of issues about how far along the process people will be taken The balance is broadly right in the defence and if a case did go to court it would be resolved in the right way

DP noted that he is aware of the problems with testing procedures and that it is a genuinely difficult area Xx added that there are also concerns about those involved in a car crash and the insurance implications for a patient if they are the innocent party but test positively for drugs

DP said that is the situation already with the existing law and that there is currently a big drop off of cases before they reach the courts let alone conviction This is partly why the new offence is needed to target illegal drug users This issue is already there Xx acknowledged this but noted that the risk for patients would be heightened and that legislation designed to give police powers to stop drug abusers from driving should not spill over to impact on patients and make them worry about driving

Xx noted xxxx xxxxx xxxxx recent lsquoFit for Workrsquo report which showed that the main problem for the workforce is low back pain therefore many more people could be forced to stop work if they felt that by taking their medication it could mean that they are not deemed fit to drive

It was also noted that in the first stages of pain patients will seek pharmacist advice and use low doses of codeine to manage their pain There are 8m Osteoarthritis sufferers in the UK and over 70 report that they are in constant pain They typically start with over-the-counter medication including NSAIDS and codeine such as Nurofen Plus They will not have a prescription so how will they fare under the legislation

DP stated that this is partly an issue for the Panel He said he hoped that there is a good swathe of people on the Panel and asked if there is anything that Napp would like to submit to them Xx said there would be and that xxx would liaise with him on behalf of NAPP and feed in any information that would be considered helpful

Xxx noted that there are some concerns about the lack of medicalpainpatient representation on the Panel and that if these groups could feed in to the Panel that would help alleviate some concerns

DP said that the Panel is bringing in materials from other experts and that subject to his clearing it with the Chair they would be very keen to see papers etc The Panel would like to see as much research as possible Although they do not meet on policy there have been a number of issues related to the science of opioids that are of interest Xx asked if it would be helpful to also send the Panel a paper from Napp on where they believe legislation contains areas of risk and burden for patients to make the Panel aware of not only where the legislation can work but also where it could go wrong Xx asked if a pain expert could feed that in DP said case studies on the impact on patients would be helpful but there should be a focus on the science The legal aspects will not concern the Panel They should be happy to receive papers although he will have to talk to the Chair about having any experts appear in front of the Panel Xx assured DP that this would be done if the Chair was in agreement

18

Xx asked for some detail on the practical process of the Panelrsquos work Is the October report interim or final

DP said that it will be an interim report as there may be more work to do afterwards but that it is hoped and expected that the report will cover all the major drug types in the terms of reference They will use the findings across Government and then the decision will be made to move to the consultation The findings will also be communicated to the Committee on the Misuse of Drugs and the MRHA Secretariat representatives from both have been at Panel meetings

The secondary legislation will be in effect from early 2014 The plan is to consult on it in early 2013 and then progress through affirmative procedure in the later part of 2013 It will allow for the possible subsequent inclusion of other drugs

Xx asked about the development of testing devices and their specificity DP said that he is not a technical authority about the machines but does have information on the approval process A decision will be made at the end of the year on those currently going through police stations There will also be the beginning of the process to develop the second generation of roadside testing but the specifications cannot be finalised until the Panel reports These will be threshold detectors not just presentabsent detectors They will cover something related to heroin Legislation has been drafted so that police can undertake multiple preliminary tests as all drugs cannot be tested for at the same time The technology is important as an offence without it would not have the impact hoped for

DP added that other countries have a zero tolerance approach with presentabsent tests but that they want a threshold approach here He said that the legislation is linked to road safety it is not intended to change the law on possession use of drugs It is about public safety The existing penalty regime is not suitable for a zero tolerance approach At the moment crossing the limit means a 12 month driving ban and other consequences which is different to abroad The reason the drink drive limit has not been reduced is because the Government does not want to create a two tier system where the lower limit becomes seen as only equivalent to being given a speeding ticket The penalty for drug driving needs to allow for a more proportionate approach to enforcement At the moment if you are well versed in the law you have a good chance of evading conviction They want to change the balance and do not want to lower the penalty in comparison to drink driving He added that problems with some detection equipment abroad would not be acceptable in the UK legal system especially evidential saliva sampling The technology appears not there yet

DP noted that the Department is also looking at appropriate policy statements to make about the legislation The press has already focussed on areas where the new offence wonrsquot be an impact Xxx said that policy statements would help those patients who are already concerned

DP asked if Napprsquos patients receive unequivocal advice that they can drive Xx said not necessarily The issue is patients do not read advice and if they did they would not necessarily fully understand it It comes down to what the Doctor says but this legislation could then put them in a difficult position too Xx noted that the advice to patients in leaflets for medication regardless of whether they are prescription only medicines or over the counter would have a statement that would alert the patient to potential drowsiness or tiredness and advise that if this symptom was experienced patients should not drive or operate machinery This would be the same advice that clinicians would give to patients

19

about their medication unless as with certain drugs the DVLA should be notified and patients specifically informed that they must not drive whilst taking this medication The onus is on the patient to determine if they have this side effect and to what extent they are impaired DP noted that there is a difference between advice that a patient cannot drive and being told not to drive if they feel drowsy Xxx added that patients on a stable dose will be unsure if they can continue to work have a good quality of life etc and this will lead them to question whether or not to take their medication

DP stated that the Government can provide the context on what they think directions are but this will still be interpreted by a court Xx said publishing that information would provide comfort to patients who are concerned DP said this would be discussed with peers as well

Xx asked who will be invited to the informal discussion with peers and MPs DP said it would be just members of the House of Lords and Commons They will be able to meet with the Panel and other Government experts Xx noted that this would be useful for peers as those Napp has spoken to have had answers to initial questions but there are still areas where they would like some clarification DP noted that he and the Lords Spokesperson met with interested peers in advance of the Committee Stage It is easier to provide more factual clarification informally than on the floor of the House and Spokespeople will value the chance to make some progress before the Report Stage

Xx confirmed that Napp would put together some helpful information for DP to pass on to the Panel and will bring in some experts to feed in to that Xx added that Napp would be happy to feed in to any policy statements etc DP said he would be happy to clarify any issues in writing Xx said Napp would put together a list of questions for DP for this Xx said xxx would involve patient groups here too

Xx asked if there has been any input in the policy from the Department for Health DP said that a quadrilateral working group from Transport Justice Home and Health are working on the policy They have met between Panel meetings to see what is said and if there are any issues to put to the Panel

Xx asked if there is anything else Napp can do DP said that the more specific Napp can be about concerns evidence on the effect of treatments on impairment etc that would be helpful The policy is very much at the evidence gathering stage at the moment

Xx reiterated Napprsquos concerns regarding the Panel membership

DP said that at some point he expected tough decisions will be made about the balance of the proscons of the policy issues No solution will tick every box

Xx said that policy statements will be key to giving the police and the CPS guidance on who they are targeting as well as what lsquodirectionsrsquo mean to allay the fears of patients and clinicians DP said he hoped they would be able to allay fears He added that there is no advantage for the police to have lots of people in stations and being processed who are not impaired There is a realistic policy possibility that heroin will have to be set aside Just because the Panel is looking at it does not mean there is a commitment that it will be in the new offence They know that there may be no test to distinguish between different types of opiates

20

Xxx passed on two emails which he explained were from xx xxxxxxx xxxxxxx and xx xxxxxx xxxxxxxxn representing the views of CPPC and RCGP respectively Both Doctors expressed their concerns for patients and offered to contribute to discussions on the proposed legislation

A Note of Napprsquos Key Concerns

Napp Pharmaceuticals Meeting with Department for Transport 31 July 2012

Note I have added in bold italicised text some DfT responses to the questions in your original note which is otherwise as you sent me ndash Duncan Price 2882012

A Statement of support for drug driving legislation to stop people from driving while under the

influence of illegal drugs

Napp is concerned about the unintended consequences of the legislation on patients taking

long‐term medication for chronic pain Napp wants to work with the Government to find a

solution

1) Impact on Patients

2) Criminalisation of Patients

3) Different to Drink Driving Law

4) Policeable Offence

B Outline of Concerns

1) Impact on Patients

Evidence shows that patients on a stable dose of opioid analgesics are not necessarily

impaired but under the proposed system patients may be inaccurately identified as taking

impairing drugs and face prosecution

Patients well established on a stable dose of an opioid analgesic may have levels of

metabolites in their system well above any threshold used for roadside and police station

testing This means they could face serious charges despite driving unimpaired

There are concerns for patients such as those with Osteoarthritis the majority of who use

over the counter medications to manage their pain

Concern that patients will stop taking their medication so that they can drive This may

make their driving more impaired as a result of the pain that they will be under

Questions

Has there been consideration of how to distinguish between opiates that are used legally

for medicinal purposes and those used illegally (Napp would be happy to share clinical

knowledge of opioids that may be helpful to the panel and to any other interested parties

in Government)

The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

21

The panel is considering natural and synthetic opioids Its terms of reference include that it should establish the likelihood of whether concentrations of drugs broadly equivalent in their impairment effects to blood alcohol concentrations of 20 50 and 80mg100ml would be exceeded This will include a consideration of prescribed or otherwise legally obtained drugs which are known to impair driving

The panel will advise the Government which will then itself consider what specified limits to propose and then consult about I can assure you that in doing so it will consider how screening equipment and evidential blood specimens would distinguish between opiates used for legitimate medical purposes and those used illicitly

I am grateful for the offer of sharing clinical knowledge you made when we met I know the panel has since considered some of the evidence your experts have provided and some of its members have met an expert you recommended and one of your legal advisors

Has there been consideration of just introducing a list of restricted drugs known to be used

recreationally as with the Australian model

The list of restricted drugs used in some states in Australia does include THC (the active ingredient of cannabis) which does have some limited medical uses here The Governmentrsquos prime targets for this legislation are controlled drugs often or exclusively used illicitly including those included in the Australian legislation (THC amphetamines and MDMA)

At this stage we are awaiting advice from the panel but the Governmentrsquos position is that it should develop a new offence with the potential to include a number of categories of drug including benzodiazepines and opiates The abuse including the use of high quantities of methadone and some benzodiazepines (which can be prescribed) appears (alongside heroin) to be a significant contributor to the public safety problems this legislation is addressing

Many of the drugs specifically identified in the panelrsquos terms of reference are used exclusively or predominantly illicitly ndash for example amphetamine-types cannabinoids cocaine and hallucinogens

There is a reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

22

We are therefore using the definition of lsquocontrolled drugrsquo in the Misuse of Drugs Act 1971 within the new offence although which controlled drugs will be determined when regulations are brought forward

What consideration have you given to the issue of patients who drive unimpaired but will

still face prosecution if tested as levels of metabolites in their system may be above any

prescribed limit

This is being considered in both the terms of reference for the technical panelrsquos advice about the setting of specified limits (to keep patients out of the scope of the offence) and the inclusion of the medical defence within the offence

The panel has also been asked to consider the degree of variability in impairment effects across the population including for habitual drug users

In the terms of reference for the panel we have also specifically included the following from the North review (paragraph 743)

ldquoSome drugs which may be proscribed for driving might also be used legitimately in accordance with medical advice (for example morphine may be prescribed for chronic pain or diazepam (a benzodiazepine) may be prescribed for anxiety) Indeed the Review recognises that in some circumstances it may be more dangerous for a person to drive having not taken their medically prescribed drug than driving without having taken it Drugs have different effects on different people and levels at which they are prescribed are likely to reflect this It would clearly be wrong to put in jeopardy of prosecution those who are properly and safely taking medically prescribed drugs and driving in accordance with medical advice for whom despite the presence of a proscribed drug there is no evidence of any driving impairmentrdquo

I should also emphasise that the content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

2) Criminalisation of Patients

Statutory defence is included in the current legislation for those who have taken

prescription medication in accordance with prescribersupplier instructions and any

accompanying instructions from the manufacturer BUT

Only applicable after patient has been arrested further tested and their case has

progressed ndash this will cause innocent patients significant stress and

inconvenience

The defence puts the burden of proof on patients to prove that they acted in

accordance with all medical advice when the burden should be on the

prosecution to prove that they didnrsquot

23

Innocent patients may face criminalisation based on a technicality in legislation

that is not intended to target them

Questions

Is an exemption feasible (If not what is going to be done to ensure that patients are

protected)

I do not consider an exemption from the offence for all controlled drugs that can possibly be supplied or used for medical reasons is feasible Many controlled drugs for example cannabis have some medicinal uses

It is perfectly feasible for decisions about which controlled drugs would be specified for the new offence to be influenced by the reasons for whether their use is often always seldom or never for medical reasons Indeed such distinctions would be vital if this legislation were being introduced to enforce further against the illegal supply or use of controlled drugs

Whether that is the right approach to decision-making related to driving with controlled drugs in the body where there are levels associated with elevated risks to public safety is however questionable This legislation is being introduced to address road safety problems and the expert panelrsquos terms of reference are focussed on providing advice about the risks of driving after taking controlled drugs

It is to no-onesrsquo benefit for patients who are innocent of the offence to be arrested and tested There are several protections in place to reduce these risks Firstly police do not have random testing powers for drink and drug driving Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving

under the influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would result in disproportionate and large numbers of patients having evidential blood tests but then being not guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

24

It is important to note that the prosecution for a case where a defence has been raised that a patient had taken a controlled drug in accordance with medical advice must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code Test about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

It is important now and it will be important with the new offence in place that medical advice does not suggest to patients that they drive when doing so would present a significant risk to themselves and the public To do so risks patients being involved in road traffic incidents and also committing the existing offence of driving whilst impaired due to drugs

3) Different to Drink Driving Law

There have been calls for a strict liability approach to drug driving as exists for drink

driving Napp believes this would not be a suitable approach for drug driving based on the

current draft Bill

Alcohol does not have any medical necessity people do not need to consume

alcohol to ensure that a chronic condition does not prevent them from

functioning on a daily basis

Prescription medications that patients may take to treat chronic pain are a

medical necessity and are essential to ensuring that they are able to function on a

daily basis

A strict liability approach could lead to patients not taking essential medication in

order to be able to drive without fear of prosecution

Alternatively patients may choose not to drive at all which could have a serious

impact on their ability to work and go about their daily lives

Questions Is an exemption feasible (If not what is going to be done to ensure that patients are protected)

There are some useful analogies with drink driving law For example prior to the introduction of the specific drink driving offence the law in relation to drink drivers was difficult to enforce The specific offence there has contributed to major improvements in public safety

I do accept one of the differences with some controlled drugs is that some people take them for medicinal not recreational purposes This is not the case for all controlled drugs This may well affect what is included in the regulations for the offence

25

When we met I did say that it is conceivable for even as prevalent a recreational drug as heroin to not be included in the regulations for the offence This might be if it transpired that a limit relevant to heroin had to be set in a metabolite itself used in or a metabolite of a medically prescribed drug If such a limit also then had the effect of criminalising driving with medically supplied controlled drugs when that did not present an elevated risk to public safety I can see it would be a limit we might well not implement However I await the advice of the expert panel to see what it recommends related to heroin and whether (and how) that might affect other opiates

4) Policeable Offence

It is argued that drivers wonrsquot be stopped by police unless they appear impaired BUT

Plans are to test all those involved in a traffic accident for drugs including

innocent parties An innocent unimpaired patient involved in a crash through no

fault of their own could then face serious charges

Impairment is subjective and police may be suspicious of someonersquos driving for a

number of reasons such as driving too cautiously This apparently lsquoimpairedrsquo

driving may be due to various factors unrelated to the driverrsquos use of prescribed

medication but if they are stopped by police they may find themselves facing

serious and unjust charges

The existing impairment offence will remain so police will still be able to catch

those who do drive while impaired by prescription medication

Questions How close is the Home Office to approval of a drug testing device for use in police stations Can you provide any details

The laboratory testing phases of the type approval process is under way and the process is due to be completed at the end of this year

Is the Home Office still aiming for a 2014 approval of a drug testing device for portable use

It is still aiming for 2014 for these devices and we are planning the timing of that process together with the work on the new offence

Since the Governmentrsquos response to the North Review in June 2010 has the drug driving data quality improved

Yes we have received more information from Coroners recently and we also have had the conclusions of the European DRUID research

C Solutions

Napp believes that the best way to protect patients is by introducing an exemption for

those who can demonstrate that they are taking prescription medication

Existing legislation against driving while impaired would allow police to charge

anyone who did drive while under the influence of impairing prescription

medication

26

This would put the burden of proof on prosecutors saving innocent patients

considerable stress inconvenience and wasted CPS and police time

The Department considers that the statutory defence affords appropriate protection to patients who drive after taking prescription medication

The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

D Other Points for Consideration

Napp is keen to support this legislation in its efforts to stop users of illegal drugs

from driving and wishes to support policy development to ensure that patients are

protected Napp would be keen to provide any further information or other

means of assistance that could be of help here

Napp would like to submit written andor oral evidence to the Expert Panelrsquos

inquiry

Napp is concerned about the lack of pain expertise and patient representatives on

the Expert panel

Lord Henley mentioned that a seminar might be held after the summer recess to

discuss the issues arising from this legislation further Napp would be keen to

receive any further information on this

I hope this has been covered satisfactorily in the discussion we had on 31st July and since then

I do consider the legislation has strong safeguards in place for patients The Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

I hope I have addressed at least some of your concerns I should be happy to discuss the issues further

Duncan Price 2882012

27

Note on controlled drugs with medical uses

(i) The reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

(ii) Circumstances in which drug testing can be administered Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under the

influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

(iii) The medical defence The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

(iv) Drugs to be covered by the new offence and any specified limits to be based on expert advice The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

(v) Other controls The content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

(vi) Prosecutions to be in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

(vii) In light of the above the Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

28

From DuncanPricedftgsigovuk Sent 13092012 1603 To xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Cc xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Subject RE NRAS - Crime and Courts Bill clauses on drug driving

Xxxxxx

Below is my draft response to this letter Irsquoll send it when I have your comments about it

Dear xx xxxxxxx

Xxxxxx xxxxxxxx has forwarded your email of 28th August to me I am the lead policy official for the legislative clause about drug impaired driving in the Crime and Courts Bill

I am aware of concerns about innocent motorists taking prescribed medications being stopped tested being taken to police stations having blood samples taken and possibly going to court before being exonerated This is not the intention of the legislation and I can assure you we are mindful of this concern as we progress the legislation and respond to advice from an expert panel about the details

There are several protections in place to reduce the risk of large numbers of innocent motorists being arrested and taken to police stations

Firstly motorists cannot be stopped randomly for drug tests Testing can only be administered in three circumstances ndash namely where a driver has committed a moving traffic offence

a driver has been involved in a road traffic accident and or

there is reason for a police officer to suspect that a person has been driving under the influence of drink or drugs

This means that in practice drivers taking prescribed medicines would not be stopped and required to undergo drug testing without there being real cause for concern Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would be likely to result in disproportionate and large numbers of people prescribed drugs having evidential blood tests but then not being found guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

Fourthly it is important to emphasise that the prosecution for a case where the medical defence has been raised must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code for Crown Prosecutors which contains a requirement about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

Finally in the context of the clause before parliament the content of the regulations (specifying which controlled drugs should be covered by the new offence and the limits to be specified for them) will be the subject of public consultation Before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of

29

Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

I hope that this letter serves to allay concerns about possible unintended consequences for people taking prescription medicines

Duncan Price Tel 020 7944 xxxx Department for Transport

From JessicaMatthewdftgsigovuk Sent 17 October 2012 1108 To xxxxxxxxxxxxadhgsigovuk Cc xxxxxxxxxxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxxxxxdhgsigovuk xxxxxxxxdhgsigovuk Subject Re Department of Health attendance at the Lords briefing for the drug driving legislation

Xxxxxxxx is out of the office today but wersquoll send over the time and venue tomorrow and share the briefing with you Irsquod be happy to brief Dr Prunty beforehand ndash perhaps over the phone

Wersquore planning on a reasonably open debate about the legislation We wonrsquot have got policy clearance on the amendments to the legislation but wersquore inclined to say that the Government is minded to or is considering x y or z

Happy to discuss

Jessica Matthew Deputy Director Road User Licensing Insurance and Safety Tel 020 7944 xxxx Zone 321 Great Minster House 76 Marsham Street London SW1P 4DR

Extract of Briefing shared with DH from the above e-mail

How will you make sure that people taking medication in accordance with their prescription arenrsquot arrested and taken to court as a result of this legislation

The medical defence in the provisions provides substantial and appropriate protection for people taking medically prescribed or supplied controlled drugs It places an evidential burden on a person accused of committing the offence So the accused must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court It is then for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on

It is unlikely that a person taking medication in accordance with their prescription would be taken to court for a number of reasons

30

1 Motorists cannot be stopped randomly for drug tests They can only be tested where They have committed a moving traffic offence They have been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under

the influence of drink or drugs

2 The drugs to be included in the legislation and their limits will be set in regulations The content of the regulations will be the subject of public consultation and an affirmative resolution This will provide an opportunity for any concerns with the proposed specified limits to be raised and carefully considered

3 The expert panel is bearing in mind the normal therapeutic ranges and expected drug concentrations in blood when setting limits for those drugs that may also be used for medicinal purposes This means that only patients on unusually high doses of medication might have a positive screening and proceed to evidential blood test

4 Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any cases before they reach the court Indeed there is a Code for Crown Prosecutors which contains a requirement that prosecutions are in the public interest

From xxxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 29 November 2012 1422 To xxxxxxxdhgsigovuk xxxxxxxxxpsncorguk xxxxxxxxxxxxxtheccaorguk xxxxxxxxxxnpacouk xxxxxxxxxxxxrpharmscom xxxxxxxxxxxsaddactionorguk xxxxxroadsafecom xxxxxxxxxxxxxxxxxxsdrconsortiumorg xxxm-allianceorguk xxxxxxxxxxxturning-pointcouk xxxxxxxxROSPAcom xxxxxxxxxxxxxxxxtheAAcom xxxxxxxxxacpopnnpoliceuk adminactionaddictionorguk xxxxxxxxxageukorguk xxxxxxxxxxxbrakeorguk xxxxxxxxbmaorguk xxxxxxxxxxxbritishpainsocietyorg xxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxcpsgsigovuk xxxxxxxxdrugscopeorguk xxxxxxxxxiamorguk xxxxxxxxxxxxxxlawsocietyorguk xxxxxxxxxxxliberty-human-rightsorguk xxxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxxpactsorguk xxxxxxxxxxparliamentuk xxxxxxxxxxxxRACFoundationorg xxxxxxxxxxdurhamgovuk xxxxxxxxxxxxxxxxPolicyConnectorguk xxxxxxxxxxxxxxpsncorguk xxxxxxxxxxxxxdvlagsigovuk Xxxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxhomeofficegsigovuk xxxxxxxxnpacouk xxxxxxxxxxxxdhgsigovuk xxxxxxxxxdrugscopeorguk Cc xxxxxxxxxxxxxxxxxxxdftgsigovuk JessicaMatthewdftgsigovuk xxxxxxxxxxxxxxxxxxdftgsigovuk Subject Drug driving seminar presentation

Dear all

Many thanks to those of you who were able to attend our Drug Driving Stakeholder Seminar last week

We hope you found as useful as we did

Please find attached a copy of the presentation as promised

Kind regards

Xxxxxx xxxxxxx

31

Xx asked for some detail on the practical process of the Panelrsquos work Is the October report interim or final

DP said that it will be an interim report as there may be more work to do afterwards but that it is hoped and expected that the report will cover all the major drug types in the terms of reference They will use the findings across Government and then the decision will be made to move to the consultation The findings will also be communicated to the Committee on the Misuse of Drugs and the MRHA Secretariat representatives from both have been at Panel meetings

The secondary legislation will be in effect from early 2014 The plan is to consult on it in early 2013 and then progress through affirmative procedure in the later part of 2013 It will allow for the possible subsequent inclusion of other drugs

Xx asked about the development of testing devices and their specificity DP said that he is not a technical authority about the machines but does have information on the approval process A decision will be made at the end of the year on those currently going through police stations There will also be the beginning of the process to develop the second generation of roadside testing but the specifications cannot be finalised until the Panel reports These will be threshold detectors not just presentabsent detectors They will cover something related to heroin Legislation has been drafted so that police can undertake multiple preliminary tests as all drugs cannot be tested for at the same time The technology is important as an offence without it would not have the impact hoped for

DP added that other countries have a zero tolerance approach with presentabsent tests but that they want a threshold approach here He said that the legislation is linked to road safety it is not intended to change the law on possession use of drugs It is about public safety The existing penalty regime is not suitable for a zero tolerance approach At the moment crossing the limit means a 12 month driving ban and other consequences which is different to abroad The reason the drink drive limit has not been reduced is because the Government does not want to create a two tier system where the lower limit becomes seen as only equivalent to being given a speeding ticket The penalty for drug driving needs to allow for a more proportionate approach to enforcement At the moment if you are well versed in the law you have a good chance of evading conviction They want to change the balance and do not want to lower the penalty in comparison to drink driving He added that problems with some detection equipment abroad would not be acceptable in the UK legal system especially evidential saliva sampling The technology appears not there yet

DP noted that the Department is also looking at appropriate policy statements to make about the legislation The press has already focussed on areas where the new offence wonrsquot be an impact Xxx said that policy statements would help those patients who are already concerned

DP asked if Napprsquos patients receive unequivocal advice that they can drive Xx said not necessarily The issue is patients do not read advice and if they did they would not necessarily fully understand it It comes down to what the Doctor says but this legislation could then put them in a difficult position too Xx noted that the advice to patients in leaflets for medication regardless of whether they are prescription only medicines or over the counter would have a statement that would alert the patient to potential drowsiness or tiredness and advise that if this symptom was experienced patients should not drive or operate machinery This would be the same advice that clinicians would give to patients

19

about their medication unless as with certain drugs the DVLA should be notified and patients specifically informed that they must not drive whilst taking this medication The onus is on the patient to determine if they have this side effect and to what extent they are impaired DP noted that there is a difference between advice that a patient cannot drive and being told not to drive if they feel drowsy Xxx added that patients on a stable dose will be unsure if they can continue to work have a good quality of life etc and this will lead them to question whether or not to take their medication

DP stated that the Government can provide the context on what they think directions are but this will still be interpreted by a court Xx said publishing that information would provide comfort to patients who are concerned DP said this would be discussed with peers as well

Xx asked who will be invited to the informal discussion with peers and MPs DP said it would be just members of the House of Lords and Commons They will be able to meet with the Panel and other Government experts Xx noted that this would be useful for peers as those Napp has spoken to have had answers to initial questions but there are still areas where they would like some clarification DP noted that he and the Lords Spokesperson met with interested peers in advance of the Committee Stage It is easier to provide more factual clarification informally than on the floor of the House and Spokespeople will value the chance to make some progress before the Report Stage

Xx confirmed that Napp would put together some helpful information for DP to pass on to the Panel and will bring in some experts to feed in to that Xx added that Napp would be happy to feed in to any policy statements etc DP said he would be happy to clarify any issues in writing Xx said Napp would put together a list of questions for DP for this Xx said xxx would involve patient groups here too

Xx asked if there has been any input in the policy from the Department for Health DP said that a quadrilateral working group from Transport Justice Home and Health are working on the policy They have met between Panel meetings to see what is said and if there are any issues to put to the Panel

Xx asked if there is anything else Napp can do DP said that the more specific Napp can be about concerns evidence on the effect of treatments on impairment etc that would be helpful The policy is very much at the evidence gathering stage at the moment

Xx reiterated Napprsquos concerns regarding the Panel membership

DP said that at some point he expected tough decisions will be made about the balance of the proscons of the policy issues No solution will tick every box

Xx said that policy statements will be key to giving the police and the CPS guidance on who they are targeting as well as what lsquodirectionsrsquo mean to allay the fears of patients and clinicians DP said he hoped they would be able to allay fears He added that there is no advantage for the police to have lots of people in stations and being processed who are not impaired There is a realistic policy possibility that heroin will have to be set aside Just because the Panel is looking at it does not mean there is a commitment that it will be in the new offence They know that there may be no test to distinguish between different types of opiates

20

Xxx passed on two emails which he explained were from xx xxxxxxx xxxxxxx and xx xxxxxx xxxxxxxxn representing the views of CPPC and RCGP respectively Both Doctors expressed their concerns for patients and offered to contribute to discussions on the proposed legislation

A Note of Napprsquos Key Concerns

Napp Pharmaceuticals Meeting with Department for Transport 31 July 2012

Note I have added in bold italicised text some DfT responses to the questions in your original note which is otherwise as you sent me ndash Duncan Price 2882012

A Statement of support for drug driving legislation to stop people from driving while under the

influence of illegal drugs

Napp is concerned about the unintended consequences of the legislation on patients taking

long‐term medication for chronic pain Napp wants to work with the Government to find a

solution

1) Impact on Patients

2) Criminalisation of Patients

3) Different to Drink Driving Law

4) Policeable Offence

B Outline of Concerns

1) Impact on Patients

Evidence shows that patients on a stable dose of opioid analgesics are not necessarily

impaired but under the proposed system patients may be inaccurately identified as taking

impairing drugs and face prosecution

Patients well established on a stable dose of an opioid analgesic may have levels of

metabolites in their system well above any threshold used for roadside and police station

testing This means they could face serious charges despite driving unimpaired

There are concerns for patients such as those with Osteoarthritis the majority of who use

over the counter medications to manage their pain

Concern that patients will stop taking their medication so that they can drive This may

make their driving more impaired as a result of the pain that they will be under

Questions

Has there been consideration of how to distinguish between opiates that are used legally

for medicinal purposes and those used illegally (Napp would be happy to share clinical

knowledge of opioids that may be helpful to the panel and to any other interested parties

in Government)

The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

21

The panel is considering natural and synthetic opioids Its terms of reference include that it should establish the likelihood of whether concentrations of drugs broadly equivalent in their impairment effects to blood alcohol concentrations of 20 50 and 80mg100ml would be exceeded This will include a consideration of prescribed or otherwise legally obtained drugs which are known to impair driving

The panel will advise the Government which will then itself consider what specified limits to propose and then consult about I can assure you that in doing so it will consider how screening equipment and evidential blood specimens would distinguish between opiates used for legitimate medical purposes and those used illicitly

I am grateful for the offer of sharing clinical knowledge you made when we met I know the panel has since considered some of the evidence your experts have provided and some of its members have met an expert you recommended and one of your legal advisors

Has there been consideration of just introducing a list of restricted drugs known to be used

recreationally as with the Australian model

The list of restricted drugs used in some states in Australia does include THC (the active ingredient of cannabis) which does have some limited medical uses here The Governmentrsquos prime targets for this legislation are controlled drugs often or exclusively used illicitly including those included in the Australian legislation (THC amphetamines and MDMA)

At this stage we are awaiting advice from the panel but the Governmentrsquos position is that it should develop a new offence with the potential to include a number of categories of drug including benzodiazepines and opiates The abuse including the use of high quantities of methadone and some benzodiazepines (which can be prescribed) appears (alongside heroin) to be a significant contributor to the public safety problems this legislation is addressing

Many of the drugs specifically identified in the panelrsquos terms of reference are used exclusively or predominantly illicitly ndash for example amphetamine-types cannabinoids cocaine and hallucinogens

There is a reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

22

We are therefore using the definition of lsquocontrolled drugrsquo in the Misuse of Drugs Act 1971 within the new offence although which controlled drugs will be determined when regulations are brought forward

What consideration have you given to the issue of patients who drive unimpaired but will

still face prosecution if tested as levels of metabolites in their system may be above any

prescribed limit

This is being considered in both the terms of reference for the technical panelrsquos advice about the setting of specified limits (to keep patients out of the scope of the offence) and the inclusion of the medical defence within the offence

The panel has also been asked to consider the degree of variability in impairment effects across the population including for habitual drug users

In the terms of reference for the panel we have also specifically included the following from the North review (paragraph 743)

ldquoSome drugs which may be proscribed for driving might also be used legitimately in accordance with medical advice (for example morphine may be prescribed for chronic pain or diazepam (a benzodiazepine) may be prescribed for anxiety) Indeed the Review recognises that in some circumstances it may be more dangerous for a person to drive having not taken their medically prescribed drug than driving without having taken it Drugs have different effects on different people and levels at which they are prescribed are likely to reflect this It would clearly be wrong to put in jeopardy of prosecution those who are properly and safely taking medically prescribed drugs and driving in accordance with medical advice for whom despite the presence of a proscribed drug there is no evidence of any driving impairmentrdquo

I should also emphasise that the content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

2) Criminalisation of Patients

Statutory defence is included in the current legislation for those who have taken

prescription medication in accordance with prescribersupplier instructions and any

accompanying instructions from the manufacturer BUT

Only applicable after patient has been arrested further tested and their case has

progressed ndash this will cause innocent patients significant stress and

inconvenience

The defence puts the burden of proof on patients to prove that they acted in

accordance with all medical advice when the burden should be on the

prosecution to prove that they didnrsquot

23

Innocent patients may face criminalisation based on a technicality in legislation

that is not intended to target them

Questions

Is an exemption feasible (If not what is going to be done to ensure that patients are

protected)

I do not consider an exemption from the offence for all controlled drugs that can possibly be supplied or used for medical reasons is feasible Many controlled drugs for example cannabis have some medicinal uses

It is perfectly feasible for decisions about which controlled drugs would be specified for the new offence to be influenced by the reasons for whether their use is often always seldom or never for medical reasons Indeed such distinctions would be vital if this legislation were being introduced to enforce further against the illegal supply or use of controlled drugs

Whether that is the right approach to decision-making related to driving with controlled drugs in the body where there are levels associated with elevated risks to public safety is however questionable This legislation is being introduced to address road safety problems and the expert panelrsquos terms of reference are focussed on providing advice about the risks of driving after taking controlled drugs

It is to no-onesrsquo benefit for patients who are innocent of the offence to be arrested and tested There are several protections in place to reduce these risks Firstly police do not have random testing powers for drink and drug driving Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving

under the influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would result in disproportionate and large numbers of patients having evidential blood tests but then being not guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

24

It is important to note that the prosecution for a case where a defence has been raised that a patient had taken a controlled drug in accordance with medical advice must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code Test about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

It is important now and it will be important with the new offence in place that medical advice does not suggest to patients that they drive when doing so would present a significant risk to themselves and the public To do so risks patients being involved in road traffic incidents and also committing the existing offence of driving whilst impaired due to drugs

3) Different to Drink Driving Law

There have been calls for a strict liability approach to drug driving as exists for drink

driving Napp believes this would not be a suitable approach for drug driving based on the

current draft Bill

Alcohol does not have any medical necessity people do not need to consume

alcohol to ensure that a chronic condition does not prevent them from

functioning on a daily basis

Prescription medications that patients may take to treat chronic pain are a

medical necessity and are essential to ensuring that they are able to function on a

daily basis

A strict liability approach could lead to patients not taking essential medication in

order to be able to drive without fear of prosecution

Alternatively patients may choose not to drive at all which could have a serious

impact on their ability to work and go about their daily lives

Questions Is an exemption feasible (If not what is going to be done to ensure that patients are protected)

There are some useful analogies with drink driving law For example prior to the introduction of the specific drink driving offence the law in relation to drink drivers was difficult to enforce The specific offence there has contributed to major improvements in public safety

I do accept one of the differences with some controlled drugs is that some people take them for medicinal not recreational purposes This is not the case for all controlled drugs This may well affect what is included in the regulations for the offence

25

When we met I did say that it is conceivable for even as prevalent a recreational drug as heroin to not be included in the regulations for the offence This might be if it transpired that a limit relevant to heroin had to be set in a metabolite itself used in or a metabolite of a medically prescribed drug If such a limit also then had the effect of criminalising driving with medically supplied controlled drugs when that did not present an elevated risk to public safety I can see it would be a limit we might well not implement However I await the advice of the expert panel to see what it recommends related to heroin and whether (and how) that might affect other opiates

4) Policeable Offence

It is argued that drivers wonrsquot be stopped by police unless they appear impaired BUT

Plans are to test all those involved in a traffic accident for drugs including

innocent parties An innocent unimpaired patient involved in a crash through no

fault of their own could then face serious charges

Impairment is subjective and police may be suspicious of someonersquos driving for a

number of reasons such as driving too cautiously This apparently lsquoimpairedrsquo

driving may be due to various factors unrelated to the driverrsquos use of prescribed

medication but if they are stopped by police they may find themselves facing

serious and unjust charges

The existing impairment offence will remain so police will still be able to catch

those who do drive while impaired by prescription medication

Questions How close is the Home Office to approval of a drug testing device for use in police stations Can you provide any details

The laboratory testing phases of the type approval process is under way and the process is due to be completed at the end of this year

Is the Home Office still aiming for a 2014 approval of a drug testing device for portable use

It is still aiming for 2014 for these devices and we are planning the timing of that process together with the work on the new offence

Since the Governmentrsquos response to the North Review in June 2010 has the drug driving data quality improved

Yes we have received more information from Coroners recently and we also have had the conclusions of the European DRUID research

C Solutions

Napp believes that the best way to protect patients is by introducing an exemption for

those who can demonstrate that they are taking prescription medication

Existing legislation against driving while impaired would allow police to charge

anyone who did drive while under the influence of impairing prescription

medication

26

This would put the burden of proof on prosecutors saving innocent patients

considerable stress inconvenience and wasted CPS and police time

The Department considers that the statutory defence affords appropriate protection to patients who drive after taking prescription medication

The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

D Other Points for Consideration

Napp is keen to support this legislation in its efforts to stop users of illegal drugs

from driving and wishes to support policy development to ensure that patients are

protected Napp would be keen to provide any further information or other

means of assistance that could be of help here

Napp would like to submit written andor oral evidence to the Expert Panelrsquos

inquiry

Napp is concerned about the lack of pain expertise and patient representatives on

the Expert panel

Lord Henley mentioned that a seminar might be held after the summer recess to

discuss the issues arising from this legislation further Napp would be keen to

receive any further information on this

I hope this has been covered satisfactorily in the discussion we had on 31st July and since then

I do consider the legislation has strong safeguards in place for patients The Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

I hope I have addressed at least some of your concerns I should be happy to discuss the issues further

Duncan Price 2882012

27

Note on controlled drugs with medical uses

(i) The reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

(ii) Circumstances in which drug testing can be administered Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under the

influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

(iii) The medical defence The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

(iv) Drugs to be covered by the new offence and any specified limits to be based on expert advice The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

(v) Other controls The content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

(vi) Prosecutions to be in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

(vii) In light of the above the Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

28

From DuncanPricedftgsigovuk Sent 13092012 1603 To xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Cc xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Subject RE NRAS - Crime and Courts Bill clauses on drug driving

Xxxxxx

Below is my draft response to this letter Irsquoll send it when I have your comments about it

Dear xx xxxxxxx

Xxxxxx xxxxxxxx has forwarded your email of 28th August to me I am the lead policy official for the legislative clause about drug impaired driving in the Crime and Courts Bill

I am aware of concerns about innocent motorists taking prescribed medications being stopped tested being taken to police stations having blood samples taken and possibly going to court before being exonerated This is not the intention of the legislation and I can assure you we are mindful of this concern as we progress the legislation and respond to advice from an expert panel about the details

There are several protections in place to reduce the risk of large numbers of innocent motorists being arrested and taken to police stations

Firstly motorists cannot be stopped randomly for drug tests Testing can only be administered in three circumstances ndash namely where a driver has committed a moving traffic offence

a driver has been involved in a road traffic accident and or

there is reason for a police officer to suspect that a person has been driving under the influence of drink or drugs

This means that in practice drivers taking prescribed medicines would not be stopped and required to undergo drug testing without there being real cause for concern Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would be likely to result in disproportionate and large numbers of people prescribed drugs having evidential blood tests but then not being found guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

Fourthly it is important to emphasise that the prosecution for a case where the medical defence has been raised must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code for Crown Prosecutors which contains a requirement about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

Finally in the context of the clause before parliament the content of the regulations (specifying which controlled drugs should be covered by the new offence and the limits to be specified for them) will be the subject of public consultation Before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of

29

Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

I hope that this letter serves to allay concerns about possible unintended consequences for people taking prescription medicines

Duncan Price Tel 020 7944 xxxx Department for Transport

From JessicaMatthewdftgsigovuk Sent 17 October 2012 1108 To xxxxxxxxxxxxadhgsigovuk Cc xxxxxxxxxxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxxxxxdhgsigovuk xxxxxxxxdhgsigovuk Subject Re Department of Health attendance at the Lords briefing for the drug driving legislation

Xxxxxxxx is out of the office today but wersquoll send over the time and venue tomorrow and share the briefing with you Irsquod be happy to brief Dr Prunty beforehand ndash perhaps over the phone

Wersquore planning on a reasonably open debate about the legislation We wonrsquot have got policy clearance on the amendments to the legislation but wersquore inclined to say that the Government is minded to or is considering x y or z

Happy to discuss

Jessica Matthew Deputy Director Road User Licensing Insurance and Safety Tel 020 7944 xxxx Zone 321 Great Minster House 76 Marsham Street London SW1P 4DR

Extract of Briefing shared with DH from the above e-mail

How will you make sure that people taking medication in accordance with their prescription arenrsquot arrested and taken to court as a result of this legislation

The medical defence in the provisions provides substantial and appropriate protection for people taking medically prescribed or supplied controlled drugs It places an evidential burden on a person accused of committing the offence So the accused must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court It is then for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on

It is unlikely that a person taking medication in accordance with their prescription would be taken to court for a number of reasons

30

1 Motorists cannot be stopped randomly for drug tests They can only be tested where They have committed a moving traffic offence They have been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under

the influence of drink or drugs

2 The drugs to be included in the legislation and their limits will be set in regulations The content of the regulations will be the subject of public consultation and an affirmative resolution This will provide an opportunity for any concerns with the proposed specified limits to be raised and carefully considered

3 The expert panel is bearing in mind the normal therapeutic ranges and expected drug concentrations in blood when setting limits for those drugs that may also be used for medicinal purposes This means that only patients on unusually high doses of medication might have a positive screening and proceed to evidential blood test

4 Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any cases before they reach the court Indeed there is a Code for Crown Prosecutors which contains a requirement that prosecutions are in the public interest

From xxxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 29 November 2012 1422 To xxxxxxxdhgsigovuk xxxxxxxxxpsncorguk xxxxxxxxxxxxxtheccaorguk xxxxxxxxxxnpacouk xxxxxxxxxxxxrpharmscom xxxxxxxxxxxsaddactionorguk xxxxxroadsafecom xxxxxxxxxxxxxxxxxxsdrconsortiumorg xxxm-allianceorguk xxxxxxxxxxxturning-pointcouk xxxxxxxxROSPAcom xxxxxxxxxxxxxxxxtheAAcom xxxxxxxxxacpopnnpoliceuk adminactionaddictionorguk xxxxxxxxxageukorguk xxxxxxxxxxxbrakeorguk xxxxxxxxbmaorguk xxxxxxxxxxxbritishpainsocietyorg xxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxcpsgsigovuk xxxxxxxxdrugscopeorguk xxxxxxxxxiamorguk xxxxxxxxxxxxxxlawsocietyorguk xxxxxxxxxxxliberty-human-rightsorguk xxxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxxpactsorguk xxxxxxxxxxparliamentuk xxxxxxxxxxxxRACFoundationorg xxxxxxxxxxdurhamgovuk xxxxxxxxxxxxxxxxPolicyConnectorguk xxxxxxxxxxxxxxpsncorguk xxxxxxxxxxxxxdvlagsigovuk Xxxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxhomeofficegsigovuk xxxxxxxxnpacouk xxxxxxxxxxxxdhgsigovuk xxxxxxxxxdrugscopeorguk Cc xxxxxxxxxxxxxxxxxxxdftgsigovuk JessicaMatthewdftgsigovuk xxxxxxxxxxxxxxxxxxdftgsigovuk Subject Drug driving seminar presentation

Dear all

Many thanks to those of you who were able to attend our Drug Driving Stakeholder Seminar last week

We hope you found as useful as we did

Please find attached a copy of the presentation as promised

Kind regards

Xxxxxx xxxxxxx

31

about their medication unless as with certain drugs the DVLA should be notified and patients specifically informed that they must not drive whilst taking this medication The onus is on the patient to determine if they have this side effect and to what extent they are impaired DP noted that there is a difference between advice that a patient cannot drive and being told not to drive if they feel drowsy Xxx added that patients on a stable dose will be unsure if they can continue to work have a good quality of life etc and this will lead them to question whether or not to take their medication

DP stated that the Government can provide the context on what they think directions are but this will still be interpreted by a court Xx said publishing that information would provide comfort to patients who are concerned DP said this would be discussed with peers as well

Xx asked who will be invited to the informal discussion with peers and MPs DP said it would be just members of the House of Lords and Commons They will be able to meet with the Panel and other Government experts Xx noted that this would be useful for peers as those Napp has spoken to have had answers to initial questions but there are still areas where they would like some clarification DP noted that he and the Lords Spokesperson met with interested peers in advance of the Committee Stage It is easier to provide more factual clarification informally than on the floor of the House and Spokespeople will value the chance to make some progress before the Report Stage

Xx confirmed that Napp would put together some helpful information for DP to pass on to the Panel and will bring in some experts to feed in to that Xx added that Napp would be happy to feed in to any policy statements etc DP said he would be happy to clarify any issues in writing Xx said Napp would put together a list of questions for DP for this Xx said xxx would involve patient groups here too

Xx asked if there has been any input in the policy from the Department for Health DP said that a quadrilateral working group from Transport Justice Home and Health are working on the policy They have met between Panel meetings to see what is said and if there are any issues to put to the Panel

Xx asked if there is anything else Napp can do DP said that the more specific Napp can be about concerns evidence on the effect of treatments on impairment etc that would be helpful The policy is very much at the evidence gathering stage at the moment

Xx reiterated Napprsquos concerns regarding the Panel membership

DP said that at some point he expected tough decisions will be made about the balance of the proscons of the policy issues No solution will tick every box

Xx said that policy statements will be key to giving the police and the CPS guidance on who they are targeting as well as what lsquodirectionsrsquo mean to allay the fears of patients and clinicians DP said he hoped they would be able to allay fears He added that there is no advantage for the police to have lots of people in stations and being processed who are not impaired There is a realistic policy possibility that heroin will have to be set aside Just because the Panel is looking at it does not mean there is a commitment that it will be in the new offence They know that there may be no test to distinguish between different types of opiates

20

Xxx passed on two emails which he explained were from xx xxxxxxx xxxxxxx and xx xxxxxx xxxxxxxxn representing the views of CPPC and RCGP respectively Both Doctors expressed their concerns for patients and offered to contribute to discussions on the proposed legislation

A Note of Napprsquos Key Concerns

Napp Pharmaceuticals Meeting with Department for Transport 31 July 2012

Note I have added in bold italicised text some DfT responses to the questions in your original note which is otherwise as you sent me ndash Duncan Price 2882012

A Statement of support for drug driving legislation to stop people from driving while under the

influence of illegal drugs

Napp is concerned about the unintended consequences of the legislation on patients taking

long‐term medication for chronic pain Napp wants to work with the Government to find a

solution

1) Impact on Patients

2) Criminalisation of Patients

3) Different to Drink Driving Law

4) Policeable Offence

B Outline of Concerns

1) Impact on Patients

Evidence shows that patients on a stable dose of opioid analgesics are not necessarily

impaired but under the proposed system patients may be inaccurately identified as taking

impairing drugs and face prosecution

Patients well established on a stable dose of an opioid analgesic may have levels of

metabolites in their system well above any threshold used for roadside and police station

testing This means they could face serious charges despite driving unimpaired

There are concerns for patients such as those with Osteoarthritis the majority of who use

over the counter medications to manage their pain

Concern that patients will stop taking their medication so that they can drive This may

make their driving more impaired as a result of the pain that they will be under

Questions

Has there been consideration of how to distinguish between opiates that are used legally

for medicinal purposes and those used illegally (Napp would be happy to share clinical

knowledge of opioids that may be helpful to the panel and to any other interested parties

in Government)

The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

21

The panel is considering natural and synthetic opioids Its terms of reference include that it should establish the likelihood of whether concentrations of drugs broadly equivalent in their impairment effects to blood alcohol concentrations of 20 50 and 80mg100ml would be exceeded This will include a consideration of prescribed or otherwise legally obtained drugs which are known to impair driving

The panel will advise the Government which will then itself consider what specified limits to propose and then consult about I can assure you that in doing so it will consider how screening equipment and evidential blood specimens would distinguish between opiates used for legitimate medical purposes and those used illicitly

I am grateful for the offer of sharing clinical knowledge you made when we met I know the panel has since considered some of the evidence your experts have provided and some of its members have met an expert you recommended and one of your legal advisors

Has there been consideration of just introducing a list of restricted drugs known to be used

recreationally as with the Australian model

The list of restricted drugs used in some states in Australia does include THC (the active ingredient of cannabis) which does have some limited medical uses here The Governmentrsquos prime targets for this legislation are controlled drugs often or exclusively used illicitly including those included in the Australian legislation (THC amphetamines and MDMA)

At this stage we are awaiting advice from the panel but the Governmentrsquos position is that it should develop a new offence with the potential to include a number of categories of drug including benzodiazepines and opiates The abuse including the use of high quantities of methadone and some benzodiazepines (which can be prescribed) appears (alongside heroin) to be a significant contributor to the public safety problems this legislation is addressing

Many of the drugs specifically identified in the panelrsquos terms of reference are used exclusively or predominantly illicitly ndash for example amphetamine-types cannabinoids cocaine and hallucinogens

There is a reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

22

We are therefore using the definition of lsquocontrolled drugrsquo in the Misuse of Drugs Act 1971 within the new offence although which controlled drugs will be determined when regulations are brought forward

What consideration have you given to the issue of patients who drive unimpaired but will

still face prosecution if tested as levels of metabolites in their system may be above any

prescribed limit

This is being considered in both the terms of reference for the technical panelrsquos advice about the setting of specified limits (to keep patients out of the scope of the offence) and the inclusion of the medical defence within the offence

The panel has also been asked to consider the degree of variability in impairment effects across the population including for habitual drug users

In the terms of reference for the panel we have also specifically included the following from the North review (paragraph 743)

ldquoSome drugs which may be proscribed for driving might also be used legitimately in accordance with medical advice (for example morphine may be prescribed for chronic pain or diazepam (a benzodiazepine) may be prescribed for anxiety) Indeed the Review recognises that in some circumstances it may be more dangerous for a person to drive having not taken their medically prescribed drug than driving without having taken it Drugs have different effects on different people and levels at which they are prescribed are likely to reflect this It would clearly be wrong to put in jeopardy of prosecution those who are properly and safely taking medically prescribed drugs and driving in accordance with medical advice for whom despite the presence of a proscribed drug there is no evidence of any driving impairmentrdquo

I should also emphasise that the content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

2) Criminalisation of Patients

Statutory defence is included in the current legislation for those who have taken

prescription medication in accordance with prescribersupplier instructions and any

accompanying instructions from the manufacturer BUT

Only applicable after patient has been arrested further tested and their case has

progressed ndash this will cause innocent patients significant stress and

inconvenience

The defence puts the burden of proof on patients to prove that they acted in

accordance with all medical advice when the burden should be on the

prosecution to prove that they didnrsquot

23

Innocent patients may face criminalisation based on a technicality in legislation

that is not intended to target them

Questions

Is an exemption feasible (If not what is going to be done to ensure that patients are

protected)

I do not consider an exemption from the offence for all controlled drugs that can possibly be supplied or used for medical reasons is feasible Many controlled drugs for example cannabis have some medicinal uses

It is perfectly feasible for decisions about which controlled drugs would be specified for the new offence to be influenced by the reasons for whether their use is often always seldom or never for medical reasons Indeed such distinctions would be vital if this legislation were being introduced to enforce further against the illegal supply or use of controlled drugs

Whether that is the right approach to decision-making related to driving with controlled drugs in the body where there are levels associated with elevated risks to public safety is however questionable This legislation is being introduced to address road safety problems and the expert panelrsquos terms of reference are focussed on providing advice about the risks of driving after taking controlled drugs

It is to no-onesrsquo benefit for patients who are innocent of the offence to be arrested and tested There are several protections in place to reduce these risks Firstly police do not have random testing powers for drink and drug driving Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving

under the influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would result in disproportionate and large numbers of patients having evidential blood tests but then being not guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

24

It is important to note that the prosecution for a case where a defence has been raised that a patient had taken a controlled drug in accordance with medical advice must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code Test about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

It is important now and it will be important with the new offence in place that medical advice does not suggest to patients that they drive when doing so would present a significant risk to themselves and the public To do so risks patients being involved in road traffic incidents and also committing the existing offence of driving whilst impaired due to drugs

3) Different to Drink Driving Law

There have been calls for a strict liability approach to drug driving as exists for drink

driving Napp believes this would not be a suitable approach for drug driving based on the

current draft Bill

Alcohol does not have any medical necessity people do not need to consume

alcohol to ensure that a chronic condition does not prevent them from

functioning on a daily basis

Prescription medications that patients may take to treat chronic pain are a

medical necessity and are essential to ensuring that they are able to function on a

daily basis

A strict liability approach could lead to patients not taking essential medication in

order to be able to drive without fear of prosecution

Alternatively patients may choose not to drive at all which could have a serious

impact on their ability to work and go about their daily lives

Questions Is an exemption feasible (If not what is going to be done to ensure that patients are protected)

There are some useful analogies with drink driving law For example prior to the introduction of the specific drink driving offence the law in relation to drink drivers was difficult to enforce The specific offence there has contributed to major improvements in public safety

I do accept one of the differences with some controlled drugs is that some people take them for medicinal not recreational purposes This is not the case for all controlled drugs This may well affect what is included in the regulations for the offence

25

When we met I did say that it is conceivable for even as prevalent a recreational drug as heroin to not be included in the regulations for the offence This might be if it transpired that a limit relevant to heroin had to be set in a metabolite itself used in or a metabolite of a medically prescribed drug If such a limit also then had the effect of criminalising driving with medically supplied controlled drugs when that did not present an elevated risk to public safety I can see it would be a limit we might well not implement However I await the advice of the expert panel to see what it recommends related to heroin and whether (and how) that might affect other opiates

4) Policeable Offence

It is argued that drivers wonrsquot be stopped by police unless they appear impaired BUT

Plans are to test all those involved in a traffic accident for drugs including

innocent parties An innocent unimpaired patient involved in a crash through no

fault of their own could then face serious charges

Impairment is subjective and police may be suspicious of someonersquos driving for a

number of reasons such as driving too cautiously This apparently lsquoimpairedrsquo

driving may be due to various factors unrelated to the driverrsquos use of prescribed

medication but if they are stopped by police they may find themselves facing

serious and unjust charges

The existing impairment offence will remain so police will still be able to catch

those who do drive while impaired by prescription medication

Questions How close is the Home Office to approval of a drug testing device for use in police stations Can you provide any details

The laboratory testing phases of the type approval process is under way and the process is due to be completed at the end of this year

Is the Home Office still aiming for a 2014 approval of a drug testing device for portable use

It is still aiming for 2014 for these devices and we are planning the timing of that process together with the work on the new offence

Since the Governmentrsquos response to the North Review in June 2010 has the drug driving data quality improved

Yes we have received more information from Coroners recently and we also have had the conclusions of the European DRUID research

C Solutions

Napp believes that the best way to protect patients is by introducing an exemption for

those who can demonstrate that they are taking prescription medication

Existing legislation against driving while impaired would allow police to charge

anyone who did drive while under the influence of impairing prescription

medication

26

This would put the burden of proof on prosecutors saving innocent patients

considerable stress inconvenience and wasted CPS and police time

The Department considers that the statutory defence affords appropriate protection to patients who drive after taking prescription medication

The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

D Other Points for Consideration

Napp is keen to support this legislation in its efforts to stop users of illegal drugs

from driving and wishes to support policy development to ensure that patients are

protected Napp would be keen to provide any further information or other

means of assistance that could be of help here

Napp would like to submit written andor oral evidence to the Expert Panelrsquos

inquiry

Napp is concerned about the lack of pain expertise and patient representatives on

the Expert panel

Lord Henley mentioned that a seminar might be held after the summer recess to

discuss the issues arising from this legislation further Napp would be keen to

receive any further information on this

I hope this has been covered satisfactorily in the discussion we had on 31st July and since then

I do consider the legislation has strong safeguards in place for patients The Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

I hope I have addressed at least some of your concerns I should be happy to discuss the issues further

Duncan Price 2882012

27

Note on controlled drugs with medical uses

(i) The reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

(ii) Circumstances in which drug testing can be administered Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under the

influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

(iii) The medical defence The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

(iv) Drugs to be covered by the new offence and any specified limits to be based on expert advice The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

(v) Other controls The content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

(vi) Prosecutions to be in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

(vii) In light of the above the Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

28

From DuncanPricedftgsigovuk Sent 13092012 1603 To xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Cc xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Subject RE NRAS - Crime and Courts Bill clauses on drug driving

Xxxxxx

Below is my draft response to this letter Irsquoll send it when I have your comments about it

Dear xx xxxxxxx

Xxxxxx xxxxxxxx has forwarded your email of 28th August to me I am the lead policy official for the legislative clause about drug impaired driving in the Crime and Courts Bill

I am aware of concerns about innocent motorists taking prescribed medications being stopped tested being taken to police stations having blood samples taken and possibly going to court before being exonerated This is not the intention of the legislation and I can assure you we are mindful of this concern as we progress the legislation and respond to advice from an expert panel about the details

There are several protections in place to reduce the risk of large numbers of innocent motorists being arrested and taken to police stations

Firstly motorists cannot be stopped randomly for drug tests Testing can only be administered in three circumstances ndash namely where a driver has committed a moving traffic offence

a driver has been involved in a road traffic accident and or

there is reason for a police officer to suspect that a person has been driving under the influence of drink or drugs

This means that in practice drivers taking prescribed medicines would not be stopped and required to undergo drug testing without there being real cause for concern Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would be likely to result in disproportionate and large numbers of people prescribed drugs having evidential blood tests but then not being found guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

Fourthly it is important to emphasise that the prosecution for a case where the medical defence has been raised must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code for Crown Prosecutors which contains a requirement about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

Finally in the context of the clause before parliament the content of the regulations (specifying which controlled drugs should be covered by the new offence and the limits to be specified for them) will be the subject of public consultation Before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of

29

Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

I hope that this letter serves to allay concerns about possible unintended consequences for people taking prescription medicines

Duncan Price Tel 020 7944 xxxx Department for Transport

From JessicaMatthewdftgsigovuk Sent 17 October 2012 1108 To xxxxxxxxxxxxadhgsigovuk Cc xxxxxxxxxxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxxxxxdhgsigovuk xxxxxxxxdhgsigovuk Subject Re Department of Health attendance at the Lords briefing for the drug driving legislation

Xxxxxxxx is out of the office today but wersquoll send over the time and venue tomorrow and share the briefing with you Irsquod be happy to brief Dr Prunty beforehand ndash perhaps over the phone

Wersquore planning on a reasonably open debate about the legislation We wonrsquot have got policy clearance on the amendments to the legislation but wersquore inclined to say that the Government is minded to or is considering x y or z

Happy to discuss

Jessica Matthew Deputy Director Road User Licensing Insurance and Safety Tel 020 7944 xxxx Zone 321 Great Minster House 76 Marsham Street London SW1P 4DR

Extract of Briefing shared with DH from the above e-mail

How will you make sure that people taking medication in accordance with their prescription arenrsquot arrested and taken to court as a result of this legislation

The medical defence in the provisions provides substantial and appropriate protection for people taking medically prescribed or supplied controlled drugs It places an evidential burden on a person accused of committing the offence So the accused must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court It is then for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on

It is unlikely that a person taking medication in accordance with their prescription would be taken to court for a number of reasons

30

1 Motorists cannot be stopped randomly for drug tests They can only be tested where They have committed a moving traffic offence They have been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under

the influence of drink or drugs

2 The drugs to be included in the legislation and their limits will be set in regulations The content of the regulations will be the subject of public consultation and an affirmative resolution This will provide an opportunity for any concerns with the proposed specified limits to be raised and carefully considered

3 The expert panel is bearing in mind the normal therapeutic ranges and expected drug concentrations in blood when setting limits for those drugs that may also be used for medicinal purposes This means that only patients on unusually high doses of medication might have a positive screening and proceed to evidential blood test

4 Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any cases before they reach the court Indeed there is a Code for Crown Prosecutors which contains a requirement that prosecutions are in the public interest

From xxxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 29 November 2012 1422 To xxxxxxxdhgsigovuk xxxxxxxxxpsncorguk xxxxxxxxxxxxxtheccaorguk xxxxxxxxxxnpacouk xxxxxxxxxxxxrpharmscom xxxxxxxxxxxsaddactionorguk xxxxxroadsafecom xxxxxxxxxxxxxxxxxxsdrconsortiumorg xxxm-allianceorguk xxxxxxxxxxxturning-pointcouk xxxxxxxxROSPAcom xxxxxxxxxxxxxxxxtheAAcom xxxxxxxxxacpopnnpoliceuk adminactionaddictionorguk xxxxxxxxxageukorguk xxxxxxxxxxxbrakeorguk xxxxxxxxbmaorguk xxxxxxxxxxxbritishpainsocietyorg xxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxcpsgsigovuk xxxxxxxxdrugscopeorguk xxxxxxxxxiamorguk xxxxxxxxxxxxxxlawsocietyorguk xxxxxxxxxxxliberty-human-rightsorguk xxxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxxpactsorguk xxxxxxxxxxparliamentuk xxxxxxxxxxxxRACFoundationorg xxxxxxxxxxdurhamgovuk xxxxxxxxxxxxxxxxPolicyConnectorguk xxxxxxxxxxxxxxpsncorguk xxxxxxxxxxxxxdvlagsigovuk Xxxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxhomeofficegsigovuk xxxxxxxxnpacouk xxxxxxxxxxxxdhgsigovuk xxxxxxxxxdrugscopeorguk Cc xxxxxxxxxxxxxxxxxxxdftgsigovuk JessicaMatthewdftgsigovuk xxxxxxxxxxxxxxxxxxdftgsigovuk Subject Drug driving seminar presentation

Dear all

Many thanks to those of you who were able to attend our Drug Driving Stakeholder Seminar last week

We hope you found as useful as we did

Please find attached a copy of the presentation as promised

Kind regards

Xxxxxx xxxxxxx

31

Xxx passed on two emails which he explained were from xx xxxxxxx xxxxxxx and xx xxxxxx xxxxxxxxn representing the views of CPPC and RCGP respectively Both Doctors expressed their concerns for patients and offered to contribute to discussions on the proposed legislation

A Note of Napprsquos Key Concerns

Napp Pharmaceuticals Meeting with Department for Transport 31 July 2012

Note I have added in bold italicised text some DfT responses to the questions in your original note which is otherwise as you sent me ndash Duncan Price 2882012

A Statement of support for drug driving legislation to stop people from driving while under the

influence of illegal drugs

Napp is concerned about the unintended consequences of the legislation on patients taking

long‐term medication for chronic pain Napp wants to work with the Government to find a

solution

1) Impact on Patients

2) Criminalisation of Patients

3) Different to Drink Driving Law

4) Policeable Offence

B Outline of Concerns

1) Impact on Patients

Evidence shows that patients on a stable dose of opioid analgesics are not necessarily

impaired but under the proposed system patients may be inaccurately identified as taking

impairing drugs and face prosecution

Patients well established on a stable dose of an opioid analgesic may have levels of

metabolites in their system well above any threshold used for roadside and police station

testing This means they could face serious charges despite driving unimpaired

There are concerns for patients such as those with Osteoarthritis the majority of who use

over the counter medications to manage their pain

Concern that patients will stop taking their medication so that they can drive This may

make their driving more impaired as a result of the pain that they will be under

Questions

Has there been consideration of how to distinguish between opiates that are used legally

for medicinal purposes and those used illegally (Napp would be happy to share clinical

knowledge of opioids that may be helpful to the panel and to any other interested parties

in Government)

The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

21

The panel is considering natural and synthetic opioids Its terms of reference include that it should establish the likelihood of whether concentrations of drugs broadly equivalent in their impairment effects to blood alcohol concentrations of 20 50 and 80mg100ml would be exceeded This will include a consideration of prescribed or otherwise legally obtained drugs which are known to impair driving

The panel will advise the Government which will then itself consider what specified limits to propose and then consult about I can assure you that in doing so it will consider how screening equipment and evidential blood specimens would distinguish between opiates used for legitimate medical purposes and those used illicitly

I am grateful for the offer of sharing clinical knowledge you made when we met I know the panel has since considered some of the evidence your experts have provided and some of its members have met an expert you recommended and one of your legal advisors

Has there been consideration of just introducing a list of restricted drugs known to be used

recreationally as with the Australian model

The list of restricted drugs used in some states in Australia does include THC (the active ingredient of cannabis) which does have some limited medical uses here The Governmentrsquos prime targets for this legislation are controlled drugs often or exclusively used illicitly including those included in the Australian legislation (THC amphetamines and MDMA)

At this stage we are awaiting advice from the panel but the Governmentrsquos position is that it should develop a new offence with the potential to include a number of categories of drug including benzodiazepines and opiates The abuse including the use of high quantities of methadone and some benzodiazepines (which can be prescribed) appears (alongside heroin) to be a significant contributor to the public safety problems this legislation is addressing

Many of the drugs specifically identified in the panelrsquos terms of reference are used exclusively or predominantly illicitly ndash for example amphetamine-types cannabinoids cocaine and hallucinogens

There is a reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

22

We are therefore using the definition of lsquocontrolled drugrsquo in the Misuse of Drugs Act 1971 within the new offence although which controlled drugs will be determined when regulations are brought forward

What consideration have you given to the issue of patients who drive unimpaired but will

still face prosecution if tested as levels of metabolites in their system may be above any

prescribed limit

This is being considered in both the terms of reference for the technical panelrsquos advice about the setting of specified limits (to keep patients out of the scope of the offence) and the inclusion of the medical defence within the offence

The panel has also been asked to consider the degree of variability in impairment effects across the population including for habitual drug users

In the terms of reference for the panel we have also specifically included the following from the North review (paragraph 743)

ldquoSome drugs which may be proscribed for driving might also be used legitimately in accordance with medical advice (for example morphine may be prescribed for chronic pain or diazepam (a benzodiazepine) may be prescribed for anxiety) Indeed the Review recognises that in some circumstances it may be more dangerous for a person to drive having not taken their medically prescribed drug than driving without having taken it Drugs have different effects on different people and levels at which they are prescribed are likely to reflect this It would clearly be wrong to put in jeopardy of prosecution those who are properly and safely taking medically prescribed drugs and driving in accordance with medical advice for whom despite the presence of a proscribed drug there is no evidence of any driving impairmentrdquo

I should also emphasise that the content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

2) Criminalisation of Patients

Statutory defence is included in the current legislation for those who have taken

prescription medication in accordance with prescribersupplier instructions and any

accompanying instructions from the manufacturer BUT

Only applicable after patient has been arrested further tested and their case has

progressed ndash this will cause innocent patients significant stress and

inconvenience

The defence puts the burden of proof on patients to prove that they acted in

accordance with all medical advice when the burden should be on the

prosecution to prove that they didnrsquot

23

Innocent patients may face criminalisation based on a technicality in legislation

that is not intended to target them

Questions

Is an exemption feasible (If not what is going to be done to ensure that patients are

protected)

I do not consider an exemption from the offence for all controlled drugs that can possibly be supplied or used for medical reasons is feasible Many controlled drugs for example cannabis have some medicinal uses

It is perfectly feasible for decisions about which controlled drugs would be specified for the new offence to be influenced by the reasons for whether their use is often always seldom or never for medical reasons Indeed such distinctions would be vital if this legislation were being introduced to enforce further against the illegal supply or use of controlled drugs

Whether that is the right approach to decision-making related to driving with controlled drugs in the body where there are levels associated with elevated risks to public safety is however questionable This legislation is being introduced to address road safety problems and the expert panelrsquos terms of reference are focussed on providing advice about the risks of driving after taking controlled drugs

It is to no-onesrsquo benefit for patients who are innocent of the offence to be arrested and tested There are several protections in place to reduce these risks Firstly police do not have random testing powers for drink and drug driving Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving

under the influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would result in disproportionate and large numbers of patients having evidential blood tests but then being not guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

24

It is important to note that the prosecution for a case where a defence has been raised that a patient had taken a controlled drug in accordance with medical advice must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code Test about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

It is important now and it will be important with the new offence in place that medical advice does not suggest to patients that they drive when doing so would present a significant risk to themselves and the public To do so risks patients being involved in road traffic incidents and also committing the existing offence of driving whilst impaired due to drugs

3) Different to Drink Driving Law

There have been calls for a strict liability approach to drug driving as exists for drink

driving Napp believes this would not be a suitable approach for drug driving based on the

current draft Bill

Alcohol does not have any medical necessity people do not need to consume

alcohol to ensure that a chronic condition does not prevent them from

functioning on a daily basis

Prescription medications that patients may take to treat chronic pain are a

medical necessity and are essential to ensuring that they are able to function on a

daily basis

A strict liability approach could lead to patients not taking essential medication in

order to be able to drive without fear of prosecution

Alternatively patients may choose not to drive at all which could have a serious

impact on their ability to work and go about their daily lives

Questions Is an exemption feasible (If not what is going to be done to ensure that patients are protected)

There are some useful analogies with drink driving law For example prior to the introduction of the specific drink driving offence the law in relation to drink drivers was difficult to enforce The specific offence there has contributed to major improvements in public safety

I do accept one of the differences with some controlled drugs is that some people take them for medicinal not recreational purposes This is not the case for all controlled drugs This may well affect what is included in the regulations for the offence

25

When we met I did say that it is conceivable for even as prevalent a recreational drug as heroin to not be included in the regulations for the offence This might be if it transpired that a limit relevant to heroin had to be set in a metabolite itself used in or a metabolite of a medically prescribed drug If such a limit also then had the effect of criminalising driving with medically supplied controlled drugs when that did not present an elevated risk to public safety I can see it would be a limit we might well not implement However I await the advice of the expert panel to see what it recommends related to heroin and whether (and how) that might affect other opiates

4) Policeable Offence

It is argued that drivers wonrsquot be stopped by police unless they appear impaired BUT

Plans are to test all those involved in a traffic accident for drugs including

innocent parties An innocent unimpaired patient involved in a crash through no

fault of their own could then face serious charges

Impairment is subjective and police may be suspicious of someonersquos driving for a

number of reasons such as driving too cautiously This apparently lsquoimpairedrsquo

driving may be due to various factors unrelated to the driverrsquos use of prescribed

medication but if they are stopped by police they may find themselves facing

serious and unjust charges

The existing impairment offence will remain so police will still be able to catch

those who do drive while impaired by prescription medication

Questions How close is the Home Office to approval of a drug testing device for use in police stations Can you provide any details

The laboratory testing phases of the type approval process is under way and the process is due to be completed at the end of this year

Is the Home Office still aiming for a 2014 approval of a drug testing device for portable use

It is still aiming for 2014 for these devices and we are planning the timing of that process together with the work on the new offence

Since the Governmentrsquos response to the North Review in June 2010 has the drug driving data quality improved

Yes we have received more information from Coroners recently and we also have had the conclusions of the European DRUID research

C Solutions

Napp believes that the best way to protect patients is by introducing an exemption for

those who can demonstrate that they are taking prescription medication

Existing legislation against driving while impaired would allow police to charge

anyone who did drive while under the influence of impairing prescription

medication

26

This would put the burden of proof on prosecutors saving innocent patients

considerable stress inconvenience and wasted CPS and police time

The Department considers that the statutory defence affords appropriate protection to patients who drive after taking prescription medication

The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

D Other Points for Consideration

Napp is keen to support this legislation in its efforts to stop users of illegal drugs

from driving and wishes to support policy development to ensure that patients are

protected Napp would be keen to provide any further information or other

means of assistance that could be of help here

Napp would like to submit written andor oral evidence to the Expert Panelrsquos

inquiry

Napp is concerned about the lack of pain expertise and patient representatives on

the Expert panel

Lord Henley mentioned that a seminar might be held after the summer recess to

discuss the issues arising from this legislation further Napp would be keen to

receive any further information on this

I hope this has been covered satisfactorily in the discussion we had on 31st July and since then

I do consider the legislation has strong safeguards in place for patients The Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

I hope I have addressed at least some of your concerns I should be happy to discuss the issues further

Duncan Price 2882012

27

Note on controlled drugs with medical uses

(i) The reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

(ii) Circumstances in which drug testing can be administered Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under the

influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

(iii) The medical defence The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

(iv) Drugs to be covered by the new offence and any specified limits to be based on expert advice The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

(v) Other controls The content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

(vi) Prosecutions to be in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

(vii) In light of the above the Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

28

From DuncanPricedftgsigovuk Sent 13092012 1603 To xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Cc xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Subject RE NRAS - Crime and Courts Bill clauses on drug driving

Xxxxxx

Below is my draft response to this letter Irsquoll send it when I have your comments about it

Dear xx xxxxxxx

Xxxxxx xxxxxxxx has forwarded your email of 28th August to me I am the lead policy official for the legislative clause about drug impaired driving in the Crime and Courts Bill

I am aware of concerns about innocent motorists taking prescribed medications being stopped tested being taken to police stations having blood samples taken and possibly going to court before being exonerated This is not the intention of the legislation and I can assure you we are mindful of this concern as we progress the legislation and respond to advice from an expert panel about the details

There are several protections in place to reduce the risk of large numbers of innocent motorists being arrested and taken to police stations

Firstly motorists cannot be stopped randomly for drug tests Testing can only be administered in three circumstances ndash namely where a driver has committed a moving traffic offence

a driver has been involved in a road traffic accident and or

there is reason for a police officer to suspect that a person has been driving under the influence of drink or drugs

This means that in practice drivers taking prescribed medicines would not be stopped and required to undergo drug testing without there being real cause for concern Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would be likely to result in disproportionate and large numbers of people prescribed drugs having evidential blood tests but then not being found guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

Fourthly it is important to emphasise that the prosecution for a case where the medical defence has been raised must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code for Crown Prosecutors which contains a requirement about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

Finally in the context of the clause before parliament the content of the regulations (specifying which controlled drugs should be covered by the new offence and the limits to be specified for them) will be the subject of public consultation Before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of

29

Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

I hope that this letter serves to allay concerns about possible unintended consequences for people taking prescription medicines

Duncan Price Tel 020 7944 xxxx Department for Transport

From JessicaMatthewdftgsigovuk Sent 17 October 2012 1108 To xxxxxxxxxxxxadhgsigovuk Cc xxxxxxxxxxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxxxxxdhgsigovuk xxxxxxxxdhgsigovuk Subject Re Department of Health attendance at the Lords briefing for the drug driving legislation

Xxxxxxxx is out of the office today but wersquoll send over the time and venue tomorrow and share the briefing with you Irsquod be happy to brief Dr Prunty beforehand ndash perhaps over the phone

Wersquore planning on a reasonably open debate about the legislation We wonrsquot have got policy clearance on the amendments to the legislation but wersquore inclined to say that the Government is minded to or is considering x y or z

Happy to discuss

Jessica Matthew Deputy Director Road User Licensing Insurance and Safety Tel 020 7944 xxxx Zone 321 Great Minster House 76 Marsham Street London SW1P 4DR

Extract of Briefing shared with DH from the above e-mail

How will you make sure that people taking medication in accordance with their prescription arenrsquot arrested and taken to court as a result of this legislation

The medical defence in the provisions provides substantial and appropriate protection for people taking medically prescribed or supplied controlled drugs It places an evidential burden on a person accused of committing the offence So the accused must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court It is then for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on

It is unlikely that a person taking medication in accordance with their prescription would be taken to court for a number of reasons

30

1 Motorists cannot be stopped randomly for drug tests They can only be tested where They have committed a moving traffic offence They have been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under

the influence of drink or drugs

2 The drugs to be included in the legislation and their limits will be set in regulations The content of the regulations will be the subject of public consultation and an affirmative resolution This will provide an opportunity for any concerns with the proposed specified limits to be raised and carefully considered

3 The expert panel is bearing in mind the normal therapeutic ranges and expected drug concentrations in blood when setting limits for those drugs that may also be used for medicinal purposes This means that only patients on unusually high doses of medication might have a positive screening and proceed to evidential blood test

4 Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any cases before they reach the court Indeed there is a Code for Crown Prosecutors which contains a requirement that prosecutions are in the public interest

From xxxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 29 November 2012 1422 To xxxxxxxdhgsigovuk xxxxxxxxxpsncorguk xxxxxxxxxxxxxtheccaorguk xxxxxxxxxxnpacouk xxxxxxxxxxxxrpharmscom xxxxxxxxxxxsaddactionorguk xxxxxroadsafecom xxxxxxxxxxxxxxxxxxsdrconsortiumorg xxxm-allianceorguk xxxxxxxxxxxturning-pointcouk xxxxxxxxROSPAcom xxxxxxxxxxxxxxxxtheAAcom xxxxxxxxxacpopnnpoliceuk adminactionaddictionorguk xxxxxxxxxageukorguk xxxxxxxxxxxbrakeorguk xxxxxxxxbmaorguk xxxxxxxxxxxbritishpainsocietyorg xxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxcpsgsigovuk xxxxxxxxdrugscopeorguk xxxxxxxxxiamorguk xxxxxxxxxxxxxxlawsocietyorguk xxxxxxxxxxxliberty-human-rightsorguk xxxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxxpactsorguk xxxxxxxxxxparliamentuk xxxxxxxxxxxxRACFoundationorg xxxxxxxxxxdurhamgovuk xxxxxxxxxxxxxxxxPolicyConnectorguk xxxxxxxxxxxxxxpsncorguk xxxxxxxxxxxxxdvlagsigovuk Xxxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxhomeofficegsigovuk xxxxxxxxnpacouk xxxxxxxxxxxxdhgsigovuk xxxxxxxxxdrugscopeorguk Cc xxxxxxxxxxxxxxxxxxxdftgsigovuk JessicaMatthewdftgsigovuk xxxxxxxxxxxxxxxxxxdftgsigovuk Subject Drug driving seminar presentation

Dear all

Many thanks to those of you who were able to attend our Drug Driving Stakeholder Seminar last week

We hope you found as useful as we did

Please find attached a copy of the presentation as promised

Kind regards

Xxxxxx xxxxxxx

31

The panel is considering natural and synthetic opioids Its terms of reference include that it should establish the likelihood of whether concentrations of drugs broadly equivalent in their impairment effects to blood alcohol concentrations of 20 50 and 80mg100ml would be exceeded This will include a consideration of prescribed or otherwise legally obtained drugs which are known to impair driving

The panel will advise the Government which will then itself consider what specified limits to propose and then consult about I can assure you that in doing so it will consider how screening equipment and evidential blood specimens would distinguish between opiates used for legitimate medical purposes and those used illicitly

I am grateful for the offer of sharing clinical knowledge you made when we met I know the panel has since considered some of the evidence your experts have provided and some of its members have met an expert you recommended and one of your legal advisors

Has there been consideration of just introducing a list of restricted drugs known to be used

recreationally as with the Australian model

The list of restricted drugs used in some states in Australia does include THC (the active ingredient of cannabis) which does have some limited medical uses here The Governmentrsquos prime targets for this legislation are controlled drugs often or exclusively used illicitly including those included in the Australian legislation (THC amphetamines and MDMA)

At this stage we are awaiting advice from the panel but the Governmentrsquos position is that it should develop a new offence with the potential to include a number of categories of drug including benzodiazepines and opiates The abuse including the use of high quantities of methadone and some benzodiazepines (which can be prescribed) appears (alongside heroin) to be a significant contributor to the public safety problems this legislation is addressing

Many of the drugs specifically identified in the panelrsquos terms of reference are used exclusively or predominantly illicitly ndash for example amphetamine-types cannabinoids cocaine and hallucinogens

There is a reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

22

We are therefore using the definition of lsquocontrolled drugrsquo in the Misuse of Drugs Act 1971 within the new offence although which controlled drugs will be determined when regulations are brought forward

What consideration have you given to the issue of patients who drive unimpaired but will

still face prosecution if tested as levels of metabolites in their system may be above any

prescribed limit

This is being considered in both the terms of reference for the technical panelrsquos advice about the setting of specified limits (to keep patients out of the scope of the offence) and the inclusion of the medical defence within the offence

The panel has also been asked to consider the degree of variability in impairment effects across the population including for habitual drug users

In the terms of reference for the panel we have also specifically included the following from the North review (paragraph 743)

ldquoSome drugs which may be proscribed for driving might also be used legitimately in accordance with medical advice (for example morphine may be prescribed for chronic pain or diazepam (a benzodiazepine) may be prescribed for anxiety) Indeed the Review recognises that in some circumstances it may be more dangerous for a person to drive having not taken their medically prescribed drug than driving without having taken it Drugs have different effects on different people and levels at which they are prescribed are likely to reflect this It would clearly be wrong to put in jeopardy of prosecution those who are properly and safely taking medically prescribed drugs and driving in accordance with medical advice for whom despite the presence of a proscribed drug there is no evidence of any driving impairmentrdquo

I should also emphasise that the content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

2) Criminalisation of Patients

Statutory defence is included in the current legislation for those who have taken

prescription medication in accordance with prescribersupplier instructions and any

accompanying instructions from the manufacturer BUT

Only applicable after patient has been arrested further tested and their case has

progressed ndash this will cause innocent patients significant stress and

inconvenience

The defence puts the burden of proof on patients to prove that they acted in

accordance with all medical advice when the burden should be on the

prosecution to prove that they didnrsquot

23

Innocent patients may face criminalisation based on a technicality in legislation

that is not intended to target them

Questions

Is an exemption feasible (If not what is going to be done to ensure that patients are

protected)

I do not consider an exemption from the offence for all controlled drugs that can possibly be supplied or used for medical reasons is feasible Many controlled drugs for example cannabis have some medicinal uses

It is perfectly feasible for decisions about which controlled drugs would be specified for the new offence to be influenced by the reasons for whether their use is often always seldom or never for medical reasons Indeed such distinctions would be vital if this legislation were being introduced to enforce further against the illegal supply or use of controlled drugs

Whether that is the right approach to decision-making related to driving with controlled drugs in the body where there are levels associated with elevated risks to public safety is however questionable This legislation is being introduced to address road safety problems and the expert panelrsquos terms of reference are focussed on providing advice about the risks of driving after taking controlled drugs

It is to no-onesrsquo benefit for patients who are innocent of the offence to be arrested and tested There are several protections in place to reduce these risks Firstly police do not have random testing powers for drink and drug driving Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving

under the influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would result in disproportionate and large numbers of patients having evidential blood tests but then being not guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

24

It is important to note that the prosecution for a case where a defence has been raised that a patient had taken a controlled drug in accordance with medical advice must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code Test about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

It is important now and it will be important with the new offence in place that medical advice does not suggest to patients that they drive when doing so would present a significant risk to themselves and the public To do so risks patients being involved in road traffic incidents and also committing the existing offence of driving whilst impaired due to drugs

3) Different to Drink Driving Law

There have been calls for a strict liability approach to drug driving as exists for drink

driving Napp believes this would not be a suitable approach for drug driving based on the

current draft Bill

Alcohol does not have any medical necessity people do not need to consume

alcohol to ensure that a chronic condition does not prevent them from

functioning on a daily basis

Prescription medications that patients may take to treat chronic pain are a

medical necessity and are essential to ensuring that they are able to function on a

daily basis

A strict liability approach could lead to patients not taking essential medication in

order to be able to drive without fear of prosecution

Alternatively patients may choose not to drive at all which could have a serious

impact on their ability to work and go about their daily lives

Questions Is an exemption feasible (If not what is going to be done to ensure that patients are protected)

There are some useful analogies with drink driving law For example prior to the introduction of the specific drink driving offence the law in relation to drink drivers was difficult to enforce The specific offence there has contributed to major improvements in public safety

I do accept one of the differences with some controlled drugs is that some people take them for medicinal not recreational purposes This is not the case for all controlled drugs This may well affect what is included in the regulations for the offence

25

When we met I did say that it is conceivable for even as prevalent a recreational drug as heroin to not be included in the regulations for the offence This might be if it transpired that a limit relevant to heroin had to be set in a metabolite itself used in or a metabolite of a medically prescribed drug If such a limit also then had the effect of criminalising driving with medically supplied controlled drugs when that did not present an elevated risk to public safety I can see it would be a limit we might well not implement However I await the advice of the expert panel to see what it recommends related to heroin and whether (and how) that might affect other opiates

4) Policeable Offence

It is argued that drivers wonrsquot be stopped by police unless they appear impaired BUT

Plans are to test all those involved in a traffic accident for drugs including

innocent parties An innocent unimpaired patient involved in a crash through no

fault of their own could then face serious charges

Impairment is subjective and police may be suspicious of someonersquos driving for a

number of reasons such as driving too cautiously This apparently lsquoimpairedrsquo

driving may be due to various factors unrelated to the driverrsquos use of prescribed

medication but if they are stopped by police they may find themselves facing

serious and unjust charges

The existing impairment offence will remain so police will still be able to catch

those who do drive while impaired by prescription medication

Questions How close is the Home Office to approval of a drug testing device for use in police stations Can you provide any details

The laboratory testing phases of the type approval process is under way and the process is due to be completed at the end of this year

Is the Home Office still aiming for a 2014 approval of a drug testing device for portable use

It is still aiming for 2014 for these devices and we are planning the timing of that process together with the work on the new offence

Since the Governmentrsquos response to the North Review in June 2010 has the drug driving data quality improved

Yes we have received more information from Coroners recently and we also have had the conclusions of the European DRUID research

C Solutions

Napp believes that the best way to protect patients is by introducing an exemption for

those who can demonstrate that they are taking prescription medication

Existing legislation against driving while impaired would allow police to charge

anyone who did drive while under the influence of impairing prescription

medication

26

This would put the burden of proof on prosecutors saving innocent patients

considerable stress inconvenience and wasted CPS and police time

The Department considers that the statutory defence affords appropriate protection to patients who drive after taking prescription medication

The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

D Other Points for Consideration

Napp is keen to support this legislation in its efforts to stop users of illegal drugs

from driving and wishes to support policy development to ensure that patients are

protected Napp would be keen to provide any further information or other

means of assistance that could be of help here

Napp would like to submit written andor oral evidence to the Expert Panelrsquos

inquiry

Napp is concerned about the lack of pain expertise and patient representatives on

the Expert panel

Lord Henley mentioned that a seminar might be held after the summer recess to

discuss the issues arising from this legislation further Napp would be keen to

receive any further information on this

I hope this has been covered satisfactorily in the discussion we had on 31st July and since then

I do consider the legislation has strong safeguards in place for patients The Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

I hope I have addressed at least some of your concerns I should be happy to discuss the issues further

Duncan Price 2882012

27

Note on controlled drugs with medical uses

(i) The reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

(ii) Circumstances in which drug testing can be administered Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under the

influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

(iii) The medical defence The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

(iv) Drugs to be covered by the new offence and any specified limits to be based on expert advice The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

(v) Other controls The content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

(vi) Prosecutions to be in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

(vii) In light of the above the Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

28

From DuncanPricedftgsigovuk Sent 13092012 1603 To xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Cc xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Subject RE NRAS - Crime and Courts Bill clauses on drug driving

Xxxxxx

Below is my draft response to this letter Irsquoll send it when I have your comments about it

Dear xx xxxxxxx

Xxxxxx xxxxxxxx has forwarded your email of 28th August to me I am the lead policy official for the legislative clause about drug impaired driving in the Crime and Courts Bill

I am aware of concerns about innocent motorists taking prescribed medications being stopped tested being taken to police stations having blood samples taken and possibly going to court before being exonerated This is not the intention of the legislation and I can assure you we are mindful of this concern as we progress the legislation and respond to advice from an expert panel about the details

There are several protections in place to reduce the risk of large numbers of innocent motorists being arrested and taken to police stations

Firstly motorists cannot be stopped randomly for drug tests Testing can only be administered in three circumstances ndash namely where a driver has committed a moving traffic offence

a driver has been involved in a road traffic accident and or

there is reason for a police officer to suspect that a person has been driving under the influence of drink or drugs

This means that in practice drivers taking prescribed medicines would not be stopped and required to undergo drug testing without there being real cause for concern Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would be likely to result in disproportionate and large numbers of people prescribed drugs having evidential blood tests but then not being found guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

Fourthly it is important to emphasise that the prosecution for a case where the medical defence has been raised must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code for Crown Prosecutors which contains a requirement about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

Finally in the context of the clause before parliament the content of the regulations (specifying which controlled drugs should be covered by the new offence and the limits to be specified for them) will be the subject of public consultation Before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of

29

Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

I hope that this letter serves to allay concerns about possible unintended consequences for people taking prescription medicines

Duncan Price Tel 020 7944 xxxx Department for Transport

From JessicaMatthewdftgsigovuk Sent 17 October 2012 1108 To xxxxxxxxxxxxadhgsigovuk Cc xxxxxxxxxxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxxxxxdhgsigovuk xxxxxxxxdhgsigovuk Subject Re Department of Health attendance at the Lords briefing for the drug driving legislation

Xxxxxxxx is out of the office today but wersquoll send over the time and venue tomorrow and share the briefing with you Irsquod be happy to brief Dr Prunty beforehand ndash perhaps over the phone

Wersquore planning on a reasonably open debate about the legislation We wonrsquot have got policy clearance on the amendments to the legislation but wersquore inclined to say that the Government is minded to or is considering x y or z

Happy to discuss

Jessica Matthew Deputy Director Road User Licensing Insurance and Safety Tel 020 7944 xxxx Zone 321 Great Minster House 76 Marsham Street London SW1P 4DR

Extract of Briefing shared with DH from the above e-mail

How will you make sure that people taking medication in accordance with their prescription arenrsquot arrested and taken to court as a result of this legislation

The medical defence in the provisions provides substantial and appropriate protection for people taking medically prescribed or supplied controlled drugs It places an evidential burden on a person accused of committing the offence So the accused must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court It is then for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on

It is unlikely that a person taking medication in accordance with their prescription would be taken to court for a number of reasons

30

1 Motorists cannot be stopped randomly for drug tests They can only be tested where They have committed a moving traffic offence They have been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under

the influence of drink or drugs

2 The drugs to be included in the legislation and their limits will be set in regulations The content of the regulations will be the subject of public consultation and an affirmative resolution This will provide an opportunity for any concerns with the proposed specified limits to be raised and carefully considered

3 The expert panel is bearing in mind the normal therapeutic ranges and expected drug concentrations in blood when setting limits for those drugs that may also be used for medicinal purposes This means that only patients on unusually high doses of medication might have a positive screening and proceed to evidential blood test

4 Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any cases before they reach the court Indeed there is a Code for Crown Prosecutors which contains a requirement that prosecutions are in the public interest

From xxxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 29 November 2012 1422 To xxxxxxxdhgsigovuk xxxxxxxxxpsncorguk xxxxxxxxxxxxxtheccaorguk xxxxxxxxxxnpacouk xxxxxxxxxxxxrpharmscom xxxxxxxxxxxsaddactionorguk xxxxxroadsafecom xxxxxxxxxxxxxxxxxxsdrconsortiumorg xxxm-allianceorguk xxxxxxxxxxxturning-pointcouk xxxxxxxxROSPAcom xxxxxxxxxxxxxxxxtheAAcom xxxxxxxxxacpopnnpoliceuk adminactionaddictionorguk xxxxxxxxxageukorguk xxxxxxxxxxxbrakeorguk xxxxxxxxbmaorguk xxxxxxxxxxxbritishpainsocietyorg xxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxcpsgsigovuk xxxxxxxxdrugscopeorguk xxxxxxxxxiamorguk xxxxxxxxxxxxxxlawsocietyorguk xxxxxxxxxxxliberty-human-rightsorguk xxxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxxpactsorguk xxxxxxxxxxparliamentuk xxxxxxxxxxxxRACFoundationorg xxxxxxxxxxdurhamgovuk xxxxxxxxxxxxxxxxPolicyConnectorguk xxxxxxxxxxxxxxpsncorguk xxxxxxxxxxxxxdvlagsigovuk Xxxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxhomeofficegsigovuk xxxxxxxxnpacouk xxxxxxxxxxxxdhgsigovuk xxxxxxxxxdrugscopeorguk Cc xxxxxxxxxxxxxxxxxxxdftgsigovuk JessicaMatthewdftgsigovuk xxxxxxxxxxxxxxxxxxdftgsigovuk Subject Drug driving seminar presentation

Dear all

Many thanks to those of you who were able to attend our Drug Driving Stakeholder Seminar last week

We hope you found as useful as we did

Please find attached a copy of the presentation as promised

Kind regards

Xxxxxx xxxxxxx

31

We are therefore using the definition of lsquocontrolled drugrsquo in the Misuse of Drugs Act 1971 within the new offence although which controlled drugs will be determined when regulations are brought forward

What consideration have you given to the issue of patients who drive unimpaired but will

still face prosecution if tested as levels of metabolites in their system may be above any

prescribed limit

This is being considered in both the terms of reference for the technical panelrsquos advice about the setting of specified limits (to keep patients out of the scope of the offence) and the inclusion of the medical defence within the offence

The panel has also been asked to consider the degree of variability in impairment effects across the population including for habitual drug users

In the terms of reference for the panel we have also specifically included the following from the North review (paragraph 743)

ldquoSome drugs which may be proscribed for driving might also be used legitimately in accordance with medical advice (for example morphine may be prescribed for chronic pain or diazepam (a benzodiazepine) may be prescribed for anxiety) Indeed the Review recognises that in some circumstances it may be more dangerous for a person to drive having not taken their medically prescribed drug than driving without having taken it Drugs have different effects on different people and levels at which they are prescribed are likely to reflect this It would clearly be wrong to put in jeopardy of prosecution those who are properly and safely taking medically prescribed drugs and driving in accordance with medical advice for whom despite the presence of a proscribed drug there is no evidence of any driving impairmentrdquo

I should also emphasise that the content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

2) Criminalisation of Patients

Statutory defence is included in the current legislation for those who have taken

prescription medication in accordance with prescribersupplier instructions and any

accompanying instructions from the manufacturer BUT

Only applicable after patient has been arrested further tested and their case has

progressed ndash this will cause innocent patients significant stress and

inconvenience

The defence puts the burden of proof on patients to prove that they acted in

accordance with all medical advice when the burden should be on the

prosecution to prove that they didnrsquot

23

Innocent patients may face criminalisation based on a technicality in legislation

that is not intended to target them

Questions

Is an exemption feasible (If not what is going to be done to ensure that patients are

protected)

I do not consider an exemption from the offence for all controlled drugs that can possibly be supplied or used for medical reasons is feasible Many controlled drugs for example cannabis have some medicinal uses

It is perfectly feasible for decisions about which controlled drugs would be specified for the new offence to be influenced by the reasons for whether their use is often always seldom or never for medical reasons Indeed such distinctions would be vital if this legislation were being introduced to enforce further against the illegal supply or use of controlled drugs

Whether that is the right approach to decision-making related to driving with controlled drugs in the body where there are levels associated with elevated risks to public safety is however questionable This legislation is being introduced to address road safety problems and the expert panelrsquos terms of reference are focussed on providing advice about the risks of driving after taking controlled drugs

It is to no-onesrsquo benefit for patients who are innocent of the offence to be arrested and tested There are several protections in place to reduce these risks Firstly police do not have random testing powers for drink and drug driving Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving

under the influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would result in disproportionate and large numbers of patients having evidential blood tests but then being not guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

24

It is important to note that the prosecution for a case where a defence has been raised that a patient had taken a controlled drug in accordance with medical advice must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code Test about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

It is important now and it will be important with the new offence in place that medical advice does not suggest to patients that they drive when doing so would present a significant risk to themselves and the public To do so risks patients being involved in road traffic incidents and also committing the existing offence of driving whilst impaired due to drugs

3) Different to Drink Driving Law

There have been calls for a strict liability approach to drug driving as exists for drink

driving Napp believes this would not be a suitable approach for drug driving based on the

current draft Bill

Alcohol does not have any medical necessity people do not need to consume

alcohol to ensure that a chronic condition does not prevent them from

functioning on a daily basis

Prescription medications that patients may take to treat chronic pain are a

medical necessity and are essential to ensuring that they are able to function on a

daily basis

A strict liability approach could lead to patients not taking essential medication in

order to be able to drive without fear of prosecution

Alternatively patients may choose not to drive at all which could have a serious

impact on their ability to work and go about their daily lives

Questions Is an exemption feasible (If not what is going to be done to ensure that patients are protected)

There are some useful analogies with drink driving law For example prior to the introduction of the specific drink driving offence the law in relation to drink drivers was difficult to enforce The specific offence there has contributed to major improvements in public safety

I do accept one of the differences with some controlled drugs is that some people take them for medicinal not recreational purposes This is not the case for all controlled drugs This may well affect what is included in the regulations for the offence

25

When we met I did say that it is conceivable for even as prevalent a recreational drug as heroin to not be included in the regulations for the offence This might be if it transpired that a limit relevant to heroin had to be set in a metabolite itself used in or a metabolite of a medically prescribed drug If such a limit also then had the effect of criminalising driving with medically supplied controlled drugs when that did not present an elevated risk to public safety I can see it would be a limit we might well not implement However I await the advice of the expert panel to see what it recommends related to heroin and whether (and how) that might affect other opiates

4) Policeable Offence

It is argued that drivers wonrsquot be stopped by police unless they appear impaired BUT

Plans are to test all those involved in a traffic accident for drugs including

innocent parties An innocent unimpaired patient involved in a crash through no

fault of their own could then face serious charges

Impairment is subjective and police may be suspicious of someonersquos driving for a

number of reasons such as driving too cautiously This apparently lsquoimpairedrsquo

driving may be due to various factors unrelated to the driverrsquos use of prescribed

medication but if they are stopped by police they may find themselves facing

serious and unjust charges

The existing impairment offence will remain so police will still be able to catch

those who do drive while impaired by prescription medication

Questions How close is the Home Office to approval of a drug testing device for use in police stations Can you provide any details

The laboratory testing phases of the type approval process is under way and the process is due to be completed at the end of this year

Is the Home Office still aiming for a 2014 approval of a drug testing device for portable use

It is still aiming for 2014 for these devices and we are planning the timing of that process together with the work on the new offence

Since the Governmentrsquos response to the North Review in June 2010 has the drug driving data quality improved

Yes we have received more information from Coroners recently and we also have had the conclusions of the European DRUID research

C Solutions

Napp believes that the best way to protect patients is by introducing an exemption for

those who can demonstrate that they are taking prescription medication

Existing legislation against driving while impaired would allow police to charge

anyone who did drive while under the influence of impairing prescription

medication

26

This would put the burden of proof on prosecutors saving innocent patients

considerable stress inconvenience and wasted CPS and police time

The Department considers that the statutory defence affords appropriate protection to patients who drive after taking prescription medication

The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

D Other Points for Consideration

Napp is keen to support this legislation in its efforts to stop users of illegal drugs

from driving and wishes to support policy development to ensure that patients are

protected Napp would be keen to provide any further information or other

means of assistance that could be of help here

Napp would like to submit written andor oral evidence to the Expert Panelrsquos

inquiry

Napp is concerned about the lack of pain expertise and patient representatives on

the Expert panel

Lord Henley mentioned that a seminar might be held after the summer recess to

discuss the issues arising from this legislation further Napp would be keen to

receive any further information on this

I hope this has been covered satisfactorily in the discussion we had on 31st July and since then

I do consider the legislation has strong safeguards in place for patients The Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

I hope I have addressed at least some of your concerns I should be happy to discuss the issues further

Duncan Price 2882012

27

Note on controlled drugs with medical uses

(i) The reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

(ii) Circumstances in which drug testing can be administered Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under the

influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

(iii) The medical defence The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

(iv) Drugs to be covered by the new offence and any specified limits to be based on expert advice The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

(v) Other controls The content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

(vi) Prosecutions to be in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

(vii) In light of the above the Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

28

From DuncanPricedftgsigovuk Sent 13092012 1603 To xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Cc xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Subject RE NRAS - Crime and Courts Bill clauses on drug driving

Xxxxxx

Below is my draft response to this letter Irsquoll send it when I have your comments about it

Dear xx xxxxxxx

Xxxxxx xxxxxxxx has forwarded your email of 28th August to me I am the lead policy official for the legislative clause about drug impaired driving in the Crime and Courts Bill

I am aware of concerns about innocent motorists taking prescribed medications being stopped tested being taken to police stations having blood samples taken and possibly going to court before being exonerated This is not the intention of the legislation and I can assure you we are mindful of this concern as we progress the legislation and respond to advice from an expert panel about the details

There are several protections in place to reduce the risk of large numbers of innocent motorists being arrested and taken to police stations

Firstly motorists cannot be stopped randomly for drug tests Testing can only be administered in three circumstances ndash namely where a driver has committed a moving traffic offence

a driver has been involved in a road traffic accident and or

there is reason for a police officer to suspect that a person has been driving under the influence of drink or drugs

This means that in practice drivers taking prescribed medicines would not be stopped and required to undergo drug testing without there being real cause for concern Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would be likely to result in disproportionate and large numbers of people prescribed drugs having evidential blood tests but then not being found guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

Fourthly it is important to emphasise that the prosecution for a case where the medical defence has been raised must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code for Crown Prosecutors which contains a requirement about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

Finally in the context of the clause before parliament the content of the regulations (specifying which controlled drugs should be covered by the new offence and the limits to be specified for them) will be the subject of public consultation Before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of

29

Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

I hope that this letter serves to allay concerns about possible unintended consequences for people taking prescription medicines

Duncan Price Tel 020 7944 xxxx Department for Transport

From JessicaMatthewdftgsigovuk Sent 17 October 2012 1108 To xxxxxxxxxxxxadhgsigovuk Cc xxxxxxxxxxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxxxxxdhgsigovuk xxxxxxxxdhgsigovuk Subject Re Department of Health attendance at the Lords briefing for the drug driving legislation

Xxxxxxxx is out of the office today but wersquoll send over the time and venue tomorrow and share the briefing with you Irsquod be happy to brief Dr Prunty beforehand ndash perhaps over the phone

Wersquore planning on a reasonably open debate about the legislation We wonrsquot have got policy clearance on the amendments to the legislation but wersquore inclined to say that the Government is minded to or is considering x y or z

Happy to discuss

Jessica Matthew Deputy Director Road User Licensing Insurance and Safety Tel 020 7944 xxxx Zone 321 Great Minster House 76 Marsham Street London SW1P 4DR

Extract of Briefing shared with DH from the above e-mail

How will you make sure that people taking medication in accordance with their prescription arenrsquot arrested and taken to court as a result of this legislation

The medical defence in the provisions provides substantial and appropriate protection for people taking medically prescribed or supplied controlled drugs It places an evidential burden on a person accused of committing the offence So the accused must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court It is then for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on

It is unlikely that a person taking medication in accordance with their prescription would be taken to court for a number of reasons

30

1 Motorists cannot be stopped randomly for drug tests They can only be tested where They have committed a moving traffic offence They have been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under

the influence of drink or drugs

2 The drugs to be included in the legislation and their limits will be set in regulations The content of the regulations will be the subject of public consultation and an affirmative resolution This will provide an opportunity for any concerns with the proposed specified limits to be raised and carefully considered

3 The expert panel is bearing in mind the normal therapeutic ranges and expected drug concentrations in blood when setting limits for those drugs that may also be used for medicinal purposes This means that only patients on unusually high doses of medication might have a positive screening and proceed to evidential blood test

4 Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any cases before they reach the court Indeed there is a Code for Crown Prosecutors which contains a requirement that prosecutions are in the public interest

From xxxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 29 November 2012 1422 To xxxxxxxdhgsigovuk xxxxxxxxxpsncorguk xxxxxxxxxxxxxtheccaorguk xxxxxxxxxxnpacouk xxxxxxxxxxxxrpharmscom xxxxxxxxxxxsaddactionorguk xxxxxroadsafecom xxxxxxxxxxxxxxxxxxsdrconsortiumorg xxxm-allianceorguk xxxxxxxxxxxturning-pointcouk xxxxxxxxROSPAcom xxxxxxxxxxxxxxxxtheAAcom xxxxxxxxxacpopnnpoliceuk adminactionaddictionorguk xxxxxxxxxageukorguk xxxxxxxxxxxbrakeorguk xxxxxxxxbmaorguk xxxxxxxxxxxbritishpainsocietyorg xxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxcpsgsigovuk xxxxxxxxdrugscopeorguk xxxxxxxxxiamorguk xxxxxxxxxxxxxxlawsocietyorguk xxxxxxxxxxxliberty-human-rightsorguk xxxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxxpactsorguk xxxxxxxxxxparliamentuk xxxxxxxxxxxxRACFoundationorg xxxxxxxxxxdurhamgovuk xxxxxxxxxxxxxxxxPolicyConnectorguk xxxxxxxxxxxxxxpsncorguk xxxxxxxxxxxxxdvlagsigovuk Xxxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxhomeofficegsigovuk xxxxxxxxnpacouk xxxxxxxxxxxxdhgsigovuk xxxxxxxxxdrugscopeorguk Cc xxxxxxxxxxxxxxxxxxxdftgsigovuk JessicaMatthewdftgsigovuk xxxxxxxxxxxxxxxxxxdftgsigovuk Subject Drug driving seminar presentation

Dear all

Many thanks to those of you who were able to attend our Drug Driving Stakeholder Seminar last week

We hope you found as useful as we did

Please find attached a copy of the presentation as promised

Kind regards

Xxxxxx xxxxxxx

31

Innocent patients may face criminalisation based on a technicality in legislation

that is not intended to target them

Questions

Is an exemption feasible (If not what is going to be done to ensure that patients are

protected)

I do not consider an exemption from the offence for all controlled drugs that can possibly be supplied or used for medical reasons is feasible Many controlled drugs for example cannabis have some medicinal uses

It is perfectly feasible for decisions about which controlled drugs would be specified for the new offence to be influenced by the reasons for whether their use is often always seldom or never for medical reasons Indeed such distinctions would be vital if this legislation were being introduced to enforce further against the illegal supply or use of controlled drugs

Whether that is the right approach to decision-making related to driving with controlled drugs in the body where there are levels associated with elevated risks to public safety is however questionable This legislation is being introduced to address road safety problems and the expert panelrsquos terms of reference are focussed on providing advice about the risks of driving after taking controlled drugs

It is to no-onesrsquo benefit for patients who are innocent of the offence to be arrested and tested There are several protections in place to reduce these risks Firstly police do not have random testing powers for drink and drug driving Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving

under the influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would result in disproportionate and large numbers of patients having evidential blood tests but then being not guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

24

It is important to note that the prosecution for a case where a defence has been raised that a patient had taken a controlled drug in accordance with medical advice must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code Test about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

It is important now and it will be important with the new offence in place that medical advice does not suggest to patients that they drive when doing so would present a significant risk to themselves and the public To do so risks patients being involved in road traffic incidents and also committing the existing offence of driving whilst impaired due to drugs

3) Different to Drink Driving Law

There have been calls for a strict liability approach to drug driving as exists for drink

driving Napp believes this would not be a suitable approach for drug driving based on the

current draft Bill

Alcohol does not have any medical necessity people do not need to consume

alcohol to ensure that a chronic condition does not prevent them from

functioning on a daily basis

Prescription medications that patients may take to treat chronic pain are a

medical necessity and are essential to ensuring that they are able to function on a

daily basis

A strict liability approach could lead to patients not taking essential medication in

order to be able to drive without fear of prosecution

Alternatively patients may choose not to drive at all which could have a serious

impact on their ability to work and go about their daily lives

Questions Is an exemption feasible (If not what is going to be done to ensure that patients are protected)

There are some useful analogies with drink driving law For example prior to the introduction of the specific drink driving offence the law in relation to drink drivers was difficult to enforce The specific offence there has contributed to major improvements in public safety

I do accept one of the differences with some controlled drugs is that some people take them for medicinal not recreational purposes This is not the case for all controlled drugs This may well affect what is included in the regulations for the offence

25

When we met I did say that it is conceivable for even as prevalent a recreational drug as heroin to not be included in the regulations for the offence This might be if it transpired that a limit relevant to heroin had to be set in a metabolite itself used in or a metabolite of a medically prescribed drug If such a limit also then had the effect of criminalising driving with medically supplied controlled drugs when that did not present an elevated risk to public safety I can see it would be a limit we might well not implement However I await the advice of the expert panel to see what it recommends related to heroin and whether (and how) that might affect other opiates

4) Policeable Offence

It is argued that drivers wonrsquot be stopped by police unless they appear impaired BUT

Plans are to test all those involved in a traffic accident for drugs including

innocent parties An innocent unimpaired patient involved in a crash through no

fault of their own could then face serious charges

Impairment is subjective and police may be suspicious of someonersquos driving for a

number of reasons such as driving too cautiously This apparently lsquoimpairedrsquo

driving may be due to various factors unrelated to the driverrsquos use of prescribed

medication but if they are stopped by police they may find themselves facing

serious and unjust charges

The existing impairment offence will remain so police will still be able to catch

those who do drive while impaired by prescription medication

Questions How close is the Home Office to approval of a drug testing device for use in police stations Can you provide any details

The laboratory testing phases of the type approval process is under way and the process is due to be completed at the end of this year

Is the Home Office still aiming for a 2014 approval of a drug testing device for portable use

It is still aiming for 2014 for these devices and we are planning the timing of that process together with the work on the new offence

Since the Governmentrsquos response to the North Review in June 2010 has the drug driving data quality improved

Yes we have received more information from Coroners recently and we also have had the conclusions of the European DRUID research

C Solutions

Napp believes that the best way to protect patients is by introducing an exemption for

those who can demonstrate that they are taking prescription medication

Existing legislation against driving while impaired would allow police to charge

anyone who did drive while under the influence of impairing prescription

medication

26

This would put the burden of proof on prosecutors saving innocent patients

considerable stress inconvenience and wasted CPS and police time

The Department considers that the statutory defence affords appropriate protection to patients who drive after taking prescription medication

The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

D Other Points for Consideration

Napp is keen to support this legislation in its efforts to stop users of illegal drugs

from driving and wishes to support policy development to ensure that patients are

protected Napp would be keen to provide any further information or other

means of assistance that could be of help here

Napp would like to submit written andor oral evidence to the Expert Panelrsquos

inquiry

Napp is concerned about the lack of pain expertise and patient representatives on

the Expert panel

Lord Henley mentioned that a seminar might be held after the summer recess to

discuss the issues arising from this legislation further Napp would be keen to

receive any further information on this

I hope this has been covered satisfactorily in the discussion we had on 31st July and since then

I do consider the legislation has strong safeguards in place for patients The Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

I hope I have addressed at least some of your concerns I should be happy to discuss the issues further

Duncan Price 2882012

27

Note on controlled drugs with medical uses

(i) The reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

(ii) Circumstances in which drug testing can be administered Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under the

influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

(iii) The medical defence The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

(iv) Drugs to be covered by the new offence and any specified limits to be based on expert advice The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

(v) Other controls The content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

(vi) Prosecutions to be in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

(vii) In light of the above the Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

28

From DuncanPricedftgsigovuk Sent 13092012 1603 To xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Cc xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Subject RE NRAS - Crime and Courts Bill clauses on drug driving

Xxxxxx

Below is my draft response to this letter Irsquoll send it when I have your comments about it

Dear xx xxxxxxx

Xxxxxx xxxxxxxx has forwarded your email of 28th August to me I am the lead policy official for the legislative clause about drug impaired driving in the Crime and Courts Bill

I am aware of concerns about innocent motorists taking prescribed medications being stopped tested being taken to police stations having blood samples taken and possibly going to court before being exonerated This is not the intention of the legislation and I can assure you we are mindful of this concern as we progress the legislation and respond to advice from an expert panel about the details

There are several protections in place to reduce the risk of large numbers of innocent motorists being arrested and taken to police stations

Firstly motorists cannot be stopped randomly for drug tests Testing can only be administered in three circumstances ndash namely where a driver has committed a moving traffic offence

a driver has been involved in a road traffic accident and or

there is reason for a police officer to suspect that a person has been driving under the influence of drink or drugs

This means that in practice drivers taking prescribed medicines would not be stopped and required to undergo drug testing without there being real cause for concern Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would be likely to result in disproportionate and large numbers of people prescribed drugs having evidential blood tests but then not being found guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

Fourthly it is important to emphasise that the prosecution for a case where the medical defence has been raised must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code for Crown Prosecutors which contains a requirement about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

Finally in the context of the clause before parliament the content of the regulations (specifying which controlled drugs should be covered by the new offence and the limits to be specified for them) will be the subject of public consultation Before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of

29

Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

I hope that this letter serves to allay concerns about possible unintended consequences for people taking prescription medicines

Duncan Price Tel 020 7944 xxxx Department for Transport

From JessicaMatthewdftgsigovuk Sent 17 October 2012 1108 To xxxxxxxxxxxxadhgsigovuk Cc xxxxxxxxxxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxxxxxdhgsigovuk xxxxxxxxdhgsigovuk Subject Re Department of Health attendance at the Lords briefing for the drug driving legislation

Xxxxxxxx is out of the office today but wersquoll send over the time and venue tomorrow and share the briefing with you Irsquod be happy to brief Dr Prunty beforehand ndash perhaps over the phone

Wersquore planning on a reasonably open debate about the legislation We wonrsquot have got policy clearance on the amendments to the legislation but wersquore inclined to say that the Government is minded to or is considering x y or z

Happy to discuss

Jessica Matthew Deputy Director Road User Licensing Insurance and Safety Tel 020 7944 xxxx Zone 321 Great Minster House 76 Marsham Street London SW1P 4DR

Extract of Briefing shared with DH from the above e-mail

How will you make sure that people taking medication in accordance with their prescription arenrsquot arrested and taken to court as a result of this legislation

The medical defence in the provisions provides substantial and appropriate protection for people taking medically prescribed or supplied controlled drugs It places an evidential burden on a person accused of committing the offence So the accused must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court It is then for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on

It is unlikely that a person taking medication in accordance with their prescription would be taken to court for a number of reasons

30

1 Motorists cannot be stopped randomly for drug tests They can only be tested where They have committed a moving traffic offence They have been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under

the influence of drink or drugs

2 The drugs to be included in the legislation and their limits will be set in regulations The content of the regulations will be the subject of public consultation and an affirmative resolution This will provide an opportunity for any concerns with the proposed specified limits to be raised and carefully considered

3 The expert panel is bearing in mind the normal therapeutic ranges and expected drug concentrations in blood when setting limits for those drugs that may also be used for medicinal purposes This means that only patients on unusually high doses of medication might have a positive screening and proceed to evidential blood test

4 Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any cases before they reach the court Indeed there is a Code for Crown Prosecutors which contains a requirement that prosecutions are in the public interest

From xxxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 29 November 2012 1422 To xxxxxxxdhgsigovuk xxxxxxxxxpsncorguk xxxxxxxxxxxxxtheccaorguk xxxxxxxxxxnpacouk xxxxxxxxxxxxrpharmscom xxxxxxxxxxxsaddactionorguk xxxxxroadsafecom xxxxxxxxxxxxxxxxxxsdrconsortiumorg xxxm-allianceorguk xxxxxxxxxxxturning-pointcouk xxxxxxxxROSPAcom xxxxxxxxxxxxxxxxtheAAcom xxxxxxxxxacpopnnpoliceuk adminactionaddictionorguk xxxxxxxxxageukorguk xxxxxxxxxxxbrakeorguk xxxxxxxxbmaorguk xxxxxxxxxxxbritishpainsocietyorg xxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxcpsgsigovuk xxxxxxxxdrugscopeorguk xxxxxxxxxiamorguk xxxxxxxxxxxxxxlawsocietyorguk xxxxxxxxxxxliberty-human-rightsorguk xxxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxxpactsorguk xxxxxxxxxxparliamentuk xxxxxxxxxxxxRACFoundationorg xxxxxxxxxxdurhamgovuk xxxxxxxxxxxxxxxxPolicyConnectorguk xxxxxxxxxxxxxxpsncorguk xxxxxxxxxxxxxdvlagsigovuk Xxxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxhomeofficegsigovuk xxxxxxxxnpacouk xxxxxxxxxxxxdhgsigovuk xxxxxxxxxdrugscopeorguk Cc xxxxxxxxxxxxxxxxxxxdftgsigovuk JessicaMatthewdftgsigovuk xxxxxxxxxxxxxxxxxxdftgsigovuk Subject Drug driving seminar presentation

Dear all

Many thanks to those of you who were able to attend our Drug Driving Stakeholder Seminar last week

We hope you found as useful as we did

Please find attached a copy of the presentation as promised

Kind regards

Xxxxxx xxxxxxx

31

It is important to note that the prosecution for a case where a defence has been raised that a patient had taken a controlled drug in accordance with medical advice must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code Test about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

It is important now and it will be important with the new offence in place that medical advice does not suggest to patients that they drive when doing so would present a significant risk to themselves and the public To do so risks patients being involved in road traffic incidents and also committing the existing offence of driving whilst impaired due to drugs

3) Different to Drink Driving Law

There have been calls for a strict liability approach to drug driving as exists for drink

driving Napp believes this would not be a suitable approach for drug driving based on the

current draft Bill

Alcohol does not have any medical necessity people do not need to consume

alcohol to ensure that a chronic condition does not prevent them from

functioning on a daily basis

Prescription medications that patients may take to treat chronic pain are a

medical necessity and are essential to ensuring that they are able to function on a

daily basis

A strict liability approach could lead to patients not taking essential medication in

order to be able to drive without fear of prosecution

Alternatively patients may choose not to drive at all which could have a serious

impact on their ability to work and go about their daily lives

Questions Is an exemption feasible (If not what is going to be done to ensure that patients are protected)

There are some useful analogies with drink driving law For example prior to the introduction of the specific drink driving offence the law in relation to drink drivers was difficult to enforce The specific offence there has contributed to major improvements in public safety

I do accept one of the differences with some controlled drugs is that some people take them for medicinal not recreational purposes This is not the case for all controlled drugs This may well affect what is included in the regulations for the offence

25

When we met I did say that it is conceivable for even as prevalent a recreational drug as heroin to not be included in the regulations for the offence This might be if it transpired that a limit relevant to heroin had to be set in a metabolite itself used in or a metabolite of a medically prescribed drug If such a limit also then had the effect of criminalising driving with medically supplied controlled drugs when that did not present an elevated risk to public safety I can see it would be a limit we might well not implement However I await the advice of the expert panel to see what it recommends related to heroin and whether (and how) that might affect other opiates

4) Policeable Offence

It is argued that drivers wonrsquot be stopped by police unless they appear impaired BUT

Plans are to test all those involved in a traffic accident for drugs including

innocent parties An innocent unimpaired patient involved in a crash through no

fault of their own could then face serious charges

Impairment is subjective and police may be suspicious of someonersquos driving for a

number of reasons such as driving too cautiously This apparently lsquoimpairedrsquo

driving may be due to various factors unrelated to the driverrsquos use of prescribed

medication but if they are stopped by police they may find themselves facing

serious and unjust charges

The existing impairment offence will remain so police will still be able to catch

those who do drive while impaired by prescription medication

Questions How close is the Home Office to approval of a drug testing device for use in police stations Can you provide any details

The laboratory testing phases of the type approval process is under way and the process is due to be completed at the end of this year

Is the Home Office still aiming for a 2014 approval of a drug testing device for portable use

It is still aiming for 2014 for these devices and we are planning the timing of that process together with the work on the new offence

Since the Governmentrsquos response to the North Review in June 2010 has the drug driving data quality improved

Yes we have received more information from Coroners recently and we also have had the conclusions of the European DRUID research

C Solutions

Napp believes that the best way to protect patients is by introducing an exemption for

those who can demonstrate that they are taking prescription medication

Existing legislation against driving while impaired would allow police to charge

anyone who did drive while under the influence of impairing prescription

medication

26

This would put the burden of proof on prosecutors saving innocent patients

considerable stress inconvenience and wasted CPS and police time

The Department considers that the statutory defence affords appropriate protection to patients who drive after taking prescription medication

The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

D Other Points for Consideration

Napp is keen to support this legislation in its efforts to stop users of illegal drugs

from driving and wishes to support policy development to ensure that patients are

protected Napp would be keen to provide any further information or other

means of assistance that could be of help here

Napp would like to submit written andor oral evidence to the Expert Panelrsquos

inquiry

Napp is concerned about the lack of pain expertise and patient representatives on

the Expert panel

Lord Henley mentioned that a seminar might be held after the summer recess to

discuss the issues arising from this legislation further Napp would be keen to

receive any further information on this

I hope this has been covered satisfactorily in the discussion we had on 31st July and since then

I do consider the legislation has strong safeguards in place for patients The Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

I hope I have addressed at least some of your concerns I should be happy to discuss the issues further

Duncan Price 2882012

27

Note on controlled drugs with medical uses

(i) The reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

(ii) Circumstances in which drug testing can be administered Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under the

influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

(iii) The medical defence The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

(iv) Drugs to be covered by the new offence and any specified limits to be based on expert advice The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

(v) Other controls The content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

(vi) Prosecutions to be in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

(vii) In light of the above the Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

28

From DuncanPricedftgsigovuk Sent 13092012 1603 To xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Cc xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Subject RE NRAS - Crime and Courts Bill clauses on drug driving

Xxxxxx

Below is my draft response to this letter Irsquoll send it when I have your comments about it

Dear xx xxxxxxx

Xxxxxx xxxxxxxx has forwarded your email of 28th August to me I am the lead policy official for the legislative clause about drug impaired driving in the Crime and Courts Bill

I am aware of concerns about innocent motorists taking prescribed medications being stopped tested being taken to police stations having blood samples taken and possibly going to court before being exonerated This is not the intention of the legislation and I can assure you we are mindful of this concern as we progress the legislation and respond to advice from an expert panel about the details

There are several protections in place to reduce the risk of large numbers of innocent motorists being arrested and taken to police stations

Firstly motorists cannot be stopped randomly for drug tests Testing can only be administered in three circumstances ndash namely where a driver has committed a moving traffic offence

a driver has been involved in a road traffic accident and or

there is reason for a police officer to suspect that a person has been driving under the influence of drink or drugs

This means that in practice drivers taking prescribed medicines would not be stopped and required to undergo drug testing without there being real cause for concern Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would be likely to result in disproportionate and large numbers of people prescribed drugs having evidential blood tests but then not being found guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

Fourthly it is important to emphasise that the prosecution for a case where the medical defence has been raised must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code for Crown Prosecutors which contains a requirement about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

Finally in the context of the clause before parliament the content of the regulations (specifying which controlled drugs should be covered by the new offence and the limits to be specified for them) will be the subject of public consultation Before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of

29

Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

I hope that this letter serves to allay concerns about possible unintended consequences for people taking prescription medicines

Duncan Price Tel 020 7944 xxxx Department for Transport

From JessicaMatthewdftgsigovuk Sent 17 October 2012 1108 To xxxxxxxxxxxxadhgsigovuk Cc xxxxxxxxxxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxxxxxdhgsigovuk xxxxxxxxdhgsigovuk Subject Re Department of Health attendance at the Lords briefing for the drug driving legislation

Xxxxxxxx is out of the office today but wersquoll send over the time and venue tomorrow and share the briefing with you Irsquod be happy to brief Dr Prunty beforehand ndash perhaps over the phone

Wersquore planning on a reasonably open debate about the legislation We wonrsquot have got policy clearance on the amendments to the legislation but wersquore inclined to say that the Government is minded to or is considering x y or z

Happy to discuss

Jessica Matthew Deputy Director Road User Licensing Insurance and Safety Tel 020 7944 xxxx Zone 321 Great Minster House 76 Marsham Street London SW1P 4DR

Extract of Briefing shared with DH from the above e-mail

How will you make sure that people taking medication in accordance with their prescription arenrsquot arrested and taken to court as a result of this legislation

The medical defence in the provisions provides substantial and appropriate protection for people taking medically prescribed or supplied controlled drugs It places an evidential burden on a person accused of committing the offence So the accused must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court It is then for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on

It is unlikely that a person taking medication in accordance with their prescription would be taken to court for a number of reasons

30

1 Motorists cannot be stopped randomly for drug tests They can only be tested where They have committed a moving traffic offence They have been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under

the influence of drink or drugs

2 The drugs to be included in the legislation and their limits will be set in regulations The content of the regulations will be the subject of public consultation and an affirmative resolution This will provide an opportunity for any concerns with the proposed specified limits to be raised and carefully considered

3 The expert panel is bearing in mind the normal therapeutic ranges and expected drug concentrations in blood when setting limits for those drugs that may also be used for medicinal purposes This means that only patients on unusually high doses of medication might have a positive screening and proceed to evidential blood test

4 Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any cases before they reach the court Indeed there is a Code for Crown Prosecutors which contains a requirement that prosecutions are in the public interest

From xxxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 29 November 2012 1422 To xxxxxxxdhgsigovuk xxxxxxxxxpsncorguk xxxxxxxxxxxxxtheccaorguk xxxxxxxxxxnpacouk xxxxxxxxxxxxrpharmscom xxxxxxxxxxxsaddactionorguk xxxxxroadsafecom xxxxxxxxxxxxxxxxxxsdrconsortiumorg xxxm-allianceorguk xxxxxxxxxxxturning-pointcouk xxxxxxxxROSPAcom xxxxxxxxxxxxxxxxtheAAcom xxxxxxxxxacpopnnpoliceuk adminactionaddictionorguk xxxxxxxxxageukorguk xxxxxxxxxxxbrakeorguk xxxxxxxxbmaorguk xxxxxxxxxxxbritishpainsocietyorg xxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxcpsgsigovuk xxxxxxxxdrugscopeorguk xxxxxxxxxiamorguk xxxxxxxxxxxxxxlawsocietyorguk xxxxxxxxxxxliberty-human-rightsorguk xxxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxxpactsorguk xxxxxxxxxxparliamentuk xxxxxxxxxxxxRACFoundationorg xxxxxxxxxxdurhamgovuk xxxxxxxxxxxxxxxxPolicyConnectorguk xxxxxxxxxxxxxxpsncorguk xxxxxxxxxxxxxdvlagsigovuk Xxxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxhomeofficegsigovuk xxxxxxxxnpacouk xxxxxxxxxxxxdhgsigovuk xxxxxxxxxdrugscopeorguk Cc xxxxxxxxxxxxxxxxxxxdftgsigovuk JessicaMatthewdftgsigovuk xxxxxxxxxxxxxxxxxxdftgsigovuk Subject Drug driving seminar presentation

Dear all

Many thanks to those of you who were able to attend our Drug Driving Stakeholder Seminar last week

We hope you found as useful as we did

Please find attached a copy of the presentation as promised

Kind regards

Xxxxxx xxxxxxx

31

When we met I did say that it is conceivable for even as prevalent a recreational drug as heroin to not be included in the regulations for the offence This might be if it transpired that a limit relevant to heroin had to be set in a metabolite itself used in or a metabolite of a medically prescribed drug If such a limit also then had the effect of criminalising driving with medically supplied controlled drugs when that did not present an elevated risk to public safety I can see it would be a limit we might well not implement However I await the advice of the expert panel to see what it recommends related to heroin and whether (and how) that might affect other opiates

4) Policeable Offence

It is argued that drivers wonrsquot be stopped by police unless they appear impaired BUT

Plans are to test all those involved in a traffic accident for drugs including

innocent parties An innocent unimpaired patient involved in a crash through no

fault of their own could then face serious charges

Impairment is subjective and police may be suspicious of someonersquos driving for a

number of reasons such as driving too cautiously This apparently lsquoimpairedrsquo

driving may be due to various factors unrelated to the driverrsquos use of prescribed

medication but if they are stopped by police they may find themselves facing

serious and unjust charges

The existing impairment offence will remain so police will still be able to catch

those who do drive while impaired by prescription medication

Questions How close is the Home Office to approval of a drug testing device for use in police stations Can you provide any details

The laboratory testing phases of the type approval process is under way and the process is due to be completed at the end of this year

Is the Home Office still aiming for a 2014 approval of a drug testing device for portable use

It is still aiming for 2014 for these devices and we are planning the timing of that process together with the work on the new offence

Since the Governmentrsquos response to the North Review in June 2010 has the drug driving data quality improved

Yes we have received more information from Coroners recently and we also have had the conclusions of the European DRUID research

C Solutions

Napp believes that the best way to protect patients is by introducing an exemption for

those who can demonstrate that they are taking prescription medication

Existing legislation against driving while impaired would allow police to charge

anyone who did drive while under the influence of impairing prescription

medication

26

This would put the burden of proof on prosecutors saving innocent patients

considerable stress inconvenience and wasted CPS and police time

The Department considers that the statutory defence affords appropriate protection to patients who drive after taking prescription medication

The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

D Other Points for Consideration

Napp is keen to support this legislation in its efforts to stop users of illegal drugs

from driving and wishes to support policy development to ensure that patients are

protected Napp would be keen to provide any further information or other

means of assistance that could be of help here

Napp would like to submit written andor oral evidence to the Expert Panelrsquos

inquiry

Napp is concerned about the lack of pain expertise and patient representatives on

the Expert panel

Lord Henley mentioned that a seminar might be held after the summer recess to

discuss the issues arising from this legislation further Napp would be keen to

receive any further information on this

I hope this has been covered satisfactorily in the discussion we had on 31st July and since then

I do consider the legislation has strong safeguards in place for patients The Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

I hope I have addressed at least some of your concerns I should be happy to discuss the issues further

Duncan Price 2882012

27

Note on controlled drugs with medical uses

(i) The reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

(ii) Circumstances in which drug testing can be administered Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under the

influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

(iii) The medical defence The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

(iv) Drugs to be covered by the new offence and any specified limits to be based on expert advice The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

(v) Other controls The content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

(vi) Prosecutions to be in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

(vii) In light of the above the Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

28

From DuncanPricedftgsigovuk Sent 13092012 1603 To xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Cc xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Subject RE NRAS - Crime and Courts Bill clauses on drug driving

Xxxxxx

Below is my draft response to this letter Irsquoll send it when I have your comments about it

Dear xx xxxxxxx

Xxxxxx xxxxxxxx has forwarded your email of 28th August to me I am the lead policy official for the legislative clause about drug impaired driving in the Crime and Courts Bill

I am aware of concerns about innocent motorists taking prescribed medications being stopped tested being taken to police stations having blood samples taken and possibly going to court before being exonerated This is not the intention of the legislation and I can assure you we are mindful of this concern as we progress the legislation and respond to advice from an expert panel about the details

There are several protections in place to reduce the risk of large numbers of innocent motorists being arrested and taken to police stations

Firstly motorists cannot be stopped randomly for drug tests Testing can only be administered in three circumstances ndash namely where a driver has committed a moving traffic offence

a driver has been involved in a road traffic accident and or

there is reason for a police officer to suspect that a person has been driving under the influence of drink or drugs

This means that in practice drivers taking prescribed medicines would not be stopped and required to undergo drug testing without there being real cause for concern Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would be likely to result in disproportionate and large numbers of people prescribed drugs having evidential blood tests but then not being found guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

Fourthly it is important to emphasise that the prosecution for a case where the medical defence has been raised must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code for Crown Prosecutors which contains a requirement about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

Finally in the context of the clause before parliament the content of the regulations (specifying which controlled drugs should be covered by the new offence and the limits to be specified for them) will be the subject of public consultation Before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of

29

Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

I hope that this letter serves to allay concerns about possible unintended consequences for people taking prescription medicines

Duncan Price Tel 020 7944 xxxx Department for Transport

From JessicaMatthewdftgsigovuk Sent 17 October 2012 1108 To xxxxxxxxxxxxadhgsigovuk Cc xxxxxxxxxxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxxxxxdhgsigovuk xxxxxxxxdhgsigovuk Subject Re Department of Health attendance at the Lords briefing for the drug driving legislation

Xxxxxxxx is out of the office today but wersquoll send over the time and venue tomorrow and share the briefing with you Irsquod be happy to brief Dr Prunty beforehand ndash perhaps over the phone

Wersquore planning on a reasonably open debate about the legislation We wonrsquot have got policy clearance on the amendments to the legislation but wersquore inclined to say that the Government is minded to or is considering x y or z

Happy to discuss

Jessica Matthew Deputy Director Road User Licensing Insurance and Safety Tel 020 7944 xxxx Zone 321 Great Minster House 76 Marsham Street London SW1P 4DR

Extract of Briefing shared with DH from the above e-mail

How will you make sure that people taking medication in accordance with their prescription arenrsquot arrested and taken to court as a result of this legislation

The medical defence in the provisions provides substantial and appropriate protection for people taking medically prescribed or supplied controlled drugs It places an evidential burden on a person accused of committing the offence So the accused must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court It is then for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on

It is unlikely that a person taking medication in accordance with their prescription would be taken to court for a number of reasons

30

1 Motorists cannot be stopped randomly for drug tests They can only be tested where They have committed a moving traffic offence They have been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under

the influence of drink or drugs

2 The drugs to be included in the legislation and their limits will be set in regulations The content of the regulations will be the subject of public consultation and an affirmative resolution This will provide an opportunity for any concerns with the proposed specified limits to be raised and carefully considered

3 The expert panel is bearing in mind the normal therapeutic ranges and expected drug concentrations in blood when setting limits for those drugs that may also be used for medicinal purposes This means that only patients on unusually high doses of medication might have a positive screening and proceed to evidential blood test

4 Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any cases before they reach the court Indeed there is a Code for Crown Prosecutors which contains a requirement that prosecutions are in the public interest

From xxxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 29 November 2012 1422 To xxxxxxxdhgsigovuk xxxxxxxxxpsncorguk xxxxxxxxxxxxxtheccaorguk xxxxxxxxxxnpacouk xxxxxxxxxxxxrpharmscom xxxxxxxxxxxsaddactionorguk xxxxxroadsafecom xxxxxxxxxxxxxxxxxxsdrconsortiumorg xxxm-allianceorguk xxxxxxxxxxxturning-pointcouk xxxxxxxxROSPAcom xxxxxxxxxxxxxxxxtheAAcom xxxxxxxxxacpopnnpoliceuk adminactionaddictionorguk xxxxxxxxxageukorguk xxxxxxxxxxxbrakeorguk xxxxxxxxbmaorguk xxxxxxxxxxxbritishpainsocietyorg xxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxcpsgsigovuk xxxxxxxxdrugscopeorguk xxxxxxxxxiamorguk xxxxxxxxxxxxxxlawsocietyorguk xxxxxxxxxxxliberty-human-rightsorguk xxxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxxpactsorguk xxxxxxxxxxparliamentuk xxxxxxxxxxxxRACFoundationorg xxxxxxxxxxdurhamgovuk xxxxxxxxxxxxxxxxPolicyConnectorguk xxxxxxxxxxxxxxpsncorguk xxxxxxxxxxxxxdvlagsigovuk Xxxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxhomeofficegsigovuk xxxxxxxxnpacouk xxxxxxxxxxxxdhgsigovuk xxxxxxxxxdrugscopeorguk Cc xxxxxxxxxxxxxxxxxxxdftgsigovuk JessicaMatthewdftgsigovuk xxxxxxxxxxxxxxxxxxdftgsigovuk Subject Drug driving seminar presentation

Dear all

Many thanks to those of you who were able to attend our Drug Driving Stakeholder Seminar last week

We hope you found as useful as we did

Please find attached a copy of the presentation as promised

Kind regards

Xxxxxx xxxxxxx

31

This would put the burden of proof on prosecutors saving innocent patients

considerable stress inconvenience and wasted CPS and police time

The Department considers that the statutory defence affords appropriate protection to patients who drive after taking prescription medication

The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

D Other Points for Consideration

Napp is keen to support this legislation in its efforts to stop users of illegal drugs

from driving and wishes to support policy development to ensure that patients are

protected Napp would be keen to provide any further information or other

means of assistance that could be of help here

Napp would like to submit written andor oral evidence to the Expert Panelrsquos

inquiry

Napp is concerned about the lack of pain expertise and patient representatives on

the Expert panel

Lord Henley mentioned that a seminar might be held after the summer recess to

discuss the issues arising from this legislation further Napp would be keen to

receive any further information on this

I hope this has been covered satisfactorily in the discussion we had on 31st July and since then

I do consider the legislation has strong safeguards in place for patients The Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

I hope I have addressed at least some of your concerns I should be happy to discuss the issues further

Duncan Price 2882012

27

Note on controlled drugs with medical uses

(i) The reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

(ii) Circumstances in which drug testing can be administered Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under the

influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

(iii) The medical defence The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

(iv) Drugs to be covered by the new offence and any specified limits to be based on expert advice The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

(v) Other controls The content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

(vi) Prosecutions to be in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

(vii) In light of the above the Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

28

From DuncanPricedftgsigovuk Sent 13092012 1603 To xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Cc xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Subject RE NRAS - Crime and Courts Bill clauses on drug driving

Xxxxxx

Below is my draft response to this letter Irsquoll send it when I have your comments about it

Dear xx xxxxxxx

Xxxxxx xxxxxxxx has forwarded your email of 28th August to me I am the lead policy official for the legislative clause about drug impaired driving in the Crime and Courts Bill

I am aware of concerns about innocent motorists taking prescribed medications being stopped tested being taken to police stations having blood samples taken and possibly going to court before being exonerated This is not the intention of the legislation and I can assure you we are mindful of this concern as we progress the legislation and respond to advice from an expert panel about the details

There are several protections in place to reduce the risk of large numbers of innocent motorists being arrested and taken to police stations

Firstly motorists cannot be stopped randomly for drug tests Testing can only be administered in three circumstances ndash namely where a driver has committed a moving traffic offence

a driver has been involved in a road traffic accident and or

there is reason for a police officer to suspect that a person has been driving under the influence of drink or drugs

This means that in practice drivers taking prescribed medicines would not be stopped and required to undergo drug testing without there being real cause for concern Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would be likely to result in disproportionate and large numbers of people prescribed drugs having evidential blood tests but then not being found guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

Fourthly it is important to emphasise that the prosecution for a case where the medical defence has been raised must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code for Crown Prosecutors which contains a requirement about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

Finally in the context of the clause before parliament the content of the regulations (specifying which controlled drugs should be covered by the new offence and the limits to be specified for them) will be the subject of public consultation Before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of

29

Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

I hope that this letter serves to allay concerns about possible unintended consequences for people taking prescription medicines

Duncan Price Tel 020 7944 xxxx Department for Transport

From JessicaMatthewdftgsigovuk Sent 17 October 2012 1108 To xxxxxxxxxxxxadhgsigovuk Cc xxxxxxxxxxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxxxxxdhgsigovuk xxxxxxxxdhgsigovuk Subject Re Department of Health attendance at the Lords briefing for the drug driving legislation

Xxxxxxxx is out of the office today but wersquoll send over the time and venue tomorrow and share the briefing with you Irsquod be happy to brief Dr Prunty beforehand ndash perhaps over the phone

Wersquore planning on a reasonably open debate about the legislation We wonrsquot have got policy clearance on the amendments to the legislation but wersquore inclined to say that the Government is minded to or is considering x y or z

Happy to discuss

Jessica Matthew Deputy Director Road User Licensing Insurance and Safety Tel 020 7944 xxxx Zone 321 Great Minster House 76 Marsham Street London SW1P 4DR

Extract of Briefing shared with DH from the above e-mail

How will you make sure that people taking medication in accordance with their prescription arenrsquot arrested and taken to court as a result of this legislation

The medical defence in the provisions provides substantial and appropriate protection for people taking medically prescribed or supplied controlled drugs It places an evidential burden on a person accused of committing the offence So the accused must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court It is then for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on

It is unlikely that a person taking medication in accordance with their prescription would be taken to court for a number of reasons

30

1 Motorists cannot be stopped randomly for drug tests They can only be tested where They have committed a moving traffic offence They have been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under

the influence of drink or drugs

2 The drugs to be included in the legislation and their limits will be set in regulations The content of the regulations will be the subject of public consultation and an affirmative resolution This will provide an opportunity for any concerns with the proposed specified limits to be raised and carefully considered

3 The expert panel is bearing in mind the normal therapeutic ranges and expected drug concentrations in blood when setting limits for those drugs that may also be used for medicinal purposes This means that only patients on unusually high doses of medication might have a positive screening and proceed to evidential blood test

4 Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any cases before they reach the court Indeed there is a Code for Crown Prosecutors which contains a requirement that prosecutions are in the public interest

From xxxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 29 November 2012 1422 To xxxxxxxdhgsigovuk xxxxxxxxxpsncorguk xxxxxxxxxxxxxtheccaorguk xxxxxxxxxxnpacouk xxxxxxxxxxxxrpharmscom xxxxxxxxxxxsaddactionorguk xxxxxroadsafecom xxxxxxxxxxxxxxxxxxsdrconsortiumorg xxxm-allianceorguk xxxxxxxxxxxturning-pointcouk xxxxxxxxROSPAcom xxxxxxxxxxxxxxxxtheAAcom xxxxxxxxxacpopnnpoliceuk adminactionaddictionorguk xxxxxxxxxageukorguk xxxxxxxxxxxbrakeorguk xxxxxxxxbmaorguk xxxxxxxxxxxbritishpainsocietyorg xxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxcpsgsigovuk xxxxxxxxdrugscopeorguk xxxxxxxxxiamorguk xxxxxxxxxxxxxxlawsocietyorguk xxxxxxxxxxxliberty-human-rightsorguk xxxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxxpactsorguk xxxxxxxxxxparliamentuk xxxxxxxxxxxxRACFoundationorg xxxxxxxxxxdurhamgovuk xxxxxxxxxxxxxxxxPolicyConnectorguk xxxxxxxxxxxxxxpsncorguk xxxxxxxxxxxxxdvlagsigovuk Xxxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxhomeofficegsigovuk xxxxxxxxnpacouk xxxxxxxxxxxxdhgsigovuk xxxxxxxxxdrugscopeorguk Cc xxxxxxxxxxxxxxxxxxxdftgsigovuk JessicaMatthewdftgsigovuk xxxxxxxxxxxxxxxxxxdftgsigovuk Subject Drug driving seminar presentation

Dear all

Many thanks to those of you who were able to attend our Drug Driving Stakeholder Seminar last week

We hope you found as useful as we did

Please find attached a copy of the presentation as promised

Kind regards

Xxxxxx xxxxxxx

31

Note on controlled drugs with medical uses

(i) The reason for not excluding controlled drugs with medical uses from the scope of the new offence Evidence indicates that drugs prescribed for medical purposes are abused in enough cases to warrant action being taken to address the problem For example such drugs can be obtained over the internet and taken in excess - by people who then drive and cause considerable danger and harm to other road users

(ii) Circumstances in which drug testing can be administered Drug testing can only be administered in 3 circumstances ndash namely where a driver has committed a moving traffic offence a driver has been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under the

influence of drink or drugs

Therefore the Department considers that those driving after taking opiate medicines prescribed to manage pain appropriately are unlikely to be required to undergo drug testing in the first place - unless their driving gives cause for real concern

(iii) The medical defence The medical defence in the new offence clause places what is known as an ldquoevidentialrdquo burden on a person accused of committing the offence This means that the accused person must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court ndash following which it is for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on Therefore the task facing the prosecution is a far more difficult one than that facing a person who wishes to rely on the medical defence Requiring the prosecution to prove beyond reasonable doubt that an accused person had ldquoknowinglyrdquo driven contrary to medical advice would seem to be an impossible task

(iv) Drugs to be covered by the new offence and any specified limits to be based on expert advice The expert panel is aware of the need to avoid the new offence targeting the wrong people ndash such as those who drive after taking prescribed medicines appropriately (Eg to manage chronic pain) and who do not endanger others The panel will take careful account of this when advising on which controlled drugs should be covered by the new offence and on suitable specified limits for each

(v) Other controls The content of the regulations will be the subject of public consultation and before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

(vi) Prosecutions to be in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code for Crown Prosecutors The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

(vii) In light of the above the Department considers that in practice the new offence would be unlikely to have the unintended consequences that are being suggested

28

From DuncanPricedftgsigovuk Sent 13092012 1603 To xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Cc xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Subject RE NRAS - Crime and Courts Bill clauses on drug driving

Xxxxxx

Below is my draft response to this letter Irsquoll send it when I have your comments about it

Dear xx xxxxxxx

Xxxxxx xxxxxxxx has forwarded your email of 28th August to me I am the lead policy official for the legislative clause about drug impaired driving in the Crime and Courts Bill

I am aware of concerns about innocent motorists taking prescribed medications being stopped tested being taken to police stations having blood samples taken and possibly going to court before being exonerated This is not the intention of the legislation and I can assure you we are mindful of this concern as we progress the legislation and respond to advice from an expert panel about the details

There are several protections in place to reduce the risk of large numbers of innocent motorists being arrested and taken to police stations

Firstly motorists cannot be stopped randomly for drug tests Testing can only be administered in three circumstances ndash namely where a driver has committed a moving traffic offence

a driver has been involved in a road traffic accident and or

there is reason for a police officer to suspect that a person has been driving under the influence of drink or drugs

This means that in practice drivers taking prescribed medicines would not be stopped and required to undergo drug testing without there being real cause for concern Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would be likely to result in disproportionate and large numbers of people prescribed drugs having evidential blood tests but then not being found guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

Fourthly it is important to emphasise that the prosecution for a case where the medical defence has been raised must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code for Crown Prosecutors which contains a requirement about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

Finally in the context of the clause before parliament the content of the regulations (specifying which controlled drugs should be covered by the new offence and the limits to be specified for them) will be the subject of public consultation Before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of

29

Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

I hope that this letter serves to allay concerns about possible unintended consequences for people taking prescription medicines

Duncan Price Tel 020 7944 xxxx Department for Transport

From JessicaMatthewdftgsigovuk Sent 17 October 2012 1108 To xxxxxxxxxxxxadhgsigovuk Cc xxxxxxxxxxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxxxxxdhgsigovuk xxxxxxxxdhgsigovuk Subject Re Department of Health attendance at the Lords briefing for the drug driving legislation

Xxxxxxxx is out of the office today but wersquoll send over the time and venue tomorrow and share the briefing with you Irsquod be happy to brief Dr Prunty beforehand ndash perhaps over the phone

Wersquore planning on a reasonably open debate about the legislation We wonrsquot have got policy clearance on the amendments to the legislation but wersquore inclined to say that the Government is minded to or is considering x y or z

Happy to discuss

Jessica Matthew Deputy Director Road User Licensing Insurance and Safety Tel 020 7944 xxxx Zone 321 Great Minster House 76 Marsham Street London SW1P 4DR

Extract of Briefing shared with DH from the above e-mail

How will you make sure that people taking medication in accordance with their prescription arenrsquot arrested and taken to court as a result of this legislation

The medical defence in the provisions provides substantial and appropriate protection for people taking medically prescribed or supplied controlled drugs It places an evidential burden on a person accused of committing the offence So the accused must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court It is then for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on

It is unlikely that a person taking medication in accordance with their prescription would be taken to court for a number of reasons

30

1 Motorists cannot be stopped randomly for drug tests They can only be tested where They have committed a moving traffic offence They have been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under

the influence of drink or drugs

2 The drugs to be included in the legislation and their limits will be set in regulations The content of the regulations will be the subject of public consultation and an affirmative resolution This will provide an opportunity for any concerns with the proposed specified limits to be raised and carefully considered

3 The expert panel is bearing in mind the normal therapeutic ranges and expected drug concentrations in blood when setting limits for those drugs that may also be used for medicinal purposes This means that only patients on unusually high doses of medication might have a positive screening and proceed to evidential blood test

4 Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any cases before they reach the court Indeed there is a Code for Crown Prosecutors which contains a requirement that prosecutions are in the public interest

From xxxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 29 November 2012 1422 To xxxxxxxdhgsigovuk xxxxxxxxxpsncorguk xxxxxxxxxxxxxtheccaorguk xxxxxxxxxxnpacouk xxxxxxxxxxxxrpharmscom xxxxxxxxxxxsaddactionorguk xxxxxroadsafecom xxxxxxxxxxxxxxxxxxsdrconsortiumorg xxxm-allianceorguk xxxxxxxxxxxturning-pointcouk xxxxxxxxROSPAcom xxxxxxxxxxxxxxxxtheAAcom xxxxxxxxxacpopnnpoliceuk adminactionaddictionorguk xxxxxxxxxageukorguk xxxxxxxxxxxbrakeorguk xxxxxxxxbmaorguk xxxxxxxxxxxbritishpainsocietyorg xxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxcpsgsigovuk xxxxxxxxdrugscopeorguk xxxxxxxxxiamorguk xxxxxxxxxxxxxxlawsocietyorguk xxxxxxxxxxxliberty-human-rightsorguk xxxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxxpactsorguk xxxxxxxxxxparliamentuk xxxxxxxxxxxxRACFoundationorg xxxxxxxxxxdurhamgovuk xxxxxxxxxxxxxxxxPolicyConnectorguk xxxxxxxxxxxxxxpsncorguk xxxxxxxxxxxxxdvlagsigovuk Xxxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxhomeofficegsigovuk xxxxxxxxnpacouk xxxxxxxxxxxxdhgsigovuk xxxxxxxxxdrugscopeorguk Cc xxxxxxxxxxxxxxxxxxxdftgsigovuk JessicaMatthewdftgsigovuk xxxxxxxxxxxxxxxxxxdftgsigovuk Subject Drug driving seminar presentation

Dear all

Many thanks to those of you who were able to attend our Drug Driving Stakeholder Seminar last week

We hope you found as useful as we did

Please find attached a copy of the presentation as promised

Kind regards

Xxxxxx xxxxxxx

31

From DuncanPricedftgsigovuk Sent 13092012 1603 To xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Cc xxxxxxxxxxxxdhgsigovuk xxxxxxxxxxxhomeofficegsigovuk Subject RE NRAS - Crime and Courts Bill clauses on drug driving

Xxxxxx

Below is my draft response to this letter Irsquoll send it when I have your comments about it

Dear xx xxxxxxx

Xxxxxx xxxxxxxx has forwarded your email of 28th August to me I am the lead policy official for the legislative clause about drug impaired driving in the Crime and Courts Bill

I am aware of concerns about innocent motorists taking prescribed medications being stopped tested being taken to police stations having blood samples taken and possibly going to court before being exonerated This is not the intention of the legislation and I can assure you we are mindful of this concern as we progress the legislation and respond to advice from an expert panel about the details

There are several protections in place to reduce the risk of large numbers of innocent motorists being arrested and taken to police stations

Firstly motorists cannot be stopped randomly for drug tests Testing can only be administered in three circumstances ndash namely where a driver has committed a moving traffic offence

a driver has been involved in a road traffic accident and or

there is reason for a police officer to suspect that a person has been driving under the influence of drink or drugs

This means that in practice drivers taking prescribed medicines would not be stopped and required to undergo drug testing without there being real cause for concern Secondly screening equipment is subject to a rigorous type approval process to ensure it gives robust readings

Thirdly regulations will need to put in place before any controlled drug is included in the new offence If there is evidence that the inclusion of a particular controlled drug would be likely to result in disproportionate and large numbers of people prescribed drugs having evidential blood tests but then not being found guilty of the offence then this would be a persuasive reason not to specify such a controlled drug in the regulations

Fourthly it is important to emphasise that the prosecution for a case where the medical defence has been raised must then prove beyond reasonable doubt that the defence is not valid Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any such cases before they reach the court

Indeed there is a Code for Crown Prosecutors which contains a requirement about prosecutions being in the public interest Each case must be decided on its own facts and circumstances and be subject to the Full Code Test as set out in the Code The Code states at paragraph 33 that prosecutors ldquoshould swiftly stop caseshellip where the public interest clearly does not require a prosecutionrdquo

Finally in the context of the clause before parliament the content of the regulations (specifying which controlled drugs should be covered by the new offence and the limits to be specified for them) will be the subject of public consultation Before being made the regulations will be subject to affirmative regulation Parliamentary procedure ndash meaning that the regulations will only be made if approved by resolution of both Houses of

29

Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

I hope that this letter serves to allay concerns about possible unintended consequences for people taking prescription medicines

Duncan Price Tel 020 7944 xxxx Department for Transport

From JessicaMatthewdftgsigovuk Sent 17 October 2012 1108 To xxxxxxxxxxxxadhgsigovuk Cc xxxxxxxxxxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxxxxxdhgsigovuk xxxxxxxxdhgsigovuk Subject Re Department of Health attendance at the Lords briefing for the drug driving legislation

Xxxxxxxx is out of the office today but wersquoll send over the time and venue tomorrow and share the briefing with you Irsquod be happy to brief Dr Prunty beforehand ndash perhaps over the phone

Wersquore planning on a reasonably open debate about the legislation We wonrsquot have got policy clearance on the amendments to the legislation but wersquore inclined to say that the Government is minded to or is considering x y or z

Happy to discuss

Jessica Matthew Deputy Director Road User Licensing Insurance and Safety Tel 020 7944 xxxx Zone 321 Great Minster House 76 Marsham Street London SW1P 4DR

Extract of Briefing shared with DH from the above e-mail

How will you make sure that people taking medication in accordance with their prescription arenrsquot arrested and taken to court as a result of this legislation

The medical defence in the provisions provides substantial and appropriate protection for people taking medically prescribed or supplied controlled drugs It places an evidential burden on a person accused of committing the offence So the accused must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court It is then for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on

It is unlikely that a person taking medication in accordance with their prescription would be taken to court for a number of reasons

30

1 Motorists cannot be stopped randomly for drug tests They can only be tested where They have committed a moving traffic offence They have been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under

the influence of drink or drugs

2 The drugs to be included in the legislation and their limits will be set in regulations The content of the regulations will be the subject of public consultation and an affirmative resolution This will provide an opportunity for any concerns with the proposed specified limits to be raised and carefully considered

3 The expert panel is bearing in mind the normal therapeutic ranges and expected drug concentrations in blood when setting limits for those drugs that may also be used for medicinal purposes This means that only patients on unusually high doses of medication might have a positive screening and proceed to evidential blood test

4 Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any cases before they reach the court Indeed there is a Code for Crown Prosecutors which contains a requirement that prosecutions are in the public interest

From xxxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 29 November 2012 1422 To xxxxxxxdhgsigovuk xxxxxxxxxpsncorguk xxxxxxxxxxxxxtheccaorguk xxxxxxxxxxnpacouk xxxxxxxxxxxxrpharmscom xxxxxxxxxxxsaddactionorguk xxxxxroadsafecom xxxxxxxxxxxxxxxxxxsdrconsortiumorg xxxm-allianceorguk xxxxxxxxxxxturning-pointcouk xxxxxxxxROSPAcom xxxxxxxxxxxxxxxxtheAAcom xxxxxxxxxacpopnnpoliceuk adminactionaddictionorguk xxxxxxxxxageukorguk xxxxxxxxxxxbrakeorguk xxxxxxxxbmaorguk xxxxxxxxxxxbritishpainsocietyorg xxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxcpsgsigovuk xxxxxxxxdrugscopeorguk xxxxxxxxxiamorguk xxxxxxxxxxxxxxlawsocietyorguk xxxxxxxxxxxliberty-human-rightsorguk xxxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxxpactsorguk xxxxxxxxxxparliamentuk xxxxxxxxxxxxRACFoundationorg xxxxxxxxxxdurhamgovuk xxxxxxxxxxxxxxxxPolicyConnectorguk xxxxxxxxxxxxxxpsncorguk xxxxxxxxxxxxxdvlagsigovuk Xxxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxhomeofficegsigovuk xxxxxxxxnpacouk xxxxxxxxxxxxdhgsigovuk xxxxxxxxxdrugscopeorguk Cc xxxxxxxxxxxxxxxxxxxdftgsigovuk JessicaMatthewdftgsigovuk xxxxxxxxxxxxxxxxxxdftgsigovuk Subject Drug driving seminar presentation

Dear all

Many thanks to those of you who were able to attend our Drug Driving Stakeholder Seminar last week

We hope you found as useful as we did

Please find attached a copy of the presentation as promised

Kind regards

Xxxxxx xxxxxxx

31

Parliament These controls will ensure firstly that there is an opportunity for any concerns with the proposed specified limits to be raised and carefully considered and secondly that the regulations will only be made if their content is specifically approved by Parliament

I hope that this letter serves to allay concerns about possible unintended consequences for people taking prescription medicines

Duncan Price Tel 020 7944 xxxx Department for Transport

From JessicaMatthewdftgsigovuk Sent 17 October 2012 1108 To xxxxxxxxxxxxadhgsigovuk Cc xxxxxxxxxxxxxxxxxxxxdftgsigovuk xxxxxxxxxxxxxxxdhgsigovuk xxxxxxxxdhgsigovuk Subject Re Department of Health attendance at the Lords briefing for the drug driving legislation

Xxxxxxxx is out of the office today but wersquoll send over the time and venue tomorrow and share the briefing with you Irsquod be happy to brief Dr Prunty beforehand ndash perhaps over the phone

Wersquore planning on a reasonably open debate about the legislation We wonrsquot have got policy clearance on the amendments to the legislation but wersquore inclined to say that the Government is minded to or is considering x y or z

Happy to discuss

Jessica Matthew Deputy Director Road User Licensing Insurance and Safety Tel 020 7944 xxxx Zone 321 Great Minster House 76 Marsham Street London SW1P 4DR

Extract of Briefing shared with DH from the above e-mail

How will you make sure that people taking medication in accordance with their prescription arenrsquot arrested and taken to court as a result of this legislation

The medical defence in the provisions provides substantial and appropriate protection for people taking medically prescribed or supplied controlled drugs It places an evidential burden on a person accused of committing the offence So the accused must simply show enough evidence to ldquoraise an issuerdquo regarding the defence that is worth consideration by the court It is then for the prosecution to prove beyond reasonable doubt that the defence cannot be relied on

It is unlikely that a person taking medication in accordance with their prescription would be taken to court for a number of reasons

30

1 Motorists cannot be stopped randomly for drug tests They can only be tested where They have committed a moving traffic offence They have been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under

the influence of drink or drugs

2 The drugs to be included in the legislation and their limits will be set in regulations The content of the regulations will be the subject of public consultation and an affirmative resolution This will provide an opportunity for any concerns with the proposed specified limits to be raised and carefully considered

3 The expert panel is bearing in mind the normal therapeutic ranges and expected drug concentrations in blood when setting limits for those drugs that may also be used for medicinal purposes This means that only patients on unusually high doses of medication might have a positive screening and proceed to evidential blood test

4 Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any cases before they reach the court Indeed there is a Code for Crown Prosecutors which contains a requirement that prosecutions are in the public interest

From xxxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 29 November 2012 1422 To xxxxxxxdhgsigovuk xxxxxxxxxpsncorguk xxxxxxxxxxxxxtheccaorguk xxxxxxxxxxnpacouk xxxxxxxxxxxxrpharmscom xxxxxxxxxxxsaddactionorguk xxxxxroadsafecom xxxxxxxxxxxxxxxxxxsdrconsortiumorg xxxm-allianceorguk xxxxxxxxxxxturning-pointcouk xxxxxxxxROSPAcom xxxxxxxxxxxxxxxxtheAAcom xxxxxxxxxacpopnnpoliceuk adminactionaddictionorguk xxxxxxxxxageukorguk xxxxxxxxxxxbrakeorguk xxxxxxxxbmaorguk xxxxxxxxxxxbritishpainsocietyorg xxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxcpsgsigovuk xxxxxxxxdrugscopeorguk xxxxxxxxxiamorguk xxxxxxxxxxxxxxlawsocietyorguk xxxxxxxxxxxliberty-human-rightsorguk xxxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxxpactsorguk xxxxxxxxxxparliamentuk xxxxxxxxxxxxRACFoundationorg xxxxxxxxxxdurhamgovuk xxxxxxxxxxxxxxxxPolicyConnectorguk xxxxxxxxxxxxxxpsncorguk xxxxxxxxxxxxxdvlagsigovuk Xxxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxhomeofficegsigovuk xxxxxxxxnpacouk xxxxxxxxxxxxdhgsigovuk xxxxxxxxxdrugscopeorguk Cc xxxxxxxxxxxxxxxxxxxdftgsigovuk JessicaMatthewdftgsigovuk xxxxxxxxxxxxxxxxxxdftgsigovuk Subject Drug driving seminar presentation

Dear all

Many thanks to those of you who were able to attend our Drug Driving Stakeholder Seminar last week

We hope you found as useful as we did

Please find attached a copy of the presentation as promised

Kind regards

Xxxxxx xxxxxxx

31

1 Motorists cannot be stopped randomly for drug tests They can only be tested where They have committed a moving traffic offence They have been involved in a road traffic accident and or there is reason for a police officer to suspect that a person has been driving under

the influence of drink or drugs

2 The drugs to be included in the legislation and their limits will be set in regulations The content of the regulations will be the subject of public consultation and an affirmative resolution This will provide an opportunity for any concerns with the proposed specified limits to be raised and carefully considered

3 The expert panel is bearing in mind the normal therapeutic ranges and expected drug concentrations in blood when setting limits for those drugs that may also be used for medicinal purposes This means that only patients on unusually high doses of medication might have a positive screening and proceed to evidential blood test

4 Both the police and Crown Prosecution Service will be aware of this defence in deciding how to deal with any cases before they reach the court Indeed there is a Code for Crown Prosecutors which contains a requirement that prosecutions are in the public interest

From xxxxxxxxxxxxxxxxxxxxxxdftgsigovuk Sent 29 November 2012 1422 To xxxxxxxdhgsigovuk xxxxxxxxxpsncorguk xxxxxxxxxxxxxtheccaorguk xxxxxxxxxxnpacouk xxxxxxxxxxxxrpharmscom xxxxxxxxxxxsaddactionorguk xxxxxroadsafecom xxxxxxxxxxxxxxxxxxsdrconsortiumorg xxxm-allianceorguk xxxxxxxxxxxturning-pointcouk xxxxxxxxROSPAcom xxxxxxxxxxxxxxxxtheAAcom xxxxxxxxxacpopnnpoliceuk adminactionaddictionorguk xxxxxxxxxageukorguk xxxxxxxxxxxbrakeorguk xxxxxxxxbmaorguk xxxxxxxxxxxbritishpainsocietyorg xxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxcpsgsigovuk xxxxxxxxdrugscopeorguk xxxxxxxxxiamorguk xxxxxxxxxxxxxxlawsocietyorguk xxxxxxxxxxxliberty-human-rightsorguk xxxxxxxxxxxxxxmhragsigovuk xxxxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxranelagh-intlcom xxxxxxxxxxxxxxpactsorguk xxxxxxxxxxparliamentuk xxxxxxxxxxxxRACFoundationorg xxxxxxxxxxdurhamgovuk xxxxxxxxxxxxxxxxPolicyConnectorguk xxxxxxxxxxxxxxpsncorguk xxxxxxxxxxxxxdvlagsigovuk Xxxxxxxxxxxxxxxhomeofficegsigovuk xxxxxxxxxxxhomeofficegsigovuk xxxxxxxxnpacouk xxxxxxxxxxxxdhgsigovuk xxxxxxxxxdrugscopeorguk Cc xxxxxxxxxxxxxxxxxxxdftgsigovuk JessicaMatthewdftgsigovuk xxxxxxxxxxxxxxxxxxdftgsigovuk Subject Drug driving seminar presentation

Dear all

Many thanks to those of you who were able to attend our Drug Driving Stakeholder Seminar last week

We hope you found as useful as we did

Please find attached a copy of the presentation as promised

Kind regards

Xxxxxx xxxxxxx

31