authority meeting
DESCRIPTION
Authority Meeting. Wednesday 11 May 2011 The Hatton, 51-53 Hatton Garden. Please turn off all mobile phones and internet dongles to prevent interference with the audio recording. Welcome, Apologies and Declarations of Interest. Item 1. Minutes of 23 March 2011. Item 2. Chair’s Report. - PowerPoint PPT PresentationTRANSCRIPT
Authority MeetingWednesday 11 May 2011The Hatton, 51-53 Hatton Garden
Please turn off all mobile phones and internet dongles to prevent interference with the audio recording
Welcome, Apologies andDeclarations of Interest
Item 1
Minutes of 23 March 2011
Item 2
Chair’s Report
Item 3
Chief Executive’s Report
Item 4
Business Plan 2011/12• Draft budget for 2011/12:
– GIA £1.85m out of total £7.3m– Planning to reduce costs by £0.7m– Cash balance increasing
• DH support to address cash balance by:– (a) reducing fees, and– (b) move to zero-rate fee for eSET (using
GIA)– Further detailed work to follow
Directors’ Reports
Item 5
Donation Consultation Update
Hannah Darby and Danielle Hamm
Item 6
Hannah Darby and Danielle Hamm
Review and consultation process
Mar 2010Dec 2009
Discussed outcome of evaluation & agreed review
Agreed plan for the reviewSEED
evaluation
Aug – Dec 2009
Evidence gathering
phase
Mar – Sep 2010
Agreed policy options for
compensation & family limit
Sep 2010
Agreed: - structure of consultation document - name of the review - consultation strategy
Oct 2010
Authority sign off consultation text and questions. Discussed
engagement plan.
Agreed policy on age limit & donor codes, policy options intra
family
July 2010
17 Jan – 8 Apr 2011Dec 2010
Consultation period
Best practice in consultationsIn line with BERR ‘Code of Practice on Consultation’.
Consultation process: Consultation launched after evaluation of current policies,
allowing identification of policies for public consultation
Evidence gathering phase – informed development of policy options
Policy options consulted on for 12 weeks
Outcome of consultation will aid the Authority when making decisions about the policy options
Details of process, options and expected costs & benefits outlined in publicly available Authority papers
Best practice in consultations contd.
Burden of consultation kept to a minimum: Consultation based online: website format & PDF
Website format accessible & easy to use, with lay language
Separate questionnaires for each topic
Responders didn’t need to register for a username & password
Best practice in consultations contd.
Methods of gathering opinions and evidence:Text written in meaningful and accessible way to encourage lay respondents
Variety of engagement methods used to suit specific groups
Raised awareness: speaking at conferences, leaflets, stakeholder newsletters, press, use of dedicated inbox etc.
Best practice in consultations contd.
Regulatory impact assessment: In the process of carrying out a regulatory impact assessment
Learning lessons:System in place for learning lessons from the consultation; this is integral to the project management system at the HFEA.
Stakeholder engagement:- Policy seminar - SAP/AHRC- Stakeholder meetings -
SING, BICA, DCN, PROGAR
- Discussions at Fertility 2011 & RCN conferences
Qualitative work: Discussion groups, online forums and interviews with donors, donor conceived and general public
Clinic meetings:Four meetings to discuss operational issues:London, Glasgow, Bath and Birmingham
Online questionnaire
Opinions and evidence gathered
Online questionnaires: breakdown & analysis
890 respondents (individuals and organisations)
NB. 157 respondents selected more than 1 respondent type
Online questionnaires: breakdown & analysis
2459 questionnaires completed
NB. These figures may vary slightly following full analysis
Proposed timetable
17 May Advisory group meeting – discussion of evidence
20 June Members’ workshop – discussion of evidence 13 July Authority to consider evidence & policy recommendations on:
- family donation- family limit- changing landscape
19 October Authority to consider evidence & policy recommendations on compensation, reimbursement & benefits in kind
Considerations
• How would Members like us to handle submissions not made through the online questionnaire?
• Is the Authority satisfied that the types of information gathered will allow Members to make well-founded policy decisions?
Licences and Enforcement: A Guide to Compliance
Dr Chris O’Toole
Head of Research Regulation & Clinical Governance
Item 7
Regulation
Authorisation of processes
Authorisation of processes
For inspectors
Licensed Activities• Procuring gametes
• Keeping gametes
• Testing gametes
• Processing gametes
• Distribution of gametes
• Use of gametes
• Creation of embryos in vitro
• Procuring embryos
• Keeping embryos
• Testing embryos
• Processing embryos
• Distribution of embryos
• Storage of sperm
• Storage of eggs
• Storage of embryos
• Placing any permitted embryo in a woman
• Using embryos for the purpose of training persons in embryo biopsy, embryo storage or other embryological techniques
Licence Conditions
All licences issued by the Authority are subject to standard licence conditions. These conditions may be either:
• statutory (prescribed in legislation) or • discretionary (applied by the HFEA pursuant to
powers conferred on it by legislation)
In addition conditions may also be applied to individual licences under powers contained in the legislation.
Review of Licence Conditions
Proposed review of discretionary licence
conditions with the aim:
• that the conditions are clear and easy to understand;
• that the conditions reflect current policy; and
• that requirements contained in licence conditions are not duplicated.
Summary of proposed changes
• T & S licences– Add 1 new discretionary
licence condition – multiple births
– Delete 5 discretionary conditions
– Move 4 discretionary conditions to Code of Practice or website
– Revise the wording of 10 discretionary conditions plus 6 statutory conditions
– Leave 10 discretionary conditions as already worded
• Research licences– Delete 2 discretionary
conditions plus one statutory condition
– Move 2 discretionary conditions to Code of Practice or website
– Revise the wording of 1 discretionary condition & 2 statutory conditions
– Leave 15 discretionary conditions as already worded
Proposal – delete from T&S Licences
Proposal – move from T&S licences to guidance
Proposal – revise wording of T&S conditions
Proposal – delete from research licences
Proposal – move from research licences to guidance
Proposal – revise wording of research conditions
HFEA Enforcement Policy
This policy sets out the Authority’s approach for promoting and maintaining compliance with:• the HF&E Act• licence conditions• directions• the Code of Practice
Assessment framework
This framework will aid:• inspectors in making consistent assessments• Inspectors determine whether non compliance
with the HF&E Act 1990 (as amended), directions, licence conditions or the Code of Practice should be categorised as critical, major or other.
Examples from the Assessment Framework
Recommendations
The Authority is asked to agree:
• the proposed changes to the discretionary licence conditions contained in Annex B to this paper;
• the enforcement policy contained in Annex D to this paper;
• that the use of the assessment framework will be tested between now and September; and
• to delegate the adoption of the assessment framework to the Authority’s Compliance Committee
Regulating new processes
Jessica Watkin, Policy Manager
Item 8
Why review this?
• Legal requirement: introduced by EUTD• Current procedure: inconsistent, unclear• Principles governing new procedure:
– Patient safety– Special status of the embryo– Legal and regulatory responsibilities– Respect clinical/ scientific judgment – Minimise administrative consequences
Options for regulating processes
1. ‘Prohibited processes’ list: Centres can proceed with any process unless Authority has evidence of harm and prohibits it
2. ‘Permitted processes’ list: centres can only proceed if Authority has considered and approved the process
3. ‘Permitted processes’ list + centre by centre approval: as option 2 with each centre needing advance permission from HFEA to carry out new process
Consultation
• Targeted consultation with members of LCP, Compliance Committee, SCAAC, BFS, ACE
• Discussion at Compliance Committee in April
• Option 1: support from LCP members
• Option 2: Compliance Committee (with extra safeguards), ACE, BFS, SCAAC‘mitigates against risk’‘proportionate and transparent’
Recommendation
Option 1Risk to patient safety/special status of the embryo; may not be compatible with EUTDOption 3Heavy administrative consequences
Option 2High level, proportionate approach (protects patient safety/special status of embryo with clinical/scientific judgement and keeps administration to a minimum)
Fertility: Have your say survey results
Sharon Neaves
Communications Manager
Item 9
Background
• Relaunch of patients’ panel• 171 members joined• March 2011 – Ipsos MORI• Online survey• 137 responses – response rate of 80%
Treatment stage
• 42% had received treatment and it was successful
• 34% had received treatment and it was unsuccessful
• 18% were currently receiving treatment• 4% were currently considering treatment• 2% had considered treatment but didn’t have it
Knowledge of HFEA
3%
17%
34%
24%21%
K nowledge of HFEA at beginning of treatment
A great deal
When you started treatment, how much would you say you knew about the HFEA?
Base: All who have received treatment (128), fieldwork dates: 1st March – 31st March 2011
Afair
amount
Justa
little
Heard of but
know nothing about
NeverHeard
of
• Relatively high awareness of HFEA• Lack of awareness of what HFEA does
Sources of information• More likely to ask their GP for information• GPs unable to provide sufficient information
47%
11%
9%
4%
3%
1%
21%
1%
2%
30%
68%
1%
Sources of information used
Yes
Q And did you receive any information from your GP on fertility treatment?
No
Don’t know/can’t remember
Q Which one of the following sources, if any, did you use when you were first looking for information about fertility treatment?
Base: All respondents (137), fieldwork dates: 1st
March – 31st March 2011
Your GP
Base: All who did not use their GP as their initial source of info (73)*, fieldwork dates: 1st March – 31st March 2011
* Small base size means findings indicative only
None of these
Don’t know
HFEA websiteIndividual fertility clinic
websitesFertility support groups
HFEA ‘Getting Started’ guideNHS Choices
Other
47%
91%
• 91% of members have used the HFEA website
• 92% found the information useful• Most say they found some of the
information• Only a minority used it as their
initial source of information
Information on the HFEA website
Patient experience• Overall positive about treatment received – 81%
44%
38%
7%
8%4%
Overall views on fertility service received
Very good
Base: All who have received treatment (128), fieldwork dates: 1st March – 31st March 2011
Overall, how would you rate the fertility service you have received at your clinic?
Fairly good
Neither/nor
Fairly poorVery poor
81%
Choosing a clinic• A clinic’s success rate – 68%• Location of the clinic – 47%
68%
47%
19%
18%
15%
8%
6%
3%
2%
6%
Important factors when choosing c linic
Location
Which one or two would you say were/would be the most important when making your choice of clinic?
Base: All respondents (137), fieldwork dates: 1st March – 31st March 2011
Physical environment
Staff
Success rates (live birth rates)
Cost
Services/treatments available
NHS referral
Personal recommendation
GP recommended
Other
Factors considered when thinking about success rates
74%
64%
55%
48%
35%
31%
9%
3%
3%
Factors considered when thinking about c linics’ success rate
The type of patients that a clinic treats (eg age or diagnosis)
Which of the following factors, if any, have you considered when thinking about clinics’ success rates?
Base: All respondents (137), fieldwork dates: 1st March – 31st March 2011
The number of embryos the clinic routinely transfers in treatment cycles
The number of treatment cycles the clinic’s success rate is based on
How the clinic compares to the national average
That success rates cannot give a personal prediction of your chance to having a baby
How recent the published success rates are
Other
I didn’t consider any of these factors when thinking about clinics’ success rates
I have never thought about clinics’ success rates
• Positive to see that people are considering the type of patient a clinic treats
Risks of treatment• 68% were told about risks• 45% felt they were told a fair amount• Just under 23% were told a great deal• 5% weren’t told about the risks
Greatest risks• OHSS & multiple births• Less than half say they know what the multiple birth
rate is at their clinic
Cost of treatment
• 45% did not receive a costed treatment plan
• More than a quarter who did receive a plan say that their treatment was more expensive
Consent
• 76% felt the staff explained what they were consenting to
• 23% said it was not explained very well
• 6% said it was not explained at all
Counselling• 83% were offered counselling
• 16% weren’t offered counselling
Patient feedback questionnaires• 57% did not complete it, as they were
not aware of the questionnaire
Improvements to treatment• Better attitude of clinic staff
• More empathy
• More counselling & follow-up care
?
Confidence in fertility treatment
• Inspecting clinics to ensure that they follow proper conduct (47%)
• Ensuring the safety of medical treatments and scientific developments (47%)
Protecting the interests of patients
• Majority agree – 66%
• 12% say HFEA is not protecting their interests well
• 22% say they don’t know
Issues to address
Provide better information to GPs
More information to patients at the start of treatment
Education on success rates, up to date statistics & HFEA’s role
Investigation into improved patient feedback mechanisms
Other areas such as counselling, consent & cost require more focus on inspection
Consent to Disclosure for Research:
Identifying donor information
Charlotte Augst,
Head of Business Intelligence
Item 10
Two separate disclosure regimes
Legal complexity
• Complicated interface of primary legislation (consents) and Research Regulations
• Initially modelled our handling of disclosure based on consent on disclosure based on the Regulations
• Legal Advice now clarifies that we can disclose information about donors, recipients and the donor conceived to researchers on the basis of consent
Unless the information links donors and donor conceived people (because then it is deemed ‘identifying donor information’)
Update from Committee Chairs
Item 12
Any Other Business
Item 13
Date of next meeting
Wednesday 13 July 2011
London