Medicines Enforcement - UK Regulator’s Perspective

Lynda Scammell / Enforcement Group / MHRA

Enforcement and Intelligence Group

• Responsible for enforcing medicines legislation in England and does so in Scotland and Wales on behalf of the Scottish Parliament and Welsh Assembly

• Powers under Human Medicines Regulations 2012 – maximum sentence two years and/or unlimited fine

• Use Crown Prosecution Service solicitors• Powers available to MHRA enforcement officers:

- Investigation and prosecution- Entry to commercial premises/ private dwellings- Inspection (search), seizure

• MHRA has surveillance powers under RIPA 2000• MHRA pursues Proceeds of Crime under POCA 2002• MHRA will use most appropriate offence available in addition to

Medicines Act, typically Trade Marks Act, Fraud Act and POCA.

• Illegal advertising• Illegal wholesaling• Illegal sale and supply• Illegal importation

medicines• Illegal manufacture• Falsified medicine

Enforcement Group responsibilities

Responsibilities continued

• Clinical trial fraud• Unlicensed medicines• Internet supply• Illegal herbal• Diversion• Stolen medicines

Guidance on MHRA’s website

• Publishes information on buying medicines online on the MHRA website:

• http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Adviceandinformationforconsumers/Buyingmedicinesonline/index.htm

Public Awareness Campaigns

• The MHRA and patient groups endorsed a hard-hitting cinema campaign run by Pfizer to warn people of the dangers of purchasing POMs from the internet without a prescription. A second phase of the initiative included TV screening of the original cinema advert and an outdoor advertising campaign.

Anti-Counterfeiting Strategy

• In order to combat counterfeit medicines infiltrating the UK supply chain, the MHRA developed a comprehensive anti-counterfeiting strategy which was implemented in 2007. The strategy introduced a number of measures to prevent counterfeit medicines and medical devices from reaching patients. These measures are being implemented through a sustained programme of communication, collaboration and regulation including, for example, the installation of 24 hour anti-counterfeit hotlines. An updated “Falsified medical products” was launched in April last year. Full details of the strategy can be found on the MHRA website at www.mhra.gov.uk.

24 hour reporting hotlines

• Reporting counterfeit medicines• If you have any concerns or information that may assist us in

tracking down those responsible for counterfeit medicines and devices you can e-mail the Enforcement Group at counterfeit@mhra.gsi.gov.uk or you can ring our 24-hour dedicated hotline on 020 3080 6701 or you can write to us at:

• CounterfeitsCase Referral CentreMHRA5th Floor151 Buckingham Palace RoadVictoriaLondonSW1W 9SZ

Notable Prosecution

• In 2011, five men were prosecuted for their involvement in the importation and supply of over two million doses of counterfeit medicines, approximately 700,000 of which reached patients through the regulated supply chain. This was codenamed Operation Singapore and culminated in a four month trial.

Notable Prosecution

• The ringleader was convicted and sentenced to eight years’ imprisonment for Conspiracy to Defraud, Trademark violations, medicines regulatory offences and Companies Act offences.

Operation PangeaGlobal response to a global issue

Operation Pangea

Concept

•International Internet Week of Action (IIWA) involving Medicine Regulators and Law Enforcement Agencies:

- tackling the demand, through raising public awareness- tackling the supply, through targeting the illegal on-line

sale of medicines including unlicensed and counterfeit products

• Protecting public health

Methodology

- Focus on the four components required by a website illegally supplying medicines

- Engage specialists on the best way to disrupt the sites

- Obtain the biggest impact for the minimum cost and effort

- Engage the media in the most • effective way to raise awareness

Objectives

• SafeguardSafeguard public health

• Raise public awarenessRaise public awareness of the increased risks in obtaining medicines from unregulated websites

• SeizeSeize counterfeit and unlicensed products and remove from the market

Objectives• Disrupt, dismantleDisrupt, dismantle and close downclose down websites and

businesses acting illegally

• Identify and investigateIdentify and investigate the producers and distributors of counterfeit and illegal medical products and the criminal networks supporting them

• ProsecuteProsecute those responsible where appropriate and seize their assets

• Enhance co-operationco-operation amongst domestic and international agencies combating the illicit trade of counterfeit and illegal medical products

Pangea VI June 2013Global Participation

• MHRA and Interpol – IIWA joint-Secretariat

• 99 countries, 201 agencies

• Participation breakdown by agency:

– Customs – 75 countries

– Medicine Regulators – 45 countries

– Police – 81 countries

• Payment providers:

– PayPal, Visa Europe, Visa Inc,

Barclaycard and Mastercard Europe

CustomsRegulators

Police

PANGEA VI Results – Global• Auction sites - 276 adverts removed

• Websites – 9,610 websites taken down/payment facility removed ( 1 affiliate network)

• Arrests/under investigation - 58

• Postal hubs / ports – 365 postal hubs inspected with 522,000 packages inspected

• Seized at hubs / ports – 58,481 packages/parcels seized

• Types of medicines seized – Abortion / contraception, AIDS/HIV, Anabolic Steroid,

Alzheimer Medicines, Analgesic/PainKiller, Anti-allergy, Anti-Asthmatic, Antibiotic/Anti-

infection, Anti-depressant, Anti-diabetic, Anti-diuretic, Anti-epileptic, Anti-fungal,

Antihistamine, Anti-Haemmorhoid, Anti-hypertension, Anti-inflammatory, Anesthetic,

Antimalarial, Anti-mucolytic, Anti-protozoal, Anti-psychotic, Anti-viral, Arthritis medicine,

Cancer medicines, Cardiovascular medicines, Nicotine Substitutes, Cholesterol medicine,

CNS Stimulant, Doping Substances,

•

Endocrine Medicines, Erectile Dysfunction, Eye/Ear Treatment, Food & Health supplements, Gastrointestinal Medicines, Hair Loss Medicines, Thyroid Medicines, Hormones, Migraine Medicines, Medical Devices, Muscle Relaxant, Osteoporosis Medicines, Gout Medicines, Ovulation, Parkinson Medicines, Prostatic illnesses, Rhinitis Medicines, Renal Medicines, Skin Disorder, E-Cigarette, Skin Tanning, Skin Whitening, Steroid, Sleep Disorder / Anxiety, Slimming/Weight Loss, Thyroid, Viral Hepatitis, Worm infections

•Public Awareness – 23 campaigns

• Total – over 9.9 million doses, valued at

approximately £26.8 million

Results - Operation PANGEAs compared

020406080

100120

Participating Countries

Doses seized (millions)

0

5

10

15

2008

2009

2010

2011

2012

2013

Website take-downs

0

5000

10000

15000

20000

Arrest/Investigation

0

20

40

60

80

100

Falsified Medicines Directive

• Directive 2011/62/EU introduces measures designed to strengthen the medicines supply chain from the threat of counterfeit medicines.

Falsified Medicines Directive

The Directive extends regulation to BROKERS - From 02/01/2013 brokers must register with

MHRA- requirement to have established premises and a

permanent address for their business which must be registered, with their corporate name.

Falsified Medicines Directive

• Brokers may only deal in medicines that have a marketing authorisation (licence), unless they are brokering medicines from outside the European Economic Area (EEA) for direct export from the UK to a third country. Brokers must:

• Keep records of all transactions for 5 years;• Maintain a quality system;• Check that those from whom they purchase and

to whom they sell hold the appropriate licence;• Report to the MHRA offers of medicines they

believe to be or suspect to be counterfeit;

Falsified Medicines Directive

• Wholesale Dealers

additional obligations to -• Verify that wholesalers, manufacturers and importers of

medicines from whom they obtain supplies hold the appropriate licence and comply with Good Distribution or Good Manufacturing Practices.

• Confirm that brokers from whom they obtain medicines fulfil the requirements for registration with the national authorities and other obligations.

Falsified Medicines Directive

• Verify that medicines they receive that are subject to the new safety feature provision are not falsified, by checking the safety features on the outer packaging.

• Record the batch numbers of medicines they receive that are subject to the safety features, including for medicines that are to be exported to third countries (together with manufacturing authorisation holders). They must report to the national competent authority and the marketing authorisation holder if they suspect that medicines they receive may be falsified.

Falsified Medicines Directive

• Maintain a quality system that sets out responsibilities, processes and risk management measures in relation to their activities.

• Competent authorities are required to enter details of holders of wholesale distribution licence holders on a public EU database (EUDRA GDP)

• The Directive clarifies the regulatory regime already in place in the UK for Wholesale Dealers who engage in “parallel trade”.

Falsified Medicines Directive

A new definition of “introducing” medicines is established for medicines that are imported into a Member State of the EU solely for the purpose of export to a third country, with no intention that the medicine will be placed on the market in the EU. Under the new legislation anyone importing a medicine from outside the EEA for export to a 3rd country must hold a Wholesale Dealer’s licence. This has the effect of extending the existing licensing regime to exporters of medicines – regardless of whether the medicine is “introduced” and removes the current exemption from the requirement for such operators to hold a Wholesale Dealers licence

Falsified Medicines Directive

Active Pharmaceutical Ingredients (APIS)

• Manufacturers of medicines will be required to conduct the necessary audits to enable a written confirmation of the compliance of the API manufacturer with GMP standards to be provided.

• Manufacturers of active substances in the EU, importers and distributors of active substances must, under the new legislation, notify the national competent authority of their activities, including the active substances concerned.

Falsified Medicines Directive

Excipients

• The holder of a manufacturing authorisation is required to verify the authenticity of excipients used and to undertake formal risk assessments to ascertain their suitability. The risk assessment must consider the source and intended use of the excipients, as well as any previous incidents of quality defects, and take account of relevant quality systems. They must use these assessments to determine the appropriate GMP standards that must be used in their manufacture. A record of the measures undertaken must be kept by the manufacturer.

Falsified Medicines Directive

• Safety Features

• The Directive provides for safety features comprising a seal on the outer packaging (to indicate whether the pack has been tampered with) and a unique identifier to be applied to certain categories of medicines. It requires these features to be applied – in principle – to all medicines subject to medical prescription and to non-prescription medicines if they are at risk of counterfeiting. The unique identifier will allow operators (including wholesale dealers and pharmacists) in the medicines supply chain to verify the authenticity of the medicine and to identify individual packs.

Falsified Medicines Directive

• The characteristics and technical specifications of the unique identifier will be determined by the European Commission in separate legislation (a delegated act) expected to be in place by 2014.

• Member States will have three further years after adoption of the delegated act to ensure the requirements are put in place. Those Member States with pre-existing national systems will have a further three years in which to comply.

Falsified Medicines Directive

Supplying Medicines from a Distance

• The Directive requires Member States to ensure that only persons entitled to do so under national law may supply medicines at a distance. Such persons must report their activities to a designated body in the Member State, providing the corporate name and address of the premises from which the activity is conducted and the website details used, together with the legal status of the medicines traded in this way. This information will be published by the Member State on a national website for persons registered as suppliers of medicines at a distance.

Falsified Medicines Directive

A common EU logo to be used, and the means by which its authenticity is protected will be determined by the European Commission and specified in separate legislation (an implementing act).

• General Pharmaceutical Council Logo (UK)

Thank you

Thank you for listening

Lynda ScammellSenior Policy Adviser

Enforcement Group