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Safeguarding public health

European Medicines Enforcement Network

14th ICDRA, Singapore – December 2010

Medicines and Healthcare products Regulatory Agency

Nimo AhmedHead of Intelligence

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Outline

• MHRA Enforcement Group

- Composition- Responsibilities- Powers

• HMA WGEO (Enforcement Network):

- Composition, Mandate and Purpose- Workstreams- Examples of Practical Use

• Conclusion

• Questions & discussion

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MHRA Chief Executive

Kent Woods

Licensing Vigilance & Risk Management ofMedicines

Inspection, Enforcement & Standards

Devices, Technical & Safety

Devices Clinical Policy

Finance & Operations Human Resources

Information Management Communications

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MHRA Enforcement GroupComposition Head

ofEnforcement

Head ofIntelligence

Head ofOperations

ProsecutionsManager

Business Manager

Case Referral Centre

IntelligenceAnalysts

Intelligence Officers

Investigation Team

London 1

Investigation Team

London 2

Investigation TeamYork

DisclosureOfficer

PropertyOfficer

OfficeSupport Staff

FinancialInvestigators

PolicyAdvisor

ExecutiveSupport

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MHRA Enforcement Responsibilities

• Illegal advertising• Illegal wholesaling• Illegal sale and supply• Illegal importation• Illegal manufacture• Counterfeit medicine• Clinical trial fraud• Unlicensed medicines• Internet supply• Illegal herbal medicines• Diversion• Stolen medicines

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MHRA Enforcement Powers

Medicines Act (1968) Legislation and Powers

• Medicines Act 1968 – max sentence 2 years and/or unlimited fine (array of administrative sanctions also)

• Departmental (Ministerial) solicitors

• Powers available to MHRA Officers:

Entry to commercial premises and private dwellingsInspectionSeizureMHRA has surveillance powers under RIPA 2000MHRA pursues Proceeds of Crime under POCA 2002

• MHRA will use most appropriate offence available in addition to Medicines Act - typically Trade Marks Act 1994 and Fraud Act 2006

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HMA WGEO (Enforcement Network)• Heads of Medicines Agencies Working Group of Enforcement Officers (HMA WGEO) – includes Mentor

• Composition:- Member countries - 27 x EU countries, 3 x EEA countries,

Switzerland – human and veterinary medicines enforcement officers including DRAs, Police and Customs

- Member organisations - European Medicines Agency and European Commission

- Partners - Europol, INTERPOL and the Pharmaceutical Security Institute

- Observer - Croatia

• Mandate –HMA WGEO is established to contribute to the protection of public health and animal health and welfare through ensuring adherence to the regulations of the manufacturing and distribution chains of medicinal products, the disruption of illegal activities and the sharing of information. The HMA WGEO contributes by facilitating Member State/agency liaison, co-operation, co-ordination and exchange of information focusing upon the regulatory responsibility of the HMA. The HMA WGEO shall work in a transparent manner.

• Purpose – the purpose of the HMA WGEO meetings are for the enforcement officers to meet every six months (hosted by the EU Presidency country) to make face-to-face contact with European counterparts to discuss aspects of pharmaceutical crime and particularly counterfeit medicines. It presents a valuable opportunity to share experience, expertise and knowledge and further provides a practical training platform.

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HMA WGEO Workstreams

• Wholesale and Distribution

• Internet (illegal sales of medicines)

• Counterfeit Medicines

• API (counterfeit) and Threats

• Training and Education

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HMA WGEO Examples of Practical Use

1. Counterfeit investigation audit trail -largest penetration of counterfeit medicines into UK supply chain (2007)

- connections to 4 other EU countries- phone calls lead to ‘visits’ on same

day and over next 2 days- investigations revealed audit trail

beyond EU within days- global conspiracy

2. Surveillance of Internet markets

- Tamiflu surveillance- Relenza surveillance- Sibutramine surveillance

3. Rapid Alert System – illegal supply chain

4. Fact finding across European region

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Conclusion• Network invaluable to:

- Share expertise- Share knowledge- Pool resources- Exchange intelligence (with legal gateways)- Deliver/receive training- Promote cooperation and collaboration- Build trust- Foster positive working relationships

• Facilitates multi-Stakeholder and multi-Agency working which:

- provides a united effort to tackle pharmaceutical crime

- significantly enhances ultimate aim to protect public health

• Need for global network(s) for global response to global issue (pharmaceutical crime)

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Questions/Discussion?

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Safeguarding public health

Thank youAll Enforcement enquiries and potential referrals to:

MHRA Case Referrals Centre casereferrals@mhra.gsi.gov.uk or tel +44 (0)20 7084 2330

Nimo AhmedHead of Intelligence,

Enforcement Group,

Medicines and Healthcare products Regulatory Agency.

+44 (0) 207 084 2576

nimo.ahmed@mhra.gsi.gov.uk