Safeguarding public health European Medicines Enforcement Network 14 th ICDRA, Singapore December 2010 Nimo Ahmed Head of Intelligence Medicines and Healthcare products Regulatory Agency
Outline MHRA Enforcement Group - Composition - Responsibilities - Powers HMA WGEO (Enforcement Network): - Composition, Mandate and Purpose - Workstreams - Examples of Practical Use Conclusion Questions & discussion
MHRA Chief Executive Kent Woods Licensing Vigilance & Risk Management of Medicines Inspection, Enforcement & Standards Devices, Technical & Safety Devices Clinical Policy Finance & Operations Human Resources Information Management Communications
MHRA Enforcement Group Composition Head of Enforcement Policy Advisor Executive Support Head of Intelligence Head of Operations Prosecutions Manager Business Manager Case Referral Centre Intelligence Analysts Intelligence Officers Investigation Team London 1 Investigation Team London 2 Investigation Team York Financial Investigators Disclosure Officer Property Officer Office Support Staff
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
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 dwellings Inspection 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 1994 and Fraud Act 2006
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.
HMA WGEO Workstreams Wholesale and Distribution Internet (illegal sales of medicines) Counterfeit Medicines API (counterfeit) and Threats Training and Education
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
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)
Questions/Discussion?
Safeguarding public health Thank you All Enforcement enquiries and potential referrals to: MHRA Case Referrals Centre casereferrals@mhra.gsi.gov.uk or tel +44 (0)20 7084 2330 Nimo Ahmed Head of Intelligence, Enforcement Group, Medicines and Healthcare products Regulatory Agency. +44 (0) 207 084 2576 nimo.ahmed@mhra.gsi.gov.uk