Post on 19-Oct-2020
©
Safeguarding public health
European Medicines Enforcement Network
14th ICDRA, Singapore – December 2010
Medicines and Healthcare products Regulatory Agency
Nimo AhmedHead of Intelligence
©
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 ofMedicines
Inspection, Enforcement & Standards
Devices, Technical & Safety
Devices Clinical Policy
Finance & Operations Human Resources
Information Management Communications
©
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
©
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 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
©
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 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