DG Enterprise and Industry Approach on Combating Counterfeit Medicines

1. European Commission Council of Europe Conference “Europe against Counterfeit Medicines” Session: Key Actors and Collaboration Partners DG Enterprise and Industry Approach on Combating Counterfeit Medicines Sabine Atzor Pharmaceuticals Unit – DG Enterprise and Industry European Commission, Brussels

2. Counterfeits in the EU • 1000% increase in counterfeit seizures in general between 1998 and 2004(DG TAXUD) • Counterfeit medicines 2001 – 2005 • 27 cases in legitimate supply chain • 170 cases in illegitimate supply chain (EU Medicines Enforcement Officers Survey)

3. Press Release: 27 March 2006Commission warns about fake drugs on the internet • Unlicensed and counterfeit Rimonabant sold over the internet • Fake copies of ViagraR, CialisR, TamifluR • Vice-President Günter Verheugen:„ I am alarmend at the ever increasing number of counterfeit medicines sold via Internet. This represents a real danger to the health of patients. The Commission is working with European and international partners to do everything possible to ensure legal methods for marketing of medicines are respected and enforced.“

4. Areas of action

5. Four Key Areas of Interest • Legislation re.- legitimate supply chain- avoiding illegitimate supply chain • Supervision/ Enforcement • Cooperation/ Communication • Awareness Raising

6. FourSteps approach • Analysis of the current situation in four key areas with subtopics • Development of policy optionsto fill in possible gaps for each subtopic • Impact assessmenton policy options for each subtopic • Development of a strategy paper with proposals for next steps (e.g. Commission communication, legislative proposals)

7. 1. Legislation - Subtopics Illegitimate supply/ distribution chain • Definition of counterfeit & pharmaceutical crime • Import, export, transshipment • Active substance control • Internet (potential to be used for illegal purposes) Legitimate supply/ distribution chain • Wholesalers • Internet • Packaging, relabelling activities • Guideline on GMP, GDP • Technologies (e.g. Markers, Track & Trace)

8. 2. Supervision/ Enforcement - Subtopics • Sampling of medicinal products • Regulatory requirements • National resources for sampling in the legitimate and illegitimate supply chain • Coordination activities • Testing of medicinal products • Inspection procedures and practices • To address counterfeit during GMP/ GDP inspections

9. 3. Cooperation & Communication Subtopics • National/ Member State level • European Union level • International level • Industry and authorities • Databases • Pharmacoviliance reporting • Rapid Alert System • Training of regulators

10. 4. Awareness raising • Analysis of existing programmes/need for additional programmes forawareness raising of the public (e.g. illegal trade via internet)

11. Summary • The DG ENTR project will focus on concrete actions for the EU. • The objective of the EC strategy is to • focus on potential areas for EC legislation • focus on aspects of international cooperation • consider any measures to combat counterfeiting in a broader context • The DG ENTR project builds on existing information (WHO, CoE, US-FDA etc.)

12. Thank you for your attention