1. Strengthening the Protection of Intellectual and Industrial Property Rights Deputy Manager Jan Hylleberg The Danish Association of the Pharmaceutical Industry (Lif) Conference in Warsaw on November 16, 2006

2. Why protection of IPR? To protect investments in R/D To establish a legal frame around IPR owners’ rights and obligations To describe legally what (and when) a generic producer or parallel importer can do (and not do) in relation to patents, trademarks, designs, packages etc. To protect the industry against piracy and counterfeits

3. Danish debate on counterfeit

4. How to debate counterfeit in Europe? WHO’s definition of counterfeit medicines: ”Deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit medicines may include products with the correct ingredients but fake packaging, with the wrong ingredients, without active ingredients or with insufficient active ingredients”.

5. A Danish example

6. Do we have a real problem ? WHO estimates counterfeits at more than 10% of the global medicines market – in underdeveloped countries 25% or more. Counterfeit Viagra ® found in 17 out of 25 EU countries. Court case running in the UK on Lipitor ®.

7. Where do we find counterfeit medicines ? The official channels: Pharmacies – not in Denmark! The unofficial channels: Purchase on the internet Bars and discotheques Fitness centres Other places

8. Confiscations of drugs by customs authorities 2001 - 2005 Source: The Danish Medicines Agency

9. Patient safety ………..!

10. WHO - Declaration of Rome Counterfeiting medicines is widespread and has escalated to such an extent that effective coordination and cooperation at the international level are necessary for regional and national strategies to be more effective. WHO – Declaration of Rome, Feb. 2006

11. What can we do to combat counterfeit medicines?

12. EFPIA’s and Lif’s work on counterfeit medicines EFPIA Anti-counterfeiting Ad Hoc Group Frequently asked questions (”FAQs”) June 2005 Position paper June 2005 White paper November 2005 Implementation For more information see: www.efpia.orgwww.efpia.org

13. EFPIA’s and Lif’s work on counterfeit medicines Content of WHITE PAPER European legislation International collaboration Role of manufacturers, repackagers, wholesalers, distributors and pharmacies Supply Chain Control Communication

14. EFPIA’s and Lif’s work on counterfeit medicines Content of WHITE PAPER European legislation Legal system Intellectual properties – right holders Medical authorities Customs & excise Police

15. EFPIA’s and Lif’s work on counterfeit medicines Content of WHITE PAPER International collaboration Key Stakeholders Government Industry Effective Anti-Counterfeiting Programmes

16. EFPIA’s and Lif’s work on counterfeit medicines Content of WHITE PAPER Role of manufacturers, repackagers, wholesalers, distributors and pharmacies.

17. EFPIA’s and Lif’s work on counterfeit medicines Content of WHITE PAPER Supply Chain Control Regulatory tasks Auditing Internet Wholesale Suppliers Industry’s tasks Track & Trace System Technology and Process

18. EFPIA’s and Lif’s work on counterfeit medicines Content of WHITE PAPER Communication Alliances and partnerships Messages to public authorities / European and national politics Communication within the supply chain

19. EFPIA’s and Lif’s work on counterfeit medicines Global collaboration/effort: IFPMA, ICC, PFIPC, INCB, Europol, EMEA, WHO, BASCAP, PSI, ICN, Council of Europe… www.safemedicines.org http://www.who.int/medicines/services/counterfeit/en/ www.coe.int

20. EFPIA’s and Lif’s work on counterfeit medicines LIF Internal Working group running the activities The Danish Pharmaceutical Association Dialogue meetings Skat – The Danish Taxation and Customs Authority Dialogue meetings Customs declaration The Danish Patent and Trademark Office The Danish Medicines Agency Dialogue meetings (establishment of a new network) Information on the homepage Rapid Alert System

21. EFPIA’s and Lif’s work on counterfeit medicines LIF Focus on improvement of the authorized channels Focus on empty packages National information campaign regarding safe purchase of medicine in Denmark / the risk of buying medicine on the internet Easier access to information about counterfeiting of medicines Conference

22. Are we able to prevent counterfeit medicines and how? Control Cooperation Information Sanctions

23. Information to the public Source: The Daily mail 10.11.05

24. Information to the public Source: The Danish Medicines Agency