1. 1 Counterfeit Medicines & Japan 1st ASEAN-CHINA Conference on combating Counterfeit Medical Product (Jakarta) 13-15 November 2007 Kazuko KIMURA Prof. Ph.D Drug Management and Policy Graduate School, Kanazawa University

2. 2 Heiligendamm G8 Summit 8 th June, 2007 Promoting Innovation - Protection Innovation - Welcome work on the WHO initiative to implement the IMPACT. -Strengthen cooperation among countries, WIPO, WTO, WCO, Interpol, WHO, OECD, APEC and CE

3. 3 Framework of the Anti-Counterfeiting Trade Agreement (ACTA) Oct23 2007 - Proposed by Junichiro Koizumi, ex-prime minister,Japan in 2005 at Gleneagles summit - Counterfeits and piracies threat not only to economics but also to consumers health and safety - A meeting to be held in Geneva 2007 - The TOYAKO Summit 2008 will take stock of the progress - Watch its effectiveness against counterfeit medical products

4. 4 Activities by WHO and Japan on Counterfeit Medicines (ctd) WHO 1985 Conference of Experts on Rational Use of Drugs (Nairobi) 1992 WHO/IFPMA International Workshop on Counterfeit Drugs 1995-7 WHO Project on Counterfeit Drugs JICWEL : Japan International Cooperation of Welfare Service JPMA : Japan Pharmaceutical Manufacturers Association Japan 1985 Participated in the conference 1989- JPMA Study Courses on Pharmaceutical Quality Control Supply of Reference Substances 1993-1996 JICWELS Counterfeit Drug Project 1995-7 Supported the WHO project 1997 JICWELS published Rapid Examination Methods against Counterfeit and Substandard Drugs (REMCSD) 1997- JICWELS Study Programme on Manifacturing Control of Essential Drugs 2000 JICWELS Issued 2nd Version of REMCSD English Chinese Ukrainian Germany Indonesia

5. 5 Overview of Activities WHO 2006 18 Feb DECLARATION OF ROME 2006 Nov 1st IMPACT General Meeting (Born) 2006-2007 Working Group Activities 2007 Nov 1st ASEAN-CHINA Conference (Jakarta) 2007 Dec 2nd IMPACT General Meeting (Lisbon) Japan 2003-2005 JICWELS: Counterfeit Drug Combating Project: Cambodia Laos Malaysia Thailand Vietnam 2006-2007 Participated in IMPACT 2006 JPMA Supported FAPA congress symposium on Counterfeit Drugs 2006- JPMA & Cambodian Ministry of Health Project of Combating Counterfeit Medicines JPMA Donated HPLC, AAS (CAMBODIA / Laos) Dispatch Experts for Technical Transfer and Training

6. 6 Lessons learnt from JICWELS Counterfeit Drug Combating Project in Lao PDR (2003) Counterfeit medicines (n=75) : 4 (5%) (2 Ampicillin, Chloramplenicol, Quinine) Substandard medicines in terms of quantity (n=76) : 28(37%) - Suspect counterfeit medicines exist in Lao PDR. - Substandard medicines is a larger problem. - The efforts to ensure quality of medicines be continued and strengthened

7. 7 Lessons learnt from JPMA/MOH Project of Combating Counterfeit Medicines in Cambodia 2006- 1. Different definitions change the prevalence of counterfeit medicines : 0 by WHO definition 2(0.79%) by Cambodian definition (Unregistered ones out of specification) 2. Functional registration system be established. (i) 42 out of 200 labeled registration were judged wrong by FDA (ii) 7 out of 9 medicines failed in laboratory tests were registered

8. 8 Q1 Legislation to combat counterfeit medical products Pharmaceutical Affairs Law prohibits counterfeit medicines from sales, grants, store and exhibit for sales or grants. (article 55) The violator is sentenced to imprisonment less than three years and/or subject to penalties less than three million yen (US$25,000). (article 84) Q2 National definition of counterfeit medical products Counterfeits are defined as goods that infringe patents right, utility model rights, design rights and trademark rights. Country Profile

9. 9 Q3 Gaps/Insufficiencies in current legislation Counterfeit medicines have not been detected in legitimate channels in Japan. But counterfeit erectile dysfunction (ED) treatment medicines are increasingly smuggled. In addition, personal imports of medical products for their own use are vulnerable to counterfeit. This may mean that the legislation is not deterrent enough. Q4 Implications of these gaps The counterfeit medicines would be more rampant in Japan in the near future.

10. 10 Q5 What is being done to fill the gaps? In July 2007 the ad hoc Committee for the expedious provision of medicines for the Ministry of Health, Labour and Welfare (MHLW) stresse a necessity to control personal imports of pharmaceuticals. MHLW strengthened the warning against personal imports by general public, esp. through brokers on internet. Japan Customs has admitted import suspension against infringement over trademarks properties of VIAGRA, Pfizer, LEVITRA, and CIALIS and the patent property of pyrazol pyrimidin (sildenafil citrate tablets).

11. 11 Q6 National Coordination The APEC IPR Service Center were established to enhance the protection of intellectual property rights (IPR), esp. the control of counterfeit and pirated products.

12. 12 Number of Cases SUSPECTEDCONFIRMEDIMPORTED /DOMESTIC NUMBER OF ROSECUTIONS (Informal Sector) 200642(107,000tab Viagra) imported 2005 By Enforcement / investigation work and Reported by affected manufacturer (Pfizer)

13. 13 Proposals for Action Measures to be taken Control personal import esp. through internet Who should do it Ministry of Health, Labors & Welfare Critical factors to ensure success Raise awareness of general public against the risk of personal import Realistic timeframe Efforts have started Until the problem solved

14. 14 Thank you Kanazawa University Hospital