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. Heiligendamm G8 Summit. 8 th June, 2007.
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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
8th June, 2007
1985Conference of Experts on Rational Use of Drugs (Nairobi)
1992WHO/IFPMAInternational Workshop on Counterfeit Drugs
1995-7 WHO Project on Counterfeit Drugs
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 IndonesiaActivities by WHO and Japan on Counterfeit Medicines
JICWEL : Japan International
Cooperation of Welfare Service
JPMA : Japan Pharmaceutical Manufacturers
2006 18 FebDECLARATION OF ROME
2006 Nov1st IMPACT General Meeting (Born)
2006-2007 Working Group Activities
2007 Nov 1st ASEAN-CHINA Conference (Jakarta)
2007 Dec 2nd IMPACT General Meeting (Lisbon)
2003-2005JICWELS: Counterfeit Drug Combating Project: Cambodia Laos Malaysia Thailand Vietnam
2006-2007 Participated in IMPACT
2006 JPMASupported 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 TrainingOverview of Activities
Counterfeit medicines (n=75) : 4 (5%)
(2 Ampicillin, Chloramplenicol, Quinine)
Substandard medicines in terms of quantity (n=76) : 28(37%)
0 by WHO definition
2(0.79%) by Cambodian definition (Unregistered ones out of specification)
(i) 42 out of 200 labeled registration were judged wrong by FDA
(ii) 7 out of 9 medicines failed in laboratory tests were registered
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.
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.
・ 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).
The APEC IPR Service Center were established to enhance the protection of intellectual property rights (IPR), esp. the control of counterfeit and pirated products.
By Enforcement / investigation work
and Reported by affected manufacturer (Pfizer)
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
Efforts have started
Until the problem solved
Kanazawa University Hospital