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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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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


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Heiligendamm G8 Summit

8th 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


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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


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WHO Oct23 2007

1985Conference of Experts on Rational Use of Drugs (Nairobi)

1992WHO/IFPMAInternational Workshop on Counterfeit Drugs

1995-7 WHO Project on Counterfeit Drugs

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

Activities by WHO and Japan on Counterfeit Medicines

JICWEL : Japan International

Cooperation of Welfare Service

JPMA : Japan Pharmaceutical Manufacturers

Association

(ctd)


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WHO Oct23 2007

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)

Japan

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 Training

Overview of Activities


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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


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Lessons learnt from JPMA/MOH Project of Combating Counterfeit Medicines in Cambodia 2006-

  • Different definitions change the prevalence of counterfeit medicines :

    0 by WHO definition

           ↓

    2(0.79%) by Cambodian definition (Unregistered ones out of specification)

  • 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


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Country Profile Counterfeit Medicines in Cambodia 2006-

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.


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Q3 Gaps/Insufficiencies in current legislation Counterfeit Medicines in Cambodia 2006-

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.


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Q5 What is being done to fill the gaps? Counterfeit Medicines in Cambodia 2006-

・ 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).


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Q6 National Coordination Counterfeit Medicines in Cambodia 2006-

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


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Number of Cases Counterfeit Medicines in Cambodia 2006-

By Enforcement / investigation work

and Reported by affected manufacturer (Pfizer)


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Proposals for Action Counterfeit Medicines in Cambodia 2006-

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


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Thank you Counterfeit Medicines in Cambodia 2006-

Kanazawa University Hospital


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