Counterfeit Medicines

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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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Activities by WHO and Japan on Counterfeit
Medicines

• 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

• 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

JICWEL Japan International
Cooperation of Welfare Service JPMA Japan
Pharmaceutical Manufacturers
Association
(ctd)
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Overview of Activities

• 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

• 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)

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Lessons learnt from JICWELS Counterfeit Drug
Combating Project in Lao PDR (2003)

• Counterfeit medicines (n75) 4 (5)
• (2 Ampicillin, Chloramplenicol, Quinine)
• Substandard medicines in terms of quantity (n76)
  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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Q1 Legislation to combat counterfeit medical
products
Country Profile

• 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 (US25,000). (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 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?

• 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

• 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
By Enforcement / investigation work and Reported
by affected manufacturer (Pfizer)
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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
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Thank you
Kanazawa University Hospital