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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.DDrug Management and Policy
Graduate School, Kanazawa University
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Framework of the Anti-CounterfeitingFramework of the Anti-Counterfeiting
Trade Agreement (ACTA) Oct23 2007Trade Agreement (ACTA) Oct23 2007
- Proposed by Junichiro Koizumi, ex-prime minister,Japanin 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 MedicinesActivities by WHO and Japan on Counterfeit Medicines
(ctd)
WHO1985 Conference of Experts on
Rational Use of Drugs (Nairobi)
1992 WHO/IFPMA InternationalWorkshop on Counterfeit Drugs
1995-7 WHO Project on Counterfeit
Drugs
JICWEL : Japan InternationalCooperation of Welfare Service
JPMA : Japan Pharmaceutical ManufacturersAssociation
Japan1985 Participated in the conference
1989- JPMA Study Courses onPharmaceutical 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 andSubstandard Drugs (REMCSD)
1997- JICWELS Study Programme onManifacturing Control of Essential Drugs
2000 JICWELS Issued 2nd Version ofREMCSD
English Chinese Ukrainian GermanyIndonesia
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Overview of ActivitiesOverview of Activities
WHO2006 18 Feb
DECLARATION OF ROME
2006 Nov 1st IMPACTGeneral Meeting (Born)
2006-2007 Working GroupActivities
2007 Nov 1st ASEAN-CHINAConference (Jakarta)
2007 Dec 2nd IMPACT
General Meeting (Lisbon)
Japan2003-2005JICWELS: Counterfeit Drug
Combating Project: Cambodia LaosMalaysia Thailand Vietnam
2006-2007 Participated in IMPACT2006 JPMASupported FAPA congress
symposium on Counterfeit Drugs
2006- JPMA & Cambodian Ministry ofHealth Project of CombatingCounterfeit Medicines
JPMA Donated HPLC, AAS(CAMBODIA / Laos)Dispatch Experts for Technical Transfer
and Training
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Lessons learnt from JICWELS CounterfeitLessons learnt from JICWELS Counterfeit
Drug Combating Project in Lao PDR (2003)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 becontinued and strengthened
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Lessons learnt from JPMA/MOH ProjectLessons learnt from JPMA/MOH Project
of Combating Counterfeit Medicines inof Combating Counterfeit Medicines in
Cambodia 2006-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
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Q1 Legislation to combat counterfeitQ1 Legislation to combat counterfeitmedical productsmedical products
Pharmaceutical Affairs Law prohibits counterfeitmedicines 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 threemillion yen (US$25,000). (article 84)
Q2 National definition of counterfeitQ2 National definition of counterfeitmedical productsmedical products Counterfeits are defined as goods that infringe
patents right, utility model rights, design rights and
trademark rights.
Country ProfileCountry Profile
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Q3 Gaps/Insufficiencies in currentQ3 Gaps/Insufficiencies in current
legislationlegislation
Counterfeit medicines have not been detected inlegitimate channels in Japan. But counterfeit erectiledysfunction (ED) treatment medicines are increasinglysmuggled. In addition, personal imports of medicalproducts for their own use are vulnerable to counterfeit.This may mean that the legislation is not deterrentenough.
Q4 Implications of these gapsQ4 Implications of these gaps
The counterfeit medicines would be more rampantin Japan in the near future.
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Q5 What is being done to fill the gaps?Q5 What is being done to fill the gaps?
In July 2007 the ad hoc Committee for the expediousprovision of medicines for the Ministry of Health, Labourand Welfare (MHLW) stresse a necessity to controlpersonal imports of pharmaceuticals. MHLW
strengthened the warning against personal imports bygeneral public, esp. through brokers on internet.
Japan Customs has admitted import suspensionagainst infringement over trademarks properties of
VIAGRA, Pfizer, LEVITRA, and CIALIS and thepatent property of pyrazol pyrimidin (sildenafil citratetablets).
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Q6 National CoordinationQ6 National Coordination
The APEC IPR Service Center wereestablished to enhance the protection of
intellectual property rights (IPR), esp. the controlof counterfeit and pirated products.
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Number of CasesNumber of CasesSUSPECTED CONFIRMED IMPORTED
/DOMESTIC
NUMBER OF ROSECUTIONS
(Informal Sector)
2006 42(107,000tab Viagra) imported
2005
By Enforcement / investigation work
and Reported by affected manufacturer (Pfizer)
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Thank youThank you
Kanazawa University HospitalKanazawa University Hospital
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