Transcript Counterfeit Medicines & Japan

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
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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
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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
Japan
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
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
(ctd)
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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
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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%)
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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 20061.
2.
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
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 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
SUSPECTED
2006
CONFIRMED
IMPORTED
/DOMESTIC
NUMBER OF ROSECUTIONS
(Informal Sector)
42(107,000tab Viagra) imported
2005
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 Hospital14