1 Counterfeit Medicines & Japan 1st ASEAN-CHINA Conference on combating Counterfeit Medical Product (Jakarta) 13-15 November 2007 Kazuko KIMURA Prof. Ph.D.

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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 SummitHeiligendamm 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 Framework of the Anti-Counterfeiting Trade Agreement (ACTA) Oct23 2007Trade 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 progres

s- 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 　 International Workshop on Counterfeit Drugs

1995-7 WHO Project on Counterfeit Drugs

JICWEL : Japan International Cooperation of Welfare ServiceJPMA : Japan Pharmaceutical Manufacturers Association

Japan1985 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

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Overview of ActivitiesOverview of Activities

WHO2006 18 Feb 　

DECLARATION OF ROME2006 Nov　 1st IMPACT

General Meeting (Born)2006-2007 Working Group

Activities2007 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 Lessons 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 be continu

ed and strengthened

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Lessons learnt from JPMA/MOH Project Lessons learnt from JPMA/MOH Project of Combating Counterfeit Medicines in of 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 counterfeit Q1 Legislation to combat counterfeit medical productsmedical 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 Q2 National definition of counterfeit medical 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 current Q3 Gaps/Insufficiencies in current legislationlegislation

　　　　 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 gapsQ4 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?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 CoordinationQ6 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 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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Proposals for ActionProposals for ActionMeasures 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 youThank you

Kanazawa University HospitalKanazawa University Hospital