japan jakarta conf

8/3/2019 Japan Jakarta Conf

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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

japan jakarta conf

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