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Counterfeit Medical Products:Anti-Counterfeit Medicines programme
update
Dr Lembit RägoCoordinator
Quality Assurance and Safety: Medicines Essential Medicines and Pharmaceutical Policies
World Health Organization
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Overview of key questions
How extensive is the problem?
What is WHO's mandate?
What is the relation between WHO and IMPACT?
What is the outcome of the survey of national legislations?
Future …
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How extensive is the problem? How extensive is the problem?
WHO receiving reports on cases of counterfeit medicines (1982)
No common definition: majority of the reports do not distinguish between substandard, counterfeit medicines, non-authorized
Most cases were are not validated or confirmed– However, certain well documented case studies do exist (e.g. Paul Newton
studies on antimalarials)
Most sources of the counterfeit medicines are unknown
WHO now refrains from making prevalence estimates, only refers to figures prepared and published by national governments
In numbers, counterfeit medicines may be less common than substandard medicines; but the health risks are much greater, and increasing
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WHO Definition of a counterfeit medicine (1992)WHO Definition of a counterfeit medicine (1992)
A product that is:
deliberately and fraudulently mislabeled with respect to source and/or identity.
Counterfeiting can apply to both
generic and branded products.
Counterfeit products may include:– products with the correct ingredients– with the wrong ingredients– without ingredients– with incorrect quantities of active ingredients– with fake packaging
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What is the problem?What is the problem?
Counterfeiting medicines is a lucrative "business" and seems emerging, affecting both developing and developed countries
The real magnitude of the problem is difficult to document both due to methodological, technical and other difficulties
– No scientifically solid methodologies with reasonable price to monitor prevalence
– Laboratory and other costs in case huge number of samples involved may be prohibitive
– Difficulties in disclosing data when investigations ongoing – Many parties reluctant to make data available and report – …
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Counterfeit Lipitor (20mg tablets) Counterfeit Lipitor (20mg tablets)
Text should
be facing
downwards
as above
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Counterfeiting: Counterfeiting: increasingly sophisticated businessincreasingly sophisticated business
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Example of a seizure ….
Ref: Interpol press release: "Arrests and major seizure of counterfeit medicines across Egypt follow international co-operation with INTERPOL and IMPACT stake-holders" (29 May 2009)
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Is there a health risk?Is there a health risk?
– Under treatment or no treatment (= in certain cases death)
Public health risk: ineffective and harmful medicines– Intoxication: harmful ingredients– No quality assurance, no traceability (a must for medicines!)– An effective product recall not possible– Erosion of public confidence in medical care and health systems– Waste of (scarce) money– ….
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1988: Resolution WHA 41.16 requests WHO to initiate programmes for prevention and detection of exportation, importation and smuggling of counterfeit medicines
1992: First international meeting on counterfeit drugs organized by WHO, CIOMS and IFPMA gives first definition of 'counterfeit drug' called all parties involved in manufacturing and distribution as well consumers to collaborate with governmental institutions in combating counterfeit drugs
1994: Resolution WHA 47.13 requests WHO to assist Member States in their efforts aimed at combating counterfeit drugs.
1996: WHO Project on Counterfeit Drugs
WHO mandate and milestones (1)
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WHO mandate and milestones (2)WHO mandate and milestones (2)
2001: WHA Technical Briefing
1994-2008: Several ICDRA* recommendations to WHO to assist Member States to adopt measures to combat counterfeit medicines. Madrid 2004: ICDRA requests WHO to work towards international convention on CF medicines
Seoul 2006: ICDRA endorses establishment of IMPACT, Bern 2008: ICDRA asks WHO further promote a harmonized definition of a counterfeit medical product that is based on the 1992 definition, focuses on the protection of public health, and takes into account the need to safeguard legitimate generic medicines.
2005: No Member States consensus on convention
2006-08: Rome conferences recommend establishment of an international taskforce. Terms of Reference and name (IMPACT) endorsed. WHO Circular Letter announcing the establishment of IMPACT to Member States. IMPACT General Meetings in Bonn, Lissabon and Hammamet.
2009: Discussion in WHO Executive Board; 2 papers to WHA 2009 and 2010
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WHO/EMP
QSM
QAS
IMPACT
Anti-counterfeit medicines WHO
54321
IMPACT Secretariat
WHO/ADG/HSS
WHO web site:WHO documents
IMPACT web site:IMPACT documents
IMPACT Chair 2009-10
http://www.who.int/impacthttp://www.who.int/medicines
Expert Committee
WHO normativedocuments
Relation between WHO and IMPACTRelation between WHO and IMPACT
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Who is/should be in IMPACT ?
Open to all 193 WHO Member States and major international partners, such as:
European Commission
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WHO's work on counterfeit medicines focuses on public health issues, and leaves IPR issues to other agencies
5 IMPACT working groups do not include any IPR agenda
Draft "IMPACT definition" specifically excludes patent disputes, non-authorized products and quality problems in legitimate products
Recent IFPMA statement: counterfeiting has nothing to do with patents, market authorization; all substandards are not counterfeits
Scope of WHO's and IMPACT's counterfeit work: Focus on public health
Scope of WHO's and IMPACT's counterfeit work: Focus on public health
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Issues arising during past months
Discussion during the World Health Assembly in May 2008 and the Executive Board in January 2009:
>- Question of transparency, WHO vs IMPACT activities
- >-Concerns that fight against counterfeit medicines may have negative impact on generics
>-Use of counterfeit argument for limiting free trade / competition / parallel trade
>-Use of term "counterfeit medicinal product" in patent disputes
>-Concerns that technical measures would be too costly, e.g. for OTC and Generics
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WHO Open Forum on IMPACTWHO Open Forum on IMPACT
WHO headquarters, Geneva,
Switzerland ,26 March 2010
EB Room ,09.30 - 12.30
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Circular Letter C.L.25.2009Circular Letter C.L.25.2009
to invite Member States to provide information regarding their use of the term "counterfeit medicines" and/or equivalent in national legislation
to draw the attention of Member States to the IMPACT document: "Draft Principles and Elements for National Legislation against Counterfeit Medical Products" posted on the IMPACT web site for consultation; and to invite Member States to provide comments on the newly proposed IMPACT definition contained therein
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Majority of Member States use the term "counterfeit" (34) in national legislation. Other terms used are: falsified (5), illicit, illegal, unregistered, unauthorized, adulterated, etc
Types of national legislation in which "counterfeit" medicines are addressed: Medicines regulatory related (31); Intellectual property related (8); Crime related (6); No legislation (12); Legislation in preparation (6)
National context of use of term "counterfeit" medicines, or equivalent, vary a lot and include many other aspects (beside the aspects of the WHO 1992 definition): Unauthorized medicines, substandard medicines (e.g. less than 80% of active), IPR infringement, etc
Draft analysis report available on WHO website www.who.int/medicines
Provisional outcome of global survey on national legislation on counterfeit medicines
60 responses in English, French, Spanish, Russian, Arabic:
Provisional outcome of global survey on national legislation on counterfeit medicines
60 responses in English, French, Spanish, Russian, Arabic:
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More details on the web ….
…Open Forum documents posted on web: http://www.who.int/medicines/services/counterfeit/en/
Further information on IMPACT: http://www.who.int/impact/en/