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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/

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•Fighting counterfeit medicines from the health

perspective is saving lives

-Working together with all parties concerned,

nationally and internationally, is the key!

Conclusions