Transcript Guidelines

Counterfeit Medical Products:
Anti-Counterfeit Medicines programme
update
Dr Lembit Rägo
Coordinator
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?
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
In numbers, counterfeit medicines may be less common than
substandard medicines; but the health risks are much greater, and
increasing
WHO now refrains from making prevalence estimates, only refers to
figures prepared and published by national governments
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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?
 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)
Text should
be facing
downwards
as above
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Counterfeiting:
increasingly 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?
– Under treatment or no treatment (= in certain cases
death)
 Public health risk: ineffective and harmful medicines
–
–
–
–
–
–
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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
….
WHO mandate and milestones (1)
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
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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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Relation between WHO and IMPACT
WHO/ADG/HSS
WHO/EMP
IMPACT Chair 2009-10
QSM
QAS
Anti-counterfeit
medicines WHO
Expert
Committee
IMPACT Secretariat
IMPACT
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3
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WHO normative
documents
WHO web site:
WHO documents
IMPACT web site:
IMPACT documents
http://www.who.int/medicines
http://www.who.int/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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Scope of WHO's and IMPACT's counterfeit work:
Focus on public health
 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
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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 IMPACT
WHO
headquarters,
Geneva,
Switzerland,
26 March 2010
EB Room,
09.30 - 12.30
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Circular 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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Provisional outcome of global survey on national legislation on
counterfeit medicines
60 responses in English, French, Spanish, Russian, Arabic:
 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
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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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Conclusions
• Fighting counterfeit
medicines from the health
perspective is saving
lives
- Working
together with all
parties concerned,
nationally and
internationally, is the key!
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