Counterfeit Medical Products: Anti-Counterfeit Medicines programme update

1. 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

2. 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 …

3. 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

4. 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

5. 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 • …

6. Counterfeit Lipitor (20mg tablets) Text should be facing downwards as above

7. Counterfeiting: increasingly sophisticated business

8. 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)

9. 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 • ….

10. 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 medicines1992: 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

11. 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

12. Relation between WHO and IMPACT WHO web site: WHO documents IMPACT web site: IMPACT documents WHO/ADG/HSS WHO/EMP IMPACT Chair 2009-10 QSM QAS Anti-counterfeit medicines WHO IMPACT Secretariat IMPACT Expert Committee 1 2 3 4 5 WHO normative documents http://www.who.int/medicines http://www.who.int/impact

14. European Commission Who is/should be in IMPACT ? Open to all 193 WHO Member States and major international partners, such as:

15. 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

16. 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

17. WHO Open Forum on IMPACT WHO headquarters, Geneva, Switzerland, 26 March 2010 EB Room, 09.30 - 12.30

18. 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

19. Provisional outcome of global survey on national legislation on counterfeit medicines60 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

20. 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/

21. Conclusions • • Fighting counterfeit medicines from the health perspective is saving lives • - Working together with all parties concerned, nationally and internationally, is the key!