REGIONAL COMMITTEE 14.5
Provisional Agenda item
Sixty-second Session Kathmandu, Nepal 7–10 September 2009
SEA/RC62/18 Rev. 6 August 2009
FOLLOW-UP ACTION ON PENDING ISSUES AND SELECTED REGIONAL COMMITTEE RESOLUTIONS/DECISIONS FOR THE LAST THREE YEARS: COMBATING COUNTERFEIT MEDICAL PRODUCTS The involvement of WHO in combating counterfeit medicines is based on its role in public health; counterfeit medicines would affect the health-care system and lead to adverse health effects. Counterfeit medicines also involve many other areas such as commerce, law enforcement and intellectual property rights, which make the issue complex. WHO has been engaged in combating counterfeit medicine since 1985, but this paper discusses activities since 2008. Following the World Health Assembly discussions on the topic in 2008, the WHO Regional Committee for South-East Asia discussed the issue and developed a clear definition of counterfeit medical products that clearly excluded intellectual property disputes. During the discussions at the Executive Board in Geneva in January 2009, there were certain extraneous incidents that sought to link intellectual property rights to counterfeit products. This resulted in a request for further information to be presented at the 2009 World Health Assembly. The issue was, however, not taken up at the World Health Assembly due to the shortened session. There are many issues that are still unresolved and this paper poses questions that need to be dealt with by Member States before the World Health Assembly in 2010. The attached working paper was submitted to the High-Level Preparatory
(HLP) Meeting for its review and recommendations for consideration by the Sixty-second Session of the Regional Committee. The HLP meeting proposed a draft resolution for the consideration of the Regional Committee. The paper is now submitted to the Sixty-second Session of the Regional Committee for its consideration, and for its decision regarding the resolution proposed by the HLP meeting.
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Introduction 1. WHO's involvement in combating counterfeit medicines is based on it’s role in public health; counterfeit medicines would affect the health-care system and lead to adverse health effects. However, the issues in counterfeit medicines extend far beyond health and involve many other areas such as commerce, law enforcement, intellectual property rights etc. These, in turn, lead to involvement of actors in other sectors both at national and international levels. 2. The issue of counterfeit medicines was on the agenda of the Sixty second
World Health Assembly in May 2009 but was deferred to the World Health Assembly in May 2010. This paper provides the background to the subject and concludes with issues that Member States need to address if progress is to be made at the World Health Assembly in 2010.
Background 3. While WHO has been engaged in combating counterfeit medicine since 1985, a useful starting point for the current discussion would be from 2008. After the deliberations at the World Health Assembly in May 2008, where further information was requested, the South-East Asia Region had an Intercountry Consultation on Combating Counterfeit Medicines in August 2008 and produced a document for the Regional Committee. Counterfeits were defined and Intellectual Property Rights disputes (patents, trademarks) were separated from counterfeits. The Regional Committee was requested to decide whether the definition should include medical diagnostics and devices (thereby making it products) or limit it to medicines. The Regional Committee decided that it should include diagnostics and devices and therefore made it “Medical Products”. 4. This definition was circulated to other regions and Latin American countries
too agreed with the definition. It was also discussed at the International Medical Products Anti-Counterfeiting Taskforce (IMPACT – the secretariat is situated in WHO) meeting in Bonn in November 2008 as a part of the Draft Principles and Elements for National Legislation against Counterfeit Medical Products.
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5.
The definition at that time of a counterfeit medical product was: “A medical
product is counterfeit when there is a false representation in relation to its identity or source. This applies to the product, it’s container or other packaging or labelling information. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct components or with the wrong components, without active ingredients, with incorrect amounts of active ingredients or with fake packaging. Quality defects or Good Manufacturing Practices / Good Distribution Practices, non-compliance in legitimate, authorized medical products should not be confused with counterfeiting. Counterfeits were also described as being the result of deliberate and fraudulent activities”. 6. The definition was discussed at the general meeting of IMPACT in December
2008 in Tunisia and adopted. Some minor changes were made at the IMPACT meeting to accommodate legal requirements but these did not alter the differentiation between counterfeits as products that are deliberately and fraudulently mislabeled with respect to its identity and/or source, and IPR (patents and trademarks) disputes. 7. The issue of combating counterfeits was discussed by the WHO Executive
Board at its 124th session in January 2009. At this time the Netherlands customs seized a legitimate consignment of pharmaceutical raw material from India bound for Brazil that was in transit through the Amsterdam airport and the label “counterfeit” was tagged onto this. This reawakened all the issues that had been carefully and deliberately laid to rest in the past six months. 8. As recently as May 2009, a shipment of amoxicillin (a medicine that is over 30
years old and has no patent issues) was seized by customs officials under European Union Regulation on Border Measures and released a month later. 9. It was clear that the issue of counterfeit medicines was being used by various
parties for other agendas and developing countries (with quite some justification) saw this as an attempt to block access to affordable medicines by the multinational pharmaceutical companies in association with the developed world countries. 10. The WHO Executive Board requested the WHO secretariat to submit information documents for the World Health Assembly for further discussion; there was no mention of a draft resolution. The two documents attached as Annexes are a part of the World Health Assembly documentation. (WHA A62/13–Counterfeit medical products, Report by the Secretariat and A62/14 Counterfeit medical
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products, International Medical Products Anti-Counterfeiting Taskforce, Report by the Secretariat). 11. The World Health Assembly was shortened and the agenda item on Combating Counterfeit Medicines was postponed to next year. However, there was some discussion on it at the briefing for delegates from the South-East Asia Region on 8 May 2009. India produced a draft resolution with an emphasis on improving medicines regulation for combating counterfeits which was supported by Thailand. 12. A major point of contention is the definition of a substandard medicine. Clearly, a medicine which does not meet the pharmacopoeial standard is easy to classify as a substandard medicine. However, a medicine that meets the pharmacopoeial standards but has been given marketing approval based on information that was deliberately false (e.g. claimed to have been manufactured by company A whereas it was made by company B) poses a different set of issues. Such a product will not create an immediate problem to the patient receiving the medicine but has violated the system of drug registration. Is such a medicine a substandard medicine? Who should deal with such medicines and how? 13. There is a continuing debate on the issue and Member States in the Region need to address the following issues. (1) Does the definition of counterfeit medicines satisfy the primary objective of public health and, almost as importantly, not stray into Intellectual Property Rights? The latter is important as otherwise it would involve WHO in issues outside its mandate. (2) Presently the term is “counterfeit”; however, the terms spurious, substandard, fake and similar are being used and are included in the legislation of Member States. These terms also have a meaning on their sub-standard drug may or may not be a counterfeit. Should there be a clarification, and standardization of terms? Or once there is international consensus, can national legislation be adapted? (3) Substandard pharmacopoeial standards are clear; are medicines that meet the also substandard? medicines as defined by products failing to meet own as well as being associated with the term counterfeit. For example, a
pharmacopoeial standards but have false information for market approval,
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(4)
At what level should the definition of counterfeit medicines be agreed upon? Usually technical matters are deliberated, discussed and decided upon by an Expert Advisory Committee and the results are presented to the World Health Assembly for noting. Given the debate and discussion that counterfeit medicines have caused, at what level should the definition be discussed and accepted? Does the definition require deliberation at the World Health Assembly?
(5)
How can boundaries be drawn between the various international
organizations dealing with counterfeits? For example, counterfeits would involve Interpol, the World Trade Organization and the World Intellectual Property Organization. Where does the role of WHO (and public health) end and other organizations such as WIPO take over?
(6)
IMPACT is one among the many taskforces in WHO; there are participants from the pharmaceutical industry. WHO has strict rules on conflict of interest, but where necessary and with appropriate safeguards, the ivermectin donations for eradication of river blindness in Africa). Do Member States think the taskforce mechanism (and those in the taskforce) what alternative strategies do they suggest? is appropriate for dealing with the issue of counterfeit medicines? If not, pharmaceutical industry has been involved in WHO activities (e.g.
(7)
“Counterfeits” interpreted beyond the scope that was intended have affected access (e.g. seizing of generic medicines in transhipment at the Amsterdam airport). How can it be ensured that this is not repeated?
14. These issues need to be discussed and dealt with by Member States before the World Health Assembly in May 2010.