The Executive Board of the World Health Organization meets next week with significant discussion expected on a new secretariat report on counterfeit medical products
The counterfeit drugs report will be the “big IP item” on the agenda next week, a developed country source predicted. A developing country source predicted a “very difficult discussion” on the document.
Several nongovernmental sources have expressed concern over the use of the term “counterfeit” in general - saying that legally speaking it is associated with violations of trademark law, a legal association which is confirmed in international law by its definition in the World Trade Organization Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement relating it specifically to trademark violations. They also say that even statements within the report itself that “legal instruments related to intellectual property rights have a broad scope and are not focused on the protection of public health,” cannot take away the fact that the terminology is focussed on IP and not on healthcare.
A Brazilian delegate agreed with this assessment, saying “we do not want to see WHO as an agency of enforcement related to trademark,” and the use of the word “counterfeit” automatically brings in discussion of IP, especially given its presence in TRIPS. Further, the delegate added, the work of IMPACT was done outside the WHO and therefore “and we cannot simply import IMPACT recommendations without discussion.” It should not be legitimized as though it were an intergovernmental process, the delegate explained.
A meeting of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) – a taskforce of anti-counterfeiting stakeholders, including pharmaceutical industry associations and drug regulatory authorities, international agencies and non-governmental agencies, and enforcement bodies, launched by the WHO in 2006 – in Tunisia in December 2008, for instance, defined counterfeits in such a way that “disputes about patents” would not be accidentally equated with counterfeits. However, the new report contains the broader statement “recognizing that disputes about IP rights are not to be confused with counterfeiting.” A developed nation delegate said that the patent definition is preferable, but expected disagreement on the issue.
The definition IMPACT agreed on is: “a product with a false representation of its identity and/or source. This applies to the product, its container or other packaging or labeling information. Counterfeiting can apply to both branded and generic products. Counterfeits may include products with correct ingredients/components, with wrong ingredients/components, without active ingredients, with incorrect amounts of active ingredients, or with fake packaging.”
The definition by IMPACT adds that “violations or disputes concerning patents must not be confused with counterfeiting of medical products,” yet there is much concern – particularly on the part of developing countries and non-governmental agencies – that disputes concerning trademarks could still be conflated with counterfeiting.
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)’s director general Alicia Greenidge approved of the report, saying it “touches on some key issues concerning the fight against counterfeits, including the appropriate definition of a counterfeit medicine,” and endorsed the IMPACT definition. She added that “generic medicines play an important role in ensuring global health and are unfortunately themselves widely counterfeited, [therefore] it is important to have a definition which provides guidance that authorized generic medicines are not counterfeits and which also assures that patent actions are not confused with counterfeit actions … this will help authorities in both developing and developed countries to identify and address counterfeits of trademarked products, including the many authorized branded generics.”
