The review addresses concerns that the proposed redefinition, discussed at a recent meeting in Geneva, Switzerland, would have been used to label legitimate generic products as fake during intellectual property (IPR) litigation in countries where patent law is a problem area.
A World Health Organization (WHO) spokesperson told in-PharmaTechnologist that, while member states agreed on the importance of addressing the health impacts of pharmaceutical counterfeiting, 25 countries in five regions had filed interventions seeking further information on the redefinition.
She explained that some members were concerned that: “The term 'counterfeit' is associated with trademark violations as defined in the WTO's Trade-related Aspects of Intellectual Property Agreement (TRIPS),” and that the WHO was becoming too involved in IPR.
“Some members, primarily developing countries, expressed concern about possible conflict of interest in the working methods of WHO and IMPACT [International Medical Products anti-counterfeiting taskforce] membership,” she continued.
As a result of these concerns the WHO executive board did not reach agreement on either the role of organisation in the global war on fake drugs or on the final wording of the proposed redefinition.
The spokesperson added that: “[The] WHO will carefully study the comments received [at] meeting and will submit a new report, without resolution, to the World Health Assembly. The report will focus on the public health impacts of substandard, spurious, and falsely labelled products and WHO's role in providing support to Member States.”