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The Members of the World Health Organization (WHO) are trying to step up the fight against counterfeit/falsified medicines. The main stumbling block in endorsing a resolution so far has been with regard to finding a commonly acceptable definition of these so-called 'counterfeit medicines'. The problem is centred on the issue of a potential overlap between intellectual property rights infringements and public health concerns.
The 65th WHA adopted the recommended draft resolution (pdf 20 KB) by consensus at the 130th meeting of the Executive Board. The draft resolution, which was negotiated by a working group of Member States - including Switzerland - in autumn 2011, deliberately no longer takes a position on the disputed definition of SSFFC medical products, but instead concentrates on the role of the WHO in helping to make available good and affordable medicinal products. It was, however, agreed to form a Member State mechanism. This mechanism is to take the form of a permanent body mainly constituted of representatives from regulatory authorities and is to coordinate the work of the WHO in the field of SSFFC. The terms of reference relating to goals, membership etc. of the new mechanism have already been included as an annex in the resolution. Even though this has not been explicitly stated, it appears that the new mechanism will, in future, replace the International Medical Products Anti-Counterfeiting Taskforce (IMPACT). The majority of states have recognised de facto that IMPACT has been clinically dead for some time due to the lack of a WHO Member States’ mandate and has consequently become irrelevant. In November 2012, Argentina proposed to organise a first meeting in Buenos Aires and to contribute towards the costs. Norway and the USA would like an initial preparatory meeting to be held in Geneva.
From Switzerland’s perspective, the definition dispute in the field of counterfeit /dangerous medicinal products appears - with the newly formed mechanism – to have been outsourced to a regulatory panel of experts and thus, to a certain extent, have been depoliticised.
At the end of May 2011, the 63rd World Health Assembly extended the Working Group’s mandate on “substandard/spurios/falsely-labelled/falsified/counterfeit/medical products” by a year, as discussions have not made substantial progress until now.
The 63rd World Health Assembly adopted a resolution on the subject of counterfeit medicines (substandard/spurious/falsely-labelled//falsified/counterfeit medical products). Thereby it was decided to form a working group, open to all member states, to analyse the role of the WHO in establishing measures to ensure the availability of safe, effective and first-class medicines as well as the relation of the WHO to the International Medical Products Anti-Counterfeiting Taskforce (IMPACT). However, in so doing the working group should explicitly limit their work to the aspects of public health and exclude commercial and immaterial propriety aspects.
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