[Ip-health] WHO/EMP Response to TWN

BAGOZZI, Daniela bagozzid at who.int
Mon Nov 30 10:26:15 PST 2015

TWN has recently made several postings on IP-Health related to the Member State Mechanism on Substandard, Spurious, Falsely labelled, Falsified and Counterfeit (SSFFC) medical products.  WHO would like to clarify a few issues, in particular with reference to postings made on 19 November: “TWN Info: WHO proposes to join Global Fund's IP enforcement initiative”, and on 26 November: "TWN Info (IP/Health): WHO: Expert working group on SSFFC definitions established".

WHO’s work in the area of SSFFC medical products is concerned with protecting public health and does not consider any aspect of intellectual property protection, as clearly outlined in resolution WHA/65.19 (http://www.who.int/medicines/services/counterfeit/mechanism/WHA65.19_extract.pdf?ua=1). The WHO position is that people everywhere should have access to quality-assured essential medicines that will save or improve their lives.  Among several activities to expand access, WHO has been prequalifying quality generic medicines since 2001, thereby facilitating access to priority treatments for millions of patients in the developing world.

With respect to the SSFFC Member State Mechanism's participation in the Global Fund's Global Steering Committee (GSC) for quality assurance of health products, the Member State Mechanism concluded, at its Geneva meeting on 19-20 November, 2015, that WHO should attend GSC meetings as a provisional observer, and requested further reporting to the Member States on the legal status, activities and future membership of the committee.

As the global health agency, WHO's observer status in such a committee is perfectly within its mandate, and is focused on ensuring the quality of the medicines supplied under international procurement.  Further, as there are overlaps in the work plans of the Member State Mechanism and the GSC, it is also in the interest of avoiding duplication of efforts and saving resources that WHO's attendance will take place.

On the issue of a possible expert working group on SSFFC definitions, WHO can only reiterate that its own and the Member State Mechanism's approach to SSFFC medical products is strictly public health oriented, has expressly excluded any consideration of intellectual property protection, and will continue to do so.

WHO/Essential Medicines and Health Products Department

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