SEA/RC66/11 Rev.1 - Reports of WHO global working/advisory groups: pandemic influenza preparedness framework
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AbstractSince 1957, influenza viruses have been shared by Member States through the WHO global influenza surveillance and response network (GISRS); but in 2007 issues were raised about how this might be linked to access to vaccines and other benefits. To address these issues, resolution WHA60.28 recommended the Director-General to: develop a framework and mechanism for benefit sharing establish an international stockpile of influenza A (H5N1) vaccine prepare guidance on vaccine distribution. The resulting Pandemic Influenza Preparedness Framework (PIP Framework) is expected to enhance capacity for surveillance, risk assessment and early warning. The PIP Framework also aims to prioritize financial and ”in-kind” benefits to developing, H5N1-affected countries that lack capacity to produce/access influenza vaccines, diagnostics and pharmaceuticals, according to public health risk and needs (i.e. there will be a structured approach to the proportional allocation of the benefit to Member States). The financial component of the expected benefit (the Partnership Contribution) is expected to be US$ 28 million per year. Approximately US$ 18 million of the Partnership Contribution was received by WHO in 2012. In order to implement the PIP Framework at national level, Member States should continue to share influenza viruses with pandemic potential with a WHO reference laboratory for influenza of their choice. Transfer of influenza viruses, and products derived from them (also referred to as PIP biological materials), is governed by type 1 and type 2 Standard Material Transfer Agreements (SMTAs). Type 1 SMTAs govern the transfer of viruses from national influenza centres to GISRS laboratories, so their adoption is a part of national implementation. Type 2 SMTAs govern the transfer of viruses to third parties (typically manufacturers of vaccines and pharmaceuticals). Although Member States have no direct role in negotiation of these agreements, they may wish to be aware of how negotiations are proceeding, and how the ensuing benefits are expected to be allocated. To date, negotiation of type 2 SMTAs has been concluded by the WHO Secretariat with only two “third parties” (GSK and the University of Florida), although discussions are underway with an additional five entities. Member States may also consider advocating for a mechanism to allow their needs to be more directly articulated to the Advisory Group/Secretariat in order to inform decisions about the allocation of benefit, and the negotiation of “in-kind” benefits/technology transfer. The High-Level Preparatory (HLP) Meeting held in the Regional Office in New Delhi from 1 to 3 July 2013 reviewed the attached document and made the following recommendations: Actions by Member States (1) To ensure that concerned laboratories continue to share influenza viruses in a timely manner, including those with pandemic potential. Actions by WHO-SEARO (1) To further accelerate the process of negotiating type 2 SMTAs. (2) To ensure the timely involvement of Member States in the process of planning for the use of Partnership Contribution funds. (2) To support the strengthening of national influenza centres and WHO collaborating centres. The working paper and the HLP recommendations are submitted to the Sixty-sixth Session of the Regional Committee for its consideration.
World Health Organization, Regional Office for South-East Asia. (2013). SEA/RC66/11 Rev.1 - Reports of WHO global working/advisory groups: pandemic influenza preparedness framework. WHO Regional Office for South-East Asia. http://www.who.int/iris/handle/10665/128293
Gov't Doc #SEA/RC66/11 Rev.1