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Title: SEA/RC62/20 - Follow-up action on pending issues and selected regional committee resolutions/decisions for the last three years: pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits
Authors: World Health Organization, Regional Office for South-East Asia
Issue Date: 21-Jul-2009
Publisher: WHO Regional Office for South-East Asia
Place of publication: New Delhi
Language: English
Abstract: Viruses have been freely shared through WHO Collaborating Centres on Influenza for the purpose of risk assessment and vaccine production. In 2007 Indonesia proposed that sharing of H5N1 avian influenza viruses should be tied to benefits of affordable and available vaccine. This led to a halt in the practice of freely sharing influenza viruses. A number of unsuccessful attempts have been made to resolve this impasse. The last Intergovernmental Meeting (IGM) was convened before the World Health Assembly, on 16-17 May 2009 in Geneva. The meeting ended with a consensus on most issues, but left data-sharing between laboratories and intellectual property rights on viruses unresolved. The main areas of progress have been in consolidating the system, structure and mechanisms of virus sharing, and include the establishment of a traceability mechanism in January 2008 to track all shared H5N1 viruses; an interim system providing full disclosure of information on transfer and movement of virus; establishment of an advisory mechanism by the WHO Director-General to monitor the functioning of the NIC and WHO Collaborating Centres; establishment of an international stockpile of vaccines for H5N1 funded by the Gates Foundation; and strengthening surveillance at animal-human interface through collaboration between WHO, FAO, UNICEF and OIE. In addition, two working groups on a Standard Material Transfer Agreement (SMTA) and terms of reference for WHO CCs and WHO H5N1 Reference labs were established. The specific policy-related technical issues are: specific clauses of IHR (2005) may need to be modified to ensure compliance with virus sharing; vaccine sharing mechanisms and agreements need to be developed between Member States; benefits must be concrete, clear and provided to developing countries, especially affected countries; do countries have sovereign right over their biological resources?; epidemiologic data related to influenza burden (both seasonal and novel pandemic influenza) are needed to justify expansion of influenza vaccine production. In addition, there is a need to explore innovative mechanisms for licensing existing or future intellectual property rights and of platforms to promote access to vaccine technology by developing countries and specific financing and funding mechanisms that could be made available to developing countries to purchase vaccine and to ensure adequate funding for needed activities such as rapid vaccine deployment. The attached working paper was submitted to the High-Level Preparatory (HLP) Meeting for its review and recommendations for consideration by the Sixty-second Session of the Regional Committee. The HLP meeting made the following recommendations: Action by Member States (1) To continue to strengthen their surveillance, diagnostic capacity and networking; (2) to explore ways to strengthen their research and development capacity, including vaccine production; and (3) to consider developing intercountry collaboration to ensure diagnostic capacity, and that vaccines are accessible to all countries in the Region. Action by WHO/SEARO (1) To support Member States in developing their national core capacities to implement International Health Regulations (IHR 2005) including surveillance and laboratory capacity to detect, diagnose and respond to public heath events of international concern; (2) to facilitate the process of bringing together potential partners for a public–private collaboration; (3) to support resource mobilization to assist vaccine production efforts in the Region; and (4) the Regional Office will take forward the seven recommendations agreed to by all Member States in July 2008, which include a firm recommendation to ensure that the sharing of biologicals and sharing of benefits take place on an equal footing. The paper is now submitted to the Sixty-second Session of the Regional Committee for its consideration.
Gov't Doc #: SEA/RC62/20
Appears in Collections:Regional Committee Meeting 62 Kathmandu, Nepal, 7-10 September 2009

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