Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits (WHO, extract, edited)

[Giuseppe]

Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits (WHO, extract, edited)

[Source: World Health Organization, Full PDF Document (LINK). Extract, edited.]

SIXTY-THIRD WORLD HEALTH ASSEMBLY A63/4 - Provisional agenda item 11.1 - 15 April 2010

Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits

Outcome of the process to finalize remaining elements under the pandemic influenza preparedness framework for the sharing of influenza viruses and access to vaccines and other benefits


Report by the Secretariat

1. In May 2007, the Health Assembly adopted resolution WHA60.28 on Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits, which focused on the risks of pandemic influenza, its likely impact in all sectors of society and the need for access, at the earliest time possible, to vaccines. The resolution urged Member States to support the WHO Global Influenza Surveillance Network and its procedures and to ensure and promote transparent, fair and equitable sharing of benefits arising from the generation of information, diagnostics, medicines, vaccines and other technologies.
2. In that resolution, the Health Assembly requested the Director-General, inter alia, to convene an intergovernmental meeting to consider frameworks and mechanisms to strengthen the timely sharing of influenza viruses with pandemic potential and the equitable access to benefits, with a view to increasing global preparedness for pandemic influenza.
3. Over the course of several sessions, the Intergovernmental Meeting on Pandemic Influenza Preparedness: Sharing of Influenza Viruses and Access to Vaccines and Other Benefits drafted and negotiated a Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and Other Benefits,1 making significant progress and reaching consensus on certain principles, notably the commitment by Member States to share, on an equal footing, influenza viruses with pandemic potential and benefits, considering these as equally important parts of the collective action for global public health. Several mechanisms were also adopted by consensus and established: an Influenza Virus Traceability Mechanism within WHO; an Advisory Group; and Terms of Reference for the four categories of laboratories within the WHO Global Influenza Surveillance Network.
4. Although consensus was reached on most of the provisions in the Framework, several significant areas remained unresolved when the Intergovernmental Meeting concluded its work and submitted its outcome document to the Director-General for transmission to the Sixty-second World Health Assembly.
5. In May 2009, the Health Assembly adopted resolution WHA62.10 on Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits. It requested the Director-General, inter alia, to facilitate a transparent process to finalize the remaining elements, including the Standard Material Transfer Agreement and its annex, and report the outcome to the Executive Board at its 126th session in January 2010.
6. The process adopted in order to respond to the Health Assembly?s mandate included:
   • (a) review and analysis of the positions expressed during the Intergovernmental Meeting on the key outstanding issues;
   • (b) production of a paper setting out specific proposals for finalizing the remaining issues (attached at Annex); and
   • (c) a two-day consultation with Member States and regional economic integration organizations, facilitated by the Director-General, to discuss the proposals.
7. The consultation, held on 19 and 20 October 2009, was attended by some 74 Member States, one regional economic integration organization and two international organizations. The discussions focused on three unresolved elements under the Framework: the Standard Material Transfer Agreement; benefit sharing; and intellectual property rights. The Secretariat underscored its intent to find a middle ground to bridge the wide divergences remaining among Member States on these three critical issues.
8. There was broad support for a system for sharing viruses and benefits that would be more sustainable, predictable and structured than the current ad hoc arrangement for sharing of vaccines and other benefits. Additional outcomes of the meeting include:
   • (a) The Standard Material Transfer Agreement. Two conclusions were drawn from the discussions:
     • (i) A stepwise approach,1 aimed at developing mechanisms to deal progressively with all relevant entities receiving biological materials from the WHO Global Influenza Surveillance Network, was deemed appropriate by many Member States. Such an approach should be flexible enough to accommodate steps taken in parallel.
     • (ii) A streamlined Standard Material Transfer Agreement, which would apply within the WHO Global Influenza Surveillance Network, was considered practical and realistic. It was stressed that any such Agreement would have to be read in conjunction with applicable terms of reference for Network?s laboratories, as contained in the Framework.

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1 Document A62/5 Add.1, Annex.
1 It was understood that a ?stepwise? approach encompassed both sequential and parallel efforts to address benefitsharing arrangements with the range of entities outside the WHO Global Influenza Surveillance Network.
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