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

Secretariat annotation of EB agenda for this item

The Open-Ended Working Group of Member States on Pandemic Influenza Preparedness: sharing of influenza viruses and access to vaccines and other benefits will meet in December 2010. A report on this meeting and other technical consultations undertaken to support the Group’s work will be made to the Sixty-fourth World Health Assembly, through the Executive Board, as decided in resolution WHA63.1

Comment on this item from PHM Letter to EB member states

The provisions of the Convention on Biological Diversity provide for benefit sharing where biological samples such as viral material are transferred internationally. Resolution WHA60/28 provides a clear direction for managing this issue.

The H5N1 and H1N1 crises have shown the need for a equitable and transparent mechanism for pandemic preparedness that puts public health as a top priority over industry’s profits.

A viable and sustainable system for pandemic preparedness must include sustainable forms of benefit sharing; ad hoc donations are unreliable solutions. This means that recipients of influenza biological materials must commit to benefit sharing on a mandatory basis. This is important to achieve public health objectives as well as to ensure compliance with international obligations under the Convention of Biological Diversity (CBD) to which almost all WHO member states (except for the US) are a party to. The CBD requires that those that receive and use genetic resources must share benefit arising from the use of those resources.

A Standard Material Transfer Agreement (SMTA), constructed as a formal contractual agreement between the provider of biological resource and the recipient of such resource, is a practical way of achieving concrete benefit sharing. MTAs have been used in the sharing of influenza biological material previously and there are no reasons why standardised MTAs should not now be mandated for use in the transfer of influenza biological materials. SMTA must have a contractual binding effect, and contain terms and conditions on the use of influenza biological material as well as benefit sharing to be an effective solution.

Claims of private intellectual property rights over the influenza biological resources or over the products/processes developed using such material should not be allowed by WHO linked centres or by third parties. If third parties are allowed to claim IPRs over the products/processes developed using such material then royalty free licenses must be made available to developing countries.

The definition of PIP biological material in the Framework must include parts of the biological material in particular their genetic and other components and parts thereof, including genes (RNA and DNA), genes sequences and polynucleotides as well as the polypeptides they encode. It further includes sequence data.

The co-chairs of the OEWG should invite civil society organizations to make written submissions as many such organization may be unable to participate the inter-sessional consultations in person due to funding constraints. 

Links

WHO Resolution 60/28 (page 102)

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Briefing_Note_Pandemic_Preparedness_for_PHM.pdf36.9 KB
4-01_PandemicInfluenza_WHOWatchReport_110124_2.pdf76.61 KB