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

The issue raises significant questions regarding intellectual property and technology transfer. There have been some political conflicts associated with the development of this item and the report of the OEWG (A64/8).

More detailed background to this item is provided in the briefing paper prepared by TWN for the EB Watch in January 2011.

See also Influenza on the WHO topics site.

See extract from the PHM letter to EB members before the January EB meeting dealing with this matter.
See EB Watch comment on this item after the January EB meeting.

See PHM statement to the OEWG

See a summary of the framework agreement by Sangeeta Sashikant.

PHM Comment

The H5N1 and H1N1 crises have shown the need for a transparent and equitable mechanism for pandemic preparedness that puts public health as a top priority.  Towards this end it was a necessity to have a Framework with contractual agreements to oblige recipients of biological material to share reasonable benefits to facilitate pandemic preparedness and response particularly in developing countries. 
 
In this regard, we view the recently agreed Framework and the Standard Material Transfer Agreements (SMTA) for sharing of influenza viruses and access to vaccines and other benefits as a positive step forward as it puts in place, for the first time, terms and conditions to govern the sharing of influenza viruses of pandemic potential and obliges the recipients of influenza biological materials to engage in benefit sharing.

However, we believe that the Framework has some shortcomings. In particular it does not secure from the private entities in particular the commercial industry a reasonable level of benefits nor does it contain mandatory commitments to share knowledge,  technology and know-how. For instance the monetary contributions required of the industry is  too low given the profits levels of the  industry. Further the benefit sharing option of manufacturers setting aside 10% of their production of vaccines and antivirals is not sufficient for 80% of the world population found in developing countries and LDCs, in the event of a pandemic. Additionally the  granting of non-exclusive licenses at affordable royalties or royalty free to developing countries for the production of vaccines and other products needed in a pandemic is only a voluntary benefit sharing option under the SMTA. This should instead have been listed as a stand-alone mandatory benefit to facilitate the sharing of knowledge, technology, and know-how, which developing countries need to prepare themselves to counter influenza pandemic.

In this context we would like to express our disappointment with developed countries that placed the interests of the industry and their profits and intellectual property over the interests of global public health, throughout the negotiations on Pandemic Influenza Preparedness, resulting in weak components in the Framework including diluted benefit sharing obligations.

In addition, we note with concern efforts made by some Member States to undermine the relevance of the Convention of Biological Diversity (CBD) and the  Nagoya Protocol on Access and Benefit Sharing in the context of PIP discussions.

We call on the WHO Member states and Dr. Margaret Chan, Director General of the WHO to ensure that the Framework and the SMTAs are implemented in the manner ,that protects and promotes public health and that is consistent with the objectives of the CBD and the Nagoya Protocol.

WHA64 Committee Session Report by PHM