Debate on access to data on bird flu drugs

Sangeeta Shashikant, North-South fight on IP, Benefit Sharing issues in influenza talks, SUNS, December 19, 2008. (Thanks to Glyn Moody.) Report on the World Health Organization’s Intergovernmental Meeting on Pandemic Influenza Preparedness.

… Brazil proposed language that “Member States should make available through WHO Secretariat in a timely manner publicly available information related to health regulatory approval of H5N1 and other influenza viruses with human pandemic potential vaccines diagnostics and pharmaceutical products … WHO Secretariat should examine the feasibility of creating a database of such information.”

[The proposal] was resisted by France on behalf of the EU and the US, as they could not accept language that required the sharing of regulatory data even when these are publicly available.

On one occasion during discussion on sharing of regulatory data, [Jane] Halton, the Chair of the IGM, on hearing Brazil’s proposal questioned Brazil whether it was seeking information that would violate commercial confidence (i.e IP laws).

A legal expert familiar with US laws privately noted that the if WHO member states are speaking of pandemic preparedness, the EU, US, Japan and Australia should be asked to share on a mandatory basis not only regulatory data that is publicly available but also data that is confidential because such data is critical for obtaining regulatory approval at the national level for treatments and vaccines used in the pre-pandemic and pandemic stages.

The expert said that Article 39.3 of the TRIPS Agreement requires countries to protect such data against disclosure, except where necessary to protect the public. …

Comment. From what I’ve read, it’s not clear to me whether there are any proposals for OA to the regulatory data, or just that the data be shared among regulators. If you have any information, please let me know.

See also our past posts on avian flu.