Health Assembly Tackles Proposals On Avian Flu Virus Sharing

By Tove Iren S. Gerhardsen
Early in the 2007 World Health Assembly, the focus has moved to avian flu virus sample sharing for the development of treatments and access by both developed and developing countries. A drafting group started work on combining various proposals, including new drafts from the United States and an Indonesia-led group of developing countries.

The 14-23 May assembly is the annual meeting and the decision-making body of the 193 member states of the World Health Organization (WHO).

Draft resolutions were put forward on 15 May by the United States and a group of developing countries including Algeria, Brunei, Cuba, Korea, Indonesia, Iran, Iraq, Laos, Malaysia, Myanmar, Maldives, Peru, Qatar, Saudi Arabia, Solomon Islands, Sudan and Timor-Leste.

In addition, there is a resolution (EB120.R7) on avian flu from the 22-29 January WHO Executive Board meeting. A number of countries expressed support for this resolution on 15 May. Draft resolutions (proposals that may lead to agreements) may be discussed by the Executive Board meeting and forwarded to the assembly, or may be introduced at the assembly itself.

None of the three resolutions mention intellectual property rights directly, but discussions during the day, including a technical briefing, showed that this was an underlying issue. There was also agreement that globally, current production capacity far from covers the potential need.

There have been 306 human cases of bird flu in 12 countries, of which 185 have died, according to WHO sources. More than 50 percent of the production capacity for treatments is found in Europe, the sources said. In case of a pandemic, it could take 4 to 6 months to develop a vaccine, sources said.

Earlier this year, Indonesia refused to share virus samples with international influenza collaboration centres operated under WHO, fearing it would not be guaranteed vaccines in return. This led to two high-level meetings in Jakarta and Geneva respectively (IPW, Public Health, 8 March 2007).

One developed country source told Intellectual Property Watch that the member-states-only drafting group would look at all three documents and consider how they could be combined into one. Some had suggested basing these discussions on the resolution from the Executive Board meeting, which the source said was agreed to by members there, but would have to be adopted by the assembly.

The Proposals

The resolution from the Executive Board focuses on best practices and international health regulations (“Avian and pandemic influenza: developments, response and follow-up, application of the International Health Regulations (2005), best practices for sharing influenza viruses and sequence data”).

The Indonesian draft resolution, “Responsible practices for sharing avian influenza viruses and resulting benefits” (A60/A/Conf.Paper No.2) focuses on transparency and “fair and equitable international mechanisms” for the sharing of diagnostics and treatments developed from shared viruses.

These “must be made available at an affordable price and in a timely manner,” it says. It also refers to the Convention on Biological Diversity (CBD) and says that prior informed consent should be obtained from the country that provided the virus before (parts of) it is given to parties outside of the WHO centres. The CBD sets out that states have sovereign rights to biological material.

Industry is concerned about requirements, such as prior informed consent, that could slow down the production process in an emergency, a source said.

The draft resolution also says that the WHO collaborating centres, “shall neither claim nor obtain any form of proprietary rights over the virus provided or any parts thereof.” It further raises the need for transferring technology and know-how to developing countries for vaccine production, and to come up with mechanisms and guidelines in an intergovernmental process, to be reported to the Health Assembly in 2008.

The US draft resolution, “Mechanisms to promote access to influenza pandemic vaccine for developing countries lacking sufficient influenza vaccine production” (A60/A/Conf.Paper No. 1) says avian flu is both a human health and global security concern.

The US resolution urges member states to help increase access to vaccines in developing countries without production capacity through financial and technical support, but also requires “unrestricted sharing” of viruses with WHO “in a timely and consistent manner.” It requests the WHO director general to “design mechanisms” to help developing countries, in particular, with access.

Finally, the draft resolution from the US proposes an “ad hoc WHO working group” that can advise member states and the director general on how big the vaccine stockpile should be, how it should be used and how access to safe vaccines may be promoted. The group should report in a year’s time.

The Link to IP

A key issue has been that some of the viruses that have been provided to any of the WHO labs have been used for products that have been patented, to which Indonesia protested out of concern for access.

Anyone who wishes to develop an avian flu vaccine may do so as the virus itself is not patented, but the product could be, a source said. There are therefore patent concerns, particularly with regard to access to existing vaccines. India said in a committee meeting that in case of emergency, countries should be able to produce vaccines themselves regardless of patents, even if compulsory licensing becomes mandatory.

David Heymann, WHO assistant director general for communicable diseases, said at the technical briefing that there had been “some IP sought” on certain parts of the vaccines developed based on virus samples shared with the WHO collaboration centres. He said it was necessary that all countries benefit from this scheme, which was a “ship being built as we sail.”

Suwit Wibulpolprasert, senior advisor on health economics at Thailand’s Ministry of Public Health, said that a system of sharing that belongs to everyone was needed, but warned about it becoming a debate of extremes in which one side referred to “IP piracy” and the other to “biopiracy.”

Tove Gerhardsen may be reached at tgerhardsen@ip-watch.ch.