A new intergovernmental negotiation, facilitated by the World Health Organization director general, will address an agreement for sharing virus-related materials and benefits and managing associated intellectual property rights in the WHO strategy for responding to pandemic influenza outbreaks.

Consensus on these issues related to the standard material transfer agreement (SMTA) has proved elusive through a previous Intergovernmental Meeting On Pandemic Influenza Preparedness (IPW, WHO, 18 May 2009) as well as through an informal negotiation with Director General Margaret Chan (IPW WHO, 22 October 2009).

The newly-minted meeting will take place from 10-12 May this year, as another preview to the 63rd World Health Assembly, the WHO’s decision-making body. Yesterday it was decided a meeting on 13 May will discuss an expert report on financing research and development, and the assembly itself will run from 17-22 May.

These discussions are happening in the context of the WHO Executive Board meeting, taking place from 18-22 January.

Intellectual property issues also came up during the Executive Board’s discussions on meeting the UN Millennium Development Goals related to health, when Michelle Childs of Médecins Sans Frontières (Doctors Without Borders) said in her intervention that flexibilities in patent law are essential to ensure the affordability of essential medicines.

Down the road from the WHO this week a meeting of the UN Office of the High Commissioner on Human Rights is reviewing a report [pdf] by a working group that studied development goal 8, on access to essential medicines, which included a report of the WHO’s programme on IP (IPW, Public Health, 15 May 2009).

Way Forward on Influenza Framework

Governments today agreed that the 10-12 May negotiation “should be conducted in the format of an open-ended working group,” and use as its basis document the final report of the first Intergovernmental Meeting to the World Health Assembly in May 2009. This document is available here [pdf].

The decision came out of an informal consultation between Australia, Bangladesh, Brazil, Canada, China, the European Union, France, India, Indonesia, Japan, Norway, South Africa, Switzerland, Thailand, the United Kingdom, the United States and Zimbabwe.

The meeting “”should focus and try to reach agreement on the remaining elements of the framework and to report the outcome to the 63rd World Health Assembly,” said Indonesia on behalf of the group.

Canada later suggested that a document produced by Chan during the informal process she coordinated, available here [pdf], be included as a base document, which was accepted.

Japan emphasised the importance of “problem-solving rather than repeating the same statement again and again” and urged “all member states to spend some time” before the meeting studying the kinds of concessions they are willing to make “so that we can reach consensus on these issues.”

Viruses Shared, But Where Are Benefits?

The importance of having a fully realised framework for handling pandemic influenza was discussed earlier in the day.

Influenza will negatively affect all societies and cause serious global impacts on health, and poor distribution and lack of access to health resources is a critical issue, said Indonesia, where many cases of H5N1 (avian flu), a disease which kicked of fears of a pandemic, originated. The intergovernmental meeting has made progress on virus and benefit-sharing, but it needs to cover pandemic risk response as well as pandemic risk assessment, the delegate added.

Indonesia said it attaches “great importance to the remaining issues, which are the SMTA and IP rights.”

Mexico, where the 2009 pandemic of H1N1 (so-called swine flu) originated, said that “despite the good faith we showed in sharing the virus” – which was credited by many at the meeting as the reason vaccines could be developed so rapidly – “we never received any benefits from that sharing.”

“We have a limited stock of the vaccines on the market,” and access has been restricted in Mexico, the delegate added, saying it is therefore essential “that we reach an agreement on medicines sharing.” The vaccines are produced companies from developed countries.

Uruguay said it was fortunate that the pandemic was not dangerous as the H1N1 vaccine cost double the price of other vaccines and that they did have the stocks that they needed from the Pan-American Health Organization (the branch of WHO operating in that region).

There was also some discussion on the way to handle virus and benefit-sharing.

India wanted assurance that the WHO does not commit to terms and conditions that might get set as precedents and upset the balance between virus and benefit-sharing. Japan said that the agreement should focus on voluntary, not mandatory, benefit-sharing but that states should do more to contribute as much as they can in terms of financial and technical resources to countries that need them.

Brazil emphasised that any such agreement should be “binding and enforceable,” as benefit-sharing is the right of member states. China said vaccine manufacturers in developing countries have different capacity from those in developed and that benefit sharing should be based on ability.

The International Federation of Pharmaceutical Manufacturers and Associations said their members had delivered years of research and development and over US$4 billion in investment by influenza vaccine manufacturers to lend in the development of new vaccines. The group, it said, made “unprecedented contributions,” including “donating over 75 percent of doses” that were WHO’s goal for procurement and using tiered pricing to lower costs in developing countries. They emphasised the voluntary nature of these actions.

Sangeeta Shashikant of the Third World Network, in an intervention on behalf of Churches Action for Health and other health-oriented civil society groups, said “the inequity of a system that delivers vaccines to developed countries but requires developing countries to rely on ad hoc measures such as donations is apparent.”

There were a few comments on the pandemic handling process. “We would like WHO to clear the air,” said the delegate of India, referencing newspaper reports that have said the WHO’s advisory experts had ties with the pharmaceutical industry. “In public perception, our work is being questioned,” she added, saying a statement from WHO must come out.

Also needed is technology transfer, said India, explaining the provision of medical supplies is important and needed in the short run, but in the long run it is important to expand vaccine manufacture.

Chan said, referring to the reports of WHO ties with the pharmaceutical industry, that there was a “lot of rumour and misinformation,” asked the media for help getting the information out and cautioned that “selective reporting may give rise to some issues in some countries.”