World Health Organization members this week offered views on the global system for virus- and benefit-sharing for pandemic influenza following recently proposed solutions by Director General Margaret Chan aimed at changing the current, ad-hoc model to a more predictable, sustainably-funded system.

“Even with the best intentions in the world, limited manufacturing capacity stands in the way of a completely fair and just system for the sharing of benefits,” Chan said in a speech[pdf] at the opening of the meeting. “Though most countries will have at least some access to vaccines, wealthy countries will be able to immunize a far greater proportion of their populations than will be the case in poorer countries.”

The new document containing Chan’s proposals, available here [pdf], sets out guidelines for a standard material transfer agreement (SMTA) for those participating in the system, as well as draft text on intellectual property rights. The task of completing these two sections was handed to the director general at the World Health Assembly in May (IPW, WHO, 22 May 2009), after members of an intergovernmental committee tasked with creating a framework for handling pandemic influenza outbreaks had failed to reach agreement on them. The intergovernmental committee did reach agreement on other parts of the framework, including a set of principles for sharing viruses and benefits for pandemic influenza preparedness.

Meanwhile, the WHO along with the World Bank and the UN Children’s Fund (UNICEF) released yesterday a report entitled “The State of the World’s Vaccines and Immunization” [pdf].

The report found that vaccines “still do not reach an estimated 24 million children who are most at risk,” says a press release, adding that an additional US $1billion will be needed annually to immunise those children. However, the rate of vaccinations is rising in the developing world, which the release says is due to an increase in the capacity of developing countries to manufacture vaccines, thanks to help from the vaccine-financing partnership the GAVI Alliance. The full report can be read here.

Within the WHO framework, the SMTA and intellectual property sections proved particularly controversial in the agreement because they will determine which parts of the pandemic influenza framework are legally binding, and who will be bound. Also at issue are definitions – for instance of the term “genetic materials” – are important, as they determine the scope of the agreement.

The director general’s closed-door consultations on 19 and 20 October were an informal sounding board and not a negotiation, so decisions were not taken, sources said. Chan will report on member states’ views, which still differ, to the WHO’s next decision-making meeting, the Executive Board, from 18-23 January 2010. The Executive Board will then make recommendations on how to proceed.

Entering the final round of the meeting, several sources at this week’s event said fundamental disagreements from last May still stand, and could make it difficult to reach agreement in January.

These disagreements mainly concern the scope of the SMTA. Some countries and pharmaceutical manufacturers argued that if it is too broad it will slow down the transfer of vaccines and related material at precisely the time when speed is most needed. Other countries and civil society groups argued that if it is too narrow then benefit-sharing commitments will be avoidable and developing countries will be left without affordable access to needed medicines.

A statement given on behalf of countries who have pledged to donate vaccines for the current epidemic outbreak of H1N1, or “swine flu,” says that the effort – which also includes the pledges of manufacturers – “exemplifies our vision of shared responsibility” and “our actions during the present pandemic may serve as important inputs to building future predictable and sustainable responses to new pandemics and other health emergencies.” It urges the WHO secretariat to identify lessons from the donation effort for future plans.

The statement was made by the United States on behalf of: Australia, Belgium, France, Germany, Italy, Japan, New Zealand, Norway, Switzerland, Thailand, United Kingdom, and the United States.

Brazil has also pledged to donate vaccines, though did not sign on to the statement. “Despite our efforts,” Brazil said in its statement to the informal meeting, “most people living in developing countries will not have access to H1N1 vaccines, in view of the limited global production capacity and impediments to access vaccine production technologies.”

Brazil then called for an increase in aid to developing countries to help with the acquisition of technology for vaccine manufacture, and for commitments to be added to the SMTA on how vaccine manufacturers from all over the world will share benefits arising from the sharing of influenza materials through the WHO system.

Critically, the current set of pledges was done without the benefit of a completed SMTA or an intellectual property rights agreement. Some argue that this is proof that these parts of the framework are not necessary to ensure equitable distribution of vaccines. Others argue that a legal framework is needed to guarantee benefits, as reliance upon donations is too uncertain to protect vulnerable people in the case of a global health emergency.

A statement by “like-minded” countries Bolivia, Brazil, Cuba, Egypt, India, Indonesia, Iran, Nigeria and Sri Lanka said, “while ad hoc solutions, including donations … can be useful” they will not provide a sustainable solution. Capacity building, affordable access to innovation, and an IP system that is balanced with principles of access to medicine are essential, the statement added. It also called for a “single undertaking approach,” which would mean no parts of the framework are considered agreed until it is all agreed.

Chan’s Proposed SMTA

The SMTA as proposed by Chan would apply to all laboratories “within the WHO Network,” but would not apply to laboratories outside the network, even if they receive influenza-related materials. This would, says Chan’s text, allow “flexibility to recognise the differences between manufacturers,” and as a practical way of handling the “potentially unlimited” number of labs that could request material, too many for WHO to enter into arrangements with.

Chan’s proposal requires the provider of materials to consent to those materials being passed to pharmaceutical manufacturers, so long as those manufacturers have or are developing a benefit-sharing arrangement with WHO in accordance with the guiding principles of the pandemic influenza preparedness framework. It says that holders of any IP rights derived from the materials “should grant to WHO” a non-exclusive, royalty-free sub-licensable license.”

But this language, said Sangeeta Shashikant of the Third World Network, does not include a basic principle previously agreed by member states, which drafted the pandemic influenza framework with the requirement that both virus- and benefit-sharing be addressed on an equal footing.

Also, she cited Shakeel Bhatti of the International Treaty on Genetic Resources for Food and Agriculture, who has said there had been 89,000 transfers of genetic material under their SMTA in the first 8 months of its operation [pdf]. The SMTA of the plant treaty was looked at as one of the models for the pandemic SMTA.

Disputes will be resolved by the director general, the proposed SMTA says, who may single-handedly revoke the WHO designation of a laboratory in case of violations.

But this is problematic, said Shashikant, as a UN agency should function at the direction of its member states. In addition, an SMTA is meant to be a legal contract, and the text of this agreement falls short from a legal perspective, she said in part because it lacks a legal recourse for dispute settlement, especially if parties disagree with the director’s decision.

Chan also proposed text for the unresolved part of the framework dealing with intellectual property rights. Her text, if accepted by members, would be added to section five of the pandemic preparedness framework, which deals with virus sharing. It reads that member states “should urge entities that receive” materials under the framework and subsequently obtain IP rights on derivatives of those materials to “agree to grant to WHO a non-exclusive, royalty-free, sub-licensable license with respect to such rights.”