How to proceed with the results of an expert initiative aimed at finding real alternatives for innovative health research financing is on the agenda at next week’s World Health Assembly (WHA). The assembly also is expected to approve the continuation of a working group on pandemic influenza preparedness, and to address problems of counterfeit medicines.

The WHA will be given a chair’s text from a 13 May consultation with member states on an expert report on innovative ways to finance and coordinate research and development on diseases disproportionately affecting the poor. Two possible ways work might continue are a successor expert working group, or an intergovernmental process, several sources told Intellectual Property Watch this week.

An open-ended working group of governments on a framework for pandemic virus and benefit-sharing met from 10-12 May, and will recommend to the assembly that their work continue, reporting to the WHA in 2011. The meeting was co-chaired by Ambassador Gomez Camacho of Mexico and Ambassador Angell-Hansen of Norway.

And with several statements from nongovernmental and industry groups already circulating, and a related case that might go before the World Trade Organization dispute settlement body, debate on the use of “counterfeit” to describe fake or dangerous medicines is likely at the WHA as well (IPW, WHO, 12 May).

A proposal for an intergovernmental working group to address counterfeiting is expected next week. The idea originated from the Union of South American Nations (UNASUR), but a unified proposal that might also involve the African Group, India, and others is being worked on, several delegates told Intellectual Property Watch.

The World Health Assembly, the annual meeting of WHO member states, is scheduled for 17-21 May.

Expert Working Group Consultation

At yesterday’s consultation on the expert report, governments heard a presentation on the experts’ methodology and discussed ways of taking their work forward.

A proposed second expert group would build on the work of the first, adding to the first’s proposals, some of which are vague. Several sources told Intellectual Property Watch this idea was first presented by Switzerland, though it was supported by several developed countries.

But some governments said that there were critical areas not addressed in the initial report, and asked that the work now be handed over to an intergovernmental process for completion. This idea was first proposed by UNASUR, several sources said, but seems to have support from some other developing countries. At least one developed country raised a concern about the price and time involved in such a process. Ways to combine these proposals were also discussed, sources said.

Discussions were also held on concerns about the expert report, many of which were previously expressed in written statements available here. An issue that received particular attention was that of de-linking the cost of research and development from the eventual price of a drug, an idea which many civil society groups and developing countries support. But as a consultation, yesterday’s meeting was intended to air ideas rather than make decisions.

The experts’ methodology presentation for the first time gave details on the criteria and process used to evaluate and analyse 94 proposals for innovative financing mechanisms submitted for their consideration. Slides from it are available here [ppt].

Extend the Working Group On Virus Sharing?

The 10-12 May meeting on pandemic influenza preparedness began for the first time real discussion on a proposed Standard Material Transfer Agreement (SMTA) for the sharing of viruses and related benefits.

A non-paper by the co-chairs, available here [pdf], was available at the beginning of the discussion. This paper said that the production of vaccines and antivirals globally is insufficient and that access to what is produced is unfair. The critical challenge for remedying this problem is to increase transparency, certainty and efficiency of systems for sharing both viruses and benefits. For benefit-sharing, affordability and fairness must also be achieved, it says; this means technology transfer and capacity building for the manufacture of needed vaccines as well as tiered-pricing mechanisms for purchasing them.

The non-paper also suggests ways to address the challenges, including the establishment of a fund for benefit-sharing, increasing global capacity to produce vaccines, expanding the WHO network of collaborating centres on influenza, and the development of principles for material transfer within the WHO network of laboratories and to institutions outside this network.

Delegates this week began text-based discussions on an SMTA for use within the WHO network laboratories. There was no time to start talks on an SMTA for use outside the network. There is a proposal for an SMTA “2″ for entities outside the WHO receiving material from the WHO network, that sources said was submitted by UNASUR. It is available here [pdf]. There are also two alternative proposals from the European region of WHO and from Switzerland. These build on an annex to the main SMTA, available here [pdf], and are suggested changes to Article 2, which places requirements on the recipient of pandemic-related materials. They are available here (Swiss) [pdf] and here (Euro) [pdf].

One participant told Intellectual Property Watch a step forward was when the United States indicated it could agree with text in the SMTA against the use of intellectual property within the WHO network, if it would be clear that this applied to government owned laboratories only. This is something many developing countries have asked for and represents a change of position for the US, which last year went so far as proposing there be no SMTA at all (IPW, WHO, 18 May 2009), though it is unclear what other developed countries think.

This week’s meeting will recommend to the WHA that their work continue for another year, assisted by the director general as well as “technical consultations and studies as necessary” in order to reach final agreement, according to a draft resolution text, available here [pdf]. The group will then report to the 2011 WHA through the January 2011 Executive Board, the draft decision says.

The chairs will also submit to the WHA the text of the draft SMTA as it stood when the meeting concluded, sources said. The latest text was not yet available as of press time, but an earlier version from midway through the meeting is here [pdf].