Some five years after setting a mandate to address barriers faced by poor countries in accessing needed medicines, World Health Organization members are near agreement on a strategy and plan of action. But a key question remains on WHO involvement in a possible treaty on biomedical research and development for diseases disproportionately affecting developing nations, and the WHO secretariat is facing accusations that the process has not been amply inclusive.

A working group at this week’s annual World Health Assembly gradually moved closer to agreement during several public and informal sessions Thursday but left off with the treaty question awaiting them Friday, along with several other late amendments.

The key question is whether the WHO itself should be a stakeholder in future talks on the treaty issue, a question that may require reopening the negotiated global strategy and plan of action. The text was negotiated over the past two years by the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG). It lays out activities along with proposed time frames and estimated funding needs.

The debate pits a group of mostly smaller countries like Barbados and Bolivia but also Argentina and Venezuela in favour of adding the WHO to the stakeholder list against the leviathans of economy and pharmaceutical production such as the United States and Europe, including Switzerland, joined by Canada. And this time, the smaller economies do not appear to have the help of larger developing nations like Brazil or India.

“We think consultations should take place in an open way,” the Bolivian ambassador told the meeting. “It is vital that everyone gets to express their views as a democratic process.”

Adding the WHO as a stakeholder could lead to the UN organisation committing financial and human resources to the process which it would not otherwise do, an informed source said.

The smaller countries are concerned that without multilateral involvement the issue will fall off the table. The group, along with another group of developing economies such as Argentina and Venezuela, also charge that the past year’s process on the treaty was not properly inclusive, but rather worked out earlier among a smaller informal coterie of developed and large developing countries and presented as finished product to the rest of the members.

They also argued that since a WHO-led working group process on alternative financing for neglected disease R&D did not finish its work in time for this assembly it by necessity makes the WHO a continued stakeholder as it oversees that process.

The WHO secretariat represented by Elil Renganathan told the meeting that it did not seek to be a stakeholder on the issue. He said the treaty is expected to come up in the working group addressing alternative R&D financing when it next meets in late June or July. He also promised a report on the R&D financing group, which was given instructions at the May 2008 assembly but met for the first time in January 2009.

The developed nations are eager to see an end to this process, as they and their pharmaceutical manufacturers have grimaced to see IP and trade-related issues discussed in the health body where economic interests can take a backseat to humanitarian concerns. They have instead preferred to pursue ways to build on the existing system through public-private partnerships and other means.

And the developed countries oppose negotiation of an R&D treaty at the multilateral level, urging that it be dealt with by national governments and other stakeholders. But the United States and others signalled a willingness to continue with “exploratory discussions” on the issue outside WHO.

Several nongovernmental groups such as Health Action International voiced opinions similar to those of Bolivia and Barbados, stating a clear need for an alternative funding approach and qualitative progress indicators. And the Global Forum for Health Research praised the plan of action but said it also should consider social innovation in addition to technological innovation.

Other Amendments

Several countries and NGOs raised concern that the indicators of progress on the plan are almost entirely quantitative rather than qualitative, lacking interpretation.

Thailand, which attended the consultation in question hosted by Canada in late 2008, proposed a separate amendment calling for a “major programme review” of the global strategy and plan of action in 2014, a year before the target date for full implementation of the plan by 2015. Developed countries objected and an agreement was reached to conduct a summary review based on the regular two-year reviews already called for in the text.

Kenya proposed to recognise a director-general’s report on implementation of the African Network for Drugs and Diagnostics Innovation. It would stress the need to “fast-track activities to reach neglected people who sick and suffering from neglected tropical diseases.” This amendment appeared likely to be accepted in a similar form.

Kenya also proposed a significant increase in WHO support toward implementation, with priority to capacity-building, and to “ensure issues of access and benefit sharing affecting local populations take front stage.”

The European Union axed the final phrase on ensuring access. The EU was represented by the Czech Republic, in the rotating presidency, which in turn was represented in the meeting by industry consultant Albert Tramposch. Canada offered to return the word “access” without the rest of the sentence, which was accepted by Kenya.

The WHO’s Renganathan also gave a cursory explanation of how the issues are broken out among WHO departments, and responded to a Thai question to say that the current 3 percent spending on neglected diseases is expected to grow to 12 percent by 2015.

The assembly is expected to be cut short, possibly Friday, to allow health ministers and their teams to return to prepare for the possible pandemic influenza. The committee’s work will go before the full assembly for final approval.