Applause broke out at the annual World Health Assembly Friday as agreement was reached at the end of a five-year process to devise a plan for boosting research and development on and access to drugs needed by developing countries. Now with the full assembly’s approval, the focus turns to five-year implementation and as-yet unclear ways to pay for it.

“You have found some elegant ways forward after many years, and many intense hours of negotiation, consensus building, and compromise,” World Health Organization Director General Margaret Chan told the closing plenary.

“This is a critical resolution, and we have come a long way to the place we are today,” committee Chair Stephen McKernan of New Zealand said at the committee meeting conclusion. The agreement reached at committee level was approved by the full assembly later on Friday, according to sources.

Agreement in committee was reached after a group of developing countries eager to discuss a possible treaty on biomedical R&D dropped a demand to include the WHO as a stakeholder in discussions about the treaty (IPW, WHO, 21 May 2009).

The approved global strategy and plan of action [pdf] on public health, innovation and intellectual property aims by 2015 to train over 500,000 R&D workers, improve research infrastructure, national capacity and technology transfer, and lead to numerous other outcomes such as creating 10 public access compound libraries and 35 new health products (vaccines, diagnostics and medicines).

The WHO legal counsel gave an opinion to the committee that dropping the WHO as a stakeholder would not prejudice the R&D treaty issue as it is addressed in a separate expert working group on financing to continue deliberations this year under a mandate from the 2008 assembly. Those proposals are still on the table and could go the assembly next year, the counsel said. It also would not prevent any member state from making any proposals to the Executive Board as is standard WHO process. But that process does not guarantee any proposal will be accepted, the counsel noted.

The group of countries read a statement to the committee – which included WHO Director General Margaret Chan – expressing their disappointment and concern about the competence of the WHO. The group included Bangladesh, Barbados, Bolivia, Cuba, Ecuador, Nicaragua, Suriname and Venezuela. Argentina was part of the concerned group but dropped out overnight.

“We believe an R&D treaty would transform the landscape of biomedical innovation to incorporate needs-driven health R&D and ensure sustainable financing mechanisms,” Bolivia said on behalf of the group. “The governments are of the firm conviction that closing the door on the WHO undermines the faith the assembled member states have in the competence of the organisation in fulfilling its public health mandate.”

“The treaty would have significant implications for global pharmaceutical research and development and much time, effort and hope may be lost if WHO, which is in a position to support the needs of developing countries, is not allowed to participate in bringing it to fruition,” the Bolivian ambassador to the United Nations continued. “We express our disappointment that such a situation has come to pass given the diligent efforts of all….”

The secretariat did not further address concerns about inclusiveness on Friday, but meeting Chair McKernan said it is “something we can all take into consideration” for the next time. He said thought should be given to how to better bring language developed in informal processes to the whole membership so as to avoid such concerns in the future.

On a related issue, Brazil brought about a small change to the evaluation mechanism for the global strategy and action plan, adding that there would be “continued monitoring” of the implementation and an overall programme review in 2014, a year before the end of the process in 2015.

To accomplish all of the proposed activities was estimated by the secretariat to cost nearly $150 billion over the period of implementation. But several participants de-emphasised those estimates as hard to verify.

Non-governmental and industry groups appeared to breathe a collective sigh of relief after the outcome, though none were perfectly satisfied.

“They can now … focus everyone on implementing” the global strategy and plan of action, said Jon Pender, government affairs director for the Global Access, IP and HIV/AIDS Issues at GlaxoSmithKline.

The agreement “has the potential to address serious medical needs” in developing countries, Pender said afterward. It provides a complementary mechanism to the existing system, he said.

“I think this is good news,” said Tido von Schoen-Angerer, executive director of the Médecins Sans Frontières access to essential medicines campaign. “The way it continues to be open for discussion for an R&D treaty, a number of countries expressed their interest.”

“Now the important thing is for the expert working group to sincerely consider this, and the expectation is for the Executive Board” to address it at its next meeting in January, he told Intellectual Property Watch.

On funding, he said a biomedical R&D treaty would contribute, and said there is a need for a look at “burden-sharing” as some countries like the United States are already making significant contributions.

Meanwhile, NGOs Health Action International and IQsensato this week issued a proposed way for countries to monitor implementation of the strategy and action plan. The proposal is available here.

Separately, a draft resolution on prevention and control of multidrug-resistant tuberculosis and extensively drug-resistant tuberculosis approved in committee included an added paragraph tying the process to the IP and innovation strategy and action plan. The added paragraph called for “ensuring affordability of these new products by de-linking cost of research and development from the prices of health products.” This echoes the effort to look for alternative funding mechanisms, and reflects the need for new mechanisms to achieve the scale-up that is called for, according to Schoen-Angerer.

Furthermore, a draft resolution on traditional medicine also included references to the global strategy and plan of action on public health, innovation and intellectual property.