World Health Assembly: Agreement Reached On Neglected Disease R&D Process, But No Convention

A proposal at this week’s World Health Assembly to negotiate a binding convention on financing research and development for neglected diseases – those predominantly afflicting poor populations – ran into resistance from developed countries which hold the view that another approach might be possible. But an agreement was reached on a way forward for the expert report that recommended the binding convention.

The 65th World Health Assembly is taking place from 21-26 May.

The agreement reached this evening in a closed-door drafting group meeting mandates the World Health Organization to hold an “open-ended” meeting of member states to analyse the report and feasibility of recommendations of an expert group that recommended the binding convention.

The agreed text is available here [pdf]. (Note: this final version contains small changes to footnotes from the penultimate version circulated after the meeting.)

The meeting will look at results from national and regional discussions and “develop proposals or options” relating to: research coordination; financing; and monitoring of R&D expenditures.

It also called for increased investment in such R&D by governments, private sector, universities and non-governmental organisations, and urged members to hold national level consultations, participate in regional meetings and improve mechanisms for neglected disease R&D at the national level.

The meeting likely will happen around October to December, sources said, as it will follow the WHO regional committee meetings around September, and will precede the annual WHO Executive Board meeting held in January.

The issue will be presented at next year’s Assembly under a “substantive item” as a follow-up to the expert report that created the recommendations.

Tomorrow morning this drafting group agreement will go before Committee A of the Assembly, and then the full Assembly itself at the closing ceremony in the afternoon.

The idea for a binding convention was the chief recommendation of the highly regarded expert group that spent the past year analysing a wide range of options for financing R&D for diseases that fail to generate private sector investment due to small prospective markets.

The Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) analysed over 100 proposals on ways to finance such R&D, and concluded that a binding convention committing every nation to pitch in on financing would be the only way to solve the problem. The expert group produced a 200-page report.

“[P]oor people suffer and die because there are no effective health technologies like medicines, vaccines or diagnostics,” the report preface said. “Markets fail because intellectual property rights are not an effective incentive in these circumstances, and public investment is also dominated by the rich world and its own health needs.”

In the end, it was the rich world’s concern about the prospect of long negotiations for a new R&D mechanism not based on the IP system that blocked the binding convention proposal. But it also suffered from a lack of enthusiasm among African countries, possibly because it suggested the possibility that they also pay a small contribution to the fund.

There were four proposals put forward to implement the CEWG report (IPW, WHO, 24 May 2012).

Under pressure, according to sources, Kenya withdrew its proposal to immediately begin negotiating the binding convention.

A developed country official told Intellectual Property Watch today that a binding convention seemed unnecessary, expensive, time-consuming, and not certain to work, as the WHO is not seeing full compliance with two other conventions, such as the International Health Regulations, perhaps because there are no sanctions. The preferable approach, the official said, would be to create voluntary measures to encourage contributions reaching the target level raised in the report – $6 billion. The WHO Framework Convention on Tobacco Control was also mentioned several times during the week.

Other funds, like the Global Fund to fight AIDS, Tuberculosis and Malaria, depend on voluntary funds. But it has recently undergone upheaval related to a shortfall in funding.

During the week, remarks by WHO Director General Margaret Chan had the effect of undermining support for the idea of a convention, when she suggested that conventions do not always work and that other approaches may be best.

A developing country official told Intellectual Property Watch today that without agreement on a binding convention, including an oversight body, the process of addressing the R&D financing shortage would continue to be ad hoc, rather than predictable and reliable.

The final outcome document from this week’s drafting group not only removed any mention of a binding convention, it left out reference to the next meeting as one of an “intergovernmental” as that suggests a more formal structure and possible negotiation. But the final language also does not include the word “informal” in reference to the group, despite the wishes of developed countries.

In the next meeting, those who want a convention will likely find a way to raise it. But those who are interested in proposals that the expert group deemed less likely to succeed also may begin raising them again.

Public health advocates, from groups such as Médicins Sans Frontières, Knowledge Ecology International, and Health Action International, were highly upset during the week about efforts to block progress toward a binding convention. They accused the United States, France and some other European countries of working against the interests of the poor. But in the end, they appeared satisfied that the process was still moving forward.

A US official said afterward, “We want to be productive. We encourage others to make a similar commitment.” The effort is to try and address the problem of these neglected diseases, the official said, “and I think we’re on a path to address them.” The US was the only country that contributes above 0.01 percent of its GDP to neglected disease R&D, the level of contribution suggested by the CEWG report.

A Brazilian official afterward called it a “good outcome,” as they “ensured the spirit was still alive.” Many countries showed reluctance in the negotiations, the official said.

Making a Long History Even Longer

The CEWG was created by last year’s World Health Assembly, taking up the work of the previous year’s working group, whose results were not accepted by all member states. That expert group had been set up by the 63rd Assembly (IPW, WHO, 21 May 2012), following the 2008 WHA approval of a Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (IPW, WHO, 29 May 2008).

The 2008 strategy and action plan followed the 2006 Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH), which was established in 2003. (Background Intellectual Property Watch stories from 2006 are here and here.)

Representatives of a range of governments praised the work of the CEWG and recognised the report and analysis as valuable and legitimate.

The 20 members of the CEWG came from academia, health ministries, science and technology offices and elsewhere, from all regions of the globe. The chair was from Norway, the vice-chair from Brazil.

During the week, an attempt was made by Switzerland in committee to defer discussion on the report and four proposals until later and form the drafting group, a suggestion that Chan advanced. But some developing countries insisted that statements be made, so the issue was re-opened.

A recurring theme at this week’s Assembly was from developing countries with concerns that WHO activities are increasingly aimed at treating illnesses rather than preventing them. The former is seen as favouring developed country medicines producers. At a presentation of the report by the chair and vice chair this week, there were several questions from developed countries inquiring how they would benefit from the scheme. Apparently, they were not convinced by what they heard.

“Everybody appreciates the report and the technical analysis the group did,” the developed country official said today. “The difficulty is about some of the recommendations.”

“Everybody agrees there’s a problem,” the official said. “More money is needed.” But once again, they could not come to agreement on how to raise it.