Perhaps the single most critical issue to resolve in addressing neglected diseases is how to ensure there is money to pay for research and clinical trials, even when the consumer demand is small and its constituents poor. A group of experts under the auspices of the World Health Organization this week is attempting to address the problem.

This is the second official gathering of the Expert Working Group on Research and Development Financing, which is seen by many governments and nongovernmental organisations as a key outcome of the WHO global strategy and plan of action on public health, innovation and intellectual property.

The global strategy was approved in May 2008, but outstanding elements of the negotiation were not completed until May 2009 (IPW, WHO, 22 May 2009). WHA Resolution 59.24 - on the global strategy and plan of action - from the 2006 World Health Assembly said there was a “need to promote new thinking on the mechanisms that support innovation.”

At this session, the working group plans to develop a methodology for dealing with submissions received during a public hearing period, in which governments and other stakeholders were invited to comment or make proposals, according to sources. The hearing ran 7 March to 15 April. This week’s meeting runs from 29 June to 1 July.

“In the area of innovative financing for R&D, in addition to the ideas being put forward by members of the [working group], several proposals have been received for consideration by the group from member states and from other stakeholders through the public hearing,” said Elil Renganathan, director of the WHO Secretariat on Public Health, Innovation and Intellectual Property in the Office of the Director-General.

The working group this week will “spend most of its time reviewing and discussing these proposals and plan to do it as an internal exercise within the group,” he said in an email.

The rather secretive gathering appears to be limited to members of the working group and their secretariat support, though Renganathan said “based on the discussions at this meeting, the group may seek additional information and clarification from proponents and others.”

The group’s first meeting in January invited key stakeholders to give presentations on financing issues. Some presenters included the Global Forum for Health Research, the Bill and Melinda Gates Foundation, the International Federation of Pharmaceutical Manufacturers & Associations, and the George Institute for International Health.

But the online comment process brought a range of different views, and it remains to be seen how the working group will accommodate these views in a balanced and transparent way.

There are concerns among health advocates that certain stakeholders will be given privileged roles in the process.

A final report of the group’s findings is due at the next World Health Assembly in May 2010, but must be submitted first through the Executive Board meeting in January 2010. That likely means completing most work by October or November.

Public Hearing Submissions

Coping with the submissions received during the public hearing will be a task, with contributions from 14 member states and 13 submissions from nongovernmental groups focussing on a wide variety of topics.

Ideas contributed range from general financing methodology, such as to find ways to separate the price of medicines from the price of research and development and encouraging public/private sector collaboration.

There were also several specific proposals. Algeria proposed a study in the interaction of socioeconomics and genetics in determining vulnerability to tuberculosis (TB), intending to study family lines and TB infection to help identify risk factors for the disease in order to aid early diagnosis.

Monaco encouraged the conclusion of technology transfer agreements in particular to Cuba and Brazil, who are developing technology to deal with neglected diseases, and Syria emphasised, among other suggestions, the need to use flexibilities in the Trade-Related Aspects of Intellectual Property Rights Agreement and the need to ensure good manufacturing practices and avoid substandard drugs. Serbia suggested that private insurers could develop their own centres of research.

Bangladesh, Barbados, Bolivia and Suriname submitted a series of proposals on prizes for different neglected diseases: on Chagas treatments, diagnostics and vaccines - on which there is “almost no” private sector research, the proposal says - and for treatments on HIV/AIDS and TB, malaria, tuberculosis diagnostics, cancer and other major diseases. The prize funds include proposals to support innovation incentive mechanisms to solve technical challenges, such as InnoCentive, and also for licensing pools for IP rights related to those medical solutions.

The four countries also submitted a proposal for WHO discussions on a research and development treaty. Though at the May Health Assembly WHO was removed as a stakeholder on this in the global strategy, the assembled delegates agreed that did not preclude its discussion at the expert group meetings.

Nongovernmental agencies Health Action International and Knowledge Ecology International (KEI) supported this treaty in their submissions.

Many suggestions for funds were forwarded. Brazil proposed a fund sustained with resources from taxing the pharmaceutical industry to support R&D for public health purposes. But making the fund innovative is that pharmaceutical companies would be able also to use those monetary resources, in partnership with those in the developing world, to develop R&D on needed areas.

Costa Rica suggested a revolving fund, working on the development of both drugs with commercial potential and with public health potential. The fund would be supported with profits of the commercially viable products, and help coordinate better existing health infrastructure in the country. Burkina Faso also suggested better coordination of national research, including in aid for human resources development, and South Africa proposed a facilitating mechanism to receive and distribute funds for health R&D in Africa as a whole.

Some proposed to make better use of nationally-held resources, including those from potentially problematic sources. Burkina Faso, for instance, suggested exploring the use of locally grown medicinal plants, and Nigeria suggested using funds from selling crude oil, from the forfeited assets of drug dealers, and from recovered money misappropriated by corrupt public officers. Serbia suggested raising funds by running lotteries, among many other suggestions.

Algeria highlighted that globalisation has heightened global vulnerability to communicable diseases - as illustrated by the recent influenza outbreak - meaning no disease can be considered confined to one place.

There were also detailed submissions from academics and nongovernmental groups. Health Action International suggested a redesign of advanced market commitments - commitments usually financed by donors or governments to companies to purchase a medicine if developed. KEI encouraged the use of prizes and also suggested “open source dividends” - extra rewards to encourage prize recipients to share their knowledge and said that some proposals.

The group has also forwarded a proposal for a new, binding World Trade Organization agreement on the supply of public goods and global taxes to support public goods.

The United States Chamber of Commerce, a business group, voiced support for cash prizes as well as patent pools but said they were limited in efficacy. They should be “useful supplements” to patents, but not replacements, it said. IFPMA highlighted the importance of IP protection in strengthening incentives for new health R&D, particularly R&D for developing countries. IP is needed to justify the “risky, costly, complex, and lengthy R&D process,” it said.

Also contributing were UNITAID, which detailed its patent pool project; Médecins Sans Frontières, which evaluated the use of a prize fund for tuberculosis diagnostics; the Health Impact Fund, which explained its market-oriented solution to pay innovators according to their impact on public health; researcher Itaru Nitta who proposed a patent insurance scheme; pharmaceutical company Novartis, and other academics and critical stakeholders.