Medical R&D Treaty Debated At World Health AssemblyPublished on 30 May 2005 @ 2:01 pm
By William New, Intellectual Property Watch
Experts attending the U.N. World Health Assembly this month debated a proposal to create an international treaty on medical research and development aimed at making medical treatment affordable globally while ensuring continuing innovation in the area.
The proposed treaty was created in consultation with a variety of non-governmental and government experts, and in February, 162 politicians, academics and non-governmental organisations called on the World Health Organisation to consider the proposal. The treaty was discussed at a Consumers International briefing in Geneva on 19 May.
“This is an attempt to look at this issue from the public health point of view instead of the commercial point of view,” said James Love, director of the Consumer Project on Technology (a Consumers International member), and an architect of the proposed treaty.
Critics argue that with some diseases, such as malaria, tuberculosis and HIV/AIDS, the global system for patenting pharmaceuticals has led to neglect. The concern is that a small market in wealthy countries makes those diseases less commercially interesting to industry, which then puts fewer resources into research and development to address them.
The proposed treaty is aimed at increasing the sharing of the high costs of research and development, providing flexibility to countries on ways to finance R&D, and create obligations and incentives to invest in priority R&D projects.
The proposal would set minimum obligations to finance R&D based on internationally agreed-upon proportions of nations’ Gross Domestic Product. Countries could count all qualifying R&D spending, which would promote local research and the targeting of local health priorities. The treaty also proposes a system of tradable “credits” for investments in priority R&D, traditional medical knowledge, open public goods (such as free and open source public databases), and technology transfer, according to the February letter.
Love said in the briefing that a “new paradigm shift” is being sought to change the trend toward to stronger intellectual property protection and new rights on data. The shift would introduce more innovation and competition into the current business methods, he said. The proposal is not for a global fund for R&D, he noted.
Love suggested that in 2006 the World Health Assembly create a committee of member states to discuss the treaty.
Dr. Tim Hubbard, head of human genome analysis at the The Wellcome Trust Sanger Institute and another treaty architect, emphasized that researchers have recognised the advantage of access to scientific research through the Internet, although he noted that “openness isn’t just giving things away for free.”
But Hubbard said that the argument for patents on data has diminished even while patents are being filed by scientists more than ever. Hubbard added in a statement that “people are dying needlessly because of economic dogma.”
The Wellcome Trust, United Kingdom’s largest medical research charity, recently announced that from 1 October 2005, all papers from new research projects must be put into open access digital archive known as PubMed Central or UK PubMed Central – once it has been formed – within 6 months of publication.
Dr. Suwit Wibulpolprasert, senior advisor on health economics in Thailand’s Ministry of Public Health, said that new ways of thinking are necessary, and said it should include thinking about social issues. “We need this kind of innovation because we are in a crisis of access to medicines,” he said.
Ellen ‘t Hoen of Médecins Sans Frontières cited examples of illnesses that showed that “despite enormous progress in medical research” there is little progress in addressing illnesses afflicting primarily the poor. Pharmaceutical development is skewed toward profits, she said, and in order to change it, an “enabling environment” and financing are needed. The recent Sars crisis showed what is possible when political will and financing for science are available, she added.
The role for the World Health Organisation could be in defining an essential research priority list, ‘t Hoen said. Proposals such as the R&D treaty “deserve serious consideration,” she added. “Change is necessary and change will not happen without [new ideas].”
Sisule Musungu of the South Centre, an inter-governmental organisation of developing countries, noted at the briefing that the 56th World Health Assembly highlighted “insufficient research and development in so-called ‘neglected diseases’ and ‘poverty-related diseases’, and that “research and development in the pharmaceutical sector must address public health needs and not only potential market gains.”
A resolution from the assembly urged member states to help create conditions for R&D that will lead to new medicines for diseases affecting developing countries, he said. It also requested the establishment of the Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH), which was mandated to collect and analyse an array of data on intellectual property rights, innovation and public health, including funding and incentives for creating new medicines for developing country diseases.
The CIPIH is holding consultations with experts and the public on Monday through Wednesday of this week at the WHO in Geneva.
Musungu said the R&D treaty is a “key initiative” because it “proceeds on the basis that we have a major problem and we have an obligation to fix it and fix it intelligently.” It also is the most advanced proposal addressing the issues raised by the 56th World Health Assembly, and assumes the best system possible should be sought, he said.
Even if it is not pursued intact, the R&D treaty proposal contains a number of key principles that the CIPIH and others should use to judge proposals and options for funding and incentive mechanisms, Musungu said. For instance, it says R&D priorities should be based on health needs, be sufficiently flexible, have a long-term view, be open to alternatives, ensure sustainable investments in R&D, drive R&D investments into areas of greatest need, and fairly allocate the burdens of covering innovation costs.
At the briefing, a Merck pharmaceutical company representative argued there is “no evidence” that they have not targeted countries in greatest need, and referenced the company’s investments in HIV/AIDS research for the past 20 years.