12/05/08

WHO urged to back radical changes in drug R&D

UAEM say R&D funding must be separated from drug profits if neglected diseases are to receive more attention Copyright: WHO

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An international group of prominent academics — including several Nobel prize winners — has urged WHO member states to support radically new ways to address the lack of research into diseases that affect the poor.

In particular, they are seeking a sizeable increase in government support for research into these diseases through an international research and development (R&D) fund, and alternatives to the financial incentives of patents.

The proposals will be presented at the 61st meeting of the World Health Assembly — the WHO’s decision-making body — which opens in Geneva, Switzerland, next week (19 May).

The suggestions come from Universities Allied for Essential Medicines (UAEM), a body that coordinates university researchers to promote research into diseases that affect developing countries but tend to be neglected because they lack the potential for substantial profits.

UAEM issued a statement aimed at the WHO’s Intergovernmental Working Group (IGWG) on Public Health, Innovation and Intellectual Property, made up of representatives from over 150 WHO member states, which met last month (28 April) and will report to the assembly next week.

IGWG was commissioned by the World Health Assembly to draft a global strategy and action plan on how to use R&D spending, innovation, intellectual property rights and other mechanisms to better address the health problems of developing countries.

The UAEM statement urges the WHO to "support the exploration of new and innovative mechanisms that seek to correct the deficiencies of the current system".

In particular, it wants the member states of the WHO to consider a treaty on biomedical R&D that would separate R&D funding from the revenue generated by medicines — considered essential by pharmaceutical companies to keep research spending high.

UAEM say such a move, accompanied by alternative incentives for R&D — such as prize funds — that fall outside the patent system would "draw investment that will serve the needs of populations too poor or too small to provide sufficient market pull" and "overcome the systematic problems of above-marginal cost pricing inherent in patent-based innovation".

John Sulston, Nobel laureate and a signatory to the UAEM statement, says that, presently, it is revenue from drug sales, underpinned by strong patent protection, that pays for both R&D and drug production.

The process is financially inefficient, with only a sixth [of profit going] back into R&D," Sulston told SciDev.Net. "The consequence is that diseases that don’t promise high profits don’t get R&D."

In their April meeting, IGWG also discussed the introduction of ‘"patent pools"’ that would enable companies to share patents, and the establishment of a WHO group of experts to examine different ways of financing R&D.

But although the meeting agreed that measures like these should be explored, it reached no consensus on how any new initiatives should be implemented.

There was resistance to major changes in R&D policy at the meeting, primarily from developed countries — particularly those with powerful pharmaceutical companies.

"The proportion of attendees at Geneva that were affiliated in one way or another to vested interests in the pharmaceutical industry was frightening. And opponents include not only the United States, but the European Union and Canada as well," says Sulston.

In a statement to the IGWG, Harvey Bale, director-general of the International Federation of Pharmaceutical Manufacturers and Associations, expressed concern about the group’s working documents that "reflect a viewpoint that somehow protection of intellectual property may be inconsistent with objectives relating to public health more generally".

Bale added that "an enabling environment for innovative healthcare-related industries is an essential component of any such strategy to ensure the continued development of new and effective medicines for neglected diseases".

But Sulston says that as a result of the stance taken by the pharmaceutical industry, "the toughest items on the agenda have been pushed to one side, including any mention of money — without which nothing can actually be done".

Despite this, he says, "the slow diplomatic process of getting more power in the hands of developing countries is continuing, and that is good."

Link to full UAEM statement