May 30. — The World Health Organisation (WHO) has taken an important step to reform the global system for supporting medical research and development (R&D). The organisation’s governing body has just passed a new — hotly-debated — resolution to set up a new intergovernmental working group that will immediately start work to "draw up a global strategy and plan of action." This will include a new framework to support sustainable, needs-driven, essential R&D work on diseases that disproportionately affect developing countries.
The WHO’s action is part of a larger effort to implement recommendations from an extensive review of intellectual property rules, by the Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH). This commission was deadlocked on key issues. Do we need new incentive system for medical R&D that is not tied to high drug prices? Should the WHO back new global agreements on medical R&D, addressing the setting priorities and sharing of costs of such research? And should these new agreements supplement or replace existing trade agreements on patents and drug prices?
For three years public health non-governmental organisations (NGOs) and scientists pushed for the new paradigm for medical R&D. Big drug companies pushed back, claiming the existing systems of strong patent protection and market driven R&D priorities were working fine. The United States aggressively opposed any discussion of R&D treaties or agreements at the WHO. The CIPIH could not reach consensus on these issues.
In January the governments of Kenya and Brazil proposed a bold new WHO initiative to create a new global framework for essential health R&D. The United States and the European Commission initially opposed it. But at the WHO’s general assembly meeting in May, the US split with the big drug companies and the European Commission, and backed the Kenya/Brazil proposal.
During the May negotiations, public health groups were gratified that the US government (1) and some members of the Congress (2) had come to see the logic and benefit of a multilaterial discussion of who pays for essential R&D, given the increasing difficulty of pushing for higher global drug prices in bilateral negotiations, the growing US outlays for medicare part D, and the failure of other governments to match the US outlays in projects such as the NIH backed research in vaccines in AIDS and other global projects.What was as surprising was the hard-line position taken by the European Commission (3), which led to calls for a investigation of undue influence by industry lobbyists. (4)
Now the WHO will be setting up a new working group that will include governments, as well as a number of observers and invited experts and stakeholders, in order to create a medium-term framework to identify R&D priorities, including methods and sources of funding. Further decisions have yet to be made.
Public health groups and some experts will be pushing for new open source methods of conducting research, and new incentive systems that
reward innovations that improve health outcomes in developing countries, which are not tied to marketing monopolies or high drug prices. Big drug companies will lobby for measures that link high prices for blockbuster drugs to R&D for neglected diseases.
This initiative is important. If we can create a global framework that stimulates R&D in areas of medical priority and also promotes access, we may be able to replace or "de-emphasise" global agreements that simply raise drug prices.