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Hot news released last week by the World Health Organization (WHO) could change the future of global health. The new report, Research and Development to Meet Health Needs in Developing Countries: Strengthening Global Financing and Coordination, concludes that “all countries should commit to spend at least 0.01% of GDP on government-funded R&D [research and development] devoted to meeting the health needs of developing countries.” The report has a double significance. First, it is a vigorous statement of the need for a binding agreement on health innovation to address diseases that mostly affect developing countries. Second, it is an important concrete step on the long path to it.
The benefits of such a binding agreement have been emphasized on various occasions by researchers and advocates. Its main role is to promote and frame a health-driven approach to drug discovery and “to shift the focus from trade to health,” as in the articleThe Courage to Change the Rules. In other words, it addresses the main limitation of the patents system (based on the TRIPS agreement), which stimulates innovation only where industry sees market opportunities for increasing sales. The result of this market/trade approach is quite cynical. According to published data, only 1% of new drugs approved between 1975 and 1999 were developed for tropical diseases and tuberculosis. Shouldn’t this be a hint that a major change is needed?
In the developed world, health workers have a myriad of drugs in their toolbox to alleviate conditions ranging from chronic dry eye to heart disease. In limited-resource settings, they are expected to make miracles while facing patients with an empty toolbox. And this is at least partially due to lack of investment in unprofitable drugs such as those for treating schistosomiasis, which has more than 200 million victims per year.
The newly released WHO report states:
Market mechanisms, and also publicly-funded research, collectively result in far too little investment in research and development on diseases that mainly affect developing countries. This means that poor people suffer and die because there are no effective health technologies like medicines, vaccines, or diagnostics. 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. This is the challenge for the world as a whole which has guided our discussions and deliberations. We have framed our recommendations to indicate that finding solutions is the responsibility of all of us in this interdependent world, in developed and developing countries alike.
We consider that the time has come for Member States to begin a process leading to the negotiation of a binding agreement on R&D relevant to the health needs of developing countries.
According to the report, the framework for a future agreement should be based on the assessment of the public health needs of developing countries with respect to diseases in order to identify R&D priorities at the national and international level. The binding agreement is expected to promote R&D for Type II and Type III diseases—in other words, the rare and neglected diseases such as autoimmune diseases. Also, the report states that building capacity for research and development in resource-limited settings as well as accelerating technology transfer should be a must.
Very importantly, the WHO report touches on a sensitive issue: the relationship of a binding agreement with the intellectual property system. As the document suggests, the future agreement shouldn’t act in conflict with the present R&D system but should “support the management of intellectual property in a manner that maximizes health-related innovation, especially to meet the R&D needs of developing countries, protects public health and promotes access to medicines for all. The WHO report also suggests that the future agreement should "explore and implement, where appropriate, possible incentive schemes for R&D.”
I hope that the operational challenges raised by such an agreement will be easily overcome and that the targets set out in the report will become reality. The ultimate goal of this effort is to reduce the vast health disparities between our worlds, which we continue to call in a reductionist way the developing and the developed.
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