Towards a new model for pharmaceutical research.

Editorials 795 Despite considerable investments in research and development (R&D) and the availability of powerful scientific and technological tools, innovation in the pharmaceutical industry has declined drastically in the last decade. In addition, most of the new molecules introduced into the market do not entail genuine therapeutic innovations or target the diseases that prevail in developing countries. Most importantly, the prices charged for new pharmaceutical products are unaffordable to the poor and, increasingly, to patients and social security systems, even in developed countries. The lack of appropriate treatments for many of the diseases afflicting developing countries leads to millions of deaths per year. 1 Governments have the responsibility to provide effective solutions to this problem. 2 They have an ethical imperative to do so, but also the duty to see that the right to health, recognized under international law and many national constitutions, is guaranteed. On 26 May 2012, the World Health Assembly adopted a resolution that could mark the beginning of a needed change in the current model of pharmaceutical R&D. The resolution calls for an intergovernmental meeting (scheduled for November 2012) to examine in depth the proposals made in April in the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG), 3 established by the World Health Assembly in 2010 under Resolution WHA63.23. Such proposals included open approaches to R&D, pooled funds, direct grants to companies in developing countries, prizes for milestones and end products, and patent pools. The main recommendation of the CEWG was, however, more far-reaching: to start multilateral negotiations for the possible adoption of a binding convention on health R&D. 3 This is quite momentous, since the only binding convention adopted so far by the World Health Organization (WHO) has been the Framework Convention on Tobacco Control. 2 The concept of a new convention rests on four main premises. First, the current R&D model, based on patents and market-oriented research, fails to generate new health technologies to face the global challenges arising from existing health needs, particularly in developing countries. Second, it is crucial not only to enhance the innovation of relevant products, but also to secure product access and affordability by de-linking R&D costs from the prices of the products. Third, the efficiency of health research can be improved through better monitoring, priority-setting and international coordination of R&D. Fourth, voluntary financing cannot be the main or unique source …