Debating the scope of a health research and development convention.

Perspectives Despite recent advances in global health, appropriate tools to prevent, diagnose and treat diseases are often in short supply in the developing world. As a result, poverty-related and neglected diseases cause an average annual loss of 13.7 million lives and 377 million years of healthy and productive life. 1 Over the past decade, the World Health Organization (WHO) has hosted a series of consultations on the financing of health research and development (R&D) to address two key needs of developing countries: filling R&D gaps when suitable products do not exist because of insufficient investment, and improving access to products that do exist but that are unaffordable or unavailable. Multiple World Health Assembly resolutions have defined the scope of these WHO consultations as " R&D related to the Type II and III diseases, and the specific R&D needs of developing countries related to Type I diseases " , based on a typology proposed in 2001 by the Commission on Macroeconomics and Health (CMH). 2 In this paper, all subsequent references to Type I, II and III diseases therefore refer to the CMH categories (Box 1). The most recent of the WHO consultations took place in 2012, through the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG). In its 2012 report, the CEWG proposed a binding convention that would mandate every signatory country to invest a minimum of 0.01% of its gross domestic product (GDP) in R&D falling within the established scope. Throughout this article we use CMH and CEWG terminology (e.g. " developing " and " developed " countries, " rich " and " poor " countries), although we acknowledge that debate exists around these terms. The CMH report distinguished three classes of diseases based on the relationship between the geographical burden of a given disease and the existence of R&D incentives. The report highlighted that as the prevalence of a disease in rich countries decreases, so too does the incentive for R&D to develop new drugs, vaccines or diagnostics. On this basis, Type I designates diseases for which sufficient R&D incentives exist, but without the resulting products being necessarily accessible to developing countries. This situation creates an access gap. By contrast, Type II and Type III designate diseases in which R&D incentives are too weak to generate enough suitable products, a situation that results in an R&D gap rather than an access gap. These were …