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Global Health Programme Working Paper No. 7/2011, November 15, 2011

In the decade since the Doha Declaration was adopted, significant progress has been made in addressing problems associated with innovation and access to medicines, including through expanded financial support for procurement and distribution of treatments and vaccines and the establishment of new research and development (R&D) mechanisms. There has been enhanced cooperation among WHO, WIPO and the WTO. Nevertheless, significant gaps remain in placing the development and supply of medicines to the world’s population on a sustainable footing; gaps that are exacerbated by the present trend toward restrained government spending. This paper reflects on the political and legal constellation making progress on global public health matters difficult, and on economic and scientific trends in the medicines sector that may affect policy over the next decade. A sustainable medicines supply system should proceed from “first principles”, encompassing financing mechanisms to assure that essential medicines are provided for all, while affording opportunity to countries at all levels of development to offer access to advanced treatments on a fair compensation basis. Improved mechanisms to incentive R&D are necessary and feasible. First principles should encompass rational prescribing based on the best interests of the patient, and should attend to regulation and enforcement adequate to assure quality, safety and efficacy. Development of a sustainable system could require some modification to the WTO TRIPS Agreement, but this should not be a determinative factor in considering an improved international framework. A new mechanism for global coordination of medicines strategy may be helpful.