Against the background of an ongoing international debate concerning the relationship between intellectual property rights, innovation and public health, in international organizations and more generally among governments and civil society organizations, the World Health Assembly decided in May 2003 to give an independent Commission the task of analysing this key issue. The World Health Organization considered that its mission demanded it should play a part in this debate, with the objective of illuminating how intellectual property rights might affect public health. There was the need for governments in the north and south, pharmaceutical companies, scientists and other stakeholders, to consider how diseases which disproportionately affect developing countries could best be addressed, and to seek solutions. Our terms of reference made it clear that the focus of our enquiry should be the development of new diagnostics, vaccines and medicines to treat these diseases. But we quickly concluded that innovation was pointless in the absence of favourable conditions for poor people in developing countries to access existing, as well as new, products. The price of medicines is an important factor in determining access, but so also are poverty and the lack of infrastructure for delivering health care to poor people. It is not just neglected diseases, but rather neglected people, that should be our main concern. The international debate has strengthened awareness and produced some very positive effects. Many stakeholders have responded to the challenge of promoting more research and development (R&D) relevant to the needs of developing countries. New partnerships have been formed, and initiatives taken, to create new products for developing countries, and to promote their delivery...Intellectual property rights are important, but as a means not an end. How relevant they are in the promotion of the needed innovation depends on context and circumstance. We know they are considered a necessary incentive in developed countries where there is both a good technological and scientific infrastructure and a supporting market for new health-care products. But they can do little to stimulate innovation in the absence of a profitable market for the products of innovation, a situation which can clearly apply in the case of products principally for use in developing country markets. The effects of intellectual property rights on innovation may also differ at successive phases of the innovation cycle – from basic research to a new pharmaceutical or vaccine. We considered the impact of TRIPS, the flexibilities in TRIPS confirmed by the Doha Declaration, and also the impact of bilateral and regional trade agreements as they might affect public health objectives. Whereas there is an innovation cycle in developed countries which broadly works to provide the health care required by their inhabitants, this is far from being the case in developing countries to meet the needs of their people, in particular poor people. Our task was to consider how this difference might be addressed...