The 2030 Agenda for Sustainable Development recognizes the need for research and development into and access to affordable essential medicines and vaccines for the communicable and noncommunicable diseases that primarily affect developing countries. Target 3.b is to support research and development of vaccines and medicines for the communicable and noncommunicable diseases that primarily affect developing countries, provide access to affordable essential medicines and vaccines, in accordance with the Doha Declaration on the TRIPS Agreement and Public Health, which affirms the right of developing countries to use to the full the provisions in the Agreement on Trade Related Aspects of Intellectual Property Rights regarding flexibilities to protect public health, and, in particular, provide access to medicines for all. The aim of the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPA-PHI), adopted in 2008 (2), is to promote new thinking on innovation and access to medicines and to secure an enhanced and sustainable basis for needs-driven essential health research and development relevant to diseases that disproportionately affect developing countries.

Intellectual property rights (IPRs) are often conceived narrowly from the vantage point of offering incentives for private sector investment in research and development (R&D), but the legal regime of IPRs can also work to improve access to public goods for global health, particularly for those disadvantaged by destitution and disease. The WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPOA), adopted by the World Health Assembly in 2008, calls for an “enhanced and sustainable basis for needs-driven, essential health research and development relevant to diseases that disproportionately affect developing countries.” How knowledge is generated, owned, and harnessed to support pro-poor development is at the heart of this effort. New approaches to tiering, pooling, and open-source collaboration have resulted from the struggle to deliver affordable treatments for AIDS and neglected diseases. In examining how intellectual property rights can most effectively and strategically support developing countries in implementing this ambitious and potentially catalytic agenda in enabling innovation for global health, this paper seeks to outline a coherent and strategic approach to address human development needs and to facilitate the harnessing of innovation and the sharing of knowledge for global health.

This study seeks to reinforce the understanding of the interplay between the distinct policy domains of health, trade and intellectual property, and of how they affect medical innovation and access to medical technologies. The second edition comprehensively reviews new developments in key areas since the initial launch of the study in 2013.