Watson Institute for International and Public Affairs
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Access to Medicines in the Global South

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), signed by members of the World Trade Organization in 1995, fundamentally alters the global governance of intellectual property (IP). Arguably, the most important change introduced by TRIPS is the requirement that all countries grant patents on pharmaceutical products. The years following TRIPS entering into effect witnessed a great deal of political conflict over the extent to which TRIPS leaves countries with “flexibilities” in how they meet their new obligations. Countries clashed most of all over provisions designed to curb the control that patents confer on their owners. At the international level, these conflicts resulted in two landmark agreements: the Doha Declaration on the TRIPS Agreement and Public Health adopted in November 2001 (the Doha Declaration) and the Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health adopted in August 2003 (the Paragraph 6 Decision).

Both the debates over flexibilities that could potentially improve access to medicines, and the international politics of the Doha Declaration and the Paragraph 6 Decision, have been the subject of an immense literature. But the extant literature leaves unanswered many key questions in the political economy of access to medicines. Once rights are secured at the international level, do countries implement these rights? If not, why not? And if so, does the introduction of flexibilities in patent systems improve access to medicines? When countries take advantage of flexibilities, do these measures have the intended effects? How, in short, have the flexibilities in TRIPS (affirmed by the Doha Declaration and extended by the Paragraph 6 Decision) affected access to medicines in the developing world? To answer these questions, this project examines events other than the formal international negotiations, including debates over implementation of TRIPS at the national level and the influence of transnational or local coalitions that attempt to affect countries’ ability to exploit their international rights. As countries that exploit their rights under TRIPS to secure non-patented drugs are rarely self-sufficient, we also look at how TRIPS implementation affects patterns of investment and production in the global and regional pharmaceutical industries. Our goal is to broaden the current discussion by offering answers to some of the most pressing questions through careful empirical studies in a range of developing countries.

Selected Publications

Chorev, Nitsan. 2012. The World Health Organization Between North and South. Ithaca: Cornell University Press.

Chorev, Nitsan. 2012. “Changing Global Norms through Reactive Diffusion: The Case of Intellectual Property Protection of AIDS Drugs.” American Sociological Review 77(5): 831-853.

Sampat, Bhaven N., Kenneth C. Shadlen and Tahir M. Amin. 2012. “Challenges to India's Pharmaceutical Patent Laws.” Science 337: 414-415.

Shadlen, Kenneth C. 2011. “The Political Contradictions of Incremental Innovation: Lessons from Pharmaceutical Patent Examination in Brazil.” Politics & Society 39 (2): 143-174.

Shadlen, Kenneth C. 2009. “The Politics of Patents and Drugs in Brazil and Mexico: The Industrial Bases of Health Policies.” Comparative Politics 42 (1): 41-58.

Shadlen, Kenneth C. 2007. “The Political Economy of AIDS Treatment: Intellectual Property and the Transformation of Generic Supply.” International Studies Quarterly 51 (3): 559-581.