Paper short abstract:

The paper presents data on patent provisions in bilateral trade agreements that exceed what is required from the World Trade Organization. I review debates over the effects on drug prices of such provisions and focus on the conceptual and methodological challenges that analysts must overcome.

Paper long abstract:

The global politics of intellectual property underwent a fundamental shift in the closing decades of the 20th Century, as the World Trade Organization's (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) made pharmaceutical patent protection obligatory for all WTO members. By 2005 pharmaceutical patents were universally available, in all but the poorest countries. Increasing the geographic scope of patent protection generated fears that public health budgets would come under stress and many would be left without access to essential medicines. These fears were augmented dramatically by the inclusion of further provisions in the flurry of regional and bilateral trade agreements that have been negotiated since the early 2000s between the USA (and also European Union) and developing countries in Asia, Africa, and Latin America. This paper analyzes the spread of "TRIPS Plus" rules in bilateral trade agreements, explaining the challenges that they create and the shortfalls of recent studies that attempt to measure their impact. The paper places particular emphasis on the conceptual and methodological challenges of assessing the effects of patent provisions in trade agreements on prices and access to drugs, including the choice of what variables to focus on, how to operationalize these variables, and the importance of timing in analyzing the effects of TRIPS Plus provisions.