Skip to content Skip to navigation

How International Trade Policy Can Be Utilized to Rectify Problems within the United States Regulatory Exclusivity System for Biologics

Caitlin Hird


The United States and the European Union are currently negotiating an international trade agreement (ITA) that will have a significant impact on the economies and innovation of every country involved. A substantial point of contention within the negotiations of the agreement, called the Transatlantic Trade and Investment Partnership (T-TIP), will be deciding what system of regulatory exclusivity to use for biologics, a complex molecular category of pharmaceuticals. I argue that the United States currently has an insufficient system for promoting the production of biosimilars, the competitors to brand name biologics, leading to a lack of competition in one of the most profitable industries in the country. I explain how the Trade Related Aspects of International Property Rights (TRIPS) and the T-TIP can and should be used to bypass the political power of U.S. pharmaceutical companies in order to foster a more competitive biosimilars market in the United States. 


Download Thesis