Policy Implications of Harmonizing Test Data Exclusivity for Biologics

Abstract

In light of both the number of countries adopting test data exclusivity provisions (and for biologics in particular), as well as the recent trend of incorporating higher levels of test data exclusivity protection for biologics (compared to small molecule drugs) in regional trade agreements, this thesis analyzes whether such provisions indeed balance incentives to innovate with access to medicines. It examines the approaches of a cross-section of countries and assesses the economic impact of test data exclusivity for biologics in terms of both investment and access to medicines. It further highlights other relevant factors that could influence these outcomes. It concludes with recommendations on how countries can adapt test data exclusivity for biologics to their own needs, particularly in the context of negotiating free trade agreements.

Keywords: Data Exclusivity, Biotechnology, Free Trade Agreements, TRIPS, Unfair Competition