Free Trade Agreements and Regulatory Change: Examples from the Generic and Biosimilar Sectors

Abstract

Comprehensive free trade agreements (FTAs) have increasing importance and impact on domestic legislation and significantly affect regulated industries, such as pharmaceuticals. Recent FTAs include provisions on regulatory cooperation and convergence, as well as intellectual property provisions going well beyond the scope of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs). These rules have particular importance for the generic and biosimilar medicines’ sectors and have important links to public health objectives. A growing number of sectors are covered by the substantive provisions of FTAs, often by means of dedicated and sector-specific rules and chapters catering to country- and/or industry-specific needs and interests. The article provides the relevant background in terms of trade law, trade negotiations and FTA trends, particularly as they relate to intellectual property rights and pharmaceuticals. The article places its core emphasis on the domestic impact of FTAs. Examples are drawn from the pharmaceutical sector of generic and biosimilar medicines. The potentially decisive impact of FTAs implies the necessity that all interested parties be more pro-actively involved in order to shape the future of the applicable legal frameworks, internationally and domestically.