Ensuring incentives for innovation and access to medicines: The balance struck in the Trans-Pacific Partnership Agreement on intellectual property (patent and regulatory data) protection for pharmaceutical products

The United Nations Economic Commission for Latin America and the Caribbean (ECLAC) commissioned this study to analyze the implications of the balance struck under the Trans-Pacific Partnership Agreement (TPPA) between the right to health and access to next-generation medicines on the one hand, and on the other, the private right to intellectual property protection and the need to maintain profit-earning incentives to spur innovation and research and development. The study focuses on the patent and data-related intellectual property protection provisions of the TPPA, specifically regarding pharmaceutical (small-molecule and biologic ) products, including on patent duration, linkage and term extensions as well as clinical test data protection and market exclusivity. The study considers the position of the United States in this respect, as it has been and remains the world’s principal demandeur for high intellectual property rights (IPR) standards in trade agreements, including the TPPA.