The test data provision of USMCA: A potential to promote or negate the timely access to genetically engineered biologics?

Abstract

With the adoption of the World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (henceforth, TRIPS), the WTO members agreed to provide a minimum level of Intellectual Property (IP) protections to a broad range of subjects, including “undisclosed test or other data.” However, following the entry into force of TRIPS, some WTO members (particularly, developed countries) have concluded Free Trade Agreements (FTAs) that consist of TRIPS-plus provisions, which go beyond the minimum standard established under TRIPS. One of the agreements that represent such a trajectory is the newly renegotiated agreement between the U.S, Mexico and Canada. The agreement has been negotiated, among other issues, to replace the North American Free Trade Agreement (NAFTA). This trilateral agreement also changed the name NAFTA to the United States-Mexico-Canada (USMCA) Agreement or NAFTA 2.0. The new agreement contains rules that govern undisclosed test or other data (hereafter, test data), which biopharmaceutical companies submit to Health Regulatory Authorities for the purpose of obtaining the right to market biological medicines (hereafter, biologics). Drawing upon the aforementioned background, this article examines if and how USMCA’s test data rule contravenes the obligations of the USMCA Parties to fulfill, protect and respect the right to biologics, as contained under the International Covenant on Economic, Social and Cultural Rights (hereafter, ICESCR) and other international human rights instruments that cover the right to health. The first section provides an overview of USMCA, the second section addresses the nature of legal protection given to test data under the TRIPS Agreement, the third section is devoted to examining the nature of obligation as contained under USMCA’s rule on test data, the fourth discusses the legal basis of the right to biologics, while the fifth section assesses if and how the rule on test data impedes the USMCA Parties from realizing the right to biologics. The last section provides a conclusion.