Abstract

Test data that is submitted by the originator to the national health regulatory agencies for the marketing authorization of a new drug or medicine is protected under Article 39.3 of the TRIPS Agreement. This test data protection regime is a debatable issue of Intellectual Property (IP) since TRIPS has not provided a comprehensive global standard of test data protection, rather it obligates the Member States to provide a minimum level of protection. Considering that Article 39.3 has established a regulatory floor of test data protection, developed countries with stronger research and development (R&D) based companies seek a greater level of protection. Accordingly, they are frequently entering into various FTAs with developing countries that include more specific models of test data protection, such as providing an exclusivity period for test data. This model of test data protection affects the affordable access to medicines in the least developed countries (LDCs) and developing countries with no or weaker pharmaceutical industries. This paper essentially evaluates the extent to which a country has obligations to protect test data under the selected two Free Trade Agreements (FTAs), namely the Australia-US FTA and the Agreement between the United States of America, the United Mexican States, and Canada (USMCA). The paper finally concludes that the provisions of those FTAs are considered to create obstacles to the entry of generic medicines into the market. However, in the context of the COVID-19 crisis, the provisions for test data protection in those FTAs can be circumvented.

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