These free trade agreements have attempted to limit flexibilities under the TRIPS agreement, such as compulsory licences or parallel imports. However, has it jeopardized the potential role of competition in generic drugs or has it weakened the bargaining power of the public sector? To draw attention to an area of concern, the United States has prioritized the creation or extension of “exclusive rights” over pharmaceutical test data in free trade negotiations (3). In accordance with Article 39.3 of the ON TRIPS agreement, WTO members must protect test data submitted to national drug regulators for the registration of medicines against “unfair commercial uses”. While TRIPS do not specify how this should be done, the United States has insisted in the free trade negotiations that countries provide data exclusivity for at least five years. Instead of submitting bioequivalence data to generic competitors, they must repeat costly marketing authorization tests that may discourage the general market. This may also raise ethical questions, as generic drug manufacturers would be forced to repeat studies of human subjects on drugs known as bioequivalents. Oliveira et al. (p. 815-821) provide an overview of the flexibilities under the ON TRIPS agreement that guarantee public health protection and how they are called into question despite the Doha Declaration. Your article on the implementation of TRIPS in Latin America and the Caribbean provides an overview of key areas where a country`s national legislation must reflect the flexibility of TRIPS, which is important for public health. Their work is particularly timely, as negotiations on the Central American Free Trade Agreement (CAFTA) have been concluded (although the agreement has not yet been ratified), while efforts towards a free trade agreement between the United States and Andean countries and the U.S.
Free Trade Area continue. G. Lee Skillington, Eric M. Solovy, The protection of test and other data required by Article 39.3 of the TRIPS Agreement, Northwestern Journal of International Law – business, Vol. 3. Any member consults, upon request, any other member who believes that an IP holder, who is a national law holder, or the member to whom the request for consultation was addressed, practices contrary to the laws and regulations of the requesting member in this area. , and who wishes to ensure compliance with this legislation, without prejudice to the measures provided by the law and the full freedom of a final decision of one of the two Member States.