Free Trade Agreements: Special Considerations

• Pages: 199-200

Contenidos

• The Issue.
• Legal and Policy Considerations.
• Practice Example.
• References.

Page 199

The Issue

Regional and bilateral free trade agreements (FTAs), particularly as concluded by the United States, commonly include commitments in the area of intellectual property rights. Frequently these go beyond what is required by the TRIPS Agreement and the Doha Declaration (see Topic 11.2). These stricter, so-called "TRIPS-plus" provisions undermine the flexibilities countries have under TRIPS and may impair access to medicines.

Legal and Policy Considerations

The U.S. pursues an active regional and bilateral free trade agreements program (e.g., the Central America-Dominican Republic-United States Free Trade Agreement, or CAFTA-DR, and the FTAs with Jordan, Singapore, Chile, Australia, Morocco, Colombia, and Peru). These agreements aim at comprehensive trade opening to enhance economic growth and welfare. However, the provisions on market access tend to be accompanied by commitments on intellectual property rights, including patents. These provisions frequently go beyond what is required by the TRIPS Agreement and the Doha Declaration. It is important, therefore, always to check the text of any FTAs to which a country is a party. U.S. trade agreements: http://www.ustr.gov/Trade_Agreements/Section_Index.html.

TRIPS-plus provisions in regional and bilateral FTAs have included: possible extensions of the patent term, more stringent protection of pharmaceutical test data than required by Art. 39.3 of the TRIPS Agreement, and establishment of a linkage between marketing approval (drug registration) and patent status. Other limitations of TRIPS flexibilities include restrictions on the grounds for compulsory licensing, expansion of patent scope and limits to challenging potentially invalid patents.

Accompanying some of these FTAs are side letters that appear to indicate that the agreement's intellectual property requirements do not affect the other party's ability to take necessary measures to protect public health and the promotion of access to medicines for all. However, the interpretation and legal enforceability of these side letters is unclear.

Practice Example

Article 15.10(2) of the CAFTA-DR provides:

2. Where a Party permits, as a condition of approving the marketing of a pharmaceutical product, persons, other than the person originally submitting safety or efficacy information, to rely on evidence or informationPage 200...