Rachel M. Cohen, Doctors Without Borders, 333 7th Ave, 2nd Floor, New York, NY 1001, 212-655-3773, email@example.com
Purpose: In this era of globalization, world trade agreements, particularly those pursued by the US, include provisions on intellectual property that will likely restrict generic competition, blocking access to essential medicines for millions throughout the developing world. Médecins Sans Frontières (MSF) will present its assessment of the specific provisions within these agreements that will negatively impact access to medicines.
Methods: MSF legal advisors analyzed the World Trade Organization’s (WTO) agreement on Trade-Related Aspect of Intellectual Property Rights (TRIPS); the Central American Free Trade Agreement (CAFTA) text, and the draft of the Free Trade Area of the Americas (FTAA).
Results: While the TRIPS agreement created several safeguards to ensure the protection of public health, MSF identified three provisions common to US trade agreements that undermine such protections: (1) Extensions on patent terms will allow for monopoly pricing beyond the normal 20-year term; (2) Linking patent status with drug regulatory authority (DRA) approval prevents DRAs from registering generic versions of patented drugs, although these agencies are not equipped to determine patent validity; (3) Data exclusivity precludes generic companies from using originator-company data to prove the bioequivalence of a generic version for at least five years. This will delay generic competition and unlike with patents there is no recourse.
Recommendations: Though it is unclear whether TRIPS safeguards are sufficient to prioritize public health because TRIPS implementation is not complete, the US is negotiating even greater restrictions on generic competition in regional and bilateral trade agreements. To assure that public health is protected, intellectual property provisions should be excluded from any trade agreements outside the WTO.
Learning Objectives: At the conclusion of this session, the participant will be able to
Presenting author's disclosure statement:
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.
The 132nd Annual Meeting (November 6-10, 2004) of APHA