Intellectual Property and Access to Medicines: An Analysis of Legislation in Central America/Propriete Intellectuelle et Acces Aux Medicaments: Analyse De la Legislation En Amerique centrale/Propiedad Intelectual Y Acceso a Los Medicamentos: Analisis De la Legislacion En America Central

Article excerpt

Introduction

Much has been written about the impact of intellectual property (IP) provisions on access to medicines in the developing world. (1-7) In recent years, this discussion has often centred on the impact of free trade agreements with the United States of America (USA) that contain elevated protection for pharmaceutical IP. Typically, views are deeply polarized: some decry the free trade agreements' provisions as inevitably disastrous for public health (8-13) while others argue that IP protection does not constitute a significant obstacle to access to medicines. (14-18) As countries contemplate ratification, the lack of available studies forecasting the impact of such regulations (or the lack of agreement on which studies to trust) has further hampered the discussion.

The United States--Dominican Republic--Central America Free Trade Agreement (DR-CAFTA) provides an important case study to examine the broader dynamics of national and international law and their public health impacts. DR-CAFTA is the largest free trade agreement to date to incorporate stronger IP provisions than those required by the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. At the time of its drafting it was widely hailed by both supporters and opponents as heralding the dawn of a new era in IP protection. It also has served as a stepping stone to the Colombia and Peru agreements, and others under negotiation with other South American countries. Understanding the way DR-CAFTA's IP provisions may affect access to affordable medicines in Central America and the Dominican Republic can help predict the impact of other related agreements still under negotiation, such as those with Malaysia, Thailand and the United Arab Emirates.

Assessing DR-CAFTA's current impact on access to medicines is a complex undertaking, beyond the scope of the present study. As a first step towards that end, however, we seek to determine which legislative changes have been implemented in each Central American country as a result of its adherence to DR-CAFTA. This study draws on analysis of the text of international agreements (DR-CAFTA and the TRIPS Agreement), analysis of national legislation in Central American countries and in the Dominican Republic, and interviews with public health and trade officials and representatives of civil society in Costa Rica, El Salvador and Guatemala.

Our research documents a dramatic tightening of Central American IP regulation in the wake of DR-CAFTA. At the same time, however, our findings suggest that the relationship between the text of international agreements (both DR-CAFTA and TRIPS) and the "public health sensitivity" of legislation (19,20) is not as direct as many assume. First, in some cases restrictive reforms were adopted prior to the ratification of the agreements themselves. Second, in many cases countries have implemented more restrictive standards than those required in these agreements. Third, in some cases, the DR-CAFTA ratification process actually led to the implementation of legislation sensitive to public health. Our purpose is not to argue that trade agreements like DR-CAFTA are not important in determining IP policy, but rather to emphasize continuities between these agreements and broader trends in IP policymaking, which are often eclipsed by the intense focus on trade agreements and their ratification. We explain the reasoning for these arguments here, using the examples of new IP provisions imported by DR-CAFTA to Central America, and conclude with a discussion of their broader implications.

IP in Central America

All of the CAFTA countries are members of the World Trade Organization (WTO). To comply with the TRIPS Agreement, El Salvador passed its first IP legislation in 1993-94; the remaining countries of the region passed legislation in 1999-2000. Prior to this time, effective IP protection was not applied to pharmaceutical products in the region, as in much of the rest of the world. …