815Bulletin of the World Health Organization | November 2004, 82 (11)Objective The World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement establishes minimum standards for intellectual property rights, including patent protection for pharmaceuticals; therefore, it may make it difficult for developing countries to gain access to medicines, especially those countries that are the least developed. This study aims to determine whether implementation of the TRIPS Agreement in Latin American and Caribbean countries has generated patent legislation that is sensitive to public health needs.Methods Legislation in 11 Latin American and Caribbean countries was analysed. The variables considered in the analysis were: the term of patents issued, patentable subject matter, transition periods (that is, time until legislation was enacted), reversal of the burden of proof of patent infringement, exhaustion of rights, compulsory licensing and the early working exception (which allows a country to complete all procedures necessary to register a generic product before the original patent expires).Findings By 2000, all of the countries studied had reformed their legislation to conform to the agreement. Brazil and Argentina used the transition period until 2005 to grant patents in the pharmaceutical industry. All countries, except Panama, made use of the safeguards and flexibilities available through the agreement by including mechanisms for compulsory licensing in their legislation. Argentina; Bolivia, Colombia, Ecuador, Peru and Venezuela (countries that represented the Andean community); the Dominican Republic; and Panama included mechanisms to allow parallel importation. Mexico did not. Brazil only permits parallel importation after a compulsory licence has been issued. The early working exception is included in legislation in Brazil and the Dominican Republic.Conclusion The countries in this study did not incorporate all of the mechanisms allowed for by the Agreement and are not adequately using the provisions that enable World Trade Organization (WTO) members to obtain better health for the public, particularly in regard to gaining access to medicines. This situation may deteriorate in future if other agreements establish more restrictive rules for intellectual property rights.Keywords Pharmaceutical preparations/supply and distribution; Patents/legislation; Treaties; Licensure/legislation; Drug industry; Drugs, Generic/supply and distribution; Drug and narcotic control/methods; Policy making; Developing countries; Latin America; Caribbean region (source: MeSH, NLM).Mots clés Préparations pharmaceutiques/ressources et distribution; Brevet/législation; Traités; Autorisation exercer/législation; Industrie pharmaceutique; Produits génériques/ressources et distribution; Contrôle drogues et stupéfiants/méthodes; Choix d’une politique; Pays en développement; Amérique latine; Caraïbes (source: MeSH, INSERM).Palabras clave Preparaciones farmacéuticas/provisión y distribución; Patentes/legislación; Tratados; Licencias/legislación; Industria farmacéutica; Medicamentos genéricos/provisión y distribución; Control de medicamentos y narcóticos/métodos Formulación de políticas; Países en desarrollo; América Latina; Región del Caribe (fuente: DeCS, BIREME).Bulletin of the World Health Organization 2004;82:815-821.Voir page 819 le résumé en français. En la página 820 figura un resumen en español.1 Adjunct Coordinator, Nucleus for Pharmaceutical Policies (WHO Collaborating Centre for Pharmaceutical Policies), National School of Public Health – Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.2 Coordinator, Nucleus for Pharmaceutical Policies (WHO Collaborating Centre for Pharmaceutical Policies), National School of Public Health – Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.3 Pharmacist, Nucleus for Pharmaceutical Policies (WHO Collaborating Centre for Pharmaceutical Policies), National School of Public Health – Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.4 Coordinator, Drug Action Programme, Essential Drugs and Medicines Policy, World Health Organization, CH-1211 Geneva 27, Switzerland (email:[email protected]). Correspondence should be sent to this author.Ref. No. 03-006809(Submitted: 11 August 2003 – Final revised version received: 15 March 2004 – Accepted: 26 April 2004)Has the implementation of the TRIPS Agreement in Latin America and the Caribbean produced intellectual property legislation that favours public health?Maria Auxiliadora Oliveira,1 Jorge Antonio Zepeda Bermudez,2 Gabriela Costa Chaves,3 & Germán Velásquez4Research816Bulletin of the World Health Organization | November 2004, 82 (11)ResearchTRIPS Agreement and public health Maria Auxiliadora Oliveira et al. IntroductionAll Member States of the World Trade Organization (WTO) must abide by a series of multilateral agreements. Among these, the Trade-Related Aspects of Intellectual Property Rights Agreement (known as the TRIPS Agreement), signed in April 1994 in Marrakesh, came into force in January 1995 (1).The Agreement establishes minimum standards for in-tellectual property rights; for example, patent protection on pharmaceutical products must last for a minimum of 20 years. Member States must incorporate these standards into their legislation. Developed countries had one year (until 1996) to become TRIPS-compliant, while developing countries had five years (until 2000), and countries designated as “least-developed countries” had 11 years (until 2006) (1, 2). Under Article 66.1, developing countries and least-developed countries that had not previously recognized pharmaceutical patents, have 10 years to become compliant (until 2005). In November 2001, this period was extended to 2016 for least-developed countries (3). Box 1 describes the provisions and mechanisms of intellectual property rights covered by the Agreement.Under the terms of the Agreement, life-saving products are treated in the same way as any other merchandise or com-modity. Therefore, the Agreement may prevent governments, representatives of nongovernmental and international organiza-tions, and experts from gaining appropriate access to medicines and other health-care products (4–7). The granting of patents may encourage innovation, but by their nature, they create Box 1. Description of the provisions and mechanisms of the TRIPS