Oliveira Maria Auxiliadora, Bermudez Jorge Antonio Zepeda, Chaves Gabriela Costa, Velásquez Germán
Nucleus for Pharmaceutical Policies, National School of Public Health, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.
Bull World Health Organ. 2004 Nov;82(11):815-21. Epub 2004 Dec 14.
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.
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).
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.
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.
世界贸易组织的《与贸易有关的知识产权协定》（TRIPS协定）确立了知识产权的最低标准，包括药品专利保护；因此，这可能使发展中国家难以获得药品，尤其是最不发达国家。本研究旨在确定拉丁美洲和加勒比国家实施TRIPS协定是否产生了对公共卫生需求敏感的专利立法。
分析了11个拉丁美洲和加勒比国家的立法。分析中考虑的变量包括：授予专利的期限、可专利主题、过渡期（即立法颁布前的时间）、专利侵权举证责任的倒置、权利穷竭、强制许可和早期实施例外（允许一个国家在原专利到期前完成注册仿制药所需的所有程序）。
到2000年，所有研究国家都已改革其立法以符合该协定。巴西和阿根廷利用过渡期至2005年在制药行业授予专利。除巴拿马外，所有国家都通过在其立法中纳入强制许可机制，利用了该协定提供的保障措施和灵活性。阿根廷、玻利维亚、哥伦比亚、厄瓜多尔、秘鲁和委内瑞拉（代表安第斯共同体的国家）、多米尼加共和国和巴拿马纳入了允许平行进口的机制。墨西哥没有。巴西仅在颁发强制许可后才允许平行进口。巴西和多米尼加共和国的立法中包含早期实施例外。
本研究中的国家并未纳入该协定允许的所有机制，也未充分利用使世界贸易组织（WTO）成员能够改善公众健康，特别是在获取药品方面的条款。如果其他协定对知识产权制定更具限制性的规则，这种情况未来可能会恶化。
