美国自由贸易协定中药品TRIPS-Plus保护  

TRIPS- Plus Protection on Drug Innovation under US FTAs

作　　者：梁志文[1] 

机构地区：[1]南京师范大学法学院

出　　处：《比较法研究》2014年第1期125-140,共16页Journal of Comparative Law

基　　金：中国博士后科学基金项目"药品创新知识产权保护:国际趋势与中国应对策略"(2012M510678)的资助

摘　　要：制药业是TRIPS协议和TRIPS-Plus规则的幕后推手。在制药业的推动下,美国在自由贸易协定(FTA)中积极推行药品的TRIPS-Plus保护。它们以美国1984年《药品价格竞争与专利保护期恢复法案》为蓝本,向贸易伙伴推销专利保护期延长、数据专有权和专利链接制度。它们以各种形式出现在美国现已生效的20个FTA和每年度《特别301报告》中,并逐步为发展中国家所采纳,成为潜在的国际新标准,对药品获取和公共健康产生严重影响。发展中国家应采取合众连横策略,不仅要将TRIPS协议弹性条款和《多哈宣言》融入TRIPS-Plus规则,而且还要构建TRIPS-Plus规则自身的弹性条款。作为美国重要的贸易伙伴之一,我国不能漠视这一发展趋势。Pharmaceutical company is not only the most important force to create TRIPS and TRIPS - Plus, but also to promote TRIPS - Plus for drug innovation under US FTA. These rules, including patent term extension, data exclusivity and patent linkage, come from Hatch - Waxman Act 1984 of USA. Since the appearance of the twenty US FTAs which become effective today, these rules have been gradually adopted by developing countries and become potential international standard for drug protection and shall seriously influence public health. Developing countries should take steps to incorporate flexible rules of TRIPs and Doha Declaration into TRIPS - Plus rules, and work out flexible rules of TRIPS - Plus. As one of the most important trade partners of US, China should take steps to balance the different interest between access to medicine and drug innovation.

关 键 词：自由贸易协定 上市许可 数据专有权 专利链接 药品专利保护期延长 

分 类 号：D971.2[政治法律—法学]