与药品有关的超出《与贸易有关的知识产权协议》保护条款的介绍与反思  

Introduction and Profound Consideration on Intellectual Property Rights Protection Standard Terms Related to Drugs beyond the Regulations of TRIPS

作　　者：陈敬[1,2] 史录文[1,2] CHEN Jing SHI Luwen(Dept. of Pharmaceutical Administration and Clinical Pharmacy, School of Pharma- ceutical Sciences, Peking University,Beijing 100191, China International Research Center for Medical Admin- istration, Peking University, Beijing 100191, China)

机构地区：[1]北京大学药学院药事管理与临床药学系,北京100191 [2]北京大学医药管理国际研究中心,北京100191

出　　处：《中国药房》2017年第4期442-445,共4页China Pharmacy

基　　金：国家自然科学基金青年项目(No.71503017)

摘　　要：目的:为提高我国应对超出《与贸易有关的知识产权协议》保护条款(TRIPS-plus条款)的能力、完善国内知识产权保护政策提供参考。方法:介绍常见的TRIPS-plus条款类型,分析其特点,反思其潜在的不良影响。结果与结论:常见的TRIPS-plus条款有数据保护、专利链接、专利期延长、限制强制许可与平行进口等,这些条款将延缓仿制药上市、提高药品价格、影响药品可及性,给发展中国家的公共健康带来巨大挑战。中国作为世界上最大的发展中国家和仿制药生产大国,在签署自由贸易协议以及国内知识产权立法时,应当科学评估TRIPS-plus对我国公共健康、药品可及性以及医药产业等方面的影响,合理利用TRIPS弹性条款,保障公众健康。OBJECTIVE： To improve response capacity of China to deal with intellectual property rights protection standard terms （Trips-plus terms） beyond the regulations of Agreement on Trade-related Aspects of Intellectual Property Rights （TRIPS）, and to provide reference for improving national intellectual property rights protection policy. METHODS： Trips-plus terms and their common types were introduced to analyze their characteristics and consider about their adverse effects. RESULTS ＆ CONCLU- SIONS ： Common TRIPS-plus terms involve data protection, patent interlinkage, patent period extension, limitation of compulsory licensing and parallel importation, etc. These terms pose a significant challenge to developing countries, resulting in delaying entry of generics, increasing drug price, influencing drug accessibility and posing a great threat to public health. China, as the largest de- veloping country mostly relying on generic drugs, should scientifically assess the effects of TRIPS-plus on public health, drug ac- cessibility and pharmaceutical industry in the process of domestic legislation and negotiating a free trade agreement, and make effec- tive use of the TRIPS flexibility to protect the public health.

关 键 词：与贸易有关的知识产权协议 超出条款 公共健康 药品可及性 反思 

分 类 号：R951[医药卫生—药学]