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
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篇名: 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
TITLE:
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。
ABSTRACT: 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 & CONCLUSIONS: 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 developing country mostly relying on generic drugs, should scientifically assess the effects of TRIPS-plus on public health, drug accessibility and pharmaceutical industry in the process of domestic legislation and negotiating a free trade agreement, and make effective use of the TRIPS flexibility to protect the public health.
期刊: 2017年第28卷第4期
作者: 陈敬,史录文
AUTHORS: CHEN Jing,SHI Luwen
关键字: 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
KEYWORDS: Agreement on Trade-related Aspects of Intellectual Property Rights; Additional terms; Public health; Drug accessibility; Profound consideration
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