挑战与回应:我国药品专利制度的未来——以药品专利与健康权的关系为视角  

The Challenges and Responses:The Future of China's Pharmaceutical Patent Regime:The Relationship between Pharmaceutical Patent and the Right to Health

作　　者：王玫黎[1] 谭畅[1] 

机构地区：[1]西南政法大学国际法学院

出　　处：《知识产权》2017年第2期41-47,共7页Intellectual Property

基　　金：教育部人文社会科学一般项目(16YJAGJW003)的研究成果

摘　　要：健康权是最基本的人权,提高药品的可及性是保障健康权的重要手段之一,也是各国的国际义务。药品专利制度垄断了专利药品的价格,提高了仿制药的行政审批门槛,阻碍了民众的药品可及性,间接地对健康权的实现起到了消极影响。美国借助FTAs在世界范围内推行高标准的药品专利保护,众多"超TRIPS"标准的药品专利制度是美国FTAs的主要特征。这些逐渐具有国际化趋势的美式药品专利制度打破了药品专利与公共健康之间的脆弱平衡。我国面临严峻的公共健康问题,鉴于此,我们应当善用公共安全条款和强制许可条款,为保护健康权而适当放松仿制药的进口,同时简化仿制药审批流程,缩短仿制药的审批时间,努力实现药品专利与公共健康的平衡。The right to health is a fundamental human right. Improving access to medicines is not only one of the important approaches to protect right to health, but also an international obligation of each state. Pharmaceutical patent regime monopolizes the price of patent medicines. By means of raising the threshold of administrative approval of generic drugs, it hampers access to medicines and puts a negative effect on the fulfi llment of right to health indirectly. The United States promotes high-standard protection of pharmaceutical patent worldwide via FTAs.The TRIPS-plus pharmaceutical patent regime constitutes one of the main characters of American FTAs and gets international influence gradually, which destroys the fragile balance between pharmaceutical patent and public health. Confronted with serious public health issues, China should make practical use of public security and compulsory license provisions. At the same time, China should deregulate appropriately the importation of generic drugs for the protection of right to health, as well as simplify the approval process and shorten the approval period of generic drugs, in order to balance the relationship between pharmaceutical patent regime and public health.

关 键 词：药品专利 健康权 药品可及性 自由贸易协定 

分 类 号：D923.42[政治法律—民商法学]