同情用药制度的国内外立法沿革及思考——兼论药品可及性相关制度的比较  

The Domestic and Foreign Legislative Evolution and Reflection of Compassionate Use——the Comparison of Drug Accessibility Related Systems

作　　者：刘晓 LIU Xiao(College of Humanities and Law,Jiaxing University)

机构地区：[1]嘉兴学院文法学院

出　　处：《中国食品药品监管》2022年第12期32-39,共8页China Food & Drug Administration Magazine

基　　金：国家社科基金重大项目“突发重大公共卫生事件防控的法治体系研究”(20&ZD188)。

摘　　要：新冠肺炎疫情发生以来,同情用药制度引起了社会的广泛关注与讨论。同情用药制度起源于美国,其作为初步引入到我国的新制度,由于目前我国法律规定过于原则,相关制度建设尚不完善,面临落地实施难的问题。本文以梳理同情用药制度的历史发展流脉和本土化进程为研究起点,通过对比研究得出同情用药制度与药品专利强制许可制度、超药品说明书用药以及药品尝试权均对拓宽药品可及性具有积极作用,但各制度之间存在着明显的制度差异。为此,应当注意厘清药品可及性相关制度的适用界限,正确发挥各自在应对突发公共卫生事件中的应有价值。Since the outbreak of COVID-19 epidemic, the compassionate use has aroused widespread concern and discussion in the society. Compassionate use originated in the United States and was introduced into China preliminary. However,since China’s current legal framework is too principled and the relevant system construction is not yet perfect, there are implementation issues that are challenging to solve. This paper takes the historical development and localization of the compassionate use system as the starting point and concludes that the compassionate use system, the compulsory license system of pharmaceutical patents, off-label drug use and drug right-to-try laws all have positive effects on widening access to drugs, but there are obvious institutional differences between them. Therefore, attention should be paid to clarifying the scope of application of drug accessibility related systems so that these systems could play their due role in response to public health emergencies correctly.

关 键 词：同情用药 药品专利强制许可 超药品说明书用药 药品尝试权 

分 类 号：R95[医药卫生—药学]