摘要
同情用药制度在应对突发公共卫生事件时具有独特价值,我国由于制度规定模糊、权责分配不明等问题,该制度难以适用。其根本原因则是患者、监管机构、医药研发企业等主体之间交织着个人利益与公共利益、当前患者利益与未来患者利益、患者利益与医药研发企业利益等多重利益冲突。因此,需要在评估必要性与可行性的前提下适时地引入利益衡量理论并将其具体化,从而为互相冲突的利益做出选择以提供方法论指导。最后,为同情用药制度的实践问题提供相应的解决路径,具体包括明确该制度的具体适用条件、严格限定开展同情用药的场所与范围以及完善诸如数据保护、上市独占期等企业激励措施等。
The compassionate use system has unique value in responding to public health emergencies,yet it is difficult to apply in China because of vague regulations and unclear allocation of authority and responsibility.The fundamental reason is that there are multiple conflicts of interests between patients,regulatory agencies,and pharmaceutical R&D companies,such as personal interests and public interests,current patients’interests and future patients’interests,and patients’interests and pharmaceutical R&D companies’interests.Therefore,it is necessary to introduce and concretize the interest measurement theory in a timely manner under the premise of assessing the necessity and feasibility,so as to provide methodological guidance for making choices among conflicting interests.Finally,on the basis of the former,we provide solutions to the practical problems of the compassionate use system,including specifying the conditions for the application of the system,strictly limiting the place and scope of compassionate use,and improving corporate incentives such as data protection and marketing exclusivity periods.
作者
刘海燕
Liu Haiyan(School of Law,Wuhan University,Wuhan 430072,China)
出处
《锦州医科大学学报（社会科学版）》
2023年第6期10-15,共6页
Journal of Jinzhou Medical University(Social Science Edition)
关键词
同情用药
利益衡量
比例原则
数据独占期
compassionate use
benefit measurement
proportionality principle
data exclusivity period
作者简介
刘海燕,女,1999年生,湖南衡阳人,民商法学专业在读硕士研究生。
