摘要
临床试验数据作为国家食品药品监督管理总局(CFDA)判断药品、医疗器械是否符合注册申请标准的重要依据,其造假的危害性不言而喻。近年来,随着医疗技术的发展,各种各样的新型药品和医疗器械如雨后春笋般涌现,而数据造假的现象也越来越严重。2017年4月,最高人民法院、最高人民检察院联合发布《关于办理药品、医疗器械注册申请数据造假刑事案件适用法律若干问题的解释》以完善数据造假行为的法律责任体系,也标志着药品、医疗器械临床试验数据造假,情节严重,将会遭受刑事制裁。通过探讨临床试验数据造假入刑之前法律规范体系在监管对象范围和违法成本的设置等方面存在的问题,针对“两高”联合发布的司法解释的文本内容,结合哈伯特·L·帕克教授的“六条件理论”、刑法的基本原则等理论,论证临床试验数据造假入刑问题的必要性。通过解读司法解释涉及罪名的法益涵盖范围,分析现有临床试验数据造假入刑路径面临的正当性困境,并据此从解释的文本空间和立法的制度场域等视角为临床试验数据造假合理入刑提供具有操作可能性的建议,从而为解决临床试验数据造假现象,确保群众用药安全提供些许思路。
Clinical trial data is an important basis for the State Food and Drug Administration(CFDA)to judge whether drugs and medical devices meet the registration application standards,and the harm of its counterfeiting is self-evident.In recent years,with the development of medical technology,a variety of new drugs and medical devices have sprung up,and the phenomenon of data fraud has become more and more serious.In April 2017,the supreme people’s court and the supreme people’s procuratorate jointly issued the Interpretations on Several Issues Concerning the Application of Laws in Handling Criminal Cases of Data Falsification of Drug and Medical Device Registration Applications(hereinafter referred to as Judicial Interpretation)to improve the legal liability system for data falsification,which also marks the falsification of clinical test data of drugs and medical devices,which will be punished if the circumstances are serious sanctions.Through discussing the problems of the legal regulation system in the scope of supervision objects and the setting of illegal costs before the falsification of clinical trial data,the text of the judicial interpretation jointly released by the“two highs”and combined with the content of Harbert L Parker’s“six conditions theory”,the basic principles of criminal law and other theories,the study demonstrated the necessity of falsification of clinical trial data into penalties.By interpreting the legal benefit coverage of judicial interpretations involving crimes,analyzing the legal dilemma faced by the existing clinical trial data for falsifying and entering the criminal path,and based on these,this study provided with operational possibility for reasonable sentencing of clinical trial data falsification from perspectives of explanatory text space and legislative institutional field,so as to solve the phenomenon of falsification of clinical trial data,and provide some ideas for ensuring the safety of people’s medication.
作者
刘阳
李筱永
LIU Yang;LI Xiaoyong(Department of Health Law,Capital Medical University,Beijing 100069,China)
出处
《中国医学伦理学》
2020年第5期564-569,共6页
Chinese Medical Ethics
关键词
临床试验数据
造假入刑
必要性
正当性
技术路径
Clinical Trials Data
Falsification into the Criminal
Necessity
Legitimacy
Technological Path
