中国药品未注册用法的司法和立法实践及相关建议。
Judicial and legislative practice and related suggestions on off-label drug use in China.
机构信息
Department of International Medical Services, Peking Union Medical College Hospital, Beijing, China.
出版信息
BMC Health Serv Res. 2023 Mar 30;23(1):312. doi: 10.1186/s12913-023-09293-y.
BACKGROUND
Off-label drug use exists widely in medical practice and is also an area which easily triggers controversy between patients and medical institutions. Previous studies have identified the reasons why off-label drug use long exists. However, there is no multidimensional analysis on real judicial precedents about off-label drug use. This study aimed to investigate the dispute points on off-label drug use based on real cases in China, and proposed suggestions based on newly-leased Physicians Law.
METHODS
Our study is a retrospective study with all the 35 judicial precedents on off-label drug use extracted from China Judgments Online from 2014 to 2019. This study mainly used the methods of statistical analysis, inferential analysis, exemplification, literature summarization and comparative analysis.
RESULTS
According to the analysis of the 35 precedents of jurisdictions from 11 different aspects, it can be seen that the second-instance and retrial rates of this kind of cases are high, and the disputes between patients and medical institutions are fierce. In judicial practice of off-label drug use, medical institutions are determined whether to bear civil liability according to the constituent elements of medical tort liability: the rate of medical institutions' bearing liability for off-label drug use is not high, and medical institutions are not directly identified as infringing acts and they don't bear tort liability. The clear provisions about off-label drug use in Law of the People's Republic of China on Physicians which was implemented in March 2022 confirm this at the legislative level.
CONCLUSIONS
By analyzing the current judicial practice of China's off-label drug use cases, and summarizing the dispute points between medical institution and patients, the constituent elements of tort liability, and the rules of evidence etc., suggestions are proposed to further regulate off-label drug use and promote safe and rational drug use.
背景
药品未注册使用在医疗实践中广泛存在，也是引发医患矛盾的热点问题之一。既往研究对药品未注册使用的存在原因进行了剖析，但缺乏对真实司法判例的多维分析。本研究旨在通过对中国真实案例进行分析，探讨药品未注册使用的争议焦点，并结合新颁布的《医师法》提出建议。
方法
本研究为回顾性研究，从 2014 年至 2019 年，在中国裁判文书网上共提取了 35 例药品未注册使用的司法判例。本研究主要采用统计分析、推断分析、例证、文献综述和比较分析等方法。
结果
通过对 11 个不同方面的 35 例判例进行分析，可以看出此类案件二审、再审率较高，医患双方争议激烈。在药品未注册使用的司法实践中，医疗机构是否承担民事责任依据医疗损害责任的构成要件进行判断：药品未注册使用的医疗机构责任承担率不高，医疗机构不直接被认定为侵权行为，不承担侵权责任。2022 年 3 月实施的《中华人民共和国医师法》在立法层面明确了这一点。
结论
通过对中国药品未注册使用案例的司法实践进行分析，总结医疗机构与患者之间的争议焦点、侵权责任构成要件、证据规则等，提出进一步规范药品未注册使用、促进安全合理用药的建议。
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