超说明书用药法律释读及应对策略分析

Legal Interpretation and Coping Strategy Analysis on Off-label Use

目的解读超说明书用药的法律属性,促进超说明书用药的规范性和合法性使用。方法通过分析药品注册流程,明确药品说明书的法律地位。根据民法基本原则和相关法律规定,界定超说明书用药行为的合法性。对当前文献报道的超说明书用药管理策略进行推荐等级和法律效力评价,进而提出建议。结果药品说明书并非规范性法律文件,其法律效力仅为医务人员临床用药的参考。超说明书用药行为本身并不违反我国相关法律法规,但其合法性在业内外仍缺乏共识。为应对风险,部分学者建议并采取了一系列措施。考虑到临床实际和法律效应,部分措施的适用性有待商榷。结论为规避执业风险,结合我国国情,建议摸索建立高效的医患沟通机制、呼吁政府不断完善药品监管体系和提请最高人民法院发布指导性案例,为合理合规的超说明书用药正名。

OBJECTIVE To interpret the legal attributes of off-label use,promote the standardization and legality of off-label use.METHODS By analyzing the drug registration process,the legal status of off-label use was clarified.According to the basic principles of civil law and relevant legal provisions,the legality of off-label use was defined.The recommendation level and legal effect evaluation of the off-label use management strategy reported in the current literature were made,and then suggestions were put forward.RESULTS The package insert was not a normative legal document,and its legal effect was only a reference for clinical use of medical personnel.The off-label use behavior didn’t violate Chinese laws,but its legitimacy still lack consensus of insides and outsides.In response to risks,some scholars had recommended and adopted a range of countermeasures.Due to clinical practice and legal effects,some of them were open to question.CONCLUSION In order to circumvent the practice risks,combined with China’s national conditions,it is recommended to explore an efficient communication mechanism for doctors and patients,call on the government to continuously improve the drug regulatory system and request the Supreme People’s Court to release guiding cases,for the recertification of reasonable off-label use.