超说明书用药临床应用的法律现实困境及对策研究

目的 对新修订的《中华人民共和国医师法》中有关超说明书用药的法律条款进行梳理与分析，为建构适应中国国情的超说明书用药法律机制提供借鉴和参考。方法 梳理超说明书用药的立法现状，分析中国超说明书用药在临床应用中存在的法律治理困境，借鉴美国超说明书用药法律制度，并针对问题提出相应的解决措施。结果 相关立法亟待完善、循证医学体系研究不足、患者知情同意权落实不全、超说明书风险控制措施不完备、临床用药管理不严等是中国超说明书用药在临床应用中面临的法律现实困境。结论 破解中国超说明书用药在临床应用中的法律困境需要通过立足实践完善立法、加强循证医学证据体系建设、落实患者知情同意权、完备超说明书用药风险防范机制、健全超说明书用药监管机制等多种途径来建构中国超说明书用药法律治理机制。

Study on the Legal Realistic Dilemmas and Countermeasures of the Clinical Application of the Off-label Drug Use

OBJECTIVE To sort out and analyze the legal provisions concerning the off-label drug use in the newly revised Law on Doctors of the People’s Republic of China, and to provides reference for the construction of the legal mechanism of the off-label drug use which is suitable for China’s national conditions.METHODS Analyzed the current situation of the legislation on the off-label drug use, analyzed the difficulties of legal governance in the clinical application of off-label drug use in China, and drawn lessons from the legal system on the off-label drug use in the United States, and put forward the corresponding measures to solve the problem. RESULTS Relevant legislation needed to be improved urgently, evidence-based medicine system research was insufficient, patients’ informed consent right was not fully implemented, risk control measures for ultra manual drugs were not complete, and clinical drug management was not strict. These were the legal and practical difficulties that China faces in the clinical application of ultra manual drugs. CONCLUSION To address the legal dilemma of off-label drug use in clinical application in China, multiple approaches need to be taken to build up related legal governance mechanism. Including the completion of legislation, construction of evidence-based medical evidence system, insurance of patients’ right to informed consent, completion of the risk prevention mechanism of off-label drug use, and the improvement of the supervision mechanism of off-label drug use, etc.