超说明书用药的医学伦理审查必要性探究——以《中华人民共和国医师法》为视角

Research on the Necessity of Medical Ethics Review of Off-label Drug Use:From the Perspective of Physician Law of the People's Republic of China

我国《中华人民共和国医师法》首次在立法上对医师超说明书用药给予合法性确认,但未明晰其是否需要医学伦理审查才能适用。从以下四个维度论证医学伦理审查并非超说明书用药的必备前置程序:现行法律规范并未有强制性要求;行业并未形成统一共识与规则;比较法考察不能提供参考与支撑;从风险视角审视,超说明书用药所涉利益群体明确,风险相对可控。但是,超说明书用药对患者而言仍有一定风险,因此应当严格遵守法律要求,限定在尚无有效或更好治疗手段等特殊情况下,明晰患者受益大于风险、坚守充分的知情同意、有循证医学支撑和经过医院内部审核等才能适用。

Physician Law of the People's Republic of China for the first time legally confirms the legitimacy of off-label drug use by physicians,but it does not clarify whether medical ethics review is required for its application.This article argues from the following four dimensions that medical ethics review is not a necessary prerequisite procedure for off-label drug use:current legal regulations has no mandatory requirement;the industry has no unified consensus or rules;comparative law investigations cannot provide reference or support;and from a risk perspective,the stakeholder groups involved in off-label drug use are clear,and the risks are relatively controllable.However,off-label drug use still poses certain risks to patients.Therefore,it is crucial to strictly adhere to legal requirements,limit its use to special cases where there is no effective or better treatment available,ensure patient benefits outweigh risks,obtain thorough informed consent,have evidence-based medical support,and undergo internal hospital review before application.