超说明书用药风险的法律规制

The Legal Regulation of the Risk of Off-Label Drug Use

摘要: 超说明书用药具有其必要性，明晰规范超说明书用药的法律风险，有利于保护医方和患者的合法权益，本文梳理超说明书用药的国内外法律规定以及可以适用于超药品说明书用药的法律责任规定，涵盖《民法典》及相关司法解释的规定。如果患者在超说明书用药后受到损害，医疗机构或者医务人员在超说明书用药的过程中有过错的，由医疗机构承担赔偿责任。患者依主张由医疗机构负担赔偿责任的，应当提交到该医疗机构就诊、受到损害的证据。由医疗机构举证证明超说明书用药没有导致患者受到损害，以及其不存在医疗过错。提出超药品说明书用药风险的法律规制构建的对策建议，如加强各环节立法，确立法律原则，明确责任类型，明确损害责任的构成要件，明确患者和医方的举证责任等。

Abstract: Off-label drug use has its own necessity, clearly regulating the legal risks of off-label drug use is conducive to the protection of the legitimate rights and interests of medical practitioners and patients, this paper combs through the domestic and international legal provisions of off-label drug use as well as the legal liability provisions that can be applied to the use of off-label drug use, covering the provisions of the Civil Code and the relevant judicial interpretations, if the patient suffers from the damage after the off-label drug use, the medical institution shall bear the liability for compensation if the medical practitioner is at fault in the process of off-label drug use. If the patient claims that the medical institution bears the responsibility for compensation, he or she should submit evidence that he or she visited the medical institution and suffered damage. It is up to the medical institution to prove that off-label drug use did not cause the patient to suffer damage, and that it is not at fault for the medical treatment. It puts forward the countermeasure suggestions for the construction of the legal regulation of the risk of off-label drug use, such as strengthening the legislation of each link, establishing the legal principles, clarifying the type of responsibility, clarifying the constituent elements of the responsibility for damages, and clarifying the burden of proof of the patient and the medical institution.