Aagaard Lise, Kristensen Kent
Havemann Law Firm, Copenhagen, Denmark.
Institute of Law, University of Southern Denmark, Odense, Denmark.
Int J Clin Pharm. 2018 Jun;40(3):509-512. doi: 10.1007/s11096-018-0646-4.
This article reviews the implications of off-label (OL) and unlicensed (UL) medicine use with respect to the legal duty to inform patients and the liability for failure to provide the patient with adequate information on benefits and risks. Informed consent is a legal prerequisite to any medical treatment and requires the physician to inform the patient about benefits and risks important for the patient's decision. Since OL/UL medicine use is common in all fields of medical practice, physicians must be aware of the stricter requirements for information of the patient. The UK High Supreme Court ruled in the case Montgomery v. Lanarkshire Health Board that physicians' information duty is not limited to the level of information that the physician finds important, but to what the patient deems important. In general, violations of the rule of informed consent does not constitute a physical injury, and patients can only claim compensation for damages, if adequate disclosure had been given, and its likely, that patients would have either rejected or opted for an alternative treatment.
本文回顾了超说明书（OL）和未获许可（UL）用药在告知患者的法律义务以及因未向患者充分提供获益和风险信息而需承担的责任方面的影响。知情同意是任何医疗治疗的法律前提，要求医生告知患者对其决策重要的获益和风险。由于OL/UL用药在所有医疗实践领域都很常见，医生必须意识到对告知患者信息有更严格的要求。英国最高法院在蒙哥马利诉拉纳克郡健康委员会案中裁定，医生的告知义务不限于医生认为重要的信息水平，而是患者认为重要的信息。一般来说，违反知情同意规则并不构成身体伤害，只有在已进行充分披露且很可能患者会拒绝或选择替代治疗的情况下，患者才能索赔损害赔偿。
