美国药品尝试权立法的历史沿革及思考
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篇名: 美国药品尝试权立法的历史沿革及思考
TITLE:
摘要: 目的:为我国未注册药品的使用管理提供参考。方法:对美国药品尝试权立法过程进行历史回顾及评价,并对比药品尝试权与以往拓展性同情用药制度的区别和联系。结果与结论:目前,美国已有41个州完成了药品尝试权立法;2018年,美国国会通过了药品尝试权联邦立法。药品尝试权是从拓展性同情用药的基础上发展而来的,两者都是致力于在临床试验之外建立一条新的路径便于终末期患者获得研究性药品,因此两者在相关法案上有着明显的相似性。然而,药品尝试权致力于要求将医疗决定权归还患者和医师,并致力于排除美国FDA的监管;而在拓展性同情用药中,美国FDA则致力于“在患者最大限度的得益与最小限度的受损之间做好平衡”。两者在监管、患者标准、持续时间、责任分配、知情同意等方面均有明显不同。药品尝试权的推行给处于终末期的患者带来了希望,但并没有带给他们更多的生存机会;而正确引导群众理性的作出选择尤为关键。
ABSTRACT: OBJECTIVE: To provide a reference for the use and management of unregistered drugs in China. METHODS: A historical review and evaluation was conducted for the legislative process of drug trial rights in the United States, and the differences and links between the drug trial rights and the previous extended sympathetic drug system were compared. RESULTS & CONCLUSIONS: At present, 41 states in the United States have completed the drug right to try law legislation. In 2018, the US Congress passed the federal legislation on drug right to try law. The right to drug right to try law has evolved from the development of sympathetic drugs, both of which are dedicated to establishing a new path beyond clinical trials to facilitate end-stage patients access to research drugs, so both have obvious similarity. However, the drug right to try law is committed to requiring medical decisions to be returned to patients and doctors, and to the exclusion of the US Food and Drug Administration. In the case of extended sympathetic drug system, the US Food and Drug Administration is committed to “balancing the maximum benefit with the minimum damage”. The two are significantly different in terms of supervision, patient criteria, duration, responsibility distribution, and informed consent. The implementation of the right to drug right to try law has brought hope to patients in the end stage, but it has not given them more opportunities for survival; and it is especially important to correctly guide the masses to make choices rationally.
期刊: 2019年第30卷第18期
作者: 薛晓,王岳
AUTHORS: XUE Xiao,WANG Yue
关键字: 美国;药品尝试权;拓展性同情用药制度;历史沿革
KEYWORDS: United States; Drug right to try law; Extended sympathetic drug system; Historical review
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