论新型传染病患者用药可及性的法律保障制度  

Legal Guarantee System of Drug Availability for Patients with New Infectious Diseases

作　　者：谢丰婴 王岳[2] XIE Feng-ying;WANG Yue(College of Law,China University of Political Scienceand Law,Beijing,100088,China)

机构地区：[1]中国政法大学法学院,北京100088 [2]北京大学医学人文学院,北京100191

出　　处：《中国医院管理》2020年第10期1-5,10,共6页Chinese Hospital Management

基　　金：国家卫生健康委《基本医疗卫生与健康促进法》重点难点问题研究课题。

摘　　要：新型冠状病毒肺炎疫情发展至今,已经在其具有极强传染力和极长潜伏期等特点的作用下成为了全球性问题。截至目前尚未发现有针对性药物能够治疗该传染病,而没有针对性药物治疗往往是伴随发生重大新型传染病后疾病治疗的困境之一。因此,如何对新型传染病患者进行用药治疗就涉及到在没有针对性药物的情况下如何尽量采取安全有效手段帮助患者的问题。在法律层面解决该问题,应当完善"同情用药""超说明书用药"和"药品临床试验快速审批"这3项重要的法律保障制度。旨在对3项法律保障制度的发展和应用进行比较和分析,以期完善我国新型传染病患者用药可及性的法律保障制度,并指引临床实践中如何选择正确的法律保障制度,能有效满足患者需求的同时又尽可能保障患者的用药安全性和有效性。Since the development of COVID-19 epidemic,it has become a global problem because the influence of its strong infectiousness and extremely long incubation period.Up to now,no targeted medicine has been able to treat the infectious disease,and the lack of targeted medicine treatment is often one of the dilemmas of the treatment of the disease after the occurrence of major new infectious diseases.Therefore,how to treat patients with new infectious diseases involves the problem of how to take safe and effective treatments without targeted drugs.To solve this problem at the legal level,the three legal guarantee systems include compassionate use,off-label drug use and rapid approval of clinical trials of drugs should be improved.The article aims to compare and analyze the development and application of the three legal guarantee systems,to improve the legal guarantee system for the accessibility of new types of infectious diseases in China,and to guide how to choose the right medication system in clinical practice,to meet the needs of patients while ensuring the safety and effectiveness of patients’medication as much as possible.

关 键 词：新型传染病 同情用药 超说明书用药 临床试验加速审批 

分 类 号：D920.0[政治法律—法学]