我国同情用药法律监管的困境及其对策  

Dilemma and Countermeasures of Legal Supervision of Compassionate Drug Use in China

作　　者：谢泓怡 罗刚 XIE Hongyi;LUO Gang(Southwest Medical University,Luzhou,Sichuan 646000,China)

机构地区：[1]西南医科大学,四川泸州646000

出　　处：《医学与法学》2024年第6期81-86,共6页Medicine and Jurisprudence

摘　　要：我国2019年修订的《药品管理法》所确立的同情用药制度,虽彰显“以人为本”的理念、为公民提供了更多医疗救助的机会,但在同情用药的法律监管上却存在监管主体不明确、监管内容尚存空白、监管方式有待优化、监管平台未有效建立、监管责任不明晰等问题,故当从明确监管主体、完善监管内容、优化监管方式、建立监管平台、明晰监管法律责任诸方面予以完善。China's Drug Administration Law,amended in 2019,establishes a system of compassionate drug use,which highlights the concept of“people-oriented”and provides citizens with more opportunities for medical assistance,but there are problems such as unclear regulatory subject,blank regulatory content,optimization of regulatory mode,ineffective establishment of regulatory platform,and unclear regulatory responsibility,etc.,which should be improved from the aspects of clarifying the regulatory subject,improving the regulatory content,optimizing the regulatory mode,establishing a regulatory platform,and clarifying the regulatory legal responsi⁃bility.

关 键 词：同情用药 法律监管 药物审批 

分 类 号：R951[医药卫生—药学] D922.1[政治法律—宪法学与行政法学]