我国“同情用药”法律制度之完善的研究--以《拓展性同情使用临床试验用药物管理办法(征求意见稿)》为对象

Research on the Improvement of the Legal System of Compassionate Use in China--Taking Expanded Compassionate Use Management for Clinical Trials(Draft for Comments)as Research Object

“同情用药”在我国引入较晚,相关制度建设尚不完善。本文在考察国内外同情用药制度的基础上,结合《拓展性同情使用临床试验用药物管理办法(征求意见稿)》,认为在“同情用药”的法律主体方面,应当考虑建立共同申请主体制度和增加省级药审中心审评主体;在适用条件方面,可以增加合理适用条件和设置兜底条款;在审批标准和程序方面,建议明确审批标准、细化程序规定、加强程序监督和设置伦理委员会;在法律责任方面,需明确对患者、医疗机构、上市许可持有人、药审中心等不同法律主体各自的法律责任。

The introduction of"Compassionate use"in China is late,and the relevant system construction is not perfect.On the basis of reviewing the system of compassionate use at home and abroad,combined with Expanded Compassionate use Management for Clinical Trials(Draft for Comments),this paper argues that in terms of the legal subject of compassionate use,we should consider establishing a common application subject system and increasing the review subject of provincial drug review centers;in terms of applicable conditions,we can increase the reason⁃able applicable conditions and set the pocket clause;in terms of approval standards and procedures,it is suggested to clarify the examination and approval standards,refine the procedures,strengthen the supervision of procedures and set up ethics committees;in terms of legal liability,it is necessary to clarify the legal liability of patients,medi⁃cal institutions,marketing authorization holders,drug audit centers and other different legal subjects.