对一起“自制药品”行为的思考与法律分析  

Reflection and Legal Analysis on the Behavior of“Self-made Drugs”

作　　者：谢金平 宋亚洋 邵蓉[1,2] XIE Jin-ping;SONG Ya-yang;SHAO Rong(Institute of Regulatory Science for Medical Products,China Pharmaceutical University;NMPA Key Laboratory for Drug Regulatory Innovation and Evaluation;JC Master Law Offices(Taizhou))

机构地区：[1]中国药科大学药品监管科学研究院 [2]国家药品监督管理局药品监管创新与评价重点实验室 [3]江苏泰和(泰州)律师事务所

出　　处：《中国食品药品监管》2023年第2期98-103,共6页China Food & Drug Administration Magazine

摘　　要：本文以徐某“自制药品”救子事件为引导,对领域内主张涉嫌的刑事罪名以及行政责任进行了谨慎分析和讨论。讨论以《刑法》的犯罪构成体系为依据,将事实发生过程与犯罪构成理论以及可能适用于出罪的责任阻却事由进行结合,对事件中所涉及的《刑法》理论进行阐述,以进一步突出限制适用刑事罪名及行政责任的依据。为此,建议我国针对罕见病及罕见病用药保障进行立法,明确各级政府及相关部门在罕见病诊疗及医疗保障、罕见病用药保障方面的职责,形成罕见病及罕见病用药政策生态环境,以期在制度体系下更好地保障罕见病患者权益,保证罕见病患者用药需求。Guided by Xu's event of“self-made drugs”to save his son,this paper carefully analyzed and discussed the possible criminal charges and claims of administrative responsibility.Based on the criminal constitution system of the Criminal Law,this paper combined the process of factual occurrence with the theory of crime constitution and the possibly applicable causes of non-imputability for decriminalization,and expounds the Criminal Law theories involved in this case,further highlighting the restrictions on the application of criminal charges and administrative responsibility.It is suggested that our country should legislate on rare diseases and rare disease drugs,and clarify the responsibilities of governments and departments at all levels in the diagnosis and treatment of rare diseases,medical insurance,and drug accessibility for rare diseases,so as to form an ecological environment system for rare disease and rare disease drug policy,better protecting the rights and interests of rare disease patients,and meeting drug demands of rare disease patients.

关 键 词：自制药品 法律行为 罕见病 罕见病用药 

分 类 号：D920.5[政治法律—法学]