妨害药品管理行为的刑法规制——以《刑法修正案(十一)》为视角  

Criminal Regulation of Obstructing Drug Administration——From the perspective of ‘Criminal Law Amendment (Ⅺ)

作　　者：肖声鹏 孙绍伟[2] Xiao Shengpeng;Sun Shaowei(Jiangxi Drug Inspector Center,Nanchang 330029,China;Law School of Jiangxi University of Science and Technology,Ganzhou,Jiangri 341000,China)

机构地区：[1]江西省药品检查员中心,南昌330029 [2]江西理工大学法学院,江西赣州市341000

出　　处：《卫生法学》2025年第1期84-91,共8页Health Law

基　　金：2023年赣州市社会科学研究课题“破解药品监管领域行政非诉执行难”(2023-NDFX18-0116)。

摘　　要：2019年修订的《药品管理法》对假药、劣药的定义进行了纯化,为了做好行刑衔接工作,刑法新设立妨害药品管理罪,该罪名的设立扩大了涉药违法犯罪的打击范围。刑法规制妨害药品管理行为的目的,是现阶段打击各类涉药违法犯罪和维护药品管理秩序的迫切需要,是保障用药群众身体健康和生命安全的根本要求。明确刑法所规制的四种妨害药品管理行为类型,是认定罪名成立的前提和基础。明确“足以严重危害人体健康”的定位和认定要求,是厘清刑法规制妨害药品管理行为的边界。The "Drug Administration Law" revised in 2019 has purified the definition of counterfeit drugs and inferior drugs. In order to ensure proper criminal enforcement, the Criminal Law has introduced a new offense for obstructing drug management, which expands the scope of punishing drug-related crimes. The purpose of criminal law to regulate the behavior of impairing drug management is the urgent need to crack down on all kinds of drug-related crimes and maintain the order of drug management at this stage, and it is the fundamental requirement to ensure the health and life safety of the drug users. It is the premise and basis for the establishment of the crime to clarify the four types of obstruction of drug management behavior regulated by the criminal law. To clarify the positioning and identification requirements of 'serious harm to human health' is to clarify the boundary of criminal regulation of drug management behavior.

关 键 词：药品监管 妨害药品管理行为 刑法规制 

分 类 号：D922.16[政治法律—宪法学与行政法学]