药品召回行政监管不作为分析  

Analysis of Administrative Omission in the Domain of Drugs Recall

作　　者：汪秋慧[1] 徐喜荣[1] 

机构地区：[1]广州医学院卫生管理学院,广东广州510082

出　　处：《武汉理工大学学报（社会科学版）》2012年第5期716-721,共6页Journal of Wuhan University of Technology:Social Sciences Edition

基　　金：2010年度广东省教育厅育苗工程项目(WYM10045);2010年度广州市社会科学规划课题(10B60);2009年度广州医学院青年基金项目

摘　　要：具有安全隐患的药品能否被召回关系到公民健康和医药产业发展,这一重要制度目前存在着不少问题,诸如药品不良反应收集体系尚未建立,对药品安全隐患的调查和监测评估形同虚设,"责令召回"权较少被使用,药品不良反应信息和药品召回信息的公示缺乏统一标准,甚或不公布等等。这些问题都与行政监管有关。针对这些问题对药品召回行政机关的法定义务和应然义务进行了分析,并判断是否构成行政不作为。认为要对药品召回行政监管不作为进行规制进而完善药品召回制度,需要通过修改《药品召回管理办法》;应将行政监管形式作为而实质上不作为,按照不作为案件进行审理;建立药品召回领域的公民参与制度。There are some problems in the system of drugs recall as follows：the collection system of adverse drugs reactions has not been established;the investigation and monitoring and evaluation of drugs safety risks has played a minor role;the right of drugs ordered to recall has seldem been used;the information of adverse drugs reactions and drugs recall publicized lacks of uniform standards or isnot publicized.All of them are related to administrative supervision.Administrative omission is judged by the executive obligation.In order to regulate it,we should modify ＂drug recall management approach＂,the formal administrative supervision but none is essentially treated as administrative omission cases to adjudicate;and establish the system involving citizen participation.

关 键 词：药品召回 行政监管不作为 规制 

分 类 号：F273.2[经济管理—企业管理] C931.2[经济管理—国民经济]