【作者】 杨男； 付绍伟； 宋浩伟； 宋民宪； 胡明；

【Author】 Yang Nan;Fu Shaowei;Song Haowei;Song Minxian;Huming;West China School of Pharmacy, Sichuan University;

【机构】 四川大学华西药学院；

【摘要】 目的:本研究通过对国内各省药品行政处罚案例公开的现状进行系统描述和分析,力求发现药械行政处罚中存在的问题,启发和引导药械监执法人员在信息公开背景下顺利、正确地开展执法工作;为我国药品行政信息公开制度的确立、完善和落实提供力所能及的改进建议。方法:采用文献研究法,检索全国省级药品监督管理部门官方网站(除港澳台地区),收集及统计公开的药品、医疗器械行政处罚案件。从药品、医疗器械行政处罚案件公开途径和形式,案件数量及比例,公开时间、公开内容、违法主体、违法行为类型、处罚依据、处罚种类等角度进行的分析。结果:部分省药械行政处罚案件公开工作推进相对滞后;以数据库公开药械行政处罚案件的形式值得借鉴;药械行政处罚案例数量分布呈现一定的规律性;少数省份药械行政处罚案件公开的内容呈现多样化;仍存在法律法规名称误用和废止的法律法规仍然作为处罚依据的情况。结论:全面推进行政处罚案件公开工作以保护公众知情权;利用公开的药械行政处罚案例数据预防违法行为的发生;采用多样化的形式充分发挥行政处罚案例公开的警示作用;统一药械法律、法规简称,定期发布药械法律法规汇总信息。更多还原

【Abstract】 Objectives:To describe and analyze the current status of opened administrative penalty cases in various provinces in China and identify problems in administrative sanctions for drugs and medical devices; to inspire law enforcement agencies to implement law and smoothly and correctly in the context of government information disclosure; to provide suggestions for the establishment, improvement, and implementation of the open system for drug administration in China. Methods:The literature research method was used to retrieve the official websites of 31 provincial drug regulatory authorities(excluding Hong Kong, Macao and Taiwan). Open administrative penalties for drugs and medical devices were collected and counted. Open methods and forms of administrative penalties for drugs and medical devices, the number and proportion of cases, the time and content of disclosure, illegal subjects, the types of violations, the basis for punishment, and the type of punishment were analyzed. Results: In some provincial regulator, the openness of administrative penalty cases for drugs and medical devices were lagging behind. The open form of administrative penalties as database was worth to learn. The number of cases of administrative punishment presented a certain regularity. The public disclosure of administrative punishment cases in a few provinces was diversified. There were still laws and regulations that misuse and abolish the names of laws and regulations as the basis for punishment. Conclusions: Open administrative punishment cases should be comprehensively promoted to protect the public’s right to know. Administrator can use data of punishment cases for drugs and medical devices to prevent the occurrence of illegal acts, adopt a variety of forms to give full play to the warning role of administrative penalty cases and unify drug laws and regulations’ name.更多还原