我国药品使用环节现行法律法规剖析

Analysis of the Current Laws and Rules of Drug Use in China

目的对我国药品使用环节现行法律法规进行剖析,为完善我国药品使用环节法律法规提供参考。方法对国家相关部门颁布的药品使用环节的现行法律法规进行分类、汇总和分析。结果我国现行药品使用环节立法规范工作虽然取得了一定成果,但仍存在着药事管理基本法中规定宽泛、缺乏统一立法、冲突较多、缺乏普遍适用性或强制力、监管执法主体职责设定不够清晰以及法律责任条款不明确和处罚措施不严厉等问题。结论应完善现行的法律法规,尤其在法律效力与责任方面,逐步形成满足安全、合理用药要求的较为成熟的药品使用管理法律法规体系。

Objective To dissect China′s existing laws and regulations in the drug use link,and provide suggestions for improving the laws and rules of drug use in China.Methods The current laws and rules of drug use issued by related government departments were collected,classified and analyzed.Results and ConclusionIn spite of many legislative achievements in the use of drugs,there are still some problems in the basic laws of drug administration,including broadly-regulated rules,lack of conformity in legislation,too many conflictions,lack of general applicability or coercive power,ambiguities in the responsibility of regulation enforcement and legal terms,and too mild penalties,etc.The current laws and regulations should be improved,especially in the aspects of responsibility and the validity of law,so as to gradually build up a mature drug administration system to safeguard the rational use of drugs.