药品监管的地方立法空间

The Possibility of Local Legislation in Pharmaceutical Regulation Area

从药品监管的地方立法制度演进来看,地方立法可以对上位法规定进行细化,亦可以在立法中体现地方特色,但是也存在"借法扩权"、与上位法相抵触的现象。我国现行药品监管法律体系仍存在一定疏漏,地方立法可以结合本行政区域的实际情况,为药品监管法律体系的完善积累经验。《立法法》修改后,设区的市在药品监管领域尚难谓具有立法权,对药品监管的地方立法,宜由省级立法机关或人民政府在本行政区域内做统一规定。在配合和深化"医改",回应现实难点热点问题,更新政府监管理念,创新政府监管方式,规范行政权力等方面,药品监管领域存在着一定的地方立法空间。在未来,应该切实提高药品监管地方立法质量,通过立法来更好地保障公众健康福祉。

From the perspective of history,the local legislation of pharmaceutical regulation concretize law provisions and reflect local characteristics,but there are also phenomena of extending local power and resisting higher-level laws.Our current legal system of pharmaceutical regulation still has some deficiencies.Local legislation can take the actual situation of local areas into account,and gain experience for improving the legal system of pharmaceutical regulation.After the modification of Legislation Law,the 'City with Subordinate Districts' still lacks legislation power in pharmaceutical regulation area.The pharmaceutical regulation needs province-level legislation.There are local legislation possibilities in five areas:cooperating Medical Reform,responding to difficult issues,renewing the idea of government regulation,innovating the regulation tools and regulating administrative power.In the future,we should improve the quality of local legislation in pharmaceutical regulation area,through which we could safeguard the public health better.