藥品監管的地方立法空間

The Possibility of Local Legislation in Pharmaceutical Regulation Area

從藥品監管的地方立法制度演進來看，地方立法可以對上位法規定進行細化，亦可以在立法中體現地方特色，但是也存在“借法擴權＂、與上位法相抵觸的現象。我國現行藥品監管法律體系仍存在一定疏漏，地方立法可以結合本行政區域的實際情況，為藥品監管法律體系的完善積累經驗。《立法法》修改後，設區的市在藥品監管領域尚難謂具有立法權，對藥品監管的地方立法，宜由省級立法機關或人民政府在本行政區域內做統一規定。在配合和深化“醫改＂，回應現實難點熱點問題，更新政府監管理念，創新政府監管方式，規範行政權力等方面，藥品監管領域存在著一定的地方立法空間。在未來，應該切實提高藥品監管地方立法質量，通過立法來更好地保障公眾健康福祉。

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.