我国药品不良反应规制现状与缺陷刍议

Status Quo and Defects of Legal Regulations on Adverse Drug Reactions

目的:探索完善我国现行药品不良反应相关法律规定的方法。方法:描述我国现行法律关于药品不良反应规定的现状,分析存在的缺陷,借鉴部分国外药品不良反应损害救济制度,提出完善我国相关法律规定的建议。结果与结论:我国应从药品不良反应的构成要件、法律责任、鉴定制度等方面切入,通过适当的立法途径,尽快完善相关法律规定,以保护患者的权益。

OBJECTIVE： To explore the ways to consummate the current domestic legal regulations on adverse drug reactions （ADRs） . METHODS： The status quo and the defects of the current legal regulations on ADRs were analyzed; and taking ADR damage relief systems adopted in some countries as reference, we put forward some suggestions on the improvement of the existing related legal regulations. RESULTS ＆ CONCLUSIONS： The existing related legal regulations should be consummated as early as possible in respect of constitutive requirements of ADRs, legal obligation, identification system etc via suitable legislation channel so as to protect patients＇ rights.