风险规制的法律规范构造——以药品安全规制为例证  

The Construction of Legal Normative System of Risk Regulation:Drug Safety Regulation as an Ilustration

作　　者：宋华琳[1] Song Hualin

机构地区：[1]南开大学法学院,天津3003501

出　　处：《浙江学刊》2024年第4期51-66,239,共17页Zhejiang Academic Journal

基　　金：国家社会科学基金重大项目“突发重大公共卫生事件防控的法治体系研究”(20&ZD188)的阶段性成果。

摘　　要：药品安全规制构成了风险规制法的重要“参照领域”。在药品安全领域,国家基于风险保护义务,进行风险规制立法,对市场主体的基本权利施以必要的限制。行政规章在风险规制中发挥重要作用,但其制定依据未能完全秉承授权明确性原则的要求。解释性规则、技术标准、指导性文件作为不具有法律规范形式的行政规则,将风险规制立法的内容予以解释和具体化,并为相对人提供导引。风险规制注重行政规制与自我规制的结合,企业应遵守行政规制;通过颁布自我规制规则、推行风险管理措施、落实组织化保障义务,来实现自我规制;对药品注册标准的核准、对药品的责令召回则体现了“受规制的自我规制”的原理。应引入风险分级分类规制理念,来配置有限的风险规制资源,实现规制收益最大化。Drug safety regulation constitutes important""reference area"of risk regulatory law.In drug safe area,risk regulation legislation occurs at national level,it based on the obligation to protect risks,which imposes the necessary limitations on the fundamental rights of market actors.Administrative regulations play important role in risk regulation,but the rule-making authority does not fully adhere to the requirements of"the principle of clarity for delegation".As administrative rules,interpretive rules,technical standards and guidance documents,which do not have the appearance of legal norms,interpret the meaning of risk-regulation legislation,concretize the content of legislation,and provide guidance to the regulated parties.Risk regulation focus on the combination of administrative regulation and self-regulation.Enterprises should comply with the administrative regulation,issue self-regulatory rule,enforce risk management measures,carry out organized safeguard obligations,to fulfill self-regulation.Both authorization of drug registration standard and mandatory drug recall reflect the rationale of"regulated self-regulation".It should introduce the philosophy of risk classification regulation,to allocate limited risk regulation resources and maximize the benefits of regulation.

关 键 词：风险规制 风险立法 行政规则 自我规制 风险分级分类规制 

分 类 号：D922.16[政治法律—宪法学与行政法学]