监管型国家的中国路径:药监领域的成就与挑战

Chinese Approach of Regulatory State:Achievements and Challenges in Drug Administration

关于"社会性监管"的研究已成为国际上政治经济学与公共管理学界的新热点。药品和医药产业是社会性监管的典型领域,中国政府从新中国成立伊始就开始对药品进行行政管理,并于1998年组建独立的国家药品监督管理局。回顾十年改革之路,中国药监机构能力大幅提升,但在药品安全、医药产业和产品结构、机构声誉等方面面临诸多挑战,出现一个看似"没有赢家"的政策结果。于是,一个困惑学界和业界的问题是:为什么机构能力的显著提升并没有带来政策绩效的好转。在归纳现有研究的基础上,提出药品监管的"目标—职权—环境"框架,具体分析监管者、政策工具以及被监管者等要素,进而得出结论。

Recent years witnessed the growing popularity of social regulation in political economy and public management study.Drug and pharmaceutical industry are classical policy sectors for social regulation students,since the establishment of SFDA(State Food and Drug Administration) in 1998,China has made great improvement in drug regulation reform,and facing big challenges as well.This article attempts to build an explanatory model of drug regulatory policy performance in China:why institutional reform leads to a'no-win' consequence? Both normative and empirical methods like literature review,narrative study,and participant-observation are employed to analyze regulator,policy instrument and regulate within a new framework.Conclusive remarks are reached in the end.