混合型监管：政策工具视野下的中国药品安全监管

在当代中国,社会性监管正在被越来越多地运用到公共卫生、生产安全和环境保护等公共治理过程.以药品安全监管为个案,结合西方社会性监管的有关理论,从建章立制、设立标准、建立奖惩机制以及优化执行系统四个政策工具角度,对当代中国药品安全监管的政策过程进行分析,结果表明,由于受到社会治理模式转型的影响,中国药品安全监管模式可以被界定为"混合型监管".一方面,中国的药品安全监管政策在形式上已经具有了一些现代监管型政府的特点,例如建章立制、设立标准,并综合运用经济、法律和行政等手段;另一方面,却在许多方面仍然带有许多前监管型政府特征,而这些特征大都是计划经济时代的产物.虽然监管型政府正在逐渐取代全能型政府而成为未来中国政府可能的治理模式,但是从政策分析的角度来看,监管型政府的建设在中国并不是一蹴而就的.建设一个高效的现代监管型政府,仍然是市场经济时代下中国国家政权建设过程中的重要目标.

Mixed Regulation: China's Drugs Safety Regulation in Policy Instrument Perspective

In contemporary China, social regulation is more frequently adopted to restrict behaviours which directly threaten public health, safety, welfare or well-being in public governance. By taking drug safety regulation as a case study, this article explores the drugs' safety regulation policy in contemporary China under a four-stage policy instrument framework: rule establishment, standard setting, penalty-reward mechanism and enforcement system betterment. The conclusion is that a terminology of "mixed regulation" can be employed to interpret the peculiarity of current Chinese regulatory state in contrast to Western countries. On one hand, China's current drug safety regulation already shows similarities with modern regulatory state pattern. On the other hand, a couple of characteristics inherited from commanding economy are still maintained. This "mixed regulation" mechanism reflects that regulatory regime change is still under its way in contemporary China.