美国药品安全法律责任设置的特点及其对我国的启示

Characteristics of Legal Liability Setting for Drug Safety in the United States and Its Enlightenment for China

目的:为完善我国药品安全法律责任设置提供借鉴。方法:采用文献研究的分析方法,全面梳理美国在药物临床研究、上市申请、生产、销售、广告、上市后监测、召回等环节设置的法律责任(包括行政责任和刑事责任)的特点,并据此对我国药品安全相关法律责任的设置提出建议。结果与结论:美国药品安全法律责任具有责任设置明确合理、惩罚机制严厉、行政制裁措施灵活高效、通过激励机制鼓励诚信自律等特点。我国应立足国内实际,充分借鉴美国药品立法方面的先进经验,通过加大对违法犯罪行为的惩罚力度、进一步完善行刑衔接机制、细化违法药品分类及法律责任划分、建立合理的激励机制等手段进一步完善我国药品安全法律责任设置,提高我国药品安全监管水平,实现保障公众健康和用药安全的目标。

OBJECTIVE：To provide reference for perfecting the legal liability setting for drug safety in China. METHODS：By literature study analysis,the characteristics of legal liability in the United States were reviewed comprehensively in respects of drug clinical research,listing application,production,marketing,advertising,post-marketing surveillance,recall,etc. Based on this,some suggestions were put forward for setting up the legal liability for drug safety in China. RESULTS CONCLUSIONS：The liability setting for drug safety in the United States has the following characteristics as clear and reasonable liability,strict punishment mechanism,flexible and efficient administrative sanctions,and incentive mechanism of encouraging honesty and self-discipline. Our country should learn from the advanced experience of drug legislation in the United States based on domestic practice. It is necessary to increase penalties for illegal activities,further improve the cohesion mechanism of administrative law enforcement and criminal justice,specify categories of illegal drugs and the legal liability,and establish a reasonable incentive mechanism,in order to improve drug safety legal liability setting,strengthen drug safety regulation and achieve the goal of ensuring public health and drug safety.