刑事治理现代化背景下危害药品安全犯罪的治理转型

Governance Transformation of Drug Crime in the Modernization of Criminal Governance

伴随着《药品管理法》的修订与《刑法修正案(十一)》的出台,药品犯罪中假药、劣药治理的二元路径转向了对假药、劣药以及妨害药品管理秩序进行治理的三元路径,从对药品的静态对象管理转向了药品风险管控的过程治理。面对刑法提前介入的预防需要,立法确立了对危害药品“源头治理”的理性预防策略,在规范中防止将药品自身危险与社会风险混淆,坚持以药品对公众健康的危害作为法益侵害的基本依据,避免将单纯违反秩序的行为规定为犯罪,着眼于药品风险防控的动态性过程治理,将中药、西药、疫苗等根据药品属性不同判断刑法介入必要作出了针对性规定。同时,着眼于风险预防的需要,在刑事责任的追究上提出用推定的方式解决药品犯罪中罪过判断的困难。在这一背景下,立足多元参与的刑法各自的合作治理路径,从法秩序统一的角度,应当整合民法、行政法、刑法制裁措施,依托刑法的激励作用实现正面预防,以“刑事合规”激发企业自治,实现多元参与对药品犯罪的社会共治。

With the revision of the Drug Administration Law and the promulgation of the Criminal Law Amendment(11),the dual governance mode against fake drugs and inferior drugs has shifted to the ternary governance mode against fake drugs,inferior drugs and violating drug management,which means the transformation from static drug management to dynamic drug management.Considering the prevention needs of the early intervention of criminal law,rational prevention strategies centering on the source of drug risk are proposed.In order to differentiate the danger of the drug and the social risk it brings,we should consider public health the basis for judging whether their legal rights are infringed.Dynamic drug risk prevention and control should be focused on to avoid defining the breach of drug management as a crime.For risk prevention,criminal punishment should depend on the attributes of Chinese medicine,western medicine and vaccines.In this context,the multiple governance mode should be built by combining the sanctions from civil law,administrative law and criminal law in which the incentive role of criminal law is played and“criminal compliance”is employed to prompt enterprises’self-management.