论我国新《药品管理法》中“假(劣)药”的认定与法律适用

Discussion on the identification and legal application of“counterfeit and substandard drugs”in China’s new“Drug Administration Law”

通过比较分析2019年新修订的《药品管理法》中假药和劣药相关条款的主要变化,探讨新法中假(劣)药的内涵与界定,结合《疫苗管理法》《刑法修正案(十一)》和《民法典》中侵权责任等相关法律条款,研究生产、销售假(劣)药行为的法律适用。经比较发现,新修订的《药品管理法》重新定义了假(劣)药,取消按假(劣)药论处的概念,新增了两条禁止性规定,并调整了罚则。关于生产、销售假(劣)药行为的法律适用,首先,针对生产、销售假劣疫苗的违法行为,适用《疫苗管理法》,其设置了比生产、销售假(劣)药更严厉的处罚;其次,《刑法》中明确规定了生产、销售假药和劣药罪,最新修正案与《药品管理法》顺应衔接,新增了对违反药品管理秩序和药品使用单位工作人员提供行为的规制;再次,药物侵权是指缺陷药物造成生命健康损害而引发的侵权责任,在《民法典》中体现在产品责任和医疗损害责任。

By comparing and analyzing main changes of relevant clause on counterfeit and inferior drugs in the newly revised"Drug Administration Law"in 2019,the connotation and definition of counterfeit and inferior drugs in new law are discussed.Combine with the relevant legal provisions of"Vaccine Management Law","Criminal Law Amendment(11)"and"Civil Code",the legal application of producing and selling counterfeit and inferior drugs is studied.The newly revised"Drug Administration Law"redefines counterfeit and inferior drugs,cancels the concept of punishing counterfeit and inferior drugs,adds two new prohibitive provisions,and adjusts penalties.With regard to the application of law to the production and sale of counterfeit and inferior drugs,first of all,for the illegal activities of producing and selling counterfeit and inferior vaccines,the"Vaccine Management Law"is applicable,which sets more severe penalties than the production and sale of counterfeit and inferior drugs.Secondly,the"Penal Code"is explicitly stipulated the crime of producing and selling counterfeit and inferior drugs.The latest amendment conforms to the connection with the"Drug Administration Law"and adds regulations on violations of the drug administration order and the provision of drugs by the staff of drug users.Thirdly,drug infringement refers to the tort liability triggered by the damage of life and health caused by defective drugs,which is reflected in the product liability and medical damage liability in the"Civil Code".