司法判例实证分析“药神案”的法律适用问题

由于境外药品审批的滞后性及患者经济负担等原因,代购未经批准进口的境外原研药及仿制药现象在我国客观存在,一旦进入公诉机关视野成为备受瞩目的“药神案”,往往要在市场秩序与患者生命健康权之间相平衡。新修订的《药品管理法》回归药品实效性,将“未经批准进口的药品”排除在“假药”范畴外,使得此类行为不再构成销售假药罪,但这并不意味着进口、销售未经批准的药品完全合法化,其仍可构成行政违法,甚至刑事犯罪。在总结裁判文书网公布的相关案例基础上,通过实证分析进一步探究此类案件的法律适用,以期实现司法裁判的统一。

Empirical Analysis of Judicial Cases on the Application of Law in God of Medicine Case

Due to the lag in the approval of overseas drugs and the financial burden of patients,the phenomenon of purchasing overseas brand-name drugs and generic drugs imported without approval exists objectively in our country.There is a balance between marketing order and patients' right to life and health.The newly revised "Pharmaceutical Administration Law" returns to the effectiveness of drugs and excludes "unapproved imported drugs" from the category of "fake drugs",so that such acts no longer constitute the crime of selling fake drugs,but this does not mean that importing and selling unapproved drugs is completely legal,and it can still constitute an administrative violation or even a criminal offence.On the basis of summarizing the relevant cases published by the China Judgements Online,this article further explores the legal application of such cases through empirical analysis,in order to achieve the unification of judicial judgments.