从实体到程序：药品安全犯罪的司法认定困境——基于假药罪与妨害药品管理罪的规范比较与个案检视

From Entity to Procedure: Predicament of Judicial Identification of Drug Safety Crime —Based on the Normative Comparison and Case Review of the Crime of Counterfeit Drugs and the Crime of Obstructing Drug Management

摘要: 本文以侯元祥等人生产、销售药品案为切入点，通过规范比较与个案检视，聚焦生产、销售假药罪与妨害药品管理罪的司法适用边界问题。研究发现，两罪在法益保护、入罪标准、犯罪主体及量刑规则上存在明确差异，侯元祥案从“假药罪”改判“妨害药品管理罪”符合刑事司法演进趋势，主刑量刑契合罪责刑相适应原则。但案件审理中仍存在事实认定不充分(“足以危害人体健康”缺乏权威医学鉴定支撑)、程序正义保障不足(行政认定替代司法鉴定、辩护权行使受限)、罚金刑计算缺乏精细化依据等问题。论文最后提出，未来需进一步厘清两罪构成要件差异、完善中药评价独立标准、强化程序保障机制，以实现药品安全保护与传统医药文化传承的双重目标。

Abstract: This article takes the case of Hou Yuanxiang et al.’s production and sales of drugs as the starting point, focusing on the judicial application boundary issues of the crimes of producing and selling fake drugs and obstructing drug management through standardized comparison and case examination. Research has found that there are clear differences between the two crimes in terms of protecting legal interests, criminalization criteria, criminal subjects, and sentencing rules. The Hou Yuanxiang case’s change of sentence from “counterfeit drug crime” to “obstructing drug management crime” is in line with the trend of criminal justice evolution, and the sentencing of the main punishment is in line with the principle of proportionality between criminal responsibility and punishment. However, there are still problems in the trial of the case, such as insufficient factual determination (lack of authoritative medical appraisal support for “sufficient harm to human health”), insufficient protection of procedural justice (administrative determination replacing judicial appraisal, limited exercise of defense rights), and lack of refined basis for fine calculation. At the end of the paper, it is proposed that in the future, it is necessary to further clarify the differences in the constituent elements of the two crimes, improve the independent standards for evaluating traditional Chinese medicine, and strengthen the procedural guarantee mechanism, in order to achieve a double-goals of drug safety protection and the inheritance of traditional Chinese medicine culture.