从“假药”到“妨害管理”：侯元祥案中的罪名嬗变、司法理性与药品安全规制重构

From “Counterfeit Drugs” to “Obstructing Management”: The Evolution of Charges, Judicial Rationality and the Reconstruction of Drug Safety Regulations in the Hou Yuanxiang Case

摘要: 青岛侯元祥案作为中医药领域刑事规制标杆性案例，从生产、销售假药罪改判妨害药品管理罪的嬗变，揭示我国药品安全刑事治理从“结果本位”向“风险控制”的范式转型。事实层面，侯氏家族通过虚构医学专家身份，针对癌症危重患者非法制售成分不明的“抗癌制剂”，形成“欺诈–生产–危害”链条。法律适用层面，法院辨析两罪本质差异：假药罪要求证明药品物质属性虚假，系行为犯；妨害药品管理罪重在规制程序违法性，需论证“足以严重危害人体健康”的具体危险。本案依托“成分不明 + 危重患者使用”构建危险要件，以销售金额认定“情节严重”，在否定涉案行为正当性的同时，避免污名化合法中医药传承，折射司法对监管秩序与行业特殊性的平衡智慧。

Abstract: The Qingdao Hou Yuanxiang case, as a benchmark case in the field of traditional Chinese medicine criminal regulation, reveals the paradigm shift in China’s criminal governance of drug safety from a “result-oriented” approach to a “risk control” approach, through the evolution of the verdict from the crime of producing and selling counterfeit drugs to the crime of impairing drug administration. At the factual level, the Hou family formed a “fraud-production-harm” chain by falsely claiming to be medical experts and illegally manufacturing and selling “anti-cancer preparations” with unknown ingredients for critically ill cancer patients. At the legal application level, the court analyzed the essential differences between the two crimes: the crime of counterfeit drugs requires proof of the falsity of the material properties of the drug, which is a behavioral offense; the crime of impairing drug administration focuses on regulating procedural illegality, requiring proof of specific dangers that are “sufficiently serious to endanger human health.” This case constructed dangerous elements based on “unknown ingredients + use by critically ill patients,” and determined “serious circumstances” based on the sales amount. While denying the legitimacy of the involved behavior, it avoids stigmatizing the legitimate inheritance of traditional Chinese medicine, reflecting the judicial wisdom in balancing regulatory order and industry specificity.