明胶生产者、胶囊制造商及药品生产企业的法律责任——以“毒胶囊事件”为视角

The law liability of gelatin makers,gelatin-capsule producers and pharmaceutical companies—from the event of chromium-tainted drug capsules

目的:以"毒胶囊事件"为视角,探讨辅料的原料提供者、辅料生产者及药品生产者在物料缺陷导致成品缺陷的情况下各自应该承担的法律责任。方法:采用文献研究和案例分析方法,首先对废皮革作为原料的工业明胶、缺陷胶囊及缺陷药品进行定性,随后分析了明胶生产厂、胶囊制造商和药品生产企业的法律责任。结果与结论:提出了辅料生产者和药品生产者应在买卖合同中约定质量责任、健全企业内部物料购进体系和实施第三方审计的建议,以确保药品安全。

Objective:From the event of the chromium-tainted drug capsules,the law liability of gelatin makers,gelatin-capsule producers and pharmaceutical companies were analyzed.Method:The literature and case analysis were used in the study.Qualitative analysis of waste leather as a raw material of industrial gelatin,defective capsules and defective drugs were carried out,and followed by an analysis of the legal responsibility of the gelatin makers,gelatin-capsule producers and pharmaceutical companies.Result & Conclusion:Excipient makers and pharmaceutical companies should consider product liability before enter into a contract.The enterprises internal material acquisition system should be consummated and third-party audit should be implemented to ensure the safety of drugs.