德国和日本药品上市许可持有人制度下的药品损害事件风险管理研究

目的：研究德国和日本两国药品上市许可持有人制度下的药品损害事件风险管理，为构建并完善我国的药品损害事件风险管理体系提供建议和参考。方法：通过文献分析法，对比研究德国和日本药品上市许可持有人制度下药品损害事件的法律责任适用、临床试验损害的补偿机制及上市后药品不良反应的救济机制制度。结果与结论：德国的药品损害事件适用于药品损害责任和侵权责任，临床试验和上市后药品损害的风险管理措施均为保险手段；日本的药品损害事件适用于侵权责任和产品责任，临床试验和上市后药品损害的风险管理措施为保险加救济手段。德国的风险管理措施相对平衡地照顾到了企业的承担能力和受害人的合法权益，值得我国参考和学习。

Study on Risk Management of Drug Damage Events under the System of Marketing Authorization Holder in Germany and Japan

Objective: To study the risk management of drug damage events under the system of marketing authorization holder in Germany and Japan and to provide suggestions and references for establishing and improving the risk management of drug damage events in China. Methods: The application of legal liability, the compensation mechanism of clinical trial damages and the relief mechanism system of adverse drug reactions after marketing concerned with drug damage events under the system of marketing authorization holder in Germany and Japan were compared by means of literature analysis. Results and Conclusion: The drug damage events in Germany applied to the medicinal product liability and tort liability. The risk management measures for clinical trials and post-marketing drug damage were insurance measures. The drug damage events in Japan applied to tort liability and product liability and the risk manage measures were insurance plus relief measures. The practices in Germany might be more suitable for China in balancing interests between victims and enterprises.