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目的比较研究美国及日本生物制品数据保护期限设置方法,为我国未来制度设置提供参考。方法通过方法介绍和特点分析,对比评价美国盈亏平衡模型方法和日本风险管理评估方法。结果美国和日本的两种设置方法分别侧重于不同的制度宗旨,我国设置方法的选择需要结合测算方法的可实施性和我国未来的政策目标与国情综合考量。结论目前及未来较长一段时间,我国医药产业仍处于“仿创结合”阶段,药品安全问题仍为核心任务。因此,建议我国未来在设置方法上,应以风险评估管理方法为主,盈亏平衡模型方法为辅,综合设置生物制品数据保护期限,从而有效发挥激励创新、改善创新药可获得性、强化药品安全监控3大政策效应。
Objective To comparatively study the method of setting the term of data protection for biological products in the United States and Japan, and to provide a reference for the setting of future system in China. Methods Through the introduction of methods and characteristics analysis, comparative analysis of the United States breakeven model method and Japan’s risk management assessment methods. As a result, the two methods of setting up the United States and Japan are respectively focused on different institutional purposes. The choice of setting methods in China requires a combination of the feasibility of measurement methods and the overall consideration of China’s future policy goals and national conditions. Conclusions At present and in the future, for a long period of time, the pharmaceutical industry in our country is still in the stage of “combining imitation and creation”, and the drug safety issue remains the core task. Therefore, it is suggested that the future of our country should be based on the risk assessment management method and supplemented by the breakeven model method, and the period of data protection for biological products should be set comprehensively so as to effectively stimulate innovation, improve the availability of innovative medicines and enhance drug safety Monitor 3 major policy effects.