基于美国与日本生物制品数据保护期限设置方法对比分析研究  

Setting Method Study of Data Protection Period for Biologics——Based on the Comparative Analysis of American and Japanese Methods

作　　者：姚雪芳[1] 丁锦希[1] 李鹏辉[1] 

机构地区：[1]中国药科大学,南京211198

出　　处：《中国药学杂志》2017年第10期891-896,共6页Chinese Pharmaceutical Journal

基　　金：国家社会科学基金项目(13BFX120);国家食品药品监督管理总局2016年委托课题<新形势下药品数据保护与专利链接制度评估与设计>的阶段性成果

摘　　要：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 compare the setting methods for biologics data protection period between America and Japan, in or- der to provide suggestions for China. METHODS We made a contrastive study of American ＂break even＂ model and Japanese ＂risk management evaluation＂ model by using method introduction and characteristic analysis. RESULTS The two setting methods in the US and Japan focus on different system objectives, respectively. The Chinese choice of setting method needs to combine the feasibility of setting methods and the national conditions and policy goals for comprehensive consideration. CONCLUSION At present and the future for a long time, China＇s pharmaceutical industry is still in the ＂imitation to innovation＂ stage, and drug safety issues remain the core task. Therefore, the period of biologics data protection should be rationally set up by using ＂risk management evaluation＂ model as the base, ＂break even＂ model as supplement, so as to bring the three policy effects such as innovation incentive, the improvement of innovative drugs availability and strengthening the drug post-market safety monitoring.

关 键 词：生物制品 数据保护期限 设置方法 美国 日本 

分 类 号：R951[医药卫生—药学]