《跨太平洋伙伴关系协定》中涉药品监管的知识产权条款研究

发布时间：2018-03-25 14:13

本文选题：跨太平洋伙伴关系协定协议　切入点：药品监管　出处：《中国药学杂志》2017年06期

【摘要】：目的本研究以跨太平洋伙伴关系协定(TPP)协议中涉药品监管的知识产权条款为研究对象,分析药品监管与知识产权在信息共享基础上的制度互动,研究其可能产生的影响,并探讨对中国的借鉴意义。方法根据TPP最终文本和相关的研究文献,分析药品监管与知识产权的制度互动内容和可能产生的影响,并比照中国的立法情况。结果 TPP协议要求协调药品监管与专利保护期限、药品数据保护、专利权保护之间的关系,建立以信息共享为基础的制度互动。这些条款是TPP成员国在鼓励创新和保障药品安全之间制度互动的经验总结和更大范围的实践尝试,将对生物医药产业产生广泛的影响。结论参考TPP的相关经验,中国在当前药品管理法和专利法修订过程中,可通过完善信息共享机制实现更高水平的制度互动。
[Abstract]:Objective to analyze the institutional interaction between drug regulation and intellectual property rights on the basis of information sharing, and to study its possible impact on the intellectual property provisions of the Trans-Pacific Partnership Agreement (TPP). Methods according to the final text of TPP and relevant research documents, the interactive content and possible impact of drug regulation and intellectual property system are analyzed. As a result of the TPP agreement, the relationship between drug regulation and patent protection duration, drug data protection, patent protection, and patent protection should be coordinated. Establishing institutional interaction based on information sharing. These provisions are a summary of the experience and a wider range of practical attempts of TPP member States to encourage institutional interaction between innovation and drug safety. Conclusion with reference to the relevant experience of TPP, China can achieve a higher level of institutional interaction through perfecting the information sharing mechanism in the process of revising the current drug management law and patent law.
【作者单位】：厦门大学知识产权研究院;
【分类号】：R95

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