《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

Intellectual Property Provisions Relating to Drug Regulation in the TPP Agreement

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。

OBJECTIVE To study the intellectual property provisions relating to drug regulation in the TPP agreement, analysize the interaction mechanism between drug regulation and intellectual property rights on the basis of information sharing, study the possible impact, and then discusses the references to China. METHODS This article analysizes the TPP final text and relevant research liter- atures, study the interaction mechanism between drug regulation and intellectual property rights and the possible impact of, and then discuss the relevantlaw of China. RESULTS The TPP agreement provides several intellectual property provisions relating to drug reg- ulation, demanding the concordant relation between the registration of pharmaceutical and patent protection period, drug data protection and patent protection, which will establish the interaction mechanism based on information sharing. The intellectual property provisions relating to drug regulation are a summary of the experience of the TPP parties forming a coordinated and interactive mechanism between encouraging innovation and ensuring drug safety and an attempt to a wide range practice, which will have abroad impact on the bio-pharmaceutical industry. CONCLUSION Refer to the relevant experience in TPP agreement, China can amend the Pharmaceutical Administration Law and the Patent Law in the process of revision by improving the information sharing mechanism to achieve a higher level of institutional interaction.