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 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 literatures, 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 regulation, 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.
关键词
跨太平洋伙伴关系协定协议 /
药品监管 /
知识产权 /
信息共享 /
启示
{{custom_keyword}} /
Key words
TPP agreement /
drug regulation /
intellectual property /
information sharing /
inspiration
{{custom_keyword}} /
中图分类号：
R951
{{custom_clc.code}}
({{custom_clc.text}})
{{custom_sec.title}}
{{custom_sec.title}}
{{custom_sec.content}}
参考文献
[1] XIE Q Y. Study on the patent provisions of the Trans-Pacific Partnership Agreement (TPP)[J]. Intellectual Property(知识产权),2016(2): 127-133.
[2] XU X. Study on The Theoeritcia Framework of Consideration inIntellectual Property——The Intellectual PropertyLaw provides condition for the drivemechanism of the human common knowledge activity[J]. Nanjing Univ Law Rev(南京大学法律评论),2009,(1):89-104.
[3] LIU L C, ZHU X Z. Choice of the Elements of Drug Patent Linkage System in US and Canada and Its Inspiration to China[J]. Forum on Sci Technol China(中国科技论坛), 2014(1):147-154.
[4] WTO,WIPO,WHO:Promoting access to medical technologies and innovation: Intersections between public health, intellectual property and trade[R]. WTO ISBN 978-92-870-3964-4,WHO ISBN 978-92-455-04,87WIPO ISBN 978-92-805-2493-2 628 C ,2013:9-15.
[5] YANG L, LI Y. Analysis on the Patent Term Extension of Drug [J]. Chin J New Drugs(中国新药杂志), 2007, 16(12):905-908.
[6] WU X Y. Expansion of TRIPS-plus Provisions and China's Counter-measures:from the Perspective of Patent Protectionfor Medicine[J]. Mod Law Sci(现代法学), 2010(5):112-120.
[7] Biomedical intellectual property research Specialized Committee of Chinese Pharmaceutical Association. Comparative Study on the Protection System of Drug Test Data(药品检测数据保护体系的比较研究)[M]. Beijing:China Biological Medicine Science and Technology Press,2013:24.
[8] DING J X, DENG M, BAI G L. Analysis of the Pediatric Drug Data Protection System of US and Its Impact on Children's Medication safety [J]. Chin Pharm J(中国药学杂志), 2012, 47(10):749-752.
[9] Alliance for retired Americans. Trans Pacific Partnership (TPP) Prescription Drugs Fact Sheet[R]. Novmenber 18th, 2015:1-2.
[10] Erik Monasterio, Deborah Gleeson. Pharmaceutical industry behaviour and the Trans Pacific Partnership Agreement[J]. New Zealand Med J, 2014,127(14):1389.
[11] Deborah Gleeson, Sharon Friel:Emerging threats to public health from regional trade agreements[J]. The Lancet, 2013, 381(9876):1507-1509.
[12] CHEN Y. A Comparison with TRIPS: The Negative Effects of TPP Pharmaceutical IPRs Proposals of United States on Public Health[J]. J Int Economic Law(国际经济法学刊), 2014,21(1):219-243.
[13] ZHANG H Z, CHEN B M, HUANG N. TPP and its impact on China's scientific and technological innovation [J]. High-Technology & Industrialization(高科技与产业化), 2016(2):28.
[14] XIE Q Y. Study on the Patent Provisions of the Trans-Pacific Partnership Agreement (TPP)[J]. Intellectual Property, 2016(2): 127-133.
[15] Public Citzien. TPP: The “Trade” Deal that Could Inflate Your Healthcare Bill[R]. July, 2014.
[16] YING M. Agreement on Chinese Regional Trade in New Regionalism Era(新区域主义时代下中国区域贸易协定研究)[M]. Beijing:China University of Political Science and Law Press, 2014:89.
[17] ZHANG Q K. Current Situation and Development Trend of Intellectual Property Protection in Pharmaceutical Biotechnology Area[J]. Chin Pharm J(中国药学杂志), 2010, 45(16):1201-1207.
[18] LIANG Z W. Disclosure of Drug Dataand Exclusive Right Protection [J]. Law Science(法学), 2013(9):102-112.
{{custom_fnGroup.title_cn}}
脚注
{{custom_fn.content}}
PDF(1206 KB)
