论药品专利保护与公共健康之冲突与协调
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摘要
近年来,随着艾滋病、非典、禽流感等世界性重大传染疾病的爆发和流行,一系列公共健康问题日益凸现。拥有世界上3／4以上人口的发展中国家因缺乏药品所引起的跨国界公共健康危机越来越成为全世界关注的焦点。药品专利与公共健康维护的冲突问题也愈演愈烈,成为WTO架构下极为重要而迫切的议题。如何平衡药品专利保护与维护公共健康的关系成为一个复杂的法律问题,也成为知识产权保护争议最大的领域之一。
本文将研究发展中国家所面临的药品专利保护与公共健康维护之间的冲突问题。首先,提出药品专利制度与全球公共健康问题,分析药品专利与公共健康维护二者之间的冲突。其次,评析《多哈宣言》和《总理事会决议》等WTO为解决二者之冲突而采取的一系列举措,阐明其不足之处及其局限性。随后,通过比较分析法和案例分析法,探讨发展中国家可采取的协调药品专利与公共健康维护之冲突的对策,寻求缓解发展中国家公共健康危机的措施。最后,着重结合我国的现状,分析我国的药品专利保护制度和公共健康问题,指出我国法律规定的不足之处并提出相关完善建议,同时提出中国解决药品专利保护与公共健康维护冲突的对策。
In recent years, with the outbreak and worldwide spread of gravely infectious diseases such as HIV/AIDS, SARS and bird flu, a series of public health problems have emerged. Transnational public health crisis resulting from shortage of pharmaceuticals in developing countries whose population accounts for three quarters of the world's total has become a global focus. The conflict between pharmaceutical patent and public health has been intensifying as well and has become an important and pressing issue. It is a complex legal issue and one of the major disputes in intellectual property as to how to balance pharmaceutical patent protection and public health preservation.
This paper studies the conflict between pharmaceutical patent protection and public health confronted by developing countries. First, it brings forward pharmaceutical patent and public health problems and analyzes the conflict between them. Then, it reviews the measures taken by WTO to solve the conflict, such as The Doha Declaration and The Implementation of paragraph 6 of the Doha Declaration, and illustrates their deficiencies and limitations. After that, the paper particularly explores the countermeasures developing countries can take so as to coordinate the conflict and relieve public health crisis. In the end, it focuses on putting forward some measures to protect public health in China through analysis of our country's current public health situation and pharmaceutical patent legislation.
本文将研究发展中国家所面临的药品专利保护与公共健康维护之间的冲突问题。首先,提出药品专利制度与全球公共健康问题,分析药品专利与公共健康维护二者之间的冲突。其次,评析《多哈宣言》和《总理事会决议》等WTO为解决二者之冲突而采取的一系列举措,阐明其不足之处及其局限性。随后,通过比较分析法和案例分析法,探讨发展中国家可采取的协调药品专利与公共健康维护之冲突的对策,寻求缓解发展中国家公共健康危机的措施。最后,着重结合我国的现状,分析我国的药品专利保护制度和公共健康问题,指出我国法律规定的不足之处并提出相关完善建议,同时提出中国解决药品专利保护与公共健康维护冲突的对策。
In recent years, with the outbreak and worldwide spread of gravely infectious diseases such as HIV/AIDS, SARS and bird flu, a series of public health problems have emerged. Transnational public health crisis resulting from shortage of pharmaceuticals in developing countries whose population accounts for three quarters of the world's total has become a global focus. The conflict between pharmaceutical patent and public health has been intensifying as well and has become an important and pressing issue. It is a complex legal issue and one of the major disputes in intellectual property as to how to balance pharmaceutical patent protection and public health preservation.
This paper studies the conflict between pharmaceutical patent protection and public health confronted by developing countries. First, it brings forward pharmaceutical patent and public health problems and analyzes the conflict between them. Then, it reviews the measures taken by WTO to solve the conflict, such as The Doha Declaration and The Implementation of paragraph 6 of the Doha Declaration, and illustrates their deficiencies and limitations. After that, the paper particularly explores the countermeasures developing countries can take so as to coordinate the conflict and relieve public health crisis. In the end, it focuses on putting forward some measures to protect public health in China through analysis of our country's current public health situation and pharmaceutical patent legislation.
引文
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[1]Silvia Salazar. Intellectual Property and the Rights to Heath, Intellectual Property and Human Rights,71(1999).
[2]WIPOI Doc. WO/INF129, Exercise, Scope and Form of Generally Accepted and Applied Standards/Norms for the Protection of Intellectual Property", GATT-DOC MTN. GNG/NGL/W24/Rev 1, Annex Ⅱ. (1998)
[3]方俊.药品专利国际保护冲突法律问题研究[D].上海：社会科学院，2007
[4]刘春田.人的健康权优于财产权：解读《修改<与贸易有关的知识产权协定>议定书》[EB/OL]. http://www.gmw.cn/content/2007-12/02/content_699493.htm,2007,12.02
[5]艾滋病25年全球夺命2500万[EB／OL].http://www.hiv-aids.cn/web/info/dynamic/2008/05/2322585463.html,2008.05.23
[6]世界卫生组织.2007年世界卫生报告：21世纪全球公共卫生安全[R].日内瓦：世界卫生组织,2007
[7]WHO. Cumulative number of confirmed human cases of avian influenza A/(H5N1) reported to WHO[EB/OL].http://www.who.int/csr/disease/avianinfluenza/country/cases_table_2008-06-19/e n/index.html,2008.07.11
[8]汤晶晶,邵蓉.药品专利强制许可制度对提高我国药品可获得性的可能性及相关对策探讨[J].中国药房,2006,17(6)：407-409.
[9]约瑟夫·施特劳斯Promoting access to medicines through balancing patent rights and responsibilities[R].北京：人民大学,2009
[10]赵希洋.关于药品专利保护与公共健康危机冲突的利益分析[J].辽宁教育行政学院学报,2006(7)：5-6
[11]史明涛.公共健康维护与知识产权保护若干问题研究[D].大连：大连海事大学硕士论文,2007
[12]冯洁涵.公共健康危机与WTO知识产权制度的改革——以TRIPS协议为中心[M].武汉：武汉大学出版社,2005
[13]WTO. Decision removes final patent obstacle to cheap drug imports[EB/OL]. http://www.wto.org/english/news_e/pres03_e/pr350_e.htm,2006.12.21
[14]MSF. Neither Expenditures, Nor A Solution:The WTO August 30th Decision Is Unworkable [EB/OL]. www.msf.ca/aids20006/files/REP_JCPA_en.pdf, 2006
[15]林秀芹.TRIPS体制下的专利强制许可制度研究[M].北京：法律出版社,2006：388-389
[16]冯洁菡.药品专利强制许可：《多哈健康宣言》之后的发展[J].武汉大学学报(哲学社会科学版),2008,61(5)
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[18]Ministry of Public Health. Thailand on the Public use of patent for Pharmaceutical Products[EB/OL]. http://www.cptech.org/ip/health/c/thailand/thaicl4efavirenz.html,2008.12.27
[19]专利药品价格高昂原因分析[N].中国医药报.2009.09.25
[20]ASEAN Workshop on the TRIPs Agreement and Its Impact on Pharmaceuticals,2000,5:2-4
[21]Krithpaka Boonfueng. Parallel Imports in Pharmaceuticals:Increase Access to HIV Drugs[J]. Intellectual Property and International Trade Law Forum Journal,2004
[22]余翔,武兰芬.瑞典药品平行进口的实证分析及其对我国的启示[J].科研管理,2007(1).
[23]Harvey E. Bale, Jr. (姜丹明译),药品获得与药品开发[A].《专利法研究》[C],北京：知识产权出版社,2002,317
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[25]韦经建,张艳梅.我国的入世承诺与药品专利保护[A].见：中国国际经济法学会2004年年会暨学术研讨会论文集[C].北京：清华大学出版社,2005：201-205
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[28]罗氏再度捐赠达菲[N].上海证券报.2006.01.19
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[35]WHO. WHO Facilitates Influenza Vaccine Technology Transfer To Developing Countries [EB/OL].http://www.who.int/mediacentre/news/notes/2007/np18/en/index.html,2007.04.24
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