遗传资源获取与惠益分享相关国际制度新进展
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摘要
遗传资源获取与惠益分享相关国际制度涉及生物多样性保护、粮食安全、公共健康、知识产权以及国际贸易等诸多领域。迄今,《名古屋议定书》、《粮食和农业植物遗传资源国际条约》和《共享流感病毒以及获得疫苗和其他利益的大流行性流感防范框架》是这一领域最富成效的国际制度范式,且相互具有可协调性。世界知识产权组织在相关领域的谈判虽然已经形成了遗传资源、传统知识和民间文艺表达3份案文,但各方在术语使用、保护客体、保护范围等关键问题上分歧严重,致使谈判举步维艰。世界贸易组织一直在讨论《与贸易有关知识产权协定》和《生物多样性公约》的相互关系,发展中国家呼吁多年的来源披露等相关要求遭到发达国家抵制。近年来,虽然世界贸易组织争端解决机制支持了多起援引"环境保护例外"条款起诉的案例,但遗传资源提供国可以从中汲取的可操作经验有限。世界知识产权组织和世界贸易组织等相关多边机制与《名古屋议定书》之间存在显见的法理冲突,制度上的变革与协调遥遥无期。相比之下,区域贸易协定的双边模式更具现实操作空间,可以纳入遗传资源获取与惠益分享规则,给予缔约方国内立法更大的灵活性和自由度,因而为协调这种冲突提供了一个新的思路。但我们也应当注意到部分自由贸易协定的获取与惠益分享规则对"私法合同模式"的肯定,在一定程度上增加了《名古屋议定书》实施效力的不确定性。
The international regimes regarding access and benefit-sharing of genetic resources(ABS) are closely related to multiple topics, including biodiversity, food security, public health, intellectual property, and international trade. Until now, the Convention on Biological Diversity(CBD), United Nations Food and Agriculture Organization(FAO), and World Health Organization(WHO) have developed some of the most effective model regimes separately in accordance with their respective mandates, namely, the Nagoya Protocol, the International Treaty on Plant Genetic Resources for Food and Agriculture(ITPGRFA) and the Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and Other Benefits(PIPF). These multilateral conventions enable parties to fulfill their respective obligations in a coordinated manner. With respect to intellectual property rights(IPRs), the members of the World Intellectual Property Organization(WIPO) have managed to produce three drafts regarding aspects of IPRs including conserving genetic resources, traditional knowledge, and folklore. However, negotiation progress has been hindered due to substantial divergence among members over key issues, such as terms of use, subject matter, and scope of protection. With regard to international trade, discussions under the framework of World Trade Organization(WTO) are still stuck on working out the complexities between CBD and the Agreement on Trade-related Aspects of Intellectual Property Rights(TRIPs), where developed members are steadfast in opposing developing countries' proposals on disclosure of the origin of genetic resources and associated traditional knowledge during the process of patent application. In recent years, although some appeals, which invoke exception clauses for environmental protection, have been sustained by WTO dispute settlement mechanisms, countries providing genetic resources still aren't yet able to draw readily practical references. There are obviously some legal conflicts among the Nagoya Protocol, WIPO, WTO, and other multilateral systems, and resolving such complexities poses difficulties. In contrast, the bilateral approach within the framework of the regional trade agreement(RTA) proves to be more practical and flexible in terms of integrating ABS rules, and providing parties with more domestic legislative freedom and flexibility, which therefore have ushered in a novel way of thinking for coordinating such dilemmas. Nevertheless, we need to be fully aware of the fact that the "private contract mode" favored by few RTAs would inevitably increase the uncertainties for effectively implementing the Nagoya Protocol to a certain extent.
The international regimes regarding access and benefit-sharing of genetic resources(ABS) are closely related to multiple topics, including biodiversity, food security, public health, intellectual property, and international trade. Until now, the Convention on Biological Diversity(CBD), United Nations Food and Agriculture Organization(FAO), and World Health Organization(WHO) have developed some of the most effective model regimes separately in accordance with their respective mandates, namely, the Nagoya Protocol, the International Treaty on Plant Genetic Resources for Food and Agriculture(ITPGRFA) and the Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and Other Benefits(PIPF). These multilateral conventions enable parties to fulfill their respective obligations in a coordinated manner. With respect to intellectual property rights(IPRs), the members of the World Intellectual Property Organization(WIPO) have managed to produce three drafts regarding aspects of IPRs including conserving genetic resources, traditional knowledge, and folklore. However, negotiation progress has been hindered due to substantial divergence among members over key issues, such as terms of use, subject matter, and scope of protection. With regard to international trade, discussions under the framework of World Trade Organization(WTO) are still stuck on working out the complexities between CBD and the Agreement on Trade-related Aspects of Intellectual Property Rights(TRIPs), where developed members are steadfast in opposing developing countries' proposals on disclosure of the origin of genetic resources and associated traditional knowledge during the process of patent application. In recent years, although some appeals, which invoke exception clauses for environmental protection, have been sustained by WTO dispute settlement mechanisms, countries providing genetic resources still aren't yet able to draw readily practical references. There are obviously some legal conflicts among the Nagoya Protocol, WIPO, WTO, and other multilateral systems, and resolving such complexities poses difficulties. In contrast, the bilateral approach within the framework of the regional trade agreement(RTA) proves to be more practical and flexible in terms of integrating ABS rules, and providing parties with more domestic legislative freedom and flexibility, which therefore have ushered in a novel way of thinking for coordinating such dilemmas. Nevertheless, we need to be fully aware of the fact that the "private contract mode" favored by few RTAs would inevitably increase the uncertainties for effectively implementing the Nagoya Protocol to a certain extent.
引文
Biodiversity Clearing-House Mechanism of China(BCMC)(2017)Accession of the United States of America to the International Treaty on Plant Genetic Resources for Food and Agriculture.http://www.biodiv.gov.cn/lygz/lydt/201708/t20170811_419595.html.(accessed on 2017-8-20)
Chen M(2014)Negotiations of gene resources and traditional knowledge protection under the framework of Free Trade Agreement and our coping strategies.Journal of Henan University(Social Science),54(5),53-61.(in Chinese with English abstract)[陈默(2014)FTA框架下遗传资源及传统知识保护谈判与我国的应对策略.河南大学学报(社会科学版),54(5),53-61.]
Chen WD(2002)Explanations on WTO’s Exception Clauses.University of International Business and Economics Press,Beijing.(in Chinese)[陈卫东(2002)WTO例外条款解读.对外经济贸易大学出版社,北京.]
Dress L,Hessel A,Cai Y,Meyers JV,Moreira A(2011)Synthetic biology:an overview.In:Comprehensive Biotechnology(ed.Murray MY),pp.629-640.Academic Press,Burlington.
Jimenez-Sanchez G,Philp J(2016)Genomics and the bioeconomy:opportunities to meet global challenges.In:Genomics and Society(eds Kumar D,Chadwick R),pp.207-238.Elsevier,Califorlia.
Laxman L,Ansari AH(2013)The interface between TRIPs and CBD:efforts towards harmonisation.Journal of International Trade Law and Policy,11,108-132.
Li MD(2005)Relationship between TRIPs agreement and CBD,traditional knowledge and folklore.Journal of Guizhou Normal University(Social Science),(1),20-23.(in Chinese with English abstract)[李明德(2005)TRIPs协议与《生物多样性公约》、传统知识和民间文学的关系.贵州师范大学学报(社会科学版),(1),20-23.]
Moeller NI,Stannard C(2013)Identifying Benefit Flows:Study on the Potential Monetary and Nonmonetary Benefits Arising from the ITPGRFA.United Nations Food and Agriculture Organization,Rome.
Secretariat of the Convention on Biological Diversity(SCBD)(2012)Nagoya Protocol on access to genetic resources and the fair and equitable sharing of benefits arising from their utilization to the Convention on Biological Diversity.SCBD,Montreal.
Vasava DS(2016)Application of biotechnological techniques for medicinal plant research.Forest Research,5,191-194.
Wan EX,Shi L,Yang CM,Deng HW(1998)International Treaty Law.Wuhan University Press,Wuhan.(in Chinese)[万鄂湘,石磊,杨成铭,邓洪武(1998)国际条约法.武汉大学出版社,武汉.]
Wang H(2010)Harmony between negotiation and conflicts of treaties:case study in the context of trade-environmental discuss.Yangtze Tribune,(4),54-58.(in Chinese)[王辉(2010)谈判协商与条约冲突之协调--“贸易-环境”论争语境下相关成案的启示.长江论坛,(4),54-58.]
Wang SM,Zhang ZW(2011)The implementation progress on the International Treaty on Plant Genetic Resources for Food and Agriculture.Journal of Plant Genetic Resources,12,493-496.(in Chinese with English abstract)[王述民,张宗文(2011)《粮食和农业植物遗传资源国际条约》实施进展.植物遗传资源学报,12,493-496.]
World Health Organization(WHO)(2017a)Review of the Pandemic Influenza Preparedness Framework.http://apps.who.int/gb/e/e_wha70.html.(accessed on 2017-11-2)
World Health Organization(WHO)(2017b)Seventieth World Health Assembly Update,25 May.http://www.who.int/me diacentre/news/releases/2017/health-assembly-polio/en/.(accessed on 2017-11-2)
World Intellectual Property Organization(WIPO)(2017)IGC:What Is Happening Now.http://www.wipo.int/tk/en/igc/sna pshot.html.(accessed on 2017-11-3)
World Trade Organization(WTO)(2017)Annual Report 2017,pp.88-91.
Xie XM(2011)On the conflicts between Nagoya Protocol and TRIPs,and its reconciliation:focus on the relationship between proper access to genetic resources norms and patent norms.Journal of Lanzhou Commercial College,27,122-126.(in Chinese with English abstract)[谢新明(2011)论《名古屋议定书》与TRIPs之冲突关系及其协调--以遗传资源的适当获取规则与专利规则之关系为切入点.兰州商学院学报,27,122-126.]
Xue DY(2011)Analysis for the main elements and potential impacts of Nagoya Protocol.Biodiversity Science,19,113-119.(in Chinese with English abstract)[薛达元(2011)《名古屋议定书》的主要内容及其潜在影响.生物多样性,19,113-119.]
Xue DY,Cai Lei(2007)Progress on negotiation of international regime on access to and benefit-sharing of genetic resources under the Convention on Biological Diversity.Environmental Protection,35(11B),72-74.(in Chinese)[薛达元,蔡蕾(2007)《生物多样性公约》遗传资源获取和惠益分享国际制度谈判进展.环境保护,35(11B),72-74.]
Zhao FW,Xue DY(2008)International trends of and state legislation on access and benefit sharing of genetic resources.Journal of Ecology and Rural Environment,24,92-96.(in Chinese with English abstract)[赵富伟,薛达元(2008)遗传资源获取与惠益分享制度的国际趋势及国家立法问题探讨.生态与农村环境学报,24,92-96.]
Zhao FW,Xue DY,Wu JY(2015)Hot spots and proposed actions of negotiations of the Nagoya Protocol after it functions.Biodiversity Science,23,536-542.(in Chinese with English abstract)[赵富伟,薛达元,武建勇(2015)《名古屋议定书》生效后的谈判焦点与对策.生物多样性,23,536-542.]
(1)见巴西2015年第13.123号法律第2条。
(1)见《美国–秘鲁自由贸易协定》、《美国–哥伦比亚自由贸易协定》中“生物多样性”相关章节与“关于生物多样性和传统知识的谅解”。
(2)据《共享流感病毒以及获得疫苗和其他利益的大流行性流感防范框架》第4.1条,“PIP生物材料”包括“人类临床标本;野生型的人类H5N1病毒及其他可能引起人类大流行的流感病毒的病毒分离物;WHO全球流感监测和应对系统实验室从H5N1或其他可能引起人类大流行的流感病毒中开发的经改造的病毒……还包括从野生型H5N1病毒及其他可能引起人类大流行的人类流感病毒中提取的核糖核酸和包含一个或多个病毒基因的整个编码区的互补脱氧核糖核酸”。
(1)见印度2002年《生物多样性法》第3、4条。
(2)见巴西2015年第13.123号法律第11条
(3)见菲律宾政府1995年第247号行政令第3条,环境与自然资源部1996年第96-20号部门行政令第6、8条。
Chen M(2014)Negotiations of gene resources and traditional knowledge protection under the framework of Free Trade Agreement and our coping strategies.Journal of Henan University(Social Science),54(5),53-61.(in Chinese with English abstract)[陈默(2014)FTA框架下遗传资源及传统知识保护谈判与我国的应对策略.河南大学学报(社会科学版),54(5),53-61.]
Chen WD(2002)Explanations on WTO’s Exception Clauses.University of International Business and Economics Press,Beijing.(in Chinese)[陈卫东(2002)WTO例外条款解读.对外经济贸易大学出版社,北京.]
Dress L,Hessel A,Cai Y,Meyers JV,Moreira A(2011)Synthetic biology:an overview.In:Comprehensive Biotechnology(ed.Murray MY),pp.629-640.Academic Press,Burlington.
Jimenez-Sanchez G,Philp J(2016)Genomics and the bioeconomy:opportunities to meet global challenges.In:Genomics and Society(eds Kumar D,Chadwick R),pp.207-238.Elsevier,Califorlia.
Laxman L,Ansari AH(2013)The interface between TRIPs and CBD:efforts towards harmonisation.Journal of International Trade Law and Policy,11,108-132.
Li MD(2005)Relationship between TRIPs agreement and CBD,traditional knowledge and folklore.Journal of Guizhou Normal University(Social Science),(1),20-23.(in Chinese with English abstract)[李明德(2005)TRIPs协议与《生物多样性公约》、传统知识和民间文学的关系.贵州师范大学学报(社会科学版),(1),20-23.]
Moeller NI,Stannard C(2013)Identifying Benefit Flows:Study on the Potential Monetary and Nonmonetary Benefits Arising from the ITPGRFA.United Nations Food and Agriculture Organization,Rome.
Secretariat of the Convention on Biological Diversity(SCBD)(2012)Nagoya Protocol on access to genetic resources and the fair and equitable sharing of benefits arising from their utilization to the Convention on Biological Diversity.SCBD,Montreal.
Vasava DS(2016)Application of biotechnological techniques for medicinal plant research.Forest Research,5,191-194.
Wan EX,Shi L,Yang CM,Deng HW(1998)International Treaty Law.Wuhan University Press,Wuhan.(in Chinese)[万鄂湘,石磊,杨成铭,邓洪武(1998)国际条约法.武汉大学出版社,武汉.]
Wang H(2010)Harmony between negotiation and conflicts of treaties:case study in the context of trade-environmental discuss.Yangtze Tribune,(4),54-58.(in Chinese)[王辉(2010)谈判协商与条约冲突之协调--“贸易-环境”论争语境下相关成案的启示.长江论坛,(4),54-58.]
Wang SM,Zhang ZW(2011)The implementation progress on the International Treaty on Plant Genetic Resources for Food and Agriculture.Journal of Plant Genetic Resources,12,493-496.(in Chinese with English abstract)[王述民,张宗文(2011)《粮食和农业植物遗传资源国际条约》实施进展.植物遗传资源学报,12,493-496.]
World Health Organization(WHO)(2017a)Review of the Pandemic Influenza Preparedness Framework.http://apps.who.int/gb/e/e_wha70.html.(accessed on 2017-11-2)
World Health Organization(WHO)(2017b)Seventieth World Health Assembly Update,25 May.http://www.who.int/me diacentre/news/releases/2017/health-assembly-polio/en/.(accessed on 2017-11-2)
World Intellectual Property Organization(WIPO)(2017)IGC:What Is Happening Now.http://www.wipo.int/tk/en/igc/sna pshot.html.(accessed on 2017-11-3)
World Trade Organization(WTO)(2017)Annual Report 2017,pp.88-91.
Xie XM(2011)On the conflicts between Nagoya Protocol and TRIPs,and its reconciliation:focus on the relationship between proper access to genetic resources norms and patent norms.Journal of Lanzhou Commercial College,27,122-126.(in Chinese with English abstract)[谢新明(2011)论《名古屋议定书》与TRIPs之冲突关系及其协调--以遗传资源的适当获取规则与专利规则之关系为切入点.兰州商学院学报,27,122-126.]
Xue DY(2011)Analysis for the main elements and potential impacts of Nagoya Protocol.Biodiversity Science,19,113-119.(in Chinese with English abstract)[薛达元(2011)《名古屋议定书》的主要内容及其潜在影响.生物多样性,19,113-119.]
Xue DY,Cai Lei(2007)Progress on negotiation of international regime on access to and benefit-sharing of genetic resources under the Convention on Biological Diversity.Environmental Protection,35(11B),72-74.(in Chinese)[薛达元,蔡蕾(2007)《生物多样性公约》遗传资源获取和惠益分享国际制度谈判进展.环境保护,35(11B),72-74.]
Zhao FW,Xue DY(2008)International trends of and state legislation on access and benefit sharing of genetic resources.Journal of Ecology and Rural Environment,24,92-96.(in Chinese with English abstract)[赵富伟,薛达元(2008)遗传资源获取与惠益分享制度的国际趋势及国家立法问题探讨.生态与农村环境学报,24,92-96.]
Zhao FW,Xue DY,Wu JY(2015)Hot spots and proposed actions of negotiations of the Nagoya Protocol after it functions.Biodiversity Science,23,536-542.(in Chinese with English abstract)[赵富伟,薛达元,武建勇(2015)《名古屋议定书》生效后的谈判焦点与对策.生物多样性,23,536-542.]
(1)见巴西2015年第13.123号法律第2条。
(1)见《美国–秘鲁自由贸易协定》、《美国–哥伦比亚自由贸易协定》中“生物多样性”相关章节与“关于生物多样性和传统知识的谅解”。
(2)据《共享流感病毒以及获得疫苗和其他利益的大流行性流感防范框架》第4.1条,“PIP生物材料”包括“人类临床标本;野生型的人类H5N1病毒及其他可能引起人类大流行的流感病毒的病毒分离物;WHO全球流感监测和应对系统实验室从H5N1或其他可能引起人类大流行的流感病毒中开发的经改造的病毒……还包括从野生型H5N1病毒及其他可能引起人类大流行的人类流感病毒中提取的核糖核酸和包含一个或多个病毒基因的整个编码区的互补脱氧核糖核酸”。
(1)见印度2002年《生物多样性法》第3、4条。
(2)见巴西2015年第13.123号法律第11条
(3)见菲律宾政府1995年第247号行政令第3条,环境与自然资源部1996年第96-20号部门行政令第6、8条。
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