《名古屋议定书》生效后的谈判焦点与对策

2014年10月12日, 《获取遗传资源和公正公平分享其利用所产生惠益的名古屋议定书》(以下简称议定书)正式生效, 10月13日在韩国平昌召开议定书缔约方大会第一次会议。这次会议重点审议了遵约机制、获取与惠益分享信息交换所、资金和财务机制、能力建设与意识提升、全球多边惠益分享机制的必要性等议题。最终各方在下列几个方面达成了一致: 建立议定书遵约机制, 通过获取与惠益分享信息交换所运作模式, 达成一揽子有关资金和财务安排的决议, 通过《支持有效执行议定书的能力建设和发展战略框架》和《议定书意识提升战略》, 启动建立全球多边惠益分享机制的进程。议定书的生效对我国遗传资源及相关传统知识的保护、利用和惠益分享可能带来多方面的影响。我国需要积极推动完善国内遗传资源相关法律法规, 积极推动加入议定书, 适时制定遗传资源获取与惠益分享行动计划, 研究建立获取与惠益分享基金, 以及积极开展议定书后续谈判研究。     

《名古屋议定书》的主要内容及其潜在影响

<生物多样性公约>第10次缔约方大会(2010年10月,日本名古屋)通过了<名古屋议定书>,这为全面实现<生物多样性公约>的三大目标,特别是第三项目标(公平公正地分享因利用遗传资源所产生的惠益)迈出了关键一步.建立遗传资源及相关传统知识获取与惠益分享(ABS)国际制度是<生物多样性公约>过去10年来的一项主要任务,<公约>缔约方大会于2000年专门建立了"ABS工作组",致力于该ABS国际制度的谈判.自2001年在德国波恩召开ABS工作组第1次会议到<名古屋议定书>达成,一共召开了9次工作组会议,其中第9次工作组会议召开了3次续会.<名古屋议定书>的主要内容包括:议定书目标;适用范围;获取遗传资源及相关传统知识的要求(事先知情同意程序);"共同商定条件"下公平分享因利用遗传资源和相关传统知识所产生的惠益;确保遵约的措施,包括披露遗传资源来源与原产地,遗传资源合法来源证书和监测遵约的检查点;能力建设等.谈判中最为核心的问题是遗传资源的定义是否包括衍生物,以及采取何种措施监测遗传资源的利用.因分歧太大,议定书文本未能规定在申请专利时强制性披露遗传资源来源及原产地,对建立遵约的监测检查点也未严格要求,在处理收集保存库中遗传资源的获取与惠益分享方面也不太明确.中国是全球生物多样性最为丰富的国家之一,是遗传资源重要提供国.<名古屋议定书>的通过和实施将对加强中国生物遗传资源的保护及促进其公平惠益分享具有重要意义.中国需要加强国家层次的立法,以配合议定书的实施.     

《名古屋议定书》背景下我国传统知识的保护:以德昂族酸茶为例

中国于2016年9月6日成为《名古屋议定书》缔约方, 意味着遗传资源及相关传统知识的保护以及获取与惠益分享制度, 在国际和国内层面已经步入履行阶段。传统知识的防御性保护是防范生物剽窃, 建设性保护是促进惠益分享。本研究通过多年的实地调研发现, 德昂族酸茶作为一类与遗传资源相关的传统知识, 在原持有方不知情同意的情况下, 被某利用方申请了专利, 构成了生物剽窃。本研究指出, 传统知识防御性保护可考虑修订国内专利法, 将传统知识强制性来源披露要求纳入其中, 进而防范生物剽窃。为促进传统知识的持有方分享应得惠益和可持续利用, 本研究建议依据《名古屋议定书》精神, 通过立法制定特殊制度, 创造性地发展出可行的惠益分享制度, 区分不同的传统知识主体资格, 以事先知情同意程序和共同商定条件为途径, 以补偿责任或知识共享许可协议为手段, 来实现《生物多样性公约》的保护与可持续利用两大目标, 方能达成传统知识的建设性保护。     

《名古屋议定书》在微生物领域的实施: 影响、最佳做法及我国立法选择

《名古屋议定书》继承了《生物多样性公约》在规范遗传资源的获取和惠益分享问题上采取的双边路径。但是, 这一路径不能完全按照《生物多样性公约》和《名古屋议定书》预设的前提和模式在微生物领域得到实施, 已有的旨在实施《名古屋议定书》的措施对微生物研究和开发活动产生了消极的影响。世界微生物菌种保藏联合会致力于推动《生物多样性公约》及其《名古屋议定书》在微生物领域的有效实施, 并为此制定了相关的行为守则和准则。2016年世界微生物菌种保藏联合会推出的TRUST准则代表了微生物领域的获取和惠益分享最佳做法, 该准则针对微生物遗传资源的原生境获取、保藏、非原生境获取以及惠益分享等问题提出了一系列务实的建议。为了实施《名古屋议定书》, 我国启动了遗传资源的获取和惠益分享立法进程, 当前立法已经进入到一个关键阶段。TRUST准则对我国遗传资源的获取和惠益分享立法具有重要的启示。立法机关可以借鉴TRUST准则提出的受规制活动类型及相对应的建议, 并结合我国国情构建一套适用于微生物遗传资源的获取和惠益分享法律规则。这套法律规则将由对植物、动物和微生物遗传资源都予以适用的法律规则和仅对微生物遗传资源适用的法律规则构成, 后者可被纳入我国获取和惠益分享立法的实施细则之中。     

《生物多样性公约》获取与惠益分享议题国际谈判动态研究

1993年生效的《生物多样性公约》(CBD,the Convention on Biological Diversity)将获取与惠益分享(ABS,access and benefit sharing)作为其三大目标之一。2010年在CBD缔约方大会第10次会议(COP-10)上达成了《生物多样性公约关于遗传资源获取与公平和公正地分享其利用所产生惠益的名古屋议定书》(简称"《名古屋议定书》"),标志着获取与惠益分享议题取得了实质性进展。随后又组织召开了3次政府间委员会会议,《名古屋议定书》于2014年10月在韩国平昌召开COP-12期间生效,并在2014年10月13-17日召开了《名古屋议定书》缔约方大会第1次会议(COP/MOP-1)。本文系统总结和梳理了获取与惠益分享议题产生背景、关键议题争论的焦点、谈判历程和发展动态,深入分析了欧盟、非洲集团、瑞士等主要国家集团和非政府组织(NGOs)、工商界等非国家行为体(NSAs)在获取与惠益分享国际谈判中的立场、策略和作用,讨论了《名古屋议定书》对发展中国家和发达国家的利益体现、影响以及中国面临的挑战。     

生物遗传资源获取与惠益分享国家立法的重要问题

2014年10月12日《生物多样性公约关于获取遗传资源和公正公平分享其利用所产生惠益的名古屋议定书》(简称《名古屋议定书》)的正式生效标志着它已进入全面实施阶段。《名古屋议定书》在国家层面的有效实施需要国家立法提供保障。本文从法律地位、术语与定义、获取与审批、后续监管、跟踪监测等方面探讨了获取与惠益分享(access and benefit-sharing,ABS)国家立法需要深入研究的问题,提出获取与惠益分享国家立法应与现有法律法规协同增效,明确生物遗传资源及相关传统知识所有权,区别商业与非商业获取;增加术语与定义以厘清概念,并促进某些条款的可操作性;明确ABS主管当局、资源主管部门和获取审批材料清单,获取申请的准予形式和内容,实行分类管理与审批获取活动,在鼓励科研的同时有效规范和监管商业开发的获取行为,特别是获取出境行为,同时要考虑特殊情形的获取管理;通过遵守证书从提供国和使用国的角度进行后续监管;保留获取样品凭证,建立检查点对获取、利用、知识产权等各个环节进行跟踪监测,以确保获取与惠益分享国家法律的有效实施。     

《名古屋议定书》政府间委员会谈判进展回顾

2010年10月《生物多样性公约》缔约方大会第十次会议通过的《生物多样性公约关于获取遗传资源和公正和公平分享其利用所产生惠益的名古屋议定书》(简称《名古屋议定书》) , 是实现《生物多样性公约》确保公平公正地分享因利用遗传资源而产生惠益目标的里程碑式文件, 该议定书将会在2014年10月12日正式生效。本文回顾了《名古屋议定书》政府间委员会上对遵约机制、全球多边惠益分享机制、信息交换所、能力建设和意识提高等议题的谈判过程, 并对下一步相关工作的开展提出了建议。     

国家管辖范围外海域遗传资源获取和惠益分享机制构建建议

随着人类对海洋资源开发利用强度的增加, 海洋生物多样性的养护面临着更大挑战。《联合国海洋法公约》及其执行协定已不能较好地应对这些挑战。为此, 联合国大会决定成立工作组, 拟订新的国际协定, 以解决国家管辖范围外海域生物多样性的养护与可持续利用问题。建立国家管辖范围外海洋遗传资源的获取和惠益分享机制是该议题的焦点问题之一, 但是目前各国对新的国际执行协定应当包含哪些要素还缺乏共同理解。本文通过分析《生物多样性公约》、《名古屋议定书》及《粮食和农业植物遗传资源国际条约》等与遗传资源获取和惠益分享相关的国际条约在遗传资源的定义、管辖范围、获取条件及惠益分享要求等方面的异同, 提出对海洋遗传资源获取和惠益分享机制的构建建议: (1)国家管辖范围外的海洋遗传资源不可自由获取; (2)海洋遗传资源的定义应当涵盖海洋生物代谢生成的海洋天然产物; (3)惠益分享责任适用于在新执行协定生效前获取, 但在其生效后进行开发利用的遗传资源; (4)获取活动都应得到主管当局批准, 并签订材料转让协议或共同商定条件; (5)应为非商业化的获取活动制定简化程序, 在人类健康、粮食安全等受到重大威胁而急需获取海洋遗传资源时, 也应适用简化程序, 但后续商业化活动须分享惠益; (6)针对海洋遗传资源的不同研发环节, 设置惠益分享类型, 并就后续利用进行披露和监测, 确保惠益得到分享。     

《遗传资源获取与惠益分享的名古屋议定书》核心内容解读及其生效预测

《生物多样性公约》缔约方大会第十次会议通过的《生物多样性公约关于遗传资源获取和公平公正地分享由遗传资源利用产生惠益的名古屋议定书》是实现《生物多样性公约》确保公平公正的分享因利用遗传资源而产生的惠益目标的里程碑式文件,将从多个方面对国际社会产生影响。对议定书进行解读、分析和评估对于决定是否签署和批准议定书至关重要。根据分析,议定书核心内容分为遵守、公平公正的惠益分享、遗传资源的获取、术语、范围、特殊考虑和与遗传资源相关的传统知识等7个方面。本文对这些核心内容进行了解读,分析了其影响,预测了议定书生效的可能性,并提出了应对措施。     

《粮食和农业植物遗传资源国际条约》与《名古屋议定书》比较研究

《粮食和农业植物遗传资源国际条约》（简称《条约》）与《生物多样性公约关于遗传资源获取和公平公正地分享由遗传资源利用产生惠益的名古屋议定书》（简称《议定书》）是遗传资源获取和惠益分享领域两个重要的国际法律文书,建立了各自的获取和惠益分享机制。由于担忧两个法律文书之间存在监管重叠,以及对我国遗传资源的保护和利用现状不够了解,我国均未批准加入。本文从目标、范围、获取和惠益分享框架和模式及受益者等4四个方面比较了《条约》和《议定书》的差异,结合我国遗传资源的保护和利用现状,就是否加入《条约》与《议定书》提出了以下建议：（1）两个国际法律文书均应加入;（2）在履行《条约》时,需要加强作物野生近缘种的保护,防止资源流失;（3）在履行《议定书》时,监测和评估我国遗传资源应用能力,并适时提出修订《议定书》条款的要求。     

Biological control and the Nagoya Protocol on access and benefit sharing – a case of effective due diligence

ABSTRACT

Biological control agents must be collected and utilised in compliance with the Nagoya Protocol on Access and Benefit Sharing (ABS) which is being implemented independently by each country that is signatory to the Protocol. By March 2018, 50 countries had legislation in place with an additional 54 designing their Legislative, Administrative or Policy Measures having become Party to the Protocol. Apart from the problem of dealing with the many different mechanisms countries are putting in place, it is often difficult to find relevant information on the ABS Clearing House and to access and receive appropriate responses from the National Focal Points or Competent National Authorities. We feel that a lot of time is lost on both sides (National authorities and scientists seeking information), and the process would benefit from streamlining. Also, open questions remain, such as how to deal with the generation digital sequence information and what specific activities are considered utilisation, especially for biological control. CABI has pro-actively developed an ABS policy and best practices for its staff to try and comply with the Nagoya Protocol. In addition, CABI has started negotiations with several provider countries, beginning with its member countries, to have its ABS policy and best practices recognised, considering the non-monetary benefits typically associated with biological control. The Nagoya Protocol was born out of the necessity to guarantee the fair and equitable sharing of benefits arising from the utilisation of genetic resources. However, it should not hinder the development of best practice solutions to protect exactly these genetic resources from threats like invasive species. It is important that research and development that addresses global societal challenges are not impeded and that science and its output are recognised as a way to preserve and use genetic resources in an equitable way.     

Best practices for the use and exchange of invertebrate biological control genetic resources relevant for food and agriculture

The Nagoya Protocol is a supplementary agreement to the Convention on Biological Diversity that provides a framework for the effective implementation of the fair and equitable sharing of benefits arising out of the utilization of genetic resources, including invertebrate biological control agents. The Protocol came into force on 12 October 2014, and requires signatories and countries acceding to the Protocol to develop a legal framework to ensure access to genetic resources, benefit-sharing and compliance. The biological control community of practice needs to comply with access and benefit sharing regulations arising under the Protocol. The IOBC Global Commission on Biological Control and Access and Benefit Sharing has prepared this best practices guide for the use and exchange of invertebrate biological control genetic resources for the biological control community of practice to demonstrate due diligence in responding to access and benefit sharing requirements, and to reassure the international community that biological control is a very successful and environmentally safe pest management method based on the use of biological diversity. We propose that components of best practice include: collaborations to facilitate information exchange about what invertebrate biological control agents are available and where they may be obtained; knowledge sharing through freely available databases that document successes (and failures); cooperative research to develop capacity in source countries; and transfer of production technology to provide opportunities for small-scale economic activity. We also provide a model concept agreement that can be used for scientific research and non-commercial release into nature where access and benefit sharing regulations exist, and a model policy for provision of invertebrate biological control agents to other parties where access and benefit sharing regulations are not restrictive or do not exist.     

主要利益相关方在履行《名古屋议定书》中的关系与义务

生物遗传资源及其相关传统知识的获取与惠益分享(Access and Benefit Sharing, ABS)涉及三个主要利益相关方, 即提供方、使用方和监管方。在我国履行《名古屋议定书》的过程中, 需深刻理解《名古屋议定书》中对于提供方、使用方和监管方的相关规定, 分析三方关系内涵及各自义务, 对有效履行《名古屋议定书》具有重要意义。本文提出, 为促进公平和公正的惠益分享, 提供方有义务明确生物遗传资源的原产地并保护和可持续利用原产的生物遗传资源, 确定生物遗传资源的原始持有社区和相关传统知识的原始持有人(或地方社区); 通过调查、登记和编目, 分析遗传资源的起源、形成及利用历史, 建立当地生物遗传资源及相关传统知识的档案; 通过ABS知识培训, 提高参与“获取与惠益分享”事务的能力, 特别是与使用方谈判ABS协议的能力。使用方有义务履行国际公约规定的“事先知情同意”和“共同商定条件”原则, 在征得土著和地方社区的事先知情同意和实质性参与下, 与土著和地方社区经共同商定条件, 签订体现公平惠益分享的ABS协议; 使用方要尊重土著和地方社区对保护和提供生物遗传资源的贡献, 制定行为守则, 履行社会责任; 还要在论文发表及专利申请时披露所使用遗传资源及相关传统知识的来源和原产地。监管方有责任建立完善的ABS政策和法规体系; 建立ABS信息交换机制, 发布ABS相关信息; 规定提交获取申请所要求的材料, 提供“ABS协议”的模本, 并审查和批准“ABS协议”, 签发“合法来源证书”; 并通过建立检查点, 监督和监测ABS协议的履行。     

遗传资源数字序列信息在生物多样性保护中的应用及对惠益分享制度的影响

遗传资源数字序列信息是近年来DNA测序技术的产物, 目前已经渗透到生命科学和环境科学等领域。遗传资源数字序列信息的应用有助于解释生命的分子基础和进化理论, 为生物多样性的保护和可持续利用提供新的技术手段。随着《名古屋议定书》的生效和履行, 各缔约方对遗传资源惠益分享的认识逐步提高, 并采取有效的立法、行政等措施对本国的生物遗传资源进行管制。遗传数字序列信息作为一种特殊的非实物性质的信息资源, 将会给获取与惠益分享制度带来挑战。近几年, 遗传资源数字序列信息已成为《生物多样性公约》缔约方大会谈判的焦点议题。中国是生物多样性大国, 也是近年来生物技术发展较快的国家之一。中国作为《名古屋议定书》的缔约方, 应积极参与遗传资源数字序列信息相关的研究, 并应对由此带来的各种挑战。     

Global biodiversity research tied up by juridical interpretations of access and benefit sharing

The toolbox of instruments regulating access, transfer and use of biological material is currently re-equipped: the Nagoya Protocol was initiated to provide a legal framework to the third objective of the Convention on Biological Diversity – the fair and equitable sharing of benefits arising from the utilisation of genetic resources and associated traditional knowledge (an aspect not discussed here). In the ongoing implementation of the protocol, potentially harmful and far-reaching effects on biological research become evident. Here, we illustrate how vague definitions, lack of legal clarity and coordination, and often restrictive and complex regulations affect the transfer of biological material and associated data. Instead of promoting basic research in conservation and biodiversity, the current situation potentially jeopardises international collaboration, biodiversity research and its applications in monitoring, biocontrol and food safety. We address these challenges and discuss possible options for its practical implementation in the future.     

Bridging molecular genetics and participatory research: how access and benefit‐sharing stimulate interdisciplinary research for tropical biology and conservation

Molecular genetics research can benefit efforts to conserve the genetic diversity of tropical plant species. Clear and efficient procedures are needed to access DNA samples, while respecting tropical countries’ and local communities’ rights on genetic resource usage. The Nagoya Protocol on Access and Benefit‐Sharing, which took effect in 2014, provides an opportunity to establish such procedures. However, scientists are concerned that its emphasis on monetary gains restricts research focused on scientific, societal, and environmental benefits. Despite much political and scientific debate, few concrete cases have demonstrated the practical functioning of the Nagoya Protocol. This paper describes the first application of the Protocol in Guatemala, where it was used to grant permission to a non‐commercial study on gene flow in mahogany (Swietenia macrophylla King) populations in the Maya Biosphere Reserve of Petén. On the basis of this study, we discuss five strategies to enhance the application of molecular genetics to conservation biology under the Nagoya Protocol: (1) generate short and standardized procedures; (2) enable science communication; (3) cultivate a common understanding between users, providers, and potential beneficiaries; (4) involve local research and practitioner organizations; and (5) integrate participatory research. Positive societal views on the application of molecular genetics to conservation biology generate further support for work in this discipline and promote adoption of research results for the conservation of genetic diversity of tropical plant species.     

Do new Access and Benefit Sharing procedures under the Convention on Biological Diversity threaten the future of biological control?

Under the Convention on Biological Diversity (CBD) countries have sovereign rights over their genetic resources. Agreements governing the access to these resources and the sharing of the benefits arising from their use need to be established between involved parties [i.e. Access and Benefit Sharing (ABS)]. This also applies to species collected for potential use in biological control. Recent applications of CBD principles have already made it difficult or impossible to collect and export natural enemies for biological control research in several countries. If such an approach is widely applied it would impede this very successful and environmentally safe pest management method based on the use of biological diversity. The CBD is required to agree a comprehensive Access and Benefit Sharing process in 2010, in preparation for which the IOBC (International Organization for Biological Control of Noxious Animals and Plants) Global Commission on Biological Control and Access and Benefit Sharing has prepared this position paper. Here, we first describe the practice of biological control in relation to the principles of ABS, illustrated extensively by case studies and successes obtained with biological control. Next, we emphasise the very limited monetary benefits generated in biological control when compared to other fields of ABS such as the collection of germplasm for development of human drugs, chemical pesticides or crop cultivars. Subsequently, we inform the biological control community of good ABS practice and challenges, and we hope to make clear to the community involved in ABS under the CBD the special situation with regard to biological control. Finally, based on the non-commercial academic research model, we make recommendations which would facilitate the practice of collection and exchange of biological control agents, propose a workable framework to assist policy makers and biological control practitioners, and urge biological control leaders in each country to get involved in the discussions with their national ABS contact point to take their needs into consideration.