《生物多样性公约》中“土著和地方社区”术语在中国的适用性和评价指标体系

《生物多样性公约》第8(j)条提出了术语“土著和地方社区”, 《名古屋议定书》关于遗传资源特别是传统知识获取与惠益分享的很多重要条款中都涉及该术语。然而, 二者均未对该术语予以定义, 国际社会对该术语的适用范围至今尚未达成一致, 缔约方只能根据公约文本内涵和各国具体国情予以推断和解读。当前的普遍理解包括殖民主义特征的“狭义土著和地方社区”和仅具有原住民特征的“广义土著和地方社区”两种情况。对于中国而言, “土著和地方社区”是否与中国少数民族社区概念上等同或完全不同, 对于全面履行《生物多样性公约》和《名古屋议定书》具有重要意义。本文通过词源分析、定性和定量化等理论和实证研究, 构建了以少数民族具体地方社区为评估单元的“土著和地方社区特征”评价指标体系, 进而对部分少数民族具体地方社区进行了实际评估。结果表明, 一些至今仍然维持传统生产和生活方式及保留传统文化的少数民族地方社区具有明显的“土著和地方社区”特征, 适用于国际公约的相关规定。这为理解国际上的“土著和地方社区”和中国“少数民族”提供了思路, 为中国履行《生物多样性公约》《名古屋议定书》中涉及“土著和地方社区”的条款提供了技术支持, 也为维护中国少数民族地方社区在遗传资源及相关传统知识获取与公平惠益分享中的应有权益提供了理论基础。     

《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。     

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》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。     

《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。     

《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。     

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。     

《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。     

《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。     

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.     

遗传资源获取与惠益分享: 背景、进展与挑战

本文回顾了《生物多样性公约》(CBD)有关遗传资源获取与惠益分享(access and benefit sharing, ABS)问题的谈判背景, 介绍了ABS问题特设工作组的工作历程。对《公约》第8次缔约方大会以来有关ABS问题的谈判进展进行了详细的分析, 特别是有关遗传资源来源证书制度的讨论与成果, 进而对当前ABS问题面临的挑战进行了分析研究, 包括国际层面上WTO体系和世界知识产权组织(WIPO)体系与CBD之间在遗传资源及相关传统知识在知识产权问题上的冲突, 国家层面上ABS问题的立法需求与焦点问题, 以及在确定遗传资源来源和实施惠益分享方面的技术限制等。     

《名古屋议定书》获取与惠益分享制度对传统生物防治研究的影响与对策

为了保证公平和公正地分享利用遗传资源所产生的惠益,研究和开发中使用的遗传资源必须按照《名古屋议定书》中规定的获取与惠益分享制度进行收集和利用.截至2020年7月,该议定书的缔约方中已有67个国家制定了相关立法,另有57个国家正在制定法律,行政或政策措施.传统生物防治通常是从有害生物的原产地或自然分布区引进天敌资源,用于可持续防治外来入侵有害生物.本文基于履约现状与挑战,分析了获取与惠益分享制度对于传统生物防治研究的影响,并以国际应用生物科学中心为例介绍了获取与惠益分享政策和最佳做法以及履约实践与对策,以期为我国从事传统生物防治研究的机构和科研人员遵守并执行《名古屋议定书》提供参考.     

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.     

生物多样性相关传统知识的国际保护及中国应对策略

数个国际多边协定、政府间组织和机构都涉及生物多样性相关的传统知识, 包括《生物多样性公约》(CBD)、关于遗传资源获取与惠益分享的《名古屋议定书》(NP)、《粮食和农业植物遗传资源国际条约》(ITPGRFA)、世界知识产权组织(WIPO)、世贸组织下的《与贸易相关的知识产权协定》(WTO/TRIPS)以及生物多样性与生态系统服务政府间科学-政策平台(IPBES)等。然而, 各个国际文书所界定的传统知识内涵和外延却有所区别和侧重。中国是生物多样性极为丰富的多民族大国, 各族人民在数千年的生产和生活实践中创造了丰富的与保护和持续利用生物遗传资源相关的传统知识、创新和实践做法。作为多个相关国际公约或协定的缔约方, 中国应厘清各相关国际公约或协定中生物多样性相关传统知识的内涵、保护目标及国际义务, 加强国家在履行相关国际公约或协定过程中的协同增效, 从而在相关传统知识的国际谈判中统一立场, 维护国家及地方社区利益。本文系统梳理了各相关国际多边协定、组织和机构对于传统知识的界定, 以及国际多边体系在保护遗传资源相关传统知识方面的工作, 根据中国遗传资源相关传统知识的现状和已有的措施, 结合当前履行国际多边协定的大背景, 提出了促进中国生物多样性相关传统知识保护的5项具体建议, 包括: (1)采取立法、行政和政策措施; (2)加强相关研究, 强化技术支撑; (3)加强传统知识保护的能力建设; (4)在国内履约过程中, 强化传统知识相关工作的协调; (5)在国际层面上加强中国传统知识的宣传力度。     

Sharing the benefits of genetic resources: from biodiversity to human genetics

Benefit sharing aims to achieve an equitable exchange between the granting of access to a genetic resource and the provision of compensation. The Convention on Biological Diversity (CBD), adopted at the 1992 Earth Summit in Rio de Janeiro, is the only international legal instrument setting out obligations for sharing the benefits derived from the use of biodiversity. The CBD excludes human genetic resources from its scope, however, this article considers whether it should be expanded to include those resources, so as to enable research subjects to claim a share of the benefits to be negotiated on a case-by-case basis. Our conclusion on this question is: 'No, the CBD should not be expanded to include human genetic resources.' There are essential differences between human and non-human genetic resources, and, in the context of research on humans, an essentially fair exchange model is already available between the health care industry and research subjects. Those who contribute to research should receive benefits in the form of accessible new health care products and services, suitable for local health needs and linked to economic prosperity (e.g. jobs). When this exchange model does not apply, as is often the case in developing countries, individually negotiated benefit sharing agreements between researchers and research subjects should not be used as 'window dressing'. Instead, national governments should focus their finances on the best economic investment they could make; the investment in population health and health research as outlined by the World Health Organization's Commission on Macroeconomics and Health; whilst international barriers to such spending need to be removed.     

Regulating access to genetic resources under the Convention on Biological Diversity: an analysis of selected case studies

In 1992 parties to the Convention on Biological Diversity (CBD) agreed to develop and implement policies to regulate and facilitate access to genetic resources (AGR). We examine regulations and agreements in Brazil, Colombia, and the Philippines in detail and discuss how these countries are implementing the AGR mandate. In particular, we evaluate progress toward achieving the CBD objectives of conserving biological diversity, using its components in a sustainable manner, and equitably sharing the benefits arising from the use of genetic resources. We highlight the difficulties in developing and implementing these policies, arising from the conflicting goals of regulating and facilitating AGR, as well as the special character of genetic resources, existing ex situ collections, issues of ownership and tenure, and the dearth of legal, institutional, and scientific capacity in many countries. We recommend (1) independent, multidisciplinary evaluation of the success of the access policy in achieving CBD objectives, (2) resolution of the conflict between traditional land tenure and legal property rights of genetic resources so as to match conservation obligations with benefit-sharing rights, (3) recognition that benefits obtained from AGR may be entirely non-monetary, and (4) that countries provide a 'two-track AGR application process separately for commercial and non-commercial users.     

Exchange of Natural Enemies for Biological Control: Is it a Rocky Road?—The Road in the Euro-Mediterranean Region and the South American Common Market

The access and benefit sharing (ABS) regulations from the Convention on Biological Diversity (CBD) for the use of natural resources became an important issue because the biodiversity of developing countries was heavily accessed and unilaterally exploited by pharmaceutical and seed companies. However, natural enemies used for biological control are living and unmodified genetic resources which cannot be patented and have been treated as resources such as drugs, seeds, or other commercial products. Consequently, the ABS requirements have limited not only the use of natural enemies but also the positive effects that scientifically supported biological control strategies have on the society, the environment, and the economy, reducing problems of pesticide residues, water and soil contamination, and non-target effects. During the last several years, the biological control scientific community has faced new and extremely complicated legislation dictated by a high and diverse number of governmental agencies at different levels, making the access to natural resources for biocontrol purposes a rocky road. Society at large should be aware of how the strict ABS regulations affect the use of natural enemies as biological resources to secure food production, food safety, and global environmental protection. We discuss in here the current difficulties derived from CBD for the exchange of natural enemies taking as example the Euro-Mediterranean region, Argentina, and Brazil to demonstrate how long and diverse are the steps to be followed to obtain the required permits for access and exportation/importation of natural enemies. We then argue that the public visibility of biocontrol strategies should be increased and their benefits highlighted in order to persuade legislators for the development of a less bureaucratic, more expedient, and more centralized regulatory frame, greatly favoring the practice and benefits of biological control. We finally propose a general framework in which ABS issues should be dealt in ways to attend the CBD, but also to make the use of natural resources for the biological control of pests to secure food production and security a possible alternative.