3.Present status, challenges and countermeasures on mechanism Xue Dayuan Bilingual by ECBP VAC

遗传资源惠益分享机制的现状、挑战与对策 Present status, challenges and countermeasures on mechanism of benefit-sharing for genetic resources 薛达元 XUE Dayuan Nanjing Institute of Environmental Science (NIES), Ministry of Environmental Protection of China (MEP) College of Life and Environmental Science, Minzu University of China (MUC) xuedayuan@hotmail.com 2010- 09-06, Shanghai

目录 Contents 1 、遗传资源获取与惠益分享国际制度谈判进展 The progress on negotiation for the international regime of access and benefit-sharing for genetic resources and associated traditional knowledge (ABS Protocol) 2 、中国在遗传资源获取与惠益分享方面的政策与立法现状 The present status for policy and legislation on ABS issue in China 3 、中国实施 ABS 国际制度的问题与挑战 The problems and challenges for ABS Protocol implementation in China 4 、遗传资源公平惠益分享领域与欧盟的合作前景 The potential cooperation with EU in the issue of ABS.

一、遗传资源获取与惠益分享国际制度谈判进展 The progress on the negotiation of ABS Protocol 《生物多样性公约》三大目标 Three objectives of the CBD （ 1 ）保护生物多样性 Conservation of biological diversity （ 2 ）持续利用生物多样性组成部分（生态系统、物种资源及遗传资源 Sustainable use of the components of biodiversity （ 3 ）公平公正地分享因利用遗传资源（及相关传统知识）而产生的惠益。 Fair and equitable sharing of the benefits arising out of the utilization of genetic resources (and associated traditional knowledge)

一、遗传资源获取与惠益分享国际制度谈判进展 The progress on the negotiation of ABS Protocol CBD/Article 15, the Convention 公约第 15 条相关规定（ 1 ） Sovereign rights principle (the authority to determine access to

genetic resources rests with the national governments and is subject to national legislation) 遗传资源具有国家主权，能否获取取决于国家政府，并服从于国家法律

（ 2 ） Prior Informed Consent (PIC) 遗传资源获取需要得到资源提供国的“事先知情同意” （ 3 ） Mutually agreed terms (MAT) 遗传资源提供方与使用方需要共同商定条件（ 4 ） Benefit Sharing (BS) 确保资源提供方与资源使用方之间的公平惠益分享（ 5 ） Endeavour to develop and carry out scientific research in the Contracting Party providing genetic resources 尽可能在提供遗传资源的国家进行开发研究（ 6 ） Cope with the relationship between IP and the access and benefit-sharing of genetic resources 处理遗传资源获取与惠益分享与知识产权的关系

一、遗传资源获取与惠益分享国际制度谈判进展 The progress on the negotiation of ABS Protocol Bonn Guidelines on access to genetic resources and the fair and equitable sharing of the benefits( 波恩准则 ) Identification of the rights and responsibilities of the relationships between Contracting Parties and stakeholders, providers and users of the genetic resources; 明确了遗传资源提供者、使用者和利益相关者的权力和责任 Enriching the process and requirements of the “Prior Informed Consent”; 丰富了“事先知情同意”的程序和具体要求 Specializing the “Mutually Agreed Terms” in Article 15, paragraph 4 、 7, of the CBD 将公约第 15 条提出的“共同商定条件”更加具体化 Bringing forward the National monitoring and reporting system 引入国家监测与报告制度 Identification of the relationship between the Guidelines and relevant international systems; 明确了《波恩准则》与其他国际协定的关系 Elements for Material Transfer Agreements (MTA) ; 提出“材料转让协议”的具体内容 But as it is a non-legally-bind guidelines, developing countries are not satisfied.

一、遗传资源获取与惠益分享国际制度谈判进展 The progress on the negotiation of ABS Protocol UN called for the negotiation for ABS International Regime (now called ABS Protocol) 联合国号召谈判 ABS 国际制度 (ABS 议定书） The World Summit on Sustainable Development (South Africa, 2002) called for negotiation on establishing an international system of enhancing benefit sharing of genetic resources equitably and fairly under the framework of the CBD; 2002 年南非全球持续发展高峰会议要求在 CBD 的框架下，建立一个旨在加强遗传资源公平惠益分享的国际制度。

Reiterated in the Fifty-Seventh Session of the U.N. General

Assembly (December, 2002, New York), World Summit of the UN (September, 2005, New York) and following UN General Assemblies. 2002 年 12 月第 57 届联大和 2005 年联合国全球高峰会议重申了这一要求。

一、遗传资源获取与惠益分享国际制度谈判进展 The progress on the negotiation of ABS Protocol Review of the history for negotiation of the International Regime for ABS of genetic resources ABS 国际制度谈判进展回顾《公约》关于 ABS 的工作开始于 COP 4 （ 1998 年 5 月，斯洛伐克，布拉迪斯拉发），缔约方国大会决定建立一个地区平衡的 ABS 专家组。专家组开了两次议会（ 1999 年，哥斯达黎加，圣何塞； 2001 年，加拿大，蒙特利尔）并提出了一系列的建议，包括 PIC ， MAT ，利益相关者在 CBD 框架内 ABS 的参与和选择途径。 COP 5 （ 2000 年 5 月，肯尼亚，内罗毕）设立了 ABS 工作组，制定指导方针和相关途径，包括： PIC 和 MAT ；利益相关方的参与；惠益分享机制；和传统知识（ TK ）的保护。 The Convention’s work on ABS was initiated at COP 4 (May 1998, Bratislava, Slovakia) when parties established a regionally-balanced expert panel on ABS. The expert panel held two meetings (October 1999, San José, Costa Rica; and March 2001, Montreal, Canada) and developed a set of recommendations, including on PIC, MAT, approaches for stakeholder involvement and options to address ABS within the CBD framework. COP 5 (May 2000, Nairobi, Kenya) established the Working Group on ABS to develop guidelines and other approaches on: PIC and MAT; participation of stakeholders; benefit-sharing mechanisms; and the preservation of traditional knowledge.

一、遗传资源获取与惠益分享国际制度谈判进展 The progress on the negotiation of ABS Protocol

ABS 1 ：在第一次会议上（ 2001 年 10 月，德国，波恩）， ABS 工作组起草了 ABS 波恩准则，确定了能力建设行动计划的内容，并审议知识产权（ IPRs ）在 ABS 安排实施中的作用。 ABS 1: At its first meeting (October 2001, Bonn, Germany), the Working Group on ABS developed the draft Bonn guidelines on ABS, identified elements for a capacity-building action plan, and considered the role of intellectual property rights (IPRs) in the implementation of ABS arrangements.

一、遗传资源获取与惠益分享国际制度谈判进展 The progress on the negotiation of ABS Protocol COP 6 ：第六次缔约方会议（ 2002 年 4 月，荷兰，海牙）通过了关于 ABS 的波恩准则，并且再次审议了知识产权（ IPRs ）在 ABS 安排实施方面的作用，以及和世界贸易组织知识产权与贸易相关方面的关系。 WSSD ：根据约翰内斯堡执行计划，联合国世界可持续发展峰会（ 2002 年 9 月，南非约翰内斯堡）号召在 CBD 框架下对国际制度进行谈判，以推动和保护遗传资源使用中公平公正的惠益分享。 COP 6: At its sixth meeting (April 2002, The Hague, the Netherlands), the COP adopted the Bonn Guidelines on ABS and also considered the role of IPRs in the implementation of ABS arrangements, and the relationship with the Agreement on Trade-related Aspects of Intellectual Property Rights of the World Trade Organization. WSSD: In the Johannesburg Plan of Implementation, the UN World Summit on Sustainable Development (WSSD) (September 2002, Johannesburg, South Africa) called for negotiating, within the CBD framework, an international regime to promote and safeguard the fair and equitable sharing of benefits arising out of the utilization of genetic resources.

一、遗传资源获取与惠益分享国际制度谈判进展 The progress on the negotiation of ABS Protocol

ABS 2 ：在第二次会议上（ 2003 年 12 月，加拿大，蒙特利尔）， ABS 工作组讨论 ABS 国际制度的进展、性质、范围、内容和方式，并且审议了确保遵守 PIC 和 MAT 的措施和能力建设措施。 ABS 2: At its second meeting (December 2003, Montreal, Canada), the ABS Working Group debated the process, nature, scope, elements and modalities of an international ABS regime, and also considered measures to ensure compliance with PIC and MAT, and capacity building.

一、遗传资源获取与惠益分享国际制度谈判进展 The progress on the negotiation of ABS Protocol

COP 7 ：第七次会议上（ 2004 年 2 月，马来西亚，吉隆坡）， COP 通过了 ABS 能力建设行动计划，授权 ABS 工作组谈判 ABS 国际制度，并确定了谈判中涉及的术语。 COP 7: At its seventh meeting (February 2004, Kuala Lumpur, Malaysia), the COP adopted the Action Plan on capacity building for ABS, mandated the ABS Working Group to elaborate and negotiate an international ABS regime and set out the terms of reference for the negotiations.

一、遗传资源获取与惠益分享国际制度谈判进展 The progress on the negotiation of ABS Protocol ABS 3 和 ABS 4 ：在第三次（ 2005 年 2 月，泰国，曼谷）和第四次会议（ 2006 年 2 月，西班牙，格拉纳达）上， ABS 工作组起草了草案文本，希望以此作为之后谈判的基础。工作组还审议了实施 ABS 波恩准则的补充方法，包括提供原产地 / 来源 / 合法来源的国际证书；确保遵守 PIC 和 MAT 的措施； ABS 指标的选择。 ABS 3 and 4: At its third and fourth meetings (February 2005, Bangkok, Thailand, and January 2006, Granada, Spain), the ABS Working Group produced draft text compilations to serve as the basis for future negotiations. It also considered additional approaches to complement the Bonn Guidelines on ABS, including an international certificate of origin/source/legal provenance, measures to support compliance with PIC and MAT, and options for indicators for ABS.

一、遗传资源获取与惠益分享国际制度谈判进展 The progress on the negotiation of ABS Protocol COP 8 ：第八次缔约方大会上（ 2006 年 3 月，巴西，库里蒂巴）， COP 责成 ABS 工作组于 2010 年 COP 10 召开之前尽早地完成关于国际 ABS 制度谈判。同时， COP 要求“第 8 （ j ）条工作组”在与传统知识相关的问题上协助 ABS 工作组。 COP 8: At its eighth meeting (March 2006, Curitiba, Brazil), the COP instructed the ABS Working Group to complete its work with regard to the international ABS regime at the earliest possible time before COP 10, to be held in 2010. The COP also requested the Working Group on Article 8(j) to contribute to the mandate of the ABS Working Group on issues relevant to traditional knowledge.

一、遗传资源获取与惠益分享国际制度谈判进展 The progress on the negotiation of ABS Protocol ABS 5 和 ABS 6 ：在第五次会议（ 2007 年 10 月，加拿大，蒙特利尔）和第六次会议（ 2008 年 1 月，日内瓦，瑞士）上， ABS 工作组讨论了 ABS 国际制度的主要内容，包括公平公正的惠益分享，遗传资源的获取，遵约，传统知识和遗传资源，以及能力建设。在瑞士，工作组制定了一份有关国际制度的简洁简要的工作文件，主要由上述的内容以及在原则上达成并一致“需要进一步详细考虑以融合到国际制度”的项目表组成，或者有必要对未达成一致的内容“进一步审议”或者进一步澄清。 ABS 5 and 6: At its fifth and sixth meetings (October 2007, Montreal, Canada, and January 2008, Geneva, Switzerland), the ABS Working Group focused on the main components of the international regime on ABS, including fair and equitable sharing of benefits, access to genetic resources, compliance, traditional knowledge and genetic resources, and capacity building. In Geneva, the Working Group produced a short and concise working document on the international regime, consisting of sections on the main components and lists of items “to be further elaborated with the aim of incorporating them in the international regime” in the case of agreement in principle, or “for further consideration” in the case of disagreement or need for further clarification.

一、遗传资源获取与惠益分享国际制度谈判进展 The progress on the negotiation of ABS Protocol COP 9 ：第九次缔约方大会（ 2008 年 5 月，德国，波恩）通过了 ABS 国际制度谈判的路线图，确保 ABS 工作组在 2010 年完成谈判的最后期限之前召开三次会议。 COP 同时构建了三个专家组，并指示 ABS 工作组完成国际制度的谈判，并提交一项 / 一套制度供 COP10 审议通过 . COP 9: At its ninth meeting (May 2008, Bonn, Germany), the COP adopted a roadmap for the negotiation of the international regime, ensuring that the ABS Working Group will meet three times before the 2010 deadline for completion of negotiations. The COP also established three expert groups, and instructed the ABS Working Group to finalize the international regime and to submit an instrument/instruments for consideration and adoption by COP 10. The three expert groups (concepts, terms, working definitions and sectoral approaches; compliance; and traditional knowledge associated with genetic resources) each met once between December 2008 and June 2009

一、遗传资源获取与惠益分享国际制度谈判进展 The progress on the negotiation of ABS Protocol ABS 7 ：在第七次会议上（ 2009 年 4 月 2-8 日，法国，巴黎），工作组重点讨论了目标、范围、遵约、公平公正的惠益分享和获取这些内容。除了一些程序性的障碍，（这些障碍大多数和协商文件的结构有关，）工作组取得的进程有巩固遵约、惠益分享和获取的提案。第 8 （ j ）条工作组第六次会议：在第 8 （ j ）条工作组第六次会议上（ 2009 年 11 月 2-6 日，加拿大，蒙特利尔），工作组结束了对道德准则的协商，（这些道德准则是为确保对 ILCs 文化和知识遗产的尊重），并表述了对 ABS 国际制度的详细观点，以递交给 ABS 8 。 ABS 7: At its seventh meeting (April 2009, Paris, France), the Working Group focused on operational text on the objective, scope, compliance, fair and equitable benefit-sharing, and access. Despite procedural obstacles, mostly related to the structure of the negotiating document, the Working Group consolidated submissions on compliance, benefit-sharing and access. ARTICLE 8(J) WG 6: At its sixth meeting (November 2009, Montreal, Canada), the Working Group on Article 8(j) expressed detailed views on the international regime on ABS, for transmission to ABS 8.

一、遗传资源获取与惠益分享国际制度谈判进展 The progress on the negotiation of ABS Protocol ABS 8 ：在第八次会议上（ 2009 年 11 月 9-15 日，加拿大，蒙特利尔），工作组处理了有关制度所有内容的执行文案，并讨论了其法律实质。会议接受了蒙特利尔附件和第二个附件。蒙特利尔附件是一份有关国际制度的单一、整体的草案，第二个附件是有关暂时搁置以供 ABS 9 商议的执行文本提案。工作组还建立了一项 ABS 9 之前的会议期间进程，包括：共同主席之友；共同主席地区间非正式协商；以及一系列地区间协商。 ABS 8: At its eighth meeting (November 2009, Montreal, Canada), the Working Group addressed operative text on all components of the regime, and discussed its legal nature. The meeting adopted the Montreal Annex, consisting of a single, consolidated draft of the international regime, and a second annex on proposals for operational texts left in abeyance for consideration at ABS 9. The Working Group also established an inter-sessional process leading up to ABS 9, including: a Friends of the Co-Chairs group; a Co-Chairs’ Interregional Informal Consultation; and a series of regional consultations.

一、遗传资源获取与惠益分享国际制度谈判进展 The progress on the negotiation of ABS Protocol ABS 9 （第一部分）：在第九次会议第一部分会议（ 2010 年 3 月，哥伦比亚，卡利）上，工作组在议定书草案的基础上进行协商。这份议定书草案被标注为共同主席文本，由这次会议之前召开的共同主席非正式地区间磋商会议制定。经过联络小组三天的讨论，大会在许多问题方面取得了进展，包括衍生物的惠益分享和国际认可的遵约证书，建立了地区间小组。由于进程的争议性，地区间小组未能进入以文本为基础的谈判。工作组最终同意：暂停会议并在 2010 年 7 月召开续会；在续会前进一步修订议定书草案，指出草案不是通过协商而制定的，但不妨碍缔约方进行进一步修改和补充文本的权利。 ABS 9 (FIRST PART): At the first part of its ninth meeting (March 2010, Cali, Colombia), the Working Group conducted negotiations on the basis of a draft protocol, tabled as a Co-Chairs’ text and developed upon a request made during the Co-Chairs’ Informal Inter-regional Consultation held prior to the meeting. Following three days of contact group discussions, which achieved progress on a number of issues, including benefit-sharing from derivatives and an internationally recognized certificate of compliance, an inter-regional group was established. Due to procedural wrangling, the inter-regional group did not enter into text-based negotiations. The Working Group eventually agreed to: suspend the meeting and convene a resumed session in July 2010; and forward the draft protocol text as revised during the meeting to the resumed session, with the understanding that the draft was not negotiated, is without prejudice to the rights of parties to make further amendments and additions to the text, and should be read together with the ABS 9 report reflecting parties’ views expressed at the meeting. After the meeting, the draft protocol was circulated to parties, in accordance with Article 28 of the Convention (Adoption of Protocols).

一、遗传资源获取与惠益分享国际制度谈判进展 The progress on the negotiation of ABS Protocol ABS 9 （第二部分）： ABS 不限成员名额特设工作组第九次会议续会于 2010 年 7 月 10 日至 16 日在加拿大蒙特利尔举行。在卡利会议附件的基础上，参加蒙特利尔会议的代表们将文本阅读了两遍，这不再是一份共同主席案文，而是一份由缔约方协商而成的文本。一些关键问题需要进一步协商，包括：范围；病原体、衍生物、遗传资源的使用概念的问题；支持遵约的制度。因此，工作组决定在第十次缔约方大会（ COP 10 ）之前，也就是 2010 年 9 月，再举行一次会议进行协商。 The resumed ninth meeting of ABS WG-9 was held from 10-16 July 2010, in Montreal, Canada. On the basis of the Cali Annex, delegates in Montreal conducted two readings of the text to isolate and resolve outstanding issues and reach consensus on language. Delegates made a number of important steps towards meeting their mandate, including approving a substantive outcome in the form of a draft ABS protocol, which is no longer a Co-Chairs’ text but rather a text negotiated by parties. They also identified the key issues that require further compromises, including scope and the issue of pathogens, derivatives and the concept of utilization of genetic resources, and mechanisms to support compliance. Several sets of brackets remain and, as a result, the Working Group decided to hold another meeting before COP 10, possibly in September 2010.

一、遗传资源获取与惠益分享国际制度谈判进展 The progress on the negotiation of ABS Protocol Main stakeholders and opinions: 主要利益相关方及其观点生物多样性大国集团的观点： Like-Minded Mega-biodiversity Countries (LMMC): Legal-binding international regime, emphasis on the authority of the genetic resources provided country, equitable benefit sharing based on Prior Informed Consent and Mutually Agreed Terms; 非洲集团、南美国家集团的观点 Similar opinions: African Group, GROLAC (South American and Caribbean Group); EU and the JUSCANZ Group ： Access and benefit-sharing of genetic resources based on contracts, IP protection; 欧盟及其他发达国家 Switzerland and Norway: agree to disclose the origin of genetic resources, reservation on Prior Informed Consent and the manner of benefit-sharing. 中间国家：挪威、瑞士。

一、遗传资源获取与惠益分享国际制度谈判进展 The progress on the negotiation of ABS Protocol Position of the Chinese Government 中国政府的谈判立场

China is the contracting party of the CBD 中国是缔约方 As the member of LMMC, China has great biodiversity and rich genetic resources. 中国是 LMMC 成员国 As the important provider of genetic resources, China supports to establish a regime on the access and benefit sharing of genetic resources in the international level so as to improve the benefit sharing of genetic resources. 中国作为遗传资源提供国，支持建立 ABS 议定书 China is also the important user of genetic resources with rapid-developing bio-technology and growing bioindustry. 中国也是重要的遗传资源使用国

二、中国在遗传资源获取与惠益分享方面的政策与立法现状 Present status for policy & legislation on ABS in China 1. Policies Related in China 中国相关政策

（ 1 ）国家知识产权战略纲要）（ 2008 年 6 月 5 日由国务院发布），提出以下战略任务： The Outline of the National IP Strategy （ promulgated by the State Council on June 5, 2008 ）， put forward the following specific tasks 2008 年 6 月 5 日，国务院正式发布了《国家知识产权战略纲要》。在《纲要》第二部分“指导思想和战略目标”中，将“遗传资源、传统知识和民间文艺的有效保护与合理利用”列入近五年的战略目标。 On June 5, 2008, the State Council issued “the Outline of the National Intellectual Property Strategy”, and genetic resources and traditional knowledge have been incorporated into the strategy Objectives and the strategy tasks in the Outline.

二、中国在遗传资源获取与惠益分享方面的政策与立法现状 Present status for policy & legislation on ABS in China 1. Policies Related in China 中国相关政策

（ 1 ）国家知识产权战略纲要提出以下战略任务： The Outline of the National IP Strategy （ promulgated by the State Council on June 5, 2008 ）， put forward the following specific tasks 1 ）完善遗传资源保护、开发和利用制度，防止遗传资源流失和无序利用。协调遗传资源保护、开发和利用的利益关系，构建合理的遗传资源获取与惠益分享机制。保障遗传资源提供者知情同意权。 1 ） Improve the protection, exploration and utilization of genetic resources, preventing the loss and abuse of genetic resources. Coordinating the relationship of the protection, exploration and utilization of Genetic Resources, and establishing a reasonable mechanism of Access to Genetic Resources and Benefit Sharing. Guarantee the rights of awareness and consent of the providers of Genetic Resources .

二、中国在遗传资源获取与惠益分享方面的政策与立法现状 Present status for policy & legislation on ABS in China 1. Policies Related in China 中国相关政策

（ 1 ）国家知识产权战略纲要）（ 2008 年 6 月 5 日由国务院发布），提出以下战略任务： The Outline of the National IP Strategy （ promulgated by the State Council on June 5, 2008 ）， put forward the following specific tasks 2 ）建立健全传统知识保护制度。扶持传统知识的整理和传承，促进传统知识发展。完善传统医药知识产权管理、保护和利用协调机制，加强对传统工艺的保护、开发和利用。 2 ） Construct a comprehensive IP system. Support the compilation and passing-down of traditional knowledge, and promote the development of TK. Improve the coordinative mechanism of the management, protection and utilization of traditional pharmaceutical intellectual property, and strengthen the protection, development and utilization of traditional arts and crafts.