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

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.

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 相关政策 （ 2 ）《全国生物物种资源保护与利用规划纲要》的要求 《 The Outline of National Biological Species Resources Conservation and Utilization Plan 》（ Approved by the state council on Oct. 2007 ） 优先行动六：建立生物遗传资源获取与惠益分享法规制度体系 优先项目 1 ：研究传统知识定义，制定重要传统知识保护名录，并制定生物资源与 传统知识的知识产权保护制度； 优先项目 2 、研究并建立专利申请中要求披露遗传资源来源地证书制度； 优先项目 3 、建立处理遗传资源和相关传统知识的机构和信息交换机制； 优先项目 4 、研究生物遗传资源和传统知识保护数据库的建设，制定遗传资源及相 关传统知识保护名录。 Priority action 6: establish legal system on the acquirement and benefit sharing of biological genetic resources and associated TK. Priority project 1 ： study the definition of TK, formulate protection list of important TK, and establish the protection system of biological resources and TK. Priority project 2: study and establish a system of requiring the disclosure of the origin of genetic resources and certificate in patent application Priority project 3: establish organizations on processing biological genetic resources and associated TK, and a mechanism of information exchange.

Priority project 4: Study on the construction of protection database of biological genetic resources and TK, formulate protection list of genetic resources and associated TK.

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 相关政策 （ 3 ）《中国生物多样性保护战略与行动计划》 (2010-2030) （最近将由国务院常务会议批准并发布） CNBSAP 《 National bio-diversity protection strategy and action plan 》（ to be enacted in 2010 ） (CNBSAP) 4.2 战略方针（ Strategic policy) 中国生物多样性保护的战略方针是：“保护优先，持续利 用 , 全民参与，惠益共享”。 National strategic policy on biodiversity in China: Conservation first compared with development, sustainable use, public participation and benefit-sharing

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 （ 3 ） CNBSAP 战略任务 (Strategic tasks) 4.4.5 实现遗传资源及相关传统知识的惠益共享

（ 1 ）建立遗传资源获取与惠益分享制度 建立适合中国基本国情的遗传资源及相关传统知识管理政策体系，包括申请专利时要求披露遗 传资源及相关传统知识来源，在获取遗传资源时遵守“事先知情同意”程序，并以共同商定的 条件公平分享惠益。 （ 2 ）保护和传承与生物多样性相关的传统知识 研究传统知识保护的特殊性，加强对与生物多样性相关的传统知识的调查、整理、编目，并建 立相应的数据库，抢救性地保护、维持、传承与生物多样性保护和可持续利用密切相关的传统 知识。建立传统知识保护特殊制度，并开展保护试点与示范。 4.4.5 To realize the fair and equitable benefit sharing for use of genetic resources To establish relevant policies that are in conformity with national conditions; besides the requirement of origin disclosure in patent application, there is also the requirement to follow the principle of prior informed agreement, so that the benefit can be shared on MAT To protect and maintain the TKs associated with GR. To enhance the survey, registration, documentation and database establishing for TK in China, especially in minority areas. To study and establish the sui generis for TK protection, and conduct the demonstration for benefit-sharing of TK

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

2 、相关法规 Relevant laws and regulations （ 1 ）新修改的《专利法》（ 2009 年 10 月 1 日起生效） Newly revised 《 Patent Law 》（ Entered into force on Oct 1, 2009 ） 第 5 条：对违反法律、行政法规的规定获取或者利用遗传 资源，并依赖该遗传资源完成的发明创造，不授予专利权 。 Article 5: inventions violating laws, social morals, and damaging public interest will not be granted a patent right.

Inventions created on the genetic resources illegally acquired or utilized will not be granted a patent right.

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

2 、相关法规 Relevant laws and regulations （ 1 ）新修改的《专利法》（ 2009 年 10 月 1 日起生效） Newly revised 《 Patent Law 》（ Entered into force on Oct 1, 2009 ） 第 26 条：依赖遗传资源完成的发明创造，申请人应当在 专利申请文件中说明该遗传资源的直接来源和原始来源； 申请人无法说明原始来源的，应当陈述理由。 Article 26: for inventions and creations made on genetic resources to apply patents, the applicant shall clarify the direct resources and origin of the genetic resources; if the applicant cannot clarify the origin, an explain shall be

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

2 、相关法规 Relevant laws and regulations （ 2 ）畜牧法（ 2005 ）首次提出“惠益共享” 《 Animal husbandry law 》（ enacted on Dec. 2005 ）， Put forward the concept of benefit sharing for the first time. 第 16 条：向境外输出或者在境内与境外机构、个人合作研究利用列入 保护名录的畜禽遗传资源的，应当向省级人民政府畜牧兽医行政主管 部门提出申请，同时提出国家共享惠益的方案；受理申请的畜牧兽医 行政主管部门经审核，报国务院畜牧兽医行政主管部门批准。 Article 16: for private export and cooperation with foreign organizations, the utilization of animal and poultry resources in the protection name list, the user shall apply husbandry administration department at the provincial level, and provide a measure of benefit sharing at the same time.

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

2 、相关法规 Relevant laws and regulations （ 3 ）《中华人民共和国畜禽遗传资源进出境和对外合作研 究利用审批办法》 （ 2008 年 10 月 1 日生效） 该《审批办法》对畜禽资源获取的条件和惠益分享提出 了更为具体的内容。 （ 3 ）《 The Measures of the People’s Republic of China for the Examination and Approval of Entry & Exit and the Foreign Cooperative Research on the Application of Genetic Resources of Livestock and Poultry 》（ entered into force on Oct 1, 2008 ）。

It prescribed the conditions for access to livestock genetic resources and the contents of benefit sharing more specifically.

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

3. 相关的管理与协调机制 Related Administration and Coordination （ 1 ）生物物种资源保护部际联席会议（环境部牵 头 , 国务院 17 个部委参加） Inter-Ministerial Joint Conference for the protection of species resource, headed by MEP and participated by 17 ministries. （ 2 ）中国履行《生物多样性公约》协调机制（ 24 个部门参加，环境部牵头） Coordination mechanism on the implementation of CBD, joined by 24 sectors and headed by MEP

三、中国实施 ABS 国际制度的问题与挑战 Problems & challenges for ABS-IR implementation 1. 与其他国际公约的协调 The relationship between ABS Protocol and other Conventions. 在 2010 年 7 月召开的 ABS 工作组第 9 次会议的续会上，对 CBD 与其他公约的关系进行了深入的讨论。 ING 会议倾向于 以下意见： ABS 议定书的任何内容不得妨碍缔约方制定和实 施其他相关的国际协议，包括其他行业的 ABS 协议， ABS 议定书与其他相关国际协议应以相互支持的方式执行，而不 是违背 CBD 和 ABS 协定书的目标。 the protocol and other relevant international instruments shall be implemented in a mutually supportive manner; and where a specialized international ABS instrument applies that is consistent with and does not run counter to the CBD and protocol objectives, the protocol does not apply for the parties to the specialized instrument in respect of the specific genetic resource covered and for the purpose of the specialized agreement.

三、中国实施 ABS 国际制度的问题与挑战 Problems & challenges for ABS-IR implementation 1. 与其他国际公约的协调 The relationship between ABS Protocol and other Conventions. 与未来《 ABS 议定书》相关的其他国际公约主要有： FAO 下 的《农业与粮食植物遗传资源国际条约》（ ITPGRFA, 中国目 前尚不是缔约方）、 WTO 下的《与贸易相关的知识产权协定 》、世界知识产权组织下的相关公约、国际新品种保护公约、 以及《联合国海洋法公约》、《南极条约》等。中国也是这些 公约和协定的缔约方，公约之间是平行关系，中国必须协调这 些关系。 The other related conventions are mainly ITPGRFA under FAO (China now is not the Contracting Party), Trade-Related Aspects of Intellectual Property Rights (TRIPS) under WTO, the agreements under WIPO, UPOV, United Nations Convention on the Law of the Sea (UNCLOS), Antarctica Treaty and so on. China is also the contracting parties for those conventions, so a coordination between the conventions seems necessary.

三、中国实施 ABS 国际制度的问题与挑战 Problems & challenges for ABS-IR implementation 2. 国内法规尚不健全 现有的法规很少提及“获取与惠益分享”问题，中国至 今尚没有一部专门处理 ABS 问题的法规。 虽然《专利法》第 5 条规定，对非法获取的遗传资源不 授予专利，但是实际上确定是否合法的法律尚不存在。 因此，《专利法》只有在 ABS 法律制定后才能真正生 效 ABS concept is just presented in a few the current laws and regulations, and China has no special law or regulation to deal with ABS issues specially.

Though the Article 5 of “Patent Law” requested to award the patents just to the legal sources of genetic resources, actually there is no special regulation to determine it is legally accessed or not legally accessed. Therefore, the Patent Law can be really used just after the ABS regulation has been

三、中国实施 ABS 国际制度的问题与挑战 Problems & challenges for ABS-IR implementation 3. 如何处理历史上的获取与惠益分享 中国有许多物种早在数百年前就已被国外获取，如中国的花 卉在欧洲许多国家的植物园和美国的基因库里都有收集、保 存与利用，但是如何追溯这些物种的惠益分享是一个难题。 中国是传统知识特别丰富的国家，中国的许多中医药传统知 识已在历史上公开发表，日本、南韩等根据这些传统知识开 发出许多新药，并取得专利和利润，中国如何与他们分享惠 益？ Many species were accessed before 100 years and collected in a lot of botanical gardens in European countries and US, but how to share the benefits with them?

China is rich in TK and many TCM prescriptions are used by pharmaceutical enterprises in Japan and South Korean who accessed the TCM books long time ago. But the TK provider has no any BS.

三、中国实施 ABS 国际制度的问题与挑战 Problems & challenges for ABS-IR implementation 4. 如何从生物资源的贸易中公平分享惠益 How to share the benefit equitably from the trade of medicinal materials 中国与欧洲的制药企业存在大量的原材料贸易，中国以相当 低的价格出口大量药材，而欧洲药商则利用专利，获得大量 利润，这种不公平的贸易有时还加剧了中国国内的生物多样 性破坏，例如，中国每年出口数千吨甘草，加剧了中国西北 地区的荒漠化，因为当地农民过度采挖甘草。如何纠正这种 不公正的贸易也是难题之一。 There is a large trade between China and pharmaceutical companies on medicinal materials. China sales the materials in a very low price, but the pharmaceutical companies make large profits by patents. This is a unfair trade and may result in environmental damage. For instance, China exports a lot of liquorice but it results in desertification in the northwest region of China. How to get more benefits from the unfair trade is big challenge.

三、中国实施 ABS 国际制度的问题与挑战 Problems & challenges for ABS-IR implementation 5. 许多术语和定义的困难 The difficulties in definition 在 ABS 议定书的谈判中，衍生物如何定义，这直接关系到 ABS 议定书的适用范围，甚至关系到 ABS 议定书的谈判能 否成功。对于衍生物如何定义以及 ABS 议定书范围是否包含 衍生物，中国与欧盟的观点大相径庭。 对于传统知识的定义也没有统一的标准，这对于国际立法和 国家立法都不利。中国（或我本人）已提出对生物多样性相 关传统知识的定义和分类，但是如何与国际接轨还有困难。 It is a problem for definition of “derivatives” during the ABS IG’s negotiation, because it is related to the scope of ABS Protocol and the scope is a key issue for success of the negotiation. China is much different with EU for derivative Another important definition is TK. There is no any uniform definition for TK, so it is not good for ABS legislation both in international level and national level. Now China (or myself) proposed the definition and classification system for TK, but how to get international recognition is a real challenge.

三、中国实施 ABS 国际制度的问题与挑战 Problems & challenges for ABS-IR implementation 6. 在确定原产地方面存在技术上的挑战 The technical challenge for identification of “origin” 区分“原产地”不是一件容易的事，有时存在技术上的困难。例如，中国 进口欧洲的花卉产品，在中国市场上有许多切花来自欧洲，但是，实际上 欧洲的许多花卉也存在中国的遗传资源，早年从中国引至欧洲的许多花卉 ，在欧洲现有切花的育种开发中发挥了作用，欧洲花卉中含有中国花卉的 血统，这发生在几十年乃至几百年的育种研究中，技术上较难确定。还有 中国引至欧洲的鸡、猪和牛等家畜禽，也有类似的情况。例如北京烤鸭使 用的“樱桃谷”，是中国花大量欧元从英国引进的一个鸭品种。但这种鸭 含有北京鸭的基因，是英国人用引入的北京鸭与当地鸭杂交后形成了“樱 桃谷”。 Identification of “origin” has technical difficulties. For example, a lot of flower products in China’s markets are introduced from European countries, such as from Dutch, but this flowers include genes from Chinese flowers which were introduced by European people many years ago. Another example is Beijing duck. Now Many Beijing toast duck is actually a duck variety introduced from UK, called “Cherry Valley”. It is the hybrid offspring of the local duck with Beijing Duck introduced from Beijing 100 years ago by England people.

三、中国实施 ABS 国际制度的问题与挑战 Problems & challenges for ABS-IR implementation 7. 在确定“原产地”方面可能存在争端 The disputes are existing in multiple “origins” 有的物种不是一个中国特有，而是分布于多个国家，特别是在边境地区， 这时惠益分享可能需要在几个国家之间协商，使获取与惠益分享的处理更 加复杂。如果处理不好，可能会发生争端。 不仅物种可能有多个原产地，传统知识也可能出现多个拥有者，例如，中 国的传统知识可能也是印度的传统知识。不久前发生一个故事，即：欧洲 专利局取消了早些时候授予中国制药企业（丽珠集团）的禽流感药物专利 ：药用薄荷和穿心莲用于 H5N1 禽流感药物。因为印度政府提出异议，称 用薄荷和穿心莲治疗流感及其他传染发热是印度的传统知识，已有很长的 历史。然而，中国利用这两种药物也有上千年和历史。 Some species are not endemic and may be distributed in several countries. This may result in dispute for benefit sharing because the origin identification is more complicated.

TK are also complicated for multi-owners. China’s TK may owned by Indian. For example, European Patent Bureau cancelled a patent of H5N1 awarded to a Chinese pharmaceutical company, made from mint and Andrographis paniculata, because Indian government said that these medicines have been used in India for many years as a TK. There is an agreement between India and EU Patent Bureau, i.e. EPB couldn’t issue patent to the medicines which were recorded in the Indian TK Digital Database. But this TK has existed in China more than 1000 years.

三、中国实施 ABS 国际制度的问题与挑战 Problems & challenges for ABS-IR implementation 8. 中国人对知识产权保护的意识普遍不强 Chinese people have lower awareness for IPR 印度已经完成了 TK 数字化图书馆，并在五年前就制定和实施了《 生物多样性法》，这部法律包含了 ABS 的内容。印度还成功地打 了几场官司，让美国的生物技术公司撤销了专利，因为印度提供了 证据，说这些传统知识在印度早已有记录。 尽管中国的古代医药著作早就有就种描述，但是中国没有这样的数 字图书馆，也没有与欧洲专利局签订这类协议。说明中国人的知识 产权意识较弱，而印度在遗传资源和相关传统知识保护方面的意识 比中国至少领先 10 年。 India has completed the TK digital database and this country formulated “Biodiversity Act” in five years ago. This Act includes ABS provisions. India has also succeeded in lawsuits for TK IP and cancellations of several patents owned by US companies, because India provided record evidences that India people have used the TK for long time.

China has many medicinal books but China has no TCM digital database. Of course China has not sign agreement with EPB. So, Chinese awareness for IPR is behind of Indian at least 10 years.

三、中国实施 ABS 国际制度的问题与挑战 Problems & challenges for ABS-IR implementation 9. 土著与地方社区的认定 Challenges in ILCs’ identification 中国是否存在土著人民？如何理解 CBD 和 ABS 议定书 中提及的“土著与地方社区” ? 中国的许多少数民族地 区至今依然保留了传统生活方式和生产方式，他们具有 部分土著的特征。 如何确定接受惠益的民族及社区，中国有许多民族，分 布有许多分支，传统知识由谁创造，谁是拥有者，如何 分配其惠益？如何进行 PIC & MAT Can the “indigenous” be used in China? How to define the ILCs in China? Some minority areas are kept traditional living and they have characteristics of ILC. How to allocate the benefits among the ILCs? How to identify the ethnic groups who are beneficiary from the use of GR and TK, as there are many branches.

四、遗传资源公平惠益分享领域与欧盟的合作前景 Potential cooperation with EU in ABS issue 1. 建立与欧盟的 ABS 合作研究计划 -- To establish the research cooperation projects with EU 中国与欧洲在物种及遗传资源的交流方面已有很长历史，并存在 千丝万缕的联系。早在 200 年前，就有欧洲的科学家在中国进行 科学考察和标本采集，中国现有物种的定名人多半是欧洲人，中 国许多植物的模式标本都保存在欧洲的植物园和标本馆，欧洲的 植物园保存有许多中国的植物。 可以开展一个中欧植物标本调查与研究计划。这个研究主要是查 清欧洲植物园、树木园引自中国的植物，还有欧洲主要标本馆保 存记录的中国物种。这个本底调查与研究的数据可以为将来实施 ABS 议定书提供技术支撑。 There is a close relationship between EU and China in exchange of genetic resources. Many European scientists worked in China even 200 years ago for species introduction and specimen collection, and many model specimen were kept in European botanical gardens To establish a Sino-EU Research Program on ABS. The first task of this research program is to investigate the living species and specimen maintained in European botanical gardens.

四、遗传资源公平惠益分享领域与欧盟的合作前景 Potential cooperation with EU in ABS issue 2. 进行 ABS 立法的中欧合作研究 Cooperation research with EU on domestic ABS regulations. 中国正在进行 ABS 国家立法的研究，这部法规将主要用于 处理和规范中国与欧洲国家和与美国等国家之间的遗传资源 获取与惠益分享事务。为了更好地使此法规更好地适用于欧 洲，欧盟可以参加中国 ABS 立法的研究，并与中国专家一 起，共同研究建立中国 ABS 政策体系、法规及制度体系。 欧洲专家将负责提供欧洲对遗传资源保护和知识产权保护方 面的经验及相关建议。 China is underway for ABS legislation, which will be mainly used to deal with the ABS affairs between China and EU countries, as well as USA, Japan and other developed countries. To let the Protocol be practical and suitable to EU, we welcome EU experts to join our research, working at establishment of ABS policies, regulations and regime system. Also EU experts can introduce EU’s experience on IPR protection and propose suggestions for our drafting work on ABS.

四、遗传资源公平惠益分享领域与欧盟的合作前景 Potential cooperation with EU in ABS issue 3. 需要加强的工作

Work needs to be enhanced

在国家和地方水平上建立传统知识特殊制度 Conduct research and develop the sui generis on traditional knowledge (TK) at national and local level. 建立《非物质文化遗产保护条例》和《中医药传统知 识知识产权保护条例》、 Some regulations are needed, such as the Regulation for protection of immaterial cultural heritage, and the regulation for protection of IP for traditional Chinese medicines. 地方立法也很重要，特别是在贵州、云南等民族地区 Local legislation in some minority provinces are also important, such as in Guizhou and Yunnan province.

四、遗传资源公平惠益分享领域与欧盟的合作前景 Potential cooperation with EU in ABS issue 4. 开展 ABS 制度相关的基础研究与示范 To conduct basic research and demonstration （ 1 ）开展有关遗传资源主权、所有权和使用权的理论与实践的 研究 （ 2 ）开展对遗传资源及相关传统知识的调查、收集、整理、数 据库建设等方面的研究 （ 3 ）对获取与惠益分享制度进行实施示范。 （ 1 ） The theoretical and practical research on the sovereignty, ownership and the right to use of genetic resources and IP.

（ 2 ） The investigation, collection, documentation and database construction of genetic resources and associated traditional knowledge （ 3 ） Pilot demonstration on Access and Benefit Sharing.

四、遗传资源公平惠益分享领域与欧盟的合作前景 Potential cooperation with EU in ABS issue 5. 加强 ABS 制度实施的国家能力建设 To enhance the national capacity building for ABS regime’s implementation （ 1 ）建立 ABS 国家联络点与主管部门 （ 2 ）建立 ABS 制度的人员培训机制，培训大量专业人员 （ 3 ）开展 ABS 制度的宣传和公众教育 （ 4 ）建立 ABS 资料交换所机制和信息体系 （ 5 ）加强 ABS 的国际合作（与欧盟） （ 1 ） To establish the national ABS focal point and competent authorities.

(2) To set up the ABS training system (3) To conduct ABS publicity and public participation (4) To build the Clearing house for ABS information (5) To enhance international cooperation with EU in ABS capacity building in both national and local level.

谢谢！ Thanks !