Summary report, 4–8 October 1999
Experts’ Panel on Access and Benefit-Sharing
The Experts’ Panel on Access and Benefit-Sharing met from 4-8 October 1999 in San José, Costa Rica. The meeting, co-hosted by the Governments of Costa Rica and Switzerland, with additional funding from Norway, drew together 58 experts representing governments, international organizations, academic institutions, NGOs, representatives of local and indigenous communities, and the private sector. Over the course of the meeting, experts focused their discussions on four substantive items: access and benefit-sharing arrangements for scientific and commercial purposes; review of legislative, administrative and policy measures at national and regional levels; review of regulatory procedures and incentive measures; and capacity building as a cross-cutting issue. The Panel resulted in a set of recommendations, including general conclusions as well as specific points on prior informed consent (PIC), mutually agreed terms (MAT), information needs and capacity building. These conclusions, as well as the Panel’s report, will be forwarded to the fifth Conference of the Parties (COP-5) to the Convention on Biological Diversity (CBD) to be held in Nairobi, Kenya, in May 2000.
A BRIEF HISTORY OF THE CBD AND ACCESS AND BENEFIT-SHARING
The Convention on Biological Diversity (CBD), negotiated under the auspices of the United Nations Environment Programme (UNEP), was opened for signature on 5 June 1992 and entered into force on 29 December 1993. To date, 175 countries have ratified the Convention. The three goals of the CBD are to promote the conservation of biodiversity, the sustainable use of its components, and the fair and equitable sharing of benefits arising from use of genetic resources. The Convention contains provisions on access to genetic resources and the sharing of benefits arising out of their use. These are contained in Article 15 (access to genetic resources), Article 16, paragraph 3 (access to and transfer of technology that makes use of genetic resources), and Article 19, paragraph 1 (participation in biotechnological research on genetic resources) and paragraph 2 (access to results and benefits from biotechnologies). These provisions address both users and providers of genetic resources. According to its medium-term programme of work, the Conference of the Parties (COP) to the CBD considered access and benefit-sharing (ABS) at its second, third and fourth meetings.
COP-2: In Decision II/11, the COP, meeting in Jakarta, Indonesia, in November 1995, requested the Executive Secretary of the CBD to further elaborate a survey of measures taken by governments to implement Article 15.
COP-3: At its third meeting in Buenos Aires, Argentina, in November 1996, the COP considered a compilation of views from Parties on possible options for developing national legislative, administrative or policy measures, as appropriate, to implement Article 15. In its Decision III/15, the COP urged governments to submit relevant information on possible elements for guidelines and other measures for the implementation of Article 15. Based on this and other COP-3 decisions, the Executive Secretary called for case studies on ABS mechanisms in order to prepare a synthesis of such experiences for COP-4.
COP-4: At its fourth meeting in Bratislava, Slovakia, in May 1998, the COP addressed matters related to benefit-sharing, including: measures to promote and advance the distribution of benefits from biotechnology in accordance with Article 19 (handling of biotechnology and distribution of its benefits); means to address the fair and equitable sharing of benefits arising out of the use of genetic resources; and the compilation of Parties’ views on possible options for developing national legislative, administrative or policy measures, as appropriate, to implement Article 15.
In Decision IV/8, the COP decided to establish a regionally balanced Panel of Experts on ABS, to be appointed by governments and composed of representatives from the private and public sectors, as well as representatives of indigenous and local communities. The mandate of the Panel was designated to draw upon all relevant sources, including legislative, policy and administrative measures, best practices and case studies on access to genetic resources and benefit-sharing arising from the use of those genetic resources, including the whole range of biotechnology, in the development of a common understanding of the basic concepts, and to explore all options for access and benefit sharing on mutually agreed terms, including guiding principles, guidelines and codes of best practices for ABS arrangements. In Decision IV/16 on institutional matters and the programme of work, the COP decided to include access to genetic resources as one of the topics for in-depth discussion at COP-5 in May 2000 and to hold a preparatory discussion on access to genetic resources at the June 1999 Intersessional meeting on the Operations of the Convention (ISOC).
ISOC: The ISOC convened in Montreal, Canada, from 28-30 June 1999, immediately following the fourth session of the CBD’s Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA). ISOC delegates conducted preparatory discussions on access to genetic resources and benefit-sharing arrangements to provide guidance to COP-5 and contribute to preparations for the Expert Panel; discussed recommendations to COP-5 for future work on ex situ collections acquired prior to the CBD’s entry into force; made recommendations for future work to develop a common appreciation of the relationship between intellectual property rights (IPR) and relevant provisions of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs); and made recommendations for the preparations, composition and agenda of the Expert Panel on ABS. Regarding the latter, the ISOC recommended that the Panel should consider the following agenda items: ABS arrangements for scientific and commercial purposes; review of legislative, administrative and policy measures at national and regional levels; review of regulatory procedures and incentive measures; and capacity building. The ISOC recommended that the Panel should also consider in its discussions: identification of benefits arising out of the use of genetic resources in different sectors; identification and review of mechanisms currently used to share benefits; the need for new and improved measures for the sharing of benefits and the implementation of such measures; and the facilitation of access.
REPORT OF THE EXPERT PANEL
Editor’s Note: While participating experts are appointed by governments, they speak in their own capacities. For the purpose of brevity, experts’ remarks are attributed by country.
On Monday, 4 October, CBD Executive Secretary Hamdallah Zedan welcomed participants to the Panel and thanked the Governments of Costa Rica and Switzerland for co-hosting the meeting. He noted the importance of the Panel for furthering efforts to implement the CBD’s provisions on access and benefit sharing and said it provides an opportunity to explore basic concepts and options for access and benefit sharing on mutually agreed terms, including guiding principles, standards, codes of conduct and best practices. He underlined that the Panel was not a negotiating exercise but a meeting of experts to define concepts and ways and means to put them into practice with respect to the CBD.
Rodolph Imhoof, Ambassador of Switzerland to Costa Rica, emphasized that this joint initiative between the Governments of Costa Rica and Switzerland would provide significant contributions to establishing guidelines for access to genetic resources and benefit-sharing.
Walter Niehaus, Costa Rican Vice-Minister of Foreign Affairs, emphasized the importance that Costa Rica places on biodiversity conservation, noting that one-third of its national territory is protected. He stressed the need to improve legally defined policies to protect biodiversity resources and highlighted the recently adopted Costa Rican Law on Biodiversity. He called for dialogue between all stakeholders and emphasized the role of the private and public sectors, intermediary institutions and local communities in bringing about consensus on ABS.
Carlos Manuel Rodriguez, Interim Costa Rican Minister of Environment and Energy, noted that the issue of benefit-sharing and access to genetic resources is one of the most important aspects of biodiversity conservation, and highlighted the need to adopt guidelines in order to control access to these resources. He underscored the need for better defined codes and models, both ethical and legal, to address ABS issues.
The Plenary then elected Jorge Cabrera Medaglia (Costa Rica) and Martin Girsberger (Switzerland) to serve as Co-Chairs of the Panel and Maureen Wolfson (South Africa) to serve as Rapporteur. The Plenary adopted the provisional agenda (UNEP/CBD/EP-ABS/1/1), as presented by Jo Mulongoy of the CBD Secretariat. Co-Chair Medaglia then asked experts to detail issues to be considered in the working groups. Several experts, including NORWAY, PERU and the US, underscored the need to clarify what the Panel is expected to produce. INDIA underscored the need to address: the definitions of PIC and MAT; the promotion of disclosure of country of origin; the transaction costs of regulatory procedures; and the promotion of equitable benefit-sharing with specific attention to technology transfer. The RUSSIAN FEDERATION emphasized addressing contractual agreements and codes of conduct and the definition of genetic resources. PERU emphasized the need for legal certainty for PIC and MAT. FRANCE called for the consideration of IPR and how they impact biodiversity. KENYA called for consideration of when benefits accrue, when they become shareable and who will share the benefits. ETHIOPIA suggested that the Panel should provide recommendations to guide national implementation of the CBD.
The Plenary decided to first divide into four working groups for initial brainstorming sessions. Each group considered one of the Panel’s four substantive topics: ABS arrangements for scientific and commercial purposes; review of legislative, administrative and policy measures at national and regional levels; review of regulatory procedures and incentive measures; and capacity building. The following day experts agreed to establish two working groups, one to address ABS arrangements for scientific and commercial purposes and the other to consider the review of legislative, administrative and policy measures at national and regional levels, regulatory procedures and incentive measures. They also agreed to consider capacity building as a cross-cutting issue in both of these groups. As had been suggested by some participants in the opening Plenary, an open-ended sub-group on IPR was established on Wednesday afternoon by the working group addressing the review of legislative, administrative and policy measures.
INTRODUCTION OF SUBSTANTIVE ITEMS: A.H. Zakri, University of Malaysia, introduced the item on ABS arrangements for scientific and commercial purposes. Zakri noted that the Panel should review and evaluate examples of existing contractual arrangements for access to genetic resources, including types of benefits that may be shared, types of mechanisms for sharing benefits, and the range of potential beneficiaries. He also distinguished between monetary benefits, including up-front payments, royalties and bioprospecting fees, and non-monetary benefits, including participation of nationals in research activities, support for conservation activities and information exchange.
Kerry ten Kate, Kew Royal Botanical Gardens, outlined the review of legislative, administrative and policy measures at national and regional levels. She emphasized the importance of voluntary measures, such as common policy guidelines. She also noted the importance of the consolidation of collecting activities, the growing role of intermediaries, recourse to ex situ collections, material transfer agreements and legal acquisitions of samples. On future scenarios, she highlighted the need for simple access laws, distinction between scientific and commercial use, and policies, guidelines and codes of conducts. In closing, she suggested that the Panel consider, inter alia, a few, strong recommendations for COP-5, options for ABS, lessons learned, and calls for information.
José Carlos Fernández Ugalde, El Colegio de la Fontera Sur (ECOSUR), introduced the review of regulatory procedures and incentive measures. He stressed that the efficiency of mechanisms should be the focus of the Panel’s discussions. He also highlighted the significance of material and social costs for enforcement of access regulations and said restrictive regulations would lead to high administrative costs and promote illegal transfers, thus inhibiting implementation of the Convention’s objectives. He underlined the need for simplicity and clarification of the issues to facilitate understanding among all relevant stakeholders, as well as for compatibility at local and national levels, particularly in issues dealing with PIC and fair and equitable benefit-sharing.
Estherine Lisinge Fotabong, WWF Cameroon, highlighted capacity-building needs and stressed the importance of partnerships between providers and users of genetic resources at all levels. She noted that for benefit-sharing provisions to work effectively, actions must be tailored not only to support the States and their indigenous and local communities supplying genetic resources, but also the users of the resources. On legislative and policy frameworks, she noted the need for improved capacity in legal drafting, negotiations and contracts at the government, community, NGO and private sector levels. She also emphasized the need to develop capacities for biological assessment and inventories so that provider countries have the ability to assess and evaluate biological and genetic resources. She added that a database of genetic resources is essential and that specific capacity needs should include taxonomy, storage, cataloguing and inventory management. On institutional capacity, Fotabong noted that specific country needs include institutional analysis and legal drafting, institutional and financial strengthening, information and awareness-raising, and technology transfer. She said efforts to develop national capacities to regulate access to genetic resources should focus on information systems, education, training, funding and mediation.
ACCESS AND BENEFIT-SHARING ARRANGEMENTS FOR SCIENTIFIC AND COMMERCIAL PURPOSES
The working group on ABS arrangements for scientific and commercial purposes, chaired by A.H. Zakri, met on Tuesday and Wednesday. The group approved its report on Wednesday, and the report was considered in Plenary on Thursday.
MUTUALLY AGREED TERMS AND CONTRACTUAL APPROACHES: Experts noted that negotiating MAT and contractual arrangements can be very time-consuming and cited difficulties encountered, such as completed contracts becoming invalid due to discoveries that certain parties lack authorization to negotiate contracts for commercial use. Experts emphasized the importance of identifying the proper authorities to approve contracts and of developing standardized procedures for achieving MAT to expedite the negotiation process. It was also emphasized that all MAT and contractual agreements should address IPR, the possibility for commercial use and benefit-sharing arrangements. Experts stressed the importance of legal certainty and the need to differentiate between research and commercial uses. Experts expressed concern that highly regulatory access regimes could increase the costs of negotiating MAT, inhibit scientific research and deter users from seeking genetic resources. Experts agreed on the importance of involving stakeholders, especially indigenous and local communities, in the process of negotiating contracts and called for capacity building to this end as well as for making information on users available to providers.
Opinions varied on the need for confidentiality of MAT contracts. While several experts stressed the need to make information publicly available to ensure equitable benefit-sharing, others underscored confidentiality for commercial purposes. Some felt that confidentiality should not be limited to commercial use. Opinions also varied as to whether the scope of MAT contracts should include derivatives of biological resources.
With regard to establishing benefit-sharing terms within a MAT contract, some experts were of the opinion that some type of benefit, monetary or non-monetary, would accrue as the result of access and thus, benefit-sharing should be ensured from the beginning. Experts noted difficulty in determining when scientific research could lead to commercial use and called for mechanisms to address this issue within MAT. It was suggested that patent applications could signify this transition. It was also noted that many parties may contribute to an end-product and that the potential complexity from involvement of additional parties should be taken into account when negotiating MAT.
Experts also noted that many countries are still in the early stages of developing ABS regimes and some suggested establishing interim solutions, such as codes of conduct. Experts also drew attention to unique aspects of genetic resources for food and agriculture and indicated that they should be treated differently from other genetic resources. Experts voiced broad support for technology transfer and capacity building for genetic resource assessment.
Final Report: The final report notes that the Panel identified contractual arrangements as the primary mechanism for ABS, but agreed that it would be premature for the COP to develop principles for contractual agreements. However, common understanding on some aspects of MAT and contractual agreements were achieved. The report, inter alia: states that legal certainty facilitates MAT and contractual arrangements; emphasizes that governments should define roles, ownership and authority to determine access; underscores the importance of balancing users’ confidentiality needs with stakeholders’ needs for transparency to ensure equitable benefit-sharing; and acknowledges that MAT contracts should include provisions on user obligations as set out in the CBD.
The report also notes that high transaction costs for obtaining genetic resources diminish the interest of users as well as the net value of providers, and identifies the following as tools for decreasing transaction costs: minimum terms in contractual agreements; umbrella arrangements allowing for repeat access under expedited arrangements; standardized MAT; and awareness of existing mechanisms. It highlights the valuable roles focal points or competent authorities could play in ensuring equitable MAT contracts, providing legal certainty and lowering transaction costs, and encourages governments to appoint such entities. The report also draws attention to the importance of stakeholder participation and calls for capacity building to enhance indigenous and local communities’ ability to negotiate MAT and to understand the value of their knowledge and practices in commercial terms. The report distinguishes genetic resources for food and agriculture as being, inter alia, essential for food security, and notes the need for specific treatment of these resources, such as by a multilateral regime.
The report further states that different resources and uses require different arrangements, and that while different uses can often be accommodated within one contract, it is important that commercial uses be anticipated at the outset. It acknowledges that benefits can arise from the commercialization of genetic resource derivatives and that, to ensure full benefit-sharing, contracts should not be restricted to only biological material. It also notes that research and development may involve numerous parties from different countries and that contractual agreements must anticipate this complexity and be aware of relevant agreements that may pre-date an agreement under negotiation. It acknowledges that many countries are still in the process of developing ABS regimes and calls for interim solutions.
The report underscores the need for: all stakeholders to be able to negotiate in order to achieve equitable MAT contracts; capacity building to develop skills and knowledge regarding all aspects of MAT; improved access to information, such as examples of contracts, codes of conduct and voluntary guidelines to assist the process of achieving MAT; and increased awareness about user institutions. It suggests that the CBD Secretariat could facilitate information availability through the CBD Clearing-House Mechanism and promote awareness on user institutions by compiling a list of institutions, companies and other relevant organizations using genetic resources, and encourages companies to provide information regarding the commercial details of ABS arrangements.
BENEFIT-SHARING OPTIONS AND MECHANISMS: Experts initially discussed concepts, definitions and clarifications of benefit-sharing options and methods. The need to identify the kinds of benefits that are to be shared as well as the beneficiaries was emphasized. Experts agreed to distinguish between monetary and non-monetary benefits. They highlighted the advantage of non-monetary benefits, such as their capacity to be tailored to stakeholders’ specific needs and circumstances at the local level. Input from local and indigenous communities helped specify this approach. One expert stated that supporting the continued vitality of traditional agricultural practices and integrated pest management as well as strengthening capacities for negotiating MAT would make a more sustainable contribution to the well-being of indigenous and local communities than short-term monetary benefits. Experts added that benefit-sharing arrangements must not interfere with existing traditional knowledge systems and contemporary innovations. Other experts noted that research should be carried out with regard to economic valuation of non-monetary benefits in order to increase their acceptance.
They also noted the distinction between the use of genetic resources for scientific and commercial purposes. Concerns were raised regarding the inherent difficulties with this distinction due to uncertainties in determining if and when scientific research would result in commercial use. Experts also discussed the complex array of collaborations that need to be reflected in benefit-sharing arrangements. Some pointed out that most bioprospecting projects involve more than one academic, governmental and industrial partner in multiple countries. They highlighted the need to monitor the implementation of benefit-sharing agreements and agreed that it needed careful consideration. They also expressed the need to bridge substantive information gaps on the part of source countries through the development of a roster of companies and institutions utilizing genetic resources. Experts discussed mechanisms to promote disclosure of the country of origin, such as user countries’ import regulations, certificates of origin, national focal point records, publications and patent applications. Experts also considered whether the country of origin should be the source of the species or the supplier of the sample. It was noted that country of origin relates to the origin of the sample. The need for further clarification of concepts contained within the CBD was expressed.
Final Report: The final report notes that benefits arising from the utilization of genetic resources can be monetary and non-monetary. Examples of monetary benefits include up-front payments, milestone payments, royalties, research funding, license fees and salaries. Examples of non-monetary benefits include, inter alia:
- participation of nationals in research activities;
- the sharing of research results;
- sets of voucher specimens left in national institutions;
- capacity strengthening for indigenous and local communities to negotiate MAT;
- reasonable access by nationals of countries of origin to duplicates or, as appropriate, originals of specimens deposited in international ex situ collections;
- reasonable access to technology and products resulting from agreements;
- protection of local existing applications of IPR; and
- capacity building for controlling bioprospecting methods, collection and monitoring of samples, and biodiversity monitoring.
The report states that other non-monetary benefits are often overlooked in benefit-sharing discussions, such as: biological inventories and taxonomy; contributions to local economies through “value-added” activities; public health benefits for source countries; institutional and personal relationships arising from ABS agreements and subsequent collaborative activities; and equipping and training of environment agencies to monitor access.
The report highlights that appreciation of the value of non-monetary benefits would increase if credible monetary values were placed on non-monetary benefits, and appreciation of the value of relative contributions in collaboration would also contribute to fair and equitable benefit-sharing. The report further emphasizes the importance of identifying and rewarding the beneficiaries according to their respective contributions to ensure fair and equitable benefit-sharing. It notes that benefits vary in the time of their delivery and that different beneficiaries desire benefits within different time-frames. In the case of local and indigenous communities, for example, payment of monetary benefits can have negative impacts on local values and cultures and thus benefit-sharing strategies could focus on non-monetary benefits. The report underscores the need to ensure that benefit-sharing arrangements do not restrict or interfere with existing traditional ecological and technological knowledge systems.
Noting that benefits, beneficiaries and specific conditions of different countries and communities vary, the report stresses that parties to ABS agreements should be allowed flexibility to negotiate fair and equitable benefit-sharing arrangements. It further notes that: trust funds are useful methods of employing monetary benefits while avoiding problems associated with direct cash payments to individuals or communities; joint ventures are innovative approaches deserving further study; international rosters of genetic resource users and market data companies should be established to help source countries play a more proactive role in identifying potential users and negotiating fair and equitable benefit-sharing terms; monitoring of ABS arrangements is complicated by their multi-party nature; and implementation of benefit-sharing terms of ABS agreements is simplified when provider country parties remain active partners in the research and development process.
REVIEW OF LEGISLATIVE, ADMINISTRATIVE AND POLICY MEASURES AT NATIONAL AND REGIONAL LEVELS, REGULATORY PROCEDURES AND INCENTIVE MEASURES
The working group on the review of legislative, administrative and policy measures, regulatory procedures and incentive measures, chaired by Lev Kalakoutskii (Russian Federation), met from Tuesday through Thursday, 5-7 October.
ACCESS LEGISLATION: Experts focused their discussions of access legislation on: the need to define the scope of genetic resources and related legislation; flexibility and clarity when regulating ABS; and capacity building.
Experts discussed the definition of genetic resources and its implications for access legislation. They observed that a number of definitions are contained in the Convention, but that broad concepts such as genetic resources and derivatives had no generally accepted definitions. Noting the importance of definitions for determining the scope of access legislation, they agreed that access legislation might best be limited to covering only genetic resources.
There was general agreement that flexibility in access legislation would facilitate the implementation of all three of the CBD’s objectives. Experts further agreed that it was difficult to determine appropriate international standards for access legislation and MAT. To balance the need for both flexibility and managed access, one expert suggested that indicators of benefit-sharing could provide a solution. Another agreed, noting that indicators could assist contracting parties without being regulatory or prescriptive. Experts raised concern that the concept of flexibility would be criticized at COP-5, where some developing countries might prefer more prescriptive approaches. One expert emphasized the need to address incentives for sustainable use of genetic resources to balance the concept of flexibility.
Capacity building was deemed to be essential if access legislation is to encompass PIC and MAT. Both users and providers of genetic resources were identified as requiring information regarding the terms of existing access legislation and who to contact about related issues. One expert emphasized that complete information was a precondition to MAT, given that potential contracting parties need to understand the benefits and problems associated with consent. Experts also discussed the importance of regional arrangements as an opportunity to share information and expand cooperation on ABS-related issues.
Final Report: This section of the final report emphasizes the need for access legislation to be designed with the CBD goals of conservation and sustainable use of biodiversity, as well as ABS, in mind. It notes that the Panel strongly endorsed the importance of preparing national strategies on ABS as part of national biodiversity strategies prior to developing legislative, administrative and policy measures on the same.
The report states that although contractual arrangements are presently the main mechanism for gaining access to genetic resources and delivering benefits, legislation is essential to ensure that contractual arrangements serve national policy goals and implement the ABS objectives of the CBD. Such legislation should be clear and simple to allow for flexibility and transparency and reduce transaction costs, and will need to be tailored to individual countries’ circumstances. It suggests that the COP may consider developing international guidelines or principles for such measures. Legislative, administrative and policy measures on access can only succeed in a broader legal framework or context, clarifying property rights, conservation and biosafety. Parties should ensure that national ABS legislation is consistent with existing international obligations and does not restrict or undermine their positions in ongoing international negotiations nor foreclose options.
The report states that genetic resources offer a suitable starting point for the scope of access legislation, although to ensure appropriate and efficient coverage in national legislation or other measures to regulate access, Parties may wish to consider the following aspects of scope: categories of genetic resources; geographical area; legal status; ex situ collections; and associated information, including the knowledge, innovations and practices of indigenous and local communities. The report notes that the Panel considered that requiring PIC for access to derivatives might prove counterproductive given the infinite range of existing or possible derivatives; however, it was stressed that derivatives intended for scientific and commercial use should be subject to the MAT of ABS arrangements from which they are derived. The Panel suggested further consideration of including PIC requirements for access to derivatives in existing access legislation.
The text reports the Panel’s observation that numerous definitions exist in CBD Article 2 (use of terms) and that, in order to promote a common understanding of these terms, those drafting access legislation should adopt such terms as they are found in the Convention. It also states that several other terms not appearing in the CBD need to be defined in access legislation. The Panel noted that since definitions often have implications that are not immediately apparent, it could be useful to invite a team of scientists and lawyers to comment on implications of definitions such as genetic resources, derivatives and country of origin.
Regarding flexibility, the report emphasizes that appropriate MAT of contractual agreements may vary according to scientific or commercial uses of genetic resources, and that if measures to regulate access are to facilitate ABS, different requirements for PIC and/or MAT may be needed for different uses and users. Therefore, there is a pressing need for flexibility in requirements for MAT in contracts, although the Panel felt that prescribing minimum standards for MAT would not achieve the necessary level of flexibility. Where specific benefits would not be prescribed in access legislation, numerous supporting measures, including indicators and guidelines, could assist Parties to ensure that MAT support fair and equitable benefit-sharing. Guidelines establishing standards for providers and users could assist Parties to supplement access legislation and support fair and equitable partnerships, and the Panel encouraged organizations to submit such guidelines to the CBD Secretariat. The report suggests that legislation under development consider and allow for the development of a multilateral system for ABS for plant genetic resources for food and agriculture, currently under negotiation at the FAO, and that Parties developing national legislation may include provisions for facilitated access to materials that are or may be covered under international agreements to which they adhere.
The report notes that access legislation will only be feasible and implementable if developed with the full participation of all to be affected. The awareness by all necessary stakeholders of the significance of ABS will need to be raised to facilitate their involvement in the development and implementation of access legislation. It emphasizes the need to build the capacity of institutions involved in administering access, including national focal points and other institutions with designated ABS functions, such as transfer of technology in taxonomy, facilitation of negotiations among stakeholders, and monitoring of ABS activities. It further states that governments, upon request and to the extent possible, should assist individuals and local communities and organizations whose consent is being sought.
The report notes that regional cooperation may help streamline access procedures internationally and promote capacity building through shared efforts. Where genetic resources are shared, regional cooperation in formulating legislative, administrative and policy measures and information exchange may help to ensure that providers do not undercut each other.
PRIOR INFORMED CONSENT: Experts devoted considerable attention to discussing the meaning and requirements of PIC. Experts highlighted the importance of flexibility in defining and applying PIC. One expert noted that, given the myriad uses of genetic resources and their derivatives, PIC procedures would need to be tailored for different uses. Some experts also stressed the need to distinguish between different types of users and providers of genetic resources.
The importance of developing national strategies for ABS were identified as a precursor for creating ABS legislation. To this end, experts focused attention on the need to establish national focal points for ABS. They identified focal points as an important means of realizing PIC and MAT involving indigenous and local communities in PIC procedures. One expert added that well-defined national focal points could help indigenous peoples gain information to access financial mechanisms, such as the GEF, and to strengthen their participation in PIC procedures.
The experts also discussed the importance of supporting capacity building for the implementation of PIC. They underscored the importance of procedures that would allow national focal points to grant PIC quickly and not inhibit research. Experts noted repeatedly the need to carefully target capacity building to support all stakeholders, including providers, intermediaries and users.
Final Report: The final report states that PIC must be sought adequately in advance to be meaningful for those seeking and those granting access; PIC should be based on specific uses for which consent can be granted; and those seeking access must provide sufficient information to enable potential providers to decide whether access should be granted and to monitor compliance with the terms for which consent is granted. It notes the possibility that the ultimate use and value of materials intended for research cannot be predicted when PIC is sought, and states that PIC should be granted based on the best current knowledge at the time access is granted and either clearly stipulate the permitted uses and require further PIC for changes or unforeseen uses, or ensure that MAT in PIC cover a broad enough range of circumstances to cover any possible future uses. Parties to ABS arrangements should make provisions for dispute resolution in MAT.
The report describes that the Panel considered that: Parties should create an educational document to demonstrate the variety of potential uses and their implications for the terms of PIC; Parties should raise awareness of donor agencies and research councils of the implications for their CBD work; and the COP may invite academies of science to raise awareness among their members on ABS issues.
The report states that: applicants for access should obtain the PIC as required by national law; PIC should provide applicants with legal certainty; and Parties should assist applicants for access in determining from whom consent is required. It notes that PIC may be required at the national or the sub-national level. The report further stresses that: PIC provisions of access legislation should be flexible enough to accommodate different types, sources and uses of genetic resources and allow for development of multilateral solutions on ABS; voluntary measures could be adopted by individual Parties, as appropriate, until full and clear access legislation is in place; and, in the absence of national access legislation, countries wishing to encourage users to access resources in accordance with the CBD’s objectives could consider identifying a body of guidelines, compliance with which would lead to presumed conformity with those objectives.
Concerning PIC and indigenous and local communities, the report notes that experience demonstrates the need for access legislation to recognize the rights of indigenous and local communities to determine access to resources on their territories and their knowledge, innovations and practices. Increasingly, countries adopting access legislation have commenced processes to develop sui generis legislation to define indigenous and local communities’ rights over such knowledge. The report highlights the Panel’s consideration that governments should urgently establish a national focal point to enable access applicants to learn from whom PIC is required, and to appoint competent national authorities on ABS, as appropriate, to have legal power to grant PIC and develop national procedures for ABS. The Panel urged the identification of such focal points’ and authorities’ capacity-building needs for the administration of procedures, including PIC, and the institution of appropriate capacity measures. Countries are called on to consult local community groups in establishing national procedures for ABS, since they could become agents that facilitate and control access for different uses and assist competent national authorities to monitor and evaluate impacts.
The report sets out international measures to support PIC, including user measures and voluntary guidelines. Regarding user measures, the report notes that national jurisdictions may impose certain limitations on implementation of PIC, and thus multilateral mechanisms to support PIC internationally may be needed. It proposes that Parties explore possible measures, regulatory or incentive-based, to support, in user countries, PIC requirements in provider countries. Parties may consider, inter alia, the following options: improved means for identification of the existence of prior art; monitoring IPR applications; development of mechanisms to control importation of genetic resources; certification schemes for institutions abiding by rules and on ABS; product approval and certification processes; a clearing-house mechanism; and establishment of processes for conflict resolution and arbitration concerning ABS. Regarding voluntary guidelines, including for ex situ collections, the report states that Parties should support the development of international guidelines regarding access to genetic resources and benefit-sharing to ensure consistency with the CBD’s objectives, and thus should study available initiatives such as the common policy guidelines for botanical gardens, the MOSAIC Code of Conduct for culture collections, and the FAO Code of Conduct for Collection and Transfer of Plant Germplasm.
INTELLECTUAL PROPERTY RIGHTS: Experts discussed the role of IPR in PIC, traditional knowledge, contractual agreements and scope with regard to genetic resources. They also considered potential benefits and conditions of IPR with respect to PIC; how IPR could facilitate PIC; tools for transparency; the need for monitoring of patent applications; and incentives for the private sector to seek PIC. Recognizing that traditional knowledge represents innovation and creativity that should be protected, many experts emphasized the need to define and further document traditional knowledge, as well as to protect sui generis systems. One also recalled the importance of prior art, a provision preventing patents on discoveries already in practice, particularly with regard to traditional knowledge. Experts repeatedly emphasized that IPR is not sufficient for protecting traditional knowledge.
Experts also highlighted: contractual agreements as a means to determine conditions under which IPR are granted; the need for licensing arrangements for genetic resources and traditional knowledge; and IPR as a means of capturing benefits in contractual agreements. They also discussed how a contract on ABS can guide users applying for IPR. They noted other issues requiring attention, inter alia: distinguishing between national and cultural patrimony; ensuring that IPR does not impede traditional uses; implementing mechanisms for the distribution of benefits; applying current IPR regimes to protect traditional knowledge; and maintaining consistency with other international agreements. Some experts stressed the need to address the IPR issue with regard to benefit-sharing, technology transfer and innovation.
Final Report: The final report outlines four main issues regarding IPR: the role of IPR in regard to PIC; traditional knowledge related to genetic resources; access and benefit-sharing; and scope, prior art and monitoring.
The report notes that IPR application procedures could require that applicants submit evidence of PIC. It also notes that other alternatives, such as user country legislation or multilateral information systems, must be explored for their effectiveness to promote the objectives of the CBD, and that the COP should explore this matter in greater depth.
On traditional knowledge, the report calls on the COP to consider how to facilitate progress in relation to the following issues: how to define relevant terms, including the subject matter of traditional knowledge and the scope of existing rights; whether existing IPR regimes can be used to protect traditional knowledge; and consideration of options for the development of sui generis protection of traditional knowledge rights. The report also emphasizes the need to: study the relationship between customary laws governing custodianship and the use and transmission of traditional knowledge with formal IPR systems; implement pilot projects to test means of protection based on existing IPR, sui generis possibilities and customary laws; and ensure that granting IPR does not preclude continued customary use of genetic resources and related knowledge. The report takes into account the work of all relevant bodies at the community, national, regional and international levels, as well as the work of the CBD and other international organizations such as UNESCO, WIPO, WTO and FAO.
On IPR and ABS agreements, the report notes that contractual agreements play an important role in promoting access and benefit-sharing under the CBD and that they must be consistent with national and international law. It also considers the following issues as guiding parameters for contractual agreements: regulating the use of resources in order to take into account ethical concerns; making provisions to ensure the continued use of genetic resources and related knowledge; making provisions for the exploitation and use of IPR; and taking into account the possibility of joint ownership of IPR. Potential parties to ABS agreements may consider the use of licenses to secure continued control by providers over genetic resources.
On the issues of scope, prior art and monitoring, the report expresses concern that the scope of protection under IPR regimes may prejudice the legitimate interests of indigenous and local communities with respect to their knowledge, innovations and practices. The report agrees that the development of traditional knowledge registers could promote the identification and accessibility of prior art.
INCENTIVE MEASURES: Experts considered various options available as incentive measures for ABS and identified principles that would facilitate ABS arrangements on MAT. Experts addressed efficient mechanisms that avoid burdensome procedures involving high transaction costs; incentive measures to encourage contractual partnerships; other measures to promote fair and equitable benefit sharing; and identification of steps to achieve economic evaluation of genetic resources.
Experts highlighted the need to review incentive measures, citing: the weak compatibility between current national legislation and the wider global debate; problems of enforcement of many national measures; lack of coordination among agencies; and lack of clarity with regard to concepts. They further discussed the role of IPR systems and other trade measures to foster the CBD’s objectives, such as disclosure of country of origin and evidence of legal rights to the use of resources. On policy and law, experts noted the need to establish a balance between national policy objectives and specific legislation to implement the CBD. They also noted that incentives should be derived from national policy and targeted to such specific objectives as conservation and sustainable use. Experts also stressed that incentives need to be identified for both providers and users at the national and multilateral levels.
Final Report: The report notes that incentives created by specific mechanisms must be evaluated with an assessment of the effectiveness of alternative regulatory measures. This assessment is based on: identification of specific objectives to be achieved by such measures as benefit-sharing, conservation, sustainable use and facilitation of access; and evaluation of the costs of implementation, in particular for monitoring and enforcement.
It also notes that different objectives may require different instruments, citing that emphasis on single-instrument approaches, such as access regulations, may run counter to some objectives such as benefit-sharing and facilitation of access.
The report also underlines that more integral approaches to incentive measures involving user, provider and multilateral approaches are desirable in contributing to: altering monitoring and enforcement costs, such as the burden of proof in case of disputes; enhancing confidence between parties; reducing costs of compliance; and fostering the credibility of measures.
The report highlights other activities, such as ecotourism, as means of providing incentives for access. It adds that ecotourism, which does not necessarily involve access to genetic resources, can offer substantial benefits to be shared with appropriate stakeholders. The report suggests that this issue should be considered in the work of SBSTTA. It was also agreed that the COP should consider establishing an Expert Panel on the issue of economic valuation of genetic resources.
KEY CONCLUSIONS OF THE PANEL
On Friday, 8 October, Panel Co-Chair Medaglia introduced a Co-Chairs’ text on draft conclusions of the Panel (UNEP/CBD/EP-ABS/L.4.Rev.1), containing general conclusions as well as specific conclusions on PIC, MAT, information needs and capacity building. The document extracts and highlights key conclusions from the Panel’s discussions. Delegates drew attention to the need to ensure consistency with other sections of the report and made minor modifications to this end.
With regard to a conclusion suggesting that Parties without ABS legislation adopt voluntary measures and guidelines to provide legal certainty over ABS agreements, the US questioned how voluntary measures could provide legal certainty. KENYA proposed suggesting that, in the absence of full and clear ABS legislation, Parties adopt voluntary measures to ensure that they meet the objectives of the Convention. DENMARK emphasized the importance of legal certainty of MAT and opposed deleting the reference. The WORLD RESOURCES INSTITUTE (WRI) remarked that while voluntary measures could not provide legal certainty, they could provide a step in the right direction. Delegates agreed to note the importance of legal certainty to MAT and accepted the suggestion made by Kenya.
PERU’s proposal to add a conclusion stating that the PIC of indigenous and local communities is dependent on clear recognition and protection of their rights, knowledge and innovation and practices and that sui generis legislation may therefore need to be considered. With regard to a conclusion noting that regulations providing the legal basis for MAT should seek to minimize transaction costs, JAMAICA opposed the term “regulations.” Delegates supported WRI’s suggestion to use “legislative, administrative and policy measures.” To a conclusion identifying areas in need of more information, JAMAICA added sui generis systems.
Regarding a conclusion acknowledging that IPR may have an influence on the implementation of ABS arrangements and suggesting that the COP consider these matters further, PERU preferred, and the EU opposed, identifying it as a general conclusion rather than one on information needs. WRI, stressing the importance of the IPR conclusion, urged its inclusion under the section outlining the Panel’s general conclusions and delegates agreed to do so.
The text notes that the Panel reviewed ABS arrangements in line with its terms of reference and, based on this review, suggests that the COP may wish to consider the ensuing elements. The following is a summary of the conclusions by topic.
GENERAL CONCLUSIONS: The general conclusions state that Parties should establish a national focal point and one or more competent national authorities, as appropriate, for ABS arrangements. The general conclusions further note that: ABS arrangements must be developed within the context of national biodiversity strategies and action plans to ensure their linkage to conservation and sustainable use objectives; legislative, administrative and policy measures for ABS should promote flexibility while balancing the need for access regulations sufficient to promote the Convention’s objectives; and flexibility in providing countries is related to the extent that user countries and organizations implement measures that provide incentives or establish control mechanisms to secure providers’ interests over their resources.
The general conclusions also state that, in the absence of full and clear legislation and national strategies for ABS, Parties may adopt voluntary measures and guidelines to help ensure that they meet the Convention’s objectives, or governments may alternatively endorse individual ABS agreements. It suggests that, in developing national access legislation, Parties should consider and allow for development of a multilateral system to facilitate ABS for plant genetic resources for food and agriculture. It states that the COP could consider development of guidelines for PIC and MAT based on common understandings described in the ensuing conclusions, and the Secretariat is requested to prepare a proposal on this for the COP’s consideration. It further highlights the Panel’s acknowledgment that IPR may influence implementation of ABS arrangements and may have a role in providing incentives for users to seek PIC. The Panel was unable to arrive at conclusions on these IPR issues and suggests that the COP further consider these matters.
PIC: The conclusions note that PIC is the core requirement of effective ABS measures, and development of PIC procedures should be guided by the following principles:
- the applicant must supply sufficient information to allow for informed consent;
- the provider must be allowed to request further information;
- information should be provided in a manner and language comprehensible to the provider; and
- consent should be construed strictly.
It is noted that the PIC of indigenous and local communities is dependent on clear recognition and protection of their rights, knowledge, innovations and practices and, therefore, development of sui generis legislation may require consideration.
MUTUALLY AGREED TERMS: The conclusions state that:
- contractual arrangements are the main mechanism for concluding access agreements and implementing benefit-sharing, and MAT are central to the contracting process;
- the negotiation of MAT must respect the provider country’s legal policy and administrative arrangements;
- MAT should include provisions on user obligations; and
- legislative, administrative and policy measures that provide the basis for MAT should seek to minimize transaction costs.
INFORMATION NEEDS: The Panel concluded that information is critical in providing the necessary parity of bargaining power for stakeholders in ABS arrangements, and thus more information is needed regarding user institutions, the market for genetic resources, non-monetary benefits, new and emerging mechanisms for benefit-sharing, intermediaries, incentive measures, and sui generis systems. These conclusions note the need for more user-friendly documents and better access to examples of actual contracts, codes of conduct and voluntary guidelines, including those used by the private sector, and request the Secretariat to prepare for the COP a proposal to address these information needs. It is further noted that the Panel considered IPR in line with its terms of reference. Regarding capacity building, the Panel’s conclusions note the need for further development of capacities regarding all aspects of ABS for all stakeholders, particularly local governments, academic institutions and indigenous communities. They identify the most critical capacity-building needs as: assessment and inventory of biological resources; contract negotiation skills; legal drafting skills for development of ABS measures; and development of sui generis regimes for the protection of traditional knowledge associated with genetic resources.
The Secretariat, in consultation with the GEF Secretariat, is called on to develop a proposal for COP consideration on how to address these needs, including support from the financial mechanism and other relevant organizations and the private sector. It is suggested that the COP consider guidance to the financial mechanism and bilateral and multilateral donors to support development of the capacities of competent national authorities and/or focal points.
Rapporteur Maureen Wolfson presented the consolidated draft report of the Experts’ Panel (UNEP/CBD/EP-ABS/L.5/Rev.1) to the Plenary for adoption. This consolidated report outlined the findings of the Panel on: ABS options for scientific and commercial purposes; review of legislative, administrative and policy measures at national and regional levels; and regulatory procedures and incentive measures. It also contains the key conclusions of the Panel. The Plenary then adopted the report.
In his closing remarks, CBD Executive Secretary Zedan thanked the Governments of Costa Rica and Switzerland for hosting the Panel and the Chairs of the Panel and working groups. He commended participants on their constructive contributions and hard work throughout the meeting. He said these efforts would be reflected in the final report to be submitted to the CBD COP-5 and would guide the decision making of the COP. Co-Chair Medaglia congratulated the participants on their work and, on behalf of his government, thanked them for making the meeting a success. He drew the meeting to a close at 9:00 pm.
THINGS TO LOOK FOR BEFORE COP-5
WTO COUNCIL ON TRIPS: This meeting will be held from 20-22 October 1999 in Geneva. For more information, contact: the World Trade Organization, 154 rue de Lausanne, 1211 Geneva 21, Switzerland; tel: +41-22-739-5111; fax: +41-22-739-5458; Internet: http://www.wto.org/wto/intellec/intellec.htm
INTERNATIONAL CONFERENCE ON BIOTECHNOLOGY: This conference will consider whether biotechnology can help improve food security, protect the environment, and reduce poverty in developing countries. It will take place from 21-22 October 1999 in Washington, DC. For more information, contact: F. Hall, CGIAR Secretariat and NAS, World Bank, 1818 H Street NW, Washington, DC 20433, USA; tel: +1-202-473-8915; fax: +1-202-614-0125; e-mail: firstname.lastname@example.org; Internet: http://www.cgiar.org.
INTERNATIONAL SYMPOSIUM ON BIODIVERSITY AND DEVELOPMENT: This symposium will be held from 20-26 October 1999 on the Isle of Vilm and in Bonn, Germany. For more information, contact: Deutsche Gesellschaft für Technische Zusammenarbeit (GTZ), Dag-Hammarskjöld-Weg 1-5, 65760 Eschborn, Germany; tel: +49-6196-79-4200, fax: +49-6196-79-6190; e-mail: email@example.com.
WIPO ROUNDTABLE ON INTELLECTUAL PROPERTY AND INDIGENOUS PEOPLES: This roundtable will take place from 1-2 November 1999 in Geneva. For more information, contact: The World Intellectual Property Organization (WIPO), P.O. Box 18, CH-1211 Geneva 20, Switzerland; tel: +41-22-338-9111; fax: +41-22-733-5428; Internet: http://www.wipo.int.
INTERNATIONAL CONFERENCE ON ETHNOMEDICINE AND DRUG DISCOVERY: This conference will take place from 3-5 November 1999 in Silver Spring, Maryland. For more information, contact: Bioresources Development and Conservation Programme, 11303 Amherst Ave., Suite 2, Silver Spring, MD, USA; tel: +1-301-962-6201; fax: +1-301-962-6205; e-mail: firstname.lastname@example.org; Internet: http://www.bioresources.org.
WIPO WORKING GROUP MEETING ON BIOTECHNOLOGY: This meeting will examine intellectual property aspects of biotechnology in relation to the CBD. It will be held from 8-10 November 1999 in Geneva. For more information, contact: WIPO, P.O. Box 18, CH-1211 Geneva 20, Switzerland; tel: +41-22-338-9111; fax: +41-22-733-5428; Internet: http://www.wipo.int.
SIXTH CONFERENCE OF PARTIES TO THE CONVENTION ON MIGRATORY SPECIES: COP-6 of the CMS will be held from 10-16 November 1999 in Cape Town, South Africa. For more information, contact: CMS Secretariat, P.O. Box 260129, Haus Carstanjen, D-53153 Bonn, Germany; tel: +49-228-815-2405; fax: +49-228-815-2449; e-mail: email@example.com; Internet: http://www.wcmc.org.uk/cms.
THIRD MINISTERIAL CONFERENCE OF THE WORLD TRADE ORGANIZATION: The third Ministerial Conference of the WTO will take place from 28 November-3 December 1999 in Seattle, Washington, USA. For more information, contact: M. Parker, SHOMSC, 600 Stewart St., Suite 1605, Seattle WA 98101, USA; tel: +1-206-441-6448; fax: +1-206-441-6369; e-mail: firstname.lastname@example.org; Internet: http://www.wto.org/wto/minist/seatmin.htm.
EXPERT MEETING IN PREPARATION FOR THE FIFTH MEETING OF THE CBD SBSTTA: This meeting will be held from 2-4 December 1999 on the Isle of Vilm, Germany. For more information, contact: J. Stadler, International Academy for Nature Conservation, Isle of Vilm, Germany; tel: +49-38-301-860; fax: +49-38-301-86150; e-mail: email@example.com.
OECD CONFERENCE ON AGRICULTURAL KNOWLEDGE SYSTEMS: This conference will convene from 10-13 January 2000 in Paris. For more information, contact: OECD, rue Andrï¿½ Citroï¿½n, 70016 Paris, France; fax: +33-1-4430-6116; e-mail: firstname.lastname@example.org; Internet: http://www.oecd.org/agr/aks/index.htm.
RESUMED SESSION OF THE FIRST EXTRAORDINARY MEETING OF THE CBD COP: This meeting will finalize and adopt a Protocol to the CBD on biosafety and will be held from 24-28 January 2000 in Montreal, Canada. It will be preceded by an informal consultation on the Protocol from 20-22 January 2000. For more information, contact: CBD Secretariat, World Trade Center, 393 Jacques St., Suite 300, Montreal, Quebec, Canada, H2Y 1N9; tel: +1-514-288-2220; fax: +1-514-288-6588; e-mail: email@example.com; Internet: http://www.biodiv.org.
CBD AD HOC WORKING GROUP ON ARTICLE 8(J): The date and venue for this meeting have yet to be determined. For more information, contact the CBD Secretariat (see above).
FIFTH MEETING OF THE CBD SBSTTA: SBSTTA-5 will be held from 31 January - 4 February 2000 in Montreal, Canada. For more information, contact the CBD Secretariat (see above).
FOURTH AND FINAL SESSION OF THE INTERGOVERNMENTAL FORUM ON FORESTS: This meeting is scheduled to meet from 31 January-11 February 2000 in New York. For more information, contact: IFF Secretariat, 2 UN Plaza, 12th Floor, New York, NY 10017, USA; tel: +1-212-963-3401; fax: +1-212-963-3463; Internet: http://www.un.org/esa/sustdev/iff.htm.
INTERNATIONAL CONFERENCE ON MANAGING NATURAL RESOURCES FOR SUSTAINABLE AGRICULTURAL PRODUCTION IN THE 21ST CENTURY: This conference will be held from 14-18 February 2000 in New Delhi, India. Themes to be discussed include: agro-biodiversity and agro-forestry; biodiversity; people and sustainable agriculture; and natural resource management and comprehensive food security. For more information, contact: A.K. Singh, Secretary-General, Indian Agricultural Research Institute, New Delhi, 110 012 India; tel: +91-11-573-1494; fax: +91-11-575-5529; e-mail: firstname.lastname@example.org.
ELEVENTH CONFERENCE OF THE PARTIES TO THE CONVENTION ON INTERNATIONAL TRADE IN ENDANGERED SPECIES: CITES COP-11 will be held from 10-20 April 2000 in Nairobi, Kenya. For more information, contact: CITES Secretariat, International Environment House, 15, Chemin des Anï¿½mones, CH-1219 Chï¿½telaine, Geneva, Switzerland; tel: +41-22-979-9139; fax: +41-22-979-3417; e-mail: email@example.com; Internet: http://www.cites.org.
EIGHTH SESSION OF THE UN COMMISSION ON SUSTAINABLE DEVELOPMENT: CSD-8 will meet from 24 April-5 May 2000 to consider integrated planning and management of land resources, agriculture, and financial resources/trade and investment/economic growth. The CSD Ad Hoc Intersessional Working Groups will meet in New York from 22 February-3 March 2000. For more information, contact: Andrey Vasilyev, Division for Sustainable Development, United Nations, 2 UN Plaza, Room DC2-2220, New York, NY 10017, USA; tel: +1-212-963-5949; fax: +1-212-963-4260; e-mail: firstname.lastname@example.org; Internet: http://www.un.org/esa/sustdev.
FIFTH MEETING OF THE CONFERENCE OF THE PARTIES TO THE CONVENTION ON BIOLOGICAL DIVERSITY: CBD COP-5 will be held from 15-26 May 2000 in Nairobi, Kenya. For more information, contact the CBD Secretariat (see above).