INTRODUCTION AND CONTENT INTRODUCTION Following an intergovernmental decision 1 taken under the auspices of the Convention on Biological Diversity2, the UK, in common with the other 180 Parties to the treaty3, is requested to "establish a national focal point4 and one or more competent national authorities5, as appropriate, to be responsible for access6 and benefit-sharing7 arrangements or to provide information on such arrangements within its jurisdiction". This Website provides information on access to genetic resources in the UK8. Any additional information can be obtained by contacting: National Focal Point on Access to Genetic Resources and Benefit-Sharing, Branch D, Research Policy and International Division, Science Directorate, Department for the Environment, Food and Rural Affairs, Cromwell House, Dean Stanley Street, Westminster, London SW1P 3JH, UK. Telephone: +44 (0) 207 238 1654 Fax: +44 (0) 207 238 1658 E-mail: Genetic.resources@defra.gsi.gov.uk WHAT IS THE CBD? The Convention on Biological Diversity is both an international treaty, now ratified by 181 Parties, and an institutional framework for the continual development of legal, policy and scientific initiatives on biological diversity. The objectives of the CBD are described in Article 1 as follows: " the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilisation of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding." Where earlier treaties dealt with specific aspects of biodiversity9, such as trade in endangered species10, particular ecosystems (e.g. wetlands11, drylands12), geographic areas13 or species14, the CBD is comprehensive in its approach. Its scope is global, covering all components of biological diversity, from ecosystems and habitats, species and communities to genomes and genes, and it deals not only with the conservation of biological diversity in situ and ex situ, but also with the sustainable use of the components of biodiversity and the sharing of benefits arising out of the use of genetic resources. ABOUT FOCAL POINTS AND COMPETENT NATIONAL AUTHORITIES ON ACCESS AND BENEFIT-SHARING In May 2000, the Conference of the Parties of the Convention on Biological Diversity requested Parties "to designate a national focal point and one or more competent national authorities, as appropriate, to be responsible for access and benefit-sharing arrangements or to provide information on such arrangements within its jurisdiction;" and to notify the CBD's Executive Secretary of the names and addresses of its focal points and competent authorities." (Decision 5/2615). Following this Decision, the international Expert Panel16 established by the CBD Secretariat on access and benefit-sharing has met twice17, and, among other issues, discussed the functions of a focal point and competent national authorities on access and benefit-sharing. In summary, the purpose of the focal point and any competent national authorities is to advise people on requirements within the country for access to genetic resources on mutually agreed terms: * Role of the focal point: to provide information on access and benefit-sharing procedures in the country and to identify any Competent National Authorities and other stakeholders whose prior informed consent may be needed. * Role of the competent national authority: to process and take decisions upon applications for access to genetic resources. A more detailed description of these roles can be found in relevant excerpts18 of the reports of the Expert Panel, or in the full reports of the first19 and second20 meetings of the Panel. In addition, information is available on the first meeting of the Ad Hoc Open-ended Working Group on Access and Benefit-sharing 21, held in Bonn, Germany, from 22-26 October 2001. This Working Group had the mandate to develop guidelines and other approaches for submission to the Conference of the Parties and to assist Parties and stakeholders in addressing the following elements as relevant to access to genetic resources and benefit-sharing, inter alia: * Terms for prior informed consent and mutually agreed terms * Roles, responsibilities and participation of stakeholders * Relevant aspects relating to in situ and ex situ conservation and sustainable use * Mechanisms for benefit-sharing, for example through technology transfer and joint research and development; * And means to ensure the respect, preservation and maintenance of knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity. The mandate and role of a national focal point and any competent national authorities on access to genetic resources and benefit-sharing also formed part of the discussion at that meeting. At present, the UK has not established any competent national authorities on access. Individuals are able to access genetic resources by following the steps described on this Focal Point Website. Access and benefit-sharing focal points and competent national authorities for a few other countries22 have also been notified to the Executive Secretary of the CBD. ACCESS TO GENETIC RESOURCES WHAT IS MEANT BY 'ACCESS'? Acquisition of genetic resources means the act of actually physically obtaining the material. It does not imply permission to use it. By contrast, 'access to genetic resources' means the permission to physically obtain and subsequently to use the genetic resources. This implies a positive and physical action to the genetic resources, going beyond, for instance, simply observing them (e.g. the passive, aesthetic, pleasure derived from looking at cut flowers or ecotourists visiting rainforests). 'Access to genetic resources' is not defined in the CBD. Certain provisions of some other international environmental treaties address access to genetic resources. For example, CITES covers the import and export of genetic resources of 'listed' species. WHAT IS MEANT BY 'GENETIC RESOURCES'? Article 2 of the CBD defines 'genetic material' as any material of plant, animal, microbial or other origin containing functional units of heredity and 'genetic resources' as genetic material of actual or potential value. These definitions can cover both living and preserved materials, such as herbarium specimens. In some countries, national legislation extends the obligation to obtain prior informed consent and to share benefits beyond genetic resources, to cover associated traditional knowledge and the derivatives of genetic resources. WHAT OBLIGATIONS DOES THE CBD INTRODUCE ON ACCESS AND BENEFIT-SHARING? The Convention endorses the sovereign right of states over their biological resources and the consequent authority of national governments to determine access to genetic resources. According to the Convention, such access shall be subject to Parties' prior informed consent, and on mutually agreed terms that promote the fair and equitable sharing of benefits. The CBD strikes a balance between a State's authority to regulate access to genetic resources, on the one hand, and, on the other, its obligation to facilitate access to genetic resources for environmentally sound uses by other Parties. Parties also commit not to impose restrictions that run counter to the objectives of the CBD. The key provisions of the Convention on access to genetic resources and benefit-sharing are summarised in the Box beneath. Summary of provisions in the CBD on access to genetic resources, on the knowledge, practices and innovations of local and indigenous communities, and on benefit-sharing Art. 8 (j) * Promote the wider application of the knowledge, innovations and practices of indigenous and local communities with their approval and involvement and encourage the equitable sharing of the benefits arising from the utilisation of the knowledge, innovations and practices of indigenous and local communities. Art.15.1 * Sovereign rights of States over their natural resources; the authority of national governments to determine access to genetic resources. Art.15.2 * Endeavour to create conditions to facilitate access to genetic resources for environmentally sound uses by other Contracting Parties and not to impose restrictions that run counter to the objectives of the CBD. Art.15.3 * Articles 15, 16 and 19 only apply to genetic resources acquired "in accordance with this Convention": i.e. not to those obtained prior to its entry into force or from non-parties. Art.15.4 * Access, where granted, to be on mutually agreed terms and subject to the provisions of Article 15. Art.15.5 * Access to genetic resources to be subject to prior informed consent of the Contracting Party providing such resources, unless otherwise determined by that Party. Art.15.6 * Endeavour to develop and carry out scientific research based on genetic resources provided by other Contracting Parties with the full participation of, and where possible in, such Contracting Parties. Art.15.7 * Take legislative, administrative or policy measures, as appropriate, . . . with the aim of sharing in a fair and equitable way the results of research and development and the benefits arising from the commercial and other utilisation of genetic resources with the Contracting Party providing such resources. Such sharing to be upon mutually agreed terms. Art.16.3 * Access to and transfer of technology using genetic resources to countries providing the genetic resources. Art.19.1 * Effective participation by providers of genetic resources in biotechnological research on the genetic resources they provide. Art 19.2 * Priority access on a fair and equitable basis by countries (especially developing countries) providing genetic resources to the results and benefits arising from biotechnologies based on them. Such access to be on mutually agreed terms. As illustrated in the Box, the obligation to share benefits arises in the context of (i) access to genetic resources, where it is triggered by the need to obtain prior informed consent (Art.15(5)), and (ii) access to the knowledge, innovations and practices of indigenous and local communities, for which the approval of the holders of that knowledge is required (Art. 8(j)). BENEFIT-SHARING WHAT IS MEANT BY 'BENEFIT-SHARING'? According to Article 1 of the CBD, "the fair and equitable sharing of the benefits arising out of the utilisation of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding" is the third objective of the treaty. The CBD does not define benefit-sharing, but the text of Article 1 and other relevant provisions. In addition, national laws related to access to genetic resources often stipulate the nature of benefits that are to be shared according to mutual agreement of the terms of access, following prior informed consent. Provided that they meet requirements of relevant laws related to access and any earlier contractual commitments with respect to genetic resources, the parties to an individual agreement can be as imaginative and ingenious as they are able in defining the benefits to be shared and mechanisms for doing so. Benefits arising out of the utilisation of genetic resources can be direct, such as knowledge produced by research on genetic resources, or indirect, such as the incentive for conservation provided by profits arising from commercialisation of genetic resources. They can be either monetary benefits, such as collection fees, royalties and research grants, or non-monetary benefits of an environmental, social or economic nature. Non-monetary benefits might include research on host-country diseases; conservation projects; technology transfer of hardware, software and know-how; training in various disciplines of science, in information management, or in legal, administrative and management matters; joint research through participation in product development and joint ventures; institutional capacity building through developing partnerships to support groups such as communities, universities, botanic gardens, and small businesses; and the creation of employment opportunities. For an introduction to the concept of benefit-sharing, see UNEP/CBD/COP/3/Inf. 53 ('Fair and Equitable Sharing of Benefits Arising from the Use of Genetic Resources'). WITH WHOM SHOULD BENEFITS BE SHARED? Although the obligations to share benefits in the CBD are phrased in terms of the governments which ratified it, access legislation in various countries (for example, the countries of the Andean Pact and the Philippines) obliges collectors to share benefits with collaborating institutions and with local and indigenous communities. Various codes of conduct governing the collection of genetic resources endorse this as best practice. HOW ARE BENEFITS SHARED? Just as the Convention does not define 'benefit', neither does it define 'sharing'. Obligations to share benefits are likely to be contained in collecting permits or material transfer agreements. The mechanisms for sharing benefits vary. Non-monetary benefits such as participation in research and the exchange of information and know-how are generally shared through partnerships between institutions, as set out in contracts such as collecting permits or material transfer agreements. Monetary benefits may be shared through financial mechanisms such as trust funds. More information on possible mechanisms for sharing benefits, identifying those who are entitled to receive a share of benefits and allocation of benefits may be found in UNEP/CBD/COP/3/Inf. 53. as well as in a range of case studies 23on benefit-sharing prepared for the CBD Secretariat. HOW ARE COUNTRIES IMPLEMENTING THE PROVISIONS OF THE CBD ON ACCESS AND BENEFIT-SHARING? Article 15(1) of the CBD makes it clear that the regulation of access to genetic resources is a matter for national governments to determine, given national sovereignty over these resources. Consequently, countries have a great deal of discretion to decide how to regulate access. In practice, the number of countries developing national laws and policies on this subject has been growing fast since 1993. At the time of launch of this Website, regional groups, national governments or state governments already regulating access to genetic resources to ensure prior informed consent and benefit-sharing included: the Andean Pact (Bolivia, Colombia, Ecuador, Peru, Venezuela); Australia (the States of Western Australia and Queensland); Brazil (at the Federal level and the States of Acre and Amapa); Cameroon; Costa Rica; the Republic of Korea; Malaysia (the State of Sarawak); Mexico; the United States of America (within Yellowstone and other national parks), and the Philippines. Those planning to regulate access to genetic resources to ensure prior informed consent and benefit-sharing included: the member countries of the Association of South-East Asian Nations (ASEAN); Australia (the Commonwealth); Ivory Coast; Cuba; Ethiopia; Eritrea; Fiji; the Gambia; Guatemala; India; Indonesia; Kenya; Lao PDR; Lesotho; Malawi; Malaysia (at the national level and the State of Sabah); Mozambique; Namibia; Nicaragua; Nigeria; the Organisation of African Unity; Pakistan, Papua New Guinea; Samoa; the Seychelles; the Solomon Islands; South Africa; Sri Lanka; Tanzania; Thailand; Uganda; Vanuatu; Vietnam; and Yemen. Belize, China, El Salvador, Ghana, Guyana, Hungary, Iceland, Panama, the Russian Federation and Zimbabwe may also be planning to regulate access to genetic resources in the near future. WHY IS THE CBD AND ACCESS TO GENETIC RESOURCES RELEVANT TO ME? The CBD is relevant to anyone interested in environment and development issues. In particular, it provides a mandate, guidance, and, in some cases, opportunities for partnerships, technology transfer, capacity building and funding, for those involved in the conservation and sustainable use of biodiversity. See www.biodiv.org. Access to genetic resources is a topic relevant for anyone involved in using biological materials that contain functional units of heredity (and, in some cases, their derivatives and associated traditional knowledge) for conservation, research, education and possible commercialisation. Any individual or organisation that collects or acquires genetic resources should establish that they are doing so legally (see 'Access to genetic resources' and 'Legal summary'). This not only supports the objectives of the CBD, to which the UK is a party, but clarifies the individual or organisation's rights and responsibilities when using the genetic resources. This protects the user's research and investment and helps to avoid potential legal action. (In many countries it is a criminal offence with severe sanctions to access genetic resources without prior informed consent. The right to use genetic resources and to derive commercial benefit from doing so might also be challenged in civil law, if the correct permission and/or agreements have not be obtained.) The linked objectives of the CBD recognise that the sustainable use of the components of biodiversity and the sharing of benefits arising from the use of genetic resources, create an economic incentive for conservation of biodiversity. Anyone using genetic resources may thus find the CBD relevant for the altruistic reason of supporting conservation and sustainable development, and for the self-interested reason of protecting their work and investment and avoiding legal action. EXCERPTS FROM REPORTS OF THE EXPERT PANEL ON ACCESS AND BENEFIT-SHARING ON THE RECOMMENDED ROLE OF A FOCAL POINT AND COMPETENT NATIONAL AUTHORITIES ON ACCESS AND BENEFIT-SHARING First report of the Panel of Experts on Access to Genetic Resources and Benefit-Sharing (October 1999) [NB only those paras of the report referring to FP/CNA reproduced. For the Panel's advice on other relevant issues, please see whole report on www.biodiv.org, Document: UNEP/CBD/COP5/8] Para 58: Governments should appoint national focal points and competent authorities, which may or may not be different entities with separate functions. These should be capable of advising on the requirements for access on mutually agreed terms, among other functions (see, for example, annex I below). These authorities have an important role to play in ensuring equitable mutually agreed terms. This can be achieved by either directly participating in the negotiating process or endorsing agreements reached by institutions according to national policy. Authorities have an especially important role in providing legal certainty and lowering transaction costs. They also have an important role in providing information. It is therefore important that they have adequate resources to carry out these tasks. Para 107: Capacity-building is also required for institutions involved in administering access, such as the national focal points, competent national authorities and other institutions with designated functions in the role of access and benefit-sharing. These functions may include the transfer of technology in fields such as taxonomy; collection methods; facilitation of negotiations between stakeholders; assisting in the establishment of national libraries of genetic resources; monitoring activities on access and benefit-sharing; and the provision of information on access and benefit-sharing in national reports. National focal points and competent national authorities Para 122: The Panel considered that, as a matter of urgency, each Government should establish a national focal point and one or more competent national authorities, as appropriate, on access an benefit-sharing. National focal points should be able to indicate to applicants for access, from whom prior informed consent is required. Competent national authorities should have the legal power to grant prior informed consent and to develop national procedures for access and benefit-sharing concerning different types, sources and uses of genetic resources. The functions of each of these kinds of body are addressed for information purposes in annex I below. Capacity-building Para 123: As a matter of priority, the capacity-building needs of both national focal points and competent national authorities for the administration of the procedures, including the procedure for prior informed consent, need to be identified and appropriate capacity-building measures instituted. Para 124: In establishing national procedures for access and benefit-sharing, individual countries should pay due attention to and should consult local community groups, and identify the traditional regulatory measures that could be integrated in acquiring access and utilizing the genetic resources. Local community groups/organizations could become the agents that could facilitate and control access for different uses and help competent national authorities to monitor and evaluate the impacts. A. General conclusions Para 147: Parties should establish a national focal point and one or more competent national authorities, as appropriate, for access and benefit-sharing arrangements. Para 173: The Conference of the Parties should consider guidance to the financial mechanism, bilateral and multilateral donors to provide support for developing the capacities of national focal points and competent national authorities. Annex I FUNCTIONS OF THE NATIONAL FOCAL POINT AND COMPETENT NATIONAL AUTHORITY The role of the focal point in a country will likely vary according to whether that country does or does not have a competent national authority or authorities regulating access and benefit-sharing. Some Governments may designate or create the same institution to serve as both the focal point and the competent national authority. The minimum functions of the national focal point and competent national authority/authorities should be the following. The national focal point * Provide basic information for those seeking access to genetic resources (whether domestic or foreign applicants) as to access and benefit-sharing procedures and identification of, or means to identify, the competent national authorities and other stakeholders involved in the access and benefit-sharing procedures. * Provide basic information to national stakeholders, such as local and indigenous communities, research institutions and companies, on legal, administrative and policy measures within the country that may entitle them to benefit from access activities and on notification procedures related to access applications. * A focal point could also provide information on organizations involved in the conservation and sustainable use of genetic resources in the country, since these organizations could be potential partners in access and benefit-sharing arrangements or could introduce applicants to a network of other potential collaborators. * Through the clearing-house mechanism, focal points could develop links or form a network, facilitating identification of those involved in the regulation of access around the world. * Increase public awareness of the implications of the implementation of the Convention on Biological Diversity at the national level. This awareness-raising should be particularly targeted to key stakeholders, such as academics and commercial users of genetic resources. The competent national authority * Process and determine applications for access to genetic resources. * Liaise with individuals, communities, organizations within the country to facilitate the processing of access applications, including the identification of those from whom prior informed consent is required and the evaluation of access applications. * Produce, as required, detailed guidelines, rules and regulations on access procedures. * Clarify the role of government in the negotiation and approval of individual access and benefit-sharing agreements. * Coordinate with other legislative, administrative and policy bodies with functions involving genetic resources (for example, national committees on biosafety). * Increase public awareness of the implications of the implementation of the Convention on Biological Diversity at the national level. This awareness-raising should be particularly targeted to key stakeholders, such as academics and commercial users of genetic resources. * Perform such other functions as may be necessary to apply these implementing rules and regulations. Some of the functions described here for competent national authorities may be exercised by the national focal point. Second report of the Panel of Experts on Access to Genetic Resources and Benefit-Sharing (October 1999) [NB only those paras of the report referring to FP/CNA reproduced. For the Panel's advice on other relevant issues, please see whole report on www.biodiv.org.] C. Prior informed consent Key elements Para 55: The Panel was of the view that the following elements of prior informed consent should be considered in international guidelines and other approaches. National focal point Para 56: The national focal point in each country should have the responsibility for providing two-way information flow on correct procedures and identification of competent authorities for particular transactions (at the national, provincial or local levels). Para 57: The functions of focal points for countries, acting in their capacity as users, need to be clarified. National focal points should address the activities of their entities as both providers and users of genetic resources. Competent national authorities Para 58: The competent national authorities may have: (a) The responsibility for advising on the requirements for access on mutually agreed terms; (b) The responsibility for ensuring mutually agreed terms (by participating in the negotiating process or endorsing agreements reached by institutions according to national policy and legislation). Para 59: These two functions may be performed by separate institutions in some countries and one institution in others. Identifying who gives consent Para 60: The focal point in each country should inform access applicants (both domestic and foreign) from whom prior informed consent should be secured, both within government and among stakeholders,and should indicate the competent national authorities. Para 61: The Panel emphasized that prior informed consent involves both national enabling measures by Parties and bottom-up approaches which identify those relevant stakeholders whose prior informed consent is required. Para 62: National procedures should facilitate the involvement of all appropriate stakeholders from the community to the government level, aiming at simplicity and clarity. Para 63: Permission to access genetic resources does not necessarily imply permission to use associated traditional knowledge and vice versa. Para 89: Nevertheless, approaches that addressed the following general needs of many stakeholders across a broad range of situations would promote stakeholder involvement: . . . Para 89 (d): Focal points and national competent authorities are important in reducing transaction costs for users and facilitating access for users. National focal point Para 103: The national focal point should provide two-way information flow on procedures for acquiring prior informed consent and mutually agreed terms and identification of competent national authorities and relevant stakeholders (including beneficiaries). These functions may be undertaken by the competent national authorities. Competent national authority(ies) Para 104: Competent national authorities, where they are established, will, in accordance with applicable national legislative, administrative or policy measures, be responsible for determining access applications and/or advising on: (c) Requirements for obtaining prior informed consent and entering into mutually agreed terms; (d) Monitoring, evaluation and enforcement of access and benefit-sharing agreements; (e) Assistance to the negotiating process; (f) Endorsement of agreements; (g) The conservation and sustainable use of the genetic resources accessed. 1 Link to: http://www.biodiv.org/decisions/default.asp?lg=0&m=cop-05&d=26 2 Link to: http://www.biodiv.org/ 3 Link to: http://www.biodiv.org/world/parties.asp?lg=0 4 Link to page below on 'focal point'. 5 Link to text on 'CNA' below. 6 Link to text on 'AGR' below. 7 Link to text on 'BS' below. 8 Link to text on 'How to access genetic resources in the UK' below. 9 Link to http://www.biodiv.org/convention/articles.asp?lg=0&a=cbd-02 10 Link to http://www.cites.org/ 11 Link to http://www.ramsar.org/. 12 Link to http://www.unccd.int/main.php 13 Link to Council Directive 92/43/EEC (Berne) Convention on the conservation of European wildlife and natural habitats http://www.ecnc.nl/doc/europe/legislat/bernconv.html 14 Link to (Bonn) Convention on Migratory Species: http://www.wcmc.org.uk/cms/ and Bonn Convention Websites 15 Link to: http://www.biodiv.org/decisions/default.asp?lg=0&m=cop-05&d=26 16 Link to http://www.biodiv.org/programmes/socio-eco/benefit/ab-pe-01.asp 17 Link to: http://www.biodiv.org/programmes/socio-eco/benefit/ab-pe-02.asp 18 Link to text 'Excerpts from reports of the Expert Panel on access and benefit-sharing on the recommended role of a focal point and competent national authorities on access and benefit-sharing', pages 9 et seq below 19 Link to http://www.biodiv.org/programmes/socio-eco/benefit/ab-pe-01.asp 20 Link to: http://www.biodiv.org/programmes/socio-eco/benefit/ab-pe-02.asp 21 Link to http://www.biodiv.org/programmes/socio-eco/benefit/ab-wg-01.asp 22 Link to http://www.biodiv.org/doc/lists/nfp-abs.pdf 23 Link to: http://www.biodiv.org/programmes/socio-eco/benefit/case-studies.asp 1