ACCESS TO GENETIC RESOURCES AND BENEFIT-SHARING UNDER THE CONVENTION ON BIOLOGICAL DIVERSITY by Valérie Normand Secretariat of the Convention on Biological Diversity First ABS Capacity-building Workshop for Africa Cape Town, South Africa, 19-24 November 2006

Outline ABS provisions of the Convention 2. Major ABS developments COP VI - Bonn Guidelines WSSD COP VII - International Regime COP VIII 3. Outlook

Provisions of the CBD Objectives: Conservation of biological diversity Sustainable use of its components Fair and equitable sharing of the benefits arising out of the utilization of genetic resources

Provisions of the CBD Article 15 of the CBD Sovereign rights of States over natural resources Parties to facilitate access to genetic resources Access subject to prior informed consent and granted on mutually agreed terms Parties to take measures to share benefits from the utilization of genetic resources, on MAT Article 15 provides the main concepts related to access to genetic resources and benefit-sharing under the Convention

Provisions of the CBD Articles 16 (3) Priority access to technologies for Parties providing genetic resources Article 19 (1) (2) Effective participation in biotechnological research activities for Parties providing genetic resources Access to the results and benefits arising from biotechnologies based upon genetic resources provided by these Parties

Overview of developments COP IV established an expert group on ABS (1998) COP-V established Open-ended Working Group on ABS (2000) COP-VI Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of Benefits Arising out of their Utilization (2002) COP-VII negotiation of an international regime on ABS (2004) Process that lead to the adoption of the Bonn Guidelines 1) Panel of Expert on ABS was established at COP-4 in 1998 - Met twice in October 1999 and March 2001 - in order to clarify concepts related to ABS 2) The Working Group on ABS established by COP 5 in 2000 - Mandate to develop guidelines and other approaches to assist Parties and stakeholders with the implementation of Article 15 - Met in October 2001 and developed draft guidelines based on the outcomes of the first two Panels of Experts.

Bonn Guidelines Voluntary guidelines to assist Governments and stakeholders: Establishing legislative, administrative or policy measures on access and benefit-sharing Negotiating contractual arrangements for access and benefit-sharing The guidelines are voluntary They are meant to assist Parties and stakeholders when: Establishing legislative, administrative or policy measures on access and benefit-sharing Negotiating contractual arrangements for access and benefit-sharing

Bonn Guidelines I. General Provisions II. Roles and responsibilities in ABS III. Participation of stakeholders IV. Steps in the ABS process V. Other provisions The structure of the guidelines is the following: ·        Section I on General Provisions covers key features, use of terms, scope, relationship with relevant international regimes and the objectives of the guidelines. ·        Section II deals with the role of the national focal point and competent national authority(ies), and responsibilities of Parties and stakeholders that are users and providers of genetic resources. ·        Section III addresses the participation of stakeholders in the development and implementation of access and benefit-sharing arrangements. ·        Section IV covers steps in the process of access and benefit-sharing, including prior informed consent and mutually agreed terms. ·        Section V covers other provisions, such as incentives, accountability, monitoring and reporting, verification, dispute settlement and remedies ·        Appendix I contains suggested elements for Material Transfer Agreements, and ·        Appendix II provides an illustrative list of monetary and non-monetary benefits.

Bonn Guidelines Steps in the ABS process Overall strategy Prior Informed Consent Basic principles of PIC Elements of PIC Mutually Agreed Terms Basic requirements for MAT Indicative list of MAT Benefit-sharing The guidelines suggest that ABS should be based on an overall ABS strategy at the country or regional level in order to develop a coherent approach to ABS. The guidelines are: - to assist with the establishment of a PIC system and - to assist with the development of Mutually Agreed Terms which will ensure the sharing of benefits.

Bonn Guidelines Roles and Responsibilities National Focal Point to be designated by each Party Competent National Authority responsible for granting access Users and Providers Contracting Parties providing the genetic resource Providers Users Contracting Parties with users of genetic resources under their jurisdiction National Focal Point Each Party to the CBD is to designate on National Focal Point The NFP should inform applicants for access on the procedures for PIC and MAT, On CNA, relevant I&LC and relevant stakeholders Competent National Authority May be established and be responsible for granting access or providing advise on: - Negotiating process,Requirements for obtaining PIC and entering into MAT, Monitoring and evaluation of ABS agreements, Implementation/Enforcement of ABS agreements, Processing of applications, Mechanisms for participation of different stakeholders, including I&LC Users and Providers In order to ensure that the system is fair and equitable different roles and responsibilities have been awarded: to the countries in which the GR are found or the providing country, the actual providers of these GR (which may be the Government itself or an individual or community), the users (e.g collectors, research institues, pharmaceutical cies) and the country in which are the users of genetic resources.

Bonn Guidelines Participation of stakeholders Determined on a case by case basis To be consulted and views taken into consideration: When determining access, in MAT, in sharing of benefits In development of national strategy, policies or regimes on ABS National consultative arrangements Involvement promoted by: Providing information Providing support for capacity-building The guidelines recognise that the involvement of relevant stakeholders is essential to ensure the adequate development and implementation of ABS arrangements. Due to diversity of stakeholders and their diverging interests, their involvement can only be determined on a case by case basis. Relevant stakeholders are to be consulted and their views taken into consideration: When determining access, in MAT, in sharing of benefits- In development of national strategy, policies or regimes on ABS Appropriate national consultative arrangements, e.g. through national consultative committees should be made. Involvement of stakeholders should be promoted by: Providing information, scientific and legal advice, in order for them to participate effectively Providing support for capacity-building, for stakeholders to be actively engaged in various stages of B-S, Stakeholders involved in ABS may wish to seek the support of a mediator or facilitator when negotiating MAT

Bonn Guidelines Other provisions Incentives Accountability National monitoring and reporting Means for verification Settlement of disputes Remedies Incentives Use of well designed economic and regulatory instruments, to foster equitable allocation of benefits Creation and use of markets to achieve conservation and sustainable use of biological diversity Accountability - Parties should endeavour to establish mechanisms to promote accountability by all stakeholders involved in ABS arrangements through mechanisms such as: reporting and disclosure of information National monitoring and reporting may include: whether the use of GR is in compliance with terms of access and B-S Research and development process Means for verification - e.g. voluntary certification mechanism to ensure compliance with PIC and MAT Settlement of disputes In conformity with contractual arrangement and applicable law and possible use of penalty fees for instance in case of non-compliance Remedies

Development at WSSD WSSD Plan of Implementation: Par. 44(o) calls for action to “negotiate within the framework of the Convention on Biological Diversity, bearing in mind the Bonn Guidelines, an international regime to promote and safeguard the fair and equitable sharing of benefits arising out of the utilization of genetic resources.” The ink was barely dry on the Bonn Guidelines when leaders at the World Summit on Sustainable Development, in September 2002, called for the “[negotiat[ion] within the framework of the Convention on Biological Diversity, bearing in mind the Bonn Guidelines, an international regime to promote and safeguard the fair and equitable sharing of benefits arising out of the utilization of genetic resources.” At its seventh meeting, the Conference of the Parties decided to mandate the Ad Hoc Open-ended Working Group on ABS to negotiate an international regime on ABS with the aim of adopting an instrument/instruments to effectively implement the provisions of Article 15 and 8(j) of the Convention.

COP 7 – February 2004 International Regime (decision VII/19D) Mandate: Working Group on ABS with collaboration of Working Group on 8(j) to negotiate an international regime on access and benefit-sharing with the aim of adopting an instrument/instruments to implement the provisions in Articles 15 and 8(j) and the three objectives of the Convention (par. 1 of decision VII/19D)

COP 7 – February 2004 Terms of Reference of WG-ABS (decision VII/19D, Annex) Process Based on a gap analysis Nature one or more instruments legally-binding or non-binding Scope Access to genetic resources and sharing of benefits Traditional Knowledge in accordance with Article 8(j) Elements Consider list of possible elements for inclusion in the regime listed in decision VII/19D, Annex, including existing instruments and processes

COP 7 – February 2004 Terms of Reference of WG-ABS (decision VII/19D, Annex) Main issues covered by elements in annex to decision VII/19D Measures to ensure benefit-sharing (i),(ii), (iii), (v), (vi),(xiii),(xiv), Measure to facilitate access (iv) Measures to ensure compliance with PIC and MAT (ix), (x), (xi) Protection of traditional knowledge (xv), (xvi), (xviii) Compliance mechanisms (xx), (xxi) Measures to facilitate implementation of the regime (viii), (xix), (xxii) Others (vii), (xii), (xxiii)

COP 7 – February 2004 Action Plan on Capacity-building Adopted by COP 7 (decision VII/19F, Annex) to facilitate and support the development of capacities for the effective implementation of the provisions of the Convention related to ABS Action Plan identifies: The objective of the Action Plan is to facilitate and support the development of capacities for the effective implementation of the provisions of the Convention related to ABS and in particular the Bonn Guidelines Key areas for capacity-building Mechanisms for the implementation of capacity-building in key areas, including actions at multiple levels, actions at the national level, actions at the regional, subregional and international levels. Mutual information-sharing and coordination at all levels to encourage synergies and to identify gaps in coverage

COP 7 follow-up Two meetings of the WG on ABS Third meeting of WG-ABS Bangkok, Thailand, 14-18 Feb. 2005 Fourth meeting of WG-ABS Granada, Spain, 30 Jan – 3 Feb. 2006

COP 8 developments Decision VIII/4 A Mandate of the Working Group on ABS renewed Two meetings prior to COP 9 WG-ABS to complete its work before COP 10 Designation of co-chairs Establishment of Group of Technical Experts on an internationally recognised certificate of origin/source/legal provenance

Preparations for GTE Notifications for nomination of experts and observers and for submissions of views and information Selection of experts and observers based on nominations received Documentation for the meeting: Agenda Annotated agenda Note by Executive Secretary Compilation of submissions

GTE Terms of reference Decision VIII/4C Consider the possible rationale, objectives and the need for an internationally recognised certificate of origin/source/legal provenance Define the potential characteristics and features of such an internationally recognised certificate Analyse the distinction between the options of certificate of origin/source/legal provenance and implications for achieving the objectives of Article 15 and 8(j) Identify associated implementation challenges

Outlook Group of Technical Experts, Lima, Peru, 22-25 January 2007 Working Group on ABS - 5th meeting: 10-14 September 2007 - 6th meeting: 21-25 January 2008 COP 9 Bonn, Germany, May 2008

Thank you for your attention!