The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits arising from their Utilization

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1 Queensland Museum Johny Keny/Shutterstock Rachel Wynberg Marsha Goldenberg/Shutterstock The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits arising from their Utilization Lyle Glowka Senior Legal Advisor, CBD Secretariat

2 Overview Background: ABS and CBD Nagoya Protocol: Innovations Next steps: The Protocol process

3 Origins of ABS: Equity and Conservation Incentives Equity: Primary principle driving CBD ABS negotiations Earliest origins: PGRFA (FAO) Aim: Redirect benefit flows back to provider(s) Conservation incentives: Provide a value to biodiversity to help conservation Well-publicized early examples (INBio-Merck) High expectations for big financial windfalls from biotech ( Green Gold ) [20 years later: Greater recognition of the value of non-monetary benefits (Bonn Guidelines and Nagoya Protocol)]

4 Why are genetic resources important? One of many ecosystem goods and services essential to human well-being (see Millennium Ecosystem Assessment (2005)) Major contributions to various formal and informal sectors contributing to sustainable development: Food and agriculture (plant varieties, animal breeds, biosecurity) Human health (pharmaceuticals, botanical medicines) Industry (products and processes) Human understanding of biodiversity (taxonomy, ecosystems) Customary use and associated traditional knowledge Shared interests of the international community to cooperate to conserve, sustainably use and share benefits (CBD 1992)

5 CBD Innovation: New Equity Relationship Access to genetic resources IN EXCHANGE FOR Fair and equitable share of the benefits derived from their use

6 CBD Provisions Fundamental access-related principles (Art 15): Sovereign rights over natural resources (art 15(1)) Prior informed consent (PIC) (art 15(5)) Mutually agreed terms (MATs) (including the sharing of benefits arising from the commercial and other utilization of genetic resources) (art 15(4) and (7))

7 Towards an ABS Protocol: The Need for Legal Certainty Outstanding key implementation issues Provider countries: Capacity to regulate access and monitor use How to ensure benefit-sharing after materials leave country? How to prevent / respond to misappropriation? Role / responsibilities of user countries? Derivatives of genetic resources? Users: Clear, transparent and efficient access rules / procedures

8 Nagoya Protocol: At Glance WSSD (2002): Initial mandate CBD (2004): WG-ABS mandated to negotiate Adopted: 29 October 2010 Operationalizes: CBD third objective and article 15 Objective: Ensure benefits arising from utilization of genetic resources are shared fairly and equitably

9 Nagoya Protocol: Innovations Scope Core elements: ABS Compliance measures Global multilateral benefit-sharing mechanism [Genetic resources of ILCs and associated traditional knowledge]

10 Nagoya Protocol Innovations: Scope Genetic resources within the scope of CBD Article 15 and the benefits arising from their utilization (art 3): Subject matter: In-situ & ex-situ materials (animal, plant or microbial) Temporal scope: No retroactivity (No pre-cbd / pre-protocol materials) Geographic scope: Areas within limits of national jurisdiction Clear application to biochemicals: Utilization of genetic resources : R&D on genetic and biochemical composition of genetic resources Derivatives : Naturally occurring biochemical compounds resulting from expression or metabolism of biological or genetic resources (even if not associated with genetic material) Suhel al-janabi

11 Nagoya Protocol Innovations: Access Sovereign rights Prior informed consent Obligation to take access measures providing: Legal certainty, clarity, transparency and timeliness Fair and non-arbitrary access rules / procedures Clear rules / procedures requiring / establishing MATs Permit or equivalent: Evidence of decision to grant PIC and that MATs established istockphoto

12 Nagoya Protocol Innovations: Benefit-sharing Benefits to be shared on MATs (art 5): Utilization Subsequent applications Commercialization Obligation to take measures to ensure benefit-sharing Monetary and non-monetary benefits (Annex) Access fees Milestone payments, license fees, royalties Technology transfer Sharing research results Effective research participation istockphoto

13 Nagoya Protocol Innovations: Compliance Obligations for each Party to take measures: Supporting compliance with provider country s domestic ABS requirements (art 15) Facilitating dispute resolution of non-compliance with MATs (contractual terms) (art 18) Monitoring use (art 17) Designate check points to collect information at any stage of value chain (research, development, innovation, pre-commercialization or commercialization) Internationally recognized certificate of compliance Encouraging model contractual clauses and codes of conduct (art 19 & 20)

14 Nagoya Protocol Innovations: Global Multilateral Benefit-sharing Mechanism (GMBSM) Some scope-related issues proved irresolvable Innovative solution needed for benefit-sharing (Preamble) Transboundary situations; or Where PIC not possible to grant or obtain Article 10: Need for and modalities GMBSM Benefits would be used to support biodiversity conservation and sustainable use globally ICNP2 (2012): First consideration

15 Next Steps: Towards Early Entry into Force Opened for signature at UN Headquarters (NY) 2 February 2011 until 1 February 2012 Entry into force Ninetieth day after deposit of 50 th instrument of ratification Target: First COP-MOP (CBD COP11, India, October 2012) Target: 10 July 2012 Open-ended Intergovernmental Committee (ICNP) Prepares COP-MOP first meeting First meeting: 6-10 June 2011 (Montreal) Second meeting: April 2012 (India) Awareness raising and capacity-building activities Government of Japan GEF

16 Thank you for your attention! Secretariat of the Convention on Biological Diversity 413 Saint Jacques Street, Suite 800 Montreal, QC, H2Y 1N9, Canada Tel: Fax: secretariat@cbd.int

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