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The Nagoya Protocol on Access to Genetic The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Resources and the Fair and Equitable Sharing of
Benefits arising from their UtilizationBenefits arising from their Utilization
Lyle GlowkaSenior Legal Advisor, CBD Secretariat
© JohnyKeny/Shutterstock
© Rachel Wynberg
© Marsha Goldenberg/Shutterstock
© Queensland Museum
• Background: ABS and CBD
• Nagoya Protocol: Innovations
• Next steps: The Protocol process
Overview
Origins of ABS: Equity and Conservation Origins of ABS: Equity and Conservation IncentivesIncentives
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)]
Why are genetic resources important?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 secto rs 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 co operate to conserve, sustainably use and share benefits (CBD 1992)
CBD Innovation: CBD Innovation: ““ NewNew”” Equity RelationshipEquity Relationship
Fair and equitable share of the benefitsderived from their use
IN EXCHANGEFOR
Access to genetic resources
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 benefitsarising from the commercial and other utilization of geneticresources) (art 15(4) and (7))
CBD ProvisionsCBD Provisions
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
Towards an ABS Protocol: Towards an ABS Protocol: The Need for Legal CertaintyThe Need for Legal Certainty
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
Nagoya Protocol: At Glance
Scope
Core elements : • ABS
• Compliance measures
Global multilateral benefit-sharing mechanism
[Genetic resources of ILCs and associated traditional kn owledge]
Nagoya Protocol: InnovationsNagoya Protocol: Innovations
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
Nagoya Protocol Innovations: ScopeNagoya Protocol Innovations: Scope
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 thatMATs established
Nagoya Protocol Innovations: AccessNagoya Protocol Innovations: Access
© iStockphoto
Benefits to be shared on MATs (art 5) :
• Utilization
• Subsequent applications
• Commercialization
Obligation to take measures to ensure benefit-shari ng
Monetary and non-monetary benefits (Annex)
• Access fees
• Milestone payments, license fees, royalties
• Technology transfer
• Sharing research results
• Effective research participation
Nagoya Protocol Innovations: Nagoya Protocol Innovations: BenefitBenefit --sharing sharing
© iStockphoto
Obligations for each Party to take measures:
Supporting compliance with provider country’s domestic ABS requirements (art 15)
Facilitating dispute resolution of non-compliance wi th 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)
Nagoya Protocol Innovations: Nagoya Protocol Innovations: ComplianceCompliance
Nagoya Protocol Innovations: Global Nagoya Protocol Innovations: Global Multilateral BenefitMultilateral Benefit --sharing Mechanism sharing Mechanism (GMBSM)(GMBSM)
Some scope-related issues proved irresolvableInnovative 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
Next Steps: Next Steps: Towards Early Entry into ForceTowards 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 50th 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
Secretariat of the Convention on Biological Diversity
413 Saint Jacques Street, Suite 800Montreal, QC, H2Y 1N9, Canada
Tel: +1 514 288 2220Fax: + 1 514 288 6588
Email: [email protected]
ThankThank youyou for for youryour attention!attention!