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

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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: secretariat@cbd.intwww.cbd.int

ThankThank youyou for for youryour attention!attention!