The Nagoya Protocol and its links to

Intellectual Property

Expert Meeting on ABS and IPRs

5th to 9th September 2011, Addis Ababa, Ethiopia

Dr. Susanne Reyes-Knoche

5th September 2011, Addis Ababa, Ethiopia

Outline

1. Background

2. Purpose and core elements of the Nagoya Protocol on ABS

3. Links to IP/IPRs

CBD’s three objectives:

• Conservation of biological diversity

• Sustainable use of its components

• Fair and equitable sharing of benefits from

the utilization of genetic resources

Background

as an (economic) incentive to practise conservation and

sustainable use of biological diversity

facilitating access to GR

equitable share in the profits and technological

progress from the use of genetic resources

and associated traditional knowledge

incl. transfer of technology and know-how

and thus to provide a benefit in return

for conserving biological resources in situ

ABS – the idea

Core: Art. 15 CBD: MAT, PIC

Benefit sharing: Art. 15.7, 16, 19 and 8 j

Indigenous people and local communities: 8j

Article 15 of the CBD

• Sovereign rights of States over

their natural resources

• Parties to facilitate access to genetic

resources for environmentally sound

purposes

• 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 8 (j)

• Protection of traditional knowledge and equitable sharing of benefits arising from the utilization of such knowledge, innovations and practices

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

Prov. User

„resource-rich„ countries shall facilitate the

access to genetic resources

„technology-rich“ countries shall share benefits

arising from GR; facilitate the access to

technologies and means important for

conservation and use

“Logic” of CBD regarding

Access regulations

PIC / MAT

Prior Informed Consent (PIC) is consent obtained by the

user from the government of the provider country (and

according to nat. leg./reg.: relevant stakeholders, including

local communities and indigenous peoples who are the owners,

managers or custodians of genetic resources, or associated

traditional knowledge.

Key question: what / how is the GR used for ?

Core: PIC, MAT and Benefit Sharing

Mutually Agreed Terms (MAT) are conditions and provisions

of access and benefit-sharing, negotiated between the user and the

provider and involving other relevant stakeholders.

Benefits are shared fairly and equitably with all those who

contributed to the resource management, scientific or

commercial process. This may include governments at different

levels, and/or indigenous and local

communities, and relevant stakeholders.

Benefit-sharing is participation in the economic,

environmental, scientific, social or cultural benefits resulting

from access to genetic resources and associated traditional

knowledge.

Benefit-sharing provides short- and

long-term, monetary and non-monetary

benefits.

Need for legal certainty and transparency

• For providers: to ensure benefit-sharing once genetic

resources leave the provider country

• To prevent misappropriation of genetic resources

and associated traditional knowledge

• For users: to provide for clear and transparent

procedures for access to genetic resources

Why a Protocol on Access and

Benefit-sharing?

Nagoya Protocol on ABS

Mandate for negotiations

• WSSD, 2002: Political mandate for international regime on ABS

• COP VII, 2004: WG-ABS mandated to negotiate an international regime on ABS

• COP X, 2010: Finalization of the negotiations and adoption of the Nagoya Protocol on ABS

Overview

• Objective

• Scope

• Core Elements

• Tools and Mechanisms to

assist with implementation

• Institutional provisions

Nagoya Protocol on ABS

Objective

“…. the fair and equitable sharing of the benefits arising from the utilization 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, thereby contributing to the conservation of biological diversity and the sustainable use of its components”

Nagoya Protocol on ABS

Scope of the Protocol

• Genetic resources within the scope of Article 15 CBD and the benefits arising from the utilization of such resources

• Traditional knowledge associated with genetic resources within the scope of the CBD and the benefits arising from the utilization of such knowledge

Nagoya Protocol on ABS

c) Utilization of genetic resources” means to conduct research and

development on the genetic and/or biochemical composition of

genetic resources, including through the application of biotechnology as

defined in Article 2 of the Convention;

(d) “Biotechnology” as defined in Article 2 of the Convention means any

technological application that uses biological systems, living organisms, or

derivatives thereof, to make or modify products or processes for specific

use;

(e) “Derivative” means a naturally occurring biochemical compound resulting

from the genetic expression or metabolism of biological or genetic

resources, even if it does not contain functional units of heredity.

Utilization Art. 2 « Definitions »

• Sovereign rights over

natural resources

• Access is subject to the

prior informed consent

(PIC) of the provider

country

Core Elements: Access

© Manuel

Schäfer/Shutterstock

Obligation to establish

ABS measures at national level,

that provide for:

• legal certainty, clarity and transparency

• fair and non-arbitrary rules and procedures

• clear rules and procedures

for PIC and MAT

• the issuance of a permit or equivalent

Core Elements: Access

© iStockphoto

Obligation to take measures:

• For benefits arising from the utilization of genetic

resources as well as subsequent applications and

commercialization to be shared with the provider

country. Benefits to be shared on Mutually agreed

terms (MAT)

Benefits may be monetary and non-monetary

• benefits: Access fees, milestone payments, licence

fees, royalties, transfer of technology, sharing results

of research, effective participation in research (see

Annex)

Core Elements: Fair and Equitable-sharing

Compliance with national ABS legislation

Obligation to take measures:

• To provide that genetic resources utilized within a

Party‘s jurisdiction have been accessed in accordance

with PIC and MAT

• To address situations of non-compliance

Obligation to cooperate in cases of alleged violation of

domestic ABS legislation or regulatory requirements

Core Elements: Compliance

Compliance with MAT - obligation to:

• Encourage users and providers to include

provisions in MATs to cover dispute resolution

(including the jurisdiction; the applicable law;

and/or options for alternative dispute resolution)

• Ensure that opportunity to seek recourse

is available under each Party's legal systems

• To take effective measures regarding access to

justice; and the utilization of mechanisms regarding

mutual recognition and enforcement of foreign

judgments and arbitral awards

Core Elements: Compliance

• Monitoring of genetic resources

Obligation to take measures to monitor the utilization

of genetic resources:

• Designation of effective check points for collection of

information at any stage of research, development,

innovation, pre-commercialization or commercialization

• Encouraging reporting requirements in MAT

• Encouraging cost-effective communication tools

•Internationally recognized certificate of compliance as

evidence that PIC was obtained and MAT established

Core Elements: Compliance

PIC Competent National

Authority

MAT -Terms of Use (e.g. Commercial or non-

commercial)

-Benefit-sharing (monetary or non-monetary)

Permit

PROVIDER COUNTRY

Checkpoints:

-Research publishing houses

-Research institutions subject to public funding

-Patent examination offices

-Authorities providing regulatory or marketing

approval of products

Provide information

on PIC, MAT, source

of GRs, use of GRs

Utilization of GRs

USER COUNTRY

GRs +

Certificate

Monitoring the utilization

of genetic resources International Certificate of

Compliance

Notified to ABS

Clearing-House

Benefit-sharing

Tools to encourage

compliance:

Obligation to encourage the

development, update and use: • Model Contractual Clauses for

MATs

• Codes of Conduct, Guidelines

and Best Practices and/or

Standards

© UNEP © iStock

Core Elements: Compliance

Core elements:

Indigenous and local communities

• Indigenous and local communities rely on

genetic resources and have helped preserve

and maintain biodiversity over centuries

• Traditional knowledge related to biological

resources can be an important source of

information for identifying new uses of

genetic resources

• The Protocol will provide incentives for the

protection and promotion of traditional

knowledge

Core elements:

Indigenous and local communities

The Protocol aims to ensure that:

• Indigenous and local communities obtain a

fair share of benefits from the use of their:

• Traditional knowledge associated to genetic resources

• Genetic resources, in cases where they have

established rights to grant access to them, in

accordance with national legislation

• Access will be subject to their prior informed consent,

taking into account their customary laws and procedures

Global Multilateral

Benefit-sharing Mechanism

The Protocol creates incentives to conserve biological

diversity and to sustainably use its components

Global Multilateral Benefit-sharing Mechanism

• To be further considered for benefits derived from the

use of GR / traditional knowledge that occur in trans-

boundary situations or for which PIC cannot be granted • Benefits from the mechanism are to be used to support

the conservation and sustainable use of biodiversity

Tools and Mechanisms

to assist with implementation

• Capacity-building/Awareness-raising

• Technology Transfer

• National Focal Points and

Competent National Authorities

• ABS Clearing House

• Financial Mechanism

• Monitoring and Compliance

with the Protocol

• Biocultural Community Protocols

Next Steps

• Opening for signature by Parties to the CBD at UN

Headquarters in New York from 2 February 2011 until 1

February 2012

• Entry into force on the ninetieth day after the date of

deposit of the 50th instrument of ratification by Parties to

the CBD

• Establishment of an Open-ended Intergovernmental

Committee to prepare for the first meeting of COP/MOP

• First meeting: 6 to 10 June 2011

Links to IP/IPRS

Art. 6 NP Access to genetic resources

Para. 3: Pursuant to paragraph 1 above, each Party requiring

prior informed consent shall take the necessary legislative,

administrative or policy measures, as appropiate, to:

lit. (g) Establish clear rules and procedures for requiring and

establishing mutually agreed terms. Such terms shall be set out

in writing and may include, inter alia: (…)

(ii) Terms on benefit-sharing, including in relation to intellectual

property rights;

Links to IP/IPRs

Annex to the Nagoya Protocol

Monetary and Non-Monetary Benefits

1. Monetary benefits may include, but not be limited to: (…)

lit. (j) Joint ownership of relevant intellectual property rights.

2. Non-monetary benefits may include, but not be limited to: (…)

lit. (q) Joint ownership of relevant intellectual property rights

Links to IP/IPRS: Where are other non explicit links?

Art. 6 NP: Obligation to establish ABS measures that provide for:

Legal certainty, clarity and transparency → important In order to attract

(research) investment and create enabling environment for valorization of

GR/BR

Fair and non-arbitrary rules and procedures → e.g. to create a trustworthy

environment for investment; important project conception and timely

implemntation

Clear rules and procedures for PIC and MAT → IP clauses in MAT

negotiations

The issuance of a permit or equivalent → Permit/equivalent evtl. needed

for IPRs applications (e.g. patents)

Links to IP/IPRs

- Compliance with MAT, Art. 15 NP, Art. 18 NP, Art. 6 lit 3 (g)

- Regulations in the context of the protection of TK

associated with GRs, e.g. Art. 12 para. 3 lit b, lit c

- The Access and Benefit-Sharing Clearing House and

Information-Sharing, Art. 14 NP

- Permits or equivalents

- Certificate of compliance

- Model and tools developed to monitor GRs

- Codes of conduct and best practices

Links to IP/IPRs

- Monitoring the utilization of GRs, Art. 17 NP

- Checkpoints

- Internationally recognized certificate of compliance

- permit or its equivalent

Thank you!