# EUR-Lex - 52012PC0577 - EN

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# 52012PC0577

**Proposal for a COUNCIL DECISION on the conclusion of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity /* COM/2012/0577 final - 2012/0279 (NLE) */**

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ANNEX

NAGOYA PROTOCOL ON
ACCESS TO GENETIC RESOURCES AND THE FAIR AND EQUITABLE SHARING OF BENEFITS
ARISING FROM THEIR UTILIZATION TO THE CONVENTION ON BIOLOGICAL DIVERSITY

The Parties to this Protocol,

Being Parties to the Convention on Biological Diversity, hereinafter
referred to as “the Convention”,

Recalling
that the fair and equitable sharing of benefits
arising from the utilization of genetic resources is one of three core
objectives of the Convention, and recognizing that this Protocol pursues
the implementation of this objective within the Convention,

Reaffirming
the sovereign rights of States over their natural
resources and according to the provisions of the Convention,

Recalling
further Article 15 of the Convention,

Recognizing the important contribution to sustainable development made by
technology transfer and cooperation to build research and innovation capacities
for adding value to genetic resources in developing countries, in accordance
with Articles 16 and 19 of the Convention,

Recognizing that public awareness of the economic value of ecosystems and
biodiversity and the fair and equitable sharing of this economic value with the
custodians of biodiversity are key incentives for the conservation of
biological diversity and the sustainable use of its components,

Acknowledging
the potential role of access and benefit-sharing to
contribute to the conservation and sustainable use of biological diversity,
poverty eradication and environmental sustainability and thereby contributing
to achieving the Millennium Development Goals,

Acknowledging
the linkage between access to genetic resources and the fair and equitable
sharing of benefits arising from the utilization of
such resources,

Recognizing
the importance of providing legal certainty with respect to access to genetic
resources and the fair and equitable sharing of benefits arising from their utilization,

Further recognizing the importance of promoting equity and fairness in
negotiation of mutually agreed terms between providers and users of genetic
resources,

Recognizing also the vital role that women play in access and
benefit-sharing and affirming the need for the full participation of
women at all levels of policymaking and implementation for biodiversity
conservation,

Determined
to further support the effective implementation of the access and
benefit-sharing provisions of the Convention,

Recognizing
that an innovative solution is required to address the fair and equitable
sharing of benefits derived from the utilization of genetic resources and
traditional knowledge associated with genetic resources that occur in
transboundary situations or for which it is not possible to grant or obtain
prior informed consent,

Recognizing the importance of genetic resources to food security, public
health, biodiversity conservation, and the mitigation of and adaptation to
climate change,

Recognizing the special nature of agricultural biodiversity, its distinctive
features and problems needing distinctive solutions,

Recognizing
the interdependence of all countries with regard to
genetic resources for food and agriculture as well as their special nature and
importance for achieving food security worldwide and for sustainable
development of agriculture in the context of poverty alleviation and climate
change and acknowledging the fundamental role of the International Treaty on
Plant Genetic Resources for Food and Agriculture and the FAO Commission on
Genetic Resources for Food and Agriculture in this regard,

Mindful of
the International Health Regulations (2005) of the World Health Organization
and the importance of ensuring access to human pathogens for public health
preparedness and response purposes,

Acknowledging ongoing work in other international forums relating to access and
benefit-sharing,

Recalling the Multilateral System of Access and Benefit-sharing established
under the International Treaty on Plant Genetic Resources for Food and
Agriculture developed in harmony with the Convention,

Recognizing that international instruments related to access and benefit-sharing
should be mutually supportive with a view to achieving the objectives of the
Convention,

Recalling
the relevance of Article 8(j) of the
Convention as it relates to traditional knowledge associated with genetic
resources and the fair and equitable sharing of benefits arising from the
utilization of such knowledge,

Noting
the interrelationship between genetic resources and
traditional knowledge, their inseparable nature for indigenous and local
communities, the importance of the traditional knowledge for the conservation
of biological diversity and the sustainable use of its components, and for the
sustainable livelihoods of these communities,

Recognizing
the diversity of circumstances in which traditional
knowledge associated with genetic resources is held or owned by indigenous and
local communities,

Mindful that it is the right of indigenous and local communities to
identify the rightful holders of their traditional knowledge associated with
genetic resources, within their communities,

Further
recognizing the unique circumstances where
traditional knowledge associated with genetic resources is held in countries,
which may be oral, documented or in other forms, reflecting a rich cultural
heritage relevant for conservation and sustainable use of biological diversity,

Noting
the United Nations Declaration on the Rights of
Indigenous Peoples, and

Affirming
that nothing in this Protocol shall be construed as
diminishing or extinguishing the existing rights of indigenous and local
communities,

Have agreed
as follows:

Article
1

OBJECTIVE

The objective of this Protocol is 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.

Article
2

USE
OF TERMS

The
terms defined in Article 2 of the Convention shall apply to this Protocol. In
addition, for the purposes of this Protocol:

(a)        “Conference
of the Parties” means the Conference of the Parties to the Convention;

(b)        “Convention”
means the Convention on Biological Diversity;

(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.

Article
3

SCOPE

This Protocol shall apply to genetic resources within the scope of
Article 15 of the Convention and to the benefits arising from the utilization
of such resources. This Protocol shall also apply to traditional knowledge
associated with genetic resources within the scope of the Convention and to the
benefits arising from the utilization of such knowledge.

ARTICLE
4

RELATIONSHIP
WITH INTERNATIONAL AGREEMENTS AND INSTRUMENTS

1.         The provisions of this Protocol shall not affect the
rights and obligations of any Party deriving from any existing international agreement,
except where the exercise of those rights and obligations would cause a serious
damage or threat to biological diversity. This paragraph is not intended to
create a hierarchy between this Protocol and other international instruments.

2.         Nothing in this Protocol shall prevent the Parties from
developing and implementing other relevant international agreements, including
other specialized access and benefit-sharing agreements, provided that they are
supportive of and do not run counter to the objectives of the Convention and
this Protocol.

3.         This
Protocol shall be implemented in a mutually
supportive manner with other international instruments relevant to this
Protocol. Due regard should be paid to useful and
relevant ongoing work or practices under such international instruments and
relevant international organizations, provided that they are supportive of and
do not run counter to the objectives of the Convention and this Protocol.

4.         This Protocol is the instrument for the implementation of
the access and benefit-sharing provisions of the Convention. Where a
specialized international access and benefit-sharing instrument applies that is
consistent with, and does not run counter to the objectives of the Convention
and this Protocol, this Protocol does not apply for the Party or Parties to the
specialized instrument in respect of the specific genetic resource covered by
and for the purpose of the specialized instrument.

Article
5

FAIR
AND EQUITABLE BENEFIT-SHARING

1.         In accordance with Article 15, paragraphs 3 and 7 of the
Convention, benefits arising from the utilization of genetic resources as well
as subsequent applications and commercialization shall be shared in a fair and
equitable way with the Party providing such resources that is the country of
origin of such resources or a Party that has acquired the genetic resources in
accordance with the Convention. Such sharing shall be upon mutually agreed
terms.

2.         Each Party shall take legislative, administrative or
policy measures, as appropriate, with the aim of ensuring that benefits arising
from the utilization of genetic resources that are held by indigenous and local
communities, in accordance with domestic legislation regarding the established
rights of these indigenous and local communities over these genetic resources,
are shared in a fair and equitable way with the communities concerned, based on
mutually agreed terms.

3.         To implement paragraph 1 above, each Party shall take
legislative, administrative or policy measures, as appropriate.

4.         Benefits may include monetary and non‑monetary
benefits, including but not limited to those listed in the Annex.

5.         Each Party shall take legislative, administrative or
policy measures as appropriate, in order that the benefits arising from the
utilization of traditional knowledge associated with genetic resources are
shared in a fair and equitable way with indigenous and local communities
holding such knowledge. Such sharing shall be upon mutually agreed terms.

Article
6

ACCESS
TO GENETIC RESOURCES

1.         In the exercise of sovereign rights over natural
resources, and subject to domestic access and benefit-sharing legislation or
regulatory requirements, access to genetic resources for their utilization
shall be subject to the prior informed consent of the Party providing such
resources that is the country of origin of such resources or a Party that has
acquired the genetic resources in accordance with the Convention, unless
otherwise determined by that Party.

2.         In accordance with domestic law, each Party shall take
measures, as appropriate, with the aim of ensuring that the prior informed
consent or approval and involvement of indigenous and local communities is
obtained for access to genetic resources where they have the established right
to grant access to such resources.

3.         Pursuant to paragraph 1 above, each Party requiring prior
informed consent shall take the necessary legislative, administrative or policy
measures, as appropriate, to:

(a)      Provide for legal certainty, clarity
and transparency of their domestic access and benefit‑sharing legislation
or regulatory requirements;

(b)     Provide for fair and non-arbitrary
rules and procedures on accessing genetic resources;

(c)      Provide information on how to apply
for prior informed consent;

(d)     Provide for a clear and transparent
written decision by a competent national authority, in a cost-effective manner
and within a reasonable period of time;

(e)      Provide for the issuance at the time
of access of a permit or its equivalent as evidence of the decision to grant
prior informed consent and of the establishment of mutually agreed terms, and
notify the Access and Benefit-sharing Clearing-House accordingly;

(f)      Where applicable, and subject to
domestic legislation, set out criteria and/or processes for obtaining prior
informed consent or approval and involvement of indigenous and local
communities for access to genetic resources; and

(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:

(i)         A dispute settlement clause;

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

(iii)        Terms on subsequent third-party
use, if any; and

(iv)        Terms on changes of intent, where
applicable.

Article
7

ACCESS
TO TRADITIONAL KNOWLEDGE ASSOCIATED WITH GENETIC RESOURCES

In accordance with domestic law, each Party shall take measures, as
appropriate, with the aim of ensuring that traditional knowledge associated
with genetic resources that is held by indigenous and local communities is
accessed with the prior and informed consent or approval and involvement of
these indigenous and local communities, and that mutually agreed terms have
been established.

Article
8

SPECIAL
CONSIDERATIONS

In the development and implementation of its access and
benefit-sharing legislation or regulatory requirements, each Party shall:

(a)      Create conditions to promote and
encourage research which contributes to the conservation and sustainable use of
biological diversity, particularly in developing countries, including through
simplified measures on access for non-commercial research purposes, taking into
account the need to address a change of intent for such research;

(b)     Pay due regard to cases of present or
imminent emergencies that threaten or damage human, animal or plant health, as
determined nationally or internationally. Parties may take into consideration
the need for expeditious access to genetic resources and expeditious fair and
equitable sharing of benefits arising out of the use of such genetic resources,
including access to affordable treatments by those in need, especially in
developing countries;

(c)      Consider the importance of
genetic resources for food and agriculture and their special role for food
security.

Article
9

CONTRIBUTION
TO CONSERVATION AND SUSTAINABLE USE

The Parties shall encourage users and
providers to direct benefits arising from the utilization of genetic resources
towards the conservation of biological diversity and the sustainable use of its
components.

ARTICLE
10

GLOBAL
MULTILATERAL BENEFIT-SHARING MECHANISM

Parties shall consider the need for and modalities of a global
multilateral benefit-sharing mechanism to address the fair and equitable
sharing of benefits derived from the utilization of genetic resources and
traditional knowledge associated with genetic resources that occur in
transboundary situations or for which it is not possible to grant or obtain
prior informed consent. The benefits shared by users of genetic resources and
traditional knowledge associated with genetic resources through this mechanism
shall be used to support the conservation of biological diversity and the
sustainable use of its components globally.

Article
11

TRANSBOUNDARY
COOPERATION

1.         In instances where the same genetic resources are found in
situ within the territory of more than one Party, those Parties shall endeavour
to cooperate, as appropriate, with the involvement of indigenous and local
communities concerned, where applicable, with a view to implementing this
Protocol.

2.         Where the same traditional knowledge associated with
genetic resources is shared by one or more indigenous and local communities in
several Parties, those Parties shall endeavour to cooperate, as appropriate,
with the involvement of the indigenous and local communities concerned, with a
view to implementing the objective of this Protocol.

Article
12

TRADITIONAL
KNOWLEDGE ASSOCIATED WITH GENETIC RESOURCES

1.         In implementing their obligations under this Protocol,
Parties shall in accordance with domestic law take into consideration
indigenous and local communities’ customary laws, community protocols and
procedures, as applicable, with respect to traditional knowledge associated
with genetic resources.

2.         Parties, with the effective participation of the
indigenous and local communities concerned, shall establish mechanisms to
inform potential users of traditional knowledge associated with genetic
resources about their obligations, including measures as made available through
the Access and Benefit-sharing Clearing-House for access to and fair and
equitable sharing of benefits arising from the utilization of such knowledge.

3.         Parties shall endeavour to support, as
appropriate, the development by indigenous and local communities, including
women within these communities, of:

(a)      Community protocols in relation to
access to traditional knowledge associated with genetic resources and the fair
and equitable sharing of benefits arising out of the utilization of such
knowledge;

(b)     Minimum requirements for mutually
agreed terms to secure the fair and equitable sharing of benefits arising from
the utilization of traditional knowledge associated with genetic resources; and

(c)      Model contractual clauses for
benefit-sharing arising from the utilization of traditional knowledge
associated with genetic resources.

4.         Parties, in their implementation of this Protocol, shall,
as far as possible, not restrict the customary use and exchange of genetic
resources and associated traditional knowledge within and amongst indigenous
and local communities in accordance with the objectives of the Convention.

Article
13

NATIONAL
FOCAL POINTS AND COMPETENT NATIONAL AUTHORITIES

1.         Each Party shall designate a national focal
point on access and benefit-sharing. The national focal point shall make
information available as follows:

(a)      For applicants
seeking access to genetic resources, information on procedures for obtaining
prior informed consent and establishing mutually agreed terms, including
benefit-sharing;

(b)     For applicants seeking access to
traditional knowledge associated with genetic resources, where possible,
information on procedures for obtaining prior informed consent or approval and
involvement, as appropriate, of indigenous and local communities and
establishing mutually agreed terms including benefit-sharing; and

(c)      Information on competent national
authorities, relevant indigenous and local communities and relevant
stakeholders.

The
national focal point shall be responsible for liaison with the Secretariat.

2.         Each Party shall designate one or more competent national
authorities on access and benefit‑sharing. Competent national authorities
shall, in accordance with applicable national legislative, administrative or
policy measures, be responsible for granting access or, as applicable, issuing
written evidence that access requirements have been met and be responsible for
advising on applicable procedures and requirements for obtaining prior informed
consent and entering into mutually agreed terms.

3.         A Party may designate a single entity to fulfil the
functions of both focal point and competent national authority.

4.         Each Party shall, no later than the date of entry into
force of this Protocol for it, notify the Secretariat of the contact
information of its national focal point and its competent national authority or
authorities. Where a Party designates more than one competent national
authority, it shall convey to the Secretariat, with its notification thereof,
relevant information on the respective responsibilities of those authorities.
Where applicable, such information shall, at a minimum, specify which competent
authority is responsible for the genetic resources sought. Each Party shall
forthwith notify the Secretariat of any changes in the designation of its
national focal point or in the contact information or responsibilities of its
competent national authority or authorities.

5.         The Secretariat shall make information received pursuant
to paragraph 4 above available through the Access and Benefit-sharing Clearing-House.

Article
14

THE
ACCESS AND BENEFIT-SHARING CLEARING-HOUSE AND INFORMATION‑SHARING

1.         An Access and Benefit-sharing Clearing-House is hereby
established as part of the clearing‑house mechanism under Article 18,
paragraph 3, of the Convention. It shall serve as a means for sharing of
information related to access and benefit-sharing. In particular, it shall
provide access to information made available by each Party relevant to the
implementation of this Protocol.

2.         Without prejudice to the protection of
confidential information, each Party shall make available to the Access and
Benefit-sharing Clearing-House any information required by this Protocol, as
well as information required pursuant to the decisions taken by the Conference
of the Parties serving as the meeting of the Parties to this Protocol. The
information shall include:

(a)      Legislative, administrative and policy measures on access and
benefit-sharing;

(b)     Information on the national focal point
and competent national authority or authorities; and

(c)      Permits or their equivalent issued at
the time of access as evidence of the decision to grant prior informed consent
and of the establishment of mutually agreed terms.

3.         Additional information, if
available and as appropriate, may include:

(a)      Relevant competent authorities of
indigenous and local communities, and information as so decided;

(b)     Model contractual clauses;

(c)      Methods and tools developed to monitor
genetic resources; and

(d)     Codes of conduct and best practices.

4.         The modalities of the operation of the Access and
Benefit-sharing Clearing-House, including reports on its activities, shall be
considered and decided upon by the Conference of the Parties serving as the
meeting of the Parties to this Protocol at its first meeting, and kept under
review thereafter.

Article
15

COMPLIANCE
WITH DOMESTIC LEGISLATION OR REGULATORY REQUIREMENTs ON ACCESS AND
BENEFIT-SHARING

1.         Each Party shall take appropriate, effective and
proportionate legislative, administrative or policy measures to provide that
genetic resources utilized within its jurisdiction have been accessed in
accordance with prior informed consent and that mutually agreed terms have been
established, as required by the domestic access and benefit-sharing legislation
or regulatory requirements of the other Party.

2.         Parties shall take appropriate, effective and
proportionate measures to address situations of non‑compliance with
measures adopted in accordance with paragraph 1 above.

3.         Parties shall, as far as possible and as appropriate,
cooperate in cases of alleged violation of domestic access and benefit-sharing
legislation or regulatory requirements referred to in paragraph 1 above.

ARTICLE 16

COMPLIANCE
WITH DOMESTIC LEGISLATION OR REGULATORY REQUIREMENTs ON ACCESS AND BENEFIT-SHARING
for traditional knowledge associated with genetic resources

1.         Each Party shall take appropriate, effective and
proportionate legislative, administrative or policy measures, as appropriate,
to provide that traditional knowledge associated with genetic resources
utilized within their jurisdiction has been accessed in accordance with prior
informed consent or approval and involvement of indigenous and local
communities and that mutually agreed terms have been established, as required
by domestic access and benefit‑sharing legislation or regulatory
requirements of the other Party where such indigenous and local communities are
located.

2.         Each Party shall take appropriate, effective and
proportionate measures to address situations of non-compliance with measures
adopted in accordance with paragraph 1 above.

3.         Parties shall, as far as possible and as appropriate,
cooperate in cases of alleged violation of domestic access and benefit-sharing
legislation or regulatory requirements referred to in paragraph 1 above.

ARTICLE 17

MONITORING
THE UTILIZATION OF GENETIC RESOURCES

1.         To support compliance, each Party shall take
measures, as appropriate, to monitor and to enhance transparency about the
utilization of genetic resources. Such measures shall include:

(a)      The
designation of one or more checkpoints, as follows:

(i)         Designated
checkpoints would collect or receive, as appropriate, relevant information
related to prior informed consent, to the source of the genetic resource, to
the establishment of mutually agreed terms, and/or to the utilization of
genetic resources, as appropriate;

(ii)         Each
Party shall, as appropriate and depending on the particular characteristics of
a designated checkpoint, require users of genetic resources to provide the information
specified in the above paragraph at a designated checkpoint. Each Party shall
take appropriate, effective and proportionate measures to address situations of
non-compliance;

(iii)        Such
information, including from internationally recognized certificates of
compliance where they are available, will, without prejudice to the protection
of confidential information, be provided to relevant national authorities, to
the Party providing prior informed consent and to the Access and
Benefit-sharing Clearing-House, as appropriate;

(iv)        Check
points must be effective and should have functions relevant to implementation
of this subparagraph (a). They should be relevant to the utilization of genetic
resources, or to the collection of relevant information at, inter alia,
any stage of research, development, innovation, pre-commercialization or
commercialization.

(b)     Encouraging
users and providers of genetic resources to include provisions in mutually
agreed terms to share information on the implementation of such terms,
including through reporting requirements; and

(c)      Encouraging
the use of cost-effective communication tools and systems.

2.         A permit or its equivalent issued in accordance with
Article 6, paragraph 3 (e) and made available to the Access and Benefit-sharing
Clearing-House, shall constitute an internationally recognized certificate of
compliance.

3.         An internationally recognized certificate of compliance
shall serve as evidence that the genetic resource which it covers has been
accessed in accordance with prior informed consent and that mutually agreed
terms have been established, as required by the domestic access and
benefit-sharing legislation or regulatory requirements of the Party providing
prior informed consent.

4.         The internationally recognized certificate
of compliance shall contain the following minimum information when it is not
confidential:

(a)      Issuing
authority;

(b)     Date
of issuance;

(c)      The
provider;

(d)     Unique
identifier of the certificate;

(e)      The
person or entity to whom prior informed consent was granted;

(f)      Subject-matter
or genetic resources covered by the certificate;

(g)      Confirmation
that mutually agreed terms were established;

(h)      Confirmation
that prior informed consent was obtained; and

(i)       Commercial
and/or non-commercial use.

ARTICLE 18

COMPLIANCE
WITH MUTUALLY AGREED TERMS

1.         In the implementation of Article 6,
paragraph 3 (g) (i) and Article 7, each Party shall encourage providers and
users of genetic resources and/or traditional knowledge associated with genetic
resources to include provisions in mutually agreed terms to cover, where
appropriate, dispute resolution including:

(a)      The
jurisdiction to which they will subject any dispute resolution processes;

(b)     The
applicable law; and/or

(c)      Options
for alternative dispute resolution, such as mediation or arbitration.

2.         Each Party shall ensure that an opportunity to seek
recourse is available under their legal systems, consistent with applicable
jurisdictional requirements, in cases of disputes arising from mutually agreed terms.

3.         Each Party shall take effective measures, as
appropriate, regarding:

(a)      Access to justice;
and

(b)     The
utilization of mechanisms regarding mutual recognition and enforcement of
foreign judgments and arbitral awards.

4.         The effectiveness of this article shall be reviewed by
the Conference of the Parties serving as the meeting of the Parties to this
Protocol in accordance with Article 31 of this Protocol.

ARTICLE 19

MODEL
CONTRACTUAL CLAUSES

1.         Each Party shall encourage, as appropriate, the development,
update and use of sectoral and cross-sectoral model contractual clauses for
mutually agreed terms.

2.         The Conference of the Parties serving as the meeting of
the Parties to this Protocol shall periodically take stock of the use of
sectoral and cross-sectoral model contractual clauses.

ARTICLE 20

CODES
OF CONDUCT, guidelines AND BEST PRACTICEs AND/OR STANDARDS

1.         Each Party shall encourage, as appropriate, the
development, update and use of voluntary codes of conduct, guidelines and best
practices and/or standards in relation to access and benefit-sharing.

2.         The Conference of the Parties serving as the meeting of
the Parties to this Protocol shall periodically take stock of the use of
voluntary codes of conduct, guidelines and best practices and/or standards and
consider the adoption of specific codes of conduct, guidelines and best
practices and/or standards.

ARTICLE 21

AWARENESS-RAISING

Each Party shall take measures to raise awareness of
the importance of genetic resources and traditional knowledge associated with
genetic resources, and related access and benefit‑sharing issues. Such
measures may include, inter alia:

(a)      Promotion
of this Protocol, including its objective;

(b)     Organization
of meetings of indigenous and local communities and relevant stakeholders;

(c)      Establishment
and maintenance of a help desk for indigenous and local communities and
relevant stakeholders;

(d)     Information
dissemination through a national clearing-house;

(e)      Promotion
of voluntary codes of conduct, guidelines and best practices and/or standards
in consultation with indigenous and local communities and relevant
stakeholders;

(f)      Promotion
of, as appropriate, domestic, regional and international exchanges of
experience;

(g)      Education
and training of users and providers of genetic resources and traditional
knowledge associated with genetic resources about their access and
benefit-sharing obligations;

(h)      Involvement
of indigenous and local communities and relevant stakeholders in the
implementation of this Protocol; and

(i)       Awareness-raising
of community protocols and procedures of indigenous and local communities.

ARTICLE 22

CAPACITY

1.         The Parties shall cooperate in
the capacity-building, capacity development and strengthening of human
resources and institutional capacities to effectively implement this Protocol
in developing country Parties, in particular the least developed countries and
small island developing States among them, and Parties with economies in
transition, including through existing global, regional, subregional and
national institutions and organizations. In this context, Parties should
facilitate the involvement of indigenous and local communities and relevant
stakeholders, including non-governmental organizations and the private sector.

2.         The need of developing country Parties, in particular the
least developed countries and small island developing States among them, and
Parties with economies in transition for financial resources in accordance with
the relevant provisions of the Convention shall be taken fully into account for
capacity‑building and development to implement this Protocol.

3.         As a basis for appropriate measures in relation to the
implementation of this Protocol, developing country Parties, in particular the
least developed countries and small island developing States among them, and
Parties with economies in transition should identify their national capacity
needs and priorities through national capacity self-assessments. In doing so,
such Parties should support the capacity needs and priorities of indigenous and
local communities and relevant stakeholders, as identified by them, emphasizing
the capacity needs and priorities of women.

4.         In support of the implementation of this
Protocol, capacity-building and development may address, inter alia, the
following key areas:

(a)      Capacity
to implement, and to comply with the obligations of, this Protocol;

(b)     Capacity
to negotiate mutually agreed terms;

(c)      Capacity
to develop, implement and enforce domestic legislative, administrative or
policy measures on access and benefit-sharing; and

(d)     Capacity
of countries to develop their endogenous research capabilities to add value to
their own genetic resources.

5.         Measures in accordance with
paragraphs 1 to 4 above may include, inter alia:

(a)      Legal
and institutional development;

(b)     Promotion
of equity and fairness in negotiations, such as training to negotiate mutually
agreed terms;

(c)      The
monitoring and enforcement of compliance;

(d)     Employment
of best available communication tools and Internet-based systems for access and
benefit-sharing activities;

(e)      Development
and use of valuation methods;

(f)      Bioprospecting,
associated research and taxonomic studies;

(g)      Technology
transfer, and infrastructure and technical capacity to make such technology
transfer sustainable;

(h)      Enhancement
of the contribution of access and benefit-sharing activities to the
conservation of biological diversity and the sustainable use of its components;

(i)       Special
measures to increase the capacity of relevant stakeholders in relation to
access and benefit-sharing; and

(j)      Special
measures to increase the capacity of indigenous and local communities with
emphasis on enhancing the capacity of women within those communities in
relation to access to genetic resources and/or traditional knowledge associated
with genetic resources.

6.         Information on capacity-building and development
initiatives at national, regional and international levels, undertaken in
accordance with paragraphs 1 to 5 above, should be provided to the Access and
Benefit-sharing Clearing-House with a view to promoting synergy and
coordination on capacity-building and development for access and
benefit-sharing.

ARTICLE 23

TECHNOLOGY
TRANSFER, collaboration AND COOPERATION

In accordance with Articles 15, 16, 18 and 19 of the Convention, the
Parties shall collaborate and cooperate in technical and scientific research
and development programmes, including biotechnological research activities, as
a means to achieve the objective of this Protocol. The Parties undertake to
promote and encourage access to technology by, and transfer of technology to,
developing country Parties, in particular the least developed countries and
small island developing States among them, and Parties with economies in
transition, in order to enable the development and strengthening of a sound and
viable technological and scientific base for the attainment of the objectives
of the Convention and this Protocol. Where possible and appropriate such
collaborative activities shall take place in and with a Party or the Parties
providing genetic resources that is the country or are the countries of origin
of such resources or a Party or Parties that have acquired the genetic
resources in accordance with the Convention.

ARTICLE 24

NON-PARTIES

The Parties shall encourage non-Parties to adhere to this Protocol
and to contribute appropriate information to the Access and Benefit-sharing
Clearing-House.

ARTICLE 25

FINANCIAL
MECHANISM AND RESOURCES

1.         In considering financial resources for the implementation
of this Protocol, the Parties shall take into account the provisions of Article
20 of the Convention.

2.         The financial mechanism of the Convention shall be the
financial mechanism for this Protocol.

3.         Regarding the capacity-building and development referred
to in Article 22 of this Protocol, the Conference of the Parties serving as the
meeting of the Parties to this Protocol, in providing guidance with respect to
the financial mechanism referred to in paragraph 2 above, for consideration by
the Conference of the Parties, shall take into account the need of developing
country Parties, in particular the least developed countries and small island
developing States among them, and of Parties with economies in transition, for
financial resources, as well as the capacity needs and priorities of indigenous
and local communities, including women within these communities.

4.         In the context of paragraph 1 above, the Parties shall
also take into account the needs of the developing country Parties, in
particular the least developed countries and small island developing States
among them, and of the Parties with economies in transition, in their efforts
to identify and implement their capacity-building and development requirements
for the purposes of the implementation of this Protocol.

5.         The guidance to the financial mechanism of the Convention
in relevant decisions of the Conference of the Parties, including those agreed
before the adoption of this Protocol, shall apply, mutatis mutandis, to
the provisions of this Article.

6.         The developed country Parties may also provide, and the
developing country Parties and the Parties with economies in transition avail
themselves of, financial and other resources for the implementation of the
provisions of this Protocol through bilateral, regional and multilateral
channels.

ARTICLE 26

CONFERENCE
OF THE PARTIES SERVING AS THE MEETING OF THE PARTIES
TO THIS PROTOCOL

1.         The Conference of the Parties shall serve as the meeting
of the Parties to this Protocol.

2.         Parties to the Convention that are not Parties to this
Protocol may participate as observers in the proceedings of any meeting of the
Conference of the Parties serving as the meeting of the Parties to this
Protocol. When the Conference of the Parties serves as the meeting of the
Parties to this Protocol, decisions under this Protocol shall be taken only by
those that are Parties to it.

3.         When the Conference of the Parties serves as the meeting
of the Parties to this Protocol, any member of the Bureau of the Conference of the
Parties representing a Party to the Convention but, at that time, not a Party
to this Protocol, shall be substituted by a member to be elected by and from
among the Parties to this Protocol.

4.         The Conference of the Parties
serving as the meeting of the Parties to this Protocol shall keep under regular
review the implementation of this Protocol and shall make, within its mandate,
the decisions necessary to promote its effective implementation. It shall
perform the functions assigned to it by this Protocol and shall:

(a)      Make recommendations
on any matters necessary for the implementation of this Protocol;

(b)     Establish
such subsidiary bodies as are deemed necessary for the implementation of this
Protocol;

(c)      Seek
and utilize, where appropriate, the services and cooperation of, and
information provided by, competent international organizations and
intergovernmental and non-governmental bodies;

(d)     Establish
the form and the intervals for transmitting the information to be submitted in
accordance with Article 29 of this Protocol and consider such information as
well as reports submitted by any subsidiary body;

(e)      Consider
and adopt, as required, amendments to this Protocol and its Annex, as well as
any additional annexes to this Protocol, that are deemed necessary for the
implementation of this Protocol; and

(f)      Exercise
such other functions as may be required for the implementation of this
Protocol.

5.         The rules of procedure of the Conference of the Parties
and financial rules of the Convention shall be applied, mutatis mutandis,
under this Protocol, except as may be otherwise decided by consensus by the
Conference of the Parties serving as the meeting of the Parties to this
Protocol.

6.         The first meeting of the Conference of the Parties
serving as the meeting of the Parties to this Protocol shall be convened by the
Secretariat and held concurrently with the first meeting of the Conference of
the Parties that is scheduled after the date of the entry into force of this
Protocol. Subsequent ordinary meetings of the Conference of the Parties serving
as the meeting of the Parties to this Protocol shall be held concurrently with
ordinary meetings of the Conference of the Parties, unless otherwise decided by
the Conference of the Parties serving as the meeting of the Parties to this
Protocol.

7.         Extraordinary meetings of the Conference of the Parties
serving as the meeting of the Parties to this Protocol shall be held at such
other times as may be deemed necessary by the Conference of the Parties serving
as the meeting of the Parties to this Protocol, or at the written request of
any Party, provided that, within six months of the request being communicated
to the Parties by the Secretariat, it is supported by at least one third of the
Parties.

8.         The United Nations, its specialized agencies and the
International Atomic Energy Agency, as well as any State member thereof or
observers thereto not party to the Convention, may be represented as observers
at meetings of the Conference of the Parties serving as the meeting of the
Parties to this Protocol. Any body or agency, whether national or
international, governmental or non-governmental, that is qualified in matters
covered by this Protocol and that has informed the Secretariat of its wish to
be represented at a meeting of the Conference of the Parties serving as a
meeting of the Parties to this Protocol as an observer, may be so admitted,
unless at least one third of the Parties present object. Except as otherwise
provided in this Article, the admission and participation of observers shall be
subject to the rules of procedure, as referred to in paragraph 5 above.

ARTICLE 27

SUBSIDIARY
BODIES

1.         Any subsidiary body established by or under the
Convention may serve this Protocol, including upon a decision of the Conference
of the Parties serving as the meeting of the Parties to this Protocol. Any such
decision shall specify the tasks to be undertaken.

2.         Parties to the Convention that are not Parties to this
Protocol may participate as observers in the proceedings of any meeting of any
such subsidiary bodies. When a subsidiary body of the Convention serves as a
subsidiary body to this Protocol, decisions under this Protocol shall be taken
only by Parties to this Protocol.

3.         When a subsidiary body of the Convention exercises its
functions with regard to matters concerning this Protocol, any member of the
bureau of that subsidiary body representing a Party to the Convention but, at
that time, not a Party to this Protocol, shall be substituted by a member to be
elected by and from among the Parties to this Protocol.

ARTICLE 28

SECRETARIAT

1.         The Secretariat established by Article 24 of the
Convention shall serve as the secretariat to this Protocol.

2.         Article 24, paragraph 1, of the Convention on the
functions of the Secretariat shall apply, mutatis mutandis, to this Protocol.

3.         To the extent that they are distinct, the costs of the
secretariat services for this Protocol shall be met by the Parties hereto. The
Conference of the Parties serving as the meeting of the Parties to this
Protocol shall, at its first meeting, decide on the necessary budgetary
arrangements to this end.

ARTICLE 29

MONITORING
AND REPORTING

Each Party shall monitor the implementation of its obligations under
this Protocol, and shall, at intervals and in the format to be determined by
the Conference of the Parties serving as the meeting of the Parties to this
Protocol, report to the Conference of the Parties serving as the meeting of the
Parties to this Protocol on measures that it has taken to implement this
Protocol.

ARTICLE 30

PROCEDURES
AND MECHANISMS to promote COMPLIANCE WITH THis PROTOCOL

The Conference of the Parties serving as the meeting of the Parties
to this Protocol shall, at its first meeting, consider and approve cooperative
procedures and institutional mechanisms to promote compliance with the
provisions of this Protocol and to address cases of non-compliance. These
procedures and mechanisms shall include provisions to offer advice or
assistance, where appropriate. They shall be separate from, and without
prejudice to, the dispute settlement procedures and mechanisms under Article 27
of the Convention.

ARTICLE 31

ASSESSMENT
AND REVIEW

The Conference of the Parties serving as the meeting of the Parties
to this Protocol shall undertake, four years after the entry into force of this
Protocol and thereafter at intervals determined by the Conference of the
Parties serving as the meeting of the Parties to this Protocol, an evaluation
of the effectiveness of this Protocol.

ARTICLE 32

SIGNATURE

This Protocol shall be open for signature by Parties to the
Convention at the United Nations Headquarters in New York, from 2 February 2011
to 1 February 2012.

ARTICLE 33

ENTRY
INTO FORCE

1.         This Protocol shall enter into force on the ninetieth day
after the date of deposit of the fiftieth instrument of ratification,
acceptance, approval or accession by States or regional economic integration
organizations that are Parties to the Convention.

2.         This Protocol shall enter into force for a State or
regional economic integration organization that ratifies, accepts or approves
this Protocol or accedes thereto after the deposit of the fiftieth instrument
as referred to in paragraph 1 above, on the ninetieth day after the date on
which that State or regional economic integration organization deposits its
instrument of ratification, acceptance, approval or accession, or on the date
on which the Convention enters into force for that State or regional economic
integration organization, whichever shall be the later.

3.         For the purposes of paragraphs 1 and 2 above, any
instrument deposited by a regional economic integration organization shall not
be counted as additional to those deposited by member States of such
organization.

ARTICLE 34

RESERVATIONS

No reservations may be made to this Protocol.

ARTICLE 35

WITHDRAWAL

1.         At any time after two years from the date on which this
Protocol has entered into force for a Party, that Party may withdraw from this
Protocol by giving written notification to the Depositary.

2.         Any such withdrawal shall take place upon expiry of one
year after the date of its receipt by the Depositary, or on such later date as
may be specified in the notification of the withdrawal.

ARTICLE 36

AUTHENTIC
TEXTS

The original of this Protocol, of which the Arabic, Chinese,
English, French, Russian and Spanish texts are equally authentic, shall be
deposited with the Secretary-General of the United Nations.

IN WITNESS WHEREOF the undersigned, being duly authorized to that
effect, have signed this Protocol on the dates indicated.

DONE at Nagoya on this twenty-ninth day of October, two thousand and
ten.

Annex

MONETARY
AND NON-MONETARY BENEFITS

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

(a)      Access
fees/fee per sample collected or otherwise acquired;

(b)     Up-front
payments;

(c)      Milestone
payments;

(d)     Payment
of royalties;

(e)      Licence
fees in case of commercialization;

(f)      Special
fees to be paid to trust funds supporting conservation and sustainable use of
biodiversity;

(g)      Salaries
and preferential terms where mutually agreed;

(h)      Research
funding;

(i)       Joint
ventures;

(j)      Joint
ownership of relevant intellectual property rights.

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

(a)      Sharing
of research and development results;

(b)     Collaboration,
cooperation and contribution in scientific research and development programmes,
particularly biotechnological research activities, where possible in the Party
providing genetic resources;

(c)      Participation
in product development;

(d)     Collaboration,
cooperation and contribution in education and training;

(e)      Admittance
to ex situ facilities of genetic resources and to databases;

(f)      Transfer
to the provider of the genetic resources of knowledge and technology under fair
and most favourable terms, including on concessional and preferential terms
where agreed, in particular, knowledge and technology that make use of genetic
resources, including biotechnology, or that are relevant to the conservation
and sustainable utilization of biological diversity;

(g)      Strengthening
capacities for technology transfer;

(h)      Institutional
capacity-building;

(i)       Human
and material resources to strengthen the capacities for the administration and
enforcement of access regulations;

(j)      Training
related to genetic resources with the full participation of countries providing
genetic resources, and where possible, in such countries;

(k)     Access
to scientific information relevant to conservation and sustainable use of
biological diversity, including biological inventories and taxonomic studies;

(l)       Contributions
to the local economy;

(m)     Research
directed towards priority needs, such as health and food security, taking into
account domestic uses of genetic resources in the Party providing genetic
resources;

(n)      Institutional
and professional relationships that can arise from an access and benefit‑sharing
agreement and subsequent collaborative activities;

(o)     Food
and livelihood security benefits;

(p)     Social
recognition;

(q)     Joint
ownership of relevant intellectual property rights.

EXPLANATORY MEMORANDUM

The Convention on Biological Diversity (the
Convention) is the main international framework for measures to conserve
biological diversity, to sustainably use its components and for the fair and
equitable sharing of benefits arising from the utilisation of genetic
resources. With currently 193 Parties, the Convention has almost universal
membership. The European Union and all of its 27 Member States are Parties to
the Convention.

Article 15 of the Convention establishes a
general framework for access to genetic resources and benefit-sharing: it
recognises the authority of states to determine access to genetic resources as
part of their sovereign rights over natural resources. Parties are obliged to
take steps to facilitate access to their genetic resources. At the same time
all Parties are obliged to take legislative, administrative or policy measures
to share in a fair and equitable way the results of research and development
and the benefits arising from the commercial and other utilisation of genetic
resources with the Party providing these resources.

Heads of state and government attending the
World Summit on Sustainable Development in August 2002 agreed to launch
negotiations on an "international regime" on access and benefit-sharing
in the framework of the Convention. On 29
October 2010, the tenth conference of the parties to the Convention adopted the
Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable
Sharing of Benefits Arising from their Utilization to the Convention on
Biological Diversity (the Protocol).

The decision of the conference of the
parties also calls upon the Parties to the Convention to sign the Protocol at
the earliest opportunity and to deposit instruments of ratification, acceptance
or approval or instruments of accession, as appropriate, with a view to
ensuring the entry into force of the Protocol as soon as possible. The Protocol
requires fifty ratifications to enter into force.

The Protocol was open for signature at the
United Nations headquarters in New York from 2 February 2011 to 1 February
2012. The EU and most of its Member States have signed the Nagoya Protocol.[1]

The European Parliament, the Council of the
European Union and the Commission have expressed their commitment to a swift implementation
and ratification of the Nagoya Protocol in the Union.[2]

The Commission has proposed a Regulation of
the European Parliament and of the Council[3]
establishing a system of measures for implementing the Nagoya Protocol in the
Union.

In view of the above, it is appropriate for
the European Union to conclude the Nagoya Protocol on Access to Genetic
Resources and the Fair and Equitable Sharing of Benefits Arising from their
Utilization to the Convention on Biological Diversity.

2012/0279 (NLE)

Proposal for a

COUNCIL DECISION

on the conclusion of the Nagoya Protocol
on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits
Arising from their Utilization to the Convention on Biological Diversity

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the
Functioning of the European Union, and in particular Article 192(1), in
conjunction with Article 218(6)(a) thereof,

Having regard to the proposal from the
European Commission,

Having regard to the consent of the
European Parliament[4],

Whereas:

(1)       The Union and its Member
States joined the consensus of the 193 Parties to the Convention on Biological
Diversity that adopted the Nagoya Protocol on Access to Genetic Resources and
the Fair and Equitable Sharing of Benefits Arising from their Utilization to
the Convention on Biological Diversity (the Nagoya Protocol) on 29 October 2010.

(2)       The Union and most of its
Member States have signed the Nagoya Protocol.

(3)       The European Parliament,
the Council and the Commission have expressed their commitment to a swift
implementation and ratification of the Nagoya Protocol in the Union[5].

(4)       The Nagoya Protocol should
be approved on behalf of the European Union.

HAS ADOPTED THIS DECISION:

Article 1

The Nagoya Protocol on
Access to Genetic Resources and the Fair and Equitable Sharing of Benefits
Arising from their Utilization to the Convention on Biological Diversity is hereby approved on behalf of the Union.

The text of the Protocol is attached to
this Decision.

Article 2

The President of the Council shall
designate the person empowered to proceed, on behalf of the European Union, to
the deposit of the instrument of approval provided for in Article 33 of the Protocol,
in order to express the consent of the European Union to be bound by the Protocol.

The deposit of the instrument of approval
shall take place simultaneously with the deposit of those of the Member States.

At the same time, the designated person
shall deposit the declaration set out in the Annex to this Decision, in accordance
with Article 34(3) of the Convention on Biological Diversity.

Article 3

This Decision shall be published in the
Official Journal of the European Union.

Done at Brussels,

For
the Council

The
President

ANNEX

DECLARATION BY THE EUROPEAN UNION IN ACCORDANCE
WITH ARTICLE 34 (PARAGRAPH 3) OF THE CONVENTION ON BIOLOGICAL DIVERSITY

"The European Union declares that, in accordance with
the Treaty on the Functioning of the European Union, and in particular Article
191 thereof, it is competent for entering into international agreements, and
for implementing the obligations resulting therefrom, which contribute to the
pursuit of the following objectives:

–
preserving, protecting and improving the
quality of the environment;

–
protecting human health;

–
prudent and rational utilisation of natural
resources;

–
promoting measures at international level to
deal with regional or worldwide environmental problems, including climate
change.

Moreover, the European Union adopts measures at European Union
level for establishing a European Research Area and for
the proper functioning of its internal market.

The European Union declares that it has
already adopted legal instruments, binding on its Member States, covering
matters governed by this Protocol."

[1]               Except Latvia, Malta and Slovakia.

[2]               Council Conclusions of 20 December 2010 (paragraphs 1
and 21), 23 June 2011 (paragraph 14), European Parliament Resolution of 20
April 2012 (paragraph 101), Commission Communication on an EU Biodiversity
Strategy to 2020 (COM (2011) 244) (Action 20).

[3]               COM(2012) 576

[4]               OJ C , , p. .

[5]               See Council Conclusions of 20 December 2010
(paragraphs 1 and 21), 23 June 2011 (paragraph 14), European Parliament
Resolution of 20 April 2012 (paragraph 101), Commission Communication on an EU
Biodiversity Strategy to 2020 (COM (2011) 244) (Action 20).