Key elements of the ABS in the framework of the CBD · PDF fileKey elements of the ABS in the framework of the CBD and the NP ... Biotechnology, pharmaceutical, agroindustrial,

Key elements of the ABS in the framework of the CBD and the NP

Workshop on the Negotiation of ABS Contracts

GEF ABS- LAC Regional Project La Habana (Cuba) 18-21 March 2013

• Did someone here participate in the negotiation of the CBD?

• Why was the CBD negotiated?

• Why did the CBD regulate ABS?

2

Layout

1.- Terms and Setting of the Problem

2.- Main International Regimes (Genetic Resources)

3.- Access and Benefit Sharing (ABS) in the CBD

4.- The Bonn Guidelines

5.- Negotiation of the Intal Regime- The Nagoya Protocol

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• Genetic Diversity: Total sum of the genetic information contained in the genes of plants, animals and micro-organisms

• At present 1,75 million of species (estimations between 3 and 100 millions- 13 millions)

– Limited knowledge

– Potential


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• Genetic Resources Base of human development

• Historically: seed selection, improvement of varieties (hybridation), biotechnology

• Base of the varieties for agriculture

• Medicine- 75% of the traditional medicine and base of primary health services

• Pharmaceutical companies, phytosanitary, cosmetics

• Base of our future development

+ Unknown world of the marine environment

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• Raw (unmodified) Genetic Resources : natural or ex-situ colections. They have not suffered any transformation

• Modified Genetic Resources: products from those Raw Genetic Resources, isolation of any genetic characteristic

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• Diferentiation between genetic material and biological material

• Historically free access to genetic resources (both in situ and ex situ)- Common heritage

• Research through Public Institutions 7


• Decade 1920- introduction of the private sector: Need of securing return of the investment:

– Lost of vigor from one generation to another

– Plants of asexual reproduction?

• 1930 U.S.A. Plants Patent Act

• Other countries: Limited property right (Plant Breeder´s Rights)

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• Decade 1970 DNA: Beginning of modern biotechnology and genetic engineering

• Pharmaceutical sector: Investment and Time • Intellectual Property Rights to secure the return of the

investment • Diamond vs. Chakrabarty Case (US Supreme Court- patent

over modified living resources) • Bayh-Dole Act • U.S.A : “A strong system of property rights is essential for the

development of the innovation systems of the modern biotechnology”

• Raw Genetic Resources continued to be collected freely by the seed companies, botanic institutions and gene banks 9


• Raw material for the elaboration of products of high added value of the new economies: Biotechnology, pharmaceutical, agroindustrial, phytosanitary, cosmetic

• Added value never paid back the access • Bigger gap between modified genetic resources

(Intellectual Property Rights) and raw genetic resources (common heritage- in favor of science and knowledge)

• Science and Knowledge is not accessible to everyone and just reaffirms the gap through the consolidation of the comparative advantages of developed countries 10

2.- Main International Regimes

• International Convention for the Protection of New Plant Varieties (UPOV, 1961)

• International Undertaking on Plant Genetic Resources (FAO, 1983)

• CBD (1992)

• WTO/TRIPS (1993)

• International Treaty on Plant Genetic Resources (ITPGR) FAO (2001)

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2.- Main International Regimes

• 1983: International Undertaking on Plant Genetic Resources (FAO)

– “ensure that plant genetic resources will be explored, preserved, evaluated and made available for plant breeding and scientific purposes...” (art. 1)

– “based on the universally accepted principle that plant genetic resources are a heritage of mankind and consequently should be available without restriction.” (art.1)

• Limited Effects

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3.- ABS in the CBD

• Main country that promoted the negotiation of the CBD in 1987?

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3.- ABS in the CBD

1987: USA requested within UNEP the negotiation of an umbrella convention for the conservation of biodiversity

1989: Developing countries conditioned their support to the negotiation of the convention on the inclusion of the national sovereignty over genetic resources (raw genetic resources) and the sharing of the benefits arising from the commercial utilization

Change of the strategy of developing countries 14

Relationship biodiversity-biotechnology

Raw material: GR

Elaborated products GR

BIODIVERSITY: DEVELOPING COUNTRIES

TECHNOLOGY: DEVELOPED COUNTRIES

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Raw material: GR


National Sovereignty:

CBD

Intellectual property

rights



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Raw material: GR




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3.- ABS in the CBD

"Genetic resources" means genetic material (any material of plant, animal, microbial or other origin containing functional units of heredity*)of actual or potential value (art. 2 CBD)

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3.- ABS in the CBD

Art. 15.1.- “Recognizing the sovereign rights of States over

their natural resources, the authority to determine access

to genetic resources rests with the national

governments and is subject to national legislation. ”

Art. 15.2.- “Each Contracting Party shall endeavour to

create conditions to facilitate access to genetic resources for environmentally sound uses by other Contracting Parties and not to impose

restrictions that run counter to the objectives of this

Convention. ”

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3.- ABS in the CBD

Art. 15.4.- “Access, where granted, shall be on mutually agreed terms and subject to the provisions of this Article.”

Art. 15.5.- “Access to genetic resources shall be subject to prior informed consent of the Contracting Party providing such resources, unless otherwise determined by that Party.”

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3.- ABS in the CBD

Art. 15.6.- “Each Contracting Party shall endeavour to develop and carry out scientific research based on genetic resources provided by other Contracting Parties with the full participation of, and where possible in, such Contracting Parties.”

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3.- ABS in the CBD

Art. 15.7.- “Each Contracting Party shall take legislative, administrative or policy measures, as appropriate, and in accordance with Articles 16 and 19 and, where necessary, through the financial mechanism established by Articles 20 and 21 with the aim of sharing in a fair and equitable way the results of research and development and the benefits arising from the commercial and other utilization of genetic resources with the Contracting Party providing such resources. Such sharing shall be upon mutually agreed terms.” 22

3.- ABS in the CBD

Other relevant articles of the CBD: • Art. 16.3 y 4 access and transfer of technology that

uses G.R. • Art. 16.5 consistency of the patent system with the

CBD system and support of the objectives of the Convention

• Art. 19.1 participation in biotech research that uses genetic resources

• Art. 19.2 access to the results and benefits of biotechnology

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3.- ABS in the CBD

Other relevant articles of the CBD: • Art. 8j- (j) Subject to its national legislation, respect,

preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity and promote their wider application with the approval and involvement of the holders of such knowledge, innovations and practices and encourage the equitable sharing of the benefits arising from the utilization of such knowledge, innovations and practices 24

3.- ABS in the CBD

• Introduction of numerous national or regional access legislations: India, South Africa, Philippines, Andean Pact, ASEAN, OAU…. some extremely restrictive.

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3.- ABS in the CBD

Evolution of the issue in the CBD: • Until COP4 (1998) only studies and compilations. • COP4 established Panel of Experts- develop basic

concepts and explore options for MAT • COP5 established the Open-Ended Working Group on

ABS- mandate to develop Guidelines on PIC, MAT, Benefit Sharing mechanisms and maintenance of TK

• COP6 (2002) Bonn Guidelines. • WSSD (2002) urged for the negotiation of an

international regime on Benefit Sharing • COP7 (2004) approved the terms of reference and

negotiation mandate for the Open-Ended Working Group 26


• What was the purpose of the Bonn Guidelines?

• Were they effective? • Why wasit decided, the same year they were

adopted, to negotiate an ABS international regime?

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Bonn Guidelines (2002):

• Reference for the establishment of:

– PIC system (Basic principles, elements, competent authorities, procedures, … )

– MAT

• Suggestion of possible economic and non economic benefits

• Voluntary 28


PIC:

• Consent of the competent national authorities of the provider country

• Specification of the Use

• Procedure

• Mechanisms for the consultation with stakeholders

• Linked to the MATs 29


MATs:

• Written agreement

• Obligations of users and providers

• Reglamentation of the use

• Guarantee the continued customary use of the genetic resources and the knowledge associated to those Genetic Resources

• Regulates the use of intellectual property rights

• Benefit Sharing (Annex II list)

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5.- Negotiation of the IR: Nagoya Protocol

Main limitations of the CBD (and the Bonn

Guidelines) (Enumerate them:) • Difficulties controlling PIC

• Difficulties with the traceability and follow up GR

• Difficulties on the enforcement of MAT

• Lack of “compliance measures” in user countries (art. 15.7)

• Very few countries had in place a transparent and properly implementable ABS national system 31

5.- Nagoya Protocol

Did someone here participate in the negotiation of the CBD?

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5.- Nagoya Protocol

Objective: “the fair and equitable sharing of the

benefits arising from the utilization of genetic

resources, … thereby contributing to the

conservation of biological diversity and the

sustainable use of its components”

(art. 1)

Conservation of

biodiversity

Sustainable use of

biodiversity

Benefit Sharing

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5.- Nagoya Protocol

SCOPE: Same scope as the CBD? (art. 3)

• New definitions: “utilization of genetic

resources”; “derivative” (any implications?)

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5.- Nagoya Protocol

RELATIONSHIP WITH INTERNATIONAL

AGREEMENTS AND INSTRUMENTS (art. 4)

(any new element or consideration?)

FAIR AND EQUITABLE BENEFIT- SHARING (art.

5) General principle of benefit sharing over: • Utilization of genetic resources • Utilization of genetic resources held by ILCs • Utilization of Traditional Knowledge (TK) of ILCs

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5.- Nagoya Protocol

ACCESS TO GENETIC RESOURCES (art. 6):

• Sovereign rights, subject to national legislation

• If regulated, main instrument: PIC and MAT

• Respect rights of ILCs to their genetic resources

(art. 6.2)

• Article 6.3 principles that access regulations

have to fulfill

• Access permit 36

5.- Nagoya Protocol


Access Permit

Notification to the ABS-

CH

Intal recognized certificate of compliance

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5.- Nagoya Protocol


• Create conditions to promote and encourage research

(…) including through simplified measures on access for

non-commercial research purposes (…) (para. a)

• Pay due regard to cases of present or imminent

emergencies that threaten or damage human, animal or

plant health (…) (para b)

• Consider the importance of genetic resources for food

and agriculture (para c)

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5.- Nagoya Protocol

CONTRIBUTION TO CONSERVATION AND

SUSTAINABLE USE (art. 9):

• “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”

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5.- Nagoya Protocol

TRANSBOUNDARY COOPERATION (art. 11):

“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”

• Any example?

• Problems?

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5.- Nagoya Protocol

NATIONAL FOCAL POINTS AND COMPETENT

AUTHORITIES (art. 13) (anything new?)

ABS- CH (art. 14) (anything new?)

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5.- Nagoya Protocol

COMPLIANCE WITH DOMESTIC ABS

LEGISLATION (art. 15):

“Each Party shall take (…) measures to provide that

genetic resources utilized within its jurisdiction have

been accessed in accordance with PIC and MAT have

been established, as required by the domestic access

and benefit-sharing legislation or regulatory

requirements of the other Party”

+ take measures to address situations of non compliance

+ cooperate in cases of non compliance with other Parties

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5.- Nagoya Protocol

MONITORING THE UTILIZATION OF GR (art. 17):

Designate one or more checkpoints

Require users to provide information

PIC, the source of GR, MAT and/or utilization of GR

internationally recognized certificates of compliance

Transmit previous information to

Relevant National Authorities

Party providing PIC

ABS-CH 43

5.- Nagoya Protocol

MONITORING THE UTILIZATION OF GR (art. 17):

“An internationally recognized certificate of compliance

shall serve as evidence that the genetic resource which it

covers has been accessed in accordance with PIC and that

MATs have been established, as required by the domestic

access and benefit-sharing legislation or regulatory

requirements of the Party providing PIC”

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5.- Nagoya Protocol

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.

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5.- Nagoya Protocol

COMPLIANCE WITH MAT(art. 18):

• Encourage providers and users to include

provisions in MAT to cover dispute resolution

• Ensure that an opportunity to seek recourse is

available under their legal systems, in cases of

disputes arising from MAT

• Effective measures regarding: Access to justice;

mutual recognition and enforcement of foreign

judgments and arbitral awards 46

5.- Nagoya Protocol

MODEL CONTRACTUAL CLAUSES (art. 19):

• Encourage the development, update and use

CODES OF CONDUCT, GUIDELINES AND BEST

PRACTICES AND/OR STANDARDS (art. 20):

• Encourage the development, update and use

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5.- Nagoya Protocol

• AWARENESS RAISING (art. 21)

• CAPACITY (art. 22)

• TECHNOLOGY TRANSFER, COLLABORATION

AND COOPERATION (art. 23)

• FINANCIAL MECHANISM AND RESOURCES

(art. 25)

• PROCEDURES AND MECHANISMS TO

PROMOTE COMPLIANCE WITH THE

PROTOCOL (art. 30) 48

5.- Nagoya Protocol

DO YOU THINK THE PROTOCOL HAS COVERED THE PURPOSE ORIGINALLY INTENDED?

ARE THERE ANY ESSENTIAL ELEMENTS YOU MISS IN THE PROTOCOL?

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5.- Nagoya Protocol

WHAT ELEMENTS DO YOU THINK WILL NEED

FURTHER DEVELOPMENT?

WHAT ELEMENTS DO YOU THINK WILL NEED

SOME DEGREE OF HARMONIZATION?

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5.- Nagoya Protocol

TOMORROW:

QUESTIONNAIRE ABOUT YOUR ABS NATIONAL SYSTEM [CBD AND NAGOYA PROTOCOL ELEMENTS THAT ARE (OR ARE NOT) PRESENT IN YOUR SYSTEM]

TRADITIONAL KNOWLEDGE IN THE NAGOYA PROTOCOL

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THANKS FOR YOUR KIND ATTENTION

THIS SLIDE MEANS YOU HAVE SURVIVED THE FIRST DAY OF THE WORKSHOP: NOW ENJOY THE RECEPTION

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Documents

Key elements of the ABS in the framework of the CBD · PDF fileKey elements of the ABS in the framework of the CBD and the NP ... Biotechnology, pharmaceutical, agroindustrial,