06 pgr access and benefit sharing

Assignment
Subject : GPB811 Plant Genetics Resourcesand their Utilization
Presented by : Mr. Indranil Bhattacharjee
Student I.D. No.: 17PHGPB102
Sam Higginbottom Universityof Agriculture,
Technology & Sciences
Allahabad-211007

Access and Benefit Sharing
Overview
•The Context
•The Patent system
•Developments on the International Level

The Context
• Convention on Biological Diversity (CBD)
– Bonn Guidelines on Access to Genetic Resources and Fair and Equitable
Sharing of the Benefits Arising outof their Utilization
– International Regimeon Access to GeneticResources and BenefitSharing
• Food and Agriculture Organization of the United Nations (FAO)
– International Treaty on PlantGeneticResources forFood and Agriculture

Conventionon Biological Diversity
• 1992 Earth Summit in Rio de Janeiro
• 3 main goals:
– the conservation of biological diversity
– the sustainable use of its components
– and the fair and equitable sharing of the benefits from the
use of genetic resources.
• entered into force on 29 December 1993
• 190 Parties (http://biodiv.org/world/parties.asp)

Article 1. Objectives
The objectives of this Convention, to be pursued in accordance
with its relevant provisions, are the conservation of biological
diversity, the sustainable use of its components and the fair
and equitable sharing of the benefits arising out of 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.

Article 15. Access to Genetic Resources
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.
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.

3. For the purpose of this Convention, the genetic resources being provided by a
Contracting Party, as referred to in this Article and Articles 16 and 19, are only
those that are provided by Contracting Parties that are countries of origin of
such resources or by the Parties that have acquired the genetic resources in
accordance with this Convention.
4. Access, where granted, shall be on mutually agreed terms and subject to the
provisionsof this Article.
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.

6. Each Contracting Party shall endeavor to develop and carry outscientific
research based on genetic resources provided by other Contracting Parties with
the full participation of,and where possiblein, such Contracting Parties.
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 agreedterms.

Article 8. In-situ Conservation
[...]
(j) Subject to its national legislation, respect, preserve and maintain
knowledge, innovations and practices of indigenous and local communities
embodyingtraditionallifestyles relevantfor the conservationand sustainable
use of biological diversity and promote their wider application with the
approvaland involvementof 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;

Article 16. Access to and Transfer of technology
1.- 4. [...]
5. The Contracting Parties, recognizing that patents and other intellectual
property rights may have an influence on the implementation of this
Convention, shall cooperatein this regard subjectto national legislation and
international law in order to ensure that such rights are supportive of and
do notrun counter to its objectives.

Bonn Guidelines and International Regime
• 6th Conference of the Parties 2002 (COP, Decision VI/24)
– voluntary guidelines to assist Parties, Governments and other stakeholders
– establishing legislative, administrativeor policy measures
– negotiating contractual arrangements
• 7th Conference of the Parties 2004 (Decision VII/19)
– negotiation of an internationalregime on access to genetic resources and benefit sharing
– mandate to the Ad Hoc Open-ended Working Group on Access and benefit-sharing.
• 8th Conference of the Parties 2006 (Decision VIII/4)
– complete the work on the international regime at the earliest possible time before the
10th meeting of the Conferenceof the Parties(2010)

Food and Agriculture Organization of the United Nations
• International Treaty on PlantGeneticResources forFood and Agriculture
– adopted in November 2001
– entered into forceon June 29,2004,112 parties
(http://www.fao.org/Legal/TREATIES/033s-e.htm)
• Definition: "any genetic material of plant origin of actual or potential value for
food and agriculture".
• objectives
– conservation and sustainable use of plant genetic resources for food and
agriculture
– the fair and equitable sharing of benefits derived from their use, in harmony
with the CBD, for sustainable agriculture and food security

International Treaty on Plant Genetic Resources
for Food and Agriculture
• Multilateral Systemto facilitate access to plantgeneticresources for food and
agriculture
(Article 12):
– over 64 major crops and forages
– access for utilizationand conservationin research,breeding and training
• Share the benefits in a fair and equitable way (Article 13):
– facilitated access itself
– information-exchange
– access to and the transfer of technology
– capacity-building
– sharing of monetary and other benefits of commercialization
• Material Transfer Agreements

The Patent System
• Andean Community
• European Community
• National Patent Law

Andean Community
DECISION486
Common Intellectual Property Regime
– Article 26 Applications for patents [...] shall contain: h) a copy of the
contract for access, if the products or processes for which a patent
application is being filed were obtained or developed from genetic
resourcesor by products originating in one of the Member Countries
– Sanction:InvalidationArticle 75 g)

European Community
Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998
on the legal protectionof biotechnologicalinventions
– Recital 26
Whereas if an invention is based on biological material of human origin or if it
uses such material, where a patent application is filed, the person from whose
body the material is taken must have had an opportunity of expressing free and
informedconsentthereto,in accordance with national law;
– Recital 27
Whereas if an invention is based on biological material of plant or animal origin
or if it uses such material, the patent application should, where appropriate,
include information on the geographical origin of such material, if known;
whereas this is without prejudice to the processing of patent applications or the
validity of rights arising from grantedpatents;

National Patent Law
• Disclosure requirement:inventionto be fully disclosed
• some European countries have implemented recital 27 of Directive
98/44/EC, e.g.
– Germany, sanction: without prejudice to the processing of patent
applications or the validity of rights arising from granted patents, (§ 34a
Patentgesetz)
– Italy, sanction: in the patent procedure: nullity (LEGGE 22 febbraio 2006 n.
78)
– Norway, sanction:penalty (Section 8b of the Patents Act)

Developments on the
International Level
• World Trade Organization
• World Intellectual Property Organization

World Trade Organization
• Doha Ministerial Declaration, November 14,2001
19. We instruct the Council for TRIPS, [...], to examine, inter alia, the
relationship between the TRIPS Agreement and the Convention on Biological
Diversity, [...]
• WTO document IP/C/W/368/Rev.1, February 8, 2006: The Relationship
between the TRIPS Agreementand the Conventionon BiologicalDiversity
– Disclosure and evidence as a TRIPS obligation (Brazil, India, Bolivia, Colombia,
Cuba, Dominican Republic, Ecuador, Peru, Thailand, African group and some
other developing countries)
– Disclosure through WIPO Amendment to the regulations of the Patent
Cooperation Treaty (Switzerland)
– Disclosure with legal consequences of not meeting this requirement outside
the patentlaw (European Union)
– National legislation and and contractual arrangements (United States of
America)

World Intellectual Property Organization
•Patent Law Treaty / Substantive Patent Law Treaty
• Patent Cooperation Treaty
• Technical Studies
• Intergovernmental Committee on Genetic Resources,
Traditional Knowledge and Folklore

Patent Law Treaty / SubstantivePatent Law Treaty
• Columbian Proposal (WIPO document SCP/3/10)
– the grant of patents or registrations that relate to biological and genetic
heritage shall be subjectto their having been acquired legally
– specification of the registration number of the contract affording access to
geneticresources and a copy thereof
• Indian Proposal (WIPO document SCP/9/8, par. 114), WIPO
document SCP/10/3: Rule 4(2) of Draft Regulations Under the
Substantive Patent Law Treaty:
A Contracting Party may require the indication of the source and geographical
origin of the depositedbiological materialin the description.

Patent Cooperation Treaty
Swiss Proposal
(May2003, now WIPO document PCT/R/WG/9/5) Declaration of the Source of
Genetic Resourcesand Traditional Knowledge in Patent Applications:
• Amendment of Rules under the PCT
– 4.17 Declarations Relating to National RequirementsReferredto in Rule
51bis.1(a)(i)to (v)
– Rule 51bis Certain National RequirementsAllowed Under Article 27
• PCT amendments applicable under the PLT by
– referenceunder PLT Article 6(1)
– use of a PCT RequestForm under PLT Rule 3(2)
– decision of the PLT Assemblyunder PLT Article 16(1)

WIPO - CBD Cooperation
• Memorandum of Understanding
– 2002: approved by WIPO’s CoordinationCommittee (WIPO document WO/CC/48/2)
– upon request and subject to approval of the competent subsidiarybodies
– undertake studies and provide other technical inputs in writing to the competent
subsidiarybodies of the requesting party on issueswithin their areas of competence
• Technical Studies
– technical input to facilitate policy discussion and analysis, not a formal paper
expressinga policy position on the part of WIPO, its Secretariat or its Member States
– Decision of WIPO’s General Assembly on a request
– Invitation to WIPO Member States for comments and proposals
– consultation process
– Approval of WIPO’s General Assembly

Technical Studies
• CBD Request for Technical Studies
1. COP 6: Decision VI/24C
2. COP 7: Decision VII/19
• Documents:
1. UNEP/CBD/COP/7/INF/17=WIPO Publication Nr.786 (E)
Background:WIPOdocuments WIPO/GA/30/7,WO/GA/30/7 ADD.1,
WIPO/GRTKF/IC/5/10
2. UNEP/CBD/COP/8/INF/7
Background:WIPOdocuments WIPO/GA/32/8

IntergovernmentalCommitteeon Intellectual
Property and Genetic Resources, Traditional
Knowledgeand Folklore
• Draft Intellectual Property Guidelines for Access and Equitable
Benefit Sharing
(WIPO document WIPO/GRTKF/IC/7/9)
• Overview about WIPO’s work on genetic resources
• Proposal of the EU
•Memorandum of Norway
• Submission of Japan

Proposal of the EU
(WIPO documentWIPO/GRTKF/IC/8/11)
• A mandatory disclosure requirementin patentapplications;
• Declare the country of origin or,if unknown,the source of the specificgenetic
resource;
• Invention directly based on the specificgeneticresources;
• Possibly also disclosure requirementregarding the specificsource of traditional
knowledgeassociated with geneticresources;a further in-depthdiscussion of
the conceptof “Traditional knowledge” is necessary;
• Sanction for failure or refusal to declare the requiredinformation after beinggiven
the opportunity to remedy:the application shouldnotbe further processed;
• Sanctions for incorrector incomplete information:outsidethe field of patentlaw;
• Notification by patentoffices of a declaration to a central body,e.g. The clearing
house mechanism of the CBD.

Memorandum of Norway Proposal of Japan
• Norway: WIPO document WIPO/GRTKF/IC/9/12
– disclosure requirements in patent applications contribute to improving transparency
and building trust in the patent system
– possible implicationsfor monitoring possible cases of misappropriationof TK/TCEs.
– separate proposalannounced
• Japan: WIPO document WIPO/GRTKF/IC/9/13
– Art. 16 CBD does not require disclosureof origin
– Indication not needed for patent examination
– Database related to genetic resources and traditional knowledge to help avoiding
erroneouslygranted patents

Decisions of the Tenth Session of the IGC
December8, 2006
9. Regarding agenda item 10 (genetic resources), on the basis of its discussions,
the proposals made by a number of delegations, document
WIPO/GRTKF/IC/8/9, and within the specific mandate of the Committee
established by the WIPO General Assembly, the Committee requested the
Secretariatto preparefor its consideration atits eleventh session:
(i) A document listing options for continuing or further work, including work
in the areas of the disclosure requirement and alternative proposals for
dealing with the relationship between intellectual property and genetic
resources; the interface between the patent system and genetic resources;
and the intellectual property aspects of access and benefit-sharing
contracts;and
(ii) A factual update of international developments relevant to the genetic
resourcesagendaitem.

• Introduction to the CBD
• How the CBD operates
• The CBD and botanical
institutions
• Practical implementation
The CBD for PGRFA

• Result of Rio Earth Summit
• A commitmentto:
– conserve biological diversity
– use biological resources sustainably
– share benefits fairly and equitably
What is the CBD?

• A framework for action
• Decisions at the national level
• Recognition that biodiversity is
not equally distributed
• Benefit-sharing
What is unique about this treaty?

Party Non-Party
Parties to the CBD

Scope of the CBD:
What is biological diversity?

Financial value of biodiversity (1)
Estimates of annual markets for some products derived
from genetic resources
Products Annual Sales (billion US$)
Low High
Pharmaceuticals 75 150
Botanical medicines 20 40
Agricultural produce 300+ 450+
Ornamental horticulture 16 19
Crop protection 0.6 3
Biotech (except health & agriculture) 60 120
Personal care & cosmetics 2.8 2.8
ROUNDED TOTAL 500 800
Source:tenKate Kand Laird SA (1999), The CommercialUse of Biodiversiy,EarthscanPublicationsLtd.

Financial value of biodiversity (2)

Threats to biodiversity
• Habitat loss
• Invasive alien species
• Over-exploitation
• Pollution and climate change

How does the CBD approach the
challenge? (1)
• Common concern of
humankind
• Sovereign rights
• Countries responsible for
conservation
• Preventativeand
precautionary approach

How does the CBD approach the
challenge? (2)
• Ecosystem approach:
– prioritises in situ conservation
– backed up by ex situ conservation
• Sustainable use

Bodies of the CBD
• COP
• SBSTTA
• Secretariat
• Ad-hocworking groups
• Clearing House Mechanism

Thematic work programmes
agricultural biodiversity
biodiversityof inland waters
biodiversityof dry and subhumidlands
forestbiodiversity
marine and coastal biodiversity
mountainbiodiversity

Cross-cutting issues
agricultural biodiversity
biodiversityof inland waters
biodiversityof dry and subhumidlands
forestbiodiversity
marine and coastal biodiversity
mountainbiodiversity

Implementation of the CBD:
Action at a national level
CBD
national
government
national laws integration into other
areas
NationalBiodiversity
Strategy and Action Plan
conservation initiatives
national
reports
goalsand
obligations

Implementation of the CBD:
Stakeholder participation
local and
Indigenous
communities
farmers
landowners universities
botanic
gardens
national
government

Botanical institutions support the CBD

Botanical institutions support the CBD
7 - identification& monitoring
8 - in-situ conservation
9 - ex-situ conservation
10 - sustainableuse
12 - research & training
13 - publiceducation& awareness
15 - access to genetic resources
16 - access to & transfer of technology
17 - exchange of information
18 - technical& scientific cooperation

Article 15: Access and benefit-
sharing - ‘the grand bargain’
• Follow national law
• Prior informed consent
• Mutually agreed terms
• Benefit-sharing

National legislation on access and
benefit-sharing
Legislationin place Planninglegislation

Benefit-sharing
• What kinds of benefits?
• With whom should they be
shared?
• What is fair and equitable?
• Bonn Guidelines

Pre-CBD collections
• Article 15(3)
– excludes pre-CBD collections

Commercialisation
• Issuesfor institutions
• What should institutions do?
– define commercialisation
– commercial use
– commercial supply
– commercialisationpolicy

Why is access and benefit-sharing
important for botanists?
• Exchange and access
• Builds partnerships
• Supportsnational
implementation
• Funding
• Builds trust

CBD-friendly work: Common challenges
© Kate Davis

CBD-friendly work: Fieldwork (1)
• Plan Ahead!
– permissionto collect
– CITES permits
– export & import permits
– plant health
• Work with local partners

• Prior Informed Consent
– whose consent?
– what information?
– who can help?

• Agree terms
– check terms on permits!
• Keep written records
– permits, letters, emails, notes

Acquisition
Use
Supply
CBD-friendly work: Institutional use
and exchange (1)

and exchange (2)
• Acquire material legally
• Use under same terms
• Supply under same terms

and exchange (3)
• Written agreements
• Tracking
• Internal procedures
• InstitutionalCBD policy

CBD-friendly work:
Benefit-sharing for botanists
• Forexample…
– joint fieldwork
– joint research
– access to information
– capacity building
– training and education
– staffexchange
– fees/royalties

CBD-friendly work: Plant sales
• Right to sell?
• What conditions?
• What benefits?

Collective action
• Stay informed and get involved!
– work with stakeholders
– work with government
– work with botanic gardens

Further information on the CBD and
National Focal Points
The Secretariat of the CBD
World Trade Centre
393 Saint Jacques, Suite 300
Montreal
Québec
Canada H2Y 1N9
CBD website: www.biodiv.org

Genetic resources
• Any material of plant, animal, fungal,
microbial or other origin containing
functionalunits of heredity of actual or
potentialvalue
• ‘Functionalunit of heredity’ a matter for
interpretation
• May include herbarium specimens

Ecosystem services
• Provide:
–goods
–ecosystem functions
–aesthetic and cultural values
• High global value
• Cost of loss greatly exceeds
benefits

• Back to country of origin
• Through exchange of
information and access
• Planning is vital!
Repatriation of information

The Bonn Guidelines
 Guidance for governments and
other stakeholders
– responsibilities
– negotiating access and benefit-sharing
– elements for agreements
– benefit-sharing examples
• Implications for collections
© RBG Kew

Traditional Knowledge (2)
• National legislation
• Indigenous Peoples’ declarations and
codes of conduct
• Professional codes of conduct
• People’s Biodiversity Registers

Intellectual Property (1)
 Types of IP include:
– patents
– copyright
– plant breeders rights
 IP and plants?

Intellectual Property (2)
 Current issues
– patents on life?
– disclose sources?
– IPand benefit-sharing
– agree, and track, benefit-sharing
terms

Global Taxonomy Initiative
• The ‘taxonomic impediment’
• GTI supports:
– taxonomicneeds assessment
– taxonomicinformation sharing
– training
– collaboration
– National Focal Points

Global Strategy for Plant Conservation
 16 Targets for:
– understanding and
documenting plant diversity
– conserving plant diversity
– sustainableuse
– education
– capacity building

Invasive alien species
 Environmental and economic
costs
 ‘Guiding Principles’:
– advice and goals
• Role of horticulture

Cartagena Protocol on Biosafety
• Promotessafe use of Living Modified
Organisms (LMOs)
• Procedure for governments on imports
containing LMOs
• Biosafety Clearing House
• Relevance to botanical collections
© Kate Davis

International Treaty on Plant Genetic
Resources for Food and Agriculture (1)
• Multilateral system
• Facilitated crop access
• Sharing of financial benefits
• Farmers’ rights

International Treaty on Plant Genetic
Resources for Food and Agriculture (2)
• Facilitated access:
– for food/feed purposes only
– quickly, with minimal cost
– standardMTA
– recipients keep material available
– no before/after date

World Summit on Sustainable
Development
• WEHAB:water & sanitation, energy,
health, agriculture, biodiversity
• 3 main outcomes:
– Plan of Implementation
– Johannesburg Declaration
– Type II initiatives

06 pgr access and benefit sharing

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