Recent Developments in Genetic Resources Policy: Impact On The Value Chain

IRRI Rice Seminar Series
Bert Visser
Current position Director Centre for Genetic Resources, the Netherlands; Wageningen University and Research Centre
Education and training
M.Sc. in Molecular Sciences, Wageningen University Ph.D. in Human Virology, University of Utrecht
Work experience
University of Utrecht: molecular virology
Wageningen UR: genetic modification (Bacillus thuringiensis)

Ministry of Foreign Affairs: biotech for small-scale agriculture Wageningen UR: genetic resources (genetic resources strategies; on-farm management; policies) National Focal Point on Access and Benefit-sharing
Various positions in FAO Commission on Genetic Resources, International Treaty
Highlights
Integrating plant, animal and forest genetic resources management relating ex situ and on-farm management of genetic resources advice on genetic resources policy development an implementation
Recent developments in genetic
resources policy: impact on the value

chain
Bert Visser IRRI, February 2012
Centre for Genetic Resources, the Netherlands
This presentation
IPRs and plant genetic resources for food and agriculture (PGRFA)
IPRs and the concept of access and benefit-sharing
IPRs and the concept of Farmers Rights
Convention on Biological Diversity (CBD) International Treaty on Plant Genetic Resources for Food and Agriculture (Treaty) Nagoya Protocol on Access and Benefit-Sharing (ABS)
Conclusions
The rationale of IPRs and its consequences

A temporary exclusive right in exchange for disclosure Balance between the interests of the inventor and of society at large
Felt inappropriate over time by some stakeholders
Resulted in ABS and in Farmers Rights

From IPRs to ABS: the Grand Bargain

South
Poor Genetically Rich
Genetic Resources
North
Rich Genetically Poor
Bio-industries
Share of benefits Products of bio-industries Incentives and means for nature conservation Justice in exchange
After Bram de Jonge
The concept of Access and Benefit-Sharing
Nested in a paradigm shift
from PGRFA as a heritage of mankind to the principle of national sovereignty over PGRFA
Meaning of the concept might seem obvious but the term ABS is not properly defined
From IPRs to Farmers Rights

Patents limit use by third parties
PBR allow use for the purpose of R&D

UPOV contains a Farmers Privilege as a recognition for traditional seed handling: the right to re-use seed produced on the same holding if provided in national legislation International Undertaking an attempt to balance Farmers Rights and Breeders Rights from Privilege to Right
Discussions in FAO Commission on Genetic Resources

Farmers Rights in the International Treaty
Art. 9.2
The Contracting Parties agree that the responsibility for realizing Farmers Rights .. rests with national governments (that should) protect and promote Farmers Rights, including
the right on protection of traditional knowledge relevant to PGRFA the right to equitably participate in sharing of benefits arising from the use of PGRFA the right to participate in decision-making on matters related to PGRFA
Farmers Rights in the International Treaty
Art. 9.3
Nothing in this article should be interpreted as to limit the rights that farmers have to save, exchange and sell farm-saved seed, subject to national law and as appropriate
Interface with PBR and patent right systems
The CBD: its historical context

established in 1992 legally binding to currently 192 states
since 28 December 1993 into force, USA missing
first international agreement on biological diversity no distinction between different types of biodiversity
e.g. terrestrial vs. marine, domesticated vs. non-domest. biennial Conferences of the Parties responsible for implementation measures
framework agreement
The CBD: its major concepts
three coherent objectives

conservation of biodiversity sustainable use of its components fair and equitable benefit-sharing
national sovereignty
bilateral negotiations on access and benefit-sharing (ABS)

Not focused on agriculture and breeding
Attention for knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles (Art. 8(j))
involves community-based organizations and indigenous peoples
Ex situ conservation seen as complementary to in situ management/conservation
genebanks vs. on-farm and in the wild

country of origin

applicable to non-domesticated resources not fit for domesticated resources

traveled the world improved in different countries
whose contributions to improvement (IRRI 36/64)?
PIC and MAT

PIC = Prior Informed Consent (medical origin)
MAT = Mutually Agreed Terms MAT may be with government, local owners or both
Relation to ITPGRFA
CBD requested negotiations for a revision of the FAO International Undertaking

PGRFA a specific domain Nairobi Final Act, 1993
Treaty the outcome of this process Treaty is in harmony with CBD, but also has a unique feature

Multilateral System of Access and Benefit-sharing back to the principle of heritage of mankind
International Regime on ABS

target agreed on WSSD Johannesburg in 2002
to be a (set of) binding instrument(s)

biodiversity-wide negotiations under CBD to be concluded in October 2010 Nagoya Protocol (2010) outcome of process

Protocol and Treaty both non-exclusive elements of the International Regime more to come? (e.g. on animal genetic resources)
Current impact of the CBD
Awareness on the value of biodiversity

intrinsic value environmental functions potential use
Strong decrease in international exchange

caused by lack of implementing regulations, lack of clarity, lack of legal certainty, lack of political willingness conditions for access for prospective users often unclear
Why the International Treaty?
Special nature of PGRFA

food security mutual interdependence large number of routine international transfers predictable use and commercialization incremental improvements, many sources for a variety
Request of CBD CoP to solve PGRFA issues within FAO Global System on PGRFA
Treaty to be in harmony with the CBD
unlike the FAO International Undertaking

Why the CBD was not appropriate?
Based on national sovereignty

bilateral negotiations bilateral basis has resulted in decreased exchange and higher transaction costs
Difficulties of determining country of origin for PGRFA
crops have travelled the world over
Status of ex situ collections acquired prior to the entry into force of the CBD needed to be resolved

including all CGIAR collections including all European collections holding tropical germplasm
Treaty negotiations
Negotiated by FAO Commission on Genetic Resources for Food and Agriculture

the recognized international forum for negotiations of policy aspects of GRFA 164 members return to common heritage concept took long process negotiations started in 1994, concluded in 2001 some major issues referred to Governing Body, e.g. Standard Material Transfer Agreement (SMTA), concluded in 2006
Objectives of the Treaty
The conservation and sustainable use of plant genetic resources for food and agriculture (= PGRFA) The fair and equitable sharing of benefits derived from their use, in harmony with the Convention on Biological Diversity, for sustainable agriculture and food security Same objectives as CBD, but on PGRFA Note: Treaty covers all PGRFA
Main elements of the Treaty
Multilateral System of Access and Benefit-Sharing

MLS forms core of the Treaty standard rules for facilitated access and benefit-sharing PGRFA of most importance for food security no longer need to negotiate access bilaterally composition a result of political considerations
List of crops (Annex 1)
PGRFA under management and control of Contracting Parties and in the public domain automatic part of the MLS MLS pools crucial plant genetic resources
Other key provisions of the Treaty
Framework for the conservation and sustainable use of PGRFA
Articles 5 and 6
Farmers Rights
Article 9
Article 15
Status of CGIAR and other international collections

agreements between Treaty (FAO) and CGIAR ex situ collections (600,000 acc. approx.), incl. IRRI collection
Annex 1 crops
Cereals

Root and tuber crops

rice, wheat, maize sorghum, pearl and finger millet barley, oats, rye, triticale
potato, sweet potato, cassava beet, aroids, carrot, yams
Miscellaneous

Pulses
pigeon pea, chickpea, lentil, pea, Phaseolus, Vicia, Vigna, grasspea
citrus, apple, banana/plantain Brassica, eggplant, asparagus, strawberry breadfruit, coconut, sunflower
Conditions of access to MLS
PGRFA available under the Standard Material Transfer Agreement (SMTA), adopted in June 2006

PGRFA available only for research, breeding and training: transfer for other purposes falls outside MLS Intellectual property or other rights that limit facilitated access to the plant genetic resources for food and agriculture, or their genetic parts and components, in the form received from the Multilateral System may not be claimed by implication IPRs on breeding products allowed
Benefit-sharing (1)
Benefits to be shared multilaterally

Genetic resources in MLS pooled No individual owner with whom individual contracts for ABS must be negotiated
Transaction costs relatively low
Administration of transfers, archiving of SMTAs
Facilitated access itself a major benefit Benefit-sharing options include

exchange of information, access to and transfer of technology, capacity-building the sharing of monetary and other benefits of commercialization
Benefit-sharing (2)
Treaty provisions for monetary benefit-sharing:
if a product that incorporates material from the MLS is commercialized in such a way that it is not available without restriction to others for further research and breeding a mandatory payment will be made if available without restriction to others, payment is voluntary
These moneys will be used in the context of the Treatys Funding Strategy (Benefit-sharing Fund)
to support small-scale farming systems in maintaining PGRFA

Status of ratification

Treaty entered into force on 29 June 2004
at present, 121 States and EU are Parties to the Treaty

almost all African and European countries
USA and China still missing
Summary on Treaty
The Treaty is a sectorial solution for food and agriculture

in harmony with CBD, but with multilateral pool part of future International Regime on ABS all other crops fall under CBD rules
MLS for only 64 crops and forages regulated
Treaty is operational with the adoption of the SMTA
Treaty may eventually become almost universal
but it may take a long time

The Nagoya Protocol: new kid on the block

Binding international agreement on Access and Benefit-sharing Adopted in October 2010 Framework agreement within a framework agreement Some concepts further defined
definition of derivative user country measures, protection of traditional knowledge

New requirements included
The Nagoya Protocol: Access
Access only by

countries of origin of genetic resources (GR) countries that have acquired GR in accordance with CBD
Most ex situ collections remain national jurisdiction
PIC and MAT needed only if required through domestic law

Transparency and predictability, due process for users by provider country
major uncertainty for users; no further details provided

The Nagoya Protocol: Benefit-sharing
Broad scope of Benefit-sharing

benefits from the utilization including subsequent applications and commercialization user measures necessary (checkpoints, certificates, etc.)
to flow to conservation of biodiversity to flow to indigenous and local communities
BS options detailed in Protocol Annex

The Nagoya Protocol: User measures
Measures to provide that GR utilized within country have been accessed in accordance with PIC and MAT

as per domestic law or requirements of donor Party Parties must ensure that GR utilized in country were of good legal status in relation to ABS checkpoints in user countries agreed internationally recognized certificate of compliance agreed (SMTA assumed to qualify as such)
The Nagoya Protocol: Traditional knowledge
Protection of holders of TK enhanced

PIC or approval and involvement of communities needed MAT established
Benefits to be shared with communities
Good legal status for use of TK to be established by user country
no precedent in CBD on protection of TK
The Nagoya Protocol: Economic scope
New definition in Protocol
Utilization of GR means to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology
Definition covers R&D on both the genes and on biochemical compounds contained in the acquired GR
The Nagoya Protocol: other elements
Protocol also applies to (plant) pathogens
special treatment considered in cases of emergencies threatening human, animal or plant health
Non-commercial use

simplified measures on access for non-commercial research purposes Party responsibility, no further indications
The Nagoya Protocol: summary
Nagoya protocol implies new domestic policy and legislation on

access benefit-sharing user measures no detailed procedures/prescribed text EU regulations in preparation

Still a framework for measures
Ratification by many CBD Parties foreseen
Impact on the rice value chain: collecting

CWR seen by some countries as a treasure Collecting from countries Party to ITPGRFA

Art. 12.3(h) ambiguous on collecting; national legislation increasingly relevant GB may set rules in absence of national legislation For IRRI: who collects and transfers? according to CBD; Nagoya Protocol expected to provide guidance (donor transparency; user country measures)
Collecting from non-Parties
possibly better facilitated access through collecting

Impact on the rice value chain: distributing
MLS PGR: uptake and distribution acc. to SMTA
slow implementation of MLS
Other PGR rice not in MLS
on conditions agreed with donor country distribution conditions preferably agreed during collecting, e.g. in the form of MoU Does IRRI want to incorporate and use such resources?
as above conditions of SMTA may apply
Breeding products

Impact on the rice value chain: improving
PGR placed in MLS

conditions of SMTA apply no specific requirements unless commercialized product incorporates MLS PGR and is protected from use by third parties for research breeding and training (in case of patents) in latter case: obligatory benefit-sharing, in other cases: voluntary benefit-sharing conditions agreed in negotiations (specified in MoU) apply
Other PGR
Impact on the rice value chain: protecting

MLS PGR: no protection possible
Products based on MLS PGR: possible but with consequences (Art. 6 SMTA)
Other PGR: depending on negotiations with provider country
provisions Nagoya Protocol will soon apply
Conclusions (1)

Implementation of three international instruments on PGRFA ongoing (CBD, ITPGRFA, Nagoya Protocol) Each instrument impacts on international exchange National sovereignty principle remains leading
including on contributions to Treatys Multilateral System
Facilitation of exchange depends on national measures
transparency of donor countries and user measures may over time provide more certainty for users
Conclusions (2)

ABS regulations on genetic resources have major impact on developments in plant breeding ABS remains battlefield

developed countries seeking facilitated access developing countries seeking more benefits
ABS part of wider power balance in other international negotiating fora (WSSD, WTO TRIPs, WIPO) Conditions for collecting and exchange may only gradually improve

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IRRI Rice Seminar Series

Education and training

University of Utrecht: molecular virology

Wageningen UR: genetic modification (Bacillus thuringiensis)

Various positions in FAO Commission on Genetic Resources, International Treaty

Recent developments in genetic

resources policy: impact on the value

IPRs and the concept of access and benefit-sharing

IPRs and the concept of Farmers Rights

The rationale of IPRs and its consequences

Felt inappropriate over time by some stakeholders

Resulted in ABS and in Farmers Rights

From IPRs to ABS: the Grand Bargain

The concept of Access and Benefit-Sharing

Nested in a paradigm shift

Centre for Genetic Resources, the Netherlands

From IPRs to Farmers Rights

Patents limit use by third parties

PBR allow use for the purpose of R&D

Discussions in FAO Commission on Genetic Resources

Farmers Rights in the International Treaty

Centre for Genetic Resources, the Netherlands

Farmers Rights in the International Treaty

Interface with PBR and patent right systems

Centre for Genetic Resources, the Netherlands

The CBD: its historical context

established in 1992 legally binding to currently 192 states

since 28 December 1993 into force, USA missing

The CBD: its major concepts

three coherent objectives

bilateral negotiations on access and benefit-sharing (ABS)

Centre for Genetic Resources, the Netherlands

The CBD: its major concepts

Not focused on agriculture and breeding

involves community-based organizations and indigenous peoples

Ex situ conservation seen as complementary to in situ management/conservation

genebanks vs. on-farm and in the wild

The CBD: its major concepts

applicable to non-domesticated resources not fit for domesticated resources

whose contributions to improvement (IRRI 36/64)?

PIC and MAT

PIC = Prior Informed Consent (medical origin)

CBD requested negotiations for a revision of the FAO International Undertaking

PGRFA a specific domain Nairobi Final Act, 1993

International Regime on ABS

target agreed on WSSD Johannesburg in 2002

to be a (set of) binding instrument(s)

Current impact of the CBD

Awareness on the value of biodiversity

intrinsic value environmental functions potential use

Strong decrease in international exchange

Why the International Treaty?

Special nature of PGRFA

Treaty to be in harmony with the CBD

unlike the FAO International Undertaking

Why the CBD was not appropriate?

Based on national sovereignty

Difficulties of determining country of origin for PGRFA

crops have travelled the world over

Negotiated by FAO Commission on Genetic Resources for Food and Agriculture

Objectives of the Treaty

Main elements of the Treaty

Multilateral System of Access and Benefit-Sharing