Recent developments in genetic resources policy: impact on the value chain

8/2/2019 Recent developments in genetic resources policy: impact on the value chain

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Bert Visser

IRRI Rice Seminar Series

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


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Centre for Genetic Resources, the Netherlands

Recent developments in genetic

resources policy: impact on the value

chain

Bert VisserIRRI, February 2012


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IPRs and plant genetic resources for food andagriculture (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

This presentation


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The rationale of IPRs and its consequences

A temporary exclusive right in exchange fordisclosure

Balance between the interests of the inventor andof society at large

Felt inappropriate over time by some stakeholders

Resulted in ABS and in Farmers Rights


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From IPRs to ABS: the Grand Bargain

South NorthPoor Rich

Genetically Rich Genetically Poor

Genetic Resources Bio-industries

Share of benefits Products of bio-industries

Incentives and means for nature conservationJustice in exchange

After Bram de Jonge


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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 butthe term ABS is not properly defined


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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 fortraditional seed handling:

the right to re-use seed produced on the same holding ifprovided in national legislation

Discussions in FAO Commission on Genetic Resources

International Undertaking an attempt to balance FarmersRights and Breeders Rights

from Privilege to Right


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Farmers Rights in the International Treaty

Art. 9.2 The Contracting Parties agree that the responsibility for

realizing Farmers Rights .. rests with nationalgovernments (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 theuse of PGRFA

the right to participate in decision-making on matters related to PGRFA


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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 sellfarm-saved seed, subject to national law and as

appropriate

Interface with PBR and patent right systems


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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 ofbiodiversity

e.g. terrestrial vs. marine, domesticated vs. non-domest.

framework agreement biennial Conferences of the Parties responsible for

implementation measures


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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)


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Not focused on agriculture and breeding Attention for knowledge, innovations and practices

of indigenous and local communities embodyingtraditional lifestyles (Art. 8(j))

involves community-based organizations and indigenouspeoples

Ex situconservation seen as complementary to in

situmanagement/conservation genebanks vs. on-farm and in the wild


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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


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Relation to ITPGRFA

CBD requested negotiations for a revision of theFAO 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 aunique feature

Multilateral System of Access and Benefit-sharing

back to the principle of heritage of mankind


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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 October2010

Nagoya Protocol (2010) outcome of process

Protocol and Treaty both non-exclusive elements of theInternational Regime

more to come? (e.g. on animal genetic resources)


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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


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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 withinFAO Global System on PGRFA

Treaty to be in harmony with the CBD

unlike the FAO International Undertaking


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Why the CBD was not appropriate?

Based on national sovereignty bilateral negotiations

bilateral basis has resulted in decreased exchange andhigher transaction costs

Difficulties of determining country of origin forPGRFA crops have travelled the world over

Status of ex situcollections acquired prior to theentry into force of the CBD needed to be resolved including all CGIAR collections including all European collections holding tropical

germplasm


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Treaty negotiations

Negotiated by FAO Commission on GeneticResources for Food and Agriculture

the recognized international forum for negotiations ofpolicy 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


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Objectives of the Treaty

The conservation and sustainable use of plantgenetic resources for food and agriculture (=PGRFA)

The fair and equitable sharing of benefits derived

from their use, in harmony with the Convention onBiological Diversity, for sustainable agriculture andfood security

Same objectives as CBD, but on PGRFA Note: Treaty covers all PGRFA


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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-sharingPGRFA of most importance for food security

no longer need to negotiate access bilaterally

List of crops (Annex 1)

composition a result of political considerations

PGRFA under management and control of

Contracting Parties and in the public domainautomatic part of the MLS

MLS pools crucial plant genetic resources


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Other key provisions of the Treaty

Framework for the conservation and sustainableuse of PGRFA

Articles 5 and 6

Farmers Rights Article 9

Status of CGIAR and other international collections

Article 15

agreements between Treaty (FAO) and CGIAR ex situcollections (600,000 acc. approx.), incl. IRRI collection


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Annex 1 crops

Cereals rice, wheat, maize

sorghum, pearl and fingermillet

barley, oats, rye, triticale

Pulses

pigeon pea, chickpea, lentil,pea, Phaseolus, Vicia,Vigna, grasspea

Root and tuber crops

potato, sweet potato,cassava

beet, aroids, carrot, yams

Miscellaneous

citrus, apple, banana/plantain

Brassica, eggplant,

asparagus, strawberry breadfruit, coconut,

sunflower


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Conditions of access to MLS

PGRFA available under the Standard MaterialTransfer 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 facilitatedaccess to the plant genetic resources for food andagriculture, or their genetic parts and components, in theform received from the Multilateral System may not be

claimed by implication IPRs on breeding products allowed


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Benefit-sharing (1)

Benefits to be shared multilaterally Genetic resources in MLS pooled

No individual owner with whom individual contracts forABS 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 oftechnology, capacity-building

the sharing of monetary and other benefits ofcommercialization


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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 availablewithout restriction to others for further research andbreeding a mandatory payment will be made

if available without restriction to others, payment isvoluntary

These moneys will be used in the context of theTreatys Funding Strategy (Benefit-sharing Fund) to support small-scale farming systems in maintaining

PGRFA


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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


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Summary on Treaty

The Treaty is a sectorial solution for food andagriculture

in harmony with CBD, but with multilateral pool

part of future International Regime on ABS

MLS for only 64 crops and forages regulated

all other crops fall under CBD rules

Treaty is operational with the adoption of the SMTA

Treaty may eventually become almost universal

but it may take a long time


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The Nagoya Protocol: new kid on the block

Binding international agreement on Access andBenefit-sharing

Adopted in October 2010

Framework agreement within a frameworkagreement

Some concepts further defined

definition of derivative

New requirements included

user country measures, protection of traditional knowledge


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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 situcollections remain national jurisdiction

PIC and MAT needed only if required throughdomestic law

Transparency and predictability, due process for

users by provider country major uncertainty for users; no further details provided


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The Nagoya Protocol: Benefit-sharing

Broad scope of Benefit-sharing benefits from the utilization includingsubsequent

applications and commercialization

user measures necessary (checkpoints, certificates, etc.)

BS options detailed in Protocol Annex

to flow to conservation of biodiversity

to flow to indigenous and local communities


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The Nagoya Protocol: User measures

Measures to provide that GR utilized within countryhave been accessed in accordance with PIC andMAT

as per domestic law or requirements of donor Party

Parties must ensure that GR utilized in country were ofgood legal status in relation to ABS

checkpoints in user countries agreed

internationally recognized certificate of complianceagreed (SMTA assumed to qualify as such)


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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 establishedby user country

no precedent in CBD on protection of TK


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The Nagoya Protocol: Economic scope

New definition in Protocol Utilization of GR means to conduct research and

development on the genetic and/or biochemicalcomposition of genetic resources, including through the

application of biotechnology Definition covers R&D on both the genes and on

biochemical compounds contained in the acquiredGR


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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-commercialresearch purposes

Party responsibility, no further indications


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The Nagoya Protocol: summary

Nagoya protocol implies new domesticpolicy andlegislation on

access

benefit-sharing

user measures

Still a framework for measures

no detailed procedures/prescribed text

Ratification by many CBD Parties foreseen EU regulations in preparation


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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 legislationincreasingly relevant

GB may set rules in absence of national legislation For IRRI: who collects and transfers?

Collecting from non-Parties

according to CBD; Nagoya Protocol expected to provideguidance (donor transparency; user country measures)

possibly better facilitated access through collecting


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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 duringcollecting, e.g. in the form of MoU

Does IRRI want to incorporate and use such resources?

Breeding products as above

conditions of SMTA may apply


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Impact on the rice value chain: improving

PGR placed in MLS

conditions of SMTA apply

no specific requirements unless commercialized productincorporates MLS PGR and is protected from use by thirdparties for research breeding and training (in case ofpatents)

in latter case: obligatory benefit-sharing, in other cases:voluntary benefit-sharing

Other PGR conditions agreed in negotiations (specified in MoU)

apply


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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 providercountry

provisions Nagoya Protocol will soon apply


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Conclusions (1)

Implementation of three international instruments onPGRFA 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 nationalmeasures

transparency of donor countries and user measures mayover time provide more certainty for users


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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 onlygradually improve

Documents

Recent developments in genetic resources policy: impact on the value chain