Patenting Human Genes and Genetic Tests: Recent Developments
Recent developments in genetic resources policy: impact on the value chain
Transcript of 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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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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The CBD: its major concepts
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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The CBD: its major concepts
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