business realities and needs - abs initiative116,695 121,025 104 24 49 west & n africa 86,447...
TRANSCRIPT
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Business realities and needs
ABS Business Dialogue
Pretoria, 7-9 October
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ICC’s role
ICC, the world business organization, promotes cross-border trade and
investment and the multilateral trading system
Members: companies, chambers of commerce and business organizations of all
sizes and from all sectors from 130 countries
Coordinates business representation in ABS discussions
2
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Business realities
Which sectors are affected?
Sectors are diverse:
• Size, turnover, markets (local/global)
• Means of access
• Use of GRs and/or TK associated with GR
• R&D cycles
• Existing ABS arrangements
BUT certain common needs and realities
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Sectors affected – depends on scope
Genetic ResourcesBiological
Resources
Derivatives
Products /
Commodities
Plant breeding, Animal breeding, Biotechnology
(pharma, industrial , agro, aquatic), Pharmaceuticals
(decreasing use of GRs), Traditional medicines,
Botanical drugs, Biological pest control etcBiotrade,
fragrances,
cosmetics,
food, drinks,
pets, timber
products etc
Distribution
(wholesale/retail)All
sectors trading
products with GR/BR
component eg
detergents, rice etc
All sectors trading in
derivatives of GRs/BRs
eg alcohol, biscuits
Potentially
millions of
transactions!
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Diversity of sectors
• Size of industry sectors vary greatly e.g.:
– Plant breeding (turnover 2005 US$34bn (global world seed market 2008 US$36,5bn); )
– Pharmaceuticals (global market 2008 US$773bn)
– Animal breeding cattle, pig, poultry and fish (global turnover €2.5 billion)
– Biotech (global market 2006 US$153.7 bn )
– Biotech crop (global market 2008 US$7.5 bn
– Pet industry ( EU+US retail markets incl cats and dogs 2007 US$85bn)
– Traditional medicines (global market US$ 60 bn)
– Biocontrol (turnover €200m)
• Many sectors using GRs/BRs consist mainly of SMEs e.g. biotech; seeds; herbal medicines; cosmetics; biotrade; animal breeding; pets
• Very diverse access and use models
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GRs : Flows and Access
• Many GRs long since extracted from original environment →
common commodities in trading system e.g. cell lines. Rare or
«new » GRs infrequent.
• GRs have moved and been transformed across continents
throughout history pre-CBD – « origin » impossible to define
All countries mutually interdependent on GRs
• Ex situ access more common in many sectors – in situ much less
common and through local intermediaries
• Every day millions of common transactions of GRs and items
including/deriving from GRs (most not used for genetic properties)
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Plant GRs - movement of cotton varieties
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Levels of Dependency of Countries on non-indigenous food resources
CountryDependency
(%)Main source of food energy
supplyPrimary region of diversity of crops
ChinaJapanRepublic of Korea
46 - 5543 - 6130 - 54
Non-native - wheat, sugar, maize, potatoNative - rice and soybean
East Asia - rice, soybean,orange, Brassica, millet, tea,onion
BangladeshIndiaNepal
14 - 2135 - 4747 - 57
Non-native - wheat, maizeNative - rice, sugarcane, millet
South Asia - rice, banana, sugarcane, sesame, millet, Brassica rapa, B juncea
KenyaSouth AfricaEthiopia
89 - 9890 - 9828 - 56
Non-native - Phaseolus, maize, sweet potato, potato, cassava, banana, plantain, wheat, riceNative (for Ethiopia) - tef, Avena Abyssinian, Brassica carinata
East and Southern Africa -sorghum, millet, yam
BrazilAndean Region
ArgentinaColombia
81 - 94
89 - 9584 - 94
Non-native - wheat, sugar, rice, maize, soybean, plantain, bananaNative - potato, Phaseolus (for Andean Region); cassava (Brazil)
Andean region – pineapple groundnut, sweet potato, tomato, cocoa, Phaseolus, potato, cassava,
USCanada
77 - 10084 - 99
Non-local - wheat, sugar, soybean, potato, maize, barley, rice, groundnut
North America - sunflower
Source: Palacios (1998)
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Dependency between regions on GRs
Region Accessions
originally
collected
from region
Samples
distributed
to region
Gain (%) Flows to
region from
within (%)
Material
'borrowed'
(%)
Asia Pacific 158,153 461,328 292 74 55
Europe 35,560 78,543 221 20 91
N America 16,557 58,987 356 7 94
S America 105,680 96,355 91 45 37
Sub Saharan
Africa
116,695 121,025 104 24 49
West & N
Africa
86,447 79,441 92 32 44
519,092 895,679
Courtesy of Radha Ranganathan, ISF
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Trade and Flow of AnGR
Gene flows N→N and N→S and regional
Product flows S→N, N →N, and regional
Animals part of populations
• ABS based systems – contractsh
• Animals privately owned
• Good working legal systems of exchanges of animals in place
• Frameworks for breeds and populations GRsdiffer accordingly to species:
• for farmfish, poultry / often privately owned
• for bovines, sheeps / often collectively managed
Widely used breeds
• Exchange daily practice of dissemination
• Active trade among breeding programmes and between countries
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0
20
40
60
80
100
120
140
1 11 21 31 41 51 61 71 81
Rank order of breeds
no. countries
Holstein-Friesian (128 countries worldwide)
Large White
Saanen
Suffolk
Rhode Island Red
Cattle
Breeds with Southern ancestry, or bred in South
Other breeds
Commercial breeds (ancestry not divulged)
Sheep
Goat
Pig
Chicken
Duroc
LandraceJersey
Leghorn
Animal Gene Flow…Product Flow
Courtesy Anne Marie-Neeteson, EFABB
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Accessing GRs and related materials
Ex situ access more common in many industries
In situ less common and through local intermediaries
• Biotechnology (pharma, industrial , agro, aquatic): genebanks, certified biological centres, cooperation with local institutions
• Pharmaceuticals (less reliance on natural genetic resources in this sector due to technology advances e.g. synthetic organic chemistry ): library compounds from past programmes, catalogues, purified natural products and fragments
• Plant breeding: genebanks, research institutes, universities, botanical gardens, own collections
• Animal breeding: exchange of animals/semen between farmers and breeding programmes. Use of wild species negligible.
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Use of GRs
Used in diverse forms
• original form modified form in whole in part
Does not necessarily appear in/add value to final product: • research tool/catalyst in research or production process (eg cell line; vectors)
step in process (e.g. GRs during cross breeding of plants)
• inactive component (e.g. in herbal medicine)
• test material (pathogens and pests to test resistance)
Relationship between the accessed genetic resource and final products• 1 →1 1 → many many → 1 many → many
The usage of genetic resources may or may not be associated with the creation of intellectual property
uses of GRs will
evolve with time
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Use in plant breeding (1)
Direct use
• Recombination
– Modern varieties 90-95%
– Research materials
– Landraces
– Wild relatives
• Gene selection
– Modern varieties
– Research materials
– Landraces
– Wild relatives
– Microbials
– Pathogens
Indirect use
• Plants/Varieties as test plants for comparison
• Pathogens to check for resistance
• Pollinators for seed production
5-10%
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Use in plant breeding (2)2
-4ye
ars
6-8
ye
ars
3-5
Ye
ars
Number of
breeding
materials
Number
of test
locations
Main
tenance
bre
edin
g
Selection plant
material
Recombination/ mutation
Evaluation
Trials in several years
and in several locations
Yield, resistance quality
agricultural characteristics
Selection
Parent line/
variety
IP application/
RegistrationOfficial
DUS tests
Modern varieties
Seed production, pre-
basic, basic,
standard/certified seed
Research
material
Landraces
Wild relatives
Varieties to
compare to
Pathogens/pests
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Complex Value Creation Procedures Require ABS Regime with Least Possible Additional Input
pro
jects
industrial value creation process
Se
cto
r B
pro
filin
glic
en
cin
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of
ing
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job
ord
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pro
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lice
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of p
roje
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external
purchas
e
own
synthesis
.
.
.
.
.
pre
-
pro
jects
Ma
rke
ti
ng
Ma
rke
ti
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les
pilo
t p
lan
t
co
mm
erc
ial p
lan
tremoval
pro
ce
ss d
eve
lop
me
nt
low value
Se
cto
r A
Research Development Production Marketing & Sales
Co
-Sa
les
Verification if providing
organization is
authorized to this effect
Identification of the desired genetic resource
Identification of the country of origin with the lowest
access hurdles
Contacting of authorized Focal Points of the
country of origin
Identification of allnecessary access
requirements
Statement on proposedutilization to obtain
„Prior Informed Consent“
Agreement on provisionsof licence agreement incl. benefit sharing
Ratification of licence agreement
Additional input so far for removal of native genetic resources
Use in biotechnology industry
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Lead
optimisation
Hit
Ident
Lead
IdentTarget
Ident
Library compounds from past programmes
Catalogues
Purified natural products and fragments
New compounds made by synthetic organic
chemistry
Enzymes,
GR’s
Non-human
target
( Production technology
and vaccine research)
Use in pharmaceuticals
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Pharma: hypothetical scenario (1)
HTS to Lead Series
700,000 compounds
(incl. 2000 natural products)
Typical result of high throughput screening
(HTS):
500 compounds identified as actives (“hits”),
Grouped in 20 clusters
Typical result of filtering of HTS hits: (*1)
Only 1 – 5 clusters selected to explore
Synthesis of 50 – 200 analogues (= “lead generation”)
Typical result of lead generation:
Only 1 – 2 hit cluster full fill lead series criteria (*2)
(*1) filtering criteria: chemical tractability, selectivity, PK, psy, chem, prop.
(*2) lead criteria: similar to filtering criteria, but more stringent.
Courtesy of EFPIA
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Pharma: hypothetical scenario (2)
Lead series to market
2 lead series
Typical result of lead optimization:
Synthesis of 10,000 analogues
Max. 1 lead series fulfill criteria
Max. 1 – 2 compound(s) fulfill criteria for development
Finally selected compound incorporates various structural elements that were not present in HTS hits
Typical result of Clinical Development:
Only 1 out of >10 compounds that enter development reaches the market
Not all compounds that are launched are profitable
Courtesy of EFPIA
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Two major categories of AnGRs
Local / traditional breeds– Local culture
– Traditional knowledge minor influence on innovation
– Quality schemes resulting in high priced products : sometimes based on breed specificity eg Jamon iberico (pigs, Spain)
– Not much exchange of AnGR*
Modern/commercial breeds– Place of origin ??? (Holstein Frisian NL,GE ???)
– Extensive data recording: performance, pedigree
– Breeding programmes run by• Farmers’ co-operatives
• SMEs
• International companies
– Very active exchange and trade of
breeding animals
Use in animal breeding (1)
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Different breeding systems
• Pastoralists - collective ownership; customary law for livestock exchange
• Small-scale farmers- individual ownership of livestock
• Centralized breeding systems with breeding organizations- breeding stock owned by famers cooperatives/private companies
AnGRs privately controlled (private ownership of animals)
Breeding of production animals on farms
• Use of pure or cross bred animals
• Reproduction technology (artificial insemination; embryo transfer)
• Cross breeding requires simultaneous improvement of several breeds
Public Gene Banks for conservation - no exchange of AnGR
Use in animal breeding (2)
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R&D: GRs →marketable product
Research and Development
Long term capital intensiveInvestment
Failures
Commercial
Product
GR
Considerable R&D on product
necessary before
commercialisation e.g.
- Pharma : 10-15 yrs; US$1.2b
- Plant breeding: 10-12 yrs;
$US60m
- Bio pest control: 3-5 years,
costs; 5 -10m Euro
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Existing ABS arrangementsPlant sector
• FAO International Treaty on Plant Genetic Resources for Food and Agriculture
– multilateral ABS system (64 major food crops)
– standard contracts for material transfer (sMTA)
– covers International Agricultural Research Centres' ex situ collections
• Plant Variety Rights breeders exemption (recognized in ITPGRFA)
– free use for breeding and free commercialization of new product
Animal breeding
• ABS arrangements and policies on the agenda of next FAO Comm for GR for Food and Agriculture –Oct. 2009
Forest, farm fish, micro organisms
• Other GRs covered by CGRFA/FAO (for food and agriculture)
• Discussions of ABS arrangements and policies on the agenda of next CGRFA/FAO – Oct. 2009
Other sectors
• Contracts/ webs of contracts (including industry models/standards)
Standard agreements more suitable for some transactions
Others need flexibility of individually negotiated contracts
BUT all sectors use contracts/agreements
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Legal uncertainty/unpredictability
Lack of transparency
Administrative costs
Regulatory costs
R&D costs/risks
Common realities and needs
SIGNIFICANT INVESTMENTS needed → GRs into commercially viable products
RISK + COST (human and financial) v RETURN ON INVESTMENT
RISKS/
COSTS
INVESTMENT
INCENTIVES
Clear legal rights
Simple transparent clear procedures
Good IP protection
Predictability
GR commercial potential
Business decisions
Risk to reputation
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Business-friendly IR
Business needs a precisely targeted IR which (is)
• Supports research, economic activity and freedom to innovate
• Flexible to accommodate sectoral differences and future developments
• Coherent with existing international instruments (e.g. IPRs, health and safety) and excludes resources already covered by other fora eg FAO ITPGRFA , ICAnGRFA
• Practical, cost effective system: no heavy administrative burdens
• Does not restrict mutual agreements and encourages use of contracts
• Promotes coherence across borders: mutual recognition of ABS agreements; info system
• Further develops and harmonizes national regimes in spirit of Bonn guidelines;
uses existing national structures; does not create untested new mechanisms
• Promotes national ABS regimes that (are) :
– Predictable
– Provide legal certainty
– Transparent (national focal point and competent authority)
– Non-discriminatory
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Legal certainty- transparency- cross border coherence
Legal certainty - essential foundation for investments
• Clear legal rights to GRs - national focal point/competent authority
• Legal clarity concerning downstream products
• Clear enforceable IPRs (no new disclosure requirements)
• Contract-based arrangements – enforceable agreements
• No retroactive legislation
• Clear rules concerning consultation of ILCs/TK associated GR
• Clear definition of « misappropriation »
Transparency
• What GRs are available and their status
• Who to obtain authorisations from and how
• What are rules - how are they applied
Coherence across borders
• No subsequent claims from other countries if bona fide agreement
• Common standards for national ABS legislations based on Bonn Guidelines
• Coherence between systems of information re ABS regimes
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Non-discrimination, practicality, cost effectiveness
Non-discrimination on basis of nationality
• All countries GR users AND providers
Practicality
• System has to be workable for every day use for both governments and users – otherwise will stifle legitimate uses of GRs
Cost-effective system
Heavy regulatory requirements and costs
• SMEs and researchers squeezed out
• Users will source other types of products, or go to other sources
CERTIFICATES: Administrative and regulatory costs for governments and users? Practicality? Legal certainty? Efficacy as compliance tool?
Nature and legal implications (PIC/MAT)?
Should not include in IR unless all questions resolved
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GRs
l q s
c m
Country A
What is the desired result?
GRs
l q s
b t f
GRs
T r s q
Z y
Country C
Country B
Alternatives to GRs/BRs
- chemical/synthetic compounds
- industrial by products
- other types of products
Too many regulatory « fences » =• discourage access • users → other sources
All countries are users and providers
More benefits from promoting exchange, innovation and collaboration
USER
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For more information
Thank you for your attention
Daphne Yong-d’Hervé
ICC : www.iccwbo.org
ICC information on ABS: http://www.iccwbo.org/policy/ip/index.html?id=2480