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THE NON-BIOLOGICAL FACTORS THAT
IMPACT BIOTECH INNOVATION
Hennie Groenewald
ICABR, Berkeley, 30 May – 2 June 2017
Department:
Science and Technology
REPUBLIC OF SOUTH AFRICA
CONTEXT
Framework for the
development and
support of an
integrated innovation
value-chain for biobased products and
services aimed at
addressing national
priorities
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BIOTECH INNOVATION
proof of
product
market
idea
marketing
concept development
success
• Sustainable products
• Diverse activities & role players
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DEFINING SUSTAINABLE BIOTECH
Health
Environment
safe
sustainable
viable
Socio-political
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Economic
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Environment Food/Feed
Biosafety assessment
Socio-political
Economic
GMO
R,D&C
Viability assessment
Sustainability assessment
INTEGRATED SUSTAINABILITY ASSESSMENT FRAMEWORK FOR GM CROPS
Wild type organism
Trans-molecules
GMO safety assessment
Monitoring
Biology, history of safe
use, anti-metabolites, etc.
Source, regulation of
expression, structure/
function, etc.
Toxicity & allergenicity,
equivalence, nutritional
analyses, food processing, etc.
Purity, possible
long-term effects,
labelling, etc.
Preparative assessment
Environmental risk assessment
Receiving environment, GM
trait, GMO, wild relatives,
persistence, risk hypotheses ,
etc.
Potential pathways to harm, generate data
required to falsify risk hypotheses,
develop appropriate mitigation strategies
to manage risks & uncertainties, etc.
Product
Crop
concept
Gene
Line
discovery transformation selection
Monitoring &
risk management
Hypothesis driven &/or general
surveillance, risk management, etc.
Development
Crop
Marketing
& testing
production
& export
Relevance & Value
Performance
Deployment
Growth & Maturation
Technology & trait,
demand, alternatives, real
benefit, etc.
Agronomy, comparative,
GM trait impart, clear
benefit, etc.
Constrains, logistics,
timeframes, etc.
Performance, endurance,
profitability, etc.
Regulatory environment Accessibility &
Legislative framework,
acceptability
precedents, indigenous, etc.
Product, IP, markets,
deployment, etc.
Implementation Stewardship
Support systems,
capacity, constraints,
structures, etc.
Responsible management
from creation to
withdrawal, etc.
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A single, well integrated, affluent company (conducive to innovation)
GMO
R,D&C
Product ideas informed
by real market exposure
Well integrated, market driven product development
pipeline with unifying oversight and ownership
The fragmented national system of innovation (non-conducive to innovation)
“Product” ideas
developed from
research interests
GMO
R,D&C
Contrasting innovation systems
SYSTEMIC CHALLENGES
Disconnected product
development “pipeline”
with varying skill levels,
knowledge gaps,
competitive overlaps &
lack of ownership
Biosafety, IP, commercialisation, etc.
Unifying technology platforms such as BSA
Short-term, risk
adverse market
focus
BIOSAFETY FRAMEWORKS & CAPACITY
• Absolute requirement – also for
cross-border trade
• Highly variable, low priority,
politically loaded, perceived as
external
• Lack of capacity / experience /
confidence
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ENSURE AN APPROPRIATE GM PERSPECTIVE
Regulatory framework
Developer
GM product
Consumer
vs.
Regulatory framework
Developer
(GM) product
Market
(need)
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2o Consumer
IMPLEMENTATION PITFALLS
• Makhathini Flats
cotton & Eastern
Cape maize
• Product misalignment
in small-scale
environment
• Sweeping judgements
based on limited,
imperfect options
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PERFORMANCE BEYOND THE GM TRAIT
Sudan’s bacterial blight susceptibility
Burkina Faso’s low lint quality
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COMMUNICATION & ENGAGEMENT
Public perception of
biotechnology in
South Africa
2016
↓ knowledge
stratified
not polarised
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COMMUNICATION & ENGAGEMENT
• Goal of the biosafety
communication initiative
AWARENESS & CONFIDENCE
in South African biosafety
system
• Public engagement by
developers / regulators now a
required to ensure success
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THANK YOU
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Dr Hennie Groenewald  [email protected]  www.biosafety.org.za