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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 2 © Biosafety SA BIOTECH INNOVATION proof of product market idea marketing concept development success • Sustainable products • Diverse activities & role players 3 © Biosafety SA DEFINING SUSTAINABLE BIOTECH Health Environment safe sustainable viable Socio-political 4 © Biosafety SA Economic 5 © Biosafety SA 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. 6 © Biosafety SA 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 7 © Biosafety SA ENSURE AN APPROPRIATE GM PERSPECTIVE Regulatory framework Developer GM product Consumer vs. Regulatory framework Developer (GM) product Market (need) 8 © Biosafety SA 2o Consumer IMPLEMENTATION PITFALLS • Makhathini Flats cotton & Eastern Cape maize • Product misalignment in small-scale environment • Sweeping judgements based on limited, imperfect options 9 © Biosafety SA PERFORMANCE BEYOND THE GM TRAIT Sudan’s bacterial blight susceptibility Burkina Faso’s low lint quality 10 © Biosafety SA COMMUNICATION & ENGAGEMENT Public perception of biotechnology in South Africa 2016 ↓ knowledge stratified not polarised 11 © Biosafety SA 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 12 © Biosafety SA THANK YOU 13 © Biosafety SA Dr Hennie Groenewald [email protected] www.biosafety.org.za