Ben Durham Director: Biotechnology Department of Science & Technology Department of Science and Technology GMO Amendment Bill (B )

The three operational objectives of the strategy are: Achieving mastery of technological change in our economy and society (Innovation) Investment in South Africa’s Science, Engineering and Technology Base (Human Capital and Transformation) Strengthening the government S&T system and private sector participation (Alignment and Delivery) Background South Africa’s National R&D Strategy

South Africa’s National Biotechnology Strategy Minister Science and Technology Department of Science and Technology National Advisory Council on Innovation Biotech Instruments Biotechnology Unit Biotech Advisory Committee Biotech Stakeholders Other govt departments

South Africa’s National Biotechnology Strategy DST & Biotechnology Unit Public Issues Frontier Programmes Technology Platforms Innovation support & commercialization BAC PUB Ethics NBN (Bioinf) Funct.Genomics Microarray Fermentation BRIC’s PlantBio Innov. Fund Incubators SAAVI BIOTECH OUTCOMES Universities Research Councils Grants Industry Start-ups

South Africa’s National Biotechnology Strategy Biotechnology Full range, but some emphasis on 3rd generation Regional Regional socio-economic, environmental and academic advantages Innovation System A: science to technology – robust platforms System B: technology to product / market – enhanced commercialization System C: embed technology/product in an enterprise – increase incubation Centres Aggregator/broker/supplier for networks & services that support systems A,B,C Developing the Innovation Chain

South Africa’s National Biotechnology Strategy National Bioinformatics Network  Develop Bioinformatics capacity in South Africa  Provide Bioinformatics network infrastructure  Developing a Functional Genomics platform Public Understanding of Biotechnology  Promote a fact-based understanding of biotechnology  Facilitate engagement on biotechnology

South Africa’s National Biotechnology Strategy BRIC scope:  Human & Animal health – diagnostics, h-t screening; vaccines; bioprospecting & gene mining  Industrial Biotech - industrial enzymes; pharmaceutical intermediates; Agroprocessing; bioleaching;  Plant biotech – Biosafety platform & transgenic crops; plant breeding & IV propagation; gene mining  IP management; business skills; mentorships;  Cluster development / network facilitation  Capacity development Cross cutting

South Africa’s National Biotechnology Strategy

Growth in R&D Expenditure of Biotechnology related disciplines in SA – SA 2004: Performers of Biotechnology and related fields according to funds spent

Click To Add Text South Africa’s National Biotechnology Strategy Tertiary Education Institutes- Science Councils- Private Companies (Core) - 37% of national core companies 34% of national research groups 41% of national core companies 40% of national research groups DST eGoliBio Biotech Survey 2003 Key biotech statistics for SA in 2003: 47 core biotech companies 59 non-core biotech- capable companies 622 biotech (and biotech-related) projects At least 3,500 employed in biotech sector >R 368m in annual revenues in biotech sector Since 1992, 2 new core biotech companies have been set up annually.

South Africa’s Biotechnology Potential South Africa has: Biosafety Legislation (GMO Act of 1997; National Environmental Management Act of 2004, etc) 22 Universities 7 Science Councils An unrivalled biodiversity Excellent infrastructure A leadership role in Africa

Biosafety Legislation: GMO Act 1997 Case-by-case, science-based Risk Assessment Human health: toxicity; pathogenicity; allergenicity; digestibility; nutrition; unexpected products, gene stability, ethics. Environment: impact on: living organisms; Biodiversity; gene flow; weediness; air, soil, water; gene stability, ethics. → RECOMMENDATION Executive Council Scientific Advisory Committee Registrar Application Completeness of applications; regulatory compliance; risk management → IMPLEMENTION National alignment: SAC advice; Sustainable development; Labour; Trade; Socio-economics; Transformation; Ethics → DECISION

“To provide for measures to promote the responsible development, production, use and application of GMO’s, to provide for an adequate level of protection during all activities [], to lay down the necessary requirements and criteria for scientifically based risk assessments, environmental impact assessments, socio- economic considerations and risk management measures []..” 5.(1) The council shall - (a) determine whether that applicant must, in addition to his or her application, submit an assessment of the impact on the environment and socio- economic considerations of such activities. (c) in considering an application have regard to the following factors: (i) Scientifically based risk assessments; and (ii) proposed risk management measures. (f) Advise the Minister […] on measures to minimise any adverse impact on the conservation and sustainable use of biological diversity []. GMO Act amendments

DST Workshop – Science-Based Risk Assessment and triggers for Environmental Impact Assessments. In the light of the rapidly developing biotechnologies, to provide science- based guidelines on risk assessment processes for new or forthcoming GMO’s. Upcoming GM event categories: –Stacked gene crops –Biopharming –Indigenous vs non-indigenous GM crops –GM microbes –GM animals Biosafety technology developments: chloroplast transformation, sterility techniques – nuclear, cytoplasmic etc, etc. Criteria for social impacts

South Africa’s National Biotechnology Strategy Thank you! Ben Durham Director: Biotechnology Department of Science & Technology