Ben DurhamDirector: BiotechnologyDepartment of Science & [email protected]
Department of Science and Technology
GMO Amendment Bill (B34-2005)
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
BiotechnologyFull range, but some emphasis on 3rd generation
RegionalRegional socio-economic, environmental and academic advantages
Innovation System A: science to technology – robust platformsSystem B: technology to product / market – enhanced commercializationSystem C: embed technology/product in an enterprise – increase
incubationCentres
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
Org
anis
ati
on
Sta
kehold
er
Cust
om
er
Offer access to high quality
financial, business and scientific resources to
commercial entities
Optimise the commercializ
ation process
Improve management of
IP for mutual benefit and
generation of investment
Build and grow an
internationally recognised
infrastructure
Build and grow
commercial knowledge
and technical skills
Leverage knowledge through
a collaborative network within the BIC infrastructure
and partners
Promote a culture of
transformation
Build economic and social value of the industry through
sustainable commercial entities
locally and internationally
Grow the biotech sector through
expanding business of existing companies and spin-off of new commercial entities
Improve operating efficiency
Pro
cess
es
S1S2
S3
C1
P1 P3
O1O2
O3O4
Improve return on funding investment
through managing risk
P4
Promote national imperatives
through responsible reporting
C3Build a responsible image
of the biotech sector through increased public
understanding and responsible marketing of biotechnology products
and services
C2
Effectively source and manage the
funds for commercialization
and research
P2
South Africa’s National Biotechnology Strategy
360%
92.6%
55.6%32.2%
0
50
100
150
200
250
300
350
400
Biotechemistry Genetics Microbiology GeneticEngineering
Biotechnology
Disciplines
Per
Cen
t G
row
th
Growth in R&D Expenditure of Biotechnology related disciplines in SA – 2002-2004
Research Councils, 51.3%
Higher Education, 30.3%
Business, 18.4%
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
ExecutiveCouncil
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 1997 + 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
www.dst.gov.za