Ben DurhamDirector: BiotechnologyDepartment of Science & Technologyben.durham@dst.gov.zawww.dst.gov.za

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

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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

ben.durham@dst.gov.za

www.dst.gov.za