BIOPROSPECTING, ACCESS &
BENEFIT SHARING IN SOUTH
AFRICA
Carina Malherbe
5th Pan African ABS Workshop, Marrakech
3 February 2011
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AIM OF THE PRESENTATION
• To give overview on the regulation of bioprospecting,
access and benefit sharing in South Africa
• To share South African experiences in the implementation
of ABS legislation
2
SOUTH AFRICAN DIVERSITY
• SA is the 3rd most biologically diverse country in the world,
after Indonesia and Brazil
• Our seas straddle 3 oceans: the Atlantic, Indian and
Southern Ocean
• SA occupies about 2% of the world's land area, but is home
to nearly
– 10% of the world's plants
– 7% of the reptiles, birds and mammals &
– 15% of known coastal marine species
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Constitution
Section 24
National Environmental
Management Act 107 of 1998
National Environmental Management
Biodiversity Act 10 of 2004
Biodiversity
Planning &
Monitoring
Threatened or
Protected
Ecosystems &
Species
Threats to
Biodiversity
Bioprospecting,
Access & Benefit
Sharing
BABS
Regulations
4
NATIONAL ENVIRONMENTAL
MANAGEMENT BIODIVERSITY ACT,
Act 10 of 2004 (NEMBA)
Objectives
• Management & conservation of biodiversity
• Ensure sustainable use of IBR
• Ensure fair and equitable sharing of benefits
with indigenous communities arising from
bioprospecting involving
– indigenous biological resources (IBR) &/or
– associated traditional knowledge (TK) in
South Africa
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BIOPROSPECTING, ACCESS &
BENEFIT SHARING REGULATIONS
The purpose of these regulations is to –
• Regulate the bioprospecting permit system
• Set out the contents, requirements and criteria for benefitsharing and material transfer agreements
The regulations govern –
• The discovery and/or commercialisation phase of a
bioprospecting project
• The export of any IBR from South Africa for purposes of
bioprospecting, or any other kind of research
• The BABS Regulations came into force on 1 April 2008
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LEGISLATIVE OVERVIEW
•
•
•
•
•
•
•
Regulation of utilization of IBR & associated TK
Protection of rights of stakeholders
Framework for Agreements
Bioprospecting Trust Fund
Exemptions – activities or species
Offences
Penalties
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NEMBA ENABLING PROVISIONS
NEMBA Chapter 6: Sections 81(1) and 81A
81(1) A person may not without a permit
• engage in commercialisation phase of bioprospecting
involving IBR, or
• export IBR for bioprospecting or any other kind of research
81A No person may without first notifying the Minister
• engage in discovery phase bioprospecting involving any
IBR; and
• a person involved in the discovery phase of bioprospecting
must sign a commitment to comply with the
requirements at the commercialisation phase of
bioprospecting
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REGULATORY SYSTEM
Research
• Export permit for research other than bioprospecting
• Export agreement for ex situ material
Discovery phase
• Notification of the Minister
Commercialisation phase
• Bioprospecting permit
• Integrated export & bioprospecting permit
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WHAT IS BIOPROSPECTING?
• Research on, development or application of indigenous
biological resources (IBR) for commercial or industrial
exploitation
• Search, collection, gathering of resources or making
extractions for research, development or application
• Utilisation of traditional uses of IBR for research or
development
• Research on, application, development or modification of
traditional uses for commercial or industrial exploitation
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INDIGENOUS BIOLOGICAL
RESOURCES
Animals, plants or other organisms of indigenous
species
Includes
Excludes
• Living or dead
• Genetic material of
• Genetic material
human origin
• Gathered from the wild
• All other exotic
• Cultivated, bred or kept in
captivity
animals, plants or
other organisms
•Exotic animals, plants or other
organisms altered with genetic
materials or bio-compounds
from indigenous species
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COMMERCIALISATION
-
Filing of intellectual property (IP) / patent application in SA
or elsewhere
Obtaining or transfer of IP rights
Commencement of clinical trials & product development,
including market research
Multiplication of IBRs through cultivation, propagation, or
cloning to develop and produce:
medicines, enzymes, food flavours, fragrances,
cosmetics, essential oils, colours and extracts
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STAKEHOLDER PROTECTION
The legislation protects the interest of certain
stakeholders:
• Access Provider
Person / community / organ of state who
provides access to indigenous biological
resources
• Traditional Knowledge Holder
Indigenous community or individual whose traditional uses,
knowledge or discoveries of the indigenous biological
resource are used as basis for bioprospecting
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STAKEHOLDER PROTECTION
The permit applicant must –
• Disclose all material information relevant to the proposed
bioprospecting to the stakeholder
• Obtain prior consent of the stakeholder for access to IBR
and / or use of the traditional knowledge <<PIC>>
• Enter into material transfer agreements (MTA) that
regulate access to IBR <<MAT>>
• Enter into benefit-sharing agreements (BSA) that provide
for the sharing in any future benefits that may be derived
from the proposed bioprospecting <<MAT>>
• BSA & MTA subject to approval by Minister
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PENALTIES
A person convicted of any offence in terms of engaging in
commercialization of bioprospecting or the export of IBR
without a permit is liable to –
• Imprisonment not exceeding 5 years
– 10 years for second offences
• Fine not exceeding R5-million
– R10-million for second offences
• Both fine and imprisonment
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APPROVAL OF BSAs
The Minister may only approve a BSA if satisfied that –
• The BSA is fair and equitable to all parties
- Consult any person competent to provide technical
advice on the agreement  bioprospecting expert group
- Invite public comment
• The Minister may refuse to approve a BSA unless it
provides for –
- Enhancement of scientific knowledge and technical
capacity of persons, organs of state or indigenous
communities to conserve, use and develop IBR
- Any other activity that promotes the conservation,
sustainable use and development of the relevant IBR
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IMPLEMENTATION STATUS
• 58 bioprospecting projects
– Notifications
– Benefit sharing / Material transfer agreements 
Permit applications
• 2 permits issued
• Stakeholder awareness campaigns
• Compliance EMI & hotline + 27 800 205 005
• Capacity building
• National Enforcement Unit – Interpol, Customs, CITES,
SA Police, National Prosecuting Authority
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KEY CHALLENGES
• Identification and protection of stakeholders
– Access providers  supply chain
– Knowledge holders: Indigenous communities &
individuals
• Verification of knowledge owners
– Traditional council / traditional healer / community
representative
– Prior informed consent & Mutually agreed terms: MTA &
BSA
• Definitions
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KEY CHALLENGES (2)
• Negotiations
communities
on
equal
footing
–
assistance
to
• Collection, use, propagation, cultivation or trade of IBR
for domestic or subsistence purposes
• Muthi markets
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CASE STUDY:
COMMERCIALISATION
• Sceletium tortuosum: small genus, low growing succulent
shrub, endemic to Western, Eastern & Northern Cape
• Used by Khoi & San 1662
• Research initiated at Paulshoek & Nourivier communities:
Nama people
• Origin of traditional knowledge
• Prior Informed Consent and Mutually Agreed Terms for
utilization and Benefit Sharing – South African San Council
• Benefits: fixed value for 3 years; once-off for logo; % of net
proceeds; 1% for use of logo
• 1st Integrated Export and Bioprospecting permit
• USA: Zembrin
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CASE STUDY: RESEARCH
• Vervet monkey (Chlorocebus aethiops)
• 3 universities: Free State (RSA), California (USA),
Wisconsin-Milwaukee (USA)
• Genetic polymorphism
• Map vervet monkey genome to establish it as non-human
primate (NHP) model organism
• Natural host of simian immunodeficiency virus (SIV) 4060% infected
• Export of genetic material
• Transfer of genetic material to 3rd parties
• Benefit Sharing: Species and genetic information 
Conservation
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CASE STUDY:
TRADITIONAL KNOWLEDGE
•
•
•
•
Pelargonium sidoides
Used in medicines: Flugon, Linctagon, Umckaloabo
Various traditional uses
Benefit sharing agreements with Xhosa nation King
Sandile and different Chiefs
• Difference in opinion on TK and BSA
• BSA public comment; Stakeholder engagement;
Estimated date March 2011
• Biodiversity Management Plan for species (BMP-s) 2011
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CASE STUDY: ROOIBOS TEA
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TO DO CHECKLIST
1. Ratification / Implementation
2011
2. National ABS Strategy
White Paper
NBSAP
NBF
3. National ABS Legislation
2004
2008
4. Stakeholder identification & analysis
Intergovernmental
Bioprospecting Colloquium
Provider / user interest groups
5. Establishing institutional arrangements, incl
CAN
Issuing authorities
Expert Group
6. Dealing with TK
DST
IKS Policy
7. Transboundary issues
Bilateral agreements
(2014)
8. Valorization strategy
DST Bioprospecting Platform
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(2011)
SUGGESTIONS FOR NATIONAL
WHAT
to
do
IMPLEMENTATION
1. Communication, Education and Public Awareness strategy
2. Stakeholder identification
• Access providers
• Traditional Knowledge holders
3. National legislation compliance
• Clear definitions
• Approval of agreements by issuing authority
• Assistance to communities
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THANK YOU
Mrs Carina Malherbe
Tel:+ 27 12 310 3799
CMalherbe@environment.gov.za
Mrs Lactitia Tshitwamulomoni
Tel: +27 12 310 3986
LMabadahane@environment.gov.za
DEA website: www.environment.gov.za
Hotline +27 800 205 005
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