BIBIOPROSPECTING, ACCESS & OPROSPECTING, ACCESS & BENEFIT SHARING IN SOUTH BENEFIT SHARING IN SOUTH

AFRICAAFRICA

Carina Malherbe

5th Pan African ABS Workshop, Marrakech3 February 2011 1

AIM OF THE PRESENTATION 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

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SOUTH AFRICAN DIVERSITYSOUTH 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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NATIONAL ENVIRONMENTAL NATIONAL ENVIRONMENTAL MANAGEMENT BIODIVERSITY ACT, MANAGEMENT BIODIVERSITY ACT,

Act 10 of 2004 (NEMBA)Act 10 of 2004 (NEMBA)

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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

BIOPROSPECTING, ACCESS & BIOPROSPECTING, ACCESS & BENEFIT SHARING REGULATIONSBENEFIT SHARING REGULATIONSThe purpose of these regulations is to –• Regulate the bioprospecting permit system• Set out the contents, requirements and criteria for benefit-sharing 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 OVERVIEWLEGISLATIVE 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 PROVISIONSNEMBA ENABLING PROVISIONSNEMBA Chapter 6: Sections 81(1) and 81A81(1) A person may not without a permit•engage in commercialisation phase of bioprospectinginvolving 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 SYSTEMREGULATORY SYSTEM

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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

WHAT IS BIOPROSPECTING?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 INDIGENOUS BIOLOGICAL RESOURCES RESOURCES

Animals, plants or other organisms of indigenous

species

Includes• Living or dead • Genetic material• Gathered from the wild • Cultivated, bred or kept in

captivity

• Exotic animals, plants or other organisms altered with genetic materials or bio-compounds from indigenous species

Excludes

• Genetic material of human origin

• All other exotic animals, plants or other organisms

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COMMERCIALISATIONCOMMERCIALISATION

- 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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• Traditional Knowledge Holder Indigenous community or individual whose traditional uses,

knowledge or discoveries of the indigenous biological resource are used as basis for bioprospecting

STAKEHOLDER PROTECTION STAKEHOLDER PROTECTION

The legislation protects the interest of certain stakeholders:•Access Provider Person / community / organ of state who provides access to indigenous biological resources

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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

STAKEHOLDER PROTECTIONSTAKEHOLDER PROTECTION

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PENALTIESPENALTIES

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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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

APPROVAL OF BSAsAPPROVAL OF BSAs

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IMPLEMENTATION STATUSIMPLEMENTATION 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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• 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 CHALLENGESKEY CHALLENGES

KEY CHALLENGES (2)KEY CHALLENGES (2)

• Negotiations on equal footing – assistance to communities

• Collection, use, propagation, cultivation or trade of IBR for domestic or subsistence purposes

• Muthi markets

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• 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: CASE STUDY: COMMERCIALISATIONCOMMERCIALISATION

• 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) 40-

60% 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: RESEARCHCASE STUDY: RESEARCH

• 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: CASE STUDY: TRADITIONAL KNOWLEDGETRADITIONAL KNOWLEDGE

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CASE STUDY: ROOIBOS TEACASE STUDY: ROOIBOS TEA

1. Ratification / Implementation 2011

2. National ABS Strategy White Paper NBSAPNBF

3. National ABS Legislation 20042008

4. Stakeholder identification & analysis Intergovernmental Bioprospecting ColloquiumProvider / user interest groups

5. Establishing institutional arrangements, incl CNA

Issuing authoritiesExpert Group

6. Dealing with TK DSTIKS Policy

7. Transboundary issues Bilateral agreements(2014)

8. Valorization strategy DST Bioprospecting Platform (2011)

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TO DO CHECKLISTTO DO CHECKLIST

WHAT to do1. 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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SUGGESTIONS FOR NATIONAL SUGGESTIONS FOR NATIONAL IMPLEMENTATION IMPLEMENTATION

THANK YOUTHANK YOUMrs Carina MalherbeTel:+ 27 12 310 3799CMalherbe@environment.gov.za

Mrs Lactitia TshitwamulomoniMrs Lactitia TshitwamulomoniTel: +27 12 310 3986LMabadahane@environment.gov.za

DEA website: DEA website: www.environment.gov.zawww.environment.gov.za

Hotline Hotline +27 800 205 005

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