OVERVIEW OF SOUTH AFRICA ‘S LEGAL FRAMEWORK ON … · • South Africa Legal Framework for ABS...

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OVERVIEW OF SOUTH AFRICA ‘S

LEGAL FRAMEWORK ON ACCESS

AND BENEFIT SHARING

Venue: Starling Hotel, Geneva,switzerland

Date: 11-12 June 2018

Mrs Lactitia Tshitwamulomoni

PRESENTATION OUTLINE • Context: Overview of South Africa’s

Biodiversity

• South Africa Legal Framework for ABS

Implementation

• Institutional Arrangement for ABS

• Overview of the National Environmental

Management: Biodiversity Act, 2004 (Act No.

10 of 2004) & the Bioprospecting, Access and

Benefit Sharing Regulations, 2015

SOUTH AFRICAN BIODIVERSITY • A mega-biodiverse country - 3rd in the world

after Brazil and Indonesia

�Rich in indigenous biological resources and

cultural diversity ; and

�Rich in traditional knowledge on properties of

plants, animals and microorganisms etc.

�IBRs & TK are desired by both non-

commercial & commercial sectors to develop

new scientific information and commercial

products.

SOUTH AFRICAN BIODIVERSITY• Occupies about 2% of the world's land area, but is

home to nearly 10% of the world’s plants; 7% of

reptiles, birds & mammals; 15% of known coastal

marine species.

2% of the

world’s land area

10% of the

world’s plantsSouth Africa

15% of the world’s

coastal marine species

7% of the world’s

reptiles, birds

and mammals

Top five plantsTop five plants

Sector in numbersSector in numbers

End productsEnd products

BIOPROSPECTING/ BIOTRADE SECTOR OVERVIEW

Rooibos Aloe ferox Honeybush

Buchu Pelargonium sidoides

15 – 20k tonnesplant

production

1,000products with IBRs

70% raw materials exported

Cosmetics Tissue OilsComplementarymedicines

Foodflavourings

South Africa’s plant resources have incredible com mercial potential

Pelargonium sidoides

2001€8 million

2008€80 million

OVERALL POLICY OBJECTIVES

1) To redress the injustice of the past in order to achieve socio-economic development goals ~ fair & equitable benefits sharing.

2)To provide regulatory framework for bioprospecting / biotrade activities ~ attain conservation & sustainable utilization of IBRs ~ Permitting System.

3)To provide obligatory requirements to the regulated sectors to recognize existing TK on the useful properties of IBRs ~ Benefit Sharing Agreements.

4)To provide obligatory requirements to the regulated sectors to seek permission from the land owners to access/collect IBRs ~ Material Transfer Agreements &

Benefit Sharing Agreements.

5) To implement international regulatory obligations adopted by South Africa ~ CBD &

Nagoya Protocol on ABS

RELEVANT FRAMEWORK LEGISLATION IN SOUTH

AFRICACBD & Nagoya Protocol on Access to

Genetic Resources & the Fair and

Equitable Sharing of Benefits Arising

from their Utilisation- administered by

NEMA (1998), NEMBA

(2004), BABS Regulations

(2008 – amendments 2015),

TOPS, CITES- administered

by DEA

Patent Amendment Act (2005)-

administered by DTI

Indigenous Knowledge Systems

Policy (2004) & IKS Bill -

administered by DST

Constitutional Concurrent

Mandate- 9 x Provincial

Ordinance

Constitutional mandate

Ratification

02 November 1995

10 January 2013

INSTITUTIONAL ARRANGEMENT FOR ABS

Nagoya Protocol Requirements South African Situation

1. National Focal Point

National Department of

Environmental Affairs

2. Competent National Authority

3. Publishing Authority

4. Checkpoints (N.B Operational but not yet

formalised through the ABS Clearing House)

Patent Office, Ports of Entry & Exit,

Provincial Permit Issuing Authorities,

National Department of Environmental

Affairs

NATIONAL ENVIRONMENTAL MANAGEMENT:

BIODIVERSITY ACT, 2004 (OBJECTIVES)

Provides for, amongst other:

• The management & conservation of biodiversity within South Africa;

• The use of IBRs in a sustainable manner; and

• The fair & equitable sharing of benefits arising from the use of IBRs &associated TK.

NEMBA CHAPTER 6 (PURPOSE)

Provides a framework for:

� The regulation of bioprospecting involving IBRs;

� The regulation of export from the Republic of IBRs for purposes ofbioprospecting & non-commercial research;

� The fair & equitable sharing of benefits arising from bioprospectinginvolving utilization of IBRs & associated TK; and

� South Africa’s IBRs to be developed & utilized in an ecologicallysustainable manner while promoting social & economic development, inparticular in the areas where the IBRs & associated TK are accessed.

NEMBA CHAPTER 6 (SCOPE OF IBRs)

� Plants

� Animals

� Microorganisms (e.g Bacteria, Fungi, Viruses)

� Algae

� Derivatives

� Genetic Resources

� Genetic Information

� Genetic materials

N.B Visit South African National Biodiversity

Institute website to confirm the names of species

that are indigenous to South Africa ~

www.sanbi.org

• Permit requirements (Section 81)

• Notification requirements (Section 81A)

• Protection of interests of Providers of Access to IBRs &/orAssociated TK (Section 82)

• Benefit Sharing Agreement requirements ( Section 83)

• Material Transfer Agreement requirements (Section 84)

• Establishment of Bioprospecting Trust Fund (Section 85)

• Exemptions (Section 86)

• Offences & Penalties ( Section 98(2), 101 &102)

NEMBA CHAPTER 6 (KEY PROVISIONS)

PERMITTING PROCESS

1. Discovery phase• Notification of the Minister (nationally)• Discovery Phase Export permit (internationally)

2. Commercialisation phase• Biotrade permit (nationally & internationally)• Bioprospecting permit (nationally & internationally)• Integrated biotrade & bioprospecting permit (nationally &

internationally)3. Any other kind of Research

• Export permit for research other than bioprospecting(internationally)

WHO MAY APPLY FOR A PERMIT OR NOTIFY

• A juristic person registered in terms of SA law.

• A natural person, who is a SA citizen or a permanent

resident of SA.

• A non-juristic or natural person jointly with a juristic

or natural person in terms of SA law.

FLOW CHART OF PERMIT ISSUING AND NOTIFICATION AUTHORITIES

ProvincialDepartments

of Environmental Affairs (MECs)

Commercial

Research (Any

other kind of

Research)

Export Permit

(outside RSA)

National

Department of Environment Affairs (Minister)

Discovery phase

bioprospecting

Notification

(in RSA)

Discovery

phase Export

permit

(outside RSA)

Commercialisation phase

bioprospecting

Bioprospecting

Permit

(in & outside RSA)

Biotrade

permit

(in & outside

Integrated

Biotrade &

Bioprospecting

permit

(in & outside

STEP-BY-STEP PROCEDURES

NEMBA CHAPTER 6 (KEY PROVISIONS)

PROTECTION OF RIGHTS OF

PROVIDERS OF ACCESS TO IBSs & TK

THROUGH MTA & BSA

REQUIREMENTS

Providers

Indigenous

biological

resources

(IBRs)

Traditional

knowledge

Material

Transfer

Agreement

Benefit

Sharing

Agreement

Benefit

Sharing

Agreement

IBRs can be provided by land owners & Farmers,

organ of states & communities.

TK can be provided only by indigenous

communities & Associations

Providers of IBRs would need to enter into an

MTA and a BSA following a successful PIC process

Providers of TK would need to enter into a BSA

following a successful PIC process

Note: Annexure 11 of the BABS Regulations provides a pro-forma MTA and Annexure 12 of the BABS Regulations

provides a pro-forma BSA

PERMIT APPLICATION PROCEDURES

� Source documents www.environment.gov.za.

� Select & complete relevant Annexes to your project.

� Attach the signed permit application form, BSA(s) & MTA (s),

where applicable.

� Attach project summary/ background

� Pay the non-refundable permit application fee as prescribed

in Annexure 4.

� Submit permit application documentation to DEA.

� Contact DEA officials for assistance, where necessary.

Discovery phase bioprospecting:

� Source documents www.environment.gov.za

�Complete Annexure 1

� Include non-disclosure agreement, where applicable

� Must also sign a commitment to comply with the requirements at

the commercialisation phase of bioprospecting

� Contact DEA officials for assistance

How do I notify about Discovery phase Bioprospecting

The permit application process

begins long before the application is

submitted to the Department of

Environmental AffairsDEA responds to applicant

with acknowledgment of

receipt

Minister takes a Final

decision and permit

issued. If not issued, give

written reason for her

decision

Negotiate and conclude

BSA and MTA. Complete

permit application form

Option to adjust

applications and re-submit

Application returned with

comments

MTA Material transfer agreement

BSA Benefit-sharing agreement

Applicant submits permit

application documentation

to DEA

Applicant must identify &

disclose all information

about the project to the

identified access provider

in order to obtain PIC

Application not

recommended for a final

decision

Application recommended

for a final decision

IBR Indigenous Biological Resource

TK Traditional Knowledge

Bioprospecting Advisory

Committee convenes

and reviews application

( Convene quarterly or

monthly)

TIMEFRAMES

• The Issuing Authority:

� must consider & decide on any permit application or notification within 120

working days after the receipt of such an application, if satisfied that all the

prescribed & requested information has been submitted.

� must within 10 working days after the date of receipt of such an application & in

writing, request the applicant to submit such information with 20 working days

after date of receipt of such a request.

• If the additional information requested is not submitted to the issuing

authority within 30 working days after such a request, such an application

must be deemed withdrawn.

Dept. of Environment Affairs

Provider Access to IBR/ Associated TK

Obtain Prior Informed Consent,

negotiate & Sign BSA &/or MTA

Benefits paid

Complete Permit Application

form for:

• Commercialisation phase

Bioprospecting

• Biotrade

• Export of IBR for Discovery

phase bioprospecting

Benefit Sharing

Grant Permit

Submit permit application, BSA

&/or MTA

Approve BSA &/ or MTA

FLOW CHART OF ABS PROCEDURE

Applicant

Bioprospecting Trust Fund/ Suspense

Account

Issuing Authority (Minister)

CONTACT DETAILS

• Ms Natalie Feltman

Tel: +2712 399 8917

Email: NFeltman@environment.gov.za

• Ms Lactitia Tshitwamulomoni

Tel: +2712 399 9611,

Email: LMabadahane@environment.gov.za

• Mr Ntambudzeni Nepfumembe,

Tel:+2712 399 9612

Email: NNepfumembe@environment.gov.za

• DEA website www.environment.gov.za

• Hotline 0800 205 005

OVERVIEW OF SOUTH AFRICA ‘S LEGAL FRAMEWORK ON … · • South Africa Legal Framework for ABS...

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