National Environmental Management: Biodiversity Act, 2004 (Act No. 10 of 2004)

Regulations

Bio-prospecting, Access and Benefit-Sharing Regulations, 2008

Interpretation and Purpose of Regulations

1. Definitions
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In these Regulations, a word or expression to which a meaning has been assigned in the Act has the meaning so assigned and, unless the context otherwise indicates—

 

"the Act"

means the National Environmental Management:  Biodiversity  Act, 2004 (Act No. 10 of 2004).

 

"any other kind of research"

means research other than bioprospecting and—

(a)includes the systematic collection, study or investigation of indigenous biological resources, conducted under the auspices of a bona fide research institute or organisation to generate scientific knowledge; but
(b)excludes incidental surveys and searches;

 

"applicant"

means a person who has submitted, a permit application;

 

"benefit-sharing agreement"

means an agreement in the form of Annexure 8, concluded between an applicant for a permit and a stakeholder, which provides for sharing by the stakeholder in any future benefits that may be derived from the bioprospecting to which the application relates;

 

"bioprospecting  permit"

means   a   permit,   issued   in  terms   of section 88 of the Act, to engage in the discovery phase  and/or commercialisation phase of a bioprospecting project;

 

"Bioprospecting Trust Fund"

means the Fund established by section 85(1) of the Act;

 

"commercialisation"

includes the following activities in relation to indigenous biological resources—

(a)the filing of any complete intellectual property application, whether in South Africa or elsewhere;
(b)obtaining or transferring any intellectual property rights or other rights;
(c)commencing clinical trials  and product development, including the conducting of market research and seeking pre-market approval for the sale of resulting products; or
(d)the multiplication of indigenous biological resources through cultivation, propagation, cloning or other means to develop and produce products, such as drugs, industrial enzymes, food flavours, fragrance, cosmetics, emulsifiers, oleoresins, colours and extracts;

 

"commercialisation phase of a bioprospecting project"

means any research on, or development or application of, indigenous biological resources where the nature and extent of any actual or potential commercial or industrial exploitation in  relation  to  the  project  is  sufficiently  established  to  begin  the  process  of commercialisation;

 

"confidential information"

means information which, if disclosed, may be detrimental to the commercial or financial interests of a party to a benefit-sharing agreement, and—

(a)        includes—

(i)information about research being or to be carried out including details of species to be collected and areas in which specified species are to be collected;
(ii)financial commercial, scientific or technical information including trade secrets;
(iii)indigenous knowledge if the disclosure of that knowledge may be detrimental to the relevant indigenous community; but

(a)        excludes information—

(i)        that has already been disclosed through publication in a scientific journal;

(ii)        if the parties consent to its disclosure;

 

"discovery phase of a bioprospecting project"

means any research on, or development or application of, indigenous biological resources where the nature and extent of any actual or potential commercial or industrial exploitation  in relation to the project is not sufficiently clear or known to begin the process of commercialisation;

 

"export permit for research other than bioprospecting"

means a  permit, issued in terms of section 88 of the Act, for exporting from  the Republic  any indigenous biological resources for the purposes of research other than bioprospecting;

 

"indigenous community"

means any community of people living  or  having rights or interests in a distinct geographical area within the Republic of South Africa with a leadership structure and—

(a)whose traditional uses of the indigenous biological resources to which an application for a permit relates, have initiated or will contribute to or form part of the proposed bioprospecting; or
(b)whose knowledge of or discoveries about the indigenous  biological resources to which an application for a permit relates are to be used for the proposed bioprospecting;

 

"indigenous use or knowledge"

includes knowledge of, discoveries about or the traditional use of indigenous biological resources, if that knowledge, discovery or use has initiated or will contribute to or form part of a proposed bio-prospecting or research project to which an application for a permit relates;

 

"integrated export and bioprospecting permit"

means a permit, issued  in terms of section 88 of the Act to export indigenous biological resources for the purpose of bioprospecting;

 

"material transfer agreement"

means an agreement in the form of Annexure 7 between an applicant for a permit and a person, including any organ of state or community, providing or giving access to the indigenous biological resources to which the application relates;

 

"NEMA"

means the National Environmental Management Act, 1998 (Act No. 107 of 1998);

 

"permit"

means a permit issued in terms of Chapter 7, being a bioprospecting permit; an integrated export and bioprospecting permit; or an export permit for research other than bioprospecting;

 

"traditional use or knowledge"

refers to the customary utilisation or knowledge of indigenous biological resources by an indigenous community, in accordance with written or unwritten rules, usages, customs or practices traditionally observed, accepted and recognised by them, and includes discoveries about the relevant indigenous biological resources by that community.