Amendments to sections of the National Environmental Management: Biodiversity Act No. 10 of 2004
15/09/2010

National Environmental Laws Amendment Act No. 14 of 2009 - Amendments to sections of the National Environmental Management: Biodiversity Act No. 10 of 2004
Abstract:

Amendment of section 81 of the National Environmental Management: Biodiversity Act No. 10 of 2004 and the introduction of a new section 81A in terms of the National Environmental Laws Amendment Act No. 14 of 2009 would remove the regulatory compliance lag at the onset of a bioprospecting project. However, although the National Environmental Laws Amendment Act No. 14 of 2009 was assented to on 25 May 2009, the date on which it will come into force has not been announced. The Regulations have also not been revised by the Minister of Environmental Affairs.
The controversial Section 81 of the National Environmental Management: Biodiversity Act No. 10 of 2004 (Biodiversity Act) prohibits any person, without a permit, to engage in bioprospecting involving any indigenous biological resources or to export from the republic any indigenous biological resources for the purposes of bioprospecting or any other kind of research. A permit is issued under chapter 7 of the Biodiversity Act.

In terms of Section 82 of the Biodiversity Act, the applicant for a permit is required to
• disclose to the issuing authority all information concerning the proposed bioprospecting and the indigenous biological resource;
• provide a material transfer agreement concluded between such applicant and the stakeholder providing access to the indigenous biological resource; and
• provide a benefit sharing agreement concluded between the applicant for the bioprospecting permit and the stakeholder providing access to the indigenous biological resource and/or the stakeholder providing indigenous knowledge relating to the indigenous biological resource, where such knowledge initiates or aids the bioprospecting.

Amongst many concerns voiced about the unintended negative impact of the Biodiversity Act the following were most prominent:
• a lack of distinction between a discovery phase and the commercialisation phase of a bioprospecting project; and
• the requirements of section 82 were rather demanding of the applicant at the onset of a bioprospecting project when no actual prospect of commercialisation was yet in sight.

The National Environmental Laws Amendment Act No. 14 of 2009 (Amendment Act) addresses these concerns. The Amendment Act was assented to on 25 May 2009. The date on which it will come into force has not been announced. The Amendment Act identifies two distinct phases of a bioprospecting project, that is, a discovery phase and a commercialisation phase. A "discovery phase of bioprospecting" is defined to include 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 yet sufficiently established to begin the process of commercialisation.

The term "commercialisation" in relation to indigenous biological resources includes the following activities:
(a) filing of any complete intellectual property application, whether in South Africa
and elsewhere;
(b) obtaining or transferring any intellectual property rights or other right;
(c) commencing clinical trials and product development, including conducting
market-research and seeking pre-market approval of the sale of resulting products; or
the manipulation of indigenous biological resources through cultivation, propagation,
cloning or other means of development and produce of products, such as drugs, industrial enzymes, food flavours, fragrances, cosmetics, emulsifiers, oleoresins, colours an extract.

Amended section 81 states that no person may, without a permit issued under chapter 7 of the Biodiversity Act,
(a) engage in the commercialisation phase of the bioprospecting project involving any indigenous biological resources; or
(b) export from the Republic any indigenous biological resources for the purposes of Bioprospecting or any other kind of research.

A new section 81A is also introduced into the Act, in terms of which no person may, without first notifying the Minister, engage in the discovery phase of the bioprospecting project involving indigenous biological resources. Also required is a commitment to comply with the requirement of the Bioprospecting permit at the onset of the commercialisation phase of the bioprospecting project.

When in force, the amended section 81 and the introduction of a new section 81A would remove the regulatory compliance lag at the beginning of the Bioprospecting project. It would effectively postpone the requirement of a bioprospecting permit application and the section 82 requirements to the onset of the commercialisation phase of a bioprospecting project.
The publication by the Minister of the revised Regulations to give effect to the provisions of the Amendment Act is awaited. However, the permit office of the Department of Environmental Affairs is already handling applications for Bioprospecting permits in the spirit of the Amendment Act.

Dr Keoagile William Modisakeng
Candidate Attorney
william-m@adamsadams.co.za
11 August 2010