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Biodiversity / Bioprospecting Act

National Environmental Management: Biodiversity Act

What are indigenous biological resources | Phases of Bioprospecting | Exemptions from the Act | Implications for Bioprospecting Research | Commercialisation | Implications for Patenting | Notification of Minister | Notification of MEC (Provincial Notification) | Notification for Collection in Other Provinces | Application for a Bioprospecting Permit | Other Permits Required

This page summarises key information relating to the National Environmental Management: Biodiversity Act 10 of 2004 (NEMBA) which controls Indigenous Biological Resources. It is intended to provide information and guidance to a UCT audience only. Much of the material here is based on presentations made by Mrs Carina Malherbe, Department of Environmental Affairs, at a Workshop at the University of the Western Cape on 30 November 2010.

NEMBA was amended by the National Environmental Laws Amendment Act 14 of 2009, with most recent legislation "Section 39" (relating to need to notify the Minister of Environmental Affairs prior to starting a discovery phase project in the bioprospecting area) coming into force on 1 April 2011.

It is important to note that this information primarily deals with National compliance in terms of permitting requirements, but at present there are also Provincial permitting requirements that may need to be met and Principal Investigators should check on Provincial requirements that may impact their specific project. Threatened or Protected Species (TOPS) regulatory requirements should also be considered - these came into force in February 2008. The figure below shows how the different Acts and regulations are related.

Bioprospecting hierarchy

What are indigenous biological 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 (NB. parasites, viruses, bacteria, etc. associated with the human body ARE regarded as indigenous biological resources. E.g. TB microorganism in sputum samples, or parasites in blood)
  • All other exotic animals, plants or other organisms

Phases of Bioprospecting

Legislation divides bioprospecting into two phases (Malherbe, 2010):

  • Discovery phase - is the systematic scientific research process in search of valuable chemical and genetic constituents of biodiversity
  • Commercialisation phase - describes research, development or application of resources with the objective of commercialising them

Exemptions from the Act

  1. Research other than bioprospecting provided that the research is conducted in SA and is not done for commercial purposes or industrial exploitation. Examples include: taxonomy, conservation, phylogenetics, systematics, behaviour ecology.
  2. Export of ex situ (i.e. from a collection outside their natural habitats, e.g. herbaria, museums, cultivation fields and culture collections within the university) indigenous biological resources for purposes other than bioprospecting, provided that the exporter has enter into an export agreement (can be a Material Transfer Agreement).
  3. The collection and use for domestic / subsistence purposes.
  4. Keeping, breeding, cultivation, moving, trading and use of wildlife not directed at the development and production of drugs, food flavours, fragrances, cosmetics, colours or extracts or new plant varieties and product.

Implications for Bioprospecting Research

  1. Research on indigenous biological resource in South Africa (Discovery Phase)
    • no bioprospecting permit required
    • must notify the minister
  2. Export of material for research
    • Export permit required from Provincial Authority
  3. Export of ex-situ material (i.e. from a collection) for research
    • Must notify provincial issuing authority (MEC) and provide a copy of the research agreement

Commercialisation

Commercialisation activities are regarded as:

  1. Filing of a full patent application (i.e. PCT, or national phase filing) in SA or elsewhere
  2. Obtaining or transfer of intellectual property rights
  3. Commencement of clinical trials & product development, including market research
  4. Multiplication of indigenous biological resources through cultivation, propagation, or cloning to develop and produce: medicines, enzymes, food flavours, fragrances, cosmetics, essential oils, colours and extracts

In all these cases a Bioprospecting Permit is required.

Implications for Patenting

  • Provisional patent application - no action required
  • Full patent application (i.e. PCT, or national phase filing) - Bioprospecting Permit required

Should you require advice on the permitting/notification procedures, after reading through the material on the website, contact Dr Andrew Bailey at RCIPS or phone 021 650 2425.

Notification of Minister

  1. Download and complete the Bioprospecting Notification Form from the right-hand panel on this page.
  2. Complete Section B (No. 9 Details of Bioprospecting Project Leader)
  3. Enter your full names in the declaration in Section C and sign the form.
  4. Initial each page of the notification
  5. Send the signed form, together with a certified copy of the Project Leader's ID document/passport via Registered Internal Mail to RC&I.
  6. RC&I will sign on behalf of UCT and submit it to Department of Environmental Affairs
  7. Remember that this is National notification and you should ensure that you meet the requirements of any Provincial permitting requirement separately.
  8. RC&I will provide you with a copy of any response received from the Department of Environmental Affairs, the original being retained by RC&I.

Notification of MEC (Provincial Notification)

Where a provincial notification is required, a cover letter attached to a Material Transfer Agreement (MTA) or Research Agreement is sent in our case to Cape Nature. The letter should detail the nature of the project, the indigenous biological resource, the quantity of resource involved during the course of the project (e.g. number of samples of a particular size) and the time of events (e.g. export to a researcher) and details of the recipient.

Please copy RC&I when sending these notifications for our records.

Cape Nature
Tel: 021 659 3400
Fax: 021 659 3415
Email: Cape Nature
Address: Private Bag x29, Gatesville, 7766

Notification for Collection in Other Provinces

Department of Environmental Affairs (DEA)

Eastern Cape Province: The Department of Finance and Economic Development, Environmental Affairs and Tourism

Free State Province: The Department of Economic, Small Business Development, Tourism and Environmental Affairs

Gauteng Province: The Gauteng Department of Agriculture and Rural Development (GDARD)

KwaZulu-Natal Province: KwaZulu-Natal Nature Conservation Board trading as Ezemvelo KZN Wildlife

Limpopo Province: Department of Economic Development, Environment and Tourism (LEDET)

Mpumalanga Province: Mpumalanga Tourism and Parks Agency (MTPA)

Northern Cape Province: Department of Environment and Nature Conservation (DENC)

North West Province: Department of Rural, Environment and Agricultural Development (READ)

Western Cape Province: The Western Cape Nature Conservation Board trading as CapeNature

Application for a Bioprospecting Permit

Applications are made as a "juristic person", i.e. as UCT and RC&I will complete details relating to the juristic person and will sign on behalf of the juristic person.

The application procedure involves:

  • Disclose all material information relevant to the proposed bioprospecting to the stakeholder
  • Obtain prior consent of the stakeholder for access to the indigenous biological resource and / or use of the traditional knowledge
  • Enter into a Materials Transfer Agreement (MTA) that regulates access to indigenous biological resource (download template from right-hand panel of this page)
  • Enter into Benefit Share Agreement (BSA) that provides for the sharing in any future benefits that may be derived from the proposed bioprospecting (download template from right-hand panel of this page)
  • Complete the Bioprospecting Permit Application form (download template from right-hand panel of this page)

The permitting process that is required for commercial activities in the biodiversity arena have proved difficult to comply with and implement, although recent amendments have streamlined processes and provided clarity. It is likely that there will be ongoing amendment of the Acts and Regulations to arrive at a fully workable solution. Guidelines are also been created and these will greatly aid understanding and useful case studies will indicate how to achieve compliance in a variety of scenarios.

For more information visit the DEA Website or call the hotline 0800 205 005.

 

Other Permits Required

The following institutions must be contacted should you wish to collect genetic resources/biological material/specimens in any of the national parks or forestry areas under their jurisdiction:
    Department of Agriculture, Forestry and Fisheries (DAFF)
    Department of Water and Sanitation (DWS)
    Eastern Cape Parks and Tourism Agency (ECPTA)
    North West Parks and Tourism Board
    South African National Parks (SANParks)