IP ENSight | 7 November 2018

An update on bioprospecting/biotrade requirements in South Africa

by Joanne van Harmelen

South Africa is considered to be the third most mega-diverse country after Indonesia and Brazil,  with an incredible 10% of the world’s plants, 7% of the world’s reptiles, birds and mammals, 15% of known coastal marine species and an entire floral kingdom. South African communities also have a wealth of traditional knowledge relating to use of indigenous biological resources for medicinal, nutritional and cosmetic purposes, and more.

Because of this biodiversity, the National Environmental Management Biodiversity Act, 2004 (the “Biodiversity Act” or the “Act”) and Regulations as amended in 2015 are administered by the Department of Environmental Affairs (“DEA”) to: 

  • conserve South African biodiversity;
  • provide for sustainable utilisation of indigenous biological resources; and 
  • to provide fair and equitable sharing of benefits among stakeholders (in compliance with South Africa’s obligations in terms of the Nagoya Protocol). 

Various legislative amendments were introduced to support the objectives of the Act, for example, the amendments to South Africa’s Patents Act in 2005 require patent applicants to disclose the origin of indigenous biological resources and indigenous genetic resources and traditional knowledge, and to show that they have obtained prior informed consent and have shared benefits with providers.

The early years of regulation in terms of the Biodiversity Act were stormy and there was much confusion around who needed to apply for permits and what exactly was required from applicants. But with experience garnered over time by DEA officials (who are custodians of the Act), stakeholder education and the publication of various guidelines, such as South Africa’s Bioprospecting, Access and Benefit-Sharing Regulatory Framework published by the DEA in 2012, there is now more clarity and certainty about what the requirements are. There have been 85 permits of various types issued up until July 2018.

What is covered

The Act regulates bioprospecting on and biotrade with indigenous biological resources, indigenous genetic resources and use of traditional knowledge. In terms of the Act: 

  • indigenous biological resources are defined quite broadly to include any living or dead organism of an indigenous species in South Africa, as well as the use of their genes or biochemicals. 
  • traditional use or knowledge refers to the customary utilisation or knowledge of indigenous biological resources and indigenous genetic resources by an indigenous community or individual, 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 or indigenous genetic resources by that community or individual. 
  • bioprospecting is defined as any research, development or application of indigenous biological resources for commercial or industrial exploitation. 
  • biotrade means the buying and selling of milled, powdered, dried, sliced or extracted indigenous biological resources and indigenous genetic resources for further commercial exploitation.

Exclusions

There are certain resources and activities excluded from the Act:

  • human genetic resources
  • exotic organisms
  • International Treaty on Plant Genetic Resources for Food and Agriculture resources
  • South African performed research not for bioprospecting 
  • export of ex-situ indigenous biological resources not for bioprospecting, provided that an export agreement is in place and the relevant provisional authority has been notified
  • artificial propagation/cultivation for the cut flower/ornamental plant markets
  • aquaculture and mariculture activities for consumption 

Permits required

No bioprospecting permit is required for basic research with no commercial intent on indigenous biological resources or indigenous genetic resources or relating to traditional knowledge, although to export material, a permit from the relevant provincial authority is needed if the material is not from an ex-situ collection such as a museum, herbarium, genebank or registered culture collection.

A bioprospecting permit is also not necessary for screening/discovery or to do further research on the commercial potential of indigenous biological resources, indigenous genetic resources or relating to traditional knowledge (the discovery phase), but the Minister of Environmental Affairs must be notified. 

A bioprospecting permit must be obtained for research/development on indigenous biological resources, indigenous genetic resources or with traditional knowledge for commercial or industrial exploitation (the commercialisation phase). A biotrade permit must be obtained to engage in biotrade relating to indigenous biological resources, indigenous genetic resources or with traditional knowledge. 

A permit is also necessary for export of indigenous biological resources or indigenous genetic resources from South Africa, in either the discovery or commercialisation phase or for biotrade. The permit will only be granted if it can be shown that the export is for a purpose that is in the public interest.

A foreign applicant must apply jointly with South African applicant for permits, and it is possible to include multiple species in one application.

Access and benefit sharing for bioprospecting

Together with the bioprospecting or biotrade permit, an applicant must submit a material transfer agreement (“MTA”) and benefit sharing agreement (“BSA”) that has been entered into with an access provider of indigenous biological resources (for example, a land owner) or a BSA with traditional knowledge holders who have contributed to bioprospecting/biotrade.

Just because traditional knowledge is in the public domain, does not preclude the necessity of entering into a BSA with an indigenous community that developed or discovered it.

The benefits provided may be monetary or non-monetary. The Act also makes provision for review of the MTA and BSA over time and for amendment of the permit and agreements.

Confidential information 

Confidential information in an application will be maintained as confidential, but will be subject the Promotion of Access to Information Act (“PAIA”).

Under PAIA, the following information can be withheld:

  • trade secrets
  • financial, commercial, scientific or technical information, if disclosure would be likely to cause commercial or financial harm to a party 
  • information, including regarding research that may reasonably place a party at a commercial disadvantage or commercially prejudice the party

Identifying traditional knowledge holders

Identification of traditional knowledge holders can be complex. It would be prudent to do some research online or on archival material, and a notice may be published in the media, asking any person or group with traditional knowledge about the indigenous biological resource to come forward. Local municipalities and local NGOs may also be able to assist.

In very difficult or complex cases, the DEA may be approached for assistance and advice. 

Duration to process a permit

This varies widely depending on the quality of the application and complexity of the circumstances. At a minimum, a permit could be issued in four months if all the permit application requirements are met, sufficient information is provided and there are no queries from the DEA.

Amnesty

The punishment for non-compliance with the Act includes imprisonment for a period not exceeding 10 years, a fine not exceeding ZAR10-million, or both.

On 1 November 2017, the Minister of Environmental Affairs gave notice of an intention to declare a period of amnesty to facilitate compliance with the provisions of the Act. Amnesty would only apply to natural or juristic persons engaging in the commercialisation phase of bioprospecting or biotrade in indigenous biological resources. Unfortunately, no amnesty period has been provided for to date. 

The process around obtaining permits for bioprospecting and biotrade is admittedly complex, but it is advisable to at least start the process of engagement with the DEA where discovery phase research, bioprospecting or biotrade is being undertaken or planned.

This article was first published on www.internationallawoffice.com.

 

Dr Joanne van Harmelen

patent attorney biotechnology | IP
jvanharmelen@ENSafrica.com
cell: +27 82 770 5396

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