Biodiversity in South Africa
Persons carrying out research on indigenous biological resources and bioprospecting projects in South Africa need to consider the effects and requirements of both the Biodiversity Act and the recent amendments to the Patents Act.
The Biodiversity Act
The National Environmental Management: Biodiversity Act No. 10 of 2004 was promulgated in September 2004. The main objectives of the Biodiversity Act are to manage and conserve the biological diversity in South Africa, ensure that indigenous biological resources are used in a sustainable manner (in particular to ensure that endangered species are protected, that invasive alien species are controlled, and to monitor genetically modified organisms that are released into the environment), and to ensure that there is fair and equitable sharing with indigenous communities of benefits arising from bioprospecting and indigenous knowledge in South Africa. Contraventions of the Biodiversity Act are a criminal offence and the Act provides for penalties in the form of a fine and/or imprisonment for a period not exceeding five years.
The chapters of the Biodiversity Act relating to conserving biological diversity came into force in 2004, while the chapters relating to bioprospecting and benefit sharing (Chapters 6 and 7 of the Act) only came into force on 1 January 2006.
Generally speaking, the biodiversity of the developing countries of the world is greater than that of the more technologically and industrially wealthy developed countries. The developed countries are therefore interested in the biodiversity of developing countries and have in the past used information gleaned from the collection of biological resources and indigenous knowledge for commercial gain. This has been particularly evident in the pharmaceutical and biosciences areas. Developed countries have benefited from this information, but often the country or community from which the information arose has not been asked for permission to use the information and has not received any benefit from the information. This has been referred to as "biopiracy".
Chapter 6 of the Biodiversity Act seeks to stop biopiracy in South Africa and the purpose of this chapter is to:
- regulate bioprospecting involving indigenous biological resources;
- regulate the export from South Africa of indigenous biological resources for the purpose of bioprospecting or any other kind of research; and
- provide for a fair and equitable sharing by stakeholders in benefits arising from bioprospecting in South Africa.
"Bioprospecting" is defined as research on, or development or application of, indigenous biological resources for commercial or industrial exploitation and includes:
- the systematic search, collection or gathering of biological resources or making extractions from biological resources;
- the utilization of information regarding any traditional uses of indigenous biological resources by indigenous communities; and
- research on, or the application, development or modification of such traditional uses for commercial exploitation.
"Indigenous biological resources" for the purposes of Chapter 6 has a broad interpretation and includes indigenous species (i.e. species of plants, animals or organisms from South Africa) gathered from the wild, as well as indigenous species that have been bred, cultivated or genetically altered; exotic species that have been altered with indigenous genetic material or compounds; and chemical compounds and genetic material derived from indigenous species; but excludes genetic material of human origin, exotic animals, plants or other organisms and indigenous biological resources listed in terms of the International Treaty on Plant Genetic Resources for Food and Agriculture.
In terms of Chapter 6, it is necessary for any person who wishes to engage in bioprospecting or export indigenous biological resources for the purpose of bioprospecting to obtain a permit which is issued in terms of Chapter 7 of the Biodiversity Act. Before a permit is issued, the applicant must:
- at the request of the permit issuing authority disclose all information relating to the bioprospecting to the authority; and
- enter into certain agreements and arrangements with "stakeholders" that have an interest in the project. A "stakeholder" may be a person, including an organ of state or a community, that provides access to biological resources, or whose traditional uses or knowledge of indigenous biological resources contribute to or form part of a bioprospecting project. In particular, the applicant must have:
disclosed all material information relating to the bioprospecting to the stakeholder and obtained prior consent from the stakeholder to use information derived from them; and
entered into a benefit-sharing agreement which provides for sharing by the stakeholder in any future benefits that may be derived from the bioprospecting and where necessary a material transfer agreement with the stakeholder that regulates the access to the biological resources. The Biodiversity Act prescribes the content of material transfer and benefit-sharing agreements, and the permit issuing authority may facilitate negotiations between the applicant and the stakeholder to ensure that the negotiations are conducted on an equal footing.
Chapter 6 also provides for the establishment of a Bioprospecting Trust Fund into which all moneys arising from material transfer and benefit-sharing agreements must be paid. Payments will then be made to the stakeholders by the administrators of the Biodiversity Act from the fund.
Although all of the chapters of the Biodiversity Act are now in force, regulations for the implementation of this Act have not yet been passed. Some of the unanswered questions at the moment which will hopefully be answered or addressed by the regulations are:
- the definition of indigenous biological resources is very broad and it is not clear if it includes activities such as traditional medicinal plant trade;
- Where does academic research, for which permits are not required, stop, and research for commercial exploitation, for which permits are required, start?
- Exactly how are the "stakeholders" with whom agreements must be entered into identified? This will be particularly difficult or even impossible where the material or knowledge spans large areas or communities;
- material transfer and benefit-sharing agreements are entered into at a very early stage of investigations and it may be difficult to agree on benefits when it is not known what the benefits will be;
- permit issuing authorities need to be identified; and
- The constitution, management and operation of the Bioprospecting Trust Fund, including the disbursement of monies paid into the fund, need to be formulated.
Section 105 of the Biodiversity Act provides that any party that was involved with a bioprospecting project before Chapter 6 of the Act came into force may proceed with the project for one year from the date on which Chapter 6 came into force (i.e. until 1 January 2007), pending the negotiation and entry into force of an appropriate benefit-sharing agreement. Parties now wishing to carry out bioprospecting before regulations for implementing the Act are passed will have to make best efforts to comply with the requirements of the Act so that permits may be applied for when it is possible to do so.
Amendments to the Patents Act
In addition to the Biodiversity Act, the South African Patents Act has recently been amended so as to ensure that indigenous communities are adequately compensated when an invention which is sought to be patented in South Africa is derived from biological or genetic resources or traditional knowledge from South Africa.
The Patents Amendment Act No. 20 of 2005 requires that every applicant who lodges an application for a patent must state whether or not the claimed invention is:
- based on or derived from an indigenous biological resource or an indigenous genetic resource; and/or
- based on or derived from traditional knowledge or use;
from South Africa.
Every applicant is required to lodge a statement of this type, irrespective of the nature of the invention sought to be protected, and it will not be possible to obtain a patent if the required statement is not lodged at the patent office. In addition, the Patents Amendment Act also provides a ground of revocation of a patent in cases where the required statement lodged by the applicant is false.
It should be noted that the required statement relates to indigenous (i.e. South African) resources and knowledge only. In other words, the required statement does not refer to biological or genetic resources or traditional knowledge from countries other than South Africa. It should also be noted that although still indigenous, the genetic resources to which the amendments to the Patents Act relate are broader than the indigenous biological resources defined in the Biodiversity Act, and in particular the amendments to the Patents Act do not have the exceptions that are included in the Biodiversity Act.
If an applicant acknowledges that the invention is based on or derived from an indigenous biological or genetic resource, or traditional knowledge, they will also have to submit proof of their title or authority to make use of the resource or traditional knowledge. In most instances, it is likely that this title or authority would need to be a permit issued in terms of Chapters 6 and 7 of the Biodiversity Act. Where, however, the resource is human genetic material or one of the other excluded sources defined in the Biodiversity Act, then it will obviously not be possible to obtain a permit in terms of the Biodiversity Act and alternative proof of title or authority will be required. Please contact us for further information in this regard.
The Patents Amendment Act of 2005 will only come into force once regulations have been passed and the Amendment Act has been proclaimed, which is expected to occur in the early part of 2006.