South African legislation on traditional medicine
Countries with well-established systems of indigenous medicine are now integrating traditional medicine into the modern health infrastructure to get the best of both worlds.
One such country is South Africa, where traditional healers treat about 30 million people.
South Africa's biodiversity is a rich source of the medicinal plants that form the basis of traditional medicine; but careful legislation is needed to ensure that this resource is not exploited or destroyed, that the rights of holders of knowledge are protected and that they receive a fair share of benefits.
Through consultation with various stakeholders including non-governmental organisations, research institutions, traditional healer representatives and private sector organisations, the South African government has developed new legislation and policies, and programmes to regulate and promote systems of indigenous knowledge.
This policy brief discusses the efforts of the South African government to create legislation for the country's traditional medicine, and provides a synopsis of national initiatives that are transforming the field of traditional knowledge. It also examines what these changes mean for the users of traditional medicines.
Indigenous knowledge is embedded in the cultural and spiritual lives of South Africans. About 200,000 traditional practitioners provide much-needed healthcare to about 30 million people who regularly consult traditional doctors.
Traditional health systems are particularly important in rural areas where access to appropriate and affordable primary healthcare is difficult and, at times, near impossible.
Traditional medicines in South Africa are also an important source of income through trade — which generates an estimated US$200 million per year — and health provision by creating employment for about 30,000 people.
South Africa's rich biodiversity is an ideal source of plant compounds that have active medicinal properties. This resource, combined with local knowledge of where to harvest and how to prepare plants for medicinal use, makes for a valuable health system.
Research into natural plant products is an established area of science and is believed by many scientists to hold great potential for the discovery of new drug leads.
In recognition of the value of indigenous knowledge, various stakeholders including government and non-governmental organisations, research institutions, traditional healer representatives and private sector organisations embarked on a process of public consultation, awareness-building and discussion to address the needs of the traditional medicinal sector.
This consultation led to the introduction of new legislation and policy, and programmes targeted at regulating and promoting systems of indigenous knowledge. Not all issues have been resolved or addressed, but areas relating to traditional medicine use and research, and to bioprospecting (the exploration of biodiversity for commercially valuable genetic resources and biochemical material), have already seen change.
Positive outcomes resulting from the use of traditional medicine include enhancement of the primary health care sector by increased human resource capacity available to provide health services; access to affordable and holistic treatment; economic and community development from the exploitation of traditional medicines; and, scientific advancement from the research and development of medicinal plants with promising physiological activity.
Despite these positive spin-offs from the use of traditional medicines, there are concerns about the exploitation of traditional medicines, the need to preserve the rights of holders of knowledge and ensure that they receive a fair share of benefits.
New national legislation addresses some of these concerns and provides a framework that incorporates the interests of traditional practitioners and users. Effective legislation requires planning, implementation and monitoring.
This brief provides a synopsis of national initiatives that are transforming the field of traditional knowledge, examines how they are changing the landscape, and discusses what the new scenario implies for the users of traditional medicines.
Regulating traditional medicines
South Africa's Department of Health's efforts to improve healthcare services and delivery began with the introduction of the National Drug Policy.  The policy makes specific reference to the need to investigate traditional medicines for safety, efficacy and quality with the aim of incorporating their use in the national health care system. It proposes to achieve this through: (1) working more closely with traditional healers to compile and develop a code of practice; (2) establishing a National Reference Centre for African Traditional Medicines ; and (3) providing for the registration and control of marketed traditional medicines.
The Medicines Control Council is responsible for the control, registration and regulation of all medicines including traditional or 'complementary' medicines. Many feel that the Medicines and Related Substances Control Act, which governs all legal matters with respect to the medicines registration system, does not adequately cater for traditional medicines and rather, is more appropriate for western or conventional medicines. Thus, African traditional medicines have been removed from the category of complementary medicines in the act, and the council is currently reviewing the medicines legislation. To help facilitate the process, the council has established an expert committee on African traditional medicines.
In the past, traditional healers have been grouped into a great number of formal and informal associations. This fragmented organisation of the traditional healing fraternity made it difficult to engage in consultation and achieve consensus to bring about development changes. Fake traditional healers who had not undergone proper training yet were able to practice without retribution took advantage of this lack of unity, putting lives in jeopardy.
The Traditional Health Practitioners Bill provides a regulatory framework to register, regulate and control African health practitioners.  The objectives of the bill are to establish the Interim Traditional Health Practitioners Council of South Africa; to make provision for control of the registration, training and practices of traditional health practitioners in the South Africa; and to serve and protect the interests of members of the public who use the services of traditional health practitioners. 
Once the bill becomes law, a Traditional Healers Council will be established to oversee the registration and regulation of the practice of traditional healers by setting practice standards. The registration process will entitle traditional health providers to practise for gain and to benefit from being associated with a recognised professional traditional healer's body.
Protecting indigenous knowledge
South Africa has a long tradition of natural plant research and is actively engaged in bioprospecting. Access to the country's biodiversity will be legally controlled by the recently promulgated Biodiversity Act.  The act dictates the management, conservation and use of biological diversity within South Africa. It also promotes the sustainable use of indigenous biological resources, and provides for the fair and equitable sharing among stakeholders of benefits arising from bioprospecting of indigenous biological resources.
The act will require permits to be obtained for all bioprospecting projects; permits will only be issued if a benefit-sharing agreement is in place. The act distinguishes between procedures to obtain biological resources and those to obtain knowledge.  In the former case, a material transfer agreement is required between the stakeholder and the applicant in addition to a benefit sharing agreement. The act also calls for the establishment of a Bioprospecting Trust Fund into which all funds arising from benefit-sharing agreements and material transfer agreements should be paid and from which payments to stakeholders will be made.
There is a growing interest in the sale, use and research of natural plant products. As a result, many indigenous plant species face a danger of extinction due to the exploitation and destruction of their natural habitat. The Biodiversity Act sets out a strategy for planning the conservation and sustainable use of biological diversity within a broader framework of planning for sustainable development. The act allows for the development, monitoring and review of a national biodiversity framework.
The following section describes the principle issues of debate in bioprospecting.
Issues of debate in bioprospecting
Under the new act, bioprospectors are required to enter into a benefit-sharing agreement with all providers of resources and knowledge, and also to obtain their prior informed consent before proceeding. This sets out an important new approach for bioprospecting in South Africa, and will also require existing projects to be renegotiated. There are many challenges ahead, including the fact that many resources are found on private and communally-owned areas, which are not easy to regulate. Community expectations may also be unrealistically high. Researchers will need to develop new ways of working and may be tempted to avoid community-owned areas, which often entail lengthy and complex negotiations. 
Intellectual property protection
The responsibility of providing intellectual property protection to owners of indigenous knowledge rests with several government departments, including the departments of Health, Trade and Industry, and Science and Technology. The Department of Science and Technology has drafted an Indigenous Knowledge Systems (IKS) Policy designed to protect, develop and promote such systems, and thus improve the livelihood and economic well-being of indigenous communities through equitable and fair benefit-sharing. This policy has recently been adopted by Cabinet and legislation will now be drafted.
Plans were underway to table the policy in cabinet at the end of 2004.
A growing number of research institutions in Africa and the rest of the world are taking an interest in natural plant product research for reasons that include: tapping into the rich biodiversity and knowledge base on the use of medicinal plants; finding local solutions to address health problems common in the developing world; benefiting from the potential economic gain through licensing and commercialising compounds screened for drug development; and responding to national imperatives of sustainable development.
The National Reference Centre for African Traditional Medicines is an initiative spearheaded by the Department of Health, in partnership with the Council for Scientific and Industrial Research and the Medical Research Council. The centre's remit is to gather, harness and synthesise information to promote, regulate and register African traditional medicines of plant origin. Five focus areas are: (1) to establish a research programme to filter claims of a cure and create information for the safe use of plants in public healthcare; (2) to design a database to collate all scientific information on medicinal plants already available and ensure its accessibility; (3) to identify and address the educational needs of all stakeholders, especially traditional practitioners; (4) to address all aspects of the legal issues related to medicinal plants, including intellectual property rights; (5) to focus on the development of new drugs and the standardisation of medicines currently in use in terms of safety, quality and efficacy.
In addition to the activities planned by the centre, local science councils
and universities are involved in different areas of natural plant research
including bioscience research, clinical studies on safety and efficacy,
documenting traditional medicines, producing plant monographs, and the
conservation and sustainable propagation of traditional medicines.
Numerous research programmes operating from science councils, universities
and public research organisations are aimed at developing new medicines based on
the knowledge of traditional medicinal plants. A large part of the work centres
around developing new treatments for the three main diseases affecting the
developing world: malaria, tuberculosis and HIV/AIDS.
A multidisciplinary team of researchers from universities and research
institutions across South Africa has been involved in the collection, extraction
and testing of plant material for anti-malarial activity. Promising leads
currently undergoing vigorous efficacy, safety and effectiveness testing have
been discovered, and the project is expected to lead to the establishment of new
agro-processing businesses for the supply of extracted plant material to be used
in development of novel antimalarial drugs.
A multicentre collaboration has been established through government funding to develop a national research and development platform for novel drug development from indigenous medicinal plants. Testing of medicinal plants for tuberculosis treatment is a major component of this programme.
In addition, the Medical Research Council in collaboration with Cambridge
University in the UK are following leads on the healing properties of South
African geraniums. Extracts of these plants have shown to be safe, and
laboratory testing is underway to determine how effective the extracts are
against tuberculosis infection.
Researchers are testing herbal preparations for the management of HIV/AIDS. Toxicity and pilot clinical trials have been undertaken, and preliminary results show promise in the reduction of HIV viral loads (i.e. the amount of virus in the blood). Sutherlandia is one such plant that has shown activity against the virus.
Despite commitment by the government and the research community to promote and support the development of traditional medicines, the process has been slow and protracted. Even with the recent legislation, local communities still do not have the bargaining power needed to benefit from the use of traditional medicines. Indigenous populations are often unaware of their rights, leaving room for exploitation and misappropriation of their knowledge.
Although guidelines exist for obtaining consent for bioprospecting, the infrastructure to process, approve and monitor applications is not fully formed. More effort needs to be directed at building the systems, providing assistance and educating people about their rights.
Current legislation does not provide adequate protection of the rights of traditional practitioners. Existing systems to protect intellectual property rights are monopolistic and do not take into account the collective and cumulative characteristic of indigenous knowledge.
The protection and commercialisation of traditional medicines should be more of a focus. Technology and knowledge transfer needs to be locally driven to ensure sustainability and that development benefits reach local communities.
Sibongile Pefile is the Intellectual Property and Commercialisation Manager at the Council for Scientific and Industrial Research, South Africa. Her professional interests include technology transfer for sustainable development, and the protection, promotion and innovation of indigenous knowledge.
 National Drug Policy for South Africa (1996). Available at: http://www.doh.gov.za/docs/index.html
 Department of Health, MRC and CSIR (2004). National Reference Centre for African Medicines: A South Africa Model.
 Department of Health (2004). Traditional Health Practitioners Bill Available at: http://www.doh.gov.za/docs/index.html
 Department of Environmental Affairs and Tourism (2004). National Environmental Management: Biodiversity Act (10 of 2004). Available at: http://www.environment.gov.za
 Wynberg R. (2004). Bioprospecting, Access and Benefit-Sharing in South Africa: Towards a Strategic Assessment. Available at: http://www.environment.gov.za
 Wynberg R. Bioprospecting delivers limited benefits in South Africa. European Intellectual Property Review 26: 239–243 (2004).