1. STATUS OF TRADITIONAL MEDICINE IN SOUTH AFRICA 16-17 NOV 2006

2. ORDER OF WORK BACKGROUND ACTIVITIES IN TRADITIONAL MEDICINE CHALLENGES WAYFORWARD

3. BACKGROUND Health needs and utilization of Traditional Medicine 70 percent of South African citizen utilize the disciplines Traditional Medicine (African and Complementary) for their healthcare needs. Economic importance of African Traditional Medicine In Gauteng, there were approximately 244 herb-traders in 1994. 70% of whom were located in Johannesburg, 20% in East Rand and 10% in the West Rand (Williams et. Al). In Kwa Zulu-Natal, South Africa, over 4 000 tones of plant material is traded a year, with a value of US$13 million [R600 million], some one third of the value of the annual maize harvest in the province. At national level, 20 000 tones may be traded a year, with a value of approximately US$60 million [R270 million] (Myles Mander at. Al)

4. BACKGROUND African Traditional Medicines are any substances or mixture of substances obtained from plants, animals, insects, micro- organism and salts that are: 1.used or administered to human beings or animals to treat disease, prevent or reverse a disease state and to maintain a good health or good look, and 2.used for sanitation purposes (insecticides) Types of traditional medicinal plants 1.Raw plant as a medicine (e.g African Ginger, Ukhathazo – Alepidea amatymbica) 2.Extemporaneous plant preparations 3.Processed & marketed plant preparations

5. ACTIVITIES IN TRADITIONAL MEDICINE Research and Development 60 ATMs Monographs - plant origin (University of Western Cape monographs project) Production of processed, labelled and marketed ATMs – Scelitium, Sutherlandia, etc) Documentation South African Primary Health Care Handbook- combining western and Traditional Practices (Taryl Haber et. Al) – ATMs formulae Cultivation of medicinal plants (Myles Mander et. Al) Medicinal Plants and their utilisation (Nigel Gerick et al; Watt J.M & Breyer-Brandwijk ) Conservation: National Botanical Gardens, National Parks

6. ACTIVITIES IN TRADITIONAL MEDICINE (2) Education and Training Western Cape Herbal College, Institute of Ethno-medicine Research into ATMs Medical Research Council – medicinal plants (MP) used for malaria, diabetes, TB, HIV and AIDS Council of Industrial and Scientific – mass screening and extraction of MP Agricultural Research Council – MP seed breeding & cultivation Universities and other Institutions - natural product chemistry Archiving of Traditional Medicines Libraries at National Botanical Gardens, South African Pharmaceutical Society

7. CHALLENGES Regulating ATMs within the context of different definitions as contained in Act 101 of 1965 and Act No 35 of 2004 Clinical trials protocol that is appropriate for ATMs Quality assurance (GMP, GAP,GHP, etc.) of ATMs ATMs registration framework with a regulatory framework that was designed for allopathic medicine Regulation of ATMs that are traded in the market Sustainable cultivation of medicinal plants Protection of Traditional Medicine Knowledge (TMK) Production of ATMs

8. GOVERNMENT INTERVENTIONS Medicines and Related Substances Control Act 101 of 1965 is utilized to regulate all medicines, including ATMs and Complementary medicines Expert Committees of African Traditional and Complementary Medicine exist. They are sub- committees of the Medicines Control Council (MCC). A sub- committee MCC on ATMs –has been established in the Medicine Regulatory Authority.

9. TASKS OF THE MCC SUB-COMMITTE ON ATMs The Committee is in the process of developing: a)a broad framework for quality assurance of ATMs – monographs, medicinal plants cultivation b)Safety assessment protocol – phytochemical analysis, toxicity studies, animals studies c)Guidelines for determining efficacy of ATMs- observational studies, clinical studies d)Criteria for exempting ATMs from being subjected to clinical trials

10. GOVERNMENT INTERVENTIONS (2) Regulation of Traditional Health Practitioners and practice –Traditional Health Practitioners Act of 2004 Regulation of disciplines of Traditional Medicine (Ayurveda, Unani-Tibb, TCM, etc) that do not originate in Africa is done within the provisions of Chiropractors, Homeopaths and Allied Health Service Professions Amendment Act No 40) SA National Drug of 1996 mentions traditional medicines regulation – facilitated the establishment of the National Reference Centre of African Traditional Medicines

11. GOVERNMENT INTERVENTIONS (3) Traditional Medicine Directorate: Focal point on African Traditional Medicine Coordinates the development of ATM and follows up on recommendations made at international fora Formulate a national policy on Traditional Medicine (TM) Facilitation of establishment of institution on ATM

12. GOVERNMENT INTERVENTIONS (4) Review or develop a new legislation for protection of Indigenous Knowledge in African Traditional Medicine Facilitates the establishment of a continuing education program for Traditional Health Practitioners (THPs) Encourage and / or support legal representation on issues related to intellectual property rights and patenting of innovations of THPs

13. GOVERNMENT INTERVENTIONS (5) Facilitate access to media and advocate for a more positive attitude towards ATM Establish a national ethical committee for research from the existing committees Adopt and adapt WHO guidelines on policy and regulatory issues, registration of TMs, continuing education & research for evaluating traditional medicines used for the management of HIV & AIDS, malaria, diabetes and hypertension

14. Ministerial Task Team – tasked inter alia to (1) review the framework for registration and regulation of medicines, including African Traditional Medicines, and (2) to make recommendations with regard to an efficient regulatory body for medicines and health technology, medical technology and medical devices for consideration by the Minister. Presidential Task Team on African Traditional Medicine SPECIAL TASK TEAMS

15. TERMS OF REFERENCE OF PRESIDENTIAL TASK TEAM To make recommendation with regard to a national policy and an appropriate regulatory legal framework for the institutionalization of African Traditional Medicine (ATM) in South Africa To investigate policies and practices devised and implemented by various government departments and agencies to promote ATM

16. TERMS OF REFERENCE OF PRESIDENTIAL TASK TEAM (2) To make recommendations on any steps that can be taken by the South African government and other stakeholders to create an enabling environment for the institutionalization of ATM in South Africa, including a)Establishment of institutions on health care based on the theory and practice of ATM in South Africa; b)Training and development of practitioners and researchers; c)Creating practical linkages between ATM in SA and other paradigms of theory and practice of medicine; and d)The production and processing of ATM in SA

17. TERMS OF REFERENCE OF PRESIDENTIAL TASK TEAM (3) To investigate and review current research methodology with regard to ATM in SA at research institutions in SA and to make recommendations in regard thereto To compile ATM knowledge in SA in order to preserve, codify and protect such knowledge including developing a pharmacopoeia on ATM in SA

18. TERMS OF REFERENCE OF PRESIDENTIAL TASK TEAM (4) To undertake a survey of comparative international practice with regard to institutionalization and utilization of ATM in the respective healthcare systems To make any recommendations and undertake any such activity that in the opinion of the Task Team will assist to achieve the objective setout in these TOR

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