Indigenous Knowledge Systems [Health] Medical Research Council – South Africa

1. Indigenous Knowledge Systems [Health] Medical Research Council – South Africa Dr Motlalepula G. Matsabisa Portfolio Committee of Science and Technology Presentation June 14th 2005

2. Our Mission and Vision To promote and advance indigenous knowledge systems through research and development by making it a valued health model in the global environment and to redress health traditions, which until now have neglected health research priorities and issues. To be a centre of excellence in traditional medicines research regionally and to be competitive globally

3. CEO Research Directorate IKS Lead Programme Director Dr MG Matsabisa IKS Research and Development IKS Utilization SBU IKS Knowledge Management Drug Discovery Clinical Trials Toxicity New Research Methodologies Poverty Eradication Programmes Pilot Farms Horticulture Production GMP Databases National Reference Centre Health Promotion Policy Advocacy Healer Liaison IKS Laboratory IKS Resource Centre IKS Production Facility & QC Laboratory DELFT: MRC’s Core IKS Facilities Clinical Trial Platforms New Research Methodology Development Toxicology Metabolism Drug-Herb Interactions studies Antimutagenicity studies System Biology studies Genomics Proteomics Metabolomics Drug targets Scale up methodologies Malaria Hypertension HIV and AIDS Tuberculosis Cancer Pain Diabetes Special projects IKS SBU Delft Community Centre Medicinal garden Resource centre TDr Training Program School outreach programs Poverty Alleviation Manufacturing IK Policy ABS IKS Research Guidelines IP Policy MCC – ATMC NRCFATM Databases Tramed III GIS TDrs Monographs Claims for cures

4. Agreements Metabolism - UFS in vitro & in vivo Signed between TDr, Individuals and MRC on Collaborative Research Antimutagenicity - UL in vitro • Breast Cancer • Gauteng • Limpopo • Traditional Immune Boosters • Eastern Cape (2) - North West • - KwaZulu/Natal • - Gauteng (3) - Limpopo • Antidiarrhoeal • KwaZulu-Natal • Antimalarial • Free State • KwaZulu-Natal International Agreements Tanzania Uganda Nigeria US, Rutgers University Kenya Botswana India Antihypertensive - North West Anti HIV - NM Med. Sch in vitro • Antidiabetic • Gauteng • Anti- TB • North West • Gauteng

5. Approaches in Drug Development – Traditional Medicines Ethno botanical approach – Traditional knowledge Chemotaxonomic approach Random screening Extraction [Hexane, DCM & H2O] Toxicology testing Pharmacological testing Isolation & characterization Clinical trials Phase 1 – Phase II/III Pharmacological testing [Registration with MCC] [Manufacturing & commercialization] Patients

6. Malaria • Preclinical studies In vitro studies CQ sensitive and Insensitive MFQ sensitive and Insensitive Resistance reversal studies • Clinical studies Toxicology – Vervet Efficacy – P. falciparum baboon model Phase I – Phase IV studies

7. Resistance Modulators Cancer Antibiotics TB Malaria – e.g. bis-benzyl alkaloids & CQ HIV and AIDS – e.g. Acemannan & AZT Uptake studies & Efflux studies Non-human models

8. Anticancer

9. Antidiabetic

10. HIV and AIDS Research • Assessment of Traditional Claims for cures • Safety, Efficacy studies • Value addition • Education and Training • Capacity Development

11. Traditional Medicines Use in USA

12. Clinical Evidence for TM Based on 50 RCTs evaluating 10 TM for 18 indications (Therapeutics Letter, Issue 25, June – July 1998)

13. Clinical Trials Ethics Ethics:Informed consent for screening Informed consent for HIV testing Informed consent for participation in the study Information leaflet for the screening Information leaflet for participation in the study Counseling: Integrated approach: To whole family Pre-screening HIV counseling 1 post screening counseling (referral of those that are HIV+, but not meeting the inclusion criteria to appropriate & accredited centres for support) Ethical approval: (scientific and ethical merits) Protocols are peer-reviewed Submitted to MRC & MCC’s Clinical Trials Committee (CTC) for ethical evaluation Toxicology 90-day sub chronic study on a non-human primate model Clinical Human Trials Both Phase I and II/III Are double blind, randomized, placebo controlled dose elevation parallel group studies

14. R&D Technologies for Analytical systems Quality Control Manufacturing Rational Drug Design Systems Biology – Mechanisms of Action & Drug Targets Proteomics Genomics Metabolomics Drug Metabolism and Drug-herb interactions Cytochrome P450 1a2 2a 2c19 2d6 2c8 2c9 2e1 3a4 IKS Technologies Antimutagenicity and mutagenicity

15. HIV and AIDS Training • Training City Health Department TB, HIV and AIDS • School Outreach • Community Partnerships • Capacity development • Medicinal Herb Garden

16. MRC Delft Community Project • Provide enabling environment for healers and scientists to interact • Formal structure for healers to interact, develop policy and develop communication products • Provide healers access to scientific infrastructure (Information, Library, Internet access, database, medicinal plant cultivation, drug discovery, Resource Centre) • Provide a forum for structured health education and promotion (Herb garden) • Develop skills in growing, processing, packaging and marketing of herbal products

17. Traditional Healer Training Program Module 1 - Collaboration, trust and cooperation with traditional healers – Identifying “good” professional traditional healers Module 2 - Record keeping, note taking, patient history taking, documentation and follow-ups. – Documentation Module 3 - Adverse Drug Reaction Reporting Systems – for TDr andCommunities Module 4 - Traditional healers and Home Based Care – care for the elderly and terminally ill, drug abuse, smoking, alcohol, women and children abuse Module 5 - Patient Referral System Module 6 - Traditional Healing, HIV/AIDS (opportunistic infections) and care for the Terminally Sick HIV/AIDS Sufferers Module 7 - Principles of Drug Development from Traditional medicines. Assessment of traditional claims for cures, Benefit-sharing Module 8 - Assessment of the Training and Compliance

18. Facts • 74% of drugs developed from plants could be attributed to the use of indigenous plants in traditional medicine by various communities (Wambembe, 1999). • The annual sales of drugs developed from traditional medicines amounted to US$43bn out of the US$130 000bn total sales of pharmaceuticals in the 1980s (Rural Advancement Fund Int. 1997). • Less than 0.001% of profits from plant-based drugs from traditional medicine knowledge accrued to the people who provided the leads for the research (Posey, 1991). • Approximately 80% of the rural population use traditional medicines.

19. Medicinal Trade in South Africa • 1988 – 1996 750 plant species used in Traditional Medicines - 200 very infrequently traded 24 000 sp of plants in SA 4 000 used in Traditional medicines (used by approx. 12-15 million people) 20 000t medicinal plants traded/year - US$60million • 1996 4300t of wildlife medicinals traded in KwaZulu-Natal- US$13.3million • 1997750t traded in Mpumalanga– US$2.25million

20. AIM OF THE PROJECT • Aim To promote the application of scientific research into practical implementation of projects oriented to create permanent sources of income, promote the development of sustainable enterprises and their integration into the value adding processes of industrial development and commercialization of products derived from medicinal plants.

21. BACKGROUND • TARGET: Identified communities with high unemployment rate, and identified as the poverty nodes by the president. Medicinal plants with scientifically validated health claims and having existing economic markets are grown for commercialization. • Target: Rural women, single run households, orphans and PLWA

22. INSTITUTIONAL SUPPORT • Different components in industrial viability • COMMERCIAL VIABILITY • TECHNICAL VIABILITY • INSTITUTIONAL SUPPORT • ENTREPRENEURIAL VIABILITY • (Alfaro, 2003).

23. IKS and Competiveness • The programme is based on the production, industrialization and commercial development of scientifically validated medicinal plants as sources of competitive advantages for entrepreneurial based projects. • Competitive advantages: BASIC

24. OPERATIONAL MODEL: Partnerships Supporting organizations: Department of Science and Technology (DST) Department of Health (DoH) Municipalities and Private sector. Established companies Partner municipalities: Tsolwana Municipality (Eastern Cape) Senqu Municipality (Eastern Cape) Namakhoi Municipality (Northern Cape) Mbombela Municipality (Mpumalanga) Makhuduthamaga Municipality (Limpopo).

25. Anticipated Outputs • Anticipated Impact • Job creation - 200 permanent jobs over 3 years • Sustainable use of medicinal plants • Application of scientific research developed by the IKS Division • Capacity building for institutions (municipalities) • Training and promotion of the culture of entrepreneurship • The promotion of registered business ventures fully owned by emerging entrepreneurs • Horizontal and vertical integration of the area surrounding the projects.

26. Conclusions • IKS as a source of competitive advantages • Export orientation possibility • Promotion of ownership and empowerment • IKS as basis for value addition – science base, IK , fauna and flora

27. Barriers • Entrepreneurial attitude • Barriers to entry • Institutional support • Long term planning • Short term solution • Resource based approach

28. CAM funding in the USA National Center for Complementary and Alternative Medicines, 2000