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1、,Medical Research Council,http:/www.mrc.ac.za Building a healthy nation through research,Indigenous Knowledge Systems Health Lead Programme Medical Research Council South Africa Managing IP and Benefit-sharing on IKS Research Presentation to Portfolio Committee on Arts and Culture Dr Motlalepula G.
2、Matsabisa 29th, August 2006,“Going back to our roots for innovative health solution”,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 heal
3、th research priorities and issues. To be a centre of excellence in traditional medicines research regionally and to be competitive globally,Our Mission and Vision,Objectives,Coordination and development of health research in indigenous knowledge Development of institutional and community networks De
4、velopment of an enabling clinical trials environment Innovations and commercialization in traditional health systems. Policies governing intellectual property and benefit-sharing Development of Research programmes that are appropriate & relevant Support academic research Funding,Organizational Struc
5、ture,Drug Discovery & Development New Method development Systems Biology Platform Clinical Trial Platform Toxicology,Malaria Hypertension HIV and AIDS Tuberculosis Cancer Diabetes,Training & Capacity Development Databases Advocacy Policy Access and Beneficiation,Databases GPS Claims for Cures Monogr
6、aphs Tramed III,SBU Spin-out Companies IKS Research Commercialization Drug Manufacturing,Job Creation Poverty Alleviation Capacitation Entrepreneurial development Business development,PPCP for job creation Ownership and Empowerment Sustainable community business enterprises,CEO,EXECUTIVE RESEARCH,IK
7、S LEAD PROGRAMME,PA,DELFT SUPPORT STAFF,RESEARCH & DEVELOPMENT,KNOWLEDGE MANAGEMENT,IKS UTILISATION,SOCIAL IMPACT,Clinical Evidence for TM,Based on 50 RCTs evaluating 10 TM for 18 indications (Therapeutics Letter, Issue 25, June July 1998),TM Research Platforms,Preclinical studies Toxicology Antimut
8、agenicity / Mutagenicity Genotoxicity Carcinogenicity Metabolism TM QA / QC Clinical studies Safety studies e.g. Immune modulators Efficacy studies e.g. Immune modulators,Platforms Old Monkey Plasmodium falciparum model efficacy Clinical trial platform Malaria, Diabetes, Hypertension Systems biology
9、 platform Metabolimics Proteomics Genomics Drug Targets Reversal of Parasite / Virus resistance,Clinical Trials,Ethics Ethics: Subject Information for screening Informed consent for screening Informed consent for HIV testing Subject information for participation in the study Informed consent for par
10、ticipation in the study 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 suppor
11、t) Ethical approval: (scientific and ethical merits) Protocols are peer-reviewed Submitted to ECRA (Animal ethics review) Submitted to MRC & MCCs Clinical Trials Committee CTC) for ethical evaluation,Toxicology 90-day sub chronic study on a non-human primate model Minimum animals: 16 Duration 3 mont
12、hs,Clinical Trials Phase II/III Are double blind, randomized, placebo controlled dose elevation parallel group studies Phase I Minimum participants: 20 Duration 12 weeks Phase II Minimum participants: 40 Duration 6 months (9 & 12),Indemnity Insurance For all trialists and participants in Phase I and
13、 II studies,Complete CV of all Trialists Complete contact details of all trialists including that of chairperson of Ethics committee,Observational studies 3 Month Observational study THP is collaborator Clinicians Clinical and Pathological evaluations,Medicinal Trade in South Africa,1988 1996 750 pl
14、ant 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
15、 1997 750t traded in Mpumalanga US$2.25million,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 U
16、S$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.,Drugs from Plants,Drug Use Sourc
