Medical Research Council 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. Matsabisa 29 th, 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 health 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   Development 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 Structure 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 Monographs 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 IKS 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 Antimutagenicity / 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 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 participation 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 support) Ethical approval: (scientific and ethical merits)   Protocols are peer-reviewed   Submitted to ECRA (Animal ethics review)   Submitted to MRC & MCC’s Clinical Trials Committee CTC) for ethical evaluation Toxicology 90-day sub chronic study on a non-human primate model Minimum animals: 16 Duration 3 months 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 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 – plant species used in Traditional Medicines very infrequently traded sp of plants in SA used in Traditional medicines (used by approx million people) t medicinal plants traded/year - US$60million t of wildlife medicinals traded in KwaZulu-Natal - US$13.3million t 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$43bn out of the US$ bn 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 Source Aspirin Pain killer Wild willow Theophylline Asthma Theobroma tree Digitoxin / Digoxin Heart failure Digitalis purperieae Artemisinin Antimalarial Artemisia annua Vincristine/ Vinblastine Anticancer Catharanthus roseus Quinine Antimalarial Cinchona Penicillin Antibacterial Fungus Cyclosporine Immunosuppressant Fungus Tachrolymus – FK506 Immunosuppressant Fungus Taxol Anticancer Taxus breviata

Handling of IP and Beneficiation

South Africa’s Brief Progress IKS Bill 2002:   To recognize, promote, develop, protect and affirm the hitherto undermined and marginalized Indigenous Knowledge Systems (IKS);   To contribute to the reclamation and realization of indigenous knowledge of South Africa’s diverse communities and value systems connected therewith;   and to establish a regulatory framework for IKS and matters connected therewith.

IKS Proposed Bill 2002 The objectives of the Bill are –   To give legal recognition to Indigenous Knowledge (IK) and Indigenous Knowledge Systems (IKS) and IK practitioners;   To establish principles to guide and manage the recognition, promotion, development, innovation and protection of IK and IKS;   To regulate forms of ownership and benefit sharing of IK and IKS at all levels of value addition;

IKS Proposed Bill 2002   To provide mechanisms for the capacity building of IK practitioners including their education, training, capacitation, development, empowerment and ownership;   To promote research and development activities in the area of IK and IKS;   To promote public awareness of IK and IKS;   To establish a regulatory mechanism called the “Indigenous Knowledge Systems Authority” to assist in achieving the above

Country’s Processes   DST- IKS Policy 2005   DST- IP from Public funded/financed Research, 2006   DEAT- Biological Diversity Act no 10, 2004   DEAT- National Environmental Management: Biodiversity Act, 2005   DOH - Traditional Health Practitioners Act, 2005?   DOH - Traditional Medicines Committee of MCC   AGRIC- Draft Policy on Protection of Indigenous Seeds, 2006   AGRIC- Plant Breeders Rights   UNESCO- Safeguarding and Protection of Intangible Heritage, 2003   DST- National Office of IKS, 2006

Country’s Processes   DST-TKDL approach - Documentation by National Biodiversity Institutions, MRC & Centre for Scientific and Industrial Research;   DTI –Amendment Patent Law & IKS protection;   DTI-Patent Amendment Bill no.17 of To amend the Patent Act,1978, so as to insert certain definitions; and to require am application for a patent to furnish information relating to any role played by an indigenous biological or genetic resource or TK or use in an invention; and to provide for matters connected therewith;   DTI- IP & IK Protection Policy: Interfacing protection and commercialisation of traditional knowledge systems with the existing intellectual property system.   DTI - Protection and Commercialization of TK within the existing IP systems (Draft)   DST - Framework for IP from Publicly Financed Research (Draft)

IKS POLICY 1   The Indigenous Knowledge Systems (IKS) Policy is an enabling framework to stimulate and strengthen the contribution of indigenous knowledge to social and economic development in South Africa. The main IKS Policy drivers in the South African context include the:   Affirmation of African cultural values in the face of globalisation – a clear imperative given the need to promote a positive African identity;   Practical measures for the development of the economic value of services provided by indigenous knowledge holders and practitioners involved in, among others, traditional medicine, technologies, spirituality, and indigenous languages;

IKS POLICY 2   Underpinning the contribution of indigenous knowledge to the economy – the role of indigenous knowledge in employment and wealth creation and innovation; and   Interfaces with other knowledge systems, for example, indigenous knowledge is used together with modern biotechnology in the pharmaceutical and other sectors to increase the rate of innovation

Challenges for IK Protection In the South African context there is a need for the formulation and development of a Policy that will also address the following problems:   Lack of due process of the law to address the protection of IKS.   Lack of due process of the law to address commercialization of IKS.   Lack of due process of the law to empower collective holders of IKS.   Lack of due process of the law to beneficiate the holders of IKS.   Lack of due process of the law to effect technology transfer.   Lack of a legal framework to address development, economic, social and socio-economic issues

National (Bioprospecting) Trust Fund Indigenous community and traditional healers MRC 1/2 Local Trust Fund Specific for Traditional Healers and their specific Community Trustees Traditional Healers & their Communities and Research/ Funding Institution Investigators Re-invest into IKS Research Individuals who supplied the Information &/or the Genetic material 5% 1/3 ? 1/2 2/3 ? Benefit-sharing Model Poverty Alleviation Different communities Companies jointly with Private Partners ?

National Trust Fund Indigenous communities and traditional healers CONSORTIUM of Institutions 1/2 Local Trust Fund Specific Traditional Healers and their specific Community Trustees Traditional Healers, their communities & Consortium Investigators Re-invest into IKS development, education & research X1 Individuals who supplied Information &/or the Genetic material X2X3X4XnXn X5 1/2 ? ?? 7% The Benefit-sharing Model Consortia Trust Account / s For Different communities and Traditional doctors

Monetary & Non-monetary Seven Models   Individuals Individual, goes into community project Finite period for benefit-sharing Authentification of novelty and ownership   University Model   Consortia Model   International Collaboration Each country to have its own model for its community Country where source of innovation, has the final say in benefit-sharing model   Poverty Alleviation model Community as majority shareholder with over 51% control on business Community not allowed to sell their shares   Selling or rights of IK to be a national decision – a partnership approach encouraged   Traditional healers as inventors in patent applications and acknowledged as main authors in publications

Concluding Remarks 1 National policies –political mandate and public-private- community partnership; Budget and inter-governmental relations; Observations on and implications of International instruments e.g. CBD, TRIPS-WTO; Best Practices in Africa and Developing Countries (South- South relation); NEPAD & AU country participation

Concluding Remarks 2 Multi-lateral and bilateral agreements; Multi-lateral and bilateral agreements; Capacity Building and Educational Awareness; Capacity Building and Educational Awareness; WIPO intergovernmental Committee - participation and implementation WIPO intergovernmental Committee - participation and implementation No single government Department has a monopoly on IKS protection & its Development No single government Department has a monopoly on IKS protection & its Development FINALLY : South Africa’s IKS POLICY to be Launched internationally at WIPO a sign of hope for sui generis. FINALLY : South Africa’s IKS POLICY to be Launched internationally at WIPO a sign of hope for sui generis. Liability clauses Liability clauses

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