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. Matsabisa 29th, August 2006 “Going back to our roots for innovative health solution” 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 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 CEO EXECUTIVE RESEARCH IKS LEAD PROGRAMME PA IKS UTILISATION DELFT SUPPORT STAFF SOCIAL IMPACT RESEARCH & DEVELOPMENT KNOWLEDGE MANAGEMENT Malaria Training & Capacity Databases Development SBU Job Creation PPCP for job creation Drug Discovery & Development Hypertension GPS Databases Spin-out Companies Poverty Alleviation Ownership and Empowerment Newand Method HIV AIDSdevelopment Claims Advocacy for Cures IKS Research Commercialization Systems Biology Platform Tuberculosis Monographs Policy Drug Manufacturing Sustainable community business Capacitation enterprises Entrepreneurial development Clinical Trial Platform Cancer Tramed Access III and Beneficiation Toxicology Diabetes Business development 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 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 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. 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 Quinine Antimalarial Cinchona Penicillin Antibacterial Fungus Cyclosporine Immunosuppressant Fungus Tachrolymus – FK506 Immunosuppressant Fungus Taxol Anticancer Catharanthus roseus 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 2005 -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 POLICY1 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 POLICY2 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 Benefit-sharing Model Poverty Alleviation 1/2 1/2 National (Bioprospecting) Trust Fund MRC Indigenous community and traditional healers ? 1/3 2/3 1/2 ? Local Trust Fund Specific for Traditional Healers and their specificcommunities Community Different Trustees Companies jointly Traditional & with PrivateHealers Partners their Communities and Research/ Funding Institution Investigators Re-invest into IKS Research ? 5% Individuals who supplied the Information &/or the Genetic material The Benefit-sharing Model Consortia 1/2 1/2 National Trust Fund CONSORTIUM of Institutions Indigenous communities and traditional healers 1/2 X1 Local Trust Fund Specific Traditional Healers and their Trust Account /s specific Community For Trustees X3 Investigators ? Re-invest into IKS development, education & research ? 7% X5 X4 ? Different communities Traditional Healers , and their communities & Consortium Traditional doctors X2 Individuals who supplied Information &/or the Genetic material Xn 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 Remarks1 National policies –political mandate and public-privatecommunity 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 (SouthSouth relation); NEPAD & AU country participation Concluding Remarks2 Multi-lateral and bilateral agreements; Capacity Building and Educational Awareness; WIPO intergovernmental Committee - participation and implementation 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. 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