Medical Research Council

1. Medical Research Council http://www.mrc.ac.za Building a healthy nation through research

2. 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”

3. 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

4. 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

5. Organizational Structure CEO EXECUTIVE RESEARCH DELFT SUPPORT STAFF IKS LEAD PROGRAMME PA SOCIAL IMPACT IKS UTILISATION RESEARCH & DEVELOPMENT KNOWLEDGE MANAGEMENT Malaria Hypertension HIV and AIDS Tuberculosis Cancer Diabetes Databases GPS Claims for Cures Monographs Tramed III Training & Capacity Development Databases Advocacy Policy Access and Beneficiation 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 Drug Discovery & Development New Method development Systems Biology Platform Clinical Trial Platform Toxicology

6. 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

7. 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.

8. 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

9. Handling of IP and Beneficiation

10. 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.

11. 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;

12. 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

13. 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

14. 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)

15. 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;

16. 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

17. 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

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

19. The Benefit-sharing Model Consortia 1/2 1/2 National Trust Fund Indigenous communities and traditional healers CONSORTIUM of Institutions 1/2 X5 X1 X2 X3 X4 Xn Trust Account / s For Different communities and Traditional doctors Local Trust Fund Specific Traditional Healers and their specific Community Trustees Traditional Healers , their communities & Consortium ? ? Investigators Re-invest into IKS development, education & research ? Individuals who supplied Information &/or the Genetic material 7%

20. 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

21. Concluding Remarks1 • 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

22. 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. • Liability clauses

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