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Indigenous Knowledge Systems [Health] Lead Programme

Medical Research Council – South Africa

Managing IP and Benefit-sharing on IKS Managing IP and Benefit-sharing on IKS ResearchResearch

Presentation to Portfolio Committee on Arts and Culture

Dr Motlalepula G. 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 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

PADELFT

SUPPORT STAFF

RESEARCH & DEVELOPMENT

KNOWLEDGE MANAGEMENT IKS UTILISATION

SOCIAL IMPACT

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 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 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

National (Bioprospecting) Trust Fund

Indigenous community and traditional healers

MRC

1/2 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

?

1/22/3

?

Benefit-sharing ModelPoverty Alleviation

Different communities

Companies jointly with Private Partners

?

National Trust Fund

Indigenous communities and traditional healers

CONSORTIUM of Institutions

1/2

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

X2 X3 X4 XnX5

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 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

Concluding RemarksConcluding Remarks22

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 implementationWIPO intergovernmental Committee - participation and implementation

No single government Department has a monopoly on IKS protection & No single government Department has a monopoly on IKS protection & its Developmentits Development

FINALLY : South Africa’s IKS POLICY to be Launched internationally at FINALLY : South Africa’s IKS POLICY to be Launched internationally at WIPO a sign of hope for WIPO a sign of hope for sui generissui generis. .

Liability clausesLiability clauses

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