Food Security and Biodiversity

Sharing the Benefit of Plant Genetic Resources Symposium

October 16, 2003 Basel, Switzerland

Case Study: SAN/CSIR Hoodia Benefit Sharing Model Dr Petro Terblanche Executive Director, CSIR Bio/Chemtek

The Cast
Biodiversity

CSIR Bio/Chemtek
nd a e ogy nc ol e ci h n S ec T

SA San Council
In d Kn igen o w ou l ed s ge

Hoodia

Intellectual Property Debate

The elements: Biodiversity & SAs botanical reserves

10% of worlds plant biodiversity occur in SA: 24 400 indigenous species 60% endemicity Home to one of the six floral kingdoms of the world (Cape Kingdom)

Convention on Biological Diversity

Three central principles: Conservation of biological diversity Sustainable use of its components Fair and equitable sharing of the benefits arising out of the utilization of genetic resources

Indigenous Knowledge
SA has a long tradition of medicinal use of indigenous plants >70% of South Africans consult a Traditional Healer; 200 000 healers active throughout country SA indigenous communities eg the San, has a wealth of unrecorded knowledge. (Considered the oldest genetic stock of contemporary humanity)

Bioprospecting Technology Platform

Core competence: Value addition to a nations Biodiversity Platform technologies: drug discovery, development and licensing, etc. Key technologies: natural product screening and isolation, structure elucidation, data mining, etc Scientific capability: Taxonomy, chemical extraction, database management

CSIR Vision for Bioprospecting

Create economic and social benefit for the nation and the region based on its biodiversity and indigenous knowledge Add maximum value to bio-resources through consortium-based research within South Africa

Time line for P57 (1)

1963 1971 19831986 19861996 1997 1998 CSIR includes Hoodia in research project on edible plants, based on ethnobotany of San Hoodia project mothballed, insurmountable technical problems Technological advances. Scientific breakthrough: new chemical entity in Hoodia discovered, structure determined. CSIR continues development of Hoodia, files worldwide patents to protect its invention of novel method of obesity control. CSIR licenses Phytopharm for further development CSIR publishes its Bioprospecting Policy, guaranteeing sharing of benefits from bioprospecting with owners of Traditional Knowledge

Time line for P57 (2)

1998 1999 Phytopharm sub-licenses Pfizer to complete P57 clinical development, obtain regulatory approval and commercialize. CSIR signs historical bioprospecting agreement with South African Traditional Healers, invited by UN to present details at Lyon Summit on Trade and Development

2001

UK newspaper reporter questions CSIR-Phytopharm-Pfizer P57 collaboration, without involvement of San CSIR and San meet regularly to share P57 information; involve independent experts in workshops; negotiate benefit sharing agreement

20022003

Time line for P57 (3)

24 March CSIR and San sign P57 2003 benefit sharing agreement 30 July 2003 Today Phytopharm announces that Pfizer has decided to discontinue development of P57 Phytopharm continues its commercialisation strategies

The Benefit-sharing agreement and biodiversity

Both parties commit themselves to the conservation of biodiversity by, inter alia , applying legal best practices with the collection of any plant species for observation, and by ensuring that no negative environmental impacts flow from the proposed bioprospecting collaboration.

The Benefit-sharing agreement and recognition of indigenous knowledge

..San people are custodians of an ancient body of traditional knowledge related inter alia to human uses of the Hoodia plant , The CSIR acknowledges the existence and the importance of the traditional knowledge of the San people, and the fact that such body of knowledge, existing for millennia, predated scientific knowledge developed by Western civilization over the past century

The Benefit-sharing agreement and benefits

Financial: CSIR will pay the San eight percent of all milestone payments it receives from its licensee, UK-based Phytopharm plc, as well as six percent of all royalties that the CSIR receives once the drug is commercially available (evergreen). Other: Existing CSIR study bursaries & scholarships available to San community. Agree future bioprospecting for the benefit of both parties.

The Value Addition/Benefit Link

Clinical development Marketing the drug License technology from CSIR Further development Clinical trials Commercialisation

market Pharmaceutical company

New chemical entity discovered, structure determined; Pre-clinical data for anti-obesity drug lead; New pharmaceutical formulation for obesity control

Phytopharm

The CSIR
Ancient knowledge relating to human use of Hoodia

The San

The Benefit-sharing agreement and administration of benefits

Potential money into a San Hoodia Benefit Sharing Trust Representation: 1 CSIR or nominee; 3 San reps. (#Khomani, !Xun and Khwe); 1 WIMSA; 1 SA professional; non-voting observer SA Dep. Science &Technology Beneficiaries: The San people: #Khomani, !Xun and Khwe communities of South Africa, + San communities elsewhere who are members of WIMSA & identified by TRUSTEES as eligible beneficiaries Agreement to remain in force for the royalty period for as long as the CSIR receives financial benefits from the commercial sales of the products Record-keeping: CSIR and San Trust

Challenges in Benefit-sharing agreement

Man-made borders vs cultural & biodiversity across borders How to contract when revenue/benefits to parties are uncertain and linked to outcome of clinical trials: expectation management Balancing trade secret/knowledge protection with transparency How to administer the potential future benefits

Challenges and lessons learnt from P57

Extremely difficult to operate in policy vacuum, draft format IKS policy and bill. Very long time from project idea to commercial success At what stage of product development cycle must benefit-sharing agreement be signed with owners of traditional knowledge? Active participation throughout Communication burden is part of operating in interdependent world sheer number of partners; needs and expectations of parties involved.

Challenges and lessons learnt from P57 Traditional Knowledge has intrinsic value, but requires significant value addition through technology/marketing to realise value Policy development benefits from real-life case studies (learn-on-the-run) Genetic resources common to more than one country

P57 licensing: benefits to South Africa

Full involvement of South African scientists in development programme (capacity building) Transfer of state-of-the-art phyto-medicine production technology to South Africa Potential royalty revenue through licensing of patented technology; milestone payments linked to clinical trials Global recognition of SAs innovation capacity

Acknowledgements
Dr Marthinus Horak (CSIR) Dr Vinesh Maharaj (CSIR) Dr Richard Dixey (Phytopharm) Various scientists SA San Council Roger Chennells (SAN Lawyer) Alida Britz (CSIR)

THANK YOU!