Hoodia Case Study

1. Hoodia Case Study Rachel Wynberg Environmental Evaluation Unit, University of Cape Town Photo: Rachel Wynberg

2. Overview • Appetite suppressant based on TK of indigenous peoples of southern Africa • Active constituents patented by CSIR • Patents and commercial development without knowledge or PIC of San • Agreement between CSIR-San The late Vetman Piet eating Hoodia in the Kalahari. Photo: Rachel Wynberg

4. The Negotiating Process Photo: Rachel Wynberg

5. Two forms of commercial development: • CSIR license agreement with Phytopharm - in turn have agreement with consumer giant Unilever. - Product will be incorporated into functional food for mass consumer market. Unilever sole agent. - Based on patent - Clinical trials, stringent safety tests (Euro 4 million), FDA and EU compliant - Working on Hoodia extract and product will be clinically active - All supply from cultivated source - Entire value chain

6. Two forms of commercial development: • Wide (and wild!) trade as a commodity – dried, ground, exported - Manufactured as extracts, pills, juice, diet bars, diet drinks … - Wild harvested but will move towards cultivation - Negative impacts on the resource – 500-600T traded 2006 alone! Unsustainable! - Cowboy industry: 100s of dealers, unsubstantiated claims, some is legally acquired but much isn’t, a lot of material is not Hoodia - Quality issue here is to ensure it is Hoodia ‘not sawdust’ but not looking for actives - Value chain highly fragmented

8. Photo: Rachel Wynberg

9. Also two forms of benefit-sharing agreement: 1. CSIR-San • Parties are the South African San Council and the CSIR (CSIR would only negotiate with a legally constituted SA entity) • San are to receive 6% of all royalties received by CSIR and 8% of milestone income • Monies payable into Trust set up by CSIR and SA San Council but including regional representatives. No individual benefits.US$80,000 to date. Much more expected! • IPR remains exclusively with CSIR. San has no right to claim co-ownership. • San prohibited from entering agreement with any third party to commercialise Hoodia

10. Photo: Rachel Wynberg

11. 2. Southern African Hoodia Growers Association (SAHGA) – WIMSA (San) • SAHGA a voluntary group of Hoodia growers wanting to promote best practice in the local industry: quality, traceability, fair trade, benefit sharing, conservation. • WIMSA represents San Councils in SA, Namibia, Botswana (not yet established) • MOU with provincial permitting authorities • Acting in anticipation of the coming into effect of Ch 6 of the Biodiversity Act through promulgation of ABS regulations • Developing a label for traceability. Want to promote recognition of its legitimacy. For food market and dietary supplements. • San levy of R24/ dry kg

12. Photo: Rachel Wynberg

14. Photo: Rachel Wynberg

15. Legal Context • Biodiversity Act (2004) but needs regulations to be effected • IKS policy (2005) • Patent Amendment Act requiring disclosure of origin (2006) • Draft ABS regulations gazetted for comment 16 March 07. Three types of permits: research involving IK (province), bioprospecting (DEAT), export (provinces, DEAT) • Threatened and protected species regulations will come into effect 1 June 07: Hoodia listed as a protected species and will come under national control. Is also CITES Appendix II. Three permits required to grow Hoodia: registration, nursery, trader.

16. ABS Regulations • Regulate: • - bioprospecting of indigenous biological resources; and • - the export of indigenous biological resources for “bioprospecting or any other kind of research” • Recognise two phases to a bioprospecting project: • - the discovery phase (commercial application unknown or unclear); and • - the commercialisation phase. • Govern: • - the commercialisation phase • - the discovery phase of bioprospecting projects where the project makes use of an indigenous community’s traditional use or knowledge of the resource; • - export • Three types of permits: • - research permits, where TK is used (require BSA); • bioprospecting permits (require MTA and BSA) • export permits.

17. The distribution of Hoodia spp. and occurrence of the San in southern Africa (Wynberg, 2006). Hoodia distribution is compiled from data provided by PRECIS. San data is obtained from Suzman (2001); http://www.san.org.za; and R. Chennells, SASI, pers. comm.

18. Key Issues • Regional collaboration and benefit sharing (SA is currently primary beneficiary and Namibia is developing alternative strategies – different capacities and interests; CITES requires coherent approach; illegal trade through SA; Devil’s Claw Regional Working Group expanded to include Hoodia) • Other knowledge holders? • Streamlining permitting systems: CITES, ABS, province-province … • Distinguishing between quality / traceability issues and those of labelling for fair trade and benefit sharing. Safety and efficacy are central. Traceability critical when products change form.

19. Key Issues • Can biotrade and GR trade be differentiated? Case demonstrates grey area. Unregulated biotrade may however jeopardise Unilever initiative. • What happens when resource is not what is claimed? (50 Hoodia products tested in States – none with Hoodia. Most traders dealing with many species). • Growing concern of Hoodia outside region: was material legally acquired? • Ensuring industry collaboration on the Hoodia trade – local industry plus support from buying countries