1. Policy and Commercialisation Frameworks for Benefit Sharing, Trade and Use of Hoodia Rachel Wynberg Environmental Evaluation Unit, University of Cape Town

2. Overview Appetite suppressant drug based on TK of indigenous peoples of southern Africa Active constituents patented by CSIR CSIR license agreement with Phytopharm Patents and commercial development without knowledge or PIC of San Agreement between CSIR- San Vetman Piet eating Hoodia in the Kalahari

4. The Negotiating Process

5. Historical South African Policy context No focused policy or legislation on IKS and PIC at the time of CSIR-San agreement No focused policy or legislation on IKS and PIC at the time of CSIR-San agreement No requirement for benefit-sharing agreements to be developed with knowledge holders No requirement for benefit-sharing agreements to be developed with knowledge holders No requirement for PIC No requirement for PIC

6. The role of IPRs in promoting benefit-sharing TK used directly by CSIR to guide their research and development Patenting of Hoodia compounds ran counter to San belief systems but the principle was too expensive and the San opted for a weak compromise Option: Adopt a no patents on life position and pursue alternative models of commercialisation. Could include a challenge of the CSIR patent. Option: Co-ownership of the patent

7. The benefit-sharing agreement: 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. Commitment to conserve biodiversity and undertake best practice procedures 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

8. The benefit-sharing agreement: was it fair and equitable? San could receive millions of dollars but this amounts to less than 0.03% of net sales Money comes from the CSIRs share: Phytopharm and others share remains untouched Criticism that relationship is disempowering and unequal SA San Council are confined to the high-tech Big Pharma model and purportedly unable to pursue other models based on non-patented herbal medicines …. But the practice is different Focus on monetary benefits only but loose commitment to capacity building

9. Figure 6.2. The distribution of Hoodia spp. and occurrence of the San in southern Africa. 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. (2006).

10. San-Hoodia Benefit-Sharing Trust Established to receive income from CSIR Established to receive income from CSIR To uplift standard of living and well being of San of southern Africa To uplift standard of living and well being of San of southern Africa To identify San beneficiaries To identify San beneficiaries To ensure benefits are shared fairly, transparently and with highest degree of diligence To ensure benefits are shared fairly, transparently and with highest degree of diligence Creates a Fund Creates a Fund Creates a Board of Trustees: CSIR, 3 reps appointed by SA San Council (=Khomani, !Xun, Khwe), three reps for the region appointed by WIMSA, WIMSA, professional appointed by SA San Council, DST Creates a Board of Trustees: CSIR, 3 reps appointed by SA San Council (=Khomani, !Xun, Khwe), three reps for the region appointed by WIMSA, WIMSA, professional appointed by SA San Council, DST No remuneration to Trustees No remuneration to Trustees

11. San-Hoodia Benefit-Sharing Trust All funds distribution based on detailed request All funds distribution based on detailed request No distribution to individuals No distribution to individuals R560,000 received to date – R200,000 to SA San Council, Namibia and Botswana still to receive their share but can only be done following establishment of their Councils R560,000 received to date – R200,000 to SA San Council, Namibia and Botswana still to receive their share but can only be done following establishment of their Councils

13. San-!Khoba Declaration September, 2006. 50 San reps from SA, Namibia and Botswana reached consensus that: All San structures should include and respect San traditional values of fair sharing, consensus decision-making, and respect for culture. All San structures should include and respect San traditional values of fair sharing, consensus decision-making, and respect for culture. A clear majority of funds received should reach and benefit San communities. A clear majority of funds received should reach and benefit San communities. Administrative costs should be kept to a bare minimum (20:80 for R1 million). Administrative costs should be kept to a bare minimum (20:80 for R1 million). Corruption in any form is totally unacceptable. Corruption in any form is totally unacceptable. Priorities are and will be different in Botswana, Namibia and South Africa and consultation needed to establish priorities. Priorities are and will be different in Botswana, Namibia and South Africa and consultation needed to establish priorities. Priority to projects that are environmentally sustainable, economically viable, and that benefit many San. Priority to projects that are environmentally sustainable, economically viable, and that benefit many San.

16. Exclusive (Corporate-State) Model: Disempowering, unequal but potentially very lucrative. Good environmental controls. Strong R&D benefits. Genetic resource approach. National focus. Free-rider (Corporate) Model: Free-riding, ecologically problematic, no benefits to San. Interventionist (Corporate-State-NGO) Model: Greater outreach but less lucrative. Good environmental controls. NGO intervention and state regulation. Low R&D benefits. Commodity approach. Regional collaboration.

17. Corporate-State (Exclusive) Model

18. Free-Rider (Corporate) Model

19. Interventionist (Corporate-State-NGO) Model

20. Hoodia production cycle

21. South(ern?) African Hoodia Growers MOU: San, SA Hoodia growers, Cape Nature, DETEC (Northern Cape) … others?? MOU: San, SA Hoodia growers, Cape Nature, DETEC (Northern Cape) … others?? Recognises San IP Recognises San IP Objective to share benefits with San, ensure traceability, quality and safety in Hoodia industy and effective conservation of the species Objective to share benefits with San, ensure traceability, quality and safety in Hoodia industy and effective conservation of the species Pre-empting requirements of Biodiversity Act and ABS regs in SA Pre-empting requirements of Biodiversity Act and ABS regs in SA Ongoing negotiations, draft agreement intended to be finalised early next year Ongoing negotiations, draft agreement intended to be finalised early next year Critical that region collaborates … how …a single seal for all Hoodia products … link to CITES Critical that region collaborates … how …a single seal for all Hoodia products … link to CITES

22. Recent policy developments in South Africa Biodiversity Act (2004) and development of ABS regulations (current) Biodiversity Act (2004) and development of ABS regulations (current) IKS policy (2005) IKS policy (2005) Patent Amendment Act requiring disclosure of origin (2006) Patent Amendment Act requiring disclosure of origin (2006) Medicines Control Act; Traditional Medical Practitioners Act Medicines Control Act; Traditional Medical Practitioners Act

23. ABS in the Biodiversity Act (i) Conservation, (ii) sustainable use and (iii) fair and equitable sharing of benefits arising from bioprospecting using indigenous biological resources (i) Conservation, (ii) sustainable use and (iii) fair and equitable sharing of benefits arising from bioprospecting using indigenous biological resources Excludes human genetic material, exotic species, ITPGRFA species. Definition has very wide scope. Excludes human genetic material, exotic species, ITPGRFA species. Definition has very wide scope. Distinguishes between procedures (i) to obtain indigenous biological resources and those (ii) to obtain knowledge Distinguishes between procedures (i) to obtain indigenous biological resources and those (ii) to obtain knowledge

24. ABS in the Biodiversity Act For resources a MTA is required as well as a BSA before a permit is issued For resources a MTA is required as well as a BSA before a permit is issued For knowledge holders a BSA is required For knowledge holders a BSA is required Negotiations must be on an equal footing Negotiations must be on an equal footing All information must be disclosed before permit issued All information must be disclosed before permit issued Establishes Trust Fund Establishes Trust Fund New ABS regulations due to be gazetted this year will give effect to these provisions New ABS regulations due to be gazetted this year will give effect to these provisions

25. 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 communitys 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.

26. Priority steps … Curbing illegal exploitation (overexploitation – trade without benefit sharing) – prohibit all wild harvesting??? Curbing illegal exploitation (overexploitation – trade without benefit sharing) – prohibit all wild harvesting??? Ensuring industry collaboration on the Hoodia trade – local industry plus support from buying countries Ensuring industry collaboration on the Hoodia trade – local industry plus support from buying countries State + industry + CBO partnerships critical ingredients for success State + industry + CBO partnerships critical ingredients for success Building San institutions and capacity Building San institutions and capacity Implementing ABS regulations Implementing ABS regulations