Hoodia Case StudyHoodia Case Study

Rachel WynbergRachel WynbergEnvironmental Evaluation Environmental Evaluation

Unit, Unit, University of Cape Town University of Cape Town

Photo: Rachel Wynberg

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

The Negotiating Process

Photo: Rachel Wynberg

Two forms of commercial development:

1. 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

Two forms of commercial development:

1. 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

Photo: Rachel Wynberg

Also two forms of benefit-sharing Also two forms of benefit-sharing agreement: agreement: 1. CSIR-San1. 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

Photo: Rachel Wynberg

2. Southern African Hoodia Growers 2. Southern African Hoodia Growers Association (SAHGA) – WIMSA (San)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

Legal Context Legal Context Biodiversity Act (2004) but needs regulations to be Biodiversity Act (2004) but needs regulations to be

effectedeffected IKS policy (2005)IKS policy (2005) Patent Amendment Act requiring disclosure of origin Patent Amendment Act requiring disclosure of origin

(2006)(2006) Draft ABS regulations Draft ABS regulations gazetted for comment 16 gazetted for comment 16

March 07. Three types of permits: research involving March 07. Three types of permits: research involving IK (province), bioprospecting (DEAT), export IK (province), bioprospecting (DEAT), export (provinces, DEAT)(provinces, DEAT)

Threatened and protected species regulations Threatened and protected species regulations will will come into effect 1 June 07: Hoodia listed as a come into effect 1 June 07: Hoodia listed as a protected species and will come under national protected species and will come under national control. Is also control. Is also CITES CITES Appendix II. Three permits Appendix II. Three permits required to grow Hoodia: registration, nursery, trader.required to grow Hoodia: registration, nursery, trader.

ABS Regulations 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.

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.

Key IssuesKey Issues Regional collaboration and benefit sharing Regional collaboration and benefit sharing

(SA is currently primary beneficiary and (SA is currently primary beneficiary and Namibia is developing alternative strategies Namibia is developing alternative strategies – different capacities and interests; CITES – different capacities and interests; CITES requires coherent approach; illegal trade requires coherent approach; illegal trade through SA; Devil’s Claw Regional Working through SA; Devil’s Claw Regional Working Group expanded to include Hoodia)Group expanded to include Hoodia)

Other knowledge holders?Other knowledge holders? Streamlining permitting systems: CITES, Streamlining permitting systems: CITES,

ABS, province-province …ABS, province-province … Distinguishing between quality / traceability Distinguishing between quality / traceability

issues and those of labelling for fair trade issues and those of labelling for fair trade and benefit sharing. Safety and efficacy are and benefit sharing. Safety and efficacy are central. Traceability critical when products central. Traceability critical when products change form.change form.

Key IssuesKey Issues Can biotrade and GR trade be Can biotrade and GR trade be

differentiated? Case demonstrates grey differentiated? Case demonstrates grey area. Unregulated biotrade may however area. Unregulated biotrade may however jeopardise Unilever initiative.jeopardise Unilever initiative.

What happens when resource is not what What happens when resource is not what is claimed? (50 Hoodia products tested in is claimed? (50 Hoodia products tested in States – none with Hoodia. Most traders States – none with Hoodia. Most traders dealing with many species).dealing with many species).

Growing concern of Hoodia outside region: Growing concern of Hoodia outside region: was material legally acquired? was material legally acquired?

Ensuring industry collaboration on the Ensuring industry collaboration on the Hoodia trade – local industry plus support Hoodia trade – local industry plus support from buying countriesfrom buying countries