Hoodia Case Study

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Hoodia Case Study

• Rachel Wynberg
• Environmental Evaluation Unit,
• University of Cape Town

Photo Rachel Wynberg
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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
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The Negotiating Process
Photo Rachel Wynberg
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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

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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 isnt, 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

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Photo Rachel Wynberg
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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.US80,000
  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

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Photo Rachel Wynberg
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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

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Photo Rachel Wynberg
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Photo Rachel Wynberg
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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.

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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.

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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.
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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 Devils 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.

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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