Policy and Commercialisation Frameworks for Benefit Sharing, Trade and Use of Hoodia

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Policy and Commercialisation Frameworks for
Benefit Sharing, Trade and Use of Hoodia

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

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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
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The Negotiating Process
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Historical South African Policy context

• 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 PIC

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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

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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

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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

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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).
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San-Hoodia Benefit-Sharing Trust

• Established to receive income from CSIR
• To uplift standard of living and well being of
  San of southern Africa
• To identify San beneficiaries
• To ensure benefits are shared fairly,
  transparently and with highest degree of
  diligence
• 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
• No remuneration to Trustees

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San-Hoodia Benefit-Sharing Trust

• All funds distribution based on detailed request
• 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

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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.
• A clear majority of funds received should reach
  and benefit San communities.
• Administrative costs should be kept to a bare
  minimum (2080 for R1 million).
• 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.
• Priority to projects that are environmentally
  sustainable, economically viable, and that
  benefit many San.

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• Exclusive (Corporate-State) Model Disempowering,
  unequal but potentially very lucrative. Good
  environmental controls. Strong RD 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 RD benefits. Commodity
  approach. Regional collaboration.

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Corporate-State (Exclusive) Model
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Free-Rider (Corporate) Model
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Interventionist (Corporate-State-NGO) Model
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Hoodia production cycle
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South(ern?) African Hoodia Growers

• MOU San, SA Hoodia growers, Cape Nature, DETEC
  (Northern Cape) others??
• Recognises San IP
• 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
• 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

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Recent policy developments in South Africa

• Biodiversity Act (2004) and development of ABS
  regulations (current)
• IKS policy (2005)
• Patent Amendment Act requiring disclosure of
  origin (2006)
• Medicines Control Act Traditional Medical
  Practitioners Act

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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
• 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

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ABS in the Biodiversity Act

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

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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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Priority steps

• 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
• State industry CBO partnerships critical
  ingredients for success
• Building San institutions and capacity
• Implementing ABS regulations