Policy and Policy and Commercialisation Commercialisation Frameworks for Frameworks for

Benefit Sharing, Trade and Benefit Sharing, Trade and Use of HoodiaUse of Hoodia

Rachel WynbergRachel WynbergEnvironmental Evaluation Environmental Evaluation

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

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

The Negotiating Process

Historical South African Historical South African Policy context Policy context

No focused policy or No focused policy or legislation on IKS and legislation on IKS and PIC at the time of CSIR-PIC at the time of CSIR-San agreementSan agreement

No requirement for No requirement for benefit-sharing benefit-sharing agreements to be agreements to be developed with developed with knowledge holdersknowledge holders

No requirement for PICNo requirement for PIC

The role of IPRs in promoting The role of IPRs in promoting benefit-sharingbenefit-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

The benefit-sharing The benefit-sharing agreement: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

The benefit-sharing The benefit-sharing agreement: agreement:

was it fair and equitable?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 CSIR’s share: Phytopharm and other’s 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’

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).

San-Hoodia Benefit-Sharing San-Hoodia Benefit-Sharing Trust Trust

Established to receive income from CSIR Established to receive income from CSIR To uplift standard of living and well being of San To uplift standard of living and well being of San

of southern Africaof southern Africa To identify San beneficiaries To identify San beneficiaries To ensure benefits are shared fairly, To ensure benefits are shared fairly,

transparently and with ‘highest degree of transparently and with ‘highest degree of diligence’ diligence’

Creates a Fund Creates a Fund Creates a Board of Trustees: CSIR, 3 reps Creates a Board of Trustees: CSIR, 3 reps

appointed by SA San Council (=Khomani, !Xun, appointed by SA San Council (=Khomani, !Xun, Khwe), three reps for the region appointed by Khwe), three reps for the region appointed by WIMSA, WIMSA, professional appointed by SA WIMSA, WIMSA, professional appointed by SA San Council, DSTSan Council, DST

No remuneration to TrusteesNo remuneration to Trustees

San-Hoodia Benefit-Sharing San-Hoodia Benefit-Sharing Trust Trust

All funds distribution based on detailed All funds distribution based on detailed requestrequest

No distribution to individualsNo distribution to individuals R560,000 received to date – R200,000 to R560,000 received to date – R200,000 to

SA San Council, Namibia and Botswana SA San Council, Namibia and Botswana still to receive their share but can only still to receive their share but can only be done following establishment of their be done following establishment of their CouncilsCouncils

San-!Khoba DeclarationSan-!Khoba DeclarationSeptember, 2006. 50 San reps from SA, Namibia and September, 2006. 50 San reps from SA, Namibia and

Botswana reached consensus that:Botswana reached consensus that:

All San structures should include and respect San All San structures should include and respect San traditional values of fair sharing, consensus decision-traditional values of fair sharing, consensus decision-making, and respect for culture.making, and respect for culture.

A clear majority of funds received should reach and A clear majority of funds received should reach and benefit San communities.benefit San communities.

Administrative costs should be kept to a bare minimum Administrative costs should be kept to a bare minimum (20:80 for R1 million).(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 Priorities are and will be different in Botswana, Namibia

and South Africa and consultation needed to establish and South Africa and consultation needed to establish priorities. priorities.

Priority to projects that are environmentally sustainable, Priority to projects that are environmentally sustainable, economically viable, and that benefit many San. economically viable, and that benefit many San.

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.

Corporate-State (Exclusive) Model

Free-Rider (Corporate) Model

Interventionist (Corporate-State-NGO) Model

Hoodia production cycle

South(ern?) African Hoodia South(ern?) African Hoodia Growers Growers

MOU: San, SA Hoodia growers, Cape Nature, MOU: San, SA Hoodia growers, Cape Nature, DETEC (Northern Cape) … others??DETEC (Northern Cape) … others??

Recognises San IP Recognises San IP Objective to share benefits with San, ensure Objective to share benefits with San, ensure

traceability, quality and safety in Hoodia traceability, quality and safety in Hoodia industy and effective conservation of the industy and effective conservation of the speciesspecies

Pre-empting requirements of Biodiversity Act Pre-empting requirements of Biodiversity Act and ABS regs in SAand ABS regs in SA

Ongoing negotiations, draft agreement Ongoing negotiations, draft agreement intended to be finalised early next yearintended to be finalised early next year

Critical that region collaborates … how …a Critical that region collaborates … how …a single seal for all Hoodia products … link to single seal for all Hoodia products … link to CITES CITES

Recent policy Recent policy developments in South developments in South

AfricaAfrica Biodiversity Act (2004) Biodiversity Act (2004)

and development of ABS and development of ABS regulations (current) regulations (current)

IKS policy (2005)IKS policy (2005) Patent Amendment Act Patent Amendment Act

requiring disclosure of requiring disclosure of origin (2006)origin (2006)

Medicines Control Act; Medicines Control Act; Traditional Medical Traditional Medical Practitioners ActPractitioners Act

ABS in the Biodiversity ABS in the Biodiversity Act Act

(i) Conservation, (ii) sustainable (i) Conservation, (ii) sustainable use and (iii) fair and equitable use and (iii) fair and equitable sharing of benefits arising from sharing of benefits arising from bioprospecting using bioprospecting using indigenous biological resources indigenous biological resources

Excludes human genetic Excludes human genetic material, exotic species, material, exotic species, ITPGRFA species. Definition has ITPGRFA species. Definition has very wide scope.very wide scope.

Distinguishes between Distinguishes between procedures (i) to obtain procedures (i) to obtain indigenous biological resources indigenous biological resources and those (ii) to obtain and those (ii) to obtain knowledgeknowledge

ABS in the Biodiversity ABS in the Biodiversity Act Act

For resources a MTA is For resources a MTA is required as well as a BSA required as well as a BSA before a permit is issuedbefore a permit is issued

For knowledge holders a BSA For knowledge holders a BSA is requiredis required

Negotiations must be on an Negotiations must be on an ‘equal footing’‘equal footing’

All information must be All information must be disclosed before permit issued disclosed before permit issued

Establishes Trust FundEstablishes Trust Fund New ABS regulations due to New ABS regulations due to

be gazetted this year will give be gazetted this year will give effect to these provisionseffect to these provisions

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.

Priority steps …Priority steps … Curbing illegal exploitation Curbing illegal exploitation

(overexploitation – trade without (overexploitation – trade without benefit sharing) – prohibit all wild benefit sharing) – prohibit all wild harvesting???harvesting???

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

State + industry + CBO partnerships State + industry + CBO partnerships critical ingredients for successcritical ingredients for success

Building San institutions and capacityBuilding San institutions and capacity Implementing ABS regulationsImplementing ABS regulations