Presentation on theme: "Rachel Wynberg Environmental Evaluation Unit, University of Cape Town"— Presentation transcript:
1Rachel Wynberg Environmental Evaluation Unit, University of Cape Town Hoodia Case StudyRachel WynbergEnvironmental Evaluation Unit,University of Cape TownPhoto: Rachel Wynberg
2OverviewAppetite suppressant based on TK of indigenous peoples of southern AfricaActive constituents patented by CSIRPatents and commercial development without knowledge or PIC of SanAgreement between CSIR-SanThe case concerns the development of an appetite suppressant drug – codenamed P57 – derived from species of Hoodia, which is a succulent plant indigenous to the arid parts of southern Africa and long used by indigenous peoples of the region, and in particular the San – one of the most marginalised groups in the region - to stave off hunger and thirst, and for a variety of medicinal purposes. Vetman Piet from the Khomani San is shown here, eating the plant in the Kalahari.Active constituents of the plant responsible for suppressing appetite have been patented by the CSIR, which is a South African state-based research organisation, one of the largest in Africa, who intend to commercialise the plant into a blockbuster drug in collaboration with Phytopharm and other international partners for the billion dollar anti-obesity market.The case has captured public attention because until recently, the San remained oblivious to the fact that their knowledge of Hoodia was commercially interesting, and that this knowledge had led to the filing of patents. They were also excluded from lucrative deals to develop the drug.The late Vetman Piet eating Hoodia in the Kalahari. Photo: Rachel Wynberg
3But in 2003, following the publicition of this article in the British Observer, the situation changed dramatically and an agreement was reached between the CSIR and the San to give the San a share of royalties from potential drug sales.
4The Negotiating Process This shows one of the workshops held between the CSIR and the San, to begin discussions about the detail of the benefit-sharing agreement.Photo: Rachel Wynberg
5Two 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
6Two 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 – T 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
7Ironically, because of media attention, there has been a surge of interest in use of Hoodia and widescale plundering of the resource from its natural habitat to package and sell as a weight loss remedy. Hoodia can now be purchased in virtually any pharmacy or natural products store – in SA, Europe or the US – and on dozens of Internet sites - as a herbal product – and is marketed blatantly using knowledge of the San to demonstrate efficacy and safety. The San in SA have their hands tied in becoming partners to such initiatives and earning real income as opposed to projected income that may or may not be realised, depending on the whims of pharmaceutical giants.
9Also 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 incomeMonies 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 HoodiaSo what were the details of the benefit-sharing agreement and was it really equitable and fair? Parties to the agreement were the SA San Council and the CSIR, and In terms of the agreement …San are to receive 6% of all royalties received by CSIR and 8% of milestone incomePayable 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’ proceduresIPR remains exclusively with CSIR. San has no right to claim co-ownership.San prohibited from entering agreement with any third party to commercialise Hoodia
112. 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 authoritiesActing in anticipation of the coming into effect of Ch 6 of the Biodiversity Act through promulgation of ABS regulationsDeveloping a label for traceability. Want to promote recognition of its legitimacy. For food market and dietary supplements.San levy of R24/ dry kgSo what were the details of the benefit-sharing agreement and was it really equitable and fair? Parties to the agreement were the SA San Council and the CSIR, and In terms of the agreement …San are to receive 6% of all royalties received by CSIR and 8% of milestone incomePayable 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’ proceduresIPR remains exclusively with CSIR. San has no right to claim co-ownership.San prohibited from entering agreement with any third party to commercialise Hoodia
15Legal ContextBiodiversity Act (2004) but needs regulations to be effectedIKS 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.In South Africa, we have made significant headway on these issues on the legislative front, and now have a focused section on ABS in the Biodiversity Act, a policy on the protection of TK (but no law yet), and also draft amendments to the Patents Act that empower the registrar to refuse a patent if there is not adequate disclosure about the use of genetic resources and TK.
16ABS 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;- exportThree types of permits:- research permits, where TK is used (require BSA);bioprospecting permits (require MTA and BSA)export permits.In South Africa we stand proud as the 3rd most biol div country in the world, containing between 250,000 and 1 million species, many of which occur nowhere else.10% of world’s plants, 7% of world’s reptiles, birds, and mammals occur here15% of known coastal and marine species3 globally recognised biodiversity ‘hotspots’ – which are regions that are important reservoirs of unique biodiversity that are also highly threatened by destruction - Cape Floristic Region; Succulent Karoo; Maputaland-PondolandNot only is the country species rich but it also include the most spectacular array of ecosystems and landscapes, ranging from desert to subtropical forest, from kelp beds to coral reefs.These resources underpin the livelihoods of millions of South Africans and contribute significantly to the country’s economy. Fisheries; agriculture, tourism and mining; for example, are but a few of the industries that directly rely on natural resources and biodiversity and combined generate billions of Rands per year and create millions of jobs.Yet SA’s biodiversity is also one of the most threatened on the planet.
17The distribution of Hoodia spp 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); and R. Chennells, SASI, pers. comm.
18Key IssuesRegional 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; Devil’s 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.
19Key IssuesCan 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