Rhetoric, Realism and Benefit Sharing: Use of Traditional Knowledge of Hoodia Species in the Development of an Appetite Suppressant
By Rachel Wynberg
Published in The Journal of World Intellectual Property
November, 2004, Vol 7, no. 6, pages 851-876.
Citation: Wynberg, R. 2004. Rhetoric, Realism and Benefit Sharing: Use of Traditional Knowledge of Hoodia Species in the Development of an Appetite Suppressant. Journal of World Intellectual Property, 7(6): 851-876.
One of the first agreements ever to give holders of traditional knowledge a share of royalties from drug and product sales was recently concluded between the CSIR, a South African state research institute and the San, indigenous peoples of southern Africa. The case concerns the development of an appetite suppressant derived from species of Hoodia, succulent plants indigenous to southern Africa and long used by the San, indigenous peoples of the region, to stave off hunger and thirst. Use of active constituents of the plant responsible for suppressing appetite has been patented by the CSIR, which represents one of the largest research organizations in Africa, accounting for about 10% of the entire African research and development budget. The appetite suppressant is likely to be commercialised into a food supplement and/or prescription medicine, with considerable financial potential. The current market potential for the dietary control of obesity is over $3 billion per annum in the United States alone. Up until 2001, the San remained oblivious to the fact that their knowledge of Hoodia had commercial application, and that this knowledge had led to research, scientific validation, and the filing of international patents by the CSIR. They were, moreover, excluded from lucrative deals being struck to develop the drug. In 2003, however, following intense negotiations, an agreement was reached between the CSIR and the San, to give the San a share of royalties from potential drug sales.
Issues raised by the Agreement on Trade-Related Intellectual Property Rights (TRIPS) of the World Trade Organisation (WTO) and the Convention on Biological Diversity (CBD) are central to the case. Under TRIPS, a global regime has been created for intellectual property rights (IPRs) over biological resources. This has significant implications for member states, which are now obliged to implement minimum IPR standards, and to allow patents and other forms of IPRs to enter the realm of agriculture, food production and healthcare. The interface between IPRs and biological resources is also addressed by the CBD, which recognises the sovereign right of countries over their biological resources and their right to determine access to these resources. The CBD notes that access to genetic resources should be on the basis of prior informed consent from providers of resources and knowledge, and on mutually agreed terms that provide fair and equitable sharing of the results of research and development and the benefits of commercialisation and use. It also calls for the fair and equitable sharing of benefits derived from the use of traditional knowledge.
These principles are encapsulated in the Bonn Guidelines on Access to Genetic Resources, adopted by parties to the CBD, and are likely to form the basis of the international ‘access and benefit-sharing’ (ABS) regime to be negotiated under the auspices of the CBD as mandated by the World Summit on Sustainable Development (WSSD). In contrast, TRIPS contains no provisions requiring prior informed consent and benefit-sharing. <
Intellectual property rights are often considered incompatible with traditional knowledge systems because they are privately held and monopolistic by nature, and are based on ‘innovations’ or ‘discoveries’, while traditional knowledge is typically collective and based on prior use. Intellectual property rights have also often worked against effective and equitable benefit-sharing with local communities for their traditional knowledge, and have provided poor protection of community resource rights. For example, the U.S. Patent and Trademark Office granted a patent to a U.S. researcher on the South American vine ayahuasca, Banisteriopsis caapi, which is used widely in traditional religious and healing ceremonies in South America. The Co-ordinating Body of Indigenous Organizations of the Amazon Basin (COICA) and the Centre for International Environmental Law (CIEL) have worked for many years to annul the patent. Patents have also been granted, and successfully challenged for their lack of novelty, based on traditional knowledge of Azadirachta indica, the neem tree. Patents can also impact negatively on communities that traditionally use certain species and varieties. For example, the granting of a patent by the U.S. Patent and Trademark Office to Colorado University based on the food crop quinoa, lapsed after it was revealed that the Bolivian origins of the biological material were not disclosed and enabled the scope of the patent to be so broad as potentially to intrude on the exportation to the United States of traditional quinoa varieties and quinoa products exported from Bolivia and its neighbouring countries. Numerous other examples exist of the illegitimate use of traditional knowledge in the granting of patents, without the consent of holders of such knowledge, or their involvement in any benefits derived from the patent.
The Hoodia case described in this paper tells a similar story but is unique in that the holders of the patent (the CSIR) and holders of traditional knowledge (the San) have reached a mutually acceptable agreement to share benefits. On face value, the case presents a good argument both for the utility of patents in benefiting holders of traditional knowledge, and for the potential benefits that holders of traditional knowledge can glean from bioprospecting. But what does this development really mean for the San and holders of traditional knowledge worldwide: business as usual with a politically correct face, or a fundamentally new way of introducing equity into the marketplace? Through the lens of the Hoodia case three distinct but related questions are asked in an attempt to enhance understanding of these intractable issues.
First, what can we learn from the negotiating process to develop a benefit-sharing agreement that can usefully be applied in similar situations? Second, is the benefit-sharing agreement one that secures fair and equitable benefits for holders of traditional knowledge, and for countries of origin, and if not, which aspects require further attention? Third, the role played by IPRs as a tool to promote benefit-sharing is explored, and both the legitimacy of the patent and alternative options for protecting indigenous knowledge, including co-ownership of the patent, sui generis systems of protection, and compulsory disclosure of the source of genetic resources and traditional knowledge in patent applications are discussed. These questions are explored sequentially below, after providing an overview of the ecology and use of Hoodia species (Section II), and a history of commercial development (Section III). In Section IV, I analyse the process by which the CSIR and the San negotiated a benefit-sharing agreement, and describe the content of the agreement. In Section V, I provide a critical review of the benefit-sharing agreement developed between the CSIR and the San, and in Section VI I analyse intellectual property considerations arising from the case. The final section of the paper draws these issues together with some concluding remarks.
II. The Ecology and Use of Hoodia spp.
Species of the genera Hoodia and Trichocaulon have long been used as thirst quenchers and appetite suppressants. Both genera are succulent perennials, and members of the Apocynaceae family, adept at storing moisture during long dry spells in their native habitats. More than twenty species have been recorded from southern Africa, although the species of most interest for their appetite suppressing properties are Hoodia gordonii, Hoodia currorii, Hoodia flava, Hoodia lugardii (now Hoodia currori subsp. lugardi), Trichocaulon piliferum (now Hoodia piliferum), and Trichocaulon officinale (now Hoodia officinale). Vernacular names for the plants include ghaap, and !khobab, |goa.-|, |khowa.b, |goai-|, |khoba, |khoba.b|s, |khowab, |goab, otjinove, !nawa#kharab, sekopane, seboka, , , ,, .
Increasing interest in the commercial application of Hoodia species, and concomitant concerns about the threats posed to plant populations through unregulated collection, have led to the (del recent) tabling – and recent adoption, in October 2004 - of a proposal to the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) to include Hoodia species in Appendix II of CITES. The proposal from range states is to establish Aa standardised international trading framework and monitoring regime for Hoodia will now be established, to ensureing that range states are able to properly regulate that trade in the species is properly regulated, and that states within the plants’ range whilst capture ing the economic benefits that accrue from its commercialisation.
The first recorded use of Hoodia was in all likelihood by the botanist Francis Masson (1741-1805), who visited the Cape in South Africa (1772-1774 & 1786-1795), recorded finding ‘Stapelia gordoni’ and wrote that the stems of Trichocaulon piliferum were eaten by the ‘Hottentots’. It was this knowledge, recorded in the literature and combined with field studies, that provided the motivation for the CSIR to include Trichocaulon spp. in a research programme aimed at determining the nutritional and possible toxic properties of ‘foods from the veld’.
Who are ‘the Hottentots’ and what claim do they presently have to knowledge about properties of the plant? Strictly speaking, the ‘Hottentots’, or Khoe peoples, were herders who arose from the San, but this distinction is not recognised in the colonial botanical accounts, which cluster all groups as ‘Hottentots’, including the San. We do however know that the San are the oldest human inhabitants in southern Africa, who lived in small nomadic groups as hunters and gatherers for thousands of years and were the sole occupants of the region. Use of Hoodia by these groups was likely for millennia, although the ways in which the plant was used are open to interpretation. A popular but perhaps simplistic version alludes to the San’s use of the plant for hunting purposes to give ‘strength’, and anecdotal accounts even suggest that hunters may have been given Hoodia to prevent their eating of the kill. But San informants suggest that this would have been insulting to the hunter, whose skills and integrity would have negated the need for any external appetite suppressants. What is undisputed, however, is use by the San of Hoodia and related species as a food and, especially, as a drink substitute and appetite suppressant, as well as for a variety of other purposes.
Some of these uses can undoubtedly be attributed exclusively and originally to the San, but the wide distribution of certain Hoodia species suggests extensive use by a range of peoples in the region, including the Nama, Damara, and Topnaar, both as a medicinal remedy and as a food and water substitute. These Khoi-speaking peoples emerged in Southern Africa many millennia after the San, occupying similar geographical regions and no doubt acquiring San knowledge of plants and their uses and evolving others,,.
Contemporary San, of course, are quite different to the rather romantic picture painted by the media, which depicts the San persisting as hunters and gatherers, living in harmony with nature in and around the Kalahari Desert and subsisting on wild food. While in the past, groups moved about the landscape, aggregating and dispersing according to season and resource-availability, today the reality is very different and many, if not most, San live in small settlements in the more remote regions of southern Africa, earning their living through a combination of agriculture, livestock raising, small-scale industries, veld (or non-timber forest) product harvesting, and wage labour. A long history of dispossession and relocation has accompanied the San, commencing with their persecution and displacement upon colonisation of the region in 1652, their discrimination along with other people of colour during South Africa’s apartheid regime, their invidious use by the South African Defence Force in Namibia and Angola for counter-insurgency operations, and continuing today through evictions and continued political marginalization,. .Many San live below the poverty datum line and face extreme hardship in terms of access to social services, employment, and income-generating opportunities. Presently, the San number between 85,000 and 90,000 in southern Africa, the overwhelming majority of whom live in the Kalahari Desert and its surrounding regions in Namibia, Botswana, and to a lesser extent, in South Africa.
III. The Commercial Development of Hoodia Spp.
The documented use of Hoodia as a food and water substitute in colonial botanical accounts is significant because it led directly to the CSIR including the plant for further investigation in a 1963 project on edible wild plants of the region, which aimed to inform the South African Defence Force about the toxic and nutritional properties of wild foods, and so ascertain their suitability for the army. Existing literature, combined with laboratory tests on mice which were fed Hoodia, led scientists to identify the potential of Hoodia as a non-toxic appetite suppressant, although insufficient evidence existed to file for a patent. The lack of technology to isolate and identify active ingredients halted progress of the research, which commenced again in the early 1980s.
In 1986, acquisition by the CSIR of high-field nuclear magnetic resonance spectroscopy made it possible to elucidate relevant molecular structures of Hoodia, and in 1995, following nine years of confidential development, a patent application was filed in South Africa by the CSIR for use of active components of the plant responsible for suppressing appetite. In 1998 the CSIR signed a licensing agreement with Phytopharm, a small British company, specialising in the development of phytomedicines, and this was followed in the same year by the granting of international patents in some countries. The agreement granted Phytopharm an exclusive world-wide license to manufacture and market Hoodia-related products and to exploit any other part of CSIR’s IPRs relating to Hoodia. Through a programme dubbed ‘P57’, Phytopharm progressed this drug lead to a more advanced stage, leading to a License and Royalty agreement in 1998 with Pfizer, the U.S.-based pharmaceutical giant, for further development and commercialisation.
In December 2001, Phase IIa / third stage ‘proof of principle’ clinical trials were reported to be successfully completed, and in July 2002, Phytopharm announced a future development programme for P57, whereby Pfizer would take responsibility for development of the programme. During July 2003, Pfizer merged with Pharmacia and closed its Natureceuticals group, responsible for the development of P57. The company announced it was to discontinue clinical development of the drug and was returning the licensing rights to Phytopharm, leaving Phytopharm free to license P57 to other parties. Some critics saw this as the death knell for the development of Hoodia as a block-buster drug, but Phytopharm and the CSIR remained confident of the possibility of finding other partners to take forward the project. Currently, Phytopharm is seeking partners to manufacture P57 as a food supplement and recent developments include its raising of £6.5 million through a new share placement in preparation for the future licensing of Hoodia formulations to manufacturers of meal replacements. However, the possibility of another partner taking P57 along a pharmaceutical route still remains. Table I sets out the chronology of the development of Hoodia.
Table I. Chronology of the commercial development of Hoodia
IV. Negotiating a Benefit-Sharing Agreement
A. Initiating talks
What did these developments mean for the San, the original holders of knowledge about the properties of Hoodia? Up until 2001, agreements for the further development and commercialisation of the Hoodia drug lead had proceeded apace without acknowledgement of the contribution of the San, let alone their prior informed consent. Indeed, a newspaper report quotes the CSIR having told their international collaborators that the 90,000-strong San ‘no longer existed’. In a defence of its position, the CSIR linked its initial reluctance to engage with the San to a concern that ‘expectations would be raised with promises that could not be met’, and insisted that the organisational policy on bioprospecting was to eventually share benefits of research based on indigenous knowledge. But clearly, the realities of implementing this policy were complex and difficult. How, it was argued by the CSIR and Phytopharm, could the real owners of traditional knowledge be identified, and what if one group had historically stolen the knowledge from another group? The potential complexities and scenarios seemed endless.
While such concerns were undoubtedly valid and are common in similar cases throughout the world, they were also obfuscatory and to some extent provided a useful defense for CSIR and Phytopharm. In point of fact, such sentiments were also in flagrant disregard of the ILO Convention 169 - an international agreement for the protection of indigenous peoples’ rights, the letter and spirit of the Convention on Biological Diversity, the African Union’s Model Law on Access and Benefit-Sharing, the Bonn Guidelines, as well as numerous indigenous peoples’ declarations and statements which explicitly refer to the importance of obtaining prior informed consent from holders of traditional knowledge before commercialisation of this knowledge; and ensuring that benefits derived from commercialisation are equitably shared with original holders of the knowledge.
In June 2001, the situation changed dramatically. Ongoing vigilance by a South African-based NGO, Biowatch South Africa, combined with assistance from the international NGO Action Aid, alerted the foreign media to the potentially exploitative nature of the agreement, and a leading story in a British newspaper The Observer was published about the case. This was not the first time that news about the patent was made public, but action on the case was catalysed by the international news coverage, heightened interest in linkages between patents, traditional knowledge and benefit-sharing, and associated pressures for a rapid response on the part of both the San and the CSIR. Ironically, the negligence of the CSIR to consult with the San in the early stages of the agreement considerably strengthened the bargaining arm and political leverage of the San, who in securing the moral high ground now had a high-profile case being followed keenly throughout the world. In contrasting images of emaciated San and obese Americans, and reinforcing popular notions of ‘biopiracy’ by large pharmaceutical companies, the media captured the public’s imagination, embarrassed the CSIR and Phytopharm, and this in turn led the CSIR to enter into high-level negotiations with the San.
On the part of the San, this was effected largely through three organisations:
– the Working Group of Indigenous Minorities in Southern Africa (WIMSA), established in 1996 at the request of San groups in the region to advocate and lobby for San rights;
– the South African San Council, a voluntary association established by the =Khomani, !Xun and Khwe communities of South Africa; and
– the Cape-Town based San Institute of South Africa (SASI), a non-governmental organisation facilitating access of San-based organisations to funding and expertise.
As a South African state institution, the CSIR was reluctant to negotiate with parties outside the country, and through WIMSA, the South African San Council was formally mandated to represent San groups in Namibia and Botswana as well as South Africa in all benefit-sharing negotiations about Hoodia. With this arrangement in place, recognition was given to the fact that knowledge about the plant crossed country borders, and that the details of sharing benefits between San in different countries needed further consideration. WIMSA and SASI instructed their lawyer to negotiate with the CSIR on behalf of the San, and discussions between the two parties began in earnest.
B. Reaching a Memorandum of Understanding
Three months later, in February 2002, a Memorandum of Understanding (MOU) was reached between the CSIR and the South African San Council. Key aspects of this agreement included recognition by the CSIR of the San as originators of the body of traditional knowledge associated with human uses of the Hoodia succulent; an acknowledgement by the San of the ‘context’ in which CSIR first registered the P57 patent, without having first engaged the San in negotiations; and a commitment, on the part of both the CSIR and the San, to a process of negotiating with one another in good faith, in order to arrive at a comprehensive benefit-sharing agreement.
An additional understanding considered the San and the CSIR to be the primary parties with regard to benefit-sharing. This latter point is especially significant because it effectively excluded other groups – genuine or opportunists – from claiming benefits through prior knowledge about Hoodia. While this helped to address earlier concerns expressed by CSIR and Phytopharm of the need to identify genuine holders of traditional knowledge about the plant, it also raised new concerns about excluding non-San groups, such as the Nama, Damara, and Topnaar, who had historically occupied and still occupy areas where Hoodia grows, and had undoubtedly used the plant as a medicinal remedy and as a food and water substitute. How were these groups to benefit from use of their knowledge?
C. Developing Positions and Identifying Key Issues of Concern
While the MOU represented an important first step, negotiation of a concrete benefit-sharing agreement was still some way off. At a series of CSIR-funded workshops and meetings, representatives of the San, CSIR, and in some cases certain government departments and NGOs, were brought together to further articulate concerns and positions. Key issues arising from these discussions focused on three main themes:
(1) building trust between parties;
(2) identifying genuine holders of traditional knowledge about Hoodia and potential beneficiaries; and
(3) ensuring the broader protection and promotion of San cultures and knowledge.
1. Building trust.
The development of trust between the CSIR and the San emerged initially as a major concern, more especially given the CSIR’s history as an institution shaped by the apartheid regime, and serving the interests of a repressive government for nearly forty years. While transformation of this state institution is now well underway, its initial inertia in drawing the San into the project created mistrust and negative impressions amongst the San. How could the San be assured that they would receive appropriate royalties and other benefits? And how could they trust that they would have access to all the necessary information?
2. Identifying beneficiaries.
An anxiety foremost in people’s minds was the potential conflict that could arise if financial benefits arose – both within the San, and between the San and other groups such as the Nama-Damara. Because both the plant and traditional knowledge about its use extend across Namibia, South Africa and Botswana, this matter was especially complex and fraught. How could a ‘post-modern’ system be created that ensured fairness and equity across the three countries, and within the relatively new organisational structures set up by different San groups in different countries? The restricted distribution of Hoodia species suggested that almost certainly, not all groups of the San had historically utilised the plant. But identifying those groups that did have a clear record of use was near impossible given the San’s history of resettlement and dislocation. Moreover, thousands of people in southern Africa claim San descent, and have a recent history of use of Hoodia.
Resolving these uncertainties presented difficult challenges but there was agreement amongst WIMSA-affiliate organisations that a nit-picking exercise to link benefit-sharing to specific communities using Hoodia was futile and potentially divisive. In addition, WIMSA had taken a decision, binding on all its members, to the effect that heritage is indivisible, and that benefits resulting from shared heritage, such as Hoodia, must thus be shared equally amongst all San peoples. Of course, if money actually materialises in the future new tensions and understandings may well be created.
3. Protecting San Culture and Knowledge.
More generally, the San wanted clarity about how they could effectively protect their cultural heritage, including unique rock art, as well as rich ethnobotanical and environmental knowledge. Increasingly, steps had been taken by San-affiliated organisations such as SASI and WIMSA to establish a code of conduct for research and researchers and to ensure the control and protection of all San intellectual property. There was growing sensitisation and awareness amongst the San about the appropriation of their knowledge, without acknowledgement, or compensation. How, it was asked, had the CSIR obtained local knowledge of Hoodia without the San knowing, and how could such knowledge be protected from future exploitation? Although legislation to protect and promote indigenous knowledge systems was under development in South Africa (and had been for at least five years), there had been no consultation with the San about its content and scope. The absence of legislation presented a major stumbling block. No legislation existed to protect holders of traditional and/or indigenous knowledge, and neither was there any legal requirement for benefit-sharing agreements to be developed with owners of knowledge and/or biological resources. A similar situation pertained in other countries of origin, such as Namibia and Botswana.
On the part of the CSIR and government, the absence of legislation created uncertainties as to who should be party to the benefit-sharing agreement, and exactly how traditional or indigenous knowledge should be obtained or used. The CSIR stepped gingerly, unsure (and undoubtedly reluctant) about ‘shedding their white coats’ and entering into protracted negotiations, but obliged politically to do so. Their intention was to ensure that the San leadership they engaged with was genuine and representative, and that their agreement with the San would not lead to a flurry of claims to the knowledge from third parties. In March 2003, less than two years after the first meeting between these groups, negotiations were concluded on the specifics of a mutually acceptable benefit-sharing agreement. Announcing the deal, the South African Minister of Arts, Culture, Science and Technology, referred to its enormous significance in “symbolising the restoration of the dignity of indigenous societies”, and in unleashing benefits by joining together owners of traditional knowledge and local scientists to add value to the biodiversity and indigenous knowledge systems of southern Africa. It was simply the “right thing” to do, he said.
D. The CSIR-San Benefit-Sharing Agreement
In terms of the agreement, the San would receive 6 percent of all royalties received by the CSIR from Phytopharm as a result of the successful exploitation of products, and this for the duration of the royalty period or for as long as the CSIR received financial benefits from commercial sales of the products. The San would also receive 8 percent of the milestone income received by the CSIR from Phytopharm when certain performance targets were reached over the product development period. In the event of successful commercialisation, these monies would be payable into a trust set up jointly by the CSIR and the South African San Council to uplift the standard of living and well-being of the San peoples of southern Africa. Clear and transparent accounting procedures would need to be in place on the part of both the CSIR and the San Trust with regard to financial benefits paid by the CSIR, and used by the San Trust.
The benefit-sharing agreement also committed the parties to conserve biodiversity and to undertake best-practice procedures for plant collection, required the CSIR to grant the San access to existing study bursaries, and, significantly, laid the ground for further collaboration in bioprospecting. This has recently taken fruit in the development of a joint bioprospecting project between the CSIR and the San.
In addition to spelling out the details with respect to benefit-sharing and administrative aspects such as accounting, the agreement also broadly covered intellectual property issues, and importantly, set out comprehensive measures to protect and indemnify the CSIR. Provision 4 of the Agreement specifies that any intellectual property arising from traditional indigenous knowledge of use of Hoodia and related to the CSIR patents for P57 remains vested exclusively with the CSIR. The San Council has no right to claim any co-ownership of the patents or products derived from the patents.
Provision 6, Warranties and Indemnity, includes an undertaking and warranty by the San that, inter alia, it is the legal custodian of traditional indigenous knowledge on the use of Hoodia; that it will not assist or enter into an agreement with any third party for the development, research and exploitation of any competing products or patents; and that it will not contest the enforceability or validity of the CSIR’s right, title and interest in the P57 patent and related products.
A further provision on third-party claims sets out various measures to protect the CSIR against claims by any third party for intellectual property infringement and stipulates that a successful third-party claim against the CSIR may lead to a review of the agreement to accommodate claimants in the sharing of financial benefits. It also requires the San Council to share financial benefits with a third party if they are successful in proving a claim.
In August 2004, the San Trust, formally named the San Hoodia Benefit Sharing Trust, was registered. The content of this agreement was discussed over several meetings, during which San delegates from South Africa, Namibia and Botswana debated issues relating to benefit-sharing, and agreed upon principles to guide the sharing of benefits. There was unanimous agreement that 75 percent of all Trust income would be equally distributed to the constituted San Councils of Namibia, Botswana and South Africa; that 10 percent would be retained by the Trust for internal and administration purposes; that 10 percent would be allocated to WIMSA as an emergency reserve fund; and that 5 percent would be allocated to WIMSA to cover administration of the San networks. Priorities within the region such as education, leadership empowerment, and land security were agreed upon as non-binding recommendations to the Councils. Principles for benefit-sharing that would bind the Trust were unanimously endorsed by the WIMSA Annual General Meeting in December 2003.
V. Rhetoric and Realism: An Analysis of the CSIR-San Benefit-Sharing Agreement
On the face of it, the agreement represents a historic breakthrough, and is one of the first of its kind ever to be negotiated in the world. However, it is clearly important to scrutinise the agreement beyond the veneer of political declarations and the rhetoric of the popular press. Two matters warrant further discussion. First, the extent to which this agreement can be considered to meet best practice and be fair and equitable; and second, the approach used through intellectual property protection, to secure benefits for the San. These are discussed in turn in this and the next section.
Closer examination of the benefit-sharing agreement reveals certain concerns that impede a wholehearted endorsement. Most notably, although the San could receive a considerable amount of money, this will be only a fraction of a percent – between 0.03 percent and 1.2 percent - of net sales of the product. Monies received by the San will be extracted from royalty and milestone payments obtained by the CSIR, whereas profits received by Phytopharm and its partners will, after deduction of the license royalties, remain unchanged. Moreover, the agreement explicitly protects Pfizer and Phytopharm from any further financial demands by the San.
Whether such benefits will be realised is of course a moot point, given Pfizer’s recent withdrawal as a partner in the development of the drug. Perhaps a more serious matter concerns the agreement’s overt prevention of the South African San from using their knowledge of Hoodia in any other commercial applications. What this means in practice is that the San are unable to independently pursue less lucrative but perhaps more viable commercialisation options based on non-patented herbal medicines (as opposed to patented pharmaceutical drugs or other products). They are also unable to claim any benefits from the dozens of new Hoodia-based products that have recently emerged in the market, which blatantly use San traditional knowledge of Hoodia in their promotion.
For example, a recent advertisement by the U.S.-based BioMed Pharmaceuticals promotes Trimphetamine as the “first commercially available product containing the revolutionary Hoodia gordonii cactus plant”, based on a standardized natural extract of the plant, and another U.S.-based company Hi-Tech Pharmaceuticals markets a similar Hoodia-based product, Lipodrene, citing use of Hoodia as an appetite suppressant by the San. A rather barefaced advertisement for Hoodoba “Hoodia gordonii diet pill” describes the “push by western drug companies” to “sideline the indigenous people and turn this remarkable plant into a synthetic prescription drug”, and then goes on to do the same, but through using the image and knowledge of the San to market the product as a natural extract. An internet advertisement for Aloe Hoodia describes how Pfizer has decided to invest “millions” to research the benefits of the plant as a new anti-obesity drug. An advertisement for Pure Hoodia refers to the success of clinical trials for Hoodia. These and related products raise important ethical issues, more especially in their neglect of the San and countries of origin as beneficiaries of commercialisation, and also in the extent to which they free-ride on the research done by CSIR and Phytopharm to demonstrate safety and efficacy. They point also to the need for range states to prevent the export of Hoodia species without suitable benefit-sharing arrangements in place, an approach now endorsed by CITES. While these concerns are addressed to some extent by the recent decision by Phytopharm to pursue P57 as a food supplement, there is surprisingly little in the benefit-sharing agreement requiring the CSIR / Phytopharm to prevent other products from emerging on the market which infringe the patent and thus potentially limit the benefits received by the San. Indeed, companies selling Hoodia openly recognise the difficulties the CSIR have in policing the patent, laying open the question as to the efficaciousness of the whether patent system is indeed efficacious. in situations such as these, where the large number of small operators make the costs of enforcement prohibitively high.
There are also other concerns. Chief amongst them is that the agreement is confined almost exclusively to monetary benefits, which hinge on product sales and successful commercialisation. Yet commercialisation is far from certain, highlighting the need for a more comprehensive and holistic approach to benefit-sharing that is not exclusively financial, is not contingent on successful drug development, and which provides immediate and tangible benefits to the San. The importance of non-monetary benefits has increasingly been recognised over the past decade, more especially in the likely absence of substantial financial rewards from bioprospecting. While the CSIR has received funds related to P57, there is no indication that this moneywill be used to assist the San with training in cultivation, harvesting of material for clinical trials, education, conservationor capacity-building. Although there is a nominal agreement to provide bursaries to assist with education, in practice, it has been acknowledged that in the haste to finalise the benefit-sharing agreement, the alternative benefits took a backseat to the negotiation of royalty shares. An additional interpretation is that the San considered non-monetary benefits foisted upon them by others to be patronising, and preferred to obtain the maximum amount of financial benefit so that they could decide upon and implement their own development priorities.
At the national level, the CSIR has purportedly benefited substantially from Hoodia. Through licensing the technology, the CSIR is likely to earn significant milestone payments, linked to success of the drug during different stages of the clinical trials. The specific royalty percentage has not been divulged publicly but is considered by the CSIR to “be substantial” compared to international norms. Typically, royalty percentages for pharmaceuticals range from 0.5 to 8 percent of total sales. Typically, royalty percentages for pharmaceuticals range from 0.5-8% of total sales. If successful, commercialisation of P57 is likely to amount to tens of millions of U.S. dollars per annum for the lifetime of the patent. In this regard, many consider South Africa to have reached an important turning point in bioprospecting. Patent rights to the active constituents of Hoodia responsible for suppressing appetite have been successfully retained by South Africa through the CSIR (although notably, other Hoodia-related patents remain foreign-owned) with foreign drug firms attaining licenses for the further development and commercialisation of the drug. Despite these benefits, some experts have argued that far more could have been done by the CSIR at a national level in assuming some of the roles of Phytopharm and Pfizer in drug development, and thus realising a greater share of national benefits.
Projected benefits to Phytopharm and other possible partners are difficult to determine due to reluctance from these parties to divulge financial details of the agreement, the variable costs of research and development (estimated to be in the range of US$400 million to US$800 million), and the unpredictability of success, and indeed commercialisation. However, press statements issued before the withdrawal of Pfizer indicate that from the pharmaceutical drug alone, Phytopharm will receive up to US$32 million in milestone payments from Pfizer (or other pharmaceutical companies), royalties on sales of P57, and an additional US$2.8 million.
In terms of non-monetary benefits, some of the more significant benefits to emanate from the agreement have been the construction of a U.S. Food and Drug Administration (FDA) approvable medicinal plant extraction facility at the CSIR for the manufacture of material for use in clinical trials on P57, as well as the establishment of a Botanical Supplies Unit – both the first of their kind in the world. South Africa is also considered a preferential site for cultivation and the production of material, although through the licensing agreement with CSIR, Phytopharm does have the right, presuming permission is granted for the export of Hoodia genetic material, to establish plantations outside of South Africa. Phytopharm have recently reported initiating a “substantial increase in its agronomy programme” for cultivating the raw material, following the successful raising of funds through the issuing of new shares, enabling the company to produce an estimated 200 million product units in 2007. Further cultivation represents an obvious development opportunity for the San and other marginalized communities, although the technical challenges of growing the plant are reportedly considerable, and many question the imposition of cultivation projects upon the San, who are not agriculturalists by nature. The scarce availability of water also constrains cultivation in the parched areas of the Kalahari where many of the San reside. A number of options are however currently being investigated by the CSIR to enable the San to engage in agroprocessing through development of a range of natural products and essential oils, some related to Hoodia cultivation. Synthesis of the active components of the plant provides another option for drug manufacture, and the development of semi-synthetic versions of active molecules discovered in the P57 programme is currently under investigation by Phytopharm.
While the technology transfer components of the CSIR-Phytopharm agreement are strong, its conservation benefits are acknowledged by the CSIR to be ‘thin’ and focused mainly on Hoodia. To some extent this is strengthened in the San-CSIR agreement, which commits parties to conserve biodiversity and to undertake best-practice procedures for plant collection, but nonetheless is clearly a critical area for policy guidance, especially if practical meaning is to be given to the oft-expressed rhetoric that biodiversity must ‘pay its way’. This applies not only to the Hoodia case, but also to many other bioprospecting initiatives underway – both in the CSIR and elsewhere in the region. For example, any money generated by the CSIR gets invested back into the organisation or partner organisations, or into providing scientific services, with no proportion of projected royalties specifically earmarked for conservation, or for benefit-sharing with holders of traditional knowledge. These deficiencies could be addressed through policy changes within the CSIR, and/or through channelling funds into a National Bioprospecting Trust Fund, as proposed in South Africa’s newly promulgated Biodiversity Act (10 of 2004). Either way, their redress requires urgent attention, given the reported and increasing depletion of Hoodia from its natural habitat.
Although benefits for the CSIR, and indirectly for South Africa, are high, the agreement has the potential to bypass other countries of origin of Hoodia species, such as Namibia and Botswana. While there are some bilateral bioprospecting agreements under development between the CSIR and countries that neighbour South Africa, many have commented that the role of South Africa in this case simply perpetuates the country’s economic dominance in the region, and that the CSIR patent infringes the rights of other range states to benefit from national sovereign ownership of Hoodia genetic resources. Although the South African San Council has independently determined to share benefits across regional boundaries, based on an acknowledgment of the shared knowledge of Hoodia, there is clearly a need for benefit-sharing strategies to be developed at a national level in cases where genetic resources are shared across boundaries.
Additional worries include the fraught questions of administering the funds, of determining beneficiaries and specific benefits across geographical boundaries and within different communities, and of minimising the social and economic impacts and conflicts that could arise with the introduction of large sums of money into poor communities. Limited international and local experience exists in the administration and implementation of such agreements and few, if any, cases address the sharing of benefits within communities. As Barreatt and Lybbert point out, thus far benefit-sharing questions have remained issues of distribution between the community in aggregate and outsiders, and at a local and intra-community level there has been little practical experience. Early experiences, however, suggest the potentially divisive impact that natural product trade can have in indigenous communities. In India, for example, the commercialisation of Jeevani, or Trychopus zeylanicus, a wild plant with anti-fatigue properties, has led to divisions among a tribal community, the Kanis, as to how their knowledge should be used, . In Peru, a 1996 Agreement of the International Cooperative Biodiversity Group also led to conflict between organisations representing Aguarana communities, as well as at a national level, .
In the case of the San, intra-community issues are especially complex. Many of the organisations set up to politically represent the San are very new and the introduction of Western values and economies into supposedly traditional communities, already fractured and ‘hybridised’, presents a suite of difficult social and economic problems. Robins describes the social complexities of contemporary San identity, knowledge and practice, and charts the intra-community divisions and conflict that emerged between self-designated ‘traditionalists’ and ‘Western bushmen’ when San land claims were lodged in the Northern Cape province of South Africa. While these claims resulted in significant benefits for the San, they also had unintended consequences in terms of generating conflict. Robins points out the contradictions between San ‘cultural survival’ and the promotion of the values of ‘civil society’ and ‘liberal individualism’, a conclusion that holds particular resonance for the Hoodia case, contextualised as it is within the international discourse of indigenous peoples, a vigilant NGO community alert to ‘biopiracy’ cases, and a new policy framework that requires fair and equitable benefit-sharing for use of traditional knowledge.
VI. Approaches Adopted towards Intellectual Property Right Protection
Intellectual property considerations are central to the case because, through a broader programme to investigate the nutritional and toxic properties of edible plants used by indigenous people, traditional knowledge was used directly by the CSIR to support their research and development about Hoodia spp. and ultimate registration of an international family of patents. Several patents have been granted based on Hoodia use, but Patent WO9846243A2, filed in 1997 and concerning the appetite suppressant properties of Hoodia, is the focus of this case. The patent is described as “a pharmaceutical composition [that] contains an extract obtainable from a plant of the genus Trichocaulon or Hoodia containing an appetite suppressant agent having the formula described”. Other aspects of the patent relate to procedures for obtaining the extract and synthesising the compound.
Early on in the negotiations, the San were faced with a difficult choice. Should they oppose or even challenge the patent, based on ethical considerations and lack of novelty, or should they adopt a more practical approach and become active partners in negotiating a share of royalties from the patent? This was a critical moral dilemma. In communities such as the San, the sharing of knowledge is a culture and is basic to their way of life. Traditional knowledge of plants is viewed as a ‘collective’ and the idea of ‘owning’ life abhorrent. The patenting of active compounds of Hoodia by the CSIR, ran counter to this belief, yet brought with it lucrative opportunities for financial benefits. As Roger Chennells, the lawyer representing the San retorts, ultimately, the principle of ‘no patents on life’ was “too expensive” and the poverty-stricken San opted to obtain a share of royalties. Writing to the CSIR President in 2001, Chennells informed the organisation that a legal challenge of any nature did “not form part of our clients’ plans”, but emphasised that the San regarded their traditional knowledge regarding Hoodia, as well as other plant uses, as being collective San intellectual property rights, that should not morally be able to be owned by any individual or entity.
The resulting Memorandum of Understanding and the Benefit-Sharing Agreement acknowledge the San as the “custodians of an ancient body of traditional knowledge and cultural values, related inter alia to human uses of the Hoodia plant”, and recognise that such knowledge pre-dated western scientific knowledge. However, the Agreement clearly specifies that any intellectual property arising from the traditional use of Hoodia and related to the CSIR patents for P57 remains vested exclusively with the CSIR. The San Council has no right to claim any co-ownership of the patents or products derived from the patents.
The decision of the San not to challenge the patent must, of course, be respected, but the
granting of the patent to the CSIR on the basis of its novelty deserves greater scrutiny and raises wider questions about the efficacy, rationale and fairness of the patent system. Why, for example, does the patent system disqualify indigenous communities from patenting particular useful characteristics of a plant known to them on the basis of ‘lack of novelty’, but allow western scientists to do so in the language of chemistry?
Dutfield suggests that a case, albeit ambiguous, exists for the San to challenge the legitimacy of the patent on the basis of its lack of novelty and of simply being a variant of the well-documented traditional use of Hoodia. He describes some of these ambiguities in a cogent analysis of the role of the patent system in benefit-sharing. One interpretation is that the patent specifically describes methods for extracting the active principle and therefore has the required characteristics of novelty and non-obviousness. According to the European Patent Office, “if a substance found in nature has first to be isolated from its surrounding and a process for obtaining it is developed, that process is patentable”. Certainly the CSIR would support this view, having spent twenty years, and many millions of Rands on research and development of the plant. But Dutfield also offers alternative interpretations, highlighting in particular the cross-cultural nuances of understanding ‘novelty’, and a related judgment in a 1995 patent appeal case in the British House of Lords. This case concerned the formation of secondary metabolites from use of the anti-histamine drug Terfenadine, and the patentability of these compounds. The point of the appeal, which led to a successful dismissal of the case, was to argue that the British 1977 Patents Act did “not confine the state of the art about products to knowledge of their chemical composition”. In other words, it is not necessary for a chemical to have been described or known about for it to be part of the state of the art. In this particular case, a secondary metabolite produced by the human body breaking down a pharmaceutical could not be considered new just because its chemical structure had been elucidated for the first time. On the basis of this judgment, and supportive rulings of the European Patent Office Technical Board of Appeal, Dutfield cautiously suggests that the CSIR’s U.K. and European Hoodia patents could be vulnerable to a challenge on the basis of lack of novelty, although achieving the hoped-for outcomes in each of the main jurisdictions would be difficult.
B. Options for Protecting San Knowledge
An important question to ask is how things could have been done better, through improved recognition of holders of traditional knowledge, and enhanced benefits. A number of scenarios present themselves, some compatible and others mutually exclusive. These include:
- co-ownership of the patent by the San and/or other groups and the CSIR;
- sui generis systems of protection for traditional knowledge;
- defensive protection through the compulsory disclosure of the source of genetic resources and associated traditional knowledge in patent applications, and the establishment of traditional knowledge databases; and
- a principled ‘no patents on life’ option and/or pursuit of alternative models of commercialising Hoodia.
The first two options, dubbed by the World Intellectual Property Organisation (WIPO) as ‘positive protection’, refer to the acquisition by traditional knowledge holders themselves of an intellectual property right such as a patent, or an alternative right provided in a sui generis system. In the first option it could be argued that had the CSIR requested the prior informed consent of the San before lodging the P57 patent, then negotiations could almost certainly have included the option of the San becoming co-owners on the patent, with entitlement to a far greater share of projected royalties. For its part, the CSIR could have contributed knowledge of the chemistry; technical knowledge and assistance in preparing the patent specifications; and capital to prepare and prosecute the application. This would have been a far more revolutionary and equitable approach to benefit-sharing, according the San equal status on the patent, rather than poor-cousin status as a tertiary beneficiary. Through assistance with technical, legal and financial aspects of the patent application, it would also have overcome some of the most important limitations of the patent system for many developing countries and holders of traditional knowledge.
But even if this model had been adopted, concerns would remain about the commodification of San knowledge, and consequent violation of cultural precepts. In this context, the second option, which would see the introduction of sui generis forms of protection for traditional knowledge, would be a far more fitting solution to the problem. Many scholars have identified the serious need for innovation in the intellectual property regime itself, and this topic is also under consideration by a large number of international bodies, include WIPO, the CBD, the United Nations Conference on Trade and Development (UNCTAD), and WTO. It is beyond the scope of this article to explore in depth the alternative options available to protect traditional knowledge, suffice it to say that the Hoodia case supports the need for sui generis systems of protection that not only give communities rights over their traditional knowledge, but also enable the wider preservation and promotion of such knowledge systems. Some countries such as the Philippines and Peru, have enacted legislation giving indigenous communities rights over their traditional knowledge, but in southern Africa such laws are still under development. In South Africa, more than five years has elapsed since the first tabling of a draft Indigenous Knowledge Bill, a reality that illustrates the political and legal complexities of working out what aspects of indigenous knowledge can be made the subject of intellectual property laws, and under what circumstances.
The Hoodia case demonstrates not only the value of having an integrated system to protect and promote traditional knowledge, but also the importance of so-called ‘defensive protection’, to prevent the misappropriation of traditional knowledge. This third option could include, for example, the compulsory disclosure of the source of genetic resources and associated traditional knowledge in patent applications, and the establishment of traditional knowledge databases.
Mechanisms for disclosure of origin of genetic materials or traditional knowledge are a matter of intense dialogue and negotiation at the international level, and are one of the major areas of overlap between the CBD and TRIPS. Many developing countries argue that any protection of genetic resources and traditional knowledge will not be effective unless and until international mechanisms are found and established within the framework of the TRIPs Agreement. They suggest that other means, such as access contracts and data bases for patent examinations, can only be supplementary to such international mechanisms, which must contain an obligation on members collectively and individually to prohibit, and to take measures to prevent, the misappropriation of genetic resources and traditional knowledge. Proposals are for Article 29 of TRIPS to be modified to include a strong disclosure of origin mechanism which would require patent holders to disclose not only detailed information about who provided the materials or the knowledge used, but also positive proof of benefit sharing and of prior informed consent.
A number of countries have adopted such proposals in various forms, and in South Africa the Hoodia case has directly catalysed a commitment from government to investigate more fully the basis upon which patents are granted, including a database for knowledge about South African biodiversity, and a proposal to amend the Patents Act to empower the registrar to refuse a patent if there is not adequate disclosure about the use of genetic resources and traditional knowledge. Whether or not the existence of such mechanisms would have prevented the Hoodia patent from being granted is, however, debatable: the different ‘languages’ of knowledge, and the cultural bias of the patent system, suggest inherent limitations to this approach. Moreover, an agreement on disclosure of origin could well lead to an increase in the patenting of plant and animal inventions.
Even in the absence of ‘positive’ or ‘defensive’ protection, the San and other groups could have asserted their rights to knowledge of Hoodia and adopted a ‘no patents on life’ position. This need not have entailed a rejection of commercialisation of Hoodia, but instead the development of non-patented botanical medicines in collaboration with suitable partners. In India, for example, the Kani tribe receives 50 percent of the 2 percent license fee and royalty from commercialisation of Jeevni, a herbal drug which rejuvenates and builds strength. While the no-patent option would bring lower financial returns than that of a patented pharmaceutical drug, so too would it bring lower levels of risk. The rapid growth of herbal products based on Hoodia described earlier, testifies to the opportunities afforded by this option, but also points to the importance of setting in place clear mechanisms to prevent the export of genetic resources without suitable benefit-sharing arrangements in place.
The case of Hoodia tells a complex story of many strands, and from it a number of important lessons and conclusions can be drawn that are important to integrate into ongoing debates about ways in which benefit-sharing for communities can be made more equitable. One of the most crucial lessons to emerge from the case is the need to get it right from the start. Obtaining the prior informed consent of communities holding knowledge about biodiversity from the very outset of a project – and engaging them as active partners – is an absolutely fundamental principle of benefit-sharing. The San case illustrates what can go wrong when this principle is ignored. If prior informed consent had been obtained from the outset then some of the more expedient provisions in the agreement, such as the exclusion of the San from other commercialisation options, may well have been dealt with more fairly. Benefits through, for example, options involving co-ownership of the patent may also have been greater.
The negotiating process between the CSIR and the San has demonstrated the importance of building trust between role-players and of having in place a political climate conducive to fair deliberations. It has also reaffirmed the importance of having community-based institutions through which holders of traditional knowledge can be represented in negotiations, and benefits channelled. The process has highlighted the prominent role played by NGOs, legal representatives, and intermediaries in benefit-sharing – in this case not only in assisting the San to attain their rights, but also in shaping San politics and economic development.
One of the major impacts of the case has been the interest it has aroused about the importance of protecting traditional knowledge and ensuring that holders of such knowledge receive fair compensation. Amongst the San, the Hoodia case is considered an important empowering tool to enable more informed decisions to be made about their intellectual property and ways to protect it. At government level, the case has led directly to an increased focus and prominence for biodiversity and its potential value, and in South Africa, the inclusion of prior informed consent and benefit-sharing within new biodiversity legislation and a proposal to require disclosure of origin prior to the granting of patents. At the international level, the case is widely considered to set precedents about the ways in which holders of traditional knowledge should be compensated for this knowledge.
There is clearly an urgent need to introduce new forms of protection for traditional knowledge that not only give communities rights over their knowledge but also enable the wider preservation and promotion of these knowledge systems. The Hoodia case demonstrates not only the value of having an integrated system to protect and promote traditional knowledge, but also the importance of so-called ‘defensive protection’, to prevent the misappropriation of traditional knowledge.
Some of the lessons are probably only beginning. If monies are eventually received by the San there will be extremely difficult issues to deal with in terms of determining who benefits and how benefits are spread across geographical boundaries and within communities, and of minimising the social and economic impacts and conflicts that could arise with the introduction of large sums of money into impoverished communities. The due compensation of other communities such as the Nama, Damara and Topnaar will also require careful consideration. What is clear is the need for regional collaboration in cases where resources and knowledge are shared.
Two principal models of Hoodia commercialisation have been described. The first model, that of a state research institution forging partnerships with large, foreign pharmaceutical or nutraceutical companies is one that is replicated throughout the world – and although yields research and development benefits for the research institution, also demonstrates some very real concerns when holders of traditional knowledge are involved. A major criticism of this model is that it simply perpetuates imbalances of the past through a very disempowering, patronising and unequal relationship.
The second model – that of a largely unregulated trade and a plethora of mostly fly-by-night operators, free riding on the publicity and patent of the first, is also highly problematic because it completely bypasses holders of traditional knowledge and countries of origin and also will likely lead to overexploitation of the wild resource.
A common feature to both of these models is the limited state involvement in developing appropriate forms of Hoodia commercialisation, hindered to some extent by the legislative vacuum that has existed for bioprospecting. Clearly, there is a need for a more holistic, innovative and ethical approach to biodiversity commercialisation beyond the models currently touted. While state intervention may be frowned upon in today’s globalised world, it does seem that strict oversight, combined with the support and partnership of ethical trading partners and service organisations, is an essential formula for more equitable benefit sharing.
 Graduate School of Environmental Studies, University of Strathclyde, Present address: PO Box 83, Kalk Bay, 7990, SOUTH AFRICA. Tel/fax: +27 21 788 9169; e-mail: Rachel@iafrica.com. This paper forms part of doctoral research conducted by the author on the commercialisation of biodiversity in southern Africa. Many people assisted with this research but I wish to thank the following in particular for the open manner in which they have shared knowledge and opinions: Roger Chennells (SASI), Petrus Vaalbooi (South African San Council), Axel Thoma (WIMSA), Dr Petro Terblanche (CSIR), Dr Marthinus Horak (CSIR), and Elsabe Powell (Northern Cape Nature Conservation). Ben Bennett, Roger Chennells, Professor Carlos Correa, Pierre du Plessis, Dr Graham Dutfield, Dr Marthinus Horak, and Dr Gillian Maggs-Kolling, provided useful comments on earlier drafts of this paper, which I thankfully acknowledge. I am grateful to the National Research Foundation, Annell Trust and Smartt Memorial Trust for providing scholarships to support this study.
 White, A. and Sloane, B.L. 1937. The Stapelieae Vol III, 2nd edition, Pasadena, California.
 Phytopharm plc, 2003. Annual Report and Accounts for the year ended 31 August 2003.
 Article 15(1).
 The Bonn Guidelines to the Convention on Biological Diversity, Conference of the Parties, Decision VI/24(2002).
 Report of the World Summit on Sustainable Development (A/CONF. 199/20, 4 September 2002), Resolution 2, Annex, para. 44(o); See also, Decision V11/19 of the 7th Conference of the Parties to the CBD.
 For further discussion see, for example, Commission on Intellectual Property Rights, 2002, Integrating Intellectual Property Rights and Development Policy; Correa, C.M. 2001, Traditional knowledge and intellectual property. Issues and options surrounding the protection of traditional knowledge. Quaker United Nations Office, Geneva; Crucible II Group, 2001, Seeding Solutions. Volume 2. Options for national laws governing control over genetic resources and biological innovations, IDRC/IPGRI/Dag Hammarskjold Foundation; Dutfield, G. 2000, Intellectual Property Rights, Trade and Biodiversity, Earthscan, London; World Intellectual Property Organisation, 2001, Intellectual Property Needs and Expectations of Traditional Knowledge Holders, WIPO report on fact-finding missions on intellectual property and traditional knowledge (1998-1999), Geneva.
 See, for example, de Rios, M.D. 1992. Amazon Healer. Prism Books; Metzner, R. (ed.). 1999. Ayahuasca. Thunder’s Mouth Press, New York; Shah, T. 2001. Trail of Feathers. In Search of the Birdmen of Peru. Phoenix, London.
 Wiser, G. 2002. The Ayahuasca Patent Case: Indigenous People’s Stand against Misappropriation. In: Laird, S.A. (ed). 2002. Biodiversity and Traditional Knowledge: Equitable Partnerships in Practice. Earthscan, London. pp. 182-184
 Dutfield, G. 2000. Intellectual Property Rights, Trade and Biodiversity: Seeds and Plant Varieties. Earthscan, London.
 see, for example, GRAIN, 2000. Biodiversity for sale. Dismantling the hype about benefit sharing. Global trade and biodiversity in conflict, Issue no. 4. http://www.grain.org/publications/
 White, A. and Sloane, B.L. 1937. The Stapelieae Vol III, 2nd edition, Pasadena, California.
 Convention on International Trade in Endangered Species of Wild Fauna and Flora, Amendments to Appendices I and II of CITES, Proposal to the Thirteenth Meeting of the Conference of the Parties, Bangkok, Thailand, 2-14 October 2004.
 van Wyk, B. and Gericke, N. 2000. People’s plants. A guide to the useful plants of southern Africa. Briza, South Africa. p. 70; White, A. and Sloane, B.L. 1937. The Stapelieae Vol III, 2nd edition, Pasadena, California; Patent WO9846243A1: Pharmaceutical compositions having appetite suppressant activity.
 van Wyk, B. and Gericke, N. 2000. People’s plants. A guide to the useful plants of southern Africa. Briza, South Africa. p. 70.
 Smith, C.A. 1966. Common Names of South African Plants. Botanical Survey Memoir No. 35, Department of Agricultural Technical Services, Republic of South Africa. p.35.
 n. 15.
 Hargreaves, B.J. and Turner, Q. 2002. Uses and misuses of Hoodia. Asklepios 86: 11-16.
 Malan, J.S. and Owen-Smith, G.L. 1974. The ethnobotany of Kaokoland. Cimbebasia, Series B, Vol 2 (5): 151.
 Masson, F. 1796. Stapelia novae: or A collection of several new species of that genus. London.
 While Marloth was the first to record use of Hoodia, knowledge about properties of the plant was obtained by the CSIR from a volume by White, A. and Sloane, B.L. 1937. The Stapelieae Vol III, 2nd edition, Pasadena, California.
 Lee, R.B., Hitchcock, R. and Biesele, M. 2002. Foragers to First Peoples: The Kalahari San. Cultural Survival Quarterly 26(1): 9-12.
 Gert Dicks, John Cloete, Stephanus Cloete, Sophie Basson, Andries Kotze, quoted in van Wyk, B. and Gericke, N. 2000. People’s plants. A guide to the useful plants of southern Africa. Briza, South Africa. p. 70.
 von Koenen, E. 2001. Medicinal, Poisonous, and Edible Plants in Namibia. Edition 4, Klaus Hess Publishers. p. 131.
 Steyn, H.P. and du Pisani, E. 1985. Grass-seeds, game and goats: an overview of Dama subsistence. SWA Wissenschaftliche Gesellschaft, Windhoek, SWA, Journal XXXIX.
 Van den Eynden, V., Vernemmen, P., van Damme, O. 1992. The ethnobotany of the Topnaar. Universiteit Gent.
 Hitchcock, R.K. and Biesele, M. 2001. San, Khwe, Basarwa, or Bushmen? Terminology, identity, and empowerment in southern Africa. http://www.kalaharipeoples.org/documents/San-term.htm. 22 November 2001.
 Gall, S. 2001. The Bushmen of Southern Africa. Slaughter of the Innocent. Pimlico, London.
 Suzman, J. 2001. An introduction to the Regional Assessment of the Status of the San in Southern Africa. Regional Assessment of the Status of the San in Southern Africa. Report series, report no. 1 of 5. Legal Assistance Centre, Windhoek.
 An alternative interpretation is that Hoodia spp. were first collected in Namibia and other range states as part of a CSIR project to determine the cause of so-called ‘turkey disease’. While this was later revealed to be aflatoxicosis, caused by a fungal secretion, initial research was targeted at investigating plants, and asking indigenous people about the properties of different plants (B. Bennett, pers. comm. 30 August 2004).
 South African patent no. 983170.
 The CSIR and Phytopharm plc. 21 August 1998. The CSIR Licence.
 Phytopharm. 23 June 1997. “Phytopharm to develop natural anti-obesity treatment”, Press release. http://www.phytopharm.com/News/PressReleases197/press010-19970623.shtml
 GB2338235 and WO9846243A2: “Pharmaceutical compositions having appetite suppressant activity”.
 Phytopharm Press Release 30 July 2003. Pfizer returns rights of P57. http://www.phytopharm.com/press/Rel%2080finalfinal.htm
 “Phytopharm seeks food partners for weight control plant extract”, 1 March 2004. http://www.nutraingredients.com/news/
 Barnett, A. 17 June 2001. “In Africa the Hoodia cactus keeps men alive. Now its secret is ‘stolen’ to make us thin”, The Observer.
 Ekpere, J.A. 2001. The OAU’s Model Law: The Protection of the Rights of Local Communities, Farmers and Breeders, and for the Regulation of Access to Biological Resources. An Explanatory Booklet. Organisation of African Unity, Scientific, Technical and Research Commission, Lagos, Nigeria.
 For a review of such statements see Dutfield, G. 2002. Indigenous peoples’ declarations and statements and equitable research relationships. In: Laird, S.A. (ed.). Biodiversity and Traditional Knowledge. Equitable partnerships in practice. Earthscan, London. pp. 228-232.
 n. 45.
 See, for example, ‘Plant helps in fighting obesity’, Cape Times, 26 June 1997; CSIR Annual Report, 1999; and ongoing correspondence between the author and NGOs involved in work with the San.
 Clause 6, MOU
 Clause 7, MOU
 Clause 8, MOU
 See Spies, C. 2002. Report on workshop on benefit-sharing between South African San Council and the CSIR on the Hoodia P57 project, 13-14 June 2002, Molopo Lodge, Kalahari.
 See, for example, the Media and Research Contract of the San of Southern Africa, approved by the WIMSA Annual General Assembly on 28 November, 2001, which sets out a procedure requiring written consent from the San to carry out any media or research project. See also, WIMSA, 2003. The San of Southern Africa. Heritage & Intellectual Property.
 See, for example, Wynberg, R. 1998. Indigenous Knowledge Under Threat. Mail & Guardian, December 18-23 1998.
 Note that South Africa promulgated a Biodiversity Act in June 2004. One of the main objectives of the Act is “to provide for the fair and equitable sharing among stakeholders of benefits arising from bioprospecting involving indigenous biological resources”. The Act also includes broad provisions requiring prior informed consent to be obtained from holders of traditional knowledge for use of such knowledge for bioprospecting (82(3a)), and for benefit-sharing agreements to be developed with knowledge holders (82(3b)).
 Address by Dr Ben Ngubane, Minister of Arts, Culture, Science and Technology, at the Signing of a Benefit-Sharing Agreement between the CSIR and the San, on 24 March 2003, Molopo Lodge, South Africa. http://www.dst.gov.za/
 Provisions 1.5 and 2, Benefit-Sharing Agreement between the CSIR and the South African San Council, March 2003.
 Deed of Trust of San Hoodia Benefit Sharing Trust.
 Provision 3.6
 Provision 3.7
 Provision 3.8
 Provision 9
 WIMSA Annual Report, period April 2003 to March 2004.
 The proportion of royalties that will be received by the CSIR from Phytopharm remains undisclosed. However, for the purposes of this calculation I have assumed that the CSIR will receive between 10-20 % of royalties from Phytopharm. This assumption is based on an understanding of the industry standards for royalties,and of the substantial value-adding that took place by the CSIR prior to it granting a licence to Phytopharm for the further development of P57.and XXX given that substantial value adding XXX.
 However, there have been attempts by some companies to gain approval by the San through donations, in order to claim a beneficial association.
 Chennells, R. 2003. Ethics and practice in ethnobiology, and prior informed consent with indigenous peoples regarding genetic resources. Paper presented at a conference on Biodiversity, Biotechnology and the Protection of Traditional Knowledge, St Louis, 4-6 April 2003.
 Roger Chennells, pers. comm. 27 August, 2004.
 While CSIR and Phytopharm have been reimbursed for their continuing roles in research and development (R&D), these funds have been allocated largely to cover R&D costs and are not considered by the CSIR as income.
 M. Horak, CSIR, pers.comm., April 2002.
 ten Kate, K. and Laird, S.A. 1999. The Commercial Use of Biodiversity. Earthscan, London.
 M. Horak, CSIR, pers.comm., April 2002.
 M. Horak, CSIR, pers.comm., April 2002.
 See, for example, Wynberg, R. 2004. Bioprospecting delivers limited benefits in South Africa. European Intellectual Property Review, June 2004, 26(6):239-243.
 Section 85.
 See for example, Ministry of Agriculture, Water and Rural Development, Namibia, 2003, Indigenous Plant Development Strategy Review. National Agricultural Support Services Programme.
 Barrett, C.B. and Lybbert, T.L. 2000. Is bioprospecting a viable strategy for conserving tropical ecosystems? Ecological Economics 34:293-300.
 Tobin, B. 2002.Biodiversity prospecting contracts: the search for equitable agreements.In: Biodiversity and Traditional Knowledge: Equitable Partnerships in Practice. (ed. S. Laird). Earthscan, London, pp. 287-309.
 Gupta, A.K. 2004. The role of intellectual property rights in the sharing of benefits arising from the use of biological resources and traditional knowledge. World Intellectual Property Organisation and United Nations Environment Programme.
Greene, S. 2004. Indigenous people incorporated? Culture as politics, culture as property in pharmaceutical bioprospecting. Current Anthropology 45(2):
 Robins, S. 2002. NGOs, ‘bushmen’, and double vision: the =Khomani San land claim and the cultural politics of ‘community’ and ‘development’ in the Kalahari. In: Contested Resources: Challenges to the Governance of Natural Resources in South Africa. Edited by T.A. Benjaminsen, B. Cousins, and L. Thompson. pp. 208-227. Programme for Land and Agrarian Studies, School of Government, University of the Western Cape.
 Patent GB233355657 (EP1099444), filed in 2001, is also based upon use of extracts of Hoodia spp. and relates to “the reduction of gastric acid secretion in animals, including humans”. Patent EP1166792, filed in 2002, relates to the use of Hoodia and Trichocaulon extracts for anti-diabetic activity, and to the use of such extracts and related compounds and analogues for the manufacture of anti-diabetic drugs.
 n. 72.
 Letter from Roger Chennells to the Executive President of the CSIR, 5 July 2001.
 Dutfield, G. 2002. Sharing the benefits of biodiversity: is there a role for the patent system? Journal of World Intellectual Property 5(6): 899-932.
 See also, First Peoples Worldwide. 2003. Case study of the patenting of P57 and related benefit-sharing and licensing agreements with regard to the intellectual property rights of the San peoples of southern Africa. Edited by D.J. Stephenson.
 European Patent Office Guidelines for Examination in the European Patent Office, cited in Dutfield, n. 94.
 n. 94.
 Merrell Dow v. HN Norton, cited in Dutfield (2002), n.94.
 As an aside, several experts argue that the CSIR could have done far more at a national level in assuming some of the roles of Phytopharm and Pfizer in drug development, and thus realising a greater share of national benefits.
 See, for example, n. 102; 103.
 See, for example, Mashelkar, R.A. 2002. The role of intellectual property in building capacity for innovation and development. A developing world perspective, In: Indigenous Knowledge and the Integration of Knowledge Systems. Towards a Philosophy of Articulation. Edited by C.A. Odora Hoppers. New Africa Books, South Africa. pp. 188-199
 For example, the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore is considering intellectual property issues that arise in the context of access to genetic resources and benefit-sharing; the protection of traditional knowledge; innovations and creativity; and the protection of expressions of folklore. Proposals examining ways to use patents to protect traditional knowledge for its holders include definitions of ‘prior art’, the scope of patents and the test of ‘inventive step’, procedural requirements such as disclosure of country of origin and proof of prior informed consent in patent applications. http://www.wipo.org/globalissues/igc/index.html
 See, for example, Commission on Intellectual Property Rights, 2002. Integrating Intellectual Property Rights and Development Policy. Report of the Commission on Intellectual Property Rights; ICTSD and UNCTAD, 2003. Intellectual Property Rights: Implications for Development. Policy discussion paper prepared for the UNCTAD-ICTSD project on IPRs and sustainable development. Crucible II Group, Seeding Solutions. Volume 2.Options for national laws governing control over genetic resources and biological innovations. International Development Research Centre, International Plant Genetic Resources Institute, Dag Hammarskjöld Foundation.
 The Indigenous Peoples Rights Act of 1997, Republican Act No. 8371. Source: http://www.grain.org/docs/philippines-ipra-1999-en.pdf and the Community Intellectual Rights Protection Act 1994 Senate Bill No. 1841. Source: http://www.grain.org/docs/philippines-cirpa-1994-en.pdf
 “Law introducing a protection regime for the collective knowledge of indiginous peoples derived from biological resources”, Law 27811 of 10 August 2002. http://www.grain.org/brl/?docid=81&lawid=2041
 See, for example, submissions to the WTO by Switzerland (IP/C/W/400, (13 pages) available at http://docsonline.wto.org/DDFDocuments/t/IP/C/W400.doc, African Group, and India on behalf of Brazil, Bolivia, Cuba, Dominican Republic, Ecuador, Thailand, Peru and Venezuela (IP/C/W/403, available at http://www.ictsd.org/).
 Republic of South Africa, Department of Trade and Industry Patents Amendment Bill 2004, Government Gazette 11 February 2004, Notice 227 of 2004. Volume 464, no. 26017.
 GRAIN, 2003. The TRIPS review at a turning point? http://www.grain.org/publications/trips-july-2003-en.cfm
 Anuradha, R.V. 1998. Sharing with the Kanis. A case study from Kerala, India. In: Case studies on benefit-sharing arrangements. Submitted to the Conference of the Parties to the Convention on Biological Diversity, Fourth meeting, Bratislava, Slovakia, 4-15 May 1998.