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Symposium on food security and biodiversity: Benefit sharing
Case Study: San/CSIR Hoodia Benefit Sharing Petro Terblanche Executive Director Bio/Chemtek, Council for Scientific and Industrial
benefits from bioprospecting with the owners of the traditional knowledge that led to its initial discovery. In 1998, Phytopharm sold the rights to the compound, now known as P57, to pharmaceutical company Pfizer to complete clinical development, obtain regulatory approval and undertake commercialisation. In 1999, the CSIR signed an historical bioprospecting agreement with South African Traditional Healers, and was invited by the United Nations to present details at the Lyon Summit on Trade and Development. However, in 2001, a newspaper reporter from the UK questioned the CSIRPhytopharm- Pfizer P57 collaboration without the involvement of the San people. In response to this, the CSIR and San met regularly throughout 2002-3 to share information on P57. This involved including independent experts in workshops and negotiating a benefit sharing agreement, which was eventually signed on 24 March 2003. On 30 July 2003, Phytopharm announced that Pfizer had decided to discontinue development of P57. Phytopharm continues its commercialisation strategies. The Benefit Sharing Agreement
The benefit sharing agreement signed with the San states that “both parties commit themselves to the conservation of biodiversity by, inter alia, applying legal “best practices” with the collection of any plant species for observation, and by ensuring that no negative environmental impacts flow from the proposed bioprospecting collaboration”. The agreement also acknowledges the importance of traditional knowledge, stating that “.San people are custodians of an ancient body of traditional knowledge…related inter alia to human uses of the Hoodia plant…”. It adds that “The CSIR acknowledges the existence and the importance of the traditional knowledge of the San people, and the fact that such body of knowledge, existing for millennia, predated scientific knowledge
developed by Western civilisation over the past century”. The benefit sharing agreement will also benefit the San financially: the CSIR will pay the San eight percent of all milestone payments it receives from Phytopharm as well as six percent of all royalties that the CSIR receives once the drug is commercially available. Existing CSIR study bursaries and scholarships have also been made available to the San and talks will be held to agree future bioprospecting for the benefit of both parties. The San Hoodia Benefit Sharing Trust
Potential money will be put into a San Hoodia Benefit Sharing Trust, whose Trustees will consist of one CSIR nominee; three San representatives from the Khomani, Xun and Khwe communities; one representative from the Working Group of Indigenous Minorities in Southern Africa (WIMSA); one South African professional; and a non- voting observer from the South African Department of Science and Technology. Beneficiaries will include the San from the Khomani, Xun and Khwe communities of South Africa plus San communities elsewhere who are members of WIMSA and are identified by the Trustees as eligible beneficiaries. The Agreement will remain in force for the royalty period for as long as the CSIR receives financial benefits from the commercial sales of the products, with record-keeping provided by both the CSIR and the San Trust. Challenges We faced many challenges in the development of the benefit sharing agreement with the San. The San is spread across South Africa, Botswana, Namibia, Zambia and Zimbabwe, and neither their cultural legacy nor biodiversity respect man-made borders. It was important to find a balance between trade secrecy/commercial knowledge protection and transparency in our negotiations. It was also challenging to produce a contract when the revenue and benefits to parties were uncertain and linked to the outcome of clinical trials: it proved very important to
manage expectations of all the parties involved and properly administer potential future benefits. Lessons learnt from P57 The development of P57 has led to many important lessons for us. We have learnt that it is extremely difficult to operate in policy vacuum – without the draft format IKS policy and bill – and that it takes a very long time to progress from project idea to commercial success. Our experiences also underlined the importance of the active participation of the owners of traditional knowledge throughout the product development cycle – and that the heavy burden of communicating needs and expectations between all partners is part of operating in interdependent world. We also need to underline that although traditional knowledge has intrinsic value, it requires significant value addition through technology and marketing for its true market value to be realised. As with many things, we found that the development of policy benefited from real-life case studies, with many lessons ‘learnt-on-the-run’. It is also important to bear in mind that genetic resources are common to more than one country. P57 Licensing: Benefits to South Africa The development of P57 required the full involvement of South African scientists in development programme (capacity building) and led to the transfer of state-of-the-art phyto-medicine production technology to South Africa. Our country will also benefit from potential revenue from royalties through licensing of patented technology, with milestone payments having been linked to clinical trials. In addition to financial benefits, the development of P57 has helped raise global recognition of South Africa’s capacity for innovation.
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