Microsoft word -

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
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
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.
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
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.



PAKKAUSSELOSTE ERITYISVAROITUKSET Eläimiä koskevat erityiset varotoimet Tempora vet 50 mg Munuaisten toiminta ja plasman kaliumpitoisuus on määritettävä ennen spironolaktonin ja ACE-estäjien purutabletti koiralle yhdistelmähoidon aloittamista. Toisin kuin ihmisillä, hy-perkalemian esiintymisen ei havaittu lisääntyvän tätä MYYNTILUVAN HALTIJAN NIMI JA OSOITE SEKÄ


New York/New Jersey AIDS Education Helpful HIV Medication Tables for Pharmacists & Training Center Nucleoside/Nucleotide Reverse Transcriptase Inhibitors Patient Counseling Points - Food Effect and Adverse Effects Abacavir Food Effect – Take without regard to meals. Adverse Effects – Patients should be warned about the abacavir hypersensitivity reac

Copyright © 2010-2014 Online pdf catalog