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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 Research (CSIR), South Africa.
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Biodiversity and South Africa’s Botanical
Reserves
South Africa boasts ten percent of world’s plant
biodiversity, with 24,400 indigenous species,
60 percent of which are endemic, and is home
to the Cape Kingdom, one of the six floral
kingdoms of the world.
With a long tradition of medicinal use of indigenous
plants, over 70 percent of South
Africans consult traditional healers, of whom
there are 200,000 active throughout the
country. Indigenous communities in Southern
Africa, such as the San bushmen of the
Kalahari (an aboriginal people considered “the
oldest genetic stock of contemporary humanity”),
have a wealth of unrecorded knowledge.
CSIR’s vision for bioprospecting is to create
economic and social benefit for the nation and
the region based on its biodiversity and indigenous
knowledge. We also seek to add maximum
value to bio-resources through consortium-
based research within South Africa.
From Hoodia to P57
In 1963, the CSIR included Hoodia Gordonii, a
Kalahari desert cactus, in a research project
on edible plants based on the ethnobotany of
the San. Hoodia has been used for centuries
by the San to suppress the appetite during long
hunting trips. However, insurmountable technical
problems arose and, in 1971, the Hoodia
project was mothballed. These problems
were not overcome until 1983-86 when technological
advances enabled a scientific breakthrough
– a new chemical entity was discovered
in Hoodia, and its structure was determined.
Over the next ten years, the CSIR continued its
development of Hoodia and filed worldwide
patents to protect its invention of a novel method
of obesity control.
After identifying the relevant bioactive compound
the CSIR obtained a patent in 1997,
which we licensed to UK-based botanical pharmaceuticals
company Phytopharm for further development. In 1998, the CSIR published
its Bioprospecting Policy, guaranteeing sharing
of 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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