Biology Reference
In-Depth Information
co-operation with specific responsibilities around the supply of raw plant materi-
als for product development, and as an author of all publications, while acknowl-
edging his right to continue using his own medical knowledge independently.
However, this had limited impact upon the subsequent negotiations to license
the rights to develop the promising new drug, under the trade name Nicosan, to
the US-based, Indian-owned company Xechem International. The entire research
team at the NIPRD, including the traditional health practitioner, was excluded
from these negotiations, which were undertaken by NIPRD management.
The outcome of this process was that, in terms of the MOU, the traditional
health practitioner was entitled to a share of a good faith payment (US$115,000),
plus 10% in perpetuity of the royalties which the NIPRD would receive from the
licensee (7.5% of gross sales).
16
However, despite Xechem's prompt payment of
its obligations to the NIPRD, no monetary benefits have been received by the tra-
ditional health practitioner (or, since his death, by his trust), which raises concerns
about the monitoring and enforcement of such agreements, even where they are of
a model status.
With regard to benefit sharing, it has been suggested that by virtue of their sta-
tus as indigenes of Oyo town, the community where Rev. Ogunyale lived should
also have benefited from the commercialization of Niprisan. However, this was not
considered during the negotiations (Wambebe
2007
: 13). Another area of concern
regarding sharing the benefits of this research relates to clinical trials for Niprisan
carried out by the NIPRD with sickle-cell disease patients in two Nigerian cities.
The price of the drug, when it entered the market as Nicosan, was not afforda-
ble for poor sickle-cell disease patients. Therefore, as has been noted retrospec-
tively (Wambebe
2007
: 13-14), since the cooperation of trial participants had been
needed to generate valuable clinical data, it would have been appropriate for the
licensee to make provision for a supply of Nicosan to those participants for life,
either free or at a much reduced fixed rate that any of them could afford (for exam-
ple, US$1 per month's supply). In fact, the duty to provide patients with access to
the medicine for which they have been study participants has been enshrined in
the Declaration of Helsinki since 2000 (WMA
2000
: paragraph 30) (for current
The significance of the Niprisan/Nicosan case is that the project was initiated
and executed by African scientists working in Africa at a time when international
provisions for benefit sharing regarding commercial products derived from indig-
enous medical knowledge were unavailable. The licensing of Niprisan to a US
company was the first case of reverse transfer of medical technology (medicine)
in Africa, and expanded interest in investigations based on African medicine. The
subsequent bankruptcy of Xechem, however, prompted the Nigerian government to
terminate the licence agreement. In March 2009 it was announced that the NIPRD
was taking over production of the drug in Nigeria. This was welcomed as a good
development for the country, with the potential for poor patients to access the drug
16
A royalty of 7.5% falls within the global practice range (Ten Kate and Laird
1999
: 68).
