Realizing Benefit Sharing: Is There a Role for Ethics Review? - Benefit Sharing - page 187

Phase II (basic efficacy), 40% of the rest fail Phase III (comprehensive efficacy)
and 23% of those still in the running will not be approved by the relevant health
agency (Lowe 2004 ). As a result, the chances for any individual participant that
the particular research she or he was involved in will actually lead to a marketable
product are very slim, particularly for donors of biological materials in the early
phases of research, and participants in Phase I and II drug trials.
Even if post-study access could be assured a decade after a study's completion,
it would only benefit those research participants lucky enough to have been part of
bench-to-bed research which overcame all hurdles smoothly. But since those whose
participation shows that a product is unsafe or not efficacious contribute as much to
medical research as their luckier counterparts, one cannot argue that only the latter
are entitled to benefit sharing - and there is no way to predict which participants
will fall into which category. By the time a research ethics committee can establish
which participants will not have an option of post-study access, it is likely to be too
late to ensure any other benefits either. The committees are therefore restricted in
their ability to provide equitable protection for all research participants.
A related problem is that of involvement in basic research, which is not likely
to lead directly to any new medical interventions. In this case, however, research
ethics committees could opt for the choice of 'other benefits' from the start.
8.4.3 Inbuilt Unfairness in Post-study Access and Possible
Side Effects
It has been argued that imposing post-study obligations on researchers or their spon-
sors could mean that developing country research focused on local health needs
would not be undertaken due to prohibitive costs (Brody 2002 : 2857; McMillan
and Conlon 2004 : 206). One could respond with Solomon Benatar that '[r]equiring
greater sensitivity to the plight of the poor and some degree of solidarity with them
is not an excessive moral requirement' (Shapiro and Benatar 2005 : 42).
However, this could mean that attempts to achieve compliance with the ben-
efit-sharing regulations of the Declaration of Helsinki in order to achieve justice
for resource providers in line with the CBD might be self-defeating. Currently,
the demand to provide post-study access to successfully tested interventions
applies equally to researchers who are using charitable funds to develop drugs
for neglected diseases that only exist in, say, South East Asia, and pharmaceuti-
cal companies running clinical trials in developing countries for diseases that are
prevalent and widespread in the North. However, the former is arguably not a case
of exploitation, whereas the latter could be. Benefit sharing is intended to be an
instrument to mitigate such exploitation. Yet if the mechanism is so coarse that it
makes valuable (and arguably non-exploitative) research prohibitively costly, then
enforcing benefit sharing through ethics review could undermine global efforts to
realise access to locally tailored health care. In this case, the global injustice in