Following the demise of apartheid, human rights in South Africa are now
constitutionally enshrined.The right to health in South Africa's Constitution has been credited with transforming the lives
of millions of people by triggering programmatic reforms in HIV treatment and the
prevention of mother to child transmission (MTCT) of HIV.However, a constitutionally
enshrined right to health offers
no guarantee that clinical trial participants will
enjoy post-trial access to beneficial
interventions. Using access to HIV
pre-exposure prophylaxis (PrEP) in South Africa as an
example, this paper argues that adherence to bioethics norms
could realize the right to health for trial participants following
the end of a clinical trial.
…While
ethical norms have pressured sponsors and investigators to realize post-trial access
of beneficial agents, access mechanisms such as implementation trials and open label
extension studies only offer post-trial access to beneficial interventions for a
limited duration. For example, iPrex OLE study participants, globally, lost their
access to PreP at the conclusion of the follow-up open label extension trial. However, as Truvada
is licensed in South Africa as a treatment drug, iPrex study participants in South
Africa can access Truvada off-label through the private sector.This is not possible
for participants in countries where Truvada is not licensed, even as a treatment
drug. Given the negative results of
the Phase 3 FACTS 001 trial because of poor adherence on the part of trial participants,
it is possible that Tenofovir gel will not be licensed in South Africa or anywhere
else as a topical PrEP, despite its efficacy being demonstrated in the earlier Phase
2b CAPRISA 004 trial. Accordingly, the participants of CAPRISA 008 may not enjoy long-term
access to Tenofovir gel, and cannot gain off-label access as it is not licensed
in South Africa or anywhere else. Furthermore, Tenofovir gel is not being produced
commercially, as it was created by the drug sponsor exclusively for use in the CAPRISA
004, FACTS 001, and CAPRISA 008 trials. This speaks to the limits of post-trial
access ethical obligations in realizing health access in the long term, and for
bioethics and human rights to play a synergistic role in ensuring that post-trial
access is initiated and sustained. To this end, post-trial access ethical obligations
could help establish a continuum of access and care by facilitating health access
to trial participants in the short-term—particularly before licensure—while the
right to health could realize long-term, sustained access to the intervention in
the public sector following licensure….
Full article at: http://goo.gl/Llt7To
By:
1Head of Ethics and Law, Center for the AIDS Programme
of Research in South Africa (CAPRISA), University of
KwaZulu-Natal, Durban, SouthAfrica, and Adjunct Professor at the Dalla
Lana School of Public Health and Joint Centre for Bioethics,
University of Toronto, Canada.
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