Challenges and prospects of the regional bioequivalence center initiative in Ethiopia: a qualitative study.
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Date
2020-10
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
Addis Abeba University
Abstract
Background: Evaluation of the interchangeability of multi-source generic drug products or bioequivalence
study has become a crucial activity since the share of generic medicines in
healthcare has enormously grown over the past few decades. Among four East African Countries,
namely, Ethiopia, Kenya, Uganda and Tanzania, there has been an initiative to establish
an accessible and affordable BE center for the regional pharmaceutical manufacturers. This
study aims at assessing the challenges and prospects of the bioequivalence center initiative in
Ethiopia.
Methods: In-depth interview was conducted with individuals who were Ethiopian affiliates of the
Regional Bioequivalence initiative; local pharmaceutical manufacturers, Ethiopian Food and
Drug Administration, Regional Bioequivalence Center and other key stakeholders who are involved
in the center capacity building. Data were collected using digital voice recorders, and
transcribed. These data were analyzed using an inductive thematic analysis using Nvivo software
and the findings were presented in narratives using the respondent‟s own words as illustrations.
Results: Based on the findings, four major themes, one as an opportunity and three as challenges,
were
identified.
The
mere
presence
of
the
Regional
Bioequivalence
Center
by
itself
was
considered
as
an
opportunity
by
most
of
the
participants.
In
addition,
a
number of favorable conditions
including
awareness
and
demand
for
product
quality
and
diversity,
the
presence
of
attractive
incentive
packages for local pharmaceutical manufacturers and the proliferation of the generic
medicines market in the region were mentioned as opportunities. On the other hand, lack
of resources and stakeholders‟ commitment as well as lack of regulatory enforcement were identified
as
challenges.
Conclusions:
The Bioequivalence center initiative has not functioned well as initially planned.
The findings of this study suggest the need for government and key stakeholders to actively engage
in the program to make the initiative viable. The significance of supporting this initiative
could positively contribute to the creation of a competitive local manufacturing sector that will
engage in the production of therapeutically interchangeable generic products and ultimately
safeguard the health of the society at large.
Description
Keywords
Bioavailability, Bioequivalence, Generic drugs, Ethiopia