Quality of medicines in resource-limited settings: need for ethical guidance.

Raffaella Ravinetto, Wim Pinxten, Lembit Rägo

Research output: Contribution to journalA1: Web of Science-articlepeer-review

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The quality of medicines is generally adequately assured by
manufacturers and regulatory authorities for well-resourced
settings, while the implementation of existing quality standards is
challenged in many low- and middle-income countries. This
situation of multiple pharmaceutical standards raises the question
whether it could ever be ethically justified to compromise on the
quality assurance of medicines depending on what individuals,
communities, or societies can afford. In this paper, we contend
that ethically, any unjustified exceptions to medicines’ quality
assurance represents a violation of the principles of beneficence
and non-maleficence. Exceptions are only acceptable in
exceptional and temporary circumstances, if based on a
meaningful quality risk assessment, guided by a rigorous ethical
framework built on the principles of independence, technical
competence, transparency, and accountability. We also discuss
how such exceptional and temporary circumstances should be
defined/justified. Finally, we propose that empirical bioethics
should acknowledge the existence of these dilemmas in public
health, and help to build a normative approach to dealing with
them. Ideally, an international group of experts in quality
assurance/regulatory affairs and health ethicists should be set up
to take up this topic and formulate a Guide to Ethical Principles of
Quality Assurance of Medical Products.
Original languageEnglish
Article numberDOI:
JournalGlobal Bioethics
Issue number1
Pages (from-to)81-94
Number of pages13
Publication statusPublished - 2018


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