Global Bioethics 29 (1):81-94 (2018)

ABSTRACTThe 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....
Keywords No keywords specified (fix it)
Categories No categories specified
(categorize this paper)
DOI 10.1080/11287462.2018.1522991
Edit this record
Mark as duplicate
Export citation
Find it on Scholar
Request removal from index
Revision history

Download options

PhilArchive copy

Upload a copy of this paper     Check publisher's policy     Papers currently archived: 63,299
Through your library

References found in this work BETA

The Nuremberg Code.[author unknown] - 1991 - Journal of Law, Medicine and Ethics 19 (3-4):266-266.

Add more references

Citations of this work BETA

No citations found.

Add more citations

Similar books and articles

What Does Quality in Health Care Mean?Franziska Pruetz - 2012 - Ethik in der Medizin 24 (2):105-115.
Supply of Medicines: Paternalism, Autonomy and Reality.D. Prayle & M. Brazier - 1998 - Journal of Medical Ethics 24 (2):93-98.
Can Designing and Selling Low-Quality Products Be Ethical?I. I. Bakker & Michael C. Loui - 1997 - Science and Engineering Ethics 3 (2):153-170.
Can Designing and Selling Low-Quality Products Be Ethical?Willem Bakker & Michael C. Loui - 1997 - Science and Engineering Ethics 3 (2):153-170.
The Concept of Quality in Clinical Research.Dorota Śwituła - 2006 - Science and Engineering Ethics 12 (1):147-156.
Transparency in Medicines Regulatory Affairs Reclaiming Missed Opportunities.Y. A. Vawda & A. Gray - 2017 - South African Journal of Bioethics and Law 10 (2):69-74.


Added to PP index

Total views
5 ( #1,171,171 of 2,448,711 )

Recent downloads (6 months)
3 ( #225,345 of 2,448,711 )

How can I increase my downloads?


My notes