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

Abstract

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.

Quality assurance systems of pharmaceutical distributors in low-income and middle-income countries: weaknesses and ways forward

“…[23][24][25] It is important not to guess, but to ensure the quality of medicines, and the quality systems of manufacturers and distributors. 26 WHO provides guidance on good practices globally. 27 28 Two guidelines are of particular interest for procurement and supply: the 2020 Good Distribution and Storage Practices for medical products (GDP) 29 and the 2014 Model Quality Assurance System for Procurement Agencies (MQAS).…”

“…31 Their customers are often insufficiently aware of risks entailed by poor management of medicines. 26 32 In 2017, our group published an evaluation of the WHO MQAS-compliance of public and non-for-profit international and national procurement agencies active in sub-Saharan Africa, showing insufficient compliance with stringent criteria, particularly for prequalification (PQ) of products and suppliers. 33 In 2018, we published an evaluation of the quality assurance (QA) system of private pharmaceutical distributors in 13 LMICs, which found a low compliance with WHO GDP standards.…”

The importance of visual inspection in national quality assurance systems for medicines

“…In summary, these real-life cases indicate that a careful visual inspection, i.e., a simple and inexpensive technology, is of paramount importance in monitoring the quality of medicines not only in the field, but also at central level. In a pharmaceutical scenario characterized by a situation of multiple quality standards [7][8][9][10], complex distribution networks [11,12], and weaknesses of the pharmaceutical systems [13,14], it can provide additional important guidance to timely recall suspicious batches, to revoke marketing authorizations of unreliable suppliers, and to protect public health [15]. Central medical stores and regulatory agencies need to consider the visual inspection as part of their prequalification and ongoing requalification system.…”

Universal health coverage: drug quality and affordability can go together

“…Risks are magnified if organisations buy drugs based exclusively on pricing considerations without stringent prerequisites for quality standards. Focusing on minimising the direct cost of drugs neglects to take into account their value—a cheaper, substandard medicine may harm the patient and a failure to cure will eventually impose higher costs on the health system 5…”

“…We believe, however, that quality and affordability can go together—as shown by the World Health Organization’s prequalification programme (WHO PQP)6 and the Medicines Patent Pool7—and that incentives to invest in pharmaceutical quality assurance may even descend from the market, as prices are not only linked to manufacturing costs but also to manufacturing volumes and market opportunities 5. In many cases, WHO PQP brought international procurement prices of quality assured drugs down, because manufacturers that invested in WHO PQP were indirectly rewarded through access to markets and, in turn, they had the opportunity for economies of scale 56…”