Quality of medicines in resource-limited settings: need for ethical guidance
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...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2018-01-01
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| Series: | Global Bioethics |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/11287462.2018.1522991 |
| _version_ | 1819263028790558720 |
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| author | Raffaella Ravinetto Wim Pinxten Lembit Rägo |
| author_facet | Raffaella Ravinetto Wim Pinxten Lembit Rägo |
| author_sort | Raffaella Ravinetto |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-23T20:07:05Z |
| format | Article |
| id | doaj.art-29ab21d9a10b4e0695bb2d4446581aa5 |
| institution | Directory Open Access Journal |
| issn | 1128-7462 1591-7398 |
| language | English |
| last_indexed | 2024-12-23T20:07:05Z |
| publishDate | 2018-01-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Global Bioethics |
| spelling | doaj.art-29ab21d9a10b4e0695bb2d4446581aa52022-12-21T17:32:54ZengTaylor & Francis GroupGlobal Bioethics1128-74621591-73982018-01-01291819410.1080/11287462.2018.15229911522991Quality of medicines in resource-limited settings: need for ethical guidanceRaffaella Ravinetto0Wim Pinxten1Lembit Rägo2Institute of Tropical MedicineHasselt UniversityCouncil for International Organizations of Medical Sciences (CIOMS)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.http://dx.doi.org/10.1080/11287462.2018.1522991Quality of medicinesethicsbeneficencejusticedeveloping countries |
| spellingShingle | Raffaella Ravinetto Wim Pinxten Lembit Rägo Quality of medicines in resource-limited settings: need for ethical guidance Global Bioethics Quality of medicines ethics beneficence justice developing countries |
| title | Quality of medicines in resource-limited settings: need for ethical guidance |
| title_full | Quality of medicines in resource-limited settings: need for ethical guidance |
| title_fullStr | Quality of medicines in resource-limited settings: need for ethical guidance |
| title_full_unstemmed | Quality of medicines in resource-limited settings: need for ethical guidance |
| title_short | Quality of medicines in resource-limited settings: need for ethical guidance |
| title_sort | quality of medicines in resource limited settings need for ethical guidance |
| topic | Quality of medicines ethics beneficence justice developing countries |
| url | http://dx.doi.org/10.1080/11287462.2018.1522991 |
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