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Monitoring, reporting and regulating medicine quality: tensions between theory and practice in Tanzania

In 2012, the WHO launched its Global Surveillance and Monitoring System (GSMS) for substandard and falsified medicines, with the aim of improving the quality of reporting and using the data to inform post-market surveillance and build regulatory capacity. However, from a regulatory governance perspe...

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Autores principales: Hamill, Heather, David-Barrett, Elizabeth, Mwanga, Joseph Rogathe, Mshana, Gerry, Hampshire, Kate
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8166622/
https://www.ncbi.nlm.nih.gov/pubmed/34049934
http://dx.doi.org/10.1136/bmjgh-2020-003043
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author Hamill, Heather
David-Barrett, Elizabeth
Mwanga, Joseph Rogathe
Mshana, Gerry
Hampshire, Kate
author_facet Hamill, Heather
David-Barrett, Elizabeth
Mwanga, Joseph Rogathe
Mshana, Gerry
Hampshire, Kate
author_sort Hamill, Heather
collection PubMed
description In 2012, the WHO launched its Global Surveillance and Monitoring System (GSMS) for substandard and falsified medicines, with the aim of improving the quality of reporting and using the data to inform post-market surveillance and build regulatory capacity. However, from a regulatory governance perspective, its effectiveness depends on the willingness and ability of actors ‘on the ground’ to identify, report and investigate possible infringements and to enforce penalties. This paper presents findings from 27 interviews with representatives of agencies charged with regulating pharmaceutical markets and 4 interviews with pharmaceutical industry representatives in Tanzania. Their experiences provide important insights into how the theorised mechanism between reporting and a reduction in undesirable behaviours can play out in a low-income context, revealing hidden assumptions about regulator behaviour and motivations. A combination of chronic under-resourcing, information gaps and enforcement challenges conspires to limit the efforts of local regulators to achieve the GSMS goals, shedding new light on the relationship between apparent ‘misconduct’ and structural constraints.
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spelling pubmed-81666222021-06-14 Monitoring, reporting and regulating medicine quality: tensions between theory and practice in Tanzania Hamill, Heather David-Barrett, Elizabeth Mwanga, Joseph Rogathe Mshana, Gerry Hampshire, Kate BMJ Glob Health Original Research In 2012, the WHO launched its Global Surveillance and Monitoring System (GSMS) for substandard and falsified medicines, with the aim of improving the quality of reporting and using the data to inform post-market surveillance and build regulatory capacity. However, from a regulatory governance perspective, its effectiveness depends on the willingness and ability of actors ‘on the ground’ to identify, report and investigate possible infringements and to enforce penalties. This paper presents findings from 27 interviews with representatives of agencies charged with regulating pharmaceutical markets and 4 interviews with pharmaceutical industry representatives in Tanzania. Their experiences provide important insights into how the theorised mechanism between reporting and a reduction in undesirable behaviours can play out in a low-income context, revealing hidden assumptions about regulator behaviour and motivations. A combination of chronic under-resourcing, information gaps and enforcement challenges conspires to limit the efforts of local regulators to achieve the GSMS goals, shedding new light on the relationship between apparent ‘misconduct’ and structural constraints. BMJ Publishing Group 2021-05-28 /pmc/articles/PMC8166622/ /pubmed/34049934 http://dx.doi.org/10.1136/bmjgh-2020-003043 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
spellingShingle Original Research
Hamill, Heather
David-Barrett, Elizabeth
Mwanga, Joseph Rogathe
Mshana, Gerry
Hampshire, Kate
Monitoring, reporting and regulating medicine quality: tensions between theory and practice in Tanzania
title Monitoring, reporting and regulating medicine quality: tensions between theory and practice in Tanzania
title_full Monitoring, reporting and regulating medicine quality: tensions between theory and practice in Tanzania
title_fullStr Monitoring, reporting and regulating medicine quality: tensions between theory and practice in Tanzania
title_full_unstemmed Monitoring, reporting and regulating medicine quality: tensions between theory and practice in Tanzania
title_short Monitoring, reporting and regulating medicine quality: tensions between theory and practice in Tanzania
title_sort monitoring, reporting and regulating medicine quality: tensions between theory and practice in tanzania
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8166622/
https://www.ncbi.nlm.nih.gov/pubmed/34049934
http://dx.doi.org/10.1136/bmjgh-2020-003043
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