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

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Version 2 2023-06-12, 09:31
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journal contribution
posted on 2023-06-12, 09:31 authored by Heather Hamill, Elizabeth David-BarrettElizabeth David-Barrett, Joseph Rogathe Mwanga, Gerry Mshana, Kate Hampshire
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.

History

Publication status

  • Published

File Version

  • Published version

Journal

BMJ Global Health

ISSN

2059-7908

Publisher

BMJ Publishing Group

Volume

6

Page range

1-8

Article number

a003043

Department affiliated with

  • Politics Publications

Full text available

  • Yes

Peer reviewed?

  • Yes

Legacy Posted Date

2020-10-06

First Open Access (FOA) Date

2021-06-01

First Compliant Deposit (FCD) Date

2020-10-06

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