Monitoring, reporting and regulating medicine quality
Tensions between theory and practice in Tanzania
Bibliographic Data
| ID | 21878956 |
|---|---|
| Authors | Heather Hamill (0000-0002-0301-7057, University of Oxford, corresponding author), Elizabeth David-Barrett (0000-0001-9761-8824, University of Sussex), J R Mwanga (0000-0002-0277-227X, Catholic University of Health and Allied Sciences), Gerry Mshana (0000-0001-8753-7561, National Institute for Medical Research), K Hampshire (0000-0003-4184-849X, Durham University) |
| Year | 2021 |
| Volume | 6 |
| Issue | Suppl 3 |
| Pages | e003043 |
| Publication date | 2021-05-01 |
| Peer Reviewed | Yes |
| Open Access | Yes |
| Type | ARTICLE |
| Venue | BMJ Global Health (JOURNAL) |
| Journal identifiers | ISSN: 2059-7908 • E-ISSN: 2059-7908 |
| Publisher | BMJ (PUBLISHER • GB) |
| DOI | 10.1136/bmjgh-2020-003043 |
| PMID | 34049934 |
| OpenAlex | W3110834449 |
| Language | EN |
| Citations received | 6 |
| References cited | 30 |
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
Business · Corporate governance · Economics · Enforcement · Misconduct · Political science · Public economics · Public relations · Tanzania · Intellectual Property and Patents · Law · Pharmaceutical Economics and Policy · Pharmaceutical Quality and Counterfeiting · Finance
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| Unique citing works | 6 |
|---|---|
| Citations per year | 1,5 |
| Citation span | 2022 - 2025 (4) |
| Citation velocity | recent |
| Highly cited | No |
| Citation types | Neutral: 6 |