PT  - JOURNAL ARTICLE
AU  - Heather Hamill
AU  - Elizabeth David-Barrett
AU  - Joseph Rogathe Mwanga
AU  - Gerry Mshana
AU  - Kate Hampshire
TI  - Monitoring, reporting and regulating medicine quality: tensions between theory and practice in Tanzania
AID  - 10.1136/bmjgh-2020-003043
DP  - 2021 May 01
TA  - BMJ Global Health
PG  - e003043
VI  - 6
IP  - Suppl 3
4099  - http://gh.bmj.com/content/6/Suppl_3/e003043.short
4100  - http://gh.bmj.com/content/6/Suppl_3/e003043.full
SO  - BMJ Global Health2021 May 01; 6
AB  - 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.Data are available upon request. Data are not publicly available but may be made available on request from heather.hamill@sociology.ox.ac.uk