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

Abstract

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.

Insights from a qualitative study of the procurement and manufacture of active pharmaceutical ingredients in India

“…The structural causes of the problem of poor-quality medicines are well documented. Resource-poor populations and high disease burdens create a ready market for cheap medicines, while under-resourced regulatory agencies and weak judicial systems provide little incentive for suppliers to prioritise quality over profits 7. These ‘hard’ economic facts have confounded efforts by national/international agencies to curb the problem through tightening regulation, improving detection rates and public education campaigns 8 9.…”

“It is very difficult in this business if you want to have a good conscience”: pharmaceutical governance and on-the-ground ethical labour in Ghana

“…They propose that “an international group of experts in quality assurance/regulatory affairs and health ethicists” be established to oversee and formulate appropriate ethical responses. While it is difficult to argue against this conclusion, the ideal of an “international group of experts” making well-informed, independent assessments is a far cry from the current reality of over-stretched, under-resourced regulatory agencies typical of many LMIC contexts (Hamill et al, 2021 ). In practice, as we show below, many decisions are taken by people working “on the ground”, far away from government offices where standards and protocols are drawn up.…”

Uncertainties about the quality of medical products globally: lessons from multidisciplinary research

“…Noor et al presented the findings of a study in Pakistan, which reveals and explains the potential distortion of prescribing behaviour, caused by pharmaceutical marketing and financial incentivisation to general practitioners 11. Hamill et al drew on interviews with manufacturers and regulators in India to investigate the under-studied issue of quality of active pharmaceutical ingredients, and called for increased attention to the risks of regulatory circumvention 12. Nistor et al discussed how political and economic factors influence the risk of falsified medicines in Romania: they warned against exclusive focus on enforcing quality-assurance, reminding that ensuring access to affordable medicines is equally critical to eliminate the factors that incentivise falsified medicines 13.…”

“…Kootstra and Kleinhout-Vliek presented a realist review of pharmaceutical track-and-trace systems, with the Turkish system used as a benchmark; their findings emphasise the interplay between technical solutions, contextual factors, and the need to align incentives for all actors in a continuous implementation process 15. Finally, Hamill et al looked at the ‘on the ground’ effectiveness of the WHO Global Surveillance and Monitoring System for SF medicines in Tanzania; they provided important insights into how the theorised mechanism between technical reporting and a reduction in undesirable behaviours plays out in a low-income setting, and revealed hidden assumptions about regulator behaviour and motivations 16…”