A new paper co-authored by Professor Heather Hamill and Dr Fanqi Zeng finds that most studies on substandard and false medicines in Africa are led by Global North researchers and focus on single countries, with limited regional collaboration.
The study, published in Nature Communications, outlines five recommendations to increase Africa-led, cross-national research on medicine quality, which the authors argue is critical to addressing the widespread problem of substandard medicines.
Substandard and falsified (SF) medicines are a growing threat to health systems across Africa. They undermine treatment efficacy, drive antimicrobial resistance, and cause preventable deaths, yet the scale of the problem remains poorly understood.
The systematic collection, testing, and reporting of information on medicine quality – activities that enable regulators to identify and trace SF products – is fragmented, under-funded or externally driven in many African countries, leaving significant gaps in national and regional coverage.
Dr Fanqi Zeng explains:
The fight against substandard and falsified medicines is often framed as a regulatory challenge. Yet, it is equally a research challenge. Africa cannot regulate what it cannot see, and it cannot see what it has not studied.
The current evidence base on SF medicines in Africa is too sparse, skewed, and externally driven to support meaningful and sustained progress.
To demonstrate this, the paper analysed over 250 research articles on false or substandard medicines worldwide, published between 1963-2021. Around 50% of the papers included African sampling records, but these disproportionately focused on a few countries: Nigeria, Ghana, the Democratic Republic of Congo, and Kenya. Most African countries were absent from the literature.
Additionally, the majority of the studies were led by countries in the Global North, and were conducted locally within individual countries with little collaboration across borders.
Moreover, the types of medicines studied in Africa were narrowly clustered around antibiotics and antimalarials. Other drug classes, including those targeting non-communicable diseases, were significantly underrepresented.
This uneven evidence base undermines the capacity of African regulators to make informed decisions, hampering efforts to coordinate surveillance, target interventions, and evaluate the effectiveness of reforms.
The authors stress that intra-African research collaboration on SF medicines is essential. Locally grounded research enables context-sensitive detection and response, and gives national regulators data reflecting their specific pharmaceutical markets and border dynamics.
But given porous borders and inter-country pharmaceutical trade, national approaches cannot succeed in isolation – collaboration across African countries allows for the identification of transnational patterns in the circulation of poor-quality medicines.
Furthermore, research collaboration fosters the development of local expertise and leadership, crucial not just for tackling the trade of falsified medicines but for broader health system resilience and pharmaceutical policy innovation in general.
The paper calls for five steps to build this infrastructure of collaboration across Africa:
- Dedicated funding mechanisms for Africa-led, cross-national research on medicine quality
- Incentives for South-South collaboration that require co-leadership between institutions in different African countries for projects investigating transnational SF medicine flows
- Support for open-access data platforms and regional knowledge-sharing hubs, enabling real-time sharing of SF medicine sampling data
- Integration of research functions within national regulatory agencies, through the establishment of partnerships with universities
- Robust evaluation frameworks to examine the social, economic, and supply chain conditions that enable the circulation of SF medicines
The study concludes:
Substandard and falsified medicines are a global health threat. Ensuring they are properly studied, tracked, and defeated in Africa is not only an African priority but a global responsibility.
