Professor Heather Hamill and Dr Fanqi Zeng have renewed their call for stronger regulation to combat the spread of substandard and falsified medicines, writing in Science.
With such medicines widespread across Africa, the African Medicines Agency has the potential to play a crucial role in addressing this global health challenge.
The spread of such medicines is a very real but often neglected global challenge – the World Health Organisation (WHO) suggests that as much as 10% of medicines in lower- and middle-income countries are either substandard (due to low quality) or falsified (due to fraud).
These poor-quality medications can have serious impacts on global health, increasing mortality, causing adverse impacts on health, contributing to loss of faith in healthcare, and increasing antimicrobial resistance worldwide.
The UN has estimated that over a quarter of a million people in sub-Saharan Africa die each year because of faulty antimalarial medicines. A further 169,000 deaths per year are linked to counterfeit and substandard antibiotics.
In order to regulate the quality of all medicines, coordinated leadership and extensive data collection are required.
However, limited coordination between international, national, and local regulatory bodies continues to undermine effective oversight and enforcement.
Professor Hamill and Dr Zeng argue that the African Medicines Agency (AMA), established in 2021, could play a central role in addressing this issue.
An effective AMA could coordinate surveillance, guide policy making, and integrate these countermeasures into broader health initiatives. The AMA could also facilitate a robust consensus on standards for serialisation, track and trace technology, and quality control, which could deter counterfeiters and encourage best practices.
The AMA could also incentivise and foster research partnerships and collaborations with African universities, increasing the database of substandard and falsified medicine prevalence rates.
By facilitating effective quality control and streamlining data collection, the AMA could help to protect millions of African lives from this silent epidemic.
How Oxford Sociology is making a difference
Dr Hamill and Dr Zeng currently work on a project entitled 'Forensic Epidemiology and Impact of Substandard and Falsified Antimicrobials on Public Health' – also known as FORESFA.
They have two major goals:
1. To identify the sources and trade routes of fake medicines using novel genomic, chemical and isotopic analysis (comparing signatures of trace DNA found in falsified, substandard and genuine antimicrobials to determine their characteristic signatures), along with social network techniques.
2. To determine the public health impacts of substandard antimicrobials on patient outcome and global public health, particularly antimicrobial resistance.
Both quantitative and qualitative social network analysis is used to map trade routes and geographical hotspots for counterfeit medicine, identifying the places where increased inspection and regulation may be most effective – techniques previously used to combat the illegal wildlife trade or to counter food fraud.
This includes finding the geographical nodes in trade routes, which if removed, would cause maximum disruption, as well as identifying the nodes best for disseminating educational messaging.
