This report is a “shallow” investigation, as described here, and was commissioned by Open Philanthropy and produced by Rethink Priorities from November 2022 to January 2023. We revised the report for publication. Open Philanthropy does not necessarily endorse our conclusions, nor do the organizations represented by those who were interviewed.
The report focuses on assessing the health burden of substandard and falsified antimalarials in sub-Saharan Africa and discusses current and potentially promising interventions to combat the problem. We initially considered the problem for a variety of drugs across low- and middle-income countries. We then narrowed the scope to antimalarials in sub-Saharan Africa due to better data availability than for other drugs and regions and high rates of substandard and falsified drugs. We reviewed the scientific and gray literature and spoke with six experts.
We do not intend this report to be Rethink Priorities’ final word on substandard and falsified drugs. We tried to flag major sources of uncertainty in the report and are open to revising our views based on new information or further research.
Executive summary
The evidence base on substandard and falsified (S&F) drugs is poor. The best available data has focused on antimalarials in sub-Saharan Africa (SSA). Therefore, this report focuses on S&F antimalarials in SSA, which also appear to have a particularly high prevalence (~19%). S&F antimalarials negatively affect health mainly through reduced treatment effectiveness. We estimate that they cause about 40k-160k deaths and 1M-3M DALYs per year in SSA (80% confidence interval), corresponding to up to one out of four deaths and one out of five DALYs due to malaria in SSA. If we also consider S&F antimalarials’ potential to contribute to widespread artemisinin resistance in SSA, we estimate the health burden could increase by up to 50k deaths and 600k DALYs.
Our best (low confidence) guess is that among S&F antimalarials, 10% are falsified (in the sense that no active pharmaceutical ingredient [API] is present), 5% are substandard but essentially ineffective (due to an API too low to have any effect), and 85% are substandard but still have some, albeit reduced, effectiveness. The high percentage of S&F antimalarials implies that the most promising interventions are likely related to improving quality assurance in manufacturing and storage/transportation rather than to mitigating criminal intent.
Several features of the market for antimalarials in SSA make us pessimistic about tractability. We think it is likely that most S&F ACTs are sold in the private sector (low-confidence estimate: 65%-85%), with 15-20% (70% confidence interval) higher prevalence than in the public sector. Private pharmacies and informal markets will likely be hard to affect in SSA without strong state capacity and political will. The market is also highly fractured, with ~15 prequalified manufacturers and 140-210 (75% confidence interval) manufacturers of non-prequalified ACTs globally.
We created a table that shows our assessment of 24 potential interventions, including our thoughts on tractability and some information about who is currently working on this research and whether there is room for more funding. Our sense is that the most prominent players are the Bill and Melinda Gates Foundation (BMGF), WHO, and United States Pharmacopeia (USP), which is associated with USAID. A low-confidence estimate of total philanthropic spending is $30m-$50m per year, with a large proportion of the money being spent by BMGF on strengthening (regional) regulatory systems.
Overall, we did not find any single intervention we thought would be highly effective and tractable. Two of our top suggestions would be to:
Limit purchasing of S&F ACTs by consumers through funding subsidized high-quality ACTs in the public sector in order to crowd out S&F ACTs and reduce the overall cost of drugs. It’s possible that this could be achieved by supporting Living Goods’ program, and an RCT was conducted between 2016 and 2021 to measure its impact (results unpublished at the time of writing).
Collect data to inform interventions, by extending a BMGF-funded prevalence study to more countries or augmenting the types of data collected.
Limited data points to S&F antihypertensives potentially having a similar burden to S&F antimalarials. As most antihypertensives are used in LMICs outside of SSA, the tractability of potential interventions might be higher in those countries due to a possibly higher state capacity to support interventions. Future work could explore this issue in more detail.
To read the full report, please visit Rethink Priorities’ website or download the PDF.
Read the full report
Acknowledgments
Aisling Leow and Jenny Kudymowa jointly researched and wrote this report. Aisling Leow also served as the project lead. Tom Hird supervised this report. Thanks to Tom Hird and Melanie Basnak for helpful comments on drafts. Further thanks to Deo Cibinda, Michael Deats (University of Oxford), Harparkash Kaur (London School of Hygiene & Tropical Medicine), Andrew Moran (Resolve to Save Lives), Paul Newton (University of Oxford), and Nicholas White (University of Oxford) for taking the time to speak with us. Open Philanthropy provided funding for this report, but it does not necessarily endorse our conclusions.
We invite you to explore more RP research via our database and stay updated on new work by subscribing to our newsletter.
Substandard and falsified antimalarials in sub-Saharan Africa: Health burden and potential interventions
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Editorial Note
This report is a “shallow” investigation, as described here, and was commissioned by Open Philanthropy and produced by Rethink Priorities from November 2022 to January 2023. We revised the report for publication. Open Philanthropy does not necessarily endorse our conclusions, nor do the organizations represented by those who were interviewed.
The report focuses on assessing the health burden of substandard and falsified antimalarials in sub-Saharan Africa and discusses current and potentially promising interventions to combat the problem. We initially considered the problem for a variety of drugs across low- and middle-income countries. We then narrowed the scope to antimalarials in sub-Saharan Africa due to better data availability than for other drugs and regions and high rates of substandard and falsified drugs. We reviewed the scientific and gray literature and spoke with six experts.
We do not intend this report to be Rethink Priorities’ final word on substandard and falsified drugs. We tried to flag major sources of uncertainty in the report and are open to revising our views based on new information or further research.
Executive summary
The evidence base on substandard and falsified (S&F) drugs is poor. The best available data has focused on antimalarials in sub-Saharan Africa (SSA). Therefore, this report focuses on S&F antimalarials in SSA, which also appear to have a particularly high prevalence (~19%). S&F antimalarials negatively affect health mainly through reduced treatment effectiveness. We estimate that they cause about 40k-160k deaths and 1M-3M DALYs per year in SSA (80% confidence interval), corresponding to up to one out of four deaths and one out of five DALYs due to malaria in SSA. If we also consider S&F antimalarials’ potential to contribute to widespread artemisinin resistance in SSA, we estimate the health burden could increase by up to 50k deaths and 600k DALYs.
Our best (low confidence) guess is that among S&F antimalarials, 10% are falsified (in the sense that no active pharmaceutical ingredient [API] is present), 5% are substandard but essentially ineffective (due to an API too low to have any effect), and 85% are substandard but still have some, albeit reduced, effectiveness. The high percentage of S&F antimalarials implies that the most promising interventions are likely related to improving quality assurance in manufacturing and storage/transportation rather than to mitigating criminal intent.
Several features of the market for antimalarials in SSA make us pessimistic about tractability. We think it is likely that most S&F ACTs are sold in the private sector (low-confidence estimate: 65%-85%), with 15-20% (70% confidence interval) higher prevalence than in the public sector. Private pharmacies and informal markets will likely be hard to affect in SSA without strong state capacity and political will. The market is also highly fractured, with ~15 prequalified manufacturers and 140-210 (75% confidence interval) manufacturers of non-prequalified ACTs globally.
We created a table that shows our assessment of 24 potential interventions, including our thoughts on tractability and some information about who is currently working on this research and whether there is room for more funding. Our sense is that the most prominent players are the Bill and Melinda Gates Foundation (BMGF), WHO, and United States Pharmacopeia (USP), which is associated with USAID. A low-confidence estimate of total philanthropic spending is $30m-$50m per year, with a large proportion of the money being spent by BMGF on strengthening (regional) regulatory systems.
Overall, we did not find any single intervention we thought would be highly effective and tractable. Two of our top suggestions would be to:
Limit purchasing of S&F ACTs by consumers through funding subsidized high-quality ACTs in the public sector in order to crowd out S&F ACTs and reduce the overall cost of drugs. It’s possible that this could be achieved by supporting Living Goods’ program, and an RCT was conducted between 2016 and 2021 to measure its impact (results unpublished at the time of writing).
Collect data to inform interventions, by extending a BMGF-funded prevalence study to more countries or augmenting the types of data collected.
Limited data points to S&F antihypertensives potentially having a similar burden to S&F antimalarials. As most antihypertensives are used in LMICs outside of SSA, the tractability of potential interventions might be higher in those countries due to a possibly higher state capacity to support interventions. Future work could explore this issue in more detail.
To read the full report, please visit Rethink Priorities’ website or download the PDF.
Read the full reportAcknowledgments
Aisling Leow and Jenny Kudymowa jointly researched and wrote this report. Aisling Leow also served as the project lead. Tom Hird supervised this report. Thanks to Tom Hird and Melanie Basnak for helpful comments on drafts. Further thanks to Deo Cibinda, Michael Deats (University of Oxford), Harparkash Kaur (London School of Hygiene & Tropical Medicine), Andrew Moran (Resolve to Save Lives), Paul Newton (University of Oxford), and Nicholas White (University of Oxford) for taking the time to speak with us. Open Philanthropy provided funding for this report, but it does not necessarily endorse our conclusions.
We invite you to explore more RP research via our database and stay updated on new work by subscribing to our newsletter.