Evidence map›Paper›PMID 39802455›Full record

ArticleJournal of pharmaceutical policy and practice2025

Understanding the regulatory-procurement interface for medicines in Africa via publicly available information on standards, implementation, and enforcement in five countries.

Jillian C Kohler, Mariangela Castro-Arteaga, Saher Panjwani, David Mukanga, Murray M Lumpkin, Bonface Fundafunda, Anthony B Kapeta, Chimwemwe Chamdimba, Anna S Y Wong, Kristin N Harper and 1 more

Abstract read
In one paragraph

Article in Journal of pharmaceutical policy and practice, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Jillian C KohlerLeslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Canada.
Mariangela Castro-ArteagaDalla Lana School of Public Health, University of Toronto, Toronto, Canada.
Saher PanjwaniDepartment of Philosophy, Rotman Institute of Philosophy, Western University, London, Canada.
David MukangaBill & Melinda Gates Foundation, Seattle, WA, USA.
Murray M LumpkinBill & Melinda Gates Foundation, Seattle, WA, USA.
Bonface FundafundaAfrica Resource Centre, Cape Town, South Africa.
Anthony B KapetaAUDA-NEPAD, Midrand, South Africa.
Chimwemwe ChamdimbaAUDA-NEPAD, Midrand, South Africa.
Anna S Y WongLeslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Canada.
Kristin N HarperHarper Health & Science Communications LLC, Seattle, WA, USA.
Charles PrestonBill & Melinda Gates Foundation, Seattle, WA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Substandard and falsified medicines in Africa are a major public health concern. Access to quality medical products in African countries is governed in large part by two major entities at the national level: the regulatory authority and the procurement agency. The importance of national regulators in ensuring quality medical products is well known. The interplay between the national regulator and the national procurement agency also has a significant impact on access to quality medicines but is less understood. This study's aim was to characterise the regulatory-procurement interface - the intersection of decision-making in these two spheres - using publicly available data from five African countries. Methods: For the five target countries, we adapted criteria from WHO's 2018 Results: Though legal and policy frameworks enabling best practices in procurement were often in place, implementation and enforcement of these practices appear to be key areas for strengthening. In addition, we documented a lack of publicly available information related to the role that quality plays in selecting medical products. Finally, none of the five countries have publicly published the results of their selection decisions with key product details, making it difficult to assess whether basic quality standards are being met. Conclusion: Based on these findings, one of the most important next steps for improving the effectiveness and transparency of national procurement is for procurement agencies to publish detailed quality selection criteria and an up-to-date list of the medical products they have purchased, with key product information. We hope these findings can help inform the conversation about implementing and enforcing best practices at the regulatory-procurement interface, with the goal of improving access to quality versions of medical products in Africa and globally.

Indexed as

access to medicinesmedicines qualityNational procurement agencynational regulatory authorityPharmaceutical System Transparency and Accountability Assessment Toolregulatory-procurement interfacesub-Saharan Africasubstandard and falsified medicines

Identifiers

PMID39802455
PMCPMC11721952

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.