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Globalization and Health
Published in: Globalization and Health 1/2018

Open Access 01-12-2018 | Review

Expanding global access to essential medicines: investment priorities for sustainably strengthening medical product regulatory systems

Authors: Lukas Roth, Daniel Bempong, Joseph B. Babigumira, Shabir Banoo, Emer Cooke, David Jeffreys, Lombe Kasonde, Hubert G. M. Leufkens, John C. W. Lim, Murray Lumpkin, Gugu Mahlangu, Rosanna W. Peeling, Helen Rees, Margareth Ndomondo-Sigonda, Andy Stergachis, Mike Ward, Jude Nwokike

Published in: Globalization and Health | Issue 1/2018

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Abstract

Access to quality-assured medical products improves health and save lives. However, one third of the world’s population lacks timely access to quality-assured medicines while estimates indicate that at least 10% of medicine in low- and middle-income countries (LMICs) are substandard or falsified (SF), costing approximately US$ 31 billion annually. National regulatory authorities are the key government institutions that promote access to quality-assured medicines and combat SF medical products but despite progress, regulatory capacity in LMICs is still insufficient. Continued and increased investment in regulatory system strengthening (RSS) is needed. We have therefore reviewed existing global normative documents and resources and engaged with our networks of global partners and stakeholders to identify three critical challenges being faced by NRAs in LMICs that are limiting access to medical products and impeding detection of and response to SF medicines. The challenges are; implementing value-added regulatory practices that best utilize available resources, a lack of timely access to new, quality medical products, and limited evidence-based data to support post-marketing regulatory actions. To address these challenges, we have identified seven focused strategies; advancing and leveraging convergence and reliance initiatives, institutionalizing sustainability, utilizing risk-based approaches for resource allocation, strengthening registration efficiency and timeliness, strengthening inspection capacity and effectiveness, developing and implementing risk-based post-marketing quality surveillance systems, and strengthening regulatory management of manufacturing variations. These proposed solutions are underpinned by 13 focused recommendations, which we believe, if financed, technically supported and implemented, will lead to stronger health system and as a consequence, positive health outcomes.
Footnotes
1
For the purposes of this article, the definition of access encompasses physical accessibility (availability within reasonable reach of those who need them), financial affordability (ability to pay without financial hardship), and acceptability (willingness to seek medical products when needed) [1].
 
2
For the purposes of this article, the definition of medical products includes medicines, biologics, vaccines, and medical devices.
 
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Metadata
Title
Expanding global access to essential medicines: investment priorities for sustainably strengthening medical product regulatory systems
Authors
Lukas Roth
Daniel Bempong
Joseph B. Babigumira
Shabir Banoo
Emer Cooke
David Jeffreys
Lombe Kasonde
Hubert G. M. Leufkens
John C. W. Lim
Murray Lumpkin
Gugu Mahlangu
Rosanna W. Peeling
Helen Rees
Margareth Ndomondo-Sigonda
Andy Stergachis
Mike Ward
Jude Nwokike
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Globalization and Health / Issue 1/2018
Electronic ISSN: 1744-8603
DOI
https://doi.org/10.1186/s12992-018-0421-2

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