Expanding global access to essential medicines: investment priorities for sustainably strengthening medical product regu
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Expanding global access to essential medicines: investment priorities for sustainably strengthening medical product regulatory systems Lukas Roth1, Daniel Bempong1, Joseph B. Babigumira2, Shabir Banoo3, Emer Cooke4, David Jeffreys5, Lombe Kasonde6, Hubert G. M. Leufkens7, John C. W. Lim8, Murray Lumpkin9, Gugu Mahlangu10, Rosanna W. Peeling11, Helen Rees12, Margareth Ndomondo-Sigonda13, Andy Stergachis14, Mike Ward4 and Jude Nwokike15*
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. Keywords: Access to essential medicines, Substandard and falsified, Regulatory system strengthening
Background Access1 to quality-assured medical products2 improves health and saves lives. Nonetheless, according to the World Health Organization (WHO), one-third of the world’s population lacks timely access to quality assured medicines [2]. Compounding this is the growing global concern of substandard and falsified (SF) medical products, which WHO estimates constitute at least 10% of * Correspondence: [email protected] 15 Promoting the Quality of Medicines program, United States Pharmacopeia, Rockville, USA Full list of author information is available at the end of the a
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