Making the investment case for national regulatory authorities

Abstract

Well-functioning national regulatory authorities (NRAs) ensure access to safe, effective, quality-assured, and affordable medical products. However, the benefits of their work are often unseen and difficult to attribute, thereby making NRAs undervalued and under-resourced, particularly in low- and middle-income countries. This paper offers three key arguments NRAs and other stakeholders can use to advocate for greater investment in regulatory systems strengthening—medical products regulation effectively safeguards public health; effective regulation improves health system’s efficiency by increasing access to affordable medical products, contributing to universal health coverage; and robust regulation strengthens local pharmaceutical manufacturing and bolsters pharmaceutical trade. NRAs’ critical role in health systems is indisputable, yet they need to better promote their value to receive the requisite resources to function effectively.

Vaccine technology transfer in a global health crisis: Actors, capabilities, and institutions

“…Effective regulation can improve the quality of locally manufactured products and facilitate entry into international markets ( Twesigye et al, 2021 ). However, low- and middle-income countries vary in their capacity to regulate vaccines, not just because authorities are often under-resourced and lacking legal mandates, but also due to their unfamiliarity with regulating novel technologies.…”

Impact of the COVID-19 pandemic on the quality of medical products in Zimbabwe: a qualitative study based on key informant interviews with health system stakeholders

“…Understanding the impacts of COVID-19 on the quality of medical products is even more urgent across low-income and middle-income countries (LMICs), where the overall prevalence of substandard and falsified essential medicines is as much as 13.6% 7 19. Further, NMRAs across LMICS are often under-resourced and have weaker regulatory capacity, compared with higher-resource settings where there may be more resilience in a pandemic 20–22…”

Strengthening regulatory systems globally: a crucial step towards pandemic preparedness and response

“…During an emergency, regulatory systems can expedite reviews of MCMs to ensure rapid availability; this must be coupled with effective communication to address manufacturer and stakeholder inquiries, connecting healthcare professionals, patients and the public and providing critical information about medical products and their regulation. A strong, pandemic-prepared regulatory system will not only improve access to safe, quality medical products but also public confidence in their healthcare system and government 5…”

“…Second, building effective national or regional regulatory systems helps ensure quality throughout product development and manufacturing processes, which promotes access to safe and effective medical products and reduces the circulation of falsified and substandard medicines. This in turn generates confidence and public trust in the country’s health system and medical products, which can lead to greater public compliance with public health measures and uptake of MCMs 5 12 13. Third, the presence of effective national or regional regulatory health agencies with clear regulatory pathways can streamline manufacturer interactions with regulatory agencies, ensuring strong alignment and efficient progress from medical product development to manufacturing to market access with respect to the national or regional context.…”