Making the investment case for national regulatory authorities

• Main Authors: Gloria Twesigye, Tamara Hafner, Javier Guzman
• Format: Article
• Language: English
• Published: BMC 2021-01-01
• Series: Journal of Pharmaceutical Policy and Practice
• Subjects: Regulatory systems; National regulatory authorities; Health systems strengthening; Access to medicines; Quality-assured medicines
• Online Access: https://doi.org/10.1186/s40545-021-00299-7

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.