Three high-impact steps could be taken by global health leaders to reshape the global regulatory framework and help address the pressing need for equitable access to diagnostics, therapeutics, and vaccines during public health emergencies, say a Georgetown global health law expert and a medical student. In their "Perspective" published today in the New England Journal of Medicine , Georgetown School of Health professor Sam Halabi, JD, and George O'Hara, a Georgetown medical student and David E. Rogers Student Fellow, say these reforms aim to enhance the capacity of national regulatory bodies, particularly in low- and middle-income countries to ensure timely and safe access to essential medical products.
The U.S. Food and Drug Administration (FDA) and a select group of national regulatory authorities currently dominate the approval process for medical products.
However, this concentration of regulatory capacity in high-income countries has led to bottlenecks and delays in the distribution of critical medical supplies during emergencies, as seen during the COVID-19 pandemic. A recent analysis highlights that few national regulatory bodies, primarily in high-income countries, meet the World Health Organization's (WHO) stringent criteria for being "highly performing." Approximately three-quarters of WHO member states lack the regulatory maturity to assure their populations of the quality of medical products, including vaccines.
To address these weaknesses, Halabi, who directs the.