Title:Gaining new perspectives on public health emergencies

By reshaping the global regulatory framework, global health leaders can help address the pressing need for equitable access to diagnostics, therapeutics, and vaccines during public health emergencies, writes Sam Halabi, a School of Health professor, and George O’Hara (M’26), a David E. Rogers Student Fellow, in a “Perspective” in the New England Journal of Medicine published in August 2024.

The U.S. Food and Drug Administration and a select group of national regulatory authorities currently dominate the approval process for medical products. However, concentrating regulatory capacity in high-income countries has led to bottlenecks and delays in the distribution of critical medical supplies during emergencies, Halabi and O’Hara explain.

A recent analysis highlights few national regulatory bodies—primarily in high-income countries—that meet the World Health Organization’s (WHO) stringent criteria for being “highly performing.”

As director of the O’Neill Institute for National and Global Health Law’s Center for Transformational Health Law—a research institute based at Georgetown Law— Halabi oversees and conducts research into public and private law in health policy analysis. He has paired up with O’Hara—whose fellowship funds projects improving the health of communities—to address vital health regulatory weaknesses.

They propose the WHO and global health leaders expand regulatory coordination and planning; leverage regional and multilateral development banks; and promote regulatory flexibility in pandemic agreements.

First, they recommend that the WHO actively engage in focused planning with an updated list of mature national regulatory authorities to expand regulatory coordination and planning, integrating regulators into regional coordination initiatives for dossier review and approval during emergencies.

Halabi and O’Hara also suggest global health leaders leverage regional and multilateral development banks. By helping extend loans for procuring medical products approved by WHO-listed authorities with a given certification, they will alleviate bottlenecks and access issues exacerbated by the dependence on WHO’s Emergency Use Listing designation.

Finally, they advise promoting regulatory flexibility in pandemic agreements. Provisions in a global pandemic agreement should focus on a coordinated and multilateral approach to leverage emerging regulatory capacity, decentralize regulatory review, and expand the approval process to include authorities from countries with stronger regulatory systems.

“Together, these steps can drive more cohesive responses to future public health emergencies,” say Halabi and O’Hara.

“Expansion of regulatory pathways would prioritize public health by enabling diagnostics, therapeutics, and vaccines to reach populations sooner,” they write. “By taking incremental but high-impact steps based on the WHO’s classifications of regulatory systems, global health leaders can mount a more equitable and rapid response.”