Basic steps for equitable access in emergency situations

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, treatments and vaccines during public health emergencies, an expert says Georgetown’s field of global health and a medical student.

In their “Outlook” published today at New England Journal of MedicineGeorgetown 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 strengthen the capacity of national regulatory agencies, particularly in low and middle income people to ensure timely and safe access to essential medical products.

The US 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 congestion 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, mainly in high-income countries, meet the World Health Organization’s (WHO) strict criteria to be “high performers”. About 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 Center for Transformative Health Law at the O’Neill Institute for National and Global Health Law, and O’Hara suggest three key steps for WHO and global health leaders:

1. Expanding regulatory coordination and planning: WHO should actively engage in focused planning with national regulatory authorities that have achieved advanced levels of maturity. This includes bringing regulators from countries such as Korea, Saudi Arabia and Singapore into a regional coordination initiative to review and approve emergency dossiers.
2. Leveraging regional and multilateral development banks: Development banks should agree to extend loans for the supply of medical products approved by WHO-registered authorities with given certification. This will alleviate bottlenecks and access problems exacerbated by reliance on the WHO emergency use list designation during the COVID-19 pandemic.
3. Promoting regulatory flexibility in pandemic agreements: As negotiators finalize a global pandemic agreement, provisions should focus on a coordinated and multilateral approach to harness emerging regulatory capacity. By decentralizing regulatory review and expanding the approval process to include authorities from countries with stronger regulatory systems, LMICs can secure vaccine doses earlier in future pandemic responses.

“Together, these steps can lead to more coherent responses to future public health emergencies,” Halabi and O’Hara write.

The WHO has already initiated steps to reduce reliance on the European Medicines Agency and the FDA by creating a new framework of WHO-listed principles to replace strict regulatory authority determination. However, the authors emphasize the need for additional efforts to ensure greater national control over vaccine procurement and reduce reliance on global entities such as COVAX.

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

O’Hara’s work was supported by a David E. Rogers Student Fellowship Award.