Redefining global health governance: Critical steps for equitable access during emergencies

Three high-impact steps can be taken by global health leaders to shape the global governance framework and help address the urgent need for equitable access to diagnosis, treatment and vaccines during public health emergencies, says Georgetown’s global health law expert and doctoral student. .

In their “Perspective” 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, said these changes are intended to improve the capacity of the nation’s administrative agencies, especially- hall with low and middle incomes. countries 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 manage the approval process for medical products. However, this regulatory pressure 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 review highlights that few national regulatory agencies, especially in high-income countries, meet the strict criteria of the World Health Organization (WHO) for “highly effective.” About three-thirds of WHO member countries do not have regulatory frameworks to ensure the quality of medical products, including vaccines, to their citizens.

To address these shortcomings, Halabi, who directs the Center for Health Law Reform at the O’Neill Center for National and Global Health Law, and O’Hara propose three key steps for the WHO and world health leaders:

1. Add Control and Design Integration: WHO should engage in focused planning with national authorities that have achieved growth. This includes bringing together authorities from countries such as Korea, Saudi Arabia and Singapore into a regional coordination plan for document review and authorization during emergencies.
2. Use Regional and Multinational Development Banks: Development banks should agree to extend loans for the purchase of medical products approved by the authorities listed by the WHO with a certificate issued. This could reduce the complications and access problems exacerbated by reliance on the WHO’s Emergency Use Listing during the COVID-19 pandemic.
3. Recommend Regulatory Change in Pandemic Agreements: As negotiations finalize a global pandemic agreement, the terms should focus on a coordinated and multilateral approach to enhancing emerging regulatory capacity. By decentralizing regulatory review and expanding the authorization process to include authorities from countries with strong regulatory systems, LMICs can obtain vaccine rates in advance of future epidemic responses. .

“Together, these measures can facilitate coordinated responses to public health emergencies,” write Halabi and O’Hara.

The WHO has begun steps to reduce reliance on the European Medicines Agency and the FDA by creating a new system of authorities listed by the WHO to replace strict regulatory controls. However, the authors emphasize the need for more efforts to ensure greater national control over vaccine supply and reduce dependence on global organizations such as COVAX.

“Expansion of regulatory pathways will prioritize public health by making diagnosis, treatment and vaccines more accessible to people,” they write. “By taking incremental but high-impact measures based on the WHO’s strategic management teams, global health leaders can provide a balanced and rapid response.”

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