Source – industrialnews.co.uk
Steps to Improve Global Health Regulation
A new perspective on global health regulation proposes three pivotal measures to enhance access to diagnostics, therapeutics, and vaccines during public health emergencies. Published today in the New England Journal of Medicine, the commentary by Georgetown experts Sam Halabi and George O’Hara highlights the urgent need to reform the current regulatory framework to address the disparities in access to essential medical products, particularly in low- and middle-income countries (LMICs).
According to Halabi, a professor at the Georgetown School of Health and director of the Center for Transformational Health Law, and O’Hara, a medical student and David E. Rogers Student Fellow, the current system, dominated by high-income countries’ regulatory bodies like the U.S. Food and Drug Administration (FDA), has led to significant delays and bottlenecks. These issues became particularly evident during the COVID-19 pandemic when critical medical supplies were not distributed in a timely manner due to the concentration of regulatory authority in high-income nations.
An analysis cited by the experts reveals that only a small number of national regulatory authorities, mostly in high-income countries, meet the World Health Organization’s (WHO) rigorous standards for high performance. Approximately 75% of WHO member states lack the regulatory maturity required to ensure the quality of medical products, including vaccines, for their populations.
This regulatory imbalance has highlighted the need for reforms to bolster the capabilities of national regulatory bodies, especially in LMICs. The existing system’s limitations underscore the urgency for a more inclusive and efficient approach to regulatory practices that can handle global emergencies more effectively.
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Proposed Reforms for a More Equitable System
To address these challenges, Halabi and O’Hara propose three strategic measures:
1. Expand Regulatory Coordination and Planning:
The WHO should enhance collaboration with national regulatory authorities that have achieved advanced regulatory maturity. This includes integrating experienced regulators from countries like Korea, Saudi Arabia, and Singapore into a regional coordination initiative for more efficient dossier review and approval processes during emergencies.
2. Leverage Regional and Multilateral Development Banks:
Development banks should facilitate loans for procuring medical products approved by WHO-listed authorities. This would help mitigate access issues and bottlenecks experienced during the COVID-19 pandemic, particularly those related to the WHO’s Emergency Use Listing designation.
3. Promote Regulatory Flexibility in Pandemic Agreements:
As global pandemic agreements are negotiated, it is crucial to incorporate provisions that support a coordinated, multilateral approach to utilizing emerging regulatory capacities. Decentralizing regulatory review and involving authorities from countries with robust regulatory systems can help LMICs secure vaccines more promptly in future pandemics.
Future Directions and Recommendations
The WHO has begun reducing reliance on major agencies like the European Medicines Agency and the FDA by establishing a new global health regulation for WHO-listed authorities. However, Halabi and O’Hara stress the importance of continuing to develop national regulatory capabilities to ensure more direct control over vaccine supplies and reduce dependency on global entities such as COVAX.
The experts argue that expanding regulatory pathways will enhance public health by enabling faster access to diagnostics, therapeutics, and vaccines. By implementing these high-impact yet incremental steps, global health leaders can foster a more equitable and swift response to future public health crises.
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