Global health authorities have suggested three crucial actions to reform regulations and ensure fair distribution of medical supplies during emergencies (). Georgetown global health law expert Sam Halabi, J.D., and medical student George O’Hara have outlined such steps. Their recommendations, published in the New England Journal of Medicine, address the need for reforms to improve the capacity of national regulatory agencies, especially in low- and middle-income countries (LMICs).
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At the moment, Regulatory authority over medical products is concentrated in high-income countries, with agencies such as the U.S. Food and Drug Administration (FDA) leading the approval process.
This concentration has led to delays and bottlenecks in the distribution of essential medical supplies during emergencies, as demonstrated by the COVID-19 pandemic.
The analysis highlights that only a few national regulatory bodies, mainly in high-income countries, meet the World Health Organization’s (WHO) strict criteria for being “high performing.”
Revolutionizing health regulations for public emergencies
Approximately three-quarters of WHO Member States lack the regulatory maturity needed to ensure the quality of medical products, including vaccines.
To address these issues, Halabi, director of the Center for Transformational Health Law at the O’Neill Institute for National and Global Health Law, and O’Hara propose that WHO enhance collaboration with national regulatory authorities that have reached advanced regulatory maturity.
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This would involve integrating regulators from countries such as Korea, Saudi Arabia and Singapore into regional initiatives for the review and approval of emergency dossiers.
Furthermore, they suggest that Regional and multilateral development banks offer loans for medical products approved by WHO-listed authorities. This approach would alleviate bottlenecks and access problems exacerbated by reliance on the WHO Emergency Use Listing during the COVID-19 pandemic.
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They also recommend that future global pandemic agreements incorporate provisions for a coordinated, multilateral approach to regulatory review, involving authorities in countries with strong regulatory systems to expedite access to vaccines for low- and middle-income countries.
These proposed reforms aim to decentralize regulatory review and expand approval processes, improving global preparedness for future health crises.
Source-IANS
