New Delhi, Aug 4 Global health leaders could implement three key measures to transform the global regulatory framework and better address the urgent need for fair access to diagnostics, therapeutics, and vaccines during public health emergencies.
Georgetown Global Health Law expert Sam Halabi, JD, and medical student George O’Hara have outlined those steps. Their recommendations, published in the New England Journal of Medicine, address the need for reforms to enhance the capacity of national regulatory bodies, especially in low-and middle-income countries (LMICs).
Currently, regulatory authority over medical products is concentrated in high-income countries, with agencies like 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 evidenced by the COVID-19 pandemic.
The analysis highlights that only a few national regulatory bodies, mainly in high-income nations, meet the World Health Organization’s (WHO) stringent criteria for being "highly performing." Approximately three-quarters of WHO member states lack the regulatory maturity necessary 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 the WHO enhance collaboration with national regulatory authorities that have achieved advanced regulatory maturity.
This would involve integrating regulators from countries such as Korea, Saudi Arabia, and Singapore into regional initiatives for emergency dossier review and approval.
Additionally, they suggest that regional and multilateral development banks provide loans for medical products approved by WHO-listed authorities. This approach would alleviate bottlenecks and access issues exacerbated by reliance on WHO's Emergency Use Listing during the COVID-19 pandemic.
Furthermore, they recommend that future global pandemic agreements incorporate provisions for a coordinated, multilateral approach to regulatory review, involving authorities from countries with strong regulatory systems to expedite vaccine access for LMICs.
These proposed reforms aim to decentralise regulatory review and expand approval processes, improving global readiness for future health crises.
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