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Published on: May 12, 2023
Advancing vaccines justice through international regulatory pathways
Katrina Perehudoff1,2,3,4, Pramiti Parwani1,2,3,4, Seraphine Bruinsma1,2
1Law Centre for Health and Life, University of Amsterdam, Amsterdam, Netherlands.
Abstract:
Vaccines are essential for preventing infectious diseases and promoting population health; however, equitable global access to vaccines remains elusive. Regulatory approval of vaccines is a critical step on the path towards global vaccines justice, yet the resources required can impede timely decision making. Regulatory reliance, where authorities use other agencies' assessments of new vaccines to make local decisions about their benefit-risk profile, can expedite regulatory decision making. In this Commentary, we apply a critical lens inspired by 'Third World Approaches to International Law' to vaccine justice that challenges the dominant narratives in international pharmaceutical regulatory policy from the perspective of historically marginalised LMICs. This Commentary's main contribution is to illustrate how modern trends in regulatory reliance - namely South-South reliance and reliance on opinions by the European Medicines Agency about medicinal products for global health (rather than evaluations of medicines destined for the European Union market) - are embracing 'third world approaches' to vaccines justice. Strengthening capacity through international regulatory pathways can help alleviate bottlenecks in the approval of vaccines that have already been deemed safe, effective, and quality-assured by qualified regulators, thereby streamlining registration processes and accelerating global access, particularly in an emergency situation.
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