Regulatory reliance pathways during health emergencies: Enabling timely authorizations for COVID-19 vaccines in Latin America.

Abstract

Abstract 1: Background: Latin American countries had to rapidly authorize COVID-19 vaccines in response to the pandemic. A common mechanism for NRAs to expedite authorizations is through relying on trusted NRAs from other jurisdictions (i.e., regulatory reliance). The use of reliance within vaccine authorizations is not known. Therefore, this study mapped the timing and nature of regulatory (reliance) pathways used to authorize COVID-19 vaccines in Latin America.

Methods: An observational study was conducted assessing the characteristics of all COVID-19 vaccine authorizations in Latin America. For every authorization it was determined whether reliance was used in the authorization process. Subgroups of reference NRAs and non-reference NRAs were compared.

Results: 56 authorizations of 10 different COVID-19 vaccines were identified in 18 countries, of which 25 (45%) used reliance and 12 (21%) authorizations did not, for the remaining 19 (34%) it was not possible to determine whether reliance was used. Reference agencies used reliance less often (40% of authorizations with a known pathway) compared to non-reference agencies (100%). The median review time was just 15 days and does not meaningfully differ between reliance and non-reliance authorizations.

Conclusions: This study demonstrated that reliance pathways can provide rapid authorizations in response to emergencies like COVID-19. Yet, independent authorization review times were not considerably longer. Thus, despite reliance pathways being associated with numerous rapid authorizations, they are not a prerequisite.

Abstract 2: Background: Regulatory reliance is seen as an efficient means to tackle the increasing workloads faced by National Regulatory Agencies (NRAs). However, a comprehensive understanding of the benefits and drawbacks of practicing reliance does not exist. This study lays the groundwork for “relianomics”: the systematic assessment of reliance impacts.

Methods: A systemic literature search through PubMed was used to identify articles mentioning (potential) impacts of practicing reliance. Articles mention (potential) impacts of reliance identified through PubMed and publications by global health and trade organizations were used to form a collection of 27 relevant documents. From these, the impacts of reliance and the metrics to measure them were extracted and categorized.

Results: The analyzed documents contained 24 (potential) impacts of reliance mentioned 110 times in total and 5 related metrics. Impacts were categorized into public health, economic, and internal NRA impacts. Impacts include improved NRA efficiency, enhanced NRA capabilities, unintended secondary reliance, improved access to medicine, higher quality regulatory action, risk of inheriting flawed approvals, increased collaboration, and pharmaceutical market growth. 5 of 27 documents contained empirical evidence relating to reliance.

Discussion: The Relianomics framework was informed by a comprehensive list of reported impacts and likely includes the most consequential impacts of reliance. However, empirical evidence was scarce, which emphasizes the need for a systematic approach to assessing the return-on-investment of reliance.