Relianomics: A proposed framework for the assessment of the societal, economic and efficiency impacts of regulatory reliance pathways

Abstract

Background: Regulatory reliance as applied to the medicines authorization process is seen as an efficient means to tackle the increasing workloads faced by national regulatory agencies (NRAs), which have expressed a strong desire to optimize their activities. However, a comprehensive methodology to understand and characterize the benefits, limitations, and return-on-investment of implementing or practicing a reliance pathway by a regulatory agency has not yet been developed. Work to date has focused on “how” to best implement reliance but has not generally focused on understanding the “why” to implement reliance through its measurable impacts. This analysis lays the groundwork for the proposed concept of “relianomics”, which we define as a structured framework for the assessment of the impact of regulatory reliance pathways on regulatory, economic, societal, and other systems. Considerations: We performed an integrative literature review using electronic databases, supplemented by grey literature searched on web sites (reports, position papers, workshop summaries). A total of 36 documents were selected and categorized for analysis: 23 primary articles and 13 reports. These were reviewed and their approaches to assessing the real and potential impacts of reliance and the metrics to measure them were identified. For regulatory efficiency, favorable impacts were categorized into the following domains: work efficiency, shortened timelines and increased collaborations, which were characterized by improved NRA efficiency, enhanced NRA capabilities, improved access to medicine, higher quality regulatory actions/decisions, increased collaboration, and pharmaceutical market growth. Unfavorable impacts included unintended consequences based on secondary reliance and the possibility of relying on regulatory decisions where there was a significant risk- based recognition of uncertainty regarding the product’s safety and efficacy. Few resources described empirical measures (metrics) that could be used to assess the impact of the use of reliance. These results underscore the need for a systematic framework approach to assess the return-on-investment of reliance, the core of which is provided herein. While we have identified consequential impacts of reliance, further contributions to this framework are needed to ensure a robust approach to relianomics.