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P123: Relianomics: A Proposed Approach to the Assessment of the Societal, Economic, and Regulatory Impacts of Reliance Pathways

Poster Presenter

Magda Bujar

Senior Manager, Regulatory Programme and Strategic Partnerships
Centre for Innovation in Regulatory Science (CIRS)
United Kingdom

Objectives

To focus on understanding “why” to implement reliance through its measurable impacts by laying groundwork for proposed concept of “relianomics” (the systematic assessment of the societal, economic, and regulatory efficiency impacts of using regulatory reliance pathways)

Method

Key resources were reviewed and impacts of reliance and their metrics were identified. Positive (efficiency, shortened timelines and increased collaborations) and negative impact domains (approval errors and knowledge detriment) were assessed. Next steps and an implementation process are proposed.

Results

Of 392 articles, 21 cited (in)direct impacts of reliance as did 6 additional sources (from WHO, PAHO, IFPMA, EFPIA, CIRS). Reliance had positive impacts on regulatory processes including improvements in efficiency and enhancing NRA capabilities. It may positively impact health several ways: shortened review times, lower costs through competition, better ability to deal with emergencies, better access to medicines and higher quality regulatory action. Reliance should reduce workloads and enhance in-house competence through shared learning and fill skill gaps through access to external experts. Other benefits: Increased focus on core national value-added activities and better market surveillance by information sharing. By building trust between agencies reliance could increase regional, continental, and international efficiency and alignment. Potential downsides of reliance include limitations of ‘secondary-reliance’ (agencies might rely on reference agencies that, in turn, relied on another agency). Difficulty in determining what products were approved through reliance reduces decision making transparency, unintentionally leading to indirect reliance on non-recognized reference agencies, albeit through an intermediary trusted agency. Reliance risks inheriting flawed regulatory decisions, approving products whose benefit-risk profiles are inappropriate for a local population based on a different cohort. Reviewers may feel their expertise may not be maintained because they are not being intellectually challenged when conducting a reliance assessment compared to a regular review with the consequent loss of internal knowledge and expertise. We observed only limited use of empirical evidence of impacts (5 of 27 publications). Metrics included: number of yearly authorizations; change in work backlog; review times; time between reference and reliance approval; market price change. These results formed the basis for a proposed relianomics approach to determining ROI.

Conclusion

We identified a spectrum of impacts of reliance, from empirically tested to author’s hypotheses. These represent recognized consequential impacts of reliance but cannot be seen as an exhaustive compilation. Publications have focused on observed/potential benefits, despite the relative paucity of supportive empirical evidence. Few described negative considerations when planning or using reliance pathways. Economic impacts of reliance were the least mentioned and centered on market growth and collaboration. While these sources focused on “how” to best implement reliance, they generally did not probe the “why” to implement reliance and its measurable impacts. Standardized assessment metrics are scarce despite WHO recommending the impact of reliance pathways be monitored and evaluated using such metrics. This imbalance illustrates the difficulty to accurately estimate the ROI of implementing or using regulatory reliance. The relatively short list of impacts limits decision makers’ ability to objectively consider implementing reliance or evaluating the impacts of their existing pathways. A comprehensive methodology to characterize the benefits, drawbacks, and ROI of implementing or practicing a reliance pathway by an agency has not yet been developed. This work provides the building blocks for a “relianomics” framework aimed at systematically assessing the societal, economic, and regulatory efficiency impacts of both exiting reliance pathways and reliance pathways that are being considered for implementation. Refining the relianomics framework will require investments (time, resources, stakeholder alignment). We believe that our proposed framework can form the starting point for relianomics analyses and that a relianomics framework is a necessary evolutionary step for understanding what effective regulatory reliance looks like and how its potential positive and negative effects can be evaluated.