HPR205 Future-Proofing European Regulatory and Market Access Practices Based on Learnings From the COVID-19 Pandemic – Stakeholder Perspectives

Abstract

Many regulatory and market access actions were taken to answer the urgent need for rapid market entry of effective and safe medicines against COVID-19. This study aims to (i) identify actions taken by European regulatory and market access authorities during the pandemic, (ii) identify learnings, and (iii) translate these learnings into recommendations for the future-proofing of regulatory and market access practices. Semi-structured interviews were conducted with regulators, policymakers, HTA assessors, payers, and pharmaceutical industry representatives across Europe to elicit their perspectives on regulatory and market access practices during the COVID-19 pandemic. Interviews were transcribed ad verbatim and transcripts analysed via the thematic framework method. The interviews (n= 10, ongoing) revealed a number of regulatory and market access actions developed and/or applied during the COVID-19 pandemic and respective learnings. Three key actions were identified as having a potential for implementation in day-to-day practice and likely future-proofing it. Firstly, increased interaction during the regulatory reviewing process under the form of a rolling review is deemed favourable for products meeting high unmet medical needs. However, policy stakeholders point out the increased workload of this hands-on approach and limited available resources. Secondly, the increased collaboration between European member states on pricing and reimbursement, referring to the joint procurement agreement, was deemed not only important in the current COVID-19 pandemic but also more and more important in regular practice. Lastly, increased flexibility in clinical trial design would facilitate the conduct and enhance patients’ participation, likely leading to timelier clinical results. The process from authorization to market access of COVID-19 vaccines and medicines differs from regular practice, with some procedures being adjusted, expedited or newly developed. There is an opportunity to leverage these insights and learnings to help future-proof regulatory and market access practices for medicines in the European Union more holistically.