Future-Proofing European Pharmaceutical Regulatory and Market Access Practices Based on EU Learnings from the COVID-19 Pandemic: Insights from Multi-Stakeholder Interviews.

Introduction: During the COVID-19 pandemic, regulatory and market access actions were taken to expedite the market entry of COVID-19 medicines. This study aims to (i) capture multi-stakeholder views on these actions, and (ii) provide recommendations for future-proofing routine and health-emergency frameworks.

Methods: Semi-structured interviews were conducted with policy makers/advisors (i.e. regulators, HTA assessors, and payers), and pharmaceutical industry representatives across Europe to elicit their perspectives on marketing authorisation and market access practices during the COVID-19 pandemic. Interviews were transcribed ad verbatim and transcripts analysed via the thematic framework method.

Results: The interviews (n = 16) resulted in an overview of stakeholder-perceived benefits and limitations for four key regulatory advice or authorisation procedures (i.e. emergency task force, rapid scientific advice, rolling review, conditional marketing authorisation) and one market access procedure (i.e. joint procurement) applied during the COVID-19 pandemic. Highlighted benefits of the procedures relate to a reduction in timelines, enhanced collaboration and alignment, procedural flexibilities, and often a combination of these. Challenges are linked to inefficient allocation of time and resources for both industry representatives and policymakers/advisors and decreased transparency in certain procedures. In addition, several recommendations for the optimisation of both the routine and health-emergency healthcare framework were proposed. Emphasis is placed on the need for enhanced interaction and alignment between industry representatives and policymakers/advisors but also within stakeholder groups, development of more pragmatic and flexible procedures, and application of clear and transparent eligibility criteria for facilitating actions.

Conclusion: This study provides an overview of the perceptions from regulatory, and market access practices during COVID-19, highlighting how these experiences can inform regulatory and market access practices both in routine times and during health emergencies. Taking stock of stakeholder reflections and lessons learned are valuable for improving preparedness and responsiveness in future health crises.