Claessens Zilke, Beirne Grace, Decouttere Catherine, Vandaele Nico, Barbier Liese, Huys Isabelle
Clinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
Access-To-Medicines Research Centre, Faculty of Economics & Business, KU Leuven, Leuven, Belgium.
Ther Innov Regul Sci. 2025 Sep 6. doi: 10.1007/s43441-025-00855-2.
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.
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.
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.
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.
在新冠疫情期间，采取了监管和市场准入行动以加速新冠药物进入市场。本研究旨在：（i）收集多方利益相关者对这些行动的看法；（ii）为完善常规和卫生应急框架提供建议。
对欧洲各地的政策制定者/顾问（即监管机构、卫生技术评估人员和支付方）以及制药行业代表进行了半结构化访谈，以了解他们对新冠疫情期间营销授权和市场准入做法的看法。访谈内容逐字记录，并通过主题框架法对记录进行分析。
访谈（n = 16）概述了利益相关者对新冠疫情期间应用的四个关键监管建议或授权程序（即应急工作组、快速科学建议、滚动审查、有条件营销授权）和一个市场准入程序（即联合采购）的感知益处和局限性。这些程序的显著益处包括时间缩短、协作与协调增强、程序灵活性，且往往是这些因素的综合。挑战与行业代表和政策制定者/顾问的时间和资源分配效率低下以及某些程序透明度降低有关。此外，还针对优化常规和卫生应急医疗框架提出了若干建议。重点强调了行业代表与政策制定者/顾问之间以及利益相关者群体内部加强互动与协调的必要性，制定更务实灵活的程序，以及应用明确透明的资格标准以促进行动。
本研究概述了新冠疫情期间监管和市场准入做法的相关看法，突出了这些经验如何为常规时期和卫生紧急情况期间的监管和市场准入做法提供参考。总结利益相关者的思考和经验教训对于提高未来卫生危机中的应对能力和响应速度具有重要价值。
