Coming of Age for the Middle Child of EU Pharmaceutical Policy: Recoil Tactics and the New-Look EU-HTA

Health Technology Assessment (HTA) determines the added value of new health technologies to inform pricing and reimbursement decisions, relying on a range of medical, economic, social, ethical, legal and other criteria. In the EU, despite two decades of voluntary collaborative initiatives, HTA had historically remained within the remit of the Member States. Nevertheless, in 2018, a surprising and ambitious Commission proposal culminated in the passing of Regulation (EU) 2021/2282. From January 2025, a new EU HTA framework comes in operation, including expansive Joint Clinical Assessments, Joint Scientific Consultations, and the establishment of a permanent governing body, the “Coordination Group”. This paper deploys a modified iteration of the Multiple Streams Framework to determine how structural policy change for HTA emerged after decades of only incremental progression. The analysis relies on template-based document analysis and elite interviews with 40 elite stakeholders. The conclusions of the study illuminate the impact of strategic policy entrepreneurship by the European Commission and the importance of institutional narratives. The paper introduces the strategy of “Recoil Tactics” policy entrepreneurship to the literature and makes contributions to EU public policy and pharmaceutical policy.