Abstract
This thesis introduces the first comprehensive policy process framework for studying EU-level policy change, focusing on agenda-setting and policy adoption dynamics, and applies it to the study of structural policy reforms in the EU pharmaceutical policy sector during the first von der Leyen Commission (2019–2024). The thesis argues that developing a policy process framework tailored to the unique multi-level governance structure of the EU political system (Hix and Høyland, 2011) is imperative for understanding policy change during the second-longest era without an EU Treaty revision since Eurosclerosis, a period in which policy shifts extend beyond the traditional European integration/disintegration dichotomy. To this end, this thesis introduces the EU-MSF, an analytical lens inspired by the Multiple Streams Framework, which evaluates the role of interests, ideas, and institutions in driving policy outputs. Using a mixed-methods process-tracing design – incorporating framework-driven document analysis, elite interviews, and Q-Methodology – the theory is tested across three case studies of recent structural reform in the EU pharmaceutical policy sector: the revision of the General Pharmaceutical Legislation, the establishment of the new EU HTA Framework, and the emergence of the European Health Union. The choice of case studies allows for an evaluation of the EU-MSF under conditions of both normalcy and crisis, providing insight into a transformative period in an EU policy sector characterised by endemic jurisdictional conflict. The findings highlight a sectoral shift in policy direction from Single Market-centred objectives to health policy outcomes, shaped by the mass surfacing of long-accumulated problems in the aftermath of crises, the emergence of previously marginalised policy entrepreneurs, and the convergence of institutional narratives toward health security and resilience. The thesis contributes to EU politics scholarship, the policy process and policy entrepreneurship literature, and the methodological advancement of public policy research.