DOI: 10.1002/epa2.70063 ISSN: 2380-6567

Policy Games Large and Small: Explaining the Inclusion of Transferable Data Exclusivity Vouchers in the EU's Pharmaceutical Revision Through Actor‐Centered Institutionalism

Paula Dornbusch

ABSTRACT

In the 2025 revision of the EU's pharmaceutical legislation, transferable data exclusivity vouchers were included as a novel incentive for antimicrobial development. In light of considerable controversy around these vouchers throughout the legislative process, this is a surprising outcome. This paper investigates their introduction through actor‐centered institutionalism. Based on qualitative analysis of documents and semi‐structured interviews, two core contributions result: Theoretically, the paper provides an application of actor‐centered institutionalism that defines the institutional context in which actors operate on a small and large scale. Empirically, it shows that this distinction adds nuance to understanding how the vouchers came about: their inception is best explained by actors who played a small game around a policy instrument while falling back on the normative assumptions of a policy field's large game. As a result of this divergence, market logics from the EU's pharmaceutical regulation carried considerable impact on AMR governance.

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