Policy Learning Without Knowledge? The Adoption of Transferable Data Exclusivity Vouchers Within EU Pharmaceutical Regulation

The proposal for a revised General Pharmaceutical Law (GPL), currently under discussion in the European Union, seeks to balance the goals of increasing the competitiveness of the pharmaceutical industry and improving access to medicines, by employing a ‘careful mix of carrots and sticks’ (Politico, 2023). One of its central concerns is the need to incentivise the development of new antimicrobials, to combat the growing public health threat of antimicrobial resistance. Within the political agreement reached in December 2025, the main ‘carrot’ of the new legislation is a provision for transferable data exclusivity vouchers (TDEVs), which would reward companies producing new antimicrobials with a tradable permit for a one-year data exclusivity extension, applicable to any medicinal product of their choice. The TDEV provision is an unusual one. Such vouchers do not currently exist in any other jurisdiction or regulatory system, meaning that there is no real-world evidence of how they might work in practice, only modelling of their potential effect. The resulting uncertainty is reflected in considerable opposition to the TDEV, centring around the cost of such a scheme to national health systems, which will be forced to pay for branded drugs for longer, consequent pressures on access to medicines, and its effectiveness compared to other available tools. These concerns have been voiced within civil society, the European Parliament and national governments, and the public consultation undertaken by the Commission services preparing the proposal reported mixed views on the feasibility of the TDEV. So how did it become a centre-piece of the final legislative text? This paper seeks to answer this question by examining the extent to which the inclusion of the TDEV represents a case of policy learning or transfer – particularly when considering more critical, interdisciplinary models of policy assemblage, mobility and mutation (McCann and Ward, 2012) – despite the piecemeal evidence and experience available to support it. Engaging in a close ‘following’ of the policy case study (Wedel et al., 2005), we use a process tracing methodology, reconstructing the movement and mutation of the TDEV idea through the legislative development of the GPL, and the Pharmaceutical Strategy which underpins it. We draw on a large dataset comprised of policy documents, interviews with key stakeholders, and policy process material not previously in the public domain, which we obtained via access-to-document requests. This enables us to assemble a detailed and comprehensive picture of when, where and how the TDEV entered the GPL policy process, how it evolved within that process, and the agency and practices involved