Pharmaceutical Shortages as a Multi-Level Governance Failure: An Exploratory Multi- Stakeholder Qualitative Study with Implications for EU and UK Policy

Abstract Background Medicine shortages increasingly threaten patient safety and health system resilience across high-income countries. Despite expanding literature on supply chain vulnerabilities, the perspectives of frontline professionals, such as pharmacists and clinicians, remain underrepresented, and the multi-level governance dimensions of shortage management remain underexplored. Methods We held a participatory multi-stakeholder workshop in March 2025 at the Università di Bologna, Italy. Eighteen participants from the UK and Italy took part in structured presentations and facilitated discussions. They included clinicians, pharmacists, procurement specialists, policymakers, industry representatives, and academic researchers. Recordings of the discussions were transcribed, anonymised, and analysed using thematic analysis in NVivo 15, with themes interpreted through a multi-level governance framework. Results Five themes were identified: diversification and cooperation; transparency and trust; regulatory frameworks; demand-side pressures and public messaging; and national and regional security. Participants highlighted geographic concentration of manufacturing, fragmented supply chain communication, and rigid regulatory frameworks as structural causes of medicines shortages. Frontline professionals, particularly community pharmacists, were identified as bearing the greatest operational burden of shortages while having the least regulatory flexibility to respond. Proposed responses included expanded domestic manufacturing, real-time inventory systems, reformed procurement criteria, greater pharmacist dispensing flexibility, and strengthened international coordination. Conclusions Our findings indicate that pharmaceutical shortages represent a systemic, multi-level governance failure rather than a purely logistical problem. Effective responses require coordinated action across supranational, national, and local levels. This should include regulatory reform such as expanded pharmacist dispensing flexibility; improved transparency and incentive-based early notification; and strategic investment in supply chain resilience to facilitate cross-sector stock redistribution. Reshoring and diversification strategies must also engage with the environmental governance implications of where and how medicines are manufactured. Our findings provide preliminary practitioner-informed evidence relevant to EU and UK policy developments to address medicine shortages, including the Critical Medicines Act (CMA), while highlighting persistent gaps in their scope.