Appraisal of the new European Union pharmaceutical legislation

Abstract

A single EU marketing authorisation does not guarantee equal patient access across Member States. Access inequalities often emerge after authorisation, through launch decisions, pricing and reimbursement, procurement and supply continuity. The 2025 Patients W.A.I.T. Indicator reported an average 597 days to availability, with only 45% of medicines available across the EU. Smaller markets may be particularly vulnerable because of weaker commercial incentives and more limited administrative capacity. The EU pharmaceutical reform aims to improve availability, timely access and supply resilience. Its impact will depend on whether the new mechanisms are clear, measurable and enforceable in practice.

To assess whether the proposed EU pharmaceutical reform contains credible and implementable mechanisms capable of reducing inequalities in medicines access across Member States. Objectives: Evaluate the likely implications of the reform for availability, timeliness of access, affordability and supply resilience. Assess whether key reform mechanisms are clear, measurable, enforceable and feasible in practice. Compare the EU approach with the United States and Türkiye to identify relevant regulatory and governance lessons. Qualitative comparative design 1. Documentary analysis • EU pharmaceutical reform • United States and Türkiye frameworks • Relevant peer reviewed literature 2. Discussion guide development • Findings translated into an eight-theme discussion guide • Pilot focus group used to refine clarity and coverage 3. Expert assessment • Two sequential online focus groups • 10 participants (regulatory, legal, procurement and supply perspectives) • Supplementary Likert ratings 4. Qualitative analysis • Sessions recorded, transcribed and anonymised • Framework Method across eight predefined themes • Emerging insights incorporated 5. Integration and synthesis • Documentary and expert evidence triangulated • SWOT informed synthesis.

To assess whether the proposed EU pharmaceutical reform contains credible and implementable mechanisms capable of reducing inequalities in medicines access across Member States. Objectives: Evaluate the likely implications of the reform for availability, timeliness of access, affordability and supply resilience. Assess whether key reform mechanisms are clear, measurable, enforceable and feasible in practice. Compare the EU approach with the United States and Türkiye to identify relevant regulatory and governance lessons.

The reform has the potential to reduce inequalities in availability, timeliness of access and affordability. Its success will depend on clear definitions, proportionate obligations, effective monitoring, adequate administrative capacity and support for smaller markets. Implementation will determine whether policy intent translates into equitable patient access.