The reform of the European Union pharmaceutical legislation

Abstract

Background: The European Union is reforming its pharmaceutical legislation to improve medicine availability, reduce delays in access, strengthen shortages governance, and realign innovation incentives. This is important because the EU marketing authorisation system has not ensured equitable access across Member States. Persistent inequalities remain after authorisation, when manufacturer launch decisions interact with national pricing, reimbursement, procurement, and administrative capacity. These challenges are particularly evident in smaller markets, such as Malta, where commercial incentives are weaker and administrative capacity is more limited. This study assessed whether the proposed reform contains implementable mechanisms capable of reducing inequalities in availability, speed of access, affordability, and supply resilience, and compared the reform with approaches in the United States and Türkiye. Method: A qualitative comparative design combined documentary analysis with expert stakeholder evidence. European Union draft legislation and the December 2025 political compromise were analysed alongside primary regulatory and policy documents from the United States and Türkiye and relevant peer-reviewed literature. Findings were translated into an eight-theme discussion guide, piloted in one focus group, and applied in a second expert focus group. Two stakeholder sessions were analysed as one dataset of ten participants, including regulatory, legal, procurement, and supply-facing perspectives. Sessions were recorded, transcribed, and analysed using framework analysis, and findings were integrated using a strengths, weaknesses, opportunities, and threats approach. Results: Triangulated findings identified a consistent pattern. The reform was found to be strongest in structured governance tools, particularly shortage prevention plans, critical medicines monitoring, and support for earlier generic and biosimilar entry. Under the political compromise, central scientific assessment would fall from 210 to 180 days, while protection would become eight years of data protection plus one year of market protection, with capped extensions. Its main implementation weakness was access-linked conditionality, as launch, sufficient supply, and continuous availability were difficult to define and verify across Member States. Comparative analysis further showed that, in the United States, litigation architecture and enforceable shortage-reporting deadlines shape competition and supply, while, in Türkiye, pricing rules, exchange-rate mechanisms, and pack-level traceability influence launch incentives and post-authorisation continuity. In the expert group, five of ten stakeholders reported familiarity (mean scores 3.30/5; range 2.75-4.00). The conditions with regards to the launch and supply of medicines in the reform (Article 82) attracted the strongest scepticism: four of ten stakeholders considered it unworkable, one expressed a conditional view, and one rated its workability one out of five. Shortage governance and critical medicines tools received the strongest support, with two of ten stakeholders agreeing and two expressing conditional views. Conclusion: The proposed reform introduces credible governance innovations, but reducing access inequalities will depend more on operational definitions, evidence standards, and administrative capacity than on legislative ambition. Shorter authorisation timelines alone are unlikely to narrow inequalities arising after authorisation. For smaller markets, success will depend on whether final rules are measurable, enforceable, and workable across national access pathways.