Session (CTI)

ISSUE: The European health policy environment is experiencing its most significant transformation in decades. In January 2025, the EU HTA Regulation began to apply. Simultaneously, revisions to the Pharmaceutical Legislation and prospective Critical Medicines Act (CMA) and Biotech Act are reshaping market access strategy. OVERVIEW: Four interconnected legislative shifts are reshaping how medicines are developed, assessed, and accessed. JCAs under the EU HTA Regulation are now underway for oncology and ATMPs, expanding to orphan medicines in 2028 and all medicines in 2030. Manufacturers face new requirements for harmonised evidence dossiers, accelerated timelines, and coordinated multi-stakeholder engagement. Reforms to the Pharmaceutical Legislation introduce changes to regulatory exclusivity periods, new launch obligations, and procedural timelines with direct consequences for development strategy, pricing negotiations, and portfolio planning. CMA will seek to improve access to not just critical medicines but also medicinal products of common interest: therapies that are not sufficiently available in several countries, including orphan drugs. The Biotech Act aims to strengthen Europe's biotechnology competitiveness, streamline regulatory pathways for innovative biologics, and address supply chain resilience while raising questions about alignment with existing HTA and regulatory processes. Not only are these four political landscape changes significant individually, they also influence one another. These reforms demand unprecedented coordination across regulatory, HTA, and market access functions among manufacturers, government stakeholders, and academia. This panel will provide authoritative perspectives on implementation status, practical challenges, and strategic intent behind each initiative; examine interdependencies between regulatory approval, JCA, and national HTA/pricing processes; and identify actionable insights for all stakeholders navigating this landscape. Panellists include the Chairs from the EMA Management Board and JCA Subgroup, and a MA specialist offering regulatory, HTA, and commercial perspectives on Europe's evolving policy environment.