Malina Müller: Rethinking Accelerated Approvals in Europe

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Dr. Malina Müller, Head of Health Economics at WifOR Institute, to explore the heated debate around accelerated and conditional approvals in Europe, how demographic and budget pressures shape HTA decisions, the tradeoffs between surrogate endpoints and overall survival, the challenges of using real world evidence under GDPR, and the broader pricing and competitiveness threats facing Europe’s life science ecosystem. 

Key Topics:

• Accelerated Approvals: Uncertainty versus early access, conditional pathways in Europe, and costs of delayed treatment.
• Health System Pressures: Aging populations, fixed-price hospital incentives, cross-country budget constraints.
• Endpoints & Evidence: Surrogate versus overall survival, patient-reported outcomes, practical limits of real-world evidence in Europe.
• HTA & Harmonization: Germany's strict assessments, JCA and EMA alignment, and equity gaps across member states.
• Global Pricing Risks: Most Favored Nation (MFN) proposals, launch delays between the FDA and EMA, and Europe’s competitiveness versus China.

Opinions expressed are those of the speakers.

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