Navigating Europe’s New Era of Health Policy Reform: How Will the EU HTA Regulation, Pharmaceutical Legislation Revision, Critical Medicines Act, and Biotech Act Shape Medicines Development and Patient Access?

About this session

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.

Speakers

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  Suzette Matthijsse

  Lumanity

  Moderator

• RI

  Rui SANTOS IVO

  European Medicines Agency

  Panelist

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  Anne Willemsen

  Zorginstituut Nederland

  Panelist

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  Neil Grubert

  Neil Grubert Consulting

  Panelist

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  Maya Matthews

  European Commission

  Panelist