Best-of Edition: Pernille Weiss & Niklas Blomberg on EU Pharma Policy

In this "Best-of" edition of the Vital Health Podcast, Duane Schulthess revisits two listener favorites on the future of medicines in Europe. First, former MEP Pernille Weiss explains how the European Parliament reshaped the EU’s General Pharmaceutical Legislation (GPL) to better support innovation while respecting member state control over pricing and reimbursement. Then, Niklas Blomberg, Executive Director of the Innovative Health Initiative (IHI), outlines how Europe’s largest public-private partnership is convening pharma, medtech, regulators, HTAs, payers, and patients to solve pre-competitive hurdles from real-world data to digital endpoints.

Key Topics

• Parliament Process: How Parliament shaped the General Pharmaceutical Legislation (GPL) and why it rejected incentives tied to launches in all 27 member states.
• Innovation and Access: Avoiding rock-bottom pricing that causes shortages and using quality-of-life outcomes in pricing and reimbursement decisions.
• EU vs National Roles: Where joint procurement helps, and where member-state control over pricing and reimbursement should prevail to reflect health system differences.
• From IMI to IHI: Evolution from the Innovative Medicines Initiative (IMI) to the Innovative Health Initiative (IHI), a cross-sector platform convening pharma, medical devices, diagnostics, imaging, regulators, health technology assessment (HTA) bodies, payers, clinicians, and patients to solve pre-competitive evidence needs such as real-world data and digital endpoints.
• Data and Regulation: Working within the General Data Protection Regulation (GDPR), the European Health Data Space (EHDS), and the Artificial Intelligence (AI) Act using federated access, shared standards, and a regulatory sandbox to pilot novel technologies.
• SME Pathways: How small and medium-sized enterprises (SMEs) join funded consortia via brokering events, with current examples in lung cancer real-world data and cardiovascular prevention and care.

Originally broadcast Sep 4, 2024 (Weiss) and Jul 3, 2024 (Blomberg). Edited and compiled Aug 2025. Opinions expressed are those of the speakers.

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