EuroGCT participated in the “Building Bridges for Medicines Justice” conference at the University of Amsterdam on 29 October 2025, hosting a workshop exploring the challenges of enabling equitable patient access to Advanced Therapy Medicinal Products (ATMPs) in the EU. The workshop abstract and the presentations are available below:
Is the EU Regulation on HTA Enhancing Equitable Access to Innovative Medicines in Europe? A EuroGCT workshop, Building Bridges for Medicines Justice, 29 October 2025, Amsterdam, The Netherlands.
Chair: Aurélie Mahalatchimy
Administrative Coordinator: Valentin Roby.
This workshop addresses the challenges of ensuring patient access to Advanced Therapy Medicinal Products (ATMPs) in the EU, where high costs and national-level reimbursement decisions create inequalities despite centralised marketing authorisation. Product withdrawals have occurred due to commercial reasons. Key obstacles include diverse Health Technology Assessment (HTA) methods and varying tolerance for uncertainty. The 2021 EU HTA regulation, effective January 2025 for ATMPs and cancer medicines, aims to support Member States in taking timely and evidenced-based decisions for patients’ access to health technologies. The workshop explores opportunities and challenges of implementing HTA at both European and National levels.
This workshop is part of the Regulatory Engagement Strategy of the European project EuroGCT (European Consortium for Communicating Gene and Cell Therapy Information), which aims to promote exchanges between stakeholders and regulators.
Presentations:
• Niklas Hedberg, co-chair of the HTA Coordination Group for medicines, and Swedish HTA body (Tandvårds- Och Läkemedelsförmånsverket)
Short introduction the Health Technology Assessment Regulation
• Lisette Vernooij – Dutch National Health Care Institute (Zorginstituut Nederland)
• Jakob Wested, Associate Professor, University of Copenhagen
Health technology assessment for academic ATMPs
Please follow each of the hyperlinks above to the presentation slides.