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In the News: EU HTA Regulation Takes Effect

Jan 15, 2025

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HTAi Responds as New Regulation Ushers in Era of Collaboration, Access, and Innovation in HTA

January 12, 2025, marked a pivotal moment for health systems across Europe as the EU HTA Regulation (EU 2021/2282) took effect. For the first time, joint clinical assessments (JCAs) will be conducted at the EU level, setting the stage for a new era of collaboration and efficiency in the evaluation of innovative health technologies.

This is a landmark achievement, one that promises to bring real benefits across the spectrum. For patients, it means improved access to groundbreaking treatments. For innovators, it simplifies processes, eliminating unnecessary duplication. And for health systems, it strengthens evidence-based decision-making with greater consistency.

Yet, as with any significant change, there are hurdles to overcome. Aligning the diverse priorities and contexts of Member States, meeting the demands of JCAs with limited resources, and maintaining transparency in stakeholder engagement are just a few of the challenges we face. The Regulation also brings with it legal and procedural complexities that will need careful navigation as it evolves.

At HTAi, we see these challenges not as roadblocks but as opportunities to demonstrate the strength of our collective expertise. We are committed to fostering open dialogue and collaboration to ensure the success of this Regulation. The road ahead will demand flexibility, inclusivity, and a willingness to innovate—but we know the HTA community is ready to rise to the occasion.

This Regulation isn’t just about Europe; it sets a precedent for HTA globally. If you’re ready to explore what this means for the future of our field, HTAi is the perfect place to engage. Together, we can shape a smarter, more effective future for health technology assessment.

Read the European Commission News Release Online