National Implementation of the EU HTA Regulation: Progress and Strategic Developments Across Member States
Author(s)
Agnieszka Kocwin, MPharm1, Malek Dimassi, MEng2, Cecile Remuzat, PharmD, MSc3, Niels Juul Brogaard, MSc4, Clement Francois, MSc, PhD3.
1Putnam, Kraków, Poland, 2Putnam, Soukra, Tunisia, 3Putnam, Paris, France, 4Novo Nordisk A/S, Bagsværd, Denmark.
1Putnam, Kraków, Poland, 2Putnam, Soukra, Tunisia, 3Putnam, Paris, France, 4Novo Nordisk A/S, Bagsværd, Denmark.
OBJECTIVES: The European Union (EU) Health Technology Assessment (HTA) Regulation (Regulation EU 2021/2282) mandates Joint Clinical Assessments (JCAs) across all 27 EU Member States, Norway, Iceland, and Liechtenstein from 2025. This research analyses Member States' readiness for its implementation and potential implications for health technology developers (HTDs).
METHODS: Literature review (01/2023-09/2025), covering the 30 countries, including HTA websites, press releases, PubMed articles, and grey literature.
RESULTS: Countries with established HTA systems demonstrate proactive preparations. Most of these countries have announced that they are adjusting their guidelines and processes. Germany will keep national timelines and processes, considering whether the JCA report is available at the time of submission or, if not, as a part of the resolution. France plans to update their dossier template, while keeping current national doctrine. Norway and Spain shortened their national timelines to match JCA schedules. Denmark, Finland, and the Netherlands intend to initiate national assessments only after JCA report availability. Italy, Norway, Austria, Portugal, and Poland are updating their HTA guidelines/methodologies to align with EU requirements and JCA process. Divergences exist in involving HTDs in the PICO scoping phase. France does not currently plan to involve HTDs in PICO scoping process, while Finland, Sweden, and Poland allow HTD input, though acceptance levels are undefined. Countries with developing HTA frameworks have communicated limited information on their preparedness, often lacking legislative or methodological foundations, capacity-building efforts, or stakeholder engagement. A few (e.g. Estonia, Greece, Lithuania) have announced intentions to incorporate JCAs and are drafting new HTA guidelines. Bulgaria is planning shorter timelines but has not disclosed implementation details.
CONCLUSIONS: As the regulation implementation evolves, HTDs must actively monitor initial JCAs and national HTA processes to assess how JCA outcomes influence national decision-making. Early engagement and strategic flexibility will be critical to navigate divergent timelines, evidence requirements, and procedural variations across jurisdictions.
METHODS: Literature review (01/2023-09/2025), covering the 30 countries, including HTA websites, press releases, PubMed articles, and grey literature.
RESULTS: Countries with established HTA systems demonstrate proactive preparations. Most of these countries have announced that they are adjusting their guidelines and processes. Germany will keep national timelines and processes, considering whether the JCA report is available at the time of submission or, if not, as a part of the resolution. France plans to update their dossier template, while keeping current national doctrine. Norway and Spain shortened their national timelines to match JCA schedules. Denmark, Finland, and the Netherlands intend to initiate national assessments only after JCA report availability. Italy, Norway, Austria, Portugal, and Poland are updating their HTA guidelines/methodologies to align with EU requirements and JCA process. Divergences exist in involving HTDs in the PICO scoping phase. France does not currently plan to involve HTDs in PICO scoping process, while Finland, Sweden, and Poland allow HTD input, though acceptance levels are undefined. Countries with developing HTA frameworks have communicated limited information on their preparedness, often lacking legislative or methodological foundations, capacity-building efforts, or stakeholder engagement. A few (e.g. Estonia, Greece, Lithuania) have announced intentions to incorporate JCAs and are drafting new HTA guidelines. Bulgaria is planning shorter timelines but has not disclosed implementation details.
CONCLUSIONS: As the regulation implementation evolves, HTDs must actively monitor initial JCAs and national HTA processes to assess how JCA outcomes influence national decision-making. Early engagement and strategic flexibility will be critical to navigate divergent timelines, evidence requirements, and procedural variations across jurisdictions.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA240
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Systems & Structure
Disease
No Additional Disease & Conditions/Specialized Treatment Areas