Navigating the path towards successful implementation of the EU HTA Regulation: key takeaways from the 2023 Spring Convention of the European Access Academy
Brinkhuis, Francine Julian, Elaine van den Ham, Hendrika Gianfrate, Fabrizio Strammiello, Valentina Berntgen, Michael Pavlovic, Mira Mol, Peter Wasem, Jürgen Van Dyck, Walter
Brinkhuis, Francine
Julian, Elaine
van den Ham, Hendrika
Gianfrate, Fabrizio
Strammiello, Valentina
Berntgen, Michael
Pavlovic, Mira
Mol, Peter
Wasem, Jürgen
Van Dyck, Walter
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Publication Year
2024
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Health Research Policy and Systems
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Publication Volume
22
Publication Issue
1
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Abstract
BackgroundThe European Regulation on Health Technology Assessment (EU HTA R), effective since January 2022, aims to harmonize and improve the efficiency of common HTA across Member States (MS), with a phased implementation from January 2025. At “midterms” of the preparation phase for the implementation of the Regulation our aim was to identify and prioritize tangible action points to move forward.MethodsDuring the 2023 Spring Convention of the European Access Academy (EAA), participants from different nationalities and stakeholder backgrounds discussed readiness and remaining challenges for the Regulation’s implementation and identified and prioritized action points. For this purpose, participants were assigned to four working groups: (i) Health Policy Challenges, (ii) Stakeholder Readiness, (iii) Approach to Uncertainty and (iv) Challenges regarding Methodology. Top four action points for each working group were identified and subsequently ranked by all participants during the final plenary session.ResultsOverall “readiness” for the Regulation was perceived as neutral. Prioritized action points included the following: Health Policy, i.e. assess adjustability of MS laws and health policy processes; Stakeholders, i.e. capacity building; Uncertainty, i.e. implement HTA guidelines as living documents; Methodology, i.e. clarify the Population, Intervention, Comparator(s), Outcomes (PICO) identification process.ConclusionsAt “midterms” of the preparation phase, the focus for the months to come is on executing the tangible action points identified at EAA’s Spring Convention. All action points centre around three overarching themes: harmonization and standardization, capacity building and collaboration, uncertainty management and robust data. These themes will ultimately determine the success of the EU HTA R in the long run.
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4203 Health Services and Systems, 4206 Public Health, 42 Health Sciences, Clinical Research, Prevention, Social Determinants of Health, 4 Quality Education, Technology Assessment, Biomedical, Humans, Health Policy, Stakeholder Participation, Uncertainty, European Union, Capacity Building, Europe, Academies and Institutes, Government Regulation