NDLI: Navigating the path towards successful implementation of the EU HTA Regulation: key takeaways from the 2023 Spring Convention of the European Access Academy

Content Provider	Springer Nature : BioMed Central
Author	Brinkhuis, Francine Julian, Elaine van den Ham, Hendrika Gianfrate, Fabrizio Strammiello, Valentina Berntgen, Michael Pavlovic, Mira Mol, Peter Wasem, Jürgen Van Dyck, Walter Cardone, Antonella Dierks, Christian Schiel, Anja Bernardini, Renato Solà-Morales, Oriol Ruof, Jörg Goettsch, Wim
Abstract	Background The 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. Methods During 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. Results Overall “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. Conclusions At “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.
Related Links	https://health-policy-systems.biomedcentral.com/counter/pdf/10.1186/s12961-024-01154-2.pdf
Ending Page	12
Page Count	12
Starting Page	1
File Format	HTM / HTML
ISSN	14784505
DOI	10.1186/s12961-024-01154-2
Journal	Health Research Policy and Systems
Issue Number	1
Volume Number	22
Language	English
Publisher	BioMed Central
Publisher Date	2024-07-02
Access Restriction	Open
Subject Keyword	Health Administration R & D Technology Policy Medicine Public Health Health Services Research Health Policy EUHTA Stakeholder involvement Health Technology Assessment Access R & D/Technology Policy Medicine/Public Health
Content Type	Text
Resource Type	Article
Subject	Health Policy
Journal Impact Factor	3.6/2023
5-Year Journal Impact Factor	4.3/2023

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

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