An Inclusive Civil Society Dialogue for Successful Implementation of the EU HTA Regulation: Call to Action to Ensure Appropriate Involvement of Stakeholders and Collaborators
Objectives: Stakeholder involvement has long been considered a success factor for a joint European health technology assessment (HTA) process, and its relevance is now anchored in the EU HTA Regulation’s (EU HTAR) legislative wording. Therefore, we aimed to explore the roles, challenges, and most im...
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| Format: | Article |
| Language: | English |
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MDPI AG
2024-03-01
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| Series: | Journal of Market Access & Health Policy |
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| Online Access: | https://www.mdpi.com/2001-6689/12/1/4 |
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| author | Thomas Desmet Elaine Julian Walter Van Dyck Isabelle Huys Steven Simoens Rosa Giuliani Mondher Toumi Christian Dierks Juliana Dierks Antonella Cardone Francois Houÿez Mira Pavlovic Michael Berntgen Peter Mol Anja Schiel Wim Goettsch Fabrizio Gianfrate Stefano Capri James Ryan Pierre Ducournau Oriol Solà-Morales Jörg Ruof |
| author_facet | Thomas Desmet Elaine Julian Walter Van Dyck Isabelle Huys Steven Simoens Rosa Giuliani Mondher Toumi Christian Dierks Juliana Dierks Antonella Cardone Francois Houÿez Mira Pavlovic Michael Berntgen Peter Mol Anja Schiel Wim Goettsch Fabrizio Gianfrate Stefano Capri James Ryan Pierre Ducournau Oriol Solà-Morales Jörg Ruof |
| author_sort | Thomas Desmet |
| collection | DOAJ |
| description | Objectives: Stakeholder involvement has long been considered a success factor for a joint European health technology assessment (HTA) process, and its relevance is now anchored in the EU HTA Regulation’s (EU HTAR) legislative wording. Therefore, we aimed to explore the roles, challenges, and most important activities to increase the level of involvement per stakeholder group. Methods: At the 2022 Fall Convention of the European Access Academy (EAA), working groups addressed the involvement of patients, clinicians, regulators, health technology developers (HTD), and national HTA bodies and payers within the EU HTA process. Each working group revisited the pre-convention survey results, determined key role characteristics for each stakeholder, and agreed on the most important activities to fulfill the role profile. Finally, the activities suggested per group were prioritized by plenary group. Results: The prioritized actions for patients included training and capacity building, the establishment of a patient involvement committee, and the establishment of a patient unit at the EC secretariat. For clinicians, it included alignment on evidence assessment from a clinical vs. HTA point of view, capacity building, and standardization of processes. The most important actions for regulators are to develop joint regulatory-HTA guidance documents, align processes and interfaces under the regulation, and share discussions on post-licensing evidence generation. HTDs prioritized scientific advice capacity and the review of the scoping process, and further development of the scope of the assessment report fact checks. The top three actions for national HTA bodies and payers included clarification on the early HTD dialogue process, political support and commitment, and clarification on financial support. Conclusions: Addressing the activities identified as the most important for stakeholders/collaborators in the EU HTA process (e.g., in the implementation of the EU HTA Stakeholder Network and of the guidance documents developed by the EUnetHTA 21 consortium) will be key to starting an “<i>inclusive civil society dialogue</i>”, as suggested by the European Commission’s Pharmaceutical Strategy. |
| first_indexed | 2024-04-24T18:08:11Z |
| format | Article |
| id | doaj.art-7f514bab01674db19ecb4093613aaea7 |
| institution | Directory Open Access Journal |
| issn | 2001-6689 |
| language | English |
| last_indexed | 2024-04-24T18:08:11Z |
| publishDate | 2024-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Journal of Market Access & Health Policy |
| spelling | doaj.art-7f514bab01674db19ecb4093613aaea72024-03-27T13:49:00ZengMDPI AGJournal of Market Access & Health Policy2001-66892024-03-01121213410.3390/jmahp12010004An Inclusive Civil Society Dialogue for Successful Implementation of the EU HTA Regulation: Call to Action to Ensure Appropriate Involvement of Stakeholders and CollaboratorsThomas Desmet0Elaine Julian1Walter Van Dyck2Isabelle Huys3Steven Simoens4Rosa Giuliani5Mondher Toumi6Christian Dierks7Juliana Dierks8Antonella Cardone9Francois Houÿez10Mira Pavlovic11Michael Berntgen12Peter Mol13Anja Schiel14Wim Goettsch15Fabrizio Gianfrate16Stefano Capri17James Ryan18Pierre Ducournau19Oriol Solà-Morales20Jörg Ruof21Healthcare Management Centre, Vlerick Business School, 1210 Brussels, BelgiumSecretariat of the European Access Academy (EAA), 4059 Basel, SwitzerlandHealthcare Management Centre, Vlerick Business School, 1210 Brussels, BelgiumDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, 3000 Leuven, BelgiumDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, 3000 Leuven, BelgiumGuy’s and St Thomas’ NHS Foundation Trust, London SE1 7EH, UKPublic Health Department, Faculty of Medicine, Aix-Marseille University, 13002 Marseille, FranceDierks+ Company, 10115 Berlin, GermanyDierks+ Company, 10115 Berlin, GermanyCancer Patients Europe, 1000 Brussels, BelgiumEuropean Organisation for Rare Diseases (EURORDIS), 75014 Paris, FranceMedicines Development and Training (MDT) Services, 75020 Paris, FranceEuropean Medicines Agency (EMA), 1083 HS Amsterdam, The NetherlandsDepartment of Clinical Pharmacy and Pharmacology, University Medical Center Groningen (UMCG), University of Groningen, 9713 GZ Groningen, The NetherlandsNorwegian Medicines Agency (NOMA), 0950 Oslo, NorwayUtrecht Centre for Pharmaceutical Policy, Division of Pharmacoepidemiology and Clinical Pharmacology, University of Utrecht, 3584 CS Utrecht, The NetherlandsDepartment of Economics and Management, University of Ferrara, 44121 Ferrara, ItalySchool of Economics and Management, Cattaneo-LIUC University, 21053 Castallanza, ItalyAstra Zeneca, Cambridge CB2 8PA, UKAbbvie AG, 6330 Cham, SwitzerlandHiTT Foundation, International University of Catalonia-UIC, 08015 Barcelona, SpainSecretariat of the European Access Academy (EAA), 4059 Basel, SwitzerlandObjectives: Stakeholder involvement has long been considered a success factor for a joint European health technology assessment (HTA) process, and its relevance is now anchored in the EU HTA Regulation’s (EU HTAR) legislative wording. Therefore, we aimed to explore the roles, challenges, and most important activities to increase the level of involvement per stakeholder group. Methods: At the 2022 Fall Convention of the European Access Academy (EAA), working groups addressed the involvement of patients, clinicians, regulators, health technology developers (HTD), and national HTA bodies and payers within the EU HTA process. Each working group revisited the pre-convention survey results, determined key role characteristics for each stakeholder, and agreed on the most important activities to fulfill the role profile. Finally, the activities suggested per group were prioritized by plenary group. Results: The prioritized actions for patients included training and capacity building, the establishment of a patient involvement committee, and the establishment of a patient unit at the EC secretariat. For clinicians, it included alignment on evidence assessment from a clinical vs. HTA point of view, capacity building, and standardization of processes. The most important actions for regulators are to develop joint regulatory-HTA guidance documents, align processes and interfaces under the regulation, and share discussions on post-licensing evidence generation. HTDs prioritized scientific advice capacity and the review of the scoping process, and further development of the scope of the assessment report fact checks. The top three actions for national HTA bodies and payers included clarification on the early HTD dialogue process, political support and commitment, and clarification on financial support. Conclusions: Addressing the activities identified as the most important for stakeholders/collaborators in the EU HTA process (e.g., in the implementation of the EU HTA Stakeholder Network and of the guidance documents developed by the EUnetHTA 21 consortium) will be key to starting an “<i>inclusive civil society dialogue</i>”, as suggested by the European Commission’s Pharmaceutical Strategy.https://www.mdpi.com/2001-6689/12/1/4EUHTAhealth policyhealth technology assessmentstakeholder involvement |
| spellingShingle | Thomas Desmet Elaine Julian Walter Van Dyck Isabelle Huys Steven Simoens Rosa Giuliani Mondher Toumi Christian Dierks Juliana Dierks Antonella Cardone Francois Houÿez Mira Pavlovic Michael Berntgen Peter Mol Anja Schiel Wim Goettsch Fabrizio Gianfrate Stefano Capri James Ryan Pierre Ducournau Oriol Solà-Morales Jörg Ruof An Inclusive Civil Society Dialogue for Successful Implementation of the EU HTA Regulation: Call to Action to Ensure Appropriate Involvement of Stakeholders and Collaborators Journal of Market Access & Health Policy EUHTA health policy health technology assessment stakeholder involvement |
| title | An Inclusive Civil Society Dialogue for Successful Implementation of the EU HTA Regulation: Call to Action to Ensure Appropriate Involvement of Stakeholders and Collaborators |
| title_full | An Inclusive Civil Society Dialogue for Successful Implementation of the EU HTA Regulation: Call to Action to Ensure Appropriate Involvement of Stakeholders and Collaborators |
| title_fullStr | An Inclusive Civil Society Dialogue for Successful Implementation of the EU HTA Regulation: Call to Action to Ensure Appropriate Involvement of Stakeholders and Collaborators |
| title_full_unstemmed | An Inclusive Civil Society Dialogue for Successful Implementation of the EU HTA Regulation: Call to Action to Ensure Appropriate Involvement of Stakeholders and Collaborators |
| title_short | An Inclusive Civil Society Dialogue for Successful Implementation of the EU HTA Regulation: Call to Action to Ensure Appropriate Involvement of Stakeholders and Collaborators |
| title_sort | inclusive civil society dialogue for successful implementation of the eu hta regulation call to action to ensure appropriate involvement of stakeholders and collaborators |
| topic | EUHTA health policy health technology assessment stakeholder involvement |
| url | https://www.mdpi.com/2001-6689/12/1/4 |
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