التفاصيل البيبلوغرافية
| العنوان: |
An Inclusive Civil Society Dialogue for Successful Implementation of the EU HTA Regulation: Call to Action to Ensure Appropriate Involvement of Stakeholders and Collaborators. |
| المؤلفون: |
Desmet, Thomas, Julian, Elaine, Van Dyck, Walter, Huys, Isabelle, Simoens, Steven, Giuliani, Rosa, Toumi, Mondher, Dierks, Christian, Dierks, Juliana, Cardone, Antonella, Houÿez, Francois, Pavlovic, Mira, Berntgen, Michael, Mol, Peter, Schiel, Anja, Goettsch, Wim, Gianfrate, Fabrizio, Capri, Stefano, Ryan, James, Ducournau, Pierre |
| المصدر: |
Journal of Market Access & Health Policy; Mar2024, Vol. 12 Issue 1, p21-34, 14p |
| مصطلحات موضوعية: |
CIVIL society, PATIENT participation, TECHNOLOGY assessment, CAPACITY building, MEDICAL technology |
| الشركة/الكيان: |
EUROPEAN Commission |
| مستخلص: |
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 "inclusive civil society dialogue", as suggested by the European Commission's Pharmaceutical Strategy. [ABSTRACT FROM AUTHOR] |
|
Copyright of Journal of Market Access & Health Policy is the property of MDPI and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) |
| قاعدة البيانات: |
Complementary Index |
PDF full text from Publisher 
Full Text Finder