TY - JOUR
T1 - Avoiding Error and Finding the Right Balance in European Health Technology Assessments
T2 - Insights Generated by the European Access Academy
AU - Julian, Elaine
AU - Belleman, Tom
AU - Garcia, Maria João
AU - Doeswijk, Robin
AU - Giuliani, Rosa
AU - Woermann, Bernhard J.
AU - Widmer, Daniel
AU - Tilleul, Patrick
AU - Casado-Arroyo, Ruben
AU - Strammiello, Valentina
AU - Morgan, Kate
AU - Guardian, Marcus
AU - Ermisch, Michael
AU - Bernardini, Renato
AU - Gianfrate, Fabrizio
AU - Capri, Stefano
AU - de Groot, Carin
AU - Pavlovic, Mira
AU - Ruof, Jörg
AU - van Molken, Maureen
N1 - © 2025 by the authors
PY - 2025/2/10
Y1 - 2025/2/10
N2 - Background: We examined four potential challenges for the implementation of the European Union (EU) Regulation 2021/2282 on Health Technology Assessment(EU HTAR): interaction with the European Medicines Agency (EMA), expert input, the interface of European health technology assessment (EU HTA) joint procedures with those within Member States, and the management of conflict of interest. This research aims to explore how to address these challenges in a balanced manner and prioritise key actions for effective collaboration in the context of the EU HTA. Methods: The methodology included a pre-convention survey among relevant stakeholders as well as working groups and the plenary ranking of discussion outcomes at the European Access Academy (EAA) Spring Convention 2024. Results: In the survey, 65.5% of respondents indicated that experts are currently not sufficiently included in the upcoming joint scientific consultations and clinical assessments; only 37.9% suggested that the EU HTA joint procedures would accelerate national appraisal decision-making, and 58.6% believed that the principles of ‘transparency’ and ‘competency’ are balanced in the EU HTA position on conflict of interest. The top priority action points identified in the working groups were the involvement of the best available expertise, the early and inclusive involvement of experts, strengthened early scientific dialogue, and the fostering of the political willingness/financial support of EU Member States to increase capacities. Conclusions: The key topics identified were an approach to conflict of interest that balances transparency obligations and the need for expertise, strengthens the involvement of clinical and patient experts, intensifies early interaction between the EMA and EU HTA, and increases the involvement of the EU Member States.
AB - Background: We examined four potential challenges for the implementation of the European Union (EU) Regulation 2021/2282 on Health Technology Assessment(EU HTAR): interaction with the European Medicines Agency (EMA), expert input, the interface of European health technology assessment (EU HTA) joint procedures with those within Member States, and the management of conflict of interest. This research aims to explore how to address these challenges in a balanced manner and prioritise key actions for effective collaboration in the context of the EU HTA. Methods: The methodology included a pre-convention survey among relevant stakeholders as well as working groups and the plenary ranking of discussion outcomes at the European Access Academy (EAA) Spring Convention 2024. Results: In the survey, 65.5% of respondents indicated that experts are currently not sufficiently included in the upcoming joint scientific consultations and clinical assessments; only 37.9% suggested that the EU HTA joint procedures would accelerate national appraisal decision-making, and 58.6% believed that the principles of ‘transparency’ and ‘competency’ are balanced in the EU HTA position on conflict of interest. The top priority action points identified in the working groups were the involvement of the best available expertise, the early and inclusive involvement of experts, strengthened early scientific dialogue, and the fostering of the political willingness/financial support of EU Member States to increase capacities. Conclusions: The key topics identified were an approach to conflict of interest that balances transparency obligations and the need for expertise, strengthens the involvement of clinical and patient experts, intensifies early interaction between the EMA and EU HTA, and increases the involvement of the EU Member States.
UR - http://www.scopus.com/inward/record.url?scp=105001261188&partnerID=8YFLogxK
U2 - 10.3390/jmahp13010006
DO - 10.3390/jmahp13010006
M3 - Article
C2 - 39990187
SN - 2001-6689
VL - 5
SP - 1
EP - 16
JO - Journal of Market Access and Health Policy
JF - Journal of Market Access and Health Policy
IS - 1
M1 - 6
ER -