Proposal for a regulation on health technology assessment in Europe – opinions of policy makers, payers and academics from the field of HTA

Patricia Vella Bonanno, Anna Bucsics, Steven Simoens, Antony P Martin, Wija Oortwijn, Jolanta Gulbinovič , Celia Rothe, Angela Timoney, Alessandra Ferrario, Mohamed Gad, Ahmed Salem, Iris Hoxha, Robert Sauermann, Maria Kamusheva, Maria Dimitrova, Ott Laius, Gisbert Selke, Vasilios Kourafalos, John Yfantopoulos, Einar Magnusson & 15 others Roberta Joppi, Arianit Jakupi, Tomasz Bochenek , Magdalene Wladysiuk, Claudia Furtado, Vanda Marković-Peković, Ileana Mardare, Dmitry Meshkov, Jurij Fürst, Dominik Tomek, Merce Obach Cortadellas, Corrine Zara, Alan Haycox, Stephen Campbell, Brian Godman

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Introduction: In January 2018 the European Commission published a Proposal for a Regulation on Health Technology Assessment (HTA): ‘Proposal for a Regulation on health technology assessment and amending Directive 2011/24/EU’. A number of stakeholders, including some Member States, welcomed this initiative as it was considered to improve collaboration, reduce duplication and improve efficiency. There were however a number of concerns including its legal basis, the establishment of a single managing authority, the preservation of national jurisdiction over HTA decision-making and the voluntary/mandatory uptake of joint assessments by Member States. Areas covered: This paper presents the consolidated views and considerations on the original Proposal as set by the European Commission of a number of policy makers, payers, experts from pricing and reimbursement authorities and academics from across Europe. Expert commentary: The Proposal has since been extensively discussed at Council and while good progress has been achieved, there are still divergent positions. The European Parliament gave a number of recommendations for amendments. If the Proposal is approved, it is important that a balanced, improved outcome is achieved for all stakeholders. If not approved, the extensive contribution and progress attained should be sustained and preserved, and the best alternative solutions found.

LanguageEnglish
Pages251-261
Number of pages11
JournalExpert Review of Pharmacoeconomics and Outcomes Research
Volume19
Issue number3
Early online date29 Jan 2019
DOIs
Publication statusPublished - 4 May 2019

Fingerprint

Biomedical Technology Assessment
Administrative Personnel
Decision Making
Joints
Costs and Cost Analysis

Keywords

  • joint collaboration on HTA
  • cross border agreementws
  • European legislation
  • health technology assessment

Cite this

Vella Bonanno, Patricia ; Bucsics, Anna ; Simoens, Steven ; Martin, Antony P ; Oortwijn, Wija ; Gulbinovič , Jolanta ; Rothe, Celia ; Timoney, Angela ; Ferrario, Alessandra ; Gad, Mohamed ; Salem, Ahmed ; Hoxha, Iris ; Sauermann, Robert ; Kamusheva, Maria ; Dimitrova, Maria ; Laius, Ott ; Selke, Gisbert ; Kourafalos, Vasilios ; Yfantopoulos, John ; Magnusson, Einar ; Joppi, Roberta ; Jakupi, Arianit ; Bochenek , Tomasz ; Wladysiuk, Magdalene ; Furtado, Claudia ; Marković-Peković, Vanda ; Mardare, Ileana ; Meshkov, Dmitry ; Fürst, Jurij ; Tomek, Dominik ; Cortadellas, Merce Obach ; Zara, Corrine ; Haycox, Alan ; Campbell, Stephen ; Godman, Brian. / Proposal for a regulation on health technology assessment in Europe – opinions of policy makers, payers and academics from the field of HTA. In: Expert Review of Pharmacoeconomics and Outcomes Research. 2019 ; Vol. 19, No. 3. pp. 251-261.
@article{be26c1a2cb1e4a80a9d27da7c9120524,
title = "Proposal for a regulation on health technology assessment in Europe – opinions of policy makers, payers and academics from the field of HTA",
abstract = "Introduction: In January 2018 the European Commission published a Proposal for a Regulation on Health Technology Assessment (HTA): ‘Proposal for a Regulation on health technology assessment and amending Directive 2011/24/EU’. A number of stakeholders, including some Member States, welcomed this initiative as it was considered to improve collaboration, reduce duplication and improve efficiency. There were however a number of concerns including its legal basis, the establishment of a single managing authority, the preservation of national jurisdiction over HTA decision-making and the voluntary/mandatory uptake of joint assessments by Member States. Areas covered: This paper presents the consolidated views and considerations on the original Proposal as set by the European Commission of a number of policy makers, payers, experts from pricing and reimbursement authorities and academics from across Europe. Expert commentary: The Proposal has since been extensively discussed at Council and while good progress has been achieved, there are still divergent positions. The European Parliament gave a number of recommendations for amendments. If the Proposal is approved, it is important that a balanced, improved outcome is achieved for all stakeholders. If not approved, the extensive contribution and progress attained should be sustained and preserved, and the best alternative solutions found.",
keywords = "joint collaboration on HTA, cross border agreementws, European legislation, health technology assessment",
author = "{Vella Bonanno}, Patricia and Anna Bucsics and Steven Simoens and Martin, {Antony P} and Wija Oortwijn and Jolanta Gulbinovič and Celia Rothe and Angela Timoney and Alessandra Ferrario and Mohamed Gad and Ahmed Salem and Iris Hoxha and Robert Sauermann and Maria Kamusheva and Maria Dimitrova and Ott Laius and Gisbert Selke and Vasilios Kourafalos and John Yfantopoulos and Einar Magnusson and Roberta Joppi and Arianit Jakupi and Tomasz Bochenek and Magdalene Wladysiuk and Claudia Furtado and Vanda Marković-Peković and Ileana Mardare and Dmitry Meshkov and Jurij F{\"u}rst and Dominik Tomek and Cortadellas, {Merce Obach} and Corrine Zara and Alan Haycox and Stephen Campbell and Brian Godman",
year = "2019",
month = "5",
day = "4",
doi = "10.1080/14737167.2019.1575730",
language = "English",
volume = "19",
pages = "251--261",
journal = "Expert Review of Pharmacoeconomics and Outcomes Research",
issn = "1473-7167",
number = "3",

}

Vella Bonanno, P, Bucsics, A, Simoens, S, Martin, AP, Oortwijn, W, Gulbinovič , J, Rothe, C, Timoney, A, Ferrario, A, Gad, M, Salem, A, Hoxha, I, Sauermann, R, Kamusheva, M, Dimitrova, M, Laius, O, Selke, G, Kourafalos, V, Yfantopoulos, J, Magnusson, E, Joppi, R, Jakupi, A, Bochenek , T, Wladysiuk, M, Furtado, C, Marković-Peković, V, Mardare, I, Meshkov, D, Fürst, J, Tomek, D, Cortadellas, MO, Zara, C, Haycox, A, Campbell, S & Godman, B 2019, 'Proposal for a regulation on health technology assessment in Europe – opinions of policy makers, payers and academics from the field of HTA' Expert Review of Pharmacoeconomics and Outcomes Research, vol. 19, no. 3, pp. 251-261. https://doi.org/10.1080/14737167.2019.1575730

Proposal for a regulation on health technology assessment in Europe – opinions of policy makers, payers and academics from the field of HTA. / Vella Bonanno, Patricia; Bucsics, Anna; Simoens, Steven; Martin, Antony P; Oortwijn, Wija; Gulbinovič , Jolanta; Rothe, Celia; Timoney, Angela; Ferrario, Alessandra; Gad, Mohamed; Salem, Ahmed; Hoxha, Iris; Sauermann, Robert; Kamusheva, Maria; Dimitrova, Maria; Laius, Ott; Selke, Gisbert; Kourafalos, Vasilios; Yfantopoulos, John; Magnusson, Einar; Joppi, Roberta; Jakupi, Arianit; Bochenek , Tomasz; Wladysiuk, Magdalene ; Furtado, Claudia; Marković-Peković, Vanda; Mardare, Ileana; Meshkov, Dmitry; Fürst, Jurij; Tomek, Dominik; Cortadellas, Merce Obach ; Zara, Corrine; Haycox, Alan; Campbell, Stephen; Godman, Brian.

In: Expert Review of Pharmacoeconomics and Outcomes Research, Vol. 19, No. 3, 04.05.2019, p. 251-261.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Proposal for a regulation on health technology assessment in Europe – opinions of policy makers, payers and academics from the field of HTA

AU - Vella Bonanno, Patricia

AU - Bucsics, Anna

AU - Simoens, Steven

AU - Martin, Antony P

AU - Oortwijn, Wija

AU - Gulbinovič , Jolanta

AU - Rothe, Celia

AU - Timoney, Angela

AU - Ferrario, Alessandra

AU - Gad, Mohamed

AU - Salem, Ahmed

AU - Hoxha, Iris

AU - Sauermann, Robert

AU - Kamusheva, Maria

AU - Dimitrova, Maria

AU - Laius, Ott

AU - Selke, Gisbert

AU - Kourafalos, Vasilios

AU - Yfantopoulos, John

AU - Magnusson, Einar

AU - Joppi, Roberta

AU - Jakupi, Arianit

AU - Bochenek , Tomasz

AU - Wladysiuk, Magdalene

AU - Furtado, Claudia

AU - Marković-Peković, Vanda

AU - Mardare, Ileana

AU - Meshkov, Dmitry

AU - Fürst, Jurij

AU - Tomek, Dominik

AU - Cortadellas, Merce Obach

AU - Zara, Corrine

AU - Haycox, Alan

AU - Campbell, Stephen

AU - Godman, Brian

PY - 2019/5/4

Y1 - 2019/5/4

N2 - Introduction: In January 2018 the European Commission published a Proposal for a Regulation on Health Technology Assessment (HTA): ‘Proposal for a Regulation on health technology assessment and amending Directive 2011/24/EU’. A number of stakeholders, including some Member States, welcomed this initiative as it was considered to improve collaboration, reduce duplication and improve efficiency. There were however a number of concerns including its legal basis, the establishment of a single managing authority, the preservation of national jurisdiction over HTA decision-making and the voluntary/mandatory uptake of joint assessments by Member States. Areas covered: This paper presents the consolidated views and considerations on the original Proposal as set by the European Commission of a number of policy makers, payers, experts from pricing and reimbursement authorities and academics from across Europe. Expert commentary: The Proposal has since been extensively discussed at Council and while good progress has been achieved, there are still divergent positions. The European Parliament gave a number of recommendations for amendments. If the Proposal is approved, it is important that a balanced, improved outcome is achieved for all stakeholders. If not approved, the extensive contribution and progress attained should be sustained and preserved, and the best alternative solutions found.

AB - Introduction: In January 2018 the European Commission published a Proposal for a Regulation on Health Technology Assessment (HTA): ‘Proposal for a Regulation on health technology assessment and amending Directive 2011/24/EU’. A number of stakeholders, including some Member States, welcomed this initiative as it was considered to improve collaboration, reduce duplication and improve efficiency. There were however a number of concerns including its legal basis, the establishment of a single managing authority, the preservation of national jurisdiction over HTA decision-making and the voluntary/mandatory uptake of joint assessments by Member States. Areas covered: This paper presents the consolidated views and considerations on the original Proposal as set by the European Commission of a number of policy makers, payers, experts from pricing and reimbursement authorities and academics from across Europe. Expert commentary: The Proposal has since been extensively discussed at Council and while good progress has been achieved, there are still divergent positions. The European Parliament gave a number of recommendations for amendments. If the Proposal is approved, it is important that a balanced, improved outcome is achieved for all stakeholders. If not approved, the extensive contribution and progress attained should be sustained and preserved, and the best alternative solutions found.

KW - joint collaboration on HTA

KW - cross border agreementws

KW - European legislation

KW - health technology assessment

U2 - 10.1080/14737167.2019.1575730

DO - 10.1080/14737167.2019.1575730

M3 - Article

VL - 19

SP - 251

EP - 261

JO - Expert Review of Pharmacoeconomics and Outcomes Research

T2 - Expert Review of Pharmacoeconomics and Outcomes Research

JF - Expert Review of Pharmacoeconomics and Outcomes Research

SN - 1473-7167

IS - 3

ER -