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 - Petrova, Guenka
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
N1 - Funding Information:
For over 20 years, there have been various initiatives to strengthen collaboration on HTA across Europe. This started with the EUR-ASSESS project funded by the European Commission during 1994–1996 [11]. This project aimed to promote coordination of HTA in Europe by improving methods of assessment, priority setting, and the use of HTA results through better dissemination and use of HTA in coverage decisions. Thereafter, two other research projects were funded by the European Commission to improve collaboration between HTA institutions in Europe. These were HTA Europe (1997–1999) and the ECHTA/ECHAHI (European Collaboration for Assessment of Health Interventions) project (1999–2001) [11,12]. These projects laid the foundation for the European Network for Health Technology Assessment (EUnetHTA). EUnetHTA is a network of government-appointed organizations combined with a large number of regional agencies and not for profit organizations. The first EUnetHTA project (2006–2008) was followed by the EUnetHTA Collaboration (2009) [11,13]. This was followed by three EU Joint Action projects JA1 (2010–2012), JA2 (2012–2015) and the ongoing JA3 (2016–2020) [13,14]. The main objectives of EUnetHTA included support of the efficient production and use of HTA in decision-making across Europe, provision of an independent and science-based platform, an access point for communication and the development of research. Over the last three years, Member States have also developed regional co-operations, e.g. BeNeLuxAIr, the Valletta Declaration, FINOSE and Visegrad projects, to undertake joint activities such as HTA, price negotiations especially for new medicines for orphan diseases, horizon scanning and information sharing [15–18].
Publisher Copyright:
© 2019, © 2019 Informa UK Limited, trading as Taylor & Francis Group.
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 - EUnetHTA
KW - European legislation
KW - Member States
KW - cross border agreements
KW - joint collaboration on HTA
UR - http://www.scopus.com/inward/record.url?scp=85061826123&partnerID=8YFLogxK
U2 - 10.1080/14737167.2019.1575730
DO - 10.1080/14737167.2019.1575730
M3 - Article
C2 - 30696372
AN - SCOPUS:85061826123
SN - 1473-7167
VL - 19
SP - 251
EP - 261
JO - Expert Review of Pharmacoeconomics and Outcomes Research
JF - Expert Review of Pharmacoeconomics and Outcomes Research
IS - 3
ER -