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 MagnussonRoberta 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

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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.

Original languageEnglish
Pages (from-to)251-261
Number of pages11
JournalExpert Review of Pharmacoeconomics and Outcomes Research
Issue number3
Early online date29 Jan 2019
Publication statusPublished - 4 May 2019


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

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