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 and Bucsics, Anna and Simoens, Steven and Martin, Antony P and Oortwijn, Wija and Gulbinovič, Jolanta and Rothe, Celia and Timoney, Angela and Ferrario, Alessandra and Gad, Mohamed and Salem, Ahmed and Hoxha, Iris and Sauermann, Robert and Kamusheva, Maria and Dimitrova, Maria and Laius, Ott and Selke, Gisbert and Kourafalos, Vasilios and Yfantopoulos, John and Magnusson, Einar and Joppi, Roberta and Jakupi, Arianit and Bochenek, Tomasz and Wladysiuk, Magdalene and Furtado, Claudia and Marković-Peković, Vanda and Mardare, Ileana and Meshkov, Dmitry and Fürst, Jurij and Tomek, Dominik and Cortadellas, Merce Obach and Zara, Corrine and Haycox, Alan and Campbell, Stephen and Godman, Brian (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, 19 (3). pp. 251-261. ISSN 1473-7167

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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.