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Expert Rev Pharmacoecon Outcomes Res. 2019 Jan 29:1-11. doi: 10.1080/14737167.2019.1575730. [Epub ahead of print]

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

Author information

1
a Strathclyde Institute of Pharmacy and Biomedical Sciences , University of Strathclyde , Glasgow , UK.
2
b Mechanism of Coordinated Access to Orphan Medicinal Products (MoCA) , Brussels , Belgium.
3
c KU Leuven Department of Pharmaceutical and Pharmacological Sciences , Leuven , Belgium.
4
d Health Economics Centre , University of Liverpool Management School , Liverpool , UK.
5
e Department for Health Evidence , Radboud University Medical Center , Nijmegen , The Netherlands.
6
f Department of Pathology, Forensic Medicine and Pharmacology , Institute of Biomedical Sciences, Faculty of Medicine, VilniusUniversity , Vilnius , Lithuania.
7
g Department of Drug Management, Faculty of Health Sciences , Jagiellonian University Medical College , Krakow , Poland.
8
h NHS Lothian , Edinburgh , UK.
9
i Division of Health Policy and Insurance Research, Department of Population Medicine , Harvard Medical School and Harvard Pilgrim Health Care Institute , Boston , MA , USA.
10
j Global Health and Development Group , Imperial College , London , UK.
11
k IQVIA , Brussels , Belgium.
12
l Department of Pharmacy, Faculty of Medicine , University of Medicine , Tirana , Albania.
13
m Hauptverband der ÖsterreichischenSozialversicherungsträger , Vienna , Austria.
14
n Department of Organization and Economics of Pharmacy, Faculty of Pharmacy , Medical University-Sofia , Bulgaria.
15
o State Agency of Medicines , Tartu , Estonia.
16
p Wissenschaftliches Institut der AOK (WidO) , Berlin , Germany.
17
q EOPYY-National Organization for the Provision of Healthcare Services , Athens , Greece.
18
r School of Economics and Political Science , University of Athens , Athens , Greece.
19
s Department of Health Services , Ministry of Health , Reykjavík , Iceland.
20
t Pharmaceutical Drug Department , Azienda Sanitaria Locale of Verona , Verona , Italy.
21
u UBT - Higher Education Institute , Prishtina , Kosovo.
22
v HTA Consulting , Cracow , Poland.
23
w Pharmaceutical Division , INFAMED , Lisbon , Portugal.
24
x Ministry of Health and Social Welfare , Banja Luka , Republic of Srpska, Bosnia and Herzegovina.
25
y Department of Social Pharmacy , University of Banja Luka, Faculty of Medicine , Banja Luka , Republic of Srpska, Bosnia and Herzegovina.
26
z Faculty of Medicine, Public Health and Management Department , "Carol Davila" University of Medicine and Pharmacy Bucharest , Bucharest , Romania.
27
aa National Research Institution for Public Health , Moscow , Russia.
28
ab Health Insurance Institute , Ljubljana , Slovenia.
29
ac Faculty of Medicine, Slovak Medical University , Bratislava , Slovakia .
30
ad Drug Territorial Action Unit , Catalan Health Service , Barcelona , Spain.
31
ae Centre for Primary Care, Division of Population Health, Health Services Research and Primary Care , University of Manchester , Manchester , UK.
32
af NIHR Greater Manchester Patient Safety Translational Research Centre, School of Health Sciences , University of Manchester , Manchester , UK.
33
ag Division of Clinical Pharmacology , Karolinska, Karolinska Institutet , Stockholm , Sweden.
34
ah Department of Public Health Pharmacy and Management, School of Pharmacy , Sefako Makgatho Health Sciences University , Garankuwa , South Africa.

Abstract

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:

EUnetHTA; European legislation; Member States; cross border agreements; joint collaboration on HTA

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