Health Technology Assessment (HTA) is a way
for national systems to efficiently distribute limited resources towards
effective health services.
The objectives of three Joint Action
projects run by the European Network for Health Technology Assessment (EUnetHTA) have been to promote scientific
exchange, develop a method for joint HTA procedures and produce the first joint
Under EU law, it will be difficult to
continue funding EUnetHTA after the current five-year financial framework
expires in 2020. On 31 January 2018, the European Commission therefore
submitted a proposal for a Regulation on clinical evaluation of health
technologies to the European Parliament and the Council (see article Oct
Associations demand more involvement
The European Commission has justified its
proposal by the fact that, despite having EUnetHTA, the positive effects of a
professional network, cooperation in further developing clinical evaluation
methods and joint HTA procedures have only been done voluntarily and on a
project-by-project basis, meaning they have not reached their full potential.
With the help of the Regulation on health technology assessment, the European Commission wants to achieve
EU-wide harmonisation of existing national HTA procedures.
Article 8 of the proposal prohibits Member
States in the future from carrying out clinical assessments of technologies for
which a joint HTA assessment is planned or are already on the List of Assessed
Health Technologies (‘List’ as per Article 7). The use of the joint HTA
assessment is mandatory for these technologies, as is notification of the outcome
of a national assessment based on a joint HTA assessment.
The German National Association of Health
Insurance Funds (GKV-Spitzenverband) generally welcomes the proposed
consolidation of cooperation between the HTA authorities. However, the
GKV-Spitzenverband strongly rejects the proposal with regard to the ban on Member
States carrying out their own clinical HTAs. One of the decisive factors is
that, due to existing differences in national health systems, there may be
clear differences regarding which therapies are considered as standard and thus
as the basis for comparison. An assessment against a comparator that is
unsuitable in the specific environment is useless. It is counterproductive and
unnecessary to impose an obligation and prohibit supplementary assessments.
The European associations (ESIP, AIM, BEUC)
welcome the proposal for a joint HTA methodology at European level. However, they
emphasise that a uniform procedure must not jeopardise the quality and safety
of healthcare and they are calling for more involvement of national
decision-makers in the development of the assessment procedure.
In a joint statement, the pharmaceutical
industry has welcomed the proposal and reiterated the need for a debate on
New rapporteur appointed
The GKV-Spitzenverband supports the
proposal with regard to the European Commission’s intention to further develop
assessment procedures at European level. However, there must be a clear
distinction between ‘assessment’ at European level and ‘appraisal’ at national
level. It must also be possible to carry out supplementary assessments on the
basis of national specificities.
The European Parliament adopted a common
position in October 2018, with the aim of creating more binding European HTA
cooperation while at the same time taking into account the needs of national
health systems and thus allowing more freedom in the use of joint assessment
This line continues to be supported by the
newly appointed rapporteur for the HTA dossier in the European Parliament,
Tiemo Wölken (S&D, DE), and by Peter Liese (EPP, DE), coordinator and group
spokesman for the Health Committee of the European Parliament.
The European Commission and the Council
have not yet taken a position on the issue.
Finland will continue the dossier during
its Presidency. The main elements of the upcoming negotiations will be the
legal process, the legally binding nature of the proposal and how health
technologies will be included in the ‘List’. It is still unclear which
priorities the upcoming Croatian Council Presidency will set with regard to the