Health Technology Assessment (Regulation)

The EU Commission wants to create joint clinical assessments and harmonised assessment procedures at EU level for innovative health technology in order to remove barriers in the internal market. Thus, redundant duplication of work both in national HTA centres and for developers of health technology can be avoided and costs, currently incurred by developers due to differing national assessment concepts, can be reduced.


In cep’s view, joint clinical assessments and the harmonisation of assessment procedures prevent Member States from designing procedures according to the preferences of their health systems. The EU also lacks the legislative competence to harmonise clinical assessments. In addition, the EU Commission wants to determine the essential assessment criteria itself although they should in fact be established by the Union legislator.

Grafik Koordinierungsgruppe  (publ. 05.06.2018)