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Parliamentary questions
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27 April 2018
E-001311/2018(ASW)
Answer given by Mr Andriukaitis on behalf of the Commission
Question reference: E-001311/2018

The Commission considers that its proposal for a regulation on Health Technology Assessment(1) (HTA) as adopted on 31 January 2018 is an appropriate and proportionate response to the problems identified in the impact assessment report(2) accompanying the proposal. The problems identified include both the duplication of assessments at national level across the EU-28 and the divergent outcomes of these assessments.

The proposal aims to tackle these problems in a number of ways. Firstly, it provides for a Union-level framework for carrying out joint clinical assessments on the most innovative health technologies. These assessments are not to be repeated at national level and their results are to be used by the Member States in their national HTA processes.

Secondly, under the proposed Regulation, harmonised rules will be developed on how clinical assessments are carried out. These rules are foreseen both for clinical assessments at Union level and for those assessments that have not been prioritised for assessment at Union-level and are therefore carried out at national level.

Thirdly, the proposal provides a framework for Member States to cooperate, on a voluntary basis, on the non-clinical aspects of HTA.

(1)https://ec.europa.eu/health/sites/health/files/technology_assessment/docs/com2018_51final_en.pdf
(2)https://ec.europa.eu/health/technology_assessment/eu_cooperation_en

Last updated: 3 May 2018Legal notice