HTA Council Presidency Progress Report

On 30 November the Council Presidency published a report on the progress within the Council on the proposal for a Regulation on health technology assessment (HTA) and amending Directive 2011/24/EU.

The Council Presidency shared a Presidency Progress Report on the Proposal for a Regulation on HTA. In this Presidency Progress Report the concerns of the Member States are expressed. Additionally, multiple solutions are presented through texts proposed by the Presidency or by Member States.

The Presidency Progress Report clarifies that contradictory opinions between the Member States persist. When the Commission’s proposal was published, on the one hand three Member States (Czech Republic, Germany and France) submitted a reasoned opinion, and the Polish parliament raised subsidiarity concerns. On the other hand the Irish and Portuguese parliaments submitted positive assessments of the proposal. If the Council remains divided, it is unlikely that inter institutional negotiations will commence before the end of this legislature and thus, will be postponed until after the EP elections in May 2019.

Next steps

  • On 7 December the HTA proposal will be discussed and raised under “Any Other Business” at the session of the Employment Social Policy, Health and Consumer Affairs (EPSCO) Council.
  • The Parliamentary Committee on Environment, Public Health and Food Safety (ENVI) decided in their Coordinators’ meeting that if negotiations have not started by end of January 2019, to conclude the EP first reading (and report back to plenary and procedural vote in February part-session).


Date: 17/01/2019 | Tag: | News: 889 of 1574
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