EUCOPE Statement on Council HTA compromise – March 2021

EUCOPE welcomes the important collaborative effort made by the Council of the EU to reach a compromise on the EU on a Proposal for a Regulation on health technology assessment (HTA) and amending Directive 2011/24/EU. However, we note that the direction of the current compromise is substantially changing central parts of the proposed Regulation.

We express our concerns regarding a number of provisions that might bring additional regulatory and administrative burden and an added level of uncertainty for small to mid-size companies.

To address these concerns, we call for the following aspects to be included in upcoming inter-institutional negotiations:

• Sufficient management of evidentiary uncertainties for OMPs and ATMPs to prevent delays in patients’ access.
• Mandatory uptake of joint clinical assessment at national level to reduce regulatory burden.
• Joint scientific consultation for all manufacturers for increased predictability

Our full statement can be consulted here.