EU Member States will now conduct health technology assessments (HTAs), which are analyses to monitor the long-term properties and effects of medicines, devices, procedures, and medical acts. Negotiators from the Council of the EU and the European Parliament reached agreement on Tuesday 22 June on a draft regulation in this regard (see EUROPE 11951/6).
The text will enter into force after final approval by the EU27 ambassadors and all MEPs. It will then apply from 2024 onwards, and future joint assessments will therefore mainly concern medicines or devices for which a marketing application has been submitted after that date.
For orphan drugs, for example, it will be 2027. For many medicines and devices, the cursor has even been set to 2029. A small victory for the Parliament, all the same. The Member States—less enthusiastic about the project—have in fact tried to push back certain deadlines to 2032.
Flexibility for states. However, MEPs were keen to defend the binding nature of the future joint assessment mechanism and had to compromise on this point.
As requested by the EU Council, the final text will only require the EU27 to “take into account” the clinical assessment reports carried out at European level. They will not be required to use these reports at national level.
In order to ensure that the common assessments are not ignored by certain States, the Parliament has obtained the introduction of a number of safeguards: in particular, the States will have to annex the European reports to their national work. They will also have to report on how the European clinical assessments will be used in their national evaluations.
Coordination. Finally, the regulation establishes a coordination group and various sub-groups that will bring together representatives from each Member State. It is specified that these representatives should not have any interests in the health technology industry that could affect their independence.
There was still some uncertainty as to how the coordination group would vote in the event that certain decisions were not adopted unanimously. It was finally decided to operate on a case-by-case basis. In the absence of unanimity, certain decisions (adoption of the annual programme, annual reports, guidelines for sub-groups) will require a qualified majority. Other decisions, of a more scientific nature, will require an absolute majority.
This new regulation “will benefit patients, health technology manufacturers, and Member States’ health systems”, summarised Portuguese Health Minister Marta Temido, whose country represented the Member States in the interinstitutional negotiations.
For his part, Parliament rapporteur Tiemo Wölken (S&D, Germany) welcomed a step forward that would eventually “significantly reduce duplication of clinical assessments” and ensure “sustainable cooperation on HTAs”. (Original version in French by Agathe Cherki)