Germany does not intend to conclude the discussions in the EU Council on the draft regulation on health technology assessments (HTA). However, it is continuing its work in a working group. A new meeting is scheduled for 1 September.
The proposed Regulation introduces “common clinical assessments” to determine the added value of a medicinal product or of certain of the most innovative in vitro medical devices, with a view to assisting Member States in making pricing and reimbursement decisions (see EUROPE 11951/6).
Discussions in the Council have been dragging on for two years.
The 1 September exchange of views will focus on how best to ensure that health technology manufacturers respond to requests for information during joint clinical assessments.
“The relevance and usefulness for Member States of a joint clinical assessment report is significantly determined, among other things, by whether the information that is requested from health technology developers in relation to the scope of the assessment is actually available to the assessors”, underlines a confidential preparatory document seen by EUROPE.
It has been drafted on the basis that Article 8 of the legislative proposal “provides that Member States shall take into consideration joint clinical assessment reports”.
Five scenarios on the table
This highly technical text puts five scenarios (three of which are new) on the table to ensure this ‘availability’.
In summary, Scenario 1 obliges manufacturers to provide information according to a certain timetable and, if this is not respected, provides for sanctions at national level and the possible interruption of the assessment at European level.
Scenario 2 takes over from scenario 1 the prohibition to submit information at national level that has been requested at EU level, but limits this prohibition in time (it ends with the publication of the joint clinical assessment report). In addition, this scenario 2 does not provide for any sanctions at national level.
Scenario 3 foresees that the information provided at national level will contribute to an update of the joint clinical assessment one year later.
Scenario 4 provides for a completeness check of the information transmitted, allowing multiple requests for additional content. However, this scenario does not foresee an end to the prohibition to submit information at national level when it has been requested at EU level.
Finally, under scenario 5, the documentation requirements are limited to what is requested by the European Medicines Agency (EMA), with the coordinating group no longer having a leading role here. (Original version in French by Sophie Petitjean)