The pharmaceutical industry is not satisfied with the common position of the Member States on the draft regulation on health technology assessments. On Monday 29 March, the European Federation of Pharmaceutical Industries and Associations (EFPIA) unambiguously deplored the lack of trust that countries have in each other.
The mandate given to the Portuguese Presidency of the EU Council on 24 March offers maximum flexibility to Member States on how to use joint assessments (see EUROPE 12685/21).
In its press release, the organisation points out that this shows a lack of confidence in the EU27 to establish a functioning European framework and to jointly produce quality clinical assessments. “The resulting lack of predictability for all parties may not only lead to suboptimal and inefficient use of limited HTA capacity of Member States but also risks to further delay patient access [to these technologies]”, the EFPIA notes.
Concerned about this predictability, the organisation suggests that an initial assessment of the system should be carried out once the rules and methodologies are adopted and before the first oncology products are evaluated or before the system is extended to orphan drugs.
According to our information, no date for the first interinstitutional meeting between the European Parliament, the Council of the EU and the Commission has yet been set. (Original version in French by Sophie Petitjean)