On Wednesday 17 June, the Croatian Presidency of the Council of the EU presented a brief update to the ambassadors of the Member States on the state of play in the discussions on health technology assessments. Reflecting the content of a progress report, she explained that she had had to interrupt discussions due to the Covid-19 pandemic.
“On the basis of its bilateral and multilateral discussions with delegations, the Presidency concludes that the outbreak of the Covid-19 pandemic underlines the importance of having a legally sound and operational HTA system in place”, the document states.
The proposal for a Regulation presented in January 2018 introduces “common clinical evaluations” to determine the added value of a medicinal product or some of the most innovative in vitro medical devices, in order to help Member States take decisions on pricing and reimbursement (see EUROPE 11951/6). Following an expeditious vote in September 2018, MEPs supported the outlines of the proposal (see EUROPE 12095/12).
Three confidential documents in circulation
In its progress report, the Croatian Presidency points out that it has finally organised only some of the meetings originally envisaged because of the coronavirus crisis. In total, it arranged 2 meetings of the working group on pharmaceuticals and medical devices, when it had planned 6. The first one examined Articles 3 to 5, 18 and 28, concerning in particular the Member State coordination group, technologies covered by the common clinical assessments and the identification of emerging health technologies. The second dealt with the technical aspects of the common clinical evaluation process, from scoping to approval (Articles 6 to 8 and Article 34a). Croatia also submitted in mid-March a third document in writing, which concerned joint scientific consultations (Articles 9, 10, 11a-16).
No public documents
Unfortunately, the document does not go into any more detail about the compromise proposals tabled by Zagreb and, as usual on this particularly sensitive dossier, no documents are public. However, the Presidency concludes with these two observations: on the one hand, the feeling that the pandemic has reinforced the need for solid legislation in this area and, on the other hand, that progress is possible on part of the dossier.
“The Presidency considers that the text it proposed for Articles 3 to 8, 18, 28 and 34a, including the articles on conflicts of interest and quality assurance and the corresponding recitals, which was discussed at the two meetings of the working group, was well received by a large number of delegations”, notes the document.
It will now be up to Germany, rather reluctant to European legislation in this area, to take up the torch on 1 July 2020 (see EUROPE 12214/30). (Original version in French by Sophie Petitjean)