The draft regulation on mandatory joint clinical assessments got off to a poor start in the Council of the EU, if one is to judge from the comments of a number of health ministers at their meeting in Luxembourg on 22 June.
The draft regulation would put in place “joint clinical assessments” to determine the added value of the most innovative medicines and certain medical or in vitro devices to help member states come to decisions on pricing and reimbursement (see EUROPE 11951). The other parts of the proposal seek to establish joint scientific consultation, identify emerging health technologies and encourage voluntary cooperation.
For the moment, neither Parliament nor Council of the EU has agreed a negotiating position. The Czech, French and German national parliaments have expressed concerns over respect for subsidiarity and Poland has submitted a contribution on this issue.
Initial exchange of views in Council. In Luxembourg on Friday, several delegations, including those of Germany, France and Denmark, were against the clinical assessments being mandatory and the prohibition of national assessments (Article 8 of the proposal).
Germany, one of the strongest critics of the proposal, said that it would prepare a discussion paper with France, arguing that there were alternatives to mandatory assessments.
Cyprus and Malta highlighted the limits of voluntary cooperation, such as currently exists through the EUnetHTA network.
Luxembourg, Latvia and Finland called for an intermediate solution, while other states, such as Belgium, argued against drawing any hasty conclusions.
Ultimately, the Bulgarian Presidency of the Council of the EU stated that, according to its calculations, nine member states (representing over 70% of the population of the EU) opposed or had serious reservations over Article 8 and only three countries (representing 5% of the population) backed it.
In their discussion paper, the Bulgarian authorities point out that other stumbling blocks could be the harmonised rules applicable to clinical assessments (Articles 20 and 22) and notification of national measures (Article 34).
And what of the European Parliament? In the environment and public health (ENVI) committee, the draft report by Soledad Cabezón Ruiz (S&D, Spain), which was published in May, comes out in favour of mandatory joint clinical assessment.
The draft report suggests more specifically that member states should make use of the joint clinical assessments in their domestic evaluations of health technologies but not conduct national-level clinical assessments.
It says, however, that states should be able to conduct assessments relating to additional clinical and non-clinical data and criteria which are specific to them, which have not been taken into account in the joint clinical assessment and which are necessary for completion of the general assessment of the health technology concerned. (Original version in French by Sophie Petitjean)