The Council of the European Union could in the coming months, with a complete lack of transparency, reach a general approach on health technology assessment. According to a series of documents seen by EUROPE following the activation of the transparency tool, the Member States are moving towards non-binding common clinical assessments, contrary to what the European Commission initially proposed.
They also provide for a “step-by-step” approach to the implementation of such evaluations and also reserve the possibility of going backwards, by instructing the Commission to examine the relevance of several provisions in an implementation report.
They also introduce, like the European Parliament, the dual legal basis under the TFEU concerning health (Article 168) and the internal market (Article 114) (see EUROPE 12095/12).
Objective: the Health Council on 16 March
The draft regulation on health technology assessments, known as “HTA”, has been under discussion for almost 3 years now. It proposes that clinical evaluations carried out by the Member States be pooled to determine the added value of a medicinal product or certain medical devices and thus help them to determine their specific position on pricing and reimbursement (see EUROPE 11951/6).
The day after the presentation of the draft, several Member States invoked subsidiarity problems, with France, Germany and the Czech Republic submitting a reasoned opinion. Discussions had nevertheless continued in working groups, and it appears, according to the timetable of the Portuguese Presidency of the EU Council, that a general approach will be considered at the Health Council on 16 March, paving the way for future negotiations with the European Parliament (which took a position in February 2019).
On the whole, the EU Council works in the greatest opacity, with attachés promising to communicate as little as possible so as not to derail the negotiations, which are extremely sensitive for some Member States. In 2020, only one document, the progress report of the Croatian Presidency, was published on the EU Council website.
Following a request for access to the documents, EUROPE was nevertheless able to consult some 20 documents, some of which include Member States’ comments on the various draft compromises.
A compromise based on flexibility
The most recent draft compromise to which EUROPE has had access, dated 22 December 2020 and therefore prepared under the German Council Presidency, is based on non-binding joint clinical assessments. Indeed, the text states that “Member States are free to draw their own value judgements and conclusions on the overall clinical added value of a health technology in the context of their specific health care system”. It added that, when a Member State disagrees, it can ask for a different scientific viewpoint to be included in the reports, which will then be adopted by consensus by the coordination group.
Also, contrary to what the Commission suggested, Member States can still carry out evaluations or re-evaluations at national level. They must take into account the methodology laid down in the regulation and the common clinical assessment, knowing that they “shall decide at their own discretion which parts of the reports they consider according to their national health care context”. However, they must be careful not to ask the developer of a health technology for information that has already been communicated at European level.
Another innovation is that the latest German compromise insists on the thoroughness of the dossier to be provided by the health technology developer. As requested by Belgium, it specifies, in annexes, the content of the files to be submitted. In Article 6b, the text provides that the assessment may be halted if the file is incomplete. In Article 34a, it further stipulates that developers may be sanctioned by Member States if they fail to provide the information requested, a provision which is contested by Hungary and Bulgaria, among others.
Gradual implementation of joint evaluations
The draft compromise suggests limiting, at the outset, joint assessments to cancer treatments only. After which they could be applied to orphan drugs or advanced therapy drugs (3 years later).
“Discussions on the scope revealed the need for a limited scope at the outset and for a high level of predictability and flexibility with regard to medicines”, explains a presentation from Berlin.
The Commission is also responsible for reporting 3 years after the application of the regulation. This report should address, inter alia, the added value for Member States of common clinical assessments, a possible extension of the scope or a possible financial contribution from producers. However, according to the comments of the Member States, Italy opposes such a contribution.
And the other aspects?
For the other chapters, the draft stipulates that the final document of the joint scientific consultation is not legally binding on the Member States, the coordination group or health technology developers. Indeed, a Member State has the right to carry out a national scientific consultation, but only has to inform the coordination group.
The text also adds emerging technologies with a major impact on patients, health or care systems in the chapter on voluntary cooperation.
Although the Portuguese Presidency of the Council of the EU confirms that discussions are well underway with a view to reaching a rapid agreement, it has refused to communicate on the different meetings planned and their agendas.
Link to the German compromise dated 22 December: http://bit.ly/3pTIPBb (Original version in French by Sophie Petitjean)