The EU Council continues its work on health technology assessments (HTAs) under significant opacity. Patient organisations are alarmed at the deletion of some key articles, but it is very difficult to know where the discussions stand. The only certainty at this stage is that the Finnish Presidency of the Council of the EU will not reach a common position before the end of the year.
The dossier will only be the subject of an information point at the Health Council on 9 December, and it reportedly has been agreed that no delegation would take the floor.
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).
Work is progressing much more slowly in the EU Council. And above all, they take place under a great deal of opacity. At this stage, only a discussion paper prepared under the Bulgarian Presidency in mid-2018 and a progress report drafted under the Austrian Presidency at the end of 2018 have been published on the European institution’s website. The rest is not public.
Two groups of countries
The balance of power is quite clear. On the one hand, there is a series of “big countries” – Germany, France, Spain, Poland, Bulgaria and the Czech Republic – that reject a binding mechanism (see EUROPE 12214/30). On the other hand, about 20 smaller countries that welcome the pooling of expertise.
According to our information, the national experts meet about once a month under the Finnish Presidency and conduct numerous informal negotiations in the meantime. According to one observer, “both sides are talking more than before” and “there is more ambition to find a solution”.
A new meeting is scheduled for 29 January 2020.
The deletion of Article 7
In this context, the European Organisation for Rare Diseases, EURORDIS, contacted the press in response to rumours that Article 7 on the list of health technologies assessed, which prohibits states from carrying out their own assessments, would be deleted.
“Nothing has been decided yet”, we were told on the institutional side.
In any case, EURORDIS warns that the deletion of Article 7 would make the rest of the legislation superfluous and the years of work necessary to establish permanent European cooperation on HTA would have been wasted.
“It is better to have no European HTA legislation rather than bad legislation. Rare disease patients need more Europe, more European collaboration with clarity, not another level of complexity”, concluded Yann Le Cam, CEO of EURORDIS. (Original version in French by Sophie Petitjean)