Ministers support the idea of extending cooperation in an attempt to ensure the accessibility and availability of innovative medicines in the EU. This is the conclusion they reached on Friday 8 December, after having listened to testimonies provided by Greece and Romania. Nonetheless, they remained divided on the binding nature of such cooperation and the need for regulatory reform.
Three dossiers were on the Health Council agenda: pharmaceutical policy, harmful alcohol consumption and health in the digital society. During a press conference, the European Commissioner, Vytenis Andriukaitis, also unveiled his work timetable: a legislative proposal on European cooperation in health technology assessment (HTA) and a report on intellectual property right incentives in February.
Medicines shortages
During the talks, almost all the delegations welcomed the voluntary cooperation between certain groups of countries (the BeNeLuxA initiative, the Valletta declaration and the existing cooperation between Baltic countries and countries in the Visegrád Group). Malta presented the high-level group on pharmaceutical products which held its first inaugural meeting last week. The Maltese delegation stated, “at the meeting, experts from 14 member states, as well as patients' representatives and those from industry attended. They agreed on beginning work in the following areas: alternative payment methods for innovative medicines, the budget impact, sustainable access to medicines, fair access in the EU and, finally, affective competition”. The delegation also announced that the next meeting would be held on 8-9 March in Brussels.
For all other issues, the delegations were divided on the need to revise the current legislative framework in order to take into account less economically attractive markets. This was one of the questions raised by the Estonian Presidency. Following an intervention by Romania and Hungary on the problem of parallel exports, Lithuania called for a legislative act in this area. The Netherlands referred to the conclusions of the report submitted to them which highlights the idea of a users' license and the possibility of patients purchasing medicines abroad. Italy mentioned the idea of extending the joint mechanism for awarding markets (Decision 1082/2013/EU) to medicines that are not related to cross-border threats. Latvia called to “change the legal framework in order to facilitate continuous access to medicines in all member states so that they do not depend on the goodwill of manufacturers”. France called for the regulations to be changed on paediatric medicines so that, “These medicines are the subject of a specific treatment and are not seen as secondary in relation to adult medicines”. Germany, Finland, Denmark and Slovakia called for the situation to be examined scrupulously before proceeding to a regulatory amendment. Finland called for a report that would examine the question of innovation, sales authorisation and the follow-up of side-effects. Denmark called for “policy document that set our challenges, objectives and common EU instruments”.
Health technologies
The next European Commission legislative proposal in the health field was briefly mentioned by the Commission and France. The former is planning on presenting a proposal to strengthen European cooperation in assessing health technologies (for all interventions that are likely to be used to promote health, prevent, diagnose or treat diseases, educate regarding long-term-care). It would like to strengthen cooperation that has existed since 2010 in the area of joint action for identifying the efficiency of new technologies compared to those that already exist.
According to the information we have received, the document which is currently subject to an inter-service consultation will establish the principle of "voluntary" cooperation, whilst explaining that member states that decide to participate in it will be “obliged" to obey new rules (tools, objectives, etc.). In this sense it swings between options 3 and 4 of the roadmap (3, cooperation for the collection, sharing and use of common tools and data or 4, cooperation on producing efficiency assessment reports on REA and their assimilation) (see EUROPE 11641).
One of the questions still pending focuses on the structure that will be in charge of such an operation. During the talks, France said that it was decidedly against these competencies being covered by the European Medicines Agency (EMA).
The French Minister stated, “the framework must remain supple and voluntary because the assessment of health technologies remains in national competency. The model of the European Medicines Agency does not appear to me to be appropriate and would create a link between the marketing process, which is not appropriate".
Alcohol and Bulgarian priorities
Eight member states also spoke during the adoption of the conclusions on the fight against harmful alcohol consumption. Ireland and Slovenia called on the Commission to take swift action on the nutritional labelling of alcoholic drinks, whilst Italy suggested taking its time on this issue. Ireland, Slovenia and the United Kingdom also highlighted the recent ruling by the British High Court concerning the introduction of minimum unit pricing in Scotland.
The meeting concluded in the middle of the afternoon with a contribution made by Bulgaria. It announced that the healthy nutrition of children and pharmaceutical policy would be the health priorities during its presidential tenure. It is planning an experts' meeting on the first subject on 6 February and on the second subject on 6 March. An informal meeting of the health ministers will take place in Sofia on 23 and 24 April, whereas the formal Council will take place in Luxembourg on 22 June. (Original version French by Sophie Petitjean)