On Thursday 3 April, Members of the European Parliament once again called on the European Commission to present a ‘European action plan on rare diseases’, which affect 30 million people in the EU (see EUROPE 13590/8).
The European Commissioner for Health, Olivér Várhelyi, acknowledged in plenary that the EU needed to do more in these areas, without saying whether or not he would present such an action plan.
The plenary debate showed “the limits of what we can do” in terms of the budget, the development of research and the availability of medicines, stressed Mr Várhelyi. “And these are the very topics that the Commission is already addressing. With the future ‘Biotech Act’, the Commission anticipates “a major scientific breakthrough that will bring treatment, personalised medicine, personalised prevention much faster to our patients”, explained the Commissioner.
The Critical Medicines Act (see EUROPE 13597/18) aims to address the problem of rare diseases and orphan drugs (joint procurement and other tools to repatriate production in Europe). He praised the major added value represented by the ‘European reference network’. “Now is the time to mainstream this and to make it fully a part of the national healthcare systems”, said the Commissioner.
Tomislav Sokol (EPP, Croatian) advocated a European action plan with clear objectives and a timetable for achieving them. He called for an increase in funding for European reference networks and measures to facilitate patient travel and simplify formalities for cross-border care.
Laurent Castillo (EPP, French) said that the right to be forgotten was not a luxury. “It’s time for the European Union to finally enshrine this in its legislation, so that these children, now adults, can build their future without hindrance”.
Vytenis Andriukaitis (S&D, Lithuanian) advocated national strategies integrated into a European strategic plan with a more harmonised approach.
According to Ondřej Knotek (PfE, Czech), it is “obvious that this area requires closer cooperation between Member States, but also instruments with a pan-European scope” (cross-border care, secondary use of data, modern financing methods for therapies, simplification of legislation, creation of a contact point to support start-ups and small businesses).
Tilly Metz (Greens/EFA, Luxemburger) called for an action plan with “adequate funding, coordinated research and a common European vision of national actions”. This ambitious plan must also remedy “the shortcomings of the current pharmaceutical monopolies, which make treatments unaffordable”.
Nicolas González Casares (S&D, Spanish) suggested the creation of a compulsory minimum European catalogue for screening for rare diseases at birth. In addition, for him, medicines for rare diseases should not be subject to customs duties.
According to Michele Picaro (ECR, Italian), an essential aspect to be taken into account in the legislative process is market exclusivity for orphan drugs, which, with its ten years of protection, offers the stability necessary for innovation. (Original version in French by Lionel Changeur)