EC rare disease consultation reaps unprecedented number of responses
The Public Consultation for a future Communication on European Action in the Field of Rare Diseases, entitled Rare Diseases: Europe's Challenges, drafted by the European Commission in close collaboration with the Rare Diseases Task Force, has culled the largest response ever for a public consultation. More than 600 contributions were received by the EC during the consultation period that ran from mid-November until 14 February, outdistancing the previous contender for most responses by over 400 comments. The average number of responses to a consultation is 60. This overwhelming reaction is being taken as a sign of proof of the pertinence of the Consultation on Rare Diseases and the desire across Europe to see its provisions implemented in the near future. France led the European countries with over 130 replies received, but responses came from most of the EU Member States and from all the rare disease stakeholders - international patient associations (64), national patient associations (156), individual patients and families (52), member state health authorities (26), regional authorities (16), centres and networks of reference (12), universities (40), research centres (4) and others. The text of the Consultation was generally supported, with three particular points evoking contrariant opinions: the use of prevalence versus incidence to define a rare disease; the necessity of European legislation specific to medical devices for rare diseases; and the proposal to create a European-level rare disease agency. All responses to the Consultation are being reviewed for inclusion in the final version of the text. After incorporating the suggestions received from the Public Consultation and the impact assessment of the EU services, the Communication will be presented to the European Parliament (most likely in September), and the Council of Ministers, the Economic and Social Committee, and the Committee of Region (hopefully by the end of the year). It is expected that the Parliament and the Council of Ministers will issue Recommendations on how to implement the suggested actions presented in this Communication. The responses to the Consultation will soon be available online, but OrphaNews Europe advises you to prepare your reading glasses and find a comfortable chair – the Consultation responses will make for over one thousand pages of reading!