Brussels, 05/04/2007 (Agence Europe) - EURORDIS, an umbrella group representing more than 300 associations at EU level and the interests of patients affected by rare diseases, was quick to react to the termination of the negotiation process between the European Parliament, Council and Commission on a draft regulation on a centralised EU authorisation system for new therapies derived from cell and tissue engineering. EURORDIS says the decision by the rapporteur, Slovak Christian Democrat Miroslav Mikolasik, to terminate the procedure (see EUROPE 9399) is 'based on personal religious beliefs' and 'shows contempt towards European children and adults suffering and dying from incurable diseases and who are eagerly awaiting innovative, effective and safe therapies.' It criticises the rapporteur for 'purposely having eliminated the possibility of a first-reading adoption of the long-awaited regulation,' describing the manoeuvre as 'totally unacceptable in a democratic Europe'.
The manoeuvre has not found favour with the European Commission and German presidency either, also involved in the negotiations, which both believed agreement in first reading was possible. The member states' representatives will have an initial discussion of the issue next week but it highly likely that what has happened will mean that the Council will refuse to grant the EP any further concessions on the subject in the future. Some analysts fear that the regulation will not be adopted until the first half of 2008, under the Slovenian presidency, unless in its wisdom, the EP plenary rejects the two controversial amendments on ethical issues. The ball is now in the plenary's court and the EP can still save the dossier from drowning in irrationality. Verdict in Strasbourg on 24 April 2007. (oj)