Brussels, 18/06/2013 (Agence Europe) - The “tobacco directive” will be the main item of the Health Council to be held on Friday 21 June in Luxembourg under the chairmanship of James Reilly, Ireland's Minister for Health.
Ministers will seek to set out general guidelines on the directive on the basis of a compromise text developed by the Irish Presidency of the EU Council. This is a highly sensitive issue on which opinions sometimes differ considerably, as the Presidency itself admitts. It will seek, on Friday, to bridge these differences. The Coreper meeting on Friday 15 June showed there was major dissent on certain points requiring intense discussion, with some member states showing proof of greater flexibility than others. The compromise text contains four provisions to address the most contentious issues identified: 1) reduce the coverage of combined picture and text health warnings on tobacco product packages from 75% to 70% but add a black border of 1mm around the area reserved for the warning; 2) give up, for the moment, on the ban on slim cigarettes but mandate the Commission with reporting on market developments of this type of cigarettes; 3) ban additives which result in a characterising flavour or that increase addictiveness and toxicity; and 4) invite the Commission to report on the feasibility of a positive list of tobacco product ingredients. The European Parliament is due to vote on the directive in July, and the interinstitutional trialogue should begin discussions under Lithuanian presidency.
The Council will also note two reports on the state of progress of work concerning, firstly, the regulation on clinical trials of medication for human use and, secondly, on two regulations, one for medical devices and the other for in vitro diagnostic medical devices. In the context of the first reading on the clinical trials of medicines for human use, four points have still to be discussed in depth. These are: - the shortening of time limits for the authorisation and validation of clinical trials; - the ethical evaluation of clinical trials; - the protection of volunteers; - and the damage compensation and indemnification mechanism. For medical devices, the procedures for clinical analysis and the method for strengthening controls by notified bodies are the main difficulties to be overcome. (IL/transl.jl)