Brussels, 24/01/2003 (Agence Europe) - During its meeting on 14 January (see EUROPE 10 January p 14), the transparency committee reached an agreement on reference terms that still have to be adopted following written procedure. These terms of reference should allow for improvements in information exchange on national procedures and criteria kept for working out prices and refunds for medicines. In keeping with the committee's mission statement set out in the "transparency directive", improvements in comparing data provided by Member States will be made in order to check whether directive provisions are respected. In this context, an exercise on preventive dialogue, outside infringement procedures is planned for Member States and candidate countries. Member States also agreed to provide information on elements that they use for working our relative therapeutic values (comparison of a medicine in relation to others in terms of effectiveness) and the consequences that they could have on prices and refunds. The third part of the exercise focuses on the pharmo-economic analyses used by Member States (cost/efficiency relationship). In the long run this information could allow procedures to be brought closer together, as well as criteria in Member States. The work group preparing the terms of reference will continue its work.
The transparency committee also approved the setting up of a new work group on orphan medicine prices. In principle, these benefit from a strict life-expectancy of ten years (banning the putting onto the market of any other product that has a similar effect) but this time span could be reduced to six years if Member States estimate that the price of a medicine is disproportionate. The first centralised authorisation for an orphan medicine covers a three years period, different analyses could also be made in those three years. The work group is seeking to define a common methodology. The next meeting of the transparency committee is planned for June.