Brussels, 27/06/2005 (Agence Europe) - Françoise Grossetête (EPP-ED, France) presented to the press on 22 June, the main elements of her report on the proposal for a regulation concerning medicines used in paediatrics (to be voted in committee on 13 July). She stressed how important it was for the EU to take realistic and clearly defined incentive measures to support research on paediatric medicine. She gave her full support to establishing an incentive system of fixed duration, rather than of variable duration which would depend on the turnover of companies. In its proposal of September 2004, the Commission had suggested a six-month extension to the complementary protection certificate for medicines that have been tested on children (see EUROPE 8795). It is “not possible” to set up a system based on proportionality, Françoise Grossetête said. If such an approach is retained, “one goes from a health to a market way of thinking”, she added, “which is not what we want”. In her view, with “a logic based on sales prices, laboratories will endeavour to give preference to sales in Member States where prices are the lowest”. She said she has discussed the matter with the European Agency for the Evaluation of Medicinal Products and received assurance that it did not have the “human and material means to monitor” a system based on proportionality. Ms Grossetête said, moreover, that “some twenty member States agree” with the proposal, which is a “sign that this will not bring about surcharges for the national health systems”. A study carried out in the Netherlands shows that the rise in costs would be contained in a range between “0.7 and 1%”. Nonetheless, the MEP asserted that she was “deeply concerned” about the fact that it was so difficult to convince some of her colleagues who “are lured by other ideas” and regretted that a public hearing has not been organised on this subject.
German Social Democrat Dagmar Roth-Behrendt totally supported the rapporteur's approach. “The six-month rule is honest and good”, she said. “In a few years from now, it will be seen that more is needed”, and that is why “a review clause” has been introduced. On the subject of creating a special fund to provide support for paediatric research - Medicine Investigation for Children of Europe or MICE - she felt that it is necessary to “integrate it into the research programme” to ensure guarantees and speed. This is also the position of the European Commission. On the other hand, Françoise Grossetête hoped such a fund would be set up by the regulation and submitted amendments along these lines.
The Association française des jeunes diabétiques (AJD), the European Association for Children in Hospital (EACH), the European Organisation for Rare Diseases (EURORDIS), Isis (the association of parents of children with cancer), the Société française de pédiatrie (SFP) and les Entreprises du medicament (LEEM) presented their manifesto for a European regulation on paediatric medicines. The proposal for a regulation provides “an opportunity not to be missed” and must allow Europe to catch up with the United States, the document says. The Isis representative, Cathérine Vergely, pointed out that she strongly supported “adoption of the regulation as drafted”, which must “not depend on economic considerations and turnover”. Speaking on behalf of EURORDIS, Flaminia Macchia, called for the “right of children to medicines of the same quality as those for adults”. Above all, the “proportional system will offset the products that are not so good, and that we need least”, she warned.