Brussels, 09/09/2005 (Agence Europe) - The European Federation of Pharmaceuticals Industries and Associations (EFPIA) welcomed the vote by the European Parliament on the dossier on medicines for paediatric use (EUROPE 9020), which was not quite so well received by the producers of generic drugs. In a press release, the association representing them (EGA) regretted the adoption of an incentive set at six months.
Speaking to the press in Strasbourg on Wednesday, Françoise Grossetête pointed out that she had fought to be rapporteur on this dossier, having been the rapporteur for the Parliament on orphan medicines and on the revision of pharmaceutical legislation. "I really wanted to do it", she admitted, speaking of her "wish to serve children" and to encourage research in Europe. We have in the region of 100 million young people under 18 years of age, so this is not an unimportant issue concerning only "a tiny percentage of our population", she said, adding: we are lagging far behind the United States (where there are some hundred paediatric medicines), and Canada, "and if European children have to depend on American or Asian research, this does not cover Europe in glory". This means, the rapporteur went on to say, that we need to incentivise the European pharmaceuticals industry, which is also made up of many SMEs, rather than just "big" industry ("and it is lucky we still have one!", said the MEP). Ms Grossetête was particularly pleased that the plenary had gone along with her proposal to grant the industry an extension on the protection for a fixed duration of six months. And other colleagues proposed a variable duration, three months plus three, or four months, depending on volume of sales, but this ran the risk of being "totally impossible to apply", and besides, the European Medicines Agency warned us that it would not be able to carry out the necessary checks, Ms Grossetête explained. The rapporteur also took pains to point out that parents' associations had played an "important role": we met parents of sick children who were "very sensible, very reasonable", and today, the plenary has also been "far more reasonable than we thought". Some twenty Member States agree with my proposal, and I hope we will build to move forward on this quickly, concluded Ms Grossetête.