Brussels, 28/06/2005 (Agence Europe) - During their meeting of 24 June, permanent representatives from the Member States again examined the most dispute point in the draft regulation on paediatric trials: the extension time for the certificate of complementary protection for medicines subject to clinical trials will help determine the parameters for their paediatric use. The fifteen older Member States, as well as the Czech Republic, Malta, Cyprus, Lithuania and Estonia, support the principle of a set six month period of additional protection, as proposed by the European Commission. Poland and Hungary are strongly opposed to this but may support the Latvian proposal introducing a variable three month incentive system with the possibility of increasing it to six months for medicines that sell less well. This proposal will be to the advantage of generic medicine producers, which would in this way, be able to copy more profitable medicines earlier. Slovakia and Slovenia have made this proposal subject to scrutiny (both countries sympathise somewhat with this proposal).
During the meeting, the Luxembourg presidency considered that the debate could be considered closed (which was opposed by Polish and Hungarian representatives) due to the existence of qualified majority in favour of a compromise it presented and to which it intends to attach the six month compensatory period with a rendezvous clause. This clause lays down that the impact of the complementary protection will be evaluated at the end of a six month period or after ten years (the deadline has not been set), for applying the regulation.
At the European Parliament, intense lobbying is being pursued in the context of the forthcoming vote at the parliamentary committee on 13 July (EUROPE 8978). A similar formula to that proposed by Latvia, but corresponding to two four month periods, has its supporters. The latter believe that this formula will be fairer with regard to significant profits made by the pharmaceutical industry. But its detractors consider it more complex and impractical. Economies made by healthcare systems would be relatively low because the high sale products (blockbusters) would be affected by this shorter period.