Brussels, 18/02/2005 (Agence Europe) - The European organisation of associations working on rare diseases (EURORDIS) has published its position on the European draft regulation to ensure child suitable medicines are developed.
EURORDIS supports the Commission's draft regulation (see EUROPE of 29 September and 1 October 2004), particularly the measure foreseeing a two year extension (from 10 to 12 years) in the length of time a medicine is protected once the laboratory producing it has carried out clinical trials on its use for children. EURORDIS believes, however, that the legislation should be more binding on laboratories by setting deadlines to ensure the rules are taken seriously. Companies would only have six months to commit to or abandon studies into a medicine's impact on children. Should they decide not to carry out tests, other companies would be able to develop the medicine in a form suitable for children. In addition, no more than two years would be allowed between the unveiling of plans to carry out tests on children and the production of the results of clinical trials carried out on children in the framework of requesting authorisation for using the medicine for children. To ensure greater clarity, EURORDIS believes the centralised authorisation procedure for marketing medicines should be made compulsory for medicines used for children. EURORDIS hoped that 'tutors' can be designated to monitor the carrying out of the clinical trials, and recommends measures to reinforce the children's committee (as foreseen in the regulation) at the European Medicines Agency and improve information provided to the public. On labelling, EURORDIS wants 'P' to feature on all packaging of new medicines suitable for paediatric use.