Brussels, 24/06/2013 (Agence Europe) - On 24 June, the European Commission published a report on the progress achieved since the entry into force of a regulation on children's medicines, five years ago. According to the report, there have been some clear improvements, even though the period of time for developing medicines is lengthy and another five years will be required to see all the effects of the legislation. Commissioner for Health Tonio Borg said that “despite the fact that children make up over 20 % of the population, many of the medicines prescribed to them were not specifically studied and authorised for use in children. I am pleased to see that, in five years, progress has been made… and I hope that this marks the beginning of a much needed paradigm shift”.
Before the 2006 Paediatric Regulation entered into force, many pharmaceutical companies considered the adult population as their main market. Research into the potential use of an adult medicine in children was often marginal or not considered at all. The regulation sought to change the situation and had three main objectives: 1) to ensure high-quality research into the development of medicines for children; 2) to ensure, over time, that the majority of medicines used by children are specifically authorised for such use with appropriate forms and formulations; and 3) to ensure the availability of high-quality information about medicines used on children. The report highlights the improvements that have been made: research is of a better quality and safer, the choice of children's medicines has been expanded and information for parents and healthcare professionals has been enhanced. In the future, the Commission will continue to monitor application of the regulation and examine shortcomings or failings that still need to be rectified. (IL/transl.fl)