There are not enough studied and safe medicines for children in Europe (there are approx. 100 million children aged 0 to 17 years in the EU, 1.2 million of whom in Finland). In clinical practice, common pediatric pharmacotherapy relies largely on medicines intended for adult use for which there is no research data on long-term effects or adverse effects, that is, on their efficacy and safety in children. Therefore, it is very important that all medicines intended for children are studied in child populations in addition to adults to ensure that they are appropriate and safe also for children and adolescents.
This development is supported by new legislation. In 2007, the Paediatric Regulation (EU 1901/2006) came into force. This regulation includes a requirement that the pharmaceutical industry conducts clinical trials with medicinal products also on children if the European Medicines Agency (EMA) judges that the medicine is essential and needed in the treatment of pediatric diseases. Furthermore, the regulation included an obligation for EMA to establish a European network for coordinating other research networks in Europe. This European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) was launched in 2011 and FINPEDMED has been a member of this network ever since.
FINPEDMED (the Finnish Investigators Network for Pediatric Medicines), established in 2007, is a non-juridical joint venture of all Finnish university hospitals and pediatric clinics, which operates on an open, non-profit service concept basis to promote both academic and sponsored research. The FINPEDMED network includes members from all medical specialties treating pediatric subjects and also from other fields of science forming an integral part of the development of medicines.
The joint target of the FINPEDMED network is to promote the health of Finnish children as well as that of European children by increasing research, development, and registration of new and safe medicines while, however, trying to avoid any unnecessary trials in children.
The main tasks of the FINPEDMED network are to:
provide expert services
improve opportunities for performing pediatric clinical trials
ensure safe conduct of trials
support academic research
provide supplementary training
foster expert services
harmonize joint national operational models
create guidelines and templates to help serve research
provide effective and timely communication; hospitals, universities, pharmaceutical industry, authorities, pediatric specialty associations, and national patient organizations.