Problems of pediatric pharmacotherapy and their international solutions

In Germany the patient-orientated clinical research including clinical pharmacology is not developed in the way needed for rational and cost-efficient pharmacotherapy. Under these conditions drug development in pediatrics has not preceded, as this area is not attractive to a profit-orientated industry. As pharmacotherapy cannot be withhold from children, 40 to 80% of drugs in hospitals are prescribed in an off-label or unlicensed manner. Based on guidelines from the International Conference of Harmonisation national and international efforts have focussed on objectives to stop discrimination of children with respect to an adequate pharmacotherapy. These international guidelines deal with general considerations about the necessity for drug development in pediatrics, with the right time for the inclusion of a pediatric medicinal product in the development program, with pediatric formulations, with questions of study design in different developmental stages and with ethical and legal issues in pediatric studies. These guidelines will have an effect on the European and national directives. The realisation of these developments make a special infrastructure necessary, which needs a budget. Furthermore, incentives have to be offered to pharmaceutical industry, which include market exclusivity provided for the pediatric medicinal product but also the request for a pediatric drug development plan. Similar procedures are needed for off-patent drugs. As the German Parliament, the European Parliament, including the European Commission, have taken over this issue, some actions have been taken by the agencies and Federal Ministries that there is hope that Germany will move along the international initiative sooner or later for the best of our children.