When it comes to administering medication, children are still often treated like small adults; suitable pills for the little ones hardly exist. That is to change soon. Since the end of January, the new EU regulation on medicines for children has already been in force, which is intended to ensure greater safety for children. It obliges pharmaceutical companies in the European Union to test medicines in studies involving children.
According to estimates by experts, around half of all preparations given to sick children have not been tested and approved specifically for their age group. As a result, sick children have so far mostly received medications from adults simply in lower doses. But finding the right amount is not always easy, even for doctors. In addition, the metabolism of children sometimes reacts differently: the little ones do not tolerate all active ingredients and absorb them differently than adults. Treating a cold with nasal drops for adults or administering essential oils, for example, can result in poisoning or breathing problems in small children. Children are just not little adults.
EU regulation currently being implemented
The regulation, which has been in effect for a few months, is intended to ensure that more medicines are developed for children and adolescents and specifically approved for use in this patient group. To this end, there is a combination of various obligations and incentives for pharmaceutical companies. For example, an application for approval of a new drug must in future include the results of clinical trials with children and adolescents, unless the drug is fundamentally unsuitable for use in children and adolescents.
The clinical trial requirements must be set out in a research and development program, the pediatric investigation plan. Each investigation plan must then be submitted for approval to a committee of scientists from the EU member states set up specifically for this purpose at the European Medicines Agency (EMEA) as the approval authority.
On the other hand, the regulation promises pharmaceutical companies incentives and benefits in the form of extended patent protection periods for the marketing of drugs as compensation for these new requirements. Such benefits may also be granted for drugs already on the market if their applicability in children and adolescents is subsequently substantiated with a pediatric investigation plan.
