Children need appropriate and safe medicines
Children need age-specific, appropriate, researched, effective and safe medicines to treat and prevent different illnesses. As a result, the Regulation on Medicinal Products for Paediatric Use entered into force at the beginning of 2007. The aim of the regulation is to improve European children's health by increasing paediatric clinical trials, the development and marketing authorisation of paediatric medicinal products and by making information on paediatric medicinal products more readily available. As a result, in the future there will be more researched and safer medicines available for children. The regulation puts the pharmaceutical industry under an obligation to investigate all new medicinal products for adults on children and adolescents as well if they are regarded as being useful for the child population. Moreover, the results of already completed paediatric clinical trials and future paediatric clinical trials must be publicly reported to medical authorities so that the paediatric population is not subjected to unnecessary trials, and that already available results can be utilised.
According to international ethical principles and agreements, children cannot be subjected to clinical trials as healthy volunteers. Paediatric clinical trials are conducted only if the same scientific results cannot be obtained in other ways. Furthermore, the trials must be expected to have direct benefit on the health of the patient, or the results can be expected to give particular benefits to a corresponding patient or age group. Generally, paediatric clinical trials are conducted on patients who are suffering from the illness that is being investigated. Clinical trials can, however, be conducted on healthy children and adolescents if preventative medicinal treatment, e.g. vaccination, is being investigated, and which can prevent serious infectious diseases in children and adolescents. In such a case, a healthy child directly benefits from the trial by avoiding the illness.
The development of paediatric medicinal products is very challenging as medicinal products suitable for children should not contain harmful supplements or additives and they should be in the appropriate form for children (e.g. a solvent, a lollipop, a straw) so that they can be easily but accurately administered. Moreover, the medicine should taste good so that the child is willing to take it. In addition to investigating the effects of medicinal products, paediatric clinical trials aim to investigate these significant factors to make the products as good as possible on the whole.