The European Directive
European Union legislation now requires that every medicine submitted for licencing - even if the main target population is adult - has a detailed "paediatric investigation plan".
Although exemptions can be applied for if the medicine is not obviously relevant in paediatric practice (in the case of female hormone replacement therapy, for example) there is now an onus on the submitting pharmaceutical company to either conduct appropriate research in children or provide compelling evidence as to why this is not appropriate.
In return, companies will receive a six month extension to their patent in EU countries in both adults and in childrenResearch on existing medicines is also encouraged, and in particular the development of child-friendly and acceptable formulations.
More details can be found on the European Commission website.