Policy and Advocacy
European Medicines Agency: Supporting medicines for children in the EU
Children and newborn babies often react differently to medicines than adults. However, information on the use in children is not always available, and specific, more suitable forms may be required. Therefore, it is important that medicines are appropriately studied and demonstrated to be safe and effective for children.
In 2007, the Paediatric Regulation introduced a system of obligations, rewards and incentives to encourage manufacturers to research and develop medicines for children's specific therapeutic needs.
In some therapeutic areas, such as infection diseases, these new indications for medicines led to positive changes in the way children are treated. In other areas, such as oncology, the Paediatric Regulation was less effective. Between 2007 and 2015 there were only 2 new oncology medicines authorised for children. The European Medicines Agency is taking steps to improve the situation in these areas.
On 20 March 2018, the European Medicines Agency held a multi-stakeholder workshop on how to better apply the Paediatric Regulation to boost development of medicines for children. The European Commission's ten-year report showed that most achievements have been made in areas where the needs of adult and paediatric patients overlap. However, the impact of the legislative framework was lower in the area of rare diseases or diseases that occur mainly in children, such as certain types of cancer.
With more than 160 participants representing all main stakeholder groups, a wide range of perspectives was heard. Stakeholders agreed that it was important to build on experience with successful models, such as the Accelerate Platform in the area of paediatric oncology.
International cooperation between regulators in the context of molecular targets for paediatric oncology was also discussed. In the USA, the Food and Drug Administration is allowed to require the development of paediatric cancer treatments based on their molecular target, in order to address paediatric medical needs.
The European Commission and European Medicines Agency, including the Paediatric Committee, are working on an action plan for the next 2 years, taking into account relevant practical and legal considerations. Information on these actions will be shared with the stakeholders by mid-2018.