10 years of the Paediatric Regulation
Medicines specially researched and developed for the treatment of young patients should also be made available to children.
MS/ST – 11/2017
Published on October 26th 2017, a report on the state of paediatric medicines in the EU analyses the success of the Paediatric Regulation. The report concludes that medicines specially researched and developed for the treatment of young patients should also be made available to children.
The figures show that the introduction of the Paediatric Regulation (EC) 1902/2006 in 2007 has had a substantial impact on the development of paediatric medicines in the EU. Pharmaceuticals companies now see development work in the paediatric sector as a core element of their general product development strategy, even though some continue to regard paediatric research as an area of activity prescribed by the regulatory authorities rather than driven by companies themselves. Over 260 new paediatric medicines were approved for commercialisation or new indications between 2007 and 2016.
There is still room for improvement
According to the report, the off-label use of medicines remains widespread in many areas of therapy, often at a rate of over 50 percent. There are also a large number of diseases that are biologically different in adults and children, lead to different levels of burden of disease or are only observed in children. In the case of these diseases, the effectiveness of the mechanism introduced by the Paediatric Regulation is sometimes restricted by scientific, clinical and market realities. The vaccination of children is a noteworthy exception in this regard, and represents one of the success stories of modern medicine.
Preparatory consultation involving the participation of the National Association of Statutory Health Insurance Funds
The introduction of the Paediatric Regulation was preceded by a public consultation used to pool the experience of all stakeholders. The National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) was invited by the Commission to take part in that consultation along with over 70 other organisations. The GKV-Spitzenverband holds the view that the number of new products being approved is still too low and the price of paediatric medicines too high.
The next steps
The Commission aims to engage in further consultation with experts and stakeholders on the topics of both paediatric medicines and medicines for rare diseases. Political measures are expected to be taken during the new legislative period starting in 2019.