European Commission Issues Report on the Impact of the Paediatric Regulation

In a report to the European Parliament and the Council of Ministers, the European Commission says that the Regulation has had a substantial impact on the development of medicines. Between 2007 and 2016 over 260 new Medicines for use by children were authorised. There is also a clear upward trend in the number of completed Paediatric Investigation Plans (PIPs) and observed progress in the availability of medicines, with Rheumatology and infectious diseases as noted examples.

The positive impact is most clearly seen in the paediatric developments integrated with the overall development of new medicines. It is less obvious in pure paediatric developments, where a company aims at developing a child-only medicine for a particular paediatric disease.

The Commission is proposing to look at the combined effects of the Orphan and Paediatric Regulations, as well as the evaluation of the costs and benefits of the Supplementary Protection Certificate Regulation, which rewards companies for their investment in paediatric research and development.

For further information, please click here.