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Parliamentary questions
1 June 2017
Answer given by Mr Andriukaitis on behalf of the Commission

The Commission is currently working on a second report to the European Parliament and Council on the Paediatric Regulation(1), which will be delivered in 2017. A public consultation to gather feedback and a study with a specific focus on the reward system provided by the regulation and its economic impact will inform the report.

The Commission is confident that this will lead to a comprehensive picture about the strengths and weaknesses of the regulation.

The questions raised by the Honourable Member mirror the calls of a recent Resolution of the European Parliament on paediatric medicines. In this regard, several obstacles to innovation are already being addressed; the new legal provisions on clinical trials(2) will facilitate the conduct of cross-border trials in the field of paediatric medicines; and under the ‘Innovative Medicines Initiative 2’ (IMI2)(3), the creation of a large pan-European paediatric network should facilitate the development and availability of new medicinal products and other therapies.

In the area of rare diseases, of which many are of genetic nature and become clinically evident during childhood, several calls have been carried out or are ongoing.(4)

Additional opportunities for research will be created by future European Reference Networks, which aim at concentrating resources and expertise, including in rare or low-prevalence complex diseases or conditions(5).

The Commission has already provided dedicated funding for paediatric research under the EU Framework Programme for Research and Innovation Horizon 2020(6).


Last updated: 6 June 2017Legal notice