On 25 November 2020, the European Commission published the Inception Impact Assessment on the revision of the Orphan and Paediatric Regulations. The public consultation was closed on 6 January 2021 and was useful to collect opinions and suggestions from the different stakeholders and explore the need for adequate measures to address several shortcomings in the functioning of the existing European paediatric framework.
CVBF, as EPTRI coordinator, provided its feedback, underlining the need for a coherent and joint approach in the procedures related to paediatric and orphan medicines interaction and addressed the following points:
1. Paediatric and orphan medicines interaction
2. Unmet medical needs specific to children of different ages
3. PRIME scheme
4. Modifications of the rewards system
5. Improvement of the procedures and regulatory framework for paediatric medicines evaluation
6. Public funding for research
In particular, in the annexes to the comments the need and the relevance to include the paediatric topics in the new EC research strategy ‘Horizon Europe’ as well as in the already planned European Partnerships have been clearly described.
The entire feedback provided by EPTRI is available here.