On 6 January 2021, The European Commission has closed the Public Consultation for the inception impact assessment on the revision of the Orphan and Paediatric Regulation.
The aim of this initiative was to explore the need for adequate measures to overcome the lack of medicines in the paediatric field. TEDDY Network participated in the EC Consultation by submitting its comments focused on the children fundamental rights.
What TEDDY Network supports, is the implementation of joint solutions to harmonise and optimise procedures, incentives and rewards addressed to paediatric and orphan medicinal products; providing its comments, In particular, TEDDY Network has released the following four points:
- Policy options should include adequate measures aimed at guarantying the implementation of the principle of the equality of treatment of all EU patients.
- Research on ethical and legal issues and social impact (ELSI) covering both paediatric and rare diseases should be specifically included and funded in all the EU initiatives.
- Research and initiatives on patients/parents’ involvement and empowerment should be supported and funded.
- All policy options should include measures and initiatives aimed at strengthening children’s participation in the decision-making process on matters regarding their health
At this link it is possible to read the complete answer provided by TEDDY Network.
