On October 16th EPTRI, after collecting the opinion of several key Paediatric Research Organisation and paediatric interested Stakeholders, provided its feedback on the EU Pharma Legislation by submitting the Position Paper ‘PROPOSED CHANGES TO THE PAEDIATRIC REGULATION IN THE FRAMEWORK OF THE NEW PHARMACEUTICAL STRATEGY: CALL TO ACTION FOR CHILDREN’
The document highlights concerns and risks arisen from the proposed suppression of the Paediatric Regulation with possible further limitations of safe and efficacious medicines available to cover paediatric therapeutic needs.
The position paper was supported by 24 paediatric experts who commonly express their convinced objection based on the following:
- The abolition of the Paediatric Regulation was never considered as an option by the Council or by the Parliament. Instead, in its 2016 Resolution, the EU Parliament recognised that the Paediatric Regulation has been beneficial to children overall (but not sufficiently effective) and thus, far from suggesting its abolition, proposed enhancing and improving measures for its more efficient functioning.
- The inclusion of relevant parts of the Paediatric Regulation into a Directive (instead of a Regulation) is very worrying. In fact, while Regulations have immediate binding legal force throughout every Member States, Directives only ‘lay down certain results but each Member State is free to decide how to transpose directives into national laws’. In 2006 the Paediatric Regulation was properly adopted to avoid misalignment at nation level, stating that ‘the objective of this Regulation cannot be sufficiently achieved by the Member States’ (whereas 38, Paed. Reg.).
- The obligation for the sponsors to submit a Paediatric Investigational Plan (PIP) to conduct paediatric studies for ‘all’ the innovative and in patent drugs is not clearly reported in the proposal as there is a lack of statements like Articles 6 and 7 of the Paediatric Regulation.
- The PDCO, as a single point for paediatric studies evaluation, would be suppressed and the PDCO paediatric competencies would be dispersed in several non-paediatric Working Groups not focused on children needs and specificities.
- In the proposed Directive (Article 83), there is no mention of specific paediatric therapeutic needs, while the therapeutic needs are defined applying criteria that may not be appropriate in the case of children of different age groups.
We consider all these as critical omissions that may severely affect the paediatric patients’ health, being in contrast with the ‘social, moral and human imperative’ to protect children’s rights, including their right to have access to medicinal products and other treatments as stated in several EU formal acts.
The complete feedback to the EU open Consultation is available here.