Revision of the EU Pharma Legislation – Contributions by our Society?

Insufficient development and limited availability of appropriate medicines for children in Europe led the ESPGHAN Council to utilise the new Liaison Officer position to actively contribute to finding solutions. The new EU Proposal for Pharmaceutical Legislation was determined as the most plausible pathway, and ESPGHAN’s position was first provided in the form of a comment (link to document below). As a next step, active collaboration, and joint work with respective members of the EU Parliament (MEP) resulted in the submission of amendments proposed both to Pharma Regulation and to Directives. An important part of them was adopted by the respectable Committee (ENVI) and was included in their final consensus document, subsequently approved by plenary voting of the EU Parliament on April 9th. Here is the breakdown of what has been achieved:
- ESPGHAN proposed not to abandon the Paediatric Committee, or to institute ad-hoc Working Group. The new Regulation proposal has adopted the ad-hoc Working Group on Paediatric Medicinal Products.
- ESPGHAN was in favour of improving incentives for the development of orphan& paediatric medicines which helped against further shortening of the proposed 9-year period of market exclusivity.
- ESPGHAN addressed the problem of significant delays in marketing authorization of drugs for paediatric use. Four key amendments addressing this problem and providing solutions, based on ESPGHAN formulations, were adopted, and are included in the approved text (those approved amendments are available at the link below).
- Amendments that were not approved were those aiming to include specifics of paediatric patients within the definition of “unmet medical needs” and two others addressing the inclusion of real-world evidence in the authorization of drugs for children. As the proposal for the new EU Pharma Legislation is currently with the EU Council and EU Commission, we will continue lobbying at that level for their inclusion.

We want to thank all the ESPGHAN members who lobbied with their country's MEPs, particularly with the ENVI rapporteurs. Without their help, all the work of the Liaison Officer and the Council would not have achieved such a result.

ESPGHAN Initial Comment