Revision of the EU Pharmaceutical Legislation

Revision of the EU Pharmaceutical Legislation

  • Proposal for a Regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006
  • Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC

The European Society for Paediatric Oncology (SIOPE), the single-united European organisation representing all healthcare professionals in paediatric oncology, and Childhood Cancer International – Europe (CCI-E), the largest European patient’ organisation in paediatric cancer, have been involved in the review and analysis process of the EU Paediatric Regulation since 2012 and the EU Orphan Regulation since 2016.

We warmly welcome the EU Commission’s revised Pharmaceutical legislation, as stated in our joint statement available here. We believe it addresses several areas of concern of the paediatric cancer community.

Today, neither the EU Paediatric nor the EU Orphan Regulations have succeeded in significantly improving young cancer patients’ chance of survival. Notably, over the last ten years, only 16 anticancer medicines have been authorised for a specific paediatric cancer indication, in contrast to over 150 for adult cancers1 . Now, we are calling for an ambitious revision that will support and accelerate innovation and put the unmet medical needs of patients and their families at the centre of a European strategy for medicine development.

Therefore, SIOPE and CCI-E have identified six key priority areas which require focused consideration during the negotiation of the revised EU Pharmaceutical legislation. We have detailed in our joint position paper areas which should be upheld, as well as areas with specific suggestions for amendments which can further strengthen the reform and ultimately, improve the outcomes of patients with unmet medical needs such as young cancer patients and restore them to their full health.

Please find here the joint SIOPE and CCI-E position paper on the Revision of the EU Pharmaceutical Legislation:

European Paediatric Cancer Community Proposal for Improvement of the EU Revised Pharmaceutical Legislation

Attached to this document is an annex listing the articles of the revised EU Pharmaceutical legislation that we propose to maintain, as well as the amendments that we advocate.


EU Commission Consultation

The EU Commission is currently asking for feedback on their proposal on the Revision of the Pharmaceutical Legislation.

Find our SIOPE Toolkit here underneath to help you fill out the consultation:

SIOPE Toolkit

The Consultation is open 26 April 2023 - 08 November 2023 (midnight Brussels time). The EU Commission takes into account the number of responses they receive so your feedback matters:

Click here to give feedback