Together with peer European patients’ and doctors’ organisations, KickCancer has been advocating a more favourable pharmaceutical legislation in Europe ever since its foundation.

We have steadily built momentum to ensure that the revision of the EU Regulations on Medicines for Children and Orphan Diseases truly addresses the unmet medical needs of young cancer patients. 

In 2023, the European Commission had published its proposal for the revision of the EU pharmaceutical legislation, which included two key measures we had long been advocating for:

1. A requirement for pharmaceutical companies to submit a Paediatric Investigation Plan when the mechanism of action of a new adult drug is relevant for a type of paediatric cancer.

2. A new pathway allowing academic data to be reviewed by the European Medicines Agency (EMA) and, if validated, added to the drug’s official label — helping reduce off-label use of medicines and ultimately facilitating reimbursement of medicines in every European Member State.

In 2024, these provisions were also included in the version adopted by the European Parliament, which KickCancer welcomed with satisfaction.

As the file moved to the level of the European Council in 2024, we launched a new phase of advocacy and held numerous meetings with health attachés from several Member States to ensure the needs of young cancer patients remain a priority in the next steps of the negotiation of the EU pharmaceutical legislation.