So far, every time a new health technology or drug comes in, each EU Member State has its own process to assess this new product and decide whether to reimburse it or not – and until which amount. This has amounted to discrepancies and lack of harmonisation on the clinical assessments of new drugs, and delayed fast and equal access to drugs to many patients in the EU region.
From January 2025, the new EU regulation on HTA – Regulation (EU) 2021/2282) – imposes that all new childhood drugs or new indications of drugs targeting childhood cancer will have to be jointly assessed by all EU national health technology authorities with the input of patients, clinicians, health experts and pharmaceutical companies.