Today, the European Commission adopted new rules for the joint clinical assessments of medicines at Union level, contributing to faster access to medicines for EU patients. These new rules define the timelines and the steps for conducting EU joint clinical assessments. The assessment reports will provide scientific evidence to Member States’ authorities at an early stage after a medicine’s marketing authorisation. This will help them to decide about its use in the national health system, assessing their value on the basis of robust evidence, and thus taking more effective, timely decisions when bringing medicines to the market.
The rules are adopted under the Regulation on Health Technology Assessment (HTA). This Regulation established a new, innovative approach to harness and pool expertise from across the EU for assessing the effectiveness of new medicines compared to medicines already in use, while supporting healthcare systems to provide quality care for patients in the EU using the latest technologies.
Stella Kyriakides, Commissioner for Health and Food Safety said: “Innovation and technology are key drivers for a strong European Health Union and for bringing medicines to patients. We want these medical technologies to be reaching our patients as quickly and equally as possible. Today’s adoption is a major milestone in facilitating better access to evidence-based healthcare and innovative technologies to patients across Europe. We need to continue working together with Member States, health technology developers, patients, and experts from the scientific and clinical communities to make the most out of the EU’s health technology assessment framework.”
Today’s rules are the first of six acts to be adopted this year under the HTA Regulation. Joint clinical assessments will start as of January 2025 for medicinal products with new active substances for the treatment of cancer and for advanced therapy medicinal products.