The European Commission (EC) has finalised new rules for the joint clinical assessment of medicines to contribute to faster access to medicine for patients living in the EU.
Commencing in January 2025, the new approach is part of a broader initiative to bolster collaboration for evaluating and paying for new products across the EU.
Established under the Regulation on Health Technology Assessment, the new approach aims to harness and pool expertise from across the EU to assess the effectiveness of new medicines compared to medicines already being used, while supporting healthcare systems to provide quality care for patients in the EU, utilising the latest technology.
Currently, new health technologies undergo national-level assessments to determine their cost-effectiveness. However, this process can be expensive and time-consuming.
The joint clinical assessment reports will be used to provide scientific evidence to Member States’ authorities at an early stage after a medicine’s marketing authorisation to help decide whether to use it in national health systems.
The medicines will be assessed by their value, supported by robust evidence, and will take more effective, timely decisions when bringing medicines to the market.
In addition, the rules set out how the EC will coordinate with the European Medicines Agency (EMA) on exchanging information and selecting experts and patients to consult with on the assessments.
The rules also lay out how the EC will coordinate with the EMA on exchanging information and selecting experts and patients to consult with on the assessments.
The joint clinical assessment will begin early next year for medicinal products with new active substances for the treatment of cancer and for advanced therapeutic medicinal products.
Stella Kyriakides, commissioner for health and food safety, EC, commented: “[The] adoption is a major milestone in facilitating better access to evidence-based healthcare and innovative technologies [for] patients across [the] EU” and “we need to continue working together with Member States, health technology developers, patients and experts…, to make the most out of the EU’s health technology assessment framework”.