This network has been established as part of the implementation of the HTA Regulation which was agreed by EU institutions and EU member states in 2021, and will come into force in January 2025.The Regulation covers both medicines and medical devices and in vitro diagnostic devices (IVDs).
The Regulation will mean that there will be joint clinical assessments conducted at EU level for all new technologies. There will be a staged entry into force for these joint assessments, starting with cancer therapies and advanced therapies in 2025, followed by orphan medicines in 2028, leading up to 2030 when all new medicines should receive a joint clinical assessment. For medical devices and IVDs, the Commission and member state coordinating group will develop a list of devices that have been selected for joint assessment. The joint clinical assessments will include input from patients and clinical experts, which could include EAU members, particularly from our relevant Clinical Practice Guidelines panels. HTA assessments play an important role in the availability of new technologies for patients across different countries.
The Stakeholder Network has been created by the Commission to support the Coordination Group from EU member states in the implementation of the joint assessments. The EAU has already provided links to clinical experts for the current voluntary assessments that are taking place at EU level through an EU Joint Action called EUnetHTA (Home - EUnetHTA).
The first meeting of the network will take place in Brussels in June 2023.