EU collaboration has been in the planning by HTA agencies for over 16 years. Since the adoption of the EU HTA Regulation in January 2022, it will become the new way of working for all stakeholders from January 2025. Whilst the Regulation covers many facets, most of the activity, and arguably the most publicly visible component, will be the Joint Clinical Assessments (JCAs). In little over 12 months from now, the first technologies mandated by the new Regulation will be starting their pathways through a JCA. Health Technology Developers & other Stakeholders are already planning for the initial assessments.

The plenary will discuss what the stakeholders require of each other, and together how they can address the anticipated challenges to ensure a smooth adoption of the new Regulation. The discussion will identify the benefits and risks of the new approach, demonstrating what will be required to turn the rhetoric into action. Will the regulation simply result in a re-engineering of the flow of information from developers to decision makers, or is it an opportunity for Europe to have a strategic input to the development of innovative technologies. The plenary will consider what will be required to ensure the new regulation, and specifically the JCAs, deliver the promised efficiencies resulting in better access for patients.

We will discuss:

• From The European Commission – What contribution the Commission require from stakeholders to develop the Implementing Acts, to ensure the Regulation is operational & fit for purpose
• From an EU HTA perspective: what the EU Coordination Group require from industry and Member States to make JCA implementation a success
• From an innovator perspective: what technology developers require to be able to re-engineer their internal processes to meet the requirements of the new Regulation and transformed National processes
• From a Member State perspective: what they require from Industry and expect from the EU process to ensure efficiency & predictability in their local processes
• For the Patient: What are the opportunities for patients from the new Regulation? What happens to the patient voice in member state processes if given a voice ‘in Europe’?