Implementation of the EU Regulation should focus on improving the efficiency, speed and quality of Health Technology Assessment[6], by reducing workload and avoiding duplication within Member States, whilst maintaining timely local decision-making processes supporting faster patient access to innovation. To achieve this, Member States need to adapt local processes to ensure the Health Technology Assessment Regulation (HTAR) delivers the efficiencies envisaged.
We encourage the European Commission and HTA Coordination Group to work closely with Health Technology Developers to ensure the processes and methodologies outlined in the implementing acts will be fit for purpose and provide a clear and transparent, workable, and predictable process. The HTAR should ensure the use of state-of-the-art scientific methodology, including appropriate handling of evidence uncertainty, reflecting specifics of the context of disease and medicine development.
For Joint Clinical Assessments (JCAs), there needs to be a clearly defined process with timelines & milestones for each step. This will ensure the process is transparent, predictable, manageable on a routine basis, and can be integrated into both internal launch processes for new technologies and external, member-state decision-making processes of new technologies.