EU implementing regulation on the EU HTA process with room for improvement

European health technology assessment (HTA) of new medicines will run parallel to the approval process starting from 2025. The aim is to improve the availability of new therapies across Europe, streamline procedures and boost innovation in Europe. Until then the processes must be realized. These must be implemented in such a way that the opportunities can actually be harnessed.

Von unten nach oben betrachtete Flaggen europäischer Länder

The EU Commission's implementing regulation on the joint clinical assessment process is a milestone on the way to a European HTA system. The regulation contains the procedural rules for interaction, information exchange and participation in the preparation and execution of joint clinical assessments at Union level. It was put out for public consultation in draft form and risks missing this opportunity.

The draft falls short of the expectations of research-based pharmaceutical companies regarding the establishment of a predictable, practicable and efficient procedure at EU level. This can quickly become a risk for the quality of the dossier submission and the subsequent joint clinical assessment. This could jeopardise the usability of the EU assessment in Germany. Improvements are therefore necessary.

Involvement of the Health technology Developer

Health technology developers should be appropriately involved in the EU HTA process - particularly in determining the scope of the assessment (scoping). This promotes predictability, efficiency and a high-quality assessment.

Workability of the process

The feasibility of dossier preparation for manufacturers must be given greater consideration and the period for preparation must be extended. This promotes the practicability of the process and quality of the dossier and the assessment.

Protection of commercially confidential information

It is of the utmost importance that the protection of trade and business secrets, which form the basis of the innovative pharmaceutical industry's business model, is guaranteed by German standards.

Download: vfa response on the EU Commission's implementing regulation on the joint clinical assessment process with further suggestions for improvement