From 2025, new drugs will be assessed uniformly across the EU. National assessment procedures must not lead to delays in early access to these therapies.
It is a good plan to provide faster access to new therapies for everyone in the EU. However, this can only be successful if the national assessment processes are carried out strictly.
Mag. Alexander Herzog, Secretary General of PHARMIG
Vienna (OTS) – An EU-wide clinical evaluation of newly approved drugs will begin at the beginning of 2025. Their goal is to avoid duplication and to make the new medicines more quickly accessible to patients through more efficient processes, throughout the EU. Austria’s hospital sector is particularly characterized by such early availability of new therapies. However, this is at stake if national assessment procedures that follow the EU-wide assessment lead to even greater complexity and as a result patients have to wait longer for their therapies in the future. It is all the more important that politicians, authorities, hospital authorities, patient organizations and the pharmaceutical industry work well together in the planning and implementation of the EU process at the national level.
The “Joint Clinical Assessment” (JCA), which will be available from 2025, compares a new therapy with an existing one based on clinical factors. The data for this is provided by the developer of the new therapy and thus by the pharmaceutical company. The result of such a comparative assessment must then be taken into account by all decision-makers who decide on the use of medicines in any national medical and health economic assessment processes.
Alexander Herzog, Secretary General of PHARMIG, says: “It is a good plan to provide faster access to new therapies for everyone in the EU. However, this can only be successful if the national assessment processes are carried out strictly.
Herzog is alluding to the new rating board that is to be set up in Austria. This has up to five months to make recommendations about the use of a new therapy. It must take into account the result of the EU assessment and therefore cannot work in parallel. “There is a risk that after the approval of a new drug and the EU assessment, there will be an extended waiting period for patients,” warns Herzog.
Last year, PHARMIG and other associations brought together healthcare stakeholders to draw attention to the necessary preparatory work in connection with the implementation of the European regulation at national level. “We will continue to do this more and more in the next few months. Only through intensive collaboration can we design such complex processes as efficiently as possible. This requires the know-how of all relevant actors who can and should make a contribution here,” says Herzog.
About PHARMIG: PHARMIG is the voluntary, politically independent interest group of the pharmaceutical industry in Austria. The approximately 120 member companies (as of February 2024) with around 18,000 employees cover a good 95 percent of the domestic pharmaceutical market. PHARMIG and its member companies stand for the best possible security of supply of medicines in the healthcare system and ensure social and medical progress through quality and innovation.
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