EU HTA Regulation comes in light version

The controversial project of an EU-wide clinical evaluation of medicinal products and medical devices (Health Technology Assessment, HTA) is coming to an end after years of wrangling. The agreement reached between Parliament and the Council in the summer has now been formally confirmed by the European Parliament. However, there will be no binding assessment of clinical benefit for all member states.

From 2024, the EU member states are to prepare joint benefit assessments of health technologies (HTA). This means that the first joint HTA reports could be available in 2025: initially for cancer drugs, later also for drugs for rare diseases, and finally for all other drugs and medical devices. But unlike the Commission’s original proposal, they will not be binding on member states.

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