Harmonized rules on health technology assessment are live as per 12 January 2025

In 2022, the Health Technology Assessment Regulation (HTA Regulation) entered into force. An HTA is an assessment of the medical, economic, social and ethical issues of a given health technology.

The new rules create an EU framework for the assessment of health technologies, such as medicines and medical devices, by fostering collaboration and coordination between EU Member States. The results of an HTA help decision makers on pricing and reimbursement aspects of a health technology (medicinal products, in vitro medical devices and high-risk medical devices).

Currently, national bodies each perform their own HTA. The HTA Regulation intends to reduce duplication of HTA’s performed by national bodies, by introducing a new and permanent EU framework for HTA’s by introducing a single EU-level submission file for joint clinical assessments, establishing faster procedures. The aim of the HTA Regulation is to bolster national HTA processes and improve the time-to-market for health technology.

As a first step, per 12 January 2025, the HTA Regulation applies to marketing authorisation applications for new medicines for the treatment of cancer, as well as advanced therapy medicinal products. The HTA Regulation will extend to new orphan medicinal products per 2028 and to all new medicinal products per 2030. It is to be determined as per when the HTA Regulation will apply to in vitro medical devices and high-risk medical devices.

For more information on the HTA Regulation, feel free to reach out to our Healthcare and Life Sciences team: Dimitri van Hoewijk and Benjamin Gideonse.