A new regulation is being planned to help facilitate joint European clinical assessments starting in 2025. This would help ensure that health technology assessments are conducted in a way that is consistent across the EU.

The regulation aims to create a harmonized system that allows for the widespread availability of innovative health technologies in the EU.

Health technology assessment (HTA) is a process that helps decision-makers determine the relative effectiveness of new or existing health technologies, focusing on the benefits these technologies offer over other possible options. The outcome of an HTA can have a significant impact on the extent to which a given health technology is adopted and/or reimbursed by a given country’s healthcare system.

Currently, HTA procedures within the European Union are conducted at a national or regional level, with some limited project-based cooperation between Member States. Multiple assessments by different Member States can lead to different data requests from health technology developers, which can lead to duplication and variation in outcomes.

The Regulation on Health Technology Assessment (Regulation (EU) 2021/2282) (the HTA Regulation), a deliverable of the EC Pharmaceutical Strategy, was adopted in December 2021 after several years of consideration. The HTA Regulation essentially establishes for the first time a permanent legal framework for collaborative HTA work that will include joint clinical assessments (JCAs), joint scientific consultations, the identification of emerging health technologies, and voluntary cooperation between Member States.

The HTA Regulation went into effect in January 2022, although it won’t start to apply until January 2025. In the meantime, preparation and implementation-related actions must be taken. When it does, it will be implemented gradually on several phases.

Developers of health technology and other key stakeholders do not need to take any immediate action because the HTA Regulation will not take effect until 2025. However, they must continue to follow the HTA Regulation’s implementation and get familiar with the rules it sets forth.