As of January 12, 2025, the EU’s Health Technology Assessment Regulation (EU 2021/2282) is officially in force, marking a significant step towards greater collaboration across 27+ countries in evaluating health technologies to improve healthcare decisions.
The European Union’s Health Technology Assessment Regulation (HTAR), effective January 12, 2025, implements a collaborative framework for health technology evaluation across 27+ countries. This regulation, which began as a vision in 2005 by European HTA bodies, aims to streamline assessments and foster joint clinical and scientific consultations. The HTAR establishes a robust network, including the HTA Coordination Group and Secretariat, providing crucial support for the collaborative efforts that will drive more informed healthcare policies across Europe.
By facilitating joint clinical assessments and consultations, HTAR creates a unified framework for evaluating new medicines and high-risk medical devices. This will aid Member States in making informed decisions about pricing, reimbursement, and resource allocation, ultimately improving healthcare outcomes.
The European Medicines Agency (EMA) will play a key role, offering support for clinical assessments and scientific consultations to ensure timely implementation. The framework initially targets cancer therapies and advanced medicinal products, with expansions planned for orphan drugs by 2028 and all medicines by 2030.
This collaborative approach builds on years of partnership among EU health authorities, aiming to balance innovation with healthcare system sustainability.
