The European Union (EU) regulation on health technology assessment (HTA) came into force on January 12, 2025 for new cancer medicines and advanced therapy medicinal products (ATMPs).
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. A press release from the European Commission shares that this framework will help national authorities to make more timely and informed decisions on the pricing and reimbursement of health technologies and streamline procedures for health technology developers. This is expected to contribute to faster and wider access to innovative, new, and more effective products for patients.
The rules will apply to companies seeking marketing authorization for their products via a new and permanent EU HTA framework, including:
- Introducing a single EU-level submission file for Joint Clinical Assessments (JCAs) to ensure pooling of resources at the EU level
- Strengthening the scientific quality of HTA across the EU
- Avoiding duplication of assessments at the national level
- Establishing faster procedures, including requiring JCA completion within 30 days after medicine or ATMP authorization
- Integrating systematic consultation of patients and clinicians during assessment preparation in addition to the involvement and consultation of the HTA stakeholders
As a first step, starting on 12 January, these new rules will apply to marketing authorization applications for new cancer medicines or ATMPs. The rules will be extended to include orphan medicines in January 2028 and will cover all new medicinal products starting in 2030. In 2026, JCA rules will include selected high-risk medical devices.
The new EU framework replaces the long-standing project-based cooperation between member states on HTA, while respecting member states’ responsibility for the management of their health services as their national context requires.
Background
Health technology assessment is a scientific, evidence-based process that aims to inform the creation of safe and effective health policies by summarizing information about the medical, social, economic, and ethical issues related to the use of a health technology.
The European Commission adopted its proposal for an HTA regulation on 31 January 2018. The regulation, a key deliverable of the EU Pharmaceutical Strategy, was adopted in December 2021 and entered into force in January 2022. It applies starting 12 January 2025. During the 3-year transitional period, the Commission and the member states prepared by establishing the necessary governance structure and drafting preparatory documents to support an effective application.