Brussels: Europe and the Arabs
As of Sunday, January 12, the Health Technology Assessment Regulation will come into effect, which will significantly improve the availability of innovative and effective health technologies to patients across the European Union.
The new rules create an EU framework for the assessment of health technologies, such as medicines and medical devices, by strengthening cooperation and coordination between EU Member States. This will help national authorities make more accurate and informed decisions on the pricing and reimbursement of health technologies and simplify procedures for health technology developers. This will contribute to faster and wider access to new and more effective innovative products for patients.

The rules will apply to companies seeking marketing authorization for their products by introducing a new and permanent EU framework for health technology assessment, including through:
Introducing a single EU-wide application file for joint clinical assessments in order to ensure the pooling of resources at EU level and enhance the scientific quality of health technology assessment across the EU while avoiding duplication of assessments at national level;
Establishing faster procedures requiring joint clinical assessments to be completed within 30 days after the medicine is authorised;
Systematic consultation of patients and doctors during the preparation of assessments as well as the involvement and consultation of stakeholders in health technology assessment.
As a first step, starting from 12 January, these new rules will apply to marketing authorization applications for a new cancer medicine or an advanced therapy medicinal product (ATMP). The rules will be extended to orphan medicines in January 2028 and will cover all new medical products from 2030. High-risk medical devices will also be assessed from 2026.

The new EU framework replaces the EU-funded project-based cooperation between Member States on health technology assessment, while fully respecting Member States’ responsibility for managing their health services as required by their national context.

Health technology assessment is a scientific, evidence-based process that aims to inform the creation of safe and effective health policies by summarising information on the medical, social, economic and ethical issues related to the use of health technologies.

The European Commission adopted its proposal for a Health Technology Assessment Regulation on 31 January 2018. The Regulation, which was adopted in December 2021 and is one of the key outcomes of the EU Medicines Strategy, entered into force in January 2022. It applies from 12 January 2025. During this three-year transition period, the Commission and Member States prepared by establishing the necessary governance structure and drafting preparatory documents to support effective implementation.