The EU HTA regulation

The new EU Health Technology Assessment (HTA) regulation will apply from January 12th, 2025.

The HTA regulation shall help facilitate and ensure a uniform decision-making basis for medical technology assessments throughout the EU.

The regulation was adopted by the European Parliament in December 2021 and is usually referred to simply as the HTA Regulation or HTAR.

The regulation covers both medicinal products and certain types of medical equipment and in vitro diagnostics (IVD). The timeline for implementation is as follows: From 2025, new medicines for the treatment of cancer and medicines for advanced therapy (ATMP) approved through the European Medicines Agency (EMA) are included in the regulation; from 2028, medicines defined as orphan drugs by EMA are included; and from 2030, the regulation covers all new medicines. With regard to medical devices and IVD, the first assessments are expected to be prepared in 2026, while the first scientific consultations for medical devices are available during 2025.

What the regulation entails

• Joint clinical assessments of medical products and devices relative effectiveness
• Joint scientific consultations, where companies can get advice on what evidence is proposed to be provided in the clinical studies
• Horizon scanning to identify new medical products and technologies with expected major impact on patients, public health and health systems

The regulation focuses solely on the assessment of the clinical effect, all additional elements of a medical technology assessment, e.g. health economics, the patient perspektive, and organisational consequences and adaptations are decided by the individual member state. In Denmark this process will still be placed in the individual HTA-organisations.

National steering group in Denmark

In Denmark, the Danish Medicines Council, the Danish Treatment Council, the Danish Medicines Agency, the Danish Regions and the Danish Health Authority collaborate on both the European work and the preparations for the implementation of the HTA regulation in Denmark.

As part of this collaboration, a national steering group has been established. The steering group consists of representatives from the Danish Health Authority, the Medicines Council, the Treatment Council and the Danish Medicines Agency as well as observers from the

Danish Regions and the Ministry of the Interior and Health. The steering group secretariat is placed in the Danish Medicines Agency.

The national steering group functions as a decision-making and cooperation body for Danish participation in European cooperation and the Danish implementation of the regulation. The steering group also aims to coordinate a common strategic line among the Danish HTA organizations in the European cooperation.