National organization Q&A
What are the tasks of the national steering group?
The national steering group functions as a decision-making and cooperation body for the Danish participation in the European cooperation and the Danish implementation. . Adaptation of the joint reports in national context is decided by each HTA-organisation. If you have questions about this, you must direct your question to the HTA organization by which the procedure, drug or equipment will normally be processed.
The secretariat for the steering group can support general EU HTA-related requests via email: Send an email.
If your question is of a journalistic nature, please contact the relevant organization’s press department.
Can the steering group advise companies in the preparation of joint scientific assessments and advice?
Which medical products and technologies are covered by the regulation?
From January 2025, the regulation will cover all new cancer medicines and advanced therapy medicines (ATMP).
From 2028, it will expand to include drugs for rare diseases, and from 2030, the regulation will cover all new drugs that are approved in the EMA. 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 will take place during 2025.
However, the regulation includes an option to include other medicines or medical technologies in the joint clinical assessments as early as 2025, if these are assessed to have a particularly high societal value for the European member states.
Where can I read more about the HTA regulation?
You can read much more about the HTA regulation on the EU Commission's website (Implementation of the Regulation on health technology assessment - European Commission).
The Medicines Council: International cooperation (medicinraadet.dk)
Treatment councils: International cooperation (behandlingsraadet.dk)