The new rules foresee the cooperation of member states at EU level on joint clinical assessments and joint scientific consultations on health technologies. This joint work will provide valuable scientific information to national health authorities when they take decisions about pricing and reimbursement of a health technology.
According to the agreed text, in order to reduce the administrative burden especially for smaller companies, developers of health technologies should only have to submit information, data and other evidence required for the joint clinical assessment once at EU-level.
The presidency will submit the outcome of the negotiations to the Council’s Permanent Representatives Committee (Coreper) for endorsement. This will be followed by adoption by the Council and then the European Parliament.
The new rules will become directly applicable, in a staged process, three years from the entry into force of the regulation…