Europe – Health Technology Assessment: Informal deal between Council and European Parliament

The EU has taken a major step towards new rules which will benefit patients' access to medicinal products and medical devices and simplify the submission procedure for producers of such health technologies. The Council and the European Parliament today struck a political deal on a legislative proposal concerning joint work on health technology assessment.

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.

Next steps

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…