Health Technology Assessment: Council agrees its negotiating position

Member states agreed today on a mandate to start negotiations with the European Parliament on a legislative proposal concerning joint work on health technology assessment for the benefit of patients.

The proposed legislation foresees, for instance, the establishment of a Coordination Group comprising national health authorities. This group will work on joint clinical assessments and joint scientific consultations on health technologies. The proposed legislation should benefit patients, member states and health technology developers. Accordingly, it will improve patients' access to health technologies. The joint work carried out at EU level should provide valuable scientific information to national health authorities. Companies will not need to provide at national level the same information abofut their products that they have already submitted at EU level. This will lead to cost savings and reduce duplication of work.

The negotiation mandate adopted today is an important milestone. The regulation on health technology assessment, once adopted, will be a major step forward in the field of health. It will constitute a robust framework for cooperation for the benefit of member states, industry and, above all, patients.

Marta Temido, Portuguese Minister of Health

Background and next steps

The Commission adopted a proposal for a Regulation on health technology assessment on 31 January 2018. The European Parliament agreed on its position in February 2019. Following the agreement of member states' ambassadors, negotiations with the European Parliament can now start.

Health technology assessment is an evidence-based process that allows competent authorities to determine the relative effectiveness of new or existing technologies. Health technology assessment focuses specifically on the added value of a health technology in comparison with other new or existing health technologies. Thanks to health technology assessment, national health authorities can take evidence-based decisions on the pricing or reimbursement of health technologies.

Health technology includes medicinal products, medical devices (for example pacemakers, dialysis equipment or infusion pumps) or medical and surgical procedures, as well as measures for disease prevention, diagnosis or treatment used in healthcare.

This page will be updated with a link to the approved text.