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.
We have reached a decisive breakthrough on a new law which will benefit patients, manufacturers of health technologies and member states’ health systems. We will all stand to gain when innovative, safe and effective health technologies can reach the market more quickly. EU-level cooperation is the way forward to make this happen.
Marta Temido, Minister of Health of Portugal
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.
Background
The Commission adopted a proposal for a regulation on health technology assessment on 31 January 2018. Following an agreement reached on 24 March 2021 between member states, the presidency engaged in negotiations with the European Parliament to settle on a common position.
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 informed 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.
