The Commission has limited competence to deal with specific situations in the Member States as regards health policy, healthcare and the organisation of health services.

As the Commission pointed out in its answer to the Written Question E-003237/2017, which also dealt with the provisions of the Law in question and was raised by the Honorable Member, ‘As medicinal products have different benefits and costs, the Health authorities of Member States need to carefully decide on reimbursement to ensure good value to the health system in general and to patients. To support the rationalisation of pharmaceutical expenditure, while guaranteeing full access, the Greek authorities revised the criteria to introduce innovative drugs into the list of publicly reimbursed ones.

New criteria have been designed to improve on the shortcomings of the previous method and allow for internal capacity building in the area of Health Technology Assessment (HTA). The Commission through the Structural Reform Support Service together with the World Health Organisation are assisting Greece to build this capacity. In the meantime, the institutions, as part of the MoU implementation agreed with the Greek authorities that these would take an informed decision based on the judgments reached following HTA processes in six Member States. The choice of six Member States was the result of a sensitivity analysis and ensures objectivity. Although this may prolong slightly the time for a decision to be taken in Greece, it will ensure the right balance between supporting patients' access whilst ensuring sustainability of the health system.’