Brussels, 27/02/2015 (Agence Europe) - The Court of Justice of the EU ruled on Thursday 26 February that the decision limiting reimbursement of the medicine Protelos (produced by the Servier laboratory) to a certain category of patient does not meet the duty to provide an explanation required by EU law (case C-691/13).
The Servier laboratory markets a medicine in France, Protelos, for the treatment of osteoporosis in menopausal women. In 2011, the French authorities took the view that reimbursement of Protelos by the health insurance system should be restricted, as use of this medicine can lead to venous thromboembolic problems. The cost of Protelos, therefore, is only reimbursed for patients who cannot be treated by any other medicine or who do not present a risk of a venous thromboembolic event.
Servier appealed to the Council of State to have the decision by the French authorities overturned. It argued that the authorities had breached an EU directive which requires that any decision amending the conditions for inclusion on the list of products to be reimbursed must be explained. The Council of State asked the Court of Justice whether this duty to explain contained in the directive applied to decisions which, although maintaining a product on the list of products to be reimbursed, restricts reimbursement to a certain category of patient.
In its ruling, the Court notes that, according to the directive, only refusals of inclusion on the list of reimbursable products need to be explained. However, the decision at issue may be seen as equivalent to such a refusal as, for those patients who do not meet certain conditions, it amounts to denying reimbursement of a medicine covered by the health insurance system. The Court points out that it would be contrary to the objective of transparency to allow a decision such as the one at issue to avoid the requirement to provide an explanation, as set out in the directive. The directive seeks to allow interested parties to check that decisions on the inclusion of medicines in national health insurance systems are taken on the basis of objective criteria and that there is no discrimination between the medicines produced in the country and those from other member states. (Lionel Changeur)