Commissie verzoekt Spanje om vergoeding medicijnen transparanter te regelen (en)

The Commission has taken steps against Spain because the conditions of reimbursement of certain medicinal products (such as different anti-inflammatory medicines, treatments for diabetics or anti-thrombosis products) are not adequately justified. In Spain, medicines are reimbursed by the health insurance system if they are included in a list of pharmaceutical products entitled to reimbursement. However, for some medicinal products, the Spanish authorities also require prior approval of individual prescriptions, in the form of an inspection visa, before patients can be effectively reimbursed. The Commission considers that this procedure is not based on objective and verifiable criteria, as required by EU legislation. Faced with this background, the Commission has formally asked Spain in a letter (reasoned opinion) to introduce more transparent decision-making procedures for the reimbursement of medicinal products.

The proper functioning of the Single Market in pharmaceuticals requires that Member States make transparent and objective decisions concerning their reimbursement. The lack of transparent procedures not only creates obstacles to trade, but it is also detrimental to patients.

The organisation of national social security schemes is under exclusive competence of the EU Member States. However, Directive 89/105/EEC lays down transparency requirements to ensure that national measures on pricing and reimbursement of pharmaceuticals do not create unjustified obstacles to trade. The Commission considers that the visa procedure applied in Spain does not respect the transparency requirements prescribed by the Directive. Indeed, no objective and verifiable criteria have been established under Spanish law for deciding which medicinal products should be made subject to a prior inspection visa. Furthermore, Spanish legislation does not include any criteria allowing the administrative authorities to decide for each individual prescription whether the visa should be granted or not.

There is evidence that the visa procedure applies to different medicinal products in Spain (e.g. anti-inflammatory medicines, certain treatments for diabetics or designated anti-thrombosis products). The Commission has therefore requested Spain to bring its procedures into line with EU legislation.

Background

The EC Treaty requires the Commission to ensure that EU law is correctly implemented. The Commission has been granted powers to do so under the infringement procedure laid down in Articles 226 and 228 of the Treaty. The main purpose of this procedure is not to bring infringement proceedings before the Court of Justice, but to bring the Member State back into line with EU law during a pre-litigation phase.

The main steps of the pre-litigation procedure are:

1. Letter of formal notice

The letter of formal notice represents the first stage in the pre-litigation procedure, during which the Commission requests a Member State to submit its observations on an identified problem regarding the application of Community law within a given time limit. The Commission does not make an accusation but offers the Member State the opportunity to give its explanation regarding an alleged infringement. The Member States is given two months to reply.

2. Reasoned opinion

The reasoned opinion gives a detailed statement, based on the letter of formal notice, of the reasons that have led the Commission to conclude that the Member State concerned has failed to fulfil one or more of its obligations under the Treaty or other EU legislation. The Member State has two months to reply.

3. Decision to refer a case to the Court of Justice

Referral to the Court of Justice of the European Communities opens the litigation procedure.