Brussels, 18th October
The Commission has decided to take Germany to the European Court of Justice for provisions regulating the supply of hospitals with medicines by external pharmacies. For example, Germany requires pharmacies not only to supply medicines, but also to provide personally counselling at the hospital by the director of the supplying pharmacy. Bundling “local” elements with other contractual elements leads to a “hidden” regional supply. By requiring that the same pharmacy market must fulfil all requirements at the same time, access for EU-pharmacies is still hampered. In the eyes of the European Commission this constitutes an impediment to the free movement of goods. The Commission is convinced that an unbundled contract, i.e. contracting different tasks to different contractors, does not impair the supply quality.
Medicines to hospitals in Germany can practically only be supplied by German regional pharmacies. Already in 2005 the Commission had decided to submit this case to the ECJ. But the Commission refrained from filing of action, as Germany had amended its legislation shortly after the Commission’s announcement. However, the new German legislation introduced a series of impediments for supplying pharmacies, such as the duty to deliver medicines immediately and to provide personally counselling at the hospital by the director of the supplying pharmacy. The pharmacist assigned must also be a member of the medicinal product Committee of the hospital. This statutory fixed principle “supply from one source” leads to a “hidden” or an “unwritten” regional supply principle and makes it very difficult for pharmacies in other Member States to supply medicines to hospitals in Germany.
The Commission is of the opinion that the German legislation is not in line with the rules on the free movement of goods enshrined in the EC-Treaty (Art. 28 ECT).
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.