The European Commission has opened a formal antitrust investigation into the international pharmaceutical undertaking Lundbeck to examine potential breaches of EU rules on restrictive business practices and on the abuse of a dominant market position under Articles 101 and 102 of the Treaty on the Functioning of the European Union.

The European Commission has opened a formal antitrust investigation into the international pharmaceutical undertaking Lundbeck to examine potential breaches of EU rules on restrictive business practices and on the abuse of a dominant market position under Articles 101 and 102 of the Treaty on the Functioning of the European Union (TFEU). The Commission in particular intends to investigate unilateral behaviour and agreements by Lundbeck which may hinder the entry of generic citalopram into markets in the European Economic Area. Citalopram, originally developed by Lundbeck, is an anti-depressant drug known as a selective serotonin reuptake inhibitor (SSRI).

Opening of proceedings does not mean that the Commission has proof of the infringements but merely means that the Commission will investigate the case as a matter of priority. The r ights of defence of companies concerned by such proceedings are fully respected.

There is no strict deadline to complete inquiries into anticompetitive conduct. Their duration depends on a number of factors, including the complexity of the case, cooperation from the undertakings concerned and the exercise of the rights of defence.

Why has the Commission opened proceedings?

The knowledge acquired during the pharmaceutical sector inquiry (see IP/09/1098 and MEMO/09/321 ), specifically on ways originator companies use obstruct the entry of generic drugs onto the market, has allowed the Commission to draw conclusions on where Commission action based on competition law could be appropriate and effective. The Commission has decided that the investigation focusing on Lundbeck's conduct should be dealt with as a matter of priority, and as a result has opened proceedings. These proceedings are separate from the sector inquiry.

What is the legal basis for the decisions?

The legal basis for this procedural step is Article 11(6) of Council Regulation No 1/2003 and Article 2(1) of Commission Regulation No 773/2004.

Article 11(6) of Regulation No 1/2003 provides that the initiation of proceedings relieves the competition authorities of the Member States of their authority to apply Articles 101 and 102 TFEU to the practices under investigation by the Commission. Moreover, Article 16(1) of the same Regulation provides that national courts must avoid giving decisions which would conflict with a decision contemplated by the Commission in proceedings that it has initiated.

Article 2 of Regulation No 773/2004 provides that the Commission can initiate proceedings with a view to adopting at a later stage a decision on substance according to Articles 7-10 of Regulation No 1/2003 at any point in time, but at the latest when issuing a statement of objections or a preliminary assessment notice in a settlement procedure. In the case at stake the Commission has chosen to open proceedings before such further steps.