Pharmaceuticals : Orphacol: Court Rejects Action, Orders Commission to Pay Costs

Article excerpt

In the Orphacol case, which concerns a medicinal product the European Commission refuses to authorise, the EU General Court rejected, in a 4 July judgement (Case T-12/12), the case brought by the laboratory but ordered the European Commission to pay the court costs. The laboratory is considering an appeal, so the saga will continue.

This medicine is used to treat an orphan disease that affects the liver (90 cases in Europe). To obtain marketing authorisation, the manufacturer CTRS submitted an application to the European Medicines Agency (EMA) in October 2009. Under the procedure applicable (Regulation 2004/726), the Commission decides whether or not to issue marketing authorisation (MA) after obtaining a positive opinion from the EMA and the approval of member states consulted in the review committee. The agency issued a positive opinion on two separate occasions, but the Commission refused to grant marketing authorisation on the grounds that the application does not fulfil the required legal conditions. The member states rejected twice the Commission's case for refusal of marketing authorisation, an extremely rare occurrence. In January 2012, CTRS lodged an action before the EU General Court. Then, on 8 May, in a third vote, the member states failed to secure a qualified majority to reject the Commission's case once again, leaving the executive free to adopt its decision rejecting marketing authorisation, which it did, on 25 May.

The action for failure to act is based on the fact that, according to the regulation, the Commission must adopt a decision within 15 days of conclusion of the review procedure, ie after the vote, on 8 November. …