Orphacol: Court rejects action, orders Commission to pay costs
By Ophélie Spanneut | Wednesday 04 July 2012
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 (see
Europolitics 4422 and 4450) 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. The laboratory also introduced on a subsidiary basis an action for annulment of the decision announced in a letter of 5 December 2011. In an exchange of correspondence, Health Commissioner John Dalli had announced the Commission’s refusal to grant marketing authorisation.
The General Court ruled the action inadmissible since this letter of 5 December constitutes a position that puts an end to the Commission’s alleged absence of action. It also held that “there is no longer any need to adjudicate on the application for annulment […] as the applicant no longer has any interest in challenging that decision because of the adoption of the decision of 25 May 2012”. The particularity of this case resides in the fact that the Commission adopted a decision during the review by the EU General Court.
While the court rejected the action for failure to take action and for annulment “in the light of the exceptional circumstances of the present case,” it ordered the Commission to pay its own costs as well as those incurred by CTRS in connection with the proceedings. CTRS President Antoine Ferry sees this as an encouragement. “The court was unimpressed with the Commission’s behaviour as it has ordered the Commission to bear CTRS’ costs in bringing the case.” “We are currently contemplating with our counsel our options for going forward,” he added, possibly an action for annulment of the decision of 25 May. “The battle does not end here,” he concluded.