Brussels, 09/01/2013 (Agence Europe) - The European Commission expects the Court of Justice of the EU to return its ruling this year on the authorisation for sale on the European market of Orphacol, a drug produced by the French laboratory CTRS and designed to treat two orphan liver diseases, which are extremely rare and serious (affecting no more than around 100 people in the European Union). This was announced on Wednesday 9 January by Frédéric Vincent, the spokesperson to Tonio Borg, the new Commissioner for Health, following a number of questions raised at the Commission's daily press conference. Vincent made no announcements regarding the allegations of obstruction on the part of the European Commission to prevent the sale of this drug on the European market, further to an article which appeared in the French daily newspaper Libération. “The Commission has a legal assessment of the conditions under which the company (CTRS) may bring its medicines to the market. There was a disagreement with this company (…). Currently, there is an accelerated procedure before the Court of Justice which the Commission has accepted (…). The final answer will come from the Court”, said Vincent.
In October 2009, the CTRS laboratory applied to the European Medicines Agency (EMA) to sell Orphacol on the European market. Despite the favourable opinion of the EMA and of the 27 member states meeting on the Standing Committee on Medicinal Products for Human Use, the European Commission opposed the authorisation, taking the view that there were not enough sufficiently in-depth clinical studies to guarantee the safety of the drug (precautionary principle). Several procedures later, the sale of Orphacol is blocked and the dossier is before the European Court of Justice, which is due to return its verdict this year. In the meantime, there are rumours of connections between the Commission and Asklepion Pharmaceuticals, an American laboratory currently developing a competitor drug to Orphacol. The Commission's attitude in this saga raises issues for the MEP Gilles Pargneaux (S&D, France), who has been following the dossier since July 2011 and had tough questions on the subject on a number of occasions for the former Health Commissioner John Dalli, then still in position. He argues that the Commission is clearly obstructing the dossier: “I particularly regret the total lack of transparency the European Commission has shown in the framework of the comitology procedure”, he blogged. He went on to add that he was in possession of documents “which prove that the European Commission has been in direct relations with [the American laboratory] to obtain information which the Commission would usually have had to ask the EMA for”. These statements go along the same lines as the article in Libération, which Vincent dismissed as “peppered with errors”. (IL/transl.fl)