Brussels, 19/09/2013 (Agence Europe) - The European Commission has finally accepted the decision of the General Court of the EU and has granted CTRS marketing authorisation for the medicine known as Orphacol. The intended use of this orphan medicine is for treating two extremely rare and potentially fatal liver diseases. In a press release on 18 September, the French laboratory CTRS welcomed this decision but said, nevertheless, that it intended to take action against the Commission for blocking the marketing of a crucial medicine for patients, for no valid reason. Antoine Ferry, the president of the CTRS Laboratory said that “this has been a long battle with many setbacks along the way. I am, however, delighted that the Commission has complied with the ruling of the Court and has finally granted the marketing authorisation for Orphacol. Patients across the EU will now have proper access to this medication”. He also said that CTRS was taking legal advice on the possibility of pursuing the Commission for this totally unjustified delay in granting marketing authorisation.
Authorisation for the marketing of Orphacol was obtained two years and nine months after the first two positive European Medicines Agency (EMA) recommendations. EMA was responsible for assessing the requests for putting the product on the market and unanimously concluded that the benefit/risk report was positive. Despite the favourable recommendations from EMA and the member states, meeting in the Standing Committee on Medicinal Products for Human Use, the Commission opposed authorisation on the grounds that there had not been sufficiently detailed clinical trials to guarantee the medicine had no harmful effects (see EUROPE 10760). CTRS took matters to the General Court, which, on 4 July 2013, finally ruled that the arguments advanced by the Commission were unfounded and called on it to grant authorisation for the marketing of this medicine (see EUROPE 10881). The Commission did not immediately comply, for procedural reasons, which has also been denounced by CTRS. As explained by Gilles Pargneaux, a French Socialist MP particularly involved in this dossier, “the delays are important insofar as commercial exclusivity is granted to any orphan medicine for a ten-year period”. This affair was revealed in the French newspaper, Libération, which, in an article, asserted that the blockage imposed by the Commission on Orphacol, was due to pressure being exerted at different levels from the US laboratory, Asklepion Pharmaceuticals, which was seeking to market a rival product. (IL/transl.fl)