MEDICINES : ORPHACOL MARKET AUTHORISATION NOT A DONE DEAL.

After having fought the European Commission all the way to the EU General Court, it seems that the French laboratory CTRS will just have to keep on waiting for a marketing authorisation for the drug Orphacol. Orphacol isaan orphan medicinal product designed to treat rare and sometimes fatal liver disorders (an estimated 90 cases in Europe). In order to be able to market it, in October 2009, CTRS applied for a marketing authorisation. The European Medicines Agency (EMA) gave a positive opinion twice. However, the Commission refused to heed this opinion. In a comitology procedure, the member states twice clashed with the Commission (review committee vote, followed by an appeal) over its wish to deny the marketing authorisation. In a third vote, the representatives of the member states did not garner a sufficient majority to oppose the Commission, which made it possible for the EU executive to deny the marketing authorisation. But the EU General Court - which CTRS had turned to - found in favour of the laboratory, rejecting all of the Commission's arguments.

The next part should have been quick and easy: as soon as the 4 July ruling was pronounced, a Commission spokesperson said the Commission would kick-start the authorisation process for the drug. Health Commissioner Tonio Borg confirmed as much in a 25 July letter addressed directly to the CTRS laboratory. The Commission then adopted a draft regulation to authorise marketing of Orphacol, which it proposed putting to the member states by 3 August in a written procedure - given that the 28 member states had already discussed the issue three times. And yet that was not the last surprise in store: one member state refused to agree to the written procedure and asked for an actual meeting to be held. Sources concur to say that it was Poland. Which does not seem much of a stretch as, at the...