Orphacol: EP asks Commission for explanations
By Ophélie Spanneut | Friday 22 June 2012
Intrigued by the case of Orphacol, a medicine developed to treat an orphan disease, members of the European Parliament’s Committee on the Environment and Public Health (ENVI) asked the European Commission to present explanations, on 21 June. A new argument has come into the picture: the existence of a competing US laboratory.
This medicine was developed to treat an extremely rare liver disease (90 cases in Europe). To obtain marketing authorisation, Laboratoires CTRS submitted an application to the European Medicines Agency (EMA), in October 2009. The EMA issued a positive opinion on two occasions. The Commission, however, considers that marketing authorisation cannot be granted because the application does not fulfil the legal requirements. For the EU executive, the scientific bibliography provided is inadequate. The member states, consulted in a review board, twice rejected the Commission’s case for refusal of marketing authorisation, relying on the EMA’s opinion. This is an extremely rare occurrence. In January 2012, CTRS lodged an action for failure to act before the EU General Court. But on 8 May, in its third attempt, the Commission finally succeeded in convincing a qualified majority of member states in the board to reject marketing authorisation.
Europolitics reported earlier (4422), this case affects member states in terms of both content – why the Commission is at odds with the EMA experts – and form. France, the United Kingdom and the Czech Republic, backing the laboratory in its legal case, question whether the Commission can convene the member states indefinitely until it gets the result it wants.
Parliament also has questions. Apart from the same concerns about institutional balance, Gilles Pargneaux (S&D, France) has added another element to the debate: the US competitor. He notes that “all the clinical arguments [presented by the Commission] are developed word for word by the competitor”. Pargneaux says he has “evidence that the Commission contacted the competitor directly”. Has there been favouritism in this case? “I do not want to believe in a conflict of interests in the Commission, but I have strong suspicions”, he told
For the Commission, Patricia Brunko firmly rejected this allegation and said the executive “never heard the competitor” but “contacted it to learn the timeframe of the request”. She maintains that “the strict legislative requirements were not respected”. Determined “not to let the case die, we continued to look for solutions,” which is why there were three votes. “Patients are entitled to safe and effective medicines,” she added.
A few days before the EP hearing, certain member states made a point of telling MEPs of their discontent with the Commission’s attitude, particularly since it continued to try to secure a majority in the review board even though the case is before the EU General Court.
The court’s decision has been postponed until mid-July.