In two months' time, the trial of the Mediator will begin in Paris. This antidiabetic medication from the Servier laboratory is prescribed to five million people. The number of deaths he would be responsible for is estimated at between 500 and 2,000. The Servier laboratory and the Agence du médicament will be on the defendants' bench.
And while each side is preparing its defense arguments for the first six-month criminal trial, Europe 1 has been able to consult an internal document of the Ministry of Health's legal services. A document that shows their concerns about a possible recognition by the justice of a responsibility of the State.
Several faults pointed
This is a multi-page memo outlining the legal risks to the state in this case. Summed up by this short sentence in the email that accompanies it: "The most unpleasant conclusion is that if the responsibility of the state is sought, it will probably be integral and not shared with Servier".
To reach this conclusion, the note details the various faults identified by the Inspectorate General of Social Affairs (IGAS) attributable to the Agency for Medicines, the health agency that issues the marketing authorizations for medicines.
The precautionary principle has not been applied, according to IGAS
The first fault noted dates back to a period from 1987 to 1995, when the agency did not rule out the indication of diabetes for the Mediator. Then from 1999, that of not having applied the precautionary principle and removed the Mediator from the market in view of available information on the risks.
Clearly, the note emphasizes that, according to IGAS, the system of pharmacovigilance has been seriously flawed and that as such, the responsibility of the State could well be engaged because of the decisions taken. Or more exactly, the abstention to take them.