/Dépakine: MEPs give the green light to the creation of a compensation fund
Dépakine: Meps Give The Green Light To The Creation Of

Dépakine: MEPs give the green light to the creation of a compensation fund

They voted unanimously on a government amendment on Tuesday evening.

A woman takes Dépakine on August 24, 2016, in Paris.  (GARO / PHANIE / AFP)

Some 14,000 women, exposed between 2007 and 2014, are concerned. The National Assembly gave, Tuesday, November 15 in the evening, its green light for the creation of the compensation fund promised by the State for the victims of the antiepileptic Depakine. This government amendment, adopted unanimously, will allow compensation to be paid in particular to the Sanofi laboratory.

The fund, the creation of which was announced in August by the government, “Aims to establish a compensation system for damage attributable to sodium valproate [la substance active de la Dépakine] and its derivatives ”. Depakine can cause fetal malformations when the drug is taken during pregnancy. MEPs greeted the vote with applause.

A committee to decide on responsibility

The adopted amendment states that “Anyone who considers himself the victim of prejudice due to one or more deformities or developmental disorders attributable to prescription before December 31, 2015 can apply to the National Medical Accident Compensation Office”.

An expert committee will then be responsible for ruling on “Accountability” damage and, if applicable, forward the file to the compensation committee. This one will have to pronounce “On the responsibility of health professionals or establishments, of the operator or of the State under its health security powers, within three months”.

As soon as liability is recognized, the persons or entities then have one month to make an offer of compensation. In the event of insufficient supply or in the absence of an offer, the National Office for Compensation for Medical Accidents will directly compensate the victims and then go back to the person (s) responsible.

Sanofi refused “any amicable compensation”

“It is women, their children, their families who are directly affected, women who sometimes have no other choice but to take Depakine”, reacted the Minister of Health, Marisol Touraine, affirming that “The State takes its responsibilities” for “Repair the consequences of the past”, in particular a failure to inform patients about the dangers of the drug.

It regrets, however, that the Sanofi laboratory, which has been marketing sodium valproate since 1967 under the Dépakine brand but also under generic brands, belonging “Refused any amicable compensation a priori”.

In a statement released after the vote, the company said it was “Ready to respond to requests for medical expertise that would be organized within the framework of this system”. Amendment adopted “In no way prejudges the responsibilities of the various actors who could be concerned”, however, added the laboratory.

Ten million euros to start

For its part, the Association for the Assistance of Parents of Children Suffering from Anticonvulsant Syndrome (Apesac) welcomed the device which “Appears compliant” to the main requests of the president of the association, according to whom “The compensation must be paid in the first place by the laboratory which remains the main responsible”. She said to herself, however “Reserved on the possibility of compensation by the State in the event of refusal by Sanofi-Aventis France”.

To finance the launch of this fund, the deputies voted for an envelope of 10 million euros for 2017. But according to Marisol Touraine, “For the following years, the sums will be much more important”.