The deputies voted, this Tuesday evening, the creation of a compensation fund for victims Depakine drug and all derivatives based on sodium valproate. This amendment, promised by the Minister of Social Affairs and Health Marisol Touraine last September, is accompanied by the creation of an envelope of 10 million euros for 2017.
The Minister believes that “the state takes its responsibilities” for “repair the consequences of the past”, in particular a lack of information for pregnant patients on the danger of the drug.
Depakine and sodium valproate medicines are anti-epileptics, sometimes also prescribed for people with bipolar disorder. They were administered to more than 14,000 pregnant women between 2007 and 2014, causing fetal malformations or serious behavioral disturbances in their children exposed in utero.
A mechanism identical to that of the Mediator
As for the Mediator, the compensation fund will be backed by the National Medical Accident Compensation Office (Oniam). “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 Oniam” underline the deputies in their text.
An expert committee will be responsible for ruling on each case and forwarding to the compensation committee which will decide “on the responsibility of professionals or health establishments, of the operator or of the State within three months”. This notion of “operator” indicated in the text means that it will be possible to have compensation paid to the Sanofi laboratory, which has been marketing Dépakine since 1967.
The laboratory ready to respond to medical expertise
After the vote on this amendment, the laboratory indicated in a press release to be “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”, added the laboratory, while telling itself “aware of the difficulties of families affected by these situations”.
To find out more: our special Dépakine file
