Tellerreport,
The National Assembly voted on Thursday to amend the compensation mechanism for the victims of Dépakine, a drug against epilepsy and bipolar disorder, which notably instituted a single instance of examination of claims, against two previously, in order to ‘speed up the process.
At the moment, the files go first to a panel of experts, composed of doctors and lawyers charged to establish if the troubles of the victim are due to the catch of Dépakine by her mother during the pregnancy.
If the answer is positive, a compensation committee then identifies the officials (the Sanofi laboratory, the State and / or the prescribing physician) and assesses the severity of the damage.
At the end of September, only 31 cases had resulted in an « amicable offer » on about 2,000 applications filed under this scheme, set up in 2017 with the National Office for Compensation of Medical Accidents (Oniam).
« This merger will speed up the processing of cases, (…) will facilitate the work of experts, to avoid problems of jurisdictional border between the two bodies, (and) reduce the operating costs of the device », explains the amendment tabled by the government, in the framework of the finance law for 2020.
The composition of the new college will be determined by decree.
« It is certainly essential to accelerate » the device, « however the real problem is not the time of the procedure, but the non-compliance by the experts of Oniam diagnostics posed by doctors, » reacted in A statement issued by President of the Apesac Victims Association, Marine Martin, referring to « discouraged families ».
The amendment voted by the deputies also included in the law the date from which the scientific data made it possible to know the toxicity of this drug for the fetus: 1982 for the congenital malformations and 1984 for the disorders of the development (autism in particular).
– « A great victory » –
For children born after these dates while their mother took Depakine during her pregnancy, there will now be « a presumptive liability regime for damage caused by (the drug) to a lack of information from the mother about its undesirable effects « , explains the statement of the amendment.
« It is a great victory for the victims that the state finally recognizes in an article of law that the autism caused by the Dépakine (Valproate) was known to the specialists that is to say by the producer Sanofi, by the ‘State (ANSM) but also by specialized practitioners: neurologists,’ welcomed Marine Martin.
The association also welcomed the fact that victims whose application has been rejected or who are not satisfied with the proposed compensation will be able to have their file reviewed by the new panel of experts.
Sodium valproate, marketed by Sanofi in particular under the name Dépakine and Dépakote, as well as in generic form, is at the center of a health scandal related to its prescription to pregnant women while its dangers for the fetus (congenital malformations). and neurodevelopmental disorders) were known.
The prescription conditions and the package leaflet were changed in 2015.
This medicine has been responsible since 1967 for malformations in 2,150 to 4,100 children, and neurodevelopmental disorders in 16,600 to 30,400 children, according to the Health Insurance and the Medicines Agency (ANSM).
Sanofi has refused to make offers of compensation, it is the Oniam which intervenes in substitution to compensate the victims when the responsibility of the laboratory is established, before claiming to him in justice the refund of the sums paid.
© 2019 AFP
Source : Tellerreport
