PARIS (Reuters) - France is setting up a fund to meet compensation claims from people affected by an epilepsy treatment made by Sanofi that is believed to cause birth malfunctions and slow neurological development.
The French parliament voted to create a nationwide compensation fund and amended the 2017 budget bill late on Tuesday to set aside an initial 10 million euros ($10.7 million) for claims relating to Depakine, a brand name for valproate, which is also used to treat bipolar disorder.
Parents of those affected say the French state and Sanofi were too slow to warn of the side effects of the drug, which has been used to successfully treat epilepsy since 1967, after the risks to fetuses became clear by the early 1980s..
More than 14,000 women were prescribed Depakine despite the potential risks in pregnant women, authorities say, while an association representing victims says it could have affected more than 50,000 people in France over the years.
“The 10 million euros are a starting point,” Health Minister Marisol Touraine told lawmakers in the lower house of parliament. “In future years, the sums should be much higher.”
Touraine told parliament later on Wednesday that compensation would ultimately be paid by “those deemed responsible” without giving details.
“I regret that Sanofi didn’t seek an amicable settlement as a matter of principle. I hope (Sanofi) will change its position,” she said.
A Sanofi spokeswoman had no comment on the minister’s remarks and referred to a statement earlier on Wednesday in response to the vote to set up the fund.
“The text of the amendment adopted by the National Assembly does not draw any conclusions ... as to the responsibilities of the various actors that may be involved,” the Sanofi spokeswoman said in the emailed statement.
In an October interview with Reuters, Sanofi said it would accept any blame attributed by a court over the harmful effects of the treatment and the company had so far made no financial provisions for compensating victims.
French social affairs inspection agency IGAS estimated earlier this year that between 2006 - when the medicine started carrying a health warning - and 2014 - when prescription rules were further tightened - some 425 to 450 babies suffered congenital birth defects or were still-born due to the drug.
A judicial investigation was launched last year after a group of families lodged a legal complaint, but no trial has been announced.
Depakine is also prescribed under other brand names and in more than 100 other countries. It lost its patent in 1998.
The Sanofi spokeswoman said there has been single claims in three other countries, without giving further details.
($1 = 0.9350 euros)
Editing by Alexander Smith, Leigh Thomas and Jane Merriman