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DRUG

EU hits French drugs company with €331m fine

French drug maker Servier was slapped with a whopping €331 million fine by the EU for allegedly colluding to delay the release of a cheaper generic drug that treats high blood pressure. Generics are some 40 percent cheaper than brand name drugs.

EU hits French drugs company with €331m fine
Europe has slapped a €331 million fine on French drug giant Servier. Photo: Guillaume Souvant/AFP

The EU on Wednesday hit French drugs giant Servier with a huge €331 million fine for colluding to delay a cheaper generic version of perindopril, a popular blood pressure treatment.

In a statement, the European Commission said total fines in the case amounted to €427.7 million ($582 million), with Israeli generic giant Teva and four other companies also subject to penalties.

Servier is accused of trying to delay the introduction of a generic version of perindopril, a cardio-vascular medicine. The allegation is the result of a broad EU probe into the pharmaceutical industry launched in 2008.

"Servier had a strategy to systematically buy out any competitive threats to make sure that they stayed out of the market," said EU Competition Commissioner Joaquin Almunia.

"Such behaviour is clearly anti-competitive and abusive," he added.

Generic products are far cheaper than brand medicines — on average generics cost 40 percent less two years after they enter the market — and are a huge savings to patients and health care providers while remaining just as effective.

But in so-called pay-for-delay deals, drug makers can pay generic rivals to thwart the introduction of cheaper versions of blockbuster drugs for an agreed time.

The generic companies fined in the Servier case are Teva, Indian companies Niche/Unichem and Lupin, US company Mylan and Slovenia's Krka.

The fine inflicted on Servier is close to the maximum possible of up to 10 percent of the group's total annual sales. In 2013, Servier posted sales of €4.2 billion, with a net profit of €325 million.

A year ago, Danish drugmaker Lundbeck was fined €93.8 million by the Commission for striking a 2002 agreement to delay the generic version of its popular anti-depressant, citalopram.

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BIRTH

14,000 pregnant women in France took ‘birth defect drug’

According to a study released by health authorities on Wednesday, a total of 14,322 pregnant women in France took a medicine between 2007 and 2014 which has been linked to birth defects.

14,000 pregnant women in France took 'birth defect drug'
Dépakine has been linked to an increased risk of various congenital defects. File photo: AFP

Valproate, the active substance in anti-convulsion drug Dépakine, prescribed in France for epilepsy and bipolar disorder, has been linked to heart, kidney and spine defects as well as autism and developmental delays. Authorities have been sharply criticized for their slow reaction in preventing pregnant women from taking the drug.

In total, 8701 children were born to women taking the drug over the seven-year period, the study published on Wednesday said, accounting for two in every 1000 pregnancies in France over the period.

This is despite the fact that since 2006, the leaflet enclosed with the drug advised against taking it during pregnancy; this warning was added to the outer box in 2014. It wasn't until 2014 that a European report urged all countries on the continent to review their conditions for prescribing valproate “to minimize risks”.

A compensation scheme will be established for those affected, Health Minister Marisol Touraine said on Wednesday.  Parliament will vote on the scheme later in the year. Touraine also pledged that in the next six months, further measures would be put in place to support the patients “completely”.

The study, published by ANSM (French National Agency for Medicines and Health Products Safety), did not give a figure for how many of the babies suffered from birth defects due to the exposure to the drug.

However, previous studies on the effects of valproate have shown that babies born to mothers who have taken the substance have a ten percent risk of suffering from heart, kidney or spine defects, and a 30-40 percent risk of being affected by delayed development or autism.

A report released in February by France's social affairs inspectorate (IGAS) estimated that around 450 French babies had been born with congenital defects after being exposed to valproate in utero. The inspectorate arrived at this number by extrapolating data obtained in the Rhone-Alpes region, it said.

Then, IGAS criticized “the lack of reactivity” from ANSM and Sanofi, the pharmaceutical company which has produced the drug in France since 1967. In 2008, two years after the drug was officially not recommended to be taken during pregnancy, an IGAS study showed that one in five doctors and one in three pharmacists were still unaware of the effects of valproate on unborn children.

“This is a huge health scandal that could have affected between 50,000 and 70,000 people over 50 years of prescription,” said Marine Martin, president of Apesac, an organization set up to assist parents affected by Dépakine, cited by Ouest-France. According to Apesac's figures, 2426 babies have been affected by the drug, of whom 401 have died.

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