The Netherlands imposes a millionaire fine on an Italian pharmacist for inflating the prices of a drug by 30,000%

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The Netherlands Authority for Consumers and Markets (ACM) has announced this Monday its decision to fine the Italian company Leadiant with 19,569,500 euros (about 23 million dollars) for abusing its dominant position in the market and selling its medicine CDCA-Leadiant at an exaggerated price.

The drug in question contains chenodeoxycholic acid, used for the treatment of patients with cerebrotendinous xanthomatosis (XCT), a rare inherited metabolic abnormality that causes irreparable damage due to the accumulation of fatty acids in different parts of the body.

There are currently around 60 people in the Netherlands who suffer from this disease, and they need to take chenodeoxycholic acid for the rest of their lives. While previously the drug, which lacks an equivalent therapeutic alternative, was available under various trade names and at affordable prices, the situation changed dramatically when Leadiant became the only manufacturer authorized to sell it on the European market.

According to the Dutch regulator, in 2008 the maximum price of the drug was 46 euros (54 dollars) for 100 capsules, but in late 2009 Leadiant changed its trade name and raised the price to 885 euros ($ 1,044). Meanwhile, in 2014, chenodeoxycholic acid cost 3,103 euros (3,661 dollars) after the pharmaceutical company requested to designate it as an ‘orphan drug’, intended to treat a rare disease that affects a small group of patients.

In 2017, Leadiant obtained the exclusive right to supply the drug to the European market for 10 years and replaced the drug in the Netherlands with an identical one under a different trade name, CDCA-Leadiant, already selling it for € 14,000 ($ 16,524).

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In such a way that in almost a decade the increase in the price of chenodeoxycholic acid in the country constituted more than 30,000%. “As a result, the drug costs approximately 153,000 euros per patient per year“concluded the Consumers and Markets Authority.

The high price sparked a huge public outcry, and the situation remained unchanged until January 2020, when the Amsterdam University Medical Center managed to produce the drug on its own premises.

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