Pharmaceutical Accountability Foundation

After Netherlands and Israel, now Italy: Leadiant fined for excessive price
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Leadiant fined €3.5 million for excessive pricing of its orphan medicine CDCA

Bergeijk, June 2, 2022

The Italian Competition Authority (ICA) decided on 31 May that pharmaceutical company Leadiant has charged the Italian National Health Service excessive prices for the life-saving medicine Chenodeoxycholic acid (CDCA), and issued a fine of €3.5million. 

“We believe that pharmaceutical companies have a duty of care to make medicines affordable and available to patients.” says Wilbert Bannenberg, chairperson of the Pharmaceutical Accountability Foundation (PAF). “We therefore welcome the ICA’s ruling that Leadiant has abused its dominant economic position and offers a significant push back to companies that charge excessive prices for their health products.” The Italian move follows decisions by the Dutch Competition Authority ACM (19 July 2021, €19.6m) and the Israeli Competition Authority (November 2021, €2.2m). Similar cases against the company are still pending in Spain and Belgium.

The ICA published a 187 page report (Italian original  / English unofficial translation) outlining the history of the case and providing detailed evidence about Leadiant’s abusive behaviour. This followed searches in Leadiant offices in Italy, Germany and the UK.

The ICA ascertained that the abuse was implemented through a multifaceted strategy, intentionally pursued by Leadiant, to delay and obstruct the Italian Medicines Agency during price negotiations. 

Leadiant further signed contracts with Italian raw material producer Prodotti Chimici Alimentari S.p.A.(PCA) that prevented the supply of CDCA raw material to compounding pharmacists in Italy, the Netherlands and other countries. Pharmacies that make their own versions of overpriced medicines are a crucial way of giving patients affordable access to overpriced medicines. Leadiants’ abuse of the supply chain caused serious problems for patients needing CDCA as they were temporarily forced to access the excessively priced CDCA from Leadiant.

The Italian complaint was brought by Italian consumer organisation AltroConsumo after collaboration with the Pharmaceutical Accountability Foundation, which brought the original complaint to the Dutch Competition Authority (ACM) in 2018.

Background information:

The Pharmaceutical Accountability Foundation (PAF, Dutch: Farma ter Verantwoording) was created in July 2018 in response to unethical gaming of the pharmaceutical incentive system that betrays the public trust, harms patients and prevents access to medicines.

PAF serves the public interest by striving to ensure access to medicine. Medicines and medical technologies are made available in a socially responsible and sustainable manner. We attach a value to fair pricing and distribution in accordance with European and international legal standards, and therefore take action to combat unjustifiable price gouging by companies abusing market monopolies.

On September 7, 2018, PAF submitted the original enforcement request to the Dutch Competition Commission (ACM) for abuse of a dominant market position by the company Leadiant with the orphan drug CDCA. The company had increased the price 500-fold from €308 per year to €153,500 per year after obtaining orphan drug market exclusivity. 

The Dutch Authority for Consumers and Markets (ACM) decided on 19 July that Leadiant had abused its dominant position in the market and imposed a fine of €19.5 million.

CDCA treats a rare genetic condition called Cerebrotendinous Xanthomatosis (CTX), which can cause cataracts, bone fractures, and neurological problems  such as dementia or seizures if untreated. More information about CDCA and its use is available from:  https://www.pharmaceuticalaccountability.org/case-studies/cdca-leadiant/

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