[Ip-health] Dutch Competition Authority ACM honours the enforcement request of Pharmaceutical Accountability Foundation and fines pharmaceutical company Leadiant with €19.5 million

Wilbert Bannenberg wjb1610 at gmail.com
Tue Jul 20 07:29:21 PDT 2021


Press release by the Pharmaceutical Accountability Foundation (PAF)

Dutch Competition Authority ACM honours the enforcement request of Pharmaceutical Accountability Foundation and fines pharmaceutical company Leadiant with €19.5 million ($23 million)

Bergeijk, July 19, 2021 – On September 7, 2018, the Pharmaceutical Accountability Foundation (PAF) submitted an enforcement request for abuse of a dominant market position by the company Leadiant with the drug CDCA. The company had increased the price 500 fold after obtaining orphan drug market exclusivity.  See https://www.farmaterverantwoording.nl/wp-content/uploads/2021/07/Pressrelease_web_PharmaAccountabilityFoundation_sept18.pdf

The Netherlands 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.
See https://www.acm.nl/en/publications/acm-imposes-fine-drug-manufacturer-leadiant-cdcas-excessive-price

“We welcome the ACM's ruling that Leadiant has abused its dominant economic position,” says Wilbert Bannenberg, Chairman of the Pharmaceutical Accountability Foundation (PAF). “Pharma-pirate Leadiant was rightly fined by the ACM for the excessively high price of CDCA. Because of this ruling, hijacking old and affordable medicines no longer pays. We believe that pharmaceutical companies have a duty of care to make medicines affordable and available to patients.”

PAF finds the fine of €19.5 million appropriate: Leadiant had increased the price 500 times from €308 per year to €153,500 per year. And for 1.5 years, health insurers paid that high amount for 60 Dutch patients instead of the 5x cheaper, pharmaceutically compounded CDCA from the Amsterdam University Medical Center (AUMC).

Leadiant has also been reported in relation to excessive pricing of CDCA to national competition authorities in Belgium, Italy and Spain:
- https://www.farmaterverantwoording.nl/wp-content/uploads/2021/07/Belgium-Plainte-relative-a-un-abus-de-position-dominante-28.03.2019.pdf
- https://www.farmaterverantwoording.nl/wp-content/uploads/2021/07/20191010-ICA-investigating-Leadiant-medicine-for-the-treatment-of-xanthomatosis.pdf
- https://www.farmaterverantwoording.nl/wp-content/uploads/2021/07/Spain-CNMC_Leadiant_Abuso-Mercado_Definitiva.pdf

The abuse of the European orphan drug regime by industry has reached epidemic proportions in recent years. Unfortunately, Leadiant is no exception. Other examples include:

•	On 7 July, Dutch Health Minister van Ark decided not to reimburse the 100 times more expensive mexiletine (Namuscla by Lupin) by the Dutch health insurance, because generic import and pharmaceutical compounding were cheaper.
•	Swedish company Egetis recently received critical press enquiries about a possible hijack of the thyroid drug triac (tiratricol), which analysts say has the potential to become 1000 times more expensive.

PAF sees this ruling by the ACM as an important first step to putting a stop to pharma-piracy.

For comments journalists can reach out to:

•	Wilbert Bannenberg, physician (np) and Chairman of the Board PAF, +31 620873123, voorzitter at farmaterverantwoording.nl
•	Emily Dowdalls, pharmacist (np) and Project Coordinator PAF, +31 612625993, projectcoordinator at farmaterverantwoording.nl
•	PAF website: https://www.farmaterverantwoording.nl/en




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