AMSTERDAM, THE NETHERLANDS: The District Court of Rotterdam has rejected the appeal of pharmaceutical company Leadiant against the 2021 decision of the Netherlands Competition Authority (the Authority for Consumers and Markets – ACM). The Court upheld the fine of €17 million imposed by the ACM for excessively increasing the price of the orphan drug CDCA.
This ruling clearly sets limits on the prices that pharmaceutical companies can charge: the court specified that a price that has risen from €46 to €13,090 per package exceeds all limits in the absence of proper substantiation. The court calls the exorbitant price increase “a textbook example of abuse of a dominant position”.
The court confirms that the Dutch health insurers have had to pay an excessive price for the drug CDCA for almost 2.5 years.
Wilbert Bannenberg, PAF chairman, said: “the Pharmaceutical Accountability Foundation is pleased that the Rotterdam court has upheld the fine of € 17 million for Leadiant for abuse of its dominant position. The court’s ruling now o\ers the health insurers an opportunity to recover the overpayment from Leadiant.”
Leadiant had obtained this market position in 2017 due to an exclusivity in the orphan drug market that can be granted by the European Commission to companies that invest in the development of a new drug for rare diseases and bring it to the market.
More information on the case is available here.
A machine translation of the Dutch ruling (linked above) is available here.