[Ip-health] Dutch competition authority extends its investigation into excessive pricing of orphan drug CDCA

Ellen 't Hoen ellenthoen at medicineslawandpolicy.net
Mon Jun 29 07:16:38 PDT 2020

Dear IP-Health Readers,

The Dutch competition authority put out a press statement saying it is extending its investigation into Leadiant’s pricing practices for CDCA, an orphan drug they obtained market exclusivity for despite the fact that it was a known compound with a known off-label used for the treatment of the rare disease CTX. The case was brought by the Foundation for Pharmaceutical Accountability on 7 September 2018.

Here is the statement of the Dutch Authority for Consumers and Market:

And here is the response by the Pharmaceutical Accountability Foundation to the press release of the Dutch Authority for Consumers and Markets, on CDCA Leadiant [https://www.acm.nl/en/publications/acm-extends-its-investigation-orphan-drug-cdca-leadiant]

29 June 2020

ACM expects to complete the fact-finding investigation into CDCA's pricing and abuse of dominant position by the pharmaceutical company Leadiant after the summer.
According to the Pharmaceutical Accountability Foundation it is high time that after two years a decision is made about Leadiant's actions. Pharmaceutical Accountability Foundation chair Wilbert Bannenberg says, "We believe that the outcome of this investigation should lead to a penalty decision and discontinuation of Leadiant's pricing practices."

ACM announced today that it is continuing to investigate the practices of pharmaceutical company Leadiant. She expects to have completed the fact-finding after the summer. This also postpones the decision period at the request of the Pharmaceutical Accountability Foundation to take enforcement action against the pharmaceutical company.

In view of the duration of the investigation to date, in which the ACM indicates that extensive investigations have already been carried out, the Foundation expects that ACM will develop a report against Leadiant on the basis of which the pharmaceutical company can be fined.

On September 7, 2018, the Foundation filed an enforcement request against Leadiant. According to the Foundation, Leadiant abused its dominant position by excessively increasing the price of the orphan drug CDCA-Leadiant. As a result, the costs of treatment per person per year increased to more than EUR 153,000, while the costs of a pharmacy compounded preparation of the medicine were only EUR 30,000. It is important in this respect that Leadiant has not made any (significant) development costs for the medicine. The medicine had been around since the 1970s and was still on sale in 2008 for 28 cents per capsule, while Leadiant now demands 500 times as much (EUR 140) per capsule. Leadiant was able to raise the price by purchasing the rights on the original medicine and all other sources in the EU and by withdrawing the registrations for the then valid indications. With CDCA's registration as an orphan drug in 2017, Leadiant gained 10 years of market exclusivity, after which Leadiant increased the price excessively to EUR 140 per capsule.

Partly as a result of the enforcement request and the efforts of the Pharmaceutical Accountability Foundation, the competition authorities in Belgium, Italy and Spain have also started investigations into the conduct of Leadiant. https://www.farmaterverantwoording.nl/information-in-english/ <https://www.farmaterverantwoording.nl/information-in-english/> 

The Dutch Journal of Medicine recently published an article by the Pharmaceutical Accountability Foundation denouncing the behaviour of medicine hijacker Leadiant: https://www.ntvg.nl/artikelen/weesgeneesmiddelen-en-medicijnkapers <https://www.ntvg.nl/artikelen/weesgeneesmiddelen-en-medicijnkapers> (Dutch only)

More information:

Wilbert Bannenberg MD, chair, Pharmaceutical Accountability Foundation, voorzitter at FarmaTerVerantwoording.nl <mailto:voorzitter at FarmaTerVerantwoording.nl>

Ellen 't Hoen, LLM PhD | Director
Medicines Law & Policy
www.medicineslawandpolicy.org <http://www.medicineslawandpolicy.org/>
e-mail: ellenthoen at medicineslawandpolicy.net <mailto:ellenthoen at medicineslawandpolicy.net>
Skype: efmthoen
My book: goo.gl/wcvAgh <https://goo.gl/wcvAgh>

More information about the Ip-health mailing list