[Ip-health] Press Release: Foundation requests the Authority for Consumers and Markets to take action against medicines manufacturer

contact at farmaterverantwoording.nl contact at farmaterverantwoording.nl
Thu Sep 6 05:48:41 PDT 2018


Thursday 6 september 2018. 

AUTHORITY FOR CONSUMERS AND MARKETS [1] to take action against medicines
manufacturer Leadiant for abuse of its dominant market position. 

FOUNDATION [2] (official Dutch name: Stichting Farma ter Verantwoording)
will submit an enforcement request to the AUTHORITY FOR CONSUMERS AND
MARKETS [1] (ACM) asking it to take action against the medicines
manufacturer Leadiant Biosciences Inc. on account of the exorbitant
price the company is asking for the product chenodeoxycholic acid

Leadiant is currently charging EUR140 per capsule (in the Netherlands).
This is equivalent to EUR153.300 per treatment-year for each person
using the medicine to treat the rare metabolic illness cerebrotendinous
xanthomatosis (CTX). CDCA is inexpensive to produce and, from 1976 until
as recently as 2008, it was available on the market in The Netherlands
at the cost of  EUR 0,28 per capsule for the treatment of gallstones.
Since 1999 the medicine was prescribed _off label_  for the treatment of
 CTX at a cost of EUR308 per treatment-year.  In 2017 Leadiant was
granted exclusive rights to market the product in Europe for the
treatment of CTX after the European Medicines Agency (EMA) granted
approval to Leadiant's  CDCA and granted the medicine designated status
as an "orphan medicine". 

"By increasing the price by a factor of 500 for a medicine which has
required only limited research by Leadiant the company is abusing its
dominant position in the market" said Wilbert Bannenberg, Chairperson of
the Pharmaceutical Accountability Foundation [2]. "Our research shows
that Leadiant has done everything it can to ensure that less expensive
versions of the medicine produced by competitors have been taken off the
European market. In this way CTX patients have been made dependant on
the availability of the over-priced Leadiant product." 

In its request for action the Foundation states that Leadiant's actions
are in violation of Dutch competition law. The Foundation argues that
Leadiant has pursued the strategy of developing a market monopoly
position by buying up alternative CDCA products and cancelling existing
CDCA registrations.  By doing this Leadiant has created the opportunity
to increase enormously the price of the only effective medicine for the
treatment of CTX. As a result of the company's actions and subsequent
price-hike anyone purchasing the medicine will be exploited and the
Dutch health care system will lose significant amounts of money. The
Foundation asks the AMC to take measures and impose a fine on Leadiant
citing article 56 of the Competition Law or to take other measures to
control the actions of Leadiant. 

For more information 

Pharmaceutical Accountability Foundation 

Email: contact at farmaterverantwoording.nl 


[1] https://www.acm.nl/en

More information about the Ip-health mailing list