Belgium - Minister of Economic Affairs Uses Price Regulation Powers against Leadiant's CDCA

• 09/09/2019
• Articles

Minister of Economic Affairs Wouter Beke took action against pharmaceutical firm Leadiant and, making use of his price regulation powers, reduced the price of chenodeoxycholic acid Leadiant (“CDCA”), a medicine indicated for the treatment of patients afflicted with cerebrotendinous xanthomatosis, a rare metabolic disorder (“CTX”). CDCA was designated as an orphan medicine in December 2014, but its active substance is no longer patented and has been used for many years as an inexpensive treatment for cholesterol gallstones.
 
In a press release (see attached, only the Dutch version is available), the Minister says that he lowered the price of what would seem to be a presentation of 100 tablets of 250mg of CDCA Leadiant to EUR 3,653.25 ex factory, while Leadiant had sought a price of EUR 14,000 ex factory. The presentation at issue covers the treatment of CTX during approximately one month.
 
The Minister has also urged the Belgian Competition Authority (“BCA”) to review as a matter of priority the alleged abuse of a dominant position of which Leadiant might be guilty. The case before the BCA results from a complaint filed by consumer organisation Test-Aankoop/Test-Achats earlier this year (see, Van Bael & Bellis Life Sciences Newsflashes of 9 April 2019 and 11 February 2019). Additionally, the Minister called on the European Commission to review the rules governing orphan medicines. However, that call is superfluous as an assessment of these rules has already been under way for quite some time (see, Van Bael & Bellis Life Sciences Newsflash of 18 October 2018) and the outcome of this exercise is expected to be high on the agenda of the incoming European Commission.