Belgium - Consumer Rights Association Files Excessive Pricing Competition Complaint Against Leadiant Over Price for Treatment of Rare Disease
Consumer rights association “Test Aankoop”/ “Test-Achats” (“TA”) piled further pressure on pharmaceutical firm Leadiant when it announced on 5 April 2019 that it had submitted a complaint to the Belgian Competition Authority challenging Leadiant’s allegedly excessive prices for chenodeoxycholic acid Leadiant (“CDCA”) (see attached press release). CDCA is 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.
Unusually, CDCA is highly similar to a medicine with the same active substance which has been indicated for many years for the treatment of cholesterol gallstones. According to TA, back in 2005 this treatment of an adult patient cost EUR 427 per annum. By contrast, the treatment of CTX in reliance on CDCA carries a cost of EUR 153,300 per patient per year. TA maintains that this difference cannot be explained by Leadiant’s research and development activities, which it dismisses as insignificant, or other justifications.
The case is understood to be under review by the Dutch competition authority as well. Additionally, it has prompted Vytenis Andriukaitis, the Commissioner responsible for health and food safety, to promise closer scrutiny of the rules governing orphan medicines in the pending assessment of the regulatory framework (see, Van Bael & Bellis Life Sciences Newsflash of 11 February 2019).