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Spanish Competition Authority Latest To Impose Fine for Excessive Pricing on Leadiant

  • 15/11/2022
  • News

On 14/11/2022, the Spanish Competition Authority (CNMC) imposed a fine of EUR 10.25 million on Leadiant because that firm was found to have abused its dominant position by applying excessive prices for chenodeoxycholic acid, an orphan medicine indicated for the treatment of patients afflicted with cerebrotendinous xanthomatosis, a rare metabolic disorder (CDCA) (see, attached press release).  In June of this year the CNMC had dismissed a challenge by Leadiant against its authority to continue the competition proceedings (seeVan Bael & Bellis Life Sciences Insights and News Alert of 27 June 2022).
As the CNMC’s press release shows in graphic detail, Leadiant increased the price of its medicine, branded CDCA-Leadiant®, 14-fold over time.  According to the CNMC, the price charged by Leadiant shows no relationship with both the risks and the costs which Leadiant bore for developing and commercialising its medicine. Additionally, the CNMC took the view that the price at issue was unfair given the medicine’s economic value.
The CNMC specified that CDCA-Leadiant® does not present a substantial added value over previous comparable medicines. In addition, the CNMC pointed out that chenodeoxycholic acid has been used for the treatment of cerebrotendinous xanthomatosis since the mid-1970s which means that the efficacy and safety of CDCA find extensive support in established clinical practice and scientific literature. The CNMC thus reached the conclusion that Leadiant had managed to secure the specific indication for CDCA-Leadiant® based on comparable products with very little in the way of R&D and clinical research.

Leadiant’s pricing practices have already been fined in the Netherlands (see, Van Bael & Bellis Life Sciences Insights and News Alert of 20 July 2021) and Italy (seeVan Bael & Bellis Life Sciences Insights and News Alert of 1 June 2022), whilst they are being investigated in other Member States including Belgium (seeVan Bael & Bellis Life Sciences Insights and News Alert of 9 September 2019)


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