On 31 May 2022, the Italian Competition Authority (Autorita’ Garante della Concorrenza e del Mercato, AGCM) imposed a fine of EUR 3.5 million on the pharmaceutical company Leadiant for abusing its dominant position by charging excessive prices for chenodeoxycholic acid Leadiant (CDCA) (see, attached press release (in English) and decision (in Italian)). CDCA is an orphan medicine indicated for the treatment of patients afflicted with cerebrotendinous xanthomatosis, a rare metabolic disorder which can lead to early death (CTX). According to AGCM, Leadiant charged excessive prices for CDCA to the Italian National Health Service through a complex strategy, comprising a range of illegal steps. Notably, Leadiant allegedly delayed and obstructed the price negotiations for the product with the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA), for instance by delaying the supply of information requested by AIFA. In the AGCM’s view, such behaviour further weakened the negotiating power of AIFA, which was already weak in view of the life-saving nature of the medicine. Leadiant also artificially differentiated CDCA from Xenbilox®, a cheaper Leadiant medicine with the same active substance as CDCA which was used off-label to treat CTX, with a view to preventing AIFA from gathering information regarding Xenbilox® and achieving a higher price for CDCA. Leadiant considered the information regarding Xenbilox® to be irrelevant because it was not marketed in Italy and, regardless of its off-label use, was indicated for a different use (to dissolve cholesterol gallstones). Regarding the level of the prices, AGCM ascertained that the price was both excessive and unfair. Based on a comparison between the product’s price and cost, AGCM concluded that the former was highly disproportionate with the latter. AGCM also concluded that the higher price was unfair in view of (i) the nature of the medicine, which is based on a molecule which had been present on the market for a long time, (ii) the limited extent of the R&D activities conducted by Leadiant, and (iii) the absence of therapeutic added value compared to previous medicines (including Xenbilox®). It thus concluded that CDCA’s price was an abuse in breach of Article 102 TFEU. AGCM also found that the purchasing of the medicine at an excessive price caused direct economic harm to the Italian National Health Service which has limited financial resources. This was the case notwithstanding the low turnover relating to the product at stake. Furthermore, AGCM disregarded the fact that Leadiant had committed to reimburse the difference between the provisional price charged pending the price negotiations and the finally agreed price as this constitutes normal business conduct and does not prove the absence of intention to cause harm. For the purposes of calculating the fine, AGCM considered that the violation was very serious in view of the life-saving nature of the product. Accordingly, the basic amount of the fine was set at 20-25% of Leadiant’s turnover for CDCA in 2021 (the regulatory ceiling being 30%) and was further increased by an additional 20-25% for the so-called ‘entry fee’ (i.e., the value added to the basic amount of the fine to ensure its effective deterrence in case of the most serious offences). AGCM’s fining decision marks the end of its investigation which started in 2019 (see, Van Bael & Bellis Life Sciences Insights and News Alert of 16 October 2019) and which was later extended in view of the complexity of the case (see, Van Bael & Bellis Life Sciences Insights and News Alert of 3 November 2020). Similar conduct by Leadiant is currently being investigated in other Member States, including Belgium (see, Van Bael & Bellis Life Sciences Insights and News Alert of 9 April 2019) and Spain (see, Van Bael & Bellis Life Sciences Insights and News Alert of 22 December 2020). The Dutch competition authority has already issued an excessive pricing decision against Leadiant and imposed a fine of almost EUR 20 million (see, Van Bael & Bellis Life Sciences Insights and News Alert of 20 July 2021), although this decision remains subject to an administrative appeal.