The Dutch competition authority, Autoriteit Consument & Markt (ACM), announced on Tuesday that it imposed a fine of EUR 19,569,500 on Leadiant which was found guilty of an abuse of dominant position by charging excessive prices for chenodeoxycholic acid Leadiant (“CDCA”), a medicine indicated for the treatment of patients afflicted with cerebrotendinous xanthomatosis, a rare metabolic disorder (“CTX”)(see, attached press release and summary of decision in Dutch and English versions). In December 2014, Leadiant secured orphan medicine status for CDCA after it had succeeded in demonstrating the significant benefit of CDCA over existing treatments of CTX. Over time, Leadiant had managed to obtain a list price for CDCA of EUR 14,000 for a pack of 100 capsules (or EUR 153,300 per patient per year), a price far higher than that of an old medicine with the same active substance indicated for the treatment of cholesterol gallstones (EUR 46 for a similar pack). ACM considered Leadiant’s price for CDCA to be excessive because it was, according to ACM, both “exorbitantly high and unfair”. ACM’s finding that the price for CDCA was exorbitantly high followed from an analysis of Leadiant’s costs, investments and revenues associated with the product as well as the risk that the product could fail. ACM reached the conclusion that the “CDCA project was characterised by low costs in comparison with the revenues, low risks, and a very high return”. ACM specified that it had considered the “reasonable” rate of return of 15%. ACM’s finding that the price for CDCA was also unfair came in spite of the orphan medicine designation of CDCA. According to ACM, Leadiant did not innovate and CDCA did not present any therapeutic added value over other CDCA-based medicines. Even on the safety and efficacy front, the contribution of CDCA had been minimal as the active substance had been prescribed and administered for decades. Leadiant maintained that it had always been open to price discussions, but for ACM there were no indications that Leadiant had ever been willing to entertain the possibility of a non-excessive price. According to ACM, Leadiant had failed to “negotiate effectively or seriously with health insurers and the ministry [of health, welfare and sport]”. Leadiant has come under competition scrutiny in several countries, including Belgium, Italy and Spain, but ACM was the first to fine it (see, Van Bael & Bellis Life Sciences News and Insights of 11 February 2019, 9 April 2019, 9 September 2019, 17 September 2019, 16 October 2019, 29 June 2020, 3 November 2020, and 22 December 2020). The decision against Leadiant also marks the first time ACM issued a fine to tackle excessive medicine pricing.