The Italian Competition Authority opens an abuse of dominance investigation into orphan drugs pricing (Leadiant Biosciences / Farmaco per la cura della Xantomasi cerebrotendinea)

On 8 October 2019 the Italian Competition Authority (ICA) has opened an Article 102 TFEU investigation against several pharmaceutical companies belonging to the Leadiant group [1]. The ICA’s attention was drawn by the selling prices applied by the parties to an orphan drug because it feared that said prices were excessive and in breach of Article 102 TFEU. Legal background For a medicinal product to be designed as an orphan drug, it must fulfil the two cumulative requirements set out in Article 3(1) of Regulation (EC) No 141/2000: a) The drug is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than 5 in 10,000 persons in the EU when the application is made or a life-threatening, seriously debilitating

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  • Desogus Law Office (Cagliari)

Quotation

Michele Giannino, The Italian Competition Authority opens an abuse of dominance investigation into orphan drugs pricing (Leadiant Biosciences / Farmaco per la cura della Xantomasi cerebrotendinea), 8 October 2019, e-Competitions Bulletin February 2020, Art. N° 93069

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