20
Nov
Anti-counterfeit drugs: Italy must comply with EU Regulation 2016/161 by February 9, 2025
Measures to combat counterfeit drugs work to prevent such drugs from entering the European supply chain. Delegated Regulation (EU) 2016/161 introduces new rules to halt counterfeit drugs from entering the European market and includes digital tools. As of February 9, 2025, Italy will have to comply with the provisions of the regulation, so there is not much time left to get in line with the new measures.
1
Jul
Pfizer ordered to pay damages to the National Health System for abusing a dominant position in managing the Xalatan patent lifecycle
From 2012 to 2014, Pfizer Italia S.r.l., Pfizer Health A.B., and Pfizer Inc. and Ratiopharm Italia S.r.l. locked horns in litigation before the AGCM and the Italian administrative court.
19
Apr 22
Council of State revokes previous judgements in a medical oxygen cartel case due to omission of decisive facts and arguments in the reasoning
On February 15, 2022, Italy’s Consiglio di Stato revoked its previous rulings confirming fines levied on five companies by the Italian Competition Authority for participating in a medical oxygen cartel, as it found manifest omission of facts and reasoning in the judgements, and asked the ICA to produce a set of documents acquired during the proceedings so it can re-examine the case.
3
Feb 22
Italian Competition Authority confirms its approach to RPM in a recent investigation into a manufacturer of products sold in pharmacies (probiotics)
In May 2021, the Italian Competition Authority (AGCM or ICA) launched an investigation into restrictions on resale prices that a pharmaceutical company, SOFAR, was alleged to have imposed upon its distribution network for a probiotic product (Enterolactis Plus).
11
Jun 21
Italian Competition Authority investigates orphan drug manufacturer (Leadiant) for excessive pricing
In October 2019, the Italian Competition Authority launched an investigation into abuse of dominance pursuant to Article 102 TFEU against the Leadiant group in connection with the marketing in Italy of the “orphan” drug Chenodeoxycholic Acid Leadiant, used to treat an ultra-rare disease.
