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.
11
Nov
Transparency in clinical trials: Revised transparency rules take effect
The revised transparency rules (“Revised Rules”) for the Clinical Trials Regulation (CTR) and its Clinical Trials Information System (CTIS), issued by the EMA in October 2023, took effect on June 28, 2024, with the launch of a new version of the dedicated portal.
18
Sep
The Italian Competition Authority launches an investigation into suspected pay-for-delay agreements between 8 pharma companies concerning a biosimilar drug (Biogen / Samsung / Genentech...)
On May 21, 2024, the Italian Competition Authority (the AGCM or ICA) opened new proceedings against eight pharmaceutical companies to investigate suspected pay-for-delay practices in breach of the prohibition on anti-competitive agreements (Article 101 TFEU).
17
Sep
The Italian Council of State upholds the Competition Authority’s €3.2M fine for abuse of dominance by negotiating an unjustifiably high reimbursement price for an “orphan” drug (Leadiant Biosciences)
With judgement No. 2967 of March 29, 2024, The Council of State [1] (Italy’s top administrative court) upheld a fine against the pharmaceutical group Leadiant (“Leadiant”) by the Italian Competition Authority (the AGCM or the “ICA”) for abuse of a dominant position pursuant to Article 102 of the Treaty on the Functioning of the European Union (TFEU).
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.
12
Jun
How Digital Procurement Platforms (PADs) change procurement
Among the main types of infrastructure needed to achieve full digitization of public procurement are Digital Procurement Platforms, or “PADs.”
On January 1, 2024, the provisions of the new Public Procurement Code on the digitization of tender procedures became fully effective.
