21
Nov
New AIFA guidelines on simplification and decentralization of clinical trials
As mentioned in our other article, this article deals with the guidelines approved by the AIFA on the same day as those on observational studies. They were also published in the Italian Official Gazette on August 20, 2024. The guidelines concern simplification and decentralization of clinical trials of medicines.
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).
11
Jun
Medical research: Advance consultation with Data Protection Authority no longer required
Medical research is one of the sectors most affected by rapid technological development and the increasing use of artificial intelligence systems.
11
Jun
Artificial Intelligence in health care: Impact of the new draft law approved by the Italian Council of Ministers
The Italian Council of Ministers approved a draft law on principles governing artificial intelligence, designed to provide an initial national framework for artificial intelligence systems.
23
Apr
Italian Data Protection Authority publishes rules for platforms (websites or apps) connecting patients and healthcare professionals
The evolution of online platforms and apps that connect patients with healthcare professionals has made medical care more accessible, but it has also raised important issues concerning privacy and the protection of personal data.
