No competitive procedures are needed to execute research agreements with public entities: The Italian administrative court of last instance overturns the TAR decision
The Italian administrative court of last instance (“Consiglio di Stato”) closed litigation undertaken by Technogenetics S.r.l. that challenged a research agreement entered into by DiaSorin S.p.A. and the Pavia Hospital (which is classified, under Italian law, as a scientific research and healthcare facility, or IRCCS) for the evaluation of certain molecular and serological tests to diagnose COVID-19 (the Consiglio di Stato’s judgement was published on December 17, 2020).
Regional Administrative Court of Tuscany: recent judgment on biosimilars
n November 26, 2019, the Regional Administrative Court of Tuscany (Tribunale Amministrativo Regionale – “T.A.R.”, “Court”) ruled on the request for the invalidation of the Regional Council of Tuscany Resolution No. 457/2019 (“Resolution”) concerning the procedures for the supply and use of biosimilars in Tuscany.
Under what circumstances may an incumbent associate with a competitor in a public tender? The ICA provides useful guidance in the field of plasma derivatives.
In January 2018, the Italian Competition Authority (AGCM, or “ICA”) launched an investigation for a possible breach of Article 101 TFEU against two international manufacturers of blood-based pharmaceuticals – Kedrion S.p.A (“Kedrion”) and Grifols Italia S.p.A (“Grifols”) – for participating as a joint venture in a public tender (issued by a contracting authority acting on behalf of a group Italian regions, “Intercent-ER”) to collect blood and plasma, to produce plasma derivatives and to deliver these to the Italian National Health System (NHS).
Italian administrative court judgments on biosimilars
In the past two months, the Italian administrative courts issued two judgments on biosimilars that substantially confirmed the previous case law on the relevant subjects.
The Consiglio di Stato rules Italian regions cannot introduce restrictions to the prescription of innovative drugs
The Italian administrative court of last instance (“Consiglio di Stato”), in its recent ruling no. 4546 of 29 September, 2017, stated that Italian regions cannot issue recommendations to limit the prescription of innovative drugs compared to those established by the Italian Agency for Medicines (the “AIFA”).