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Background: The Payback Mechanism and Its Impact - Italy’s payback system for medical devices has been a source of significant upheaval in the sector, with both domestic and international companies closely monitoring...more
Expectations of MedTech companies on a possible repeal of the payback mechanism for medical devices have been disappointed by two recent rulings of the Italian Constitutional Court (no. 139/2024 and 140/2024), which confirmed...more
While waiting for a new governance to make the process of selecting and purchasing medical devices more efficient, thus incentivizing investment in innovative technologies, the activation of the payback mechanism may...more
From June 26th, 2022, the “Italian Sunshine Act” entered into force. This is a piece of legislation aimed at preventing corruption and fostering transparency in the health sector by imposing disclosure obligations on...more
Today’s global healthcare marketplace is marked by unprecedented transformation. The seismic shifts in healthcare delivery and drug development during COVID-19 have, in 2021, continued to demonstrate the power and capacity...more
The spread of COVID-19 is causing Europe to experience one of the greatest health crises in decades, the consequences of which are still unpredictable. Faced with this unprecedented situation, the governments of different...more
Italy was the first and among the hardest-hit countries in Europe by the COVID-19 pandemic. Emergency regulation for COVID-19 clinical trials and compassionate uses...more
The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more
By decision No. 10892 published on 7 May 2018, the Italian Supreme Court ruled on an appeal brought by the Ministry of Health against a decision of the appellate Court of Padua in a case concerning the administrative...more
The Situation: On January 31, 2018, the Italian Supreme Court ruled on the first Italian product-related class action promoted by a consumers' association. The Result: The Court upheld the consumer's class action claim...more
By a recent judgment published on 31 January 2018, the Italian Supreme Court brought to an end - after more than seven years from its beginning - the first product-related class action promoted in Italy....more
Welcome to March's edition of our EU & Competition Law Bulletin covering recent legal developments impacting upon you and your business: - ..United Kindgdom: Large pay for delay fine imposed by CMA. ..Germany and...more
Several press articles in recent weeks have anticipated the upcoming enactment of the Ministerial Decree which will eventually implement the Italian Patent Box regime. The Ministry of Economics and Finance announced on 29...more