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In Europe, the regulation of pricing and reimbursement for medicinal products is primarily governed by national policies, as EU-level regulation is limited. Our latest brochure “Market Access in Europe: Navigating Pricing &...more
Celltrion’s ustekinumab biosimilar, STEQEYMA®, has won its first bid within 2 months of its launch in January of 2025. Since launch, STEQEYMA® has secured contracts in four regions of Italy, including, Piemonte, Valle...more
Despite the summer doldrums, cartel enforcers around the world had several notable enforcement actions and, perhaps more importantly, signaled a busy fall and winter. In the United States, the Department of Justice’s...more
On June 28, 2024, the United States Patent and Trademark Office (“USPTO”) requested the public’s views on the current state of the common law experimental use exception to patent infringement and whether legislative action...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
On 31 May 2022, the Italian Competition Authority (ICA) published its decision sanctioning the pharmaceutical company Leadiant EUR3.5 million for charging excessive prices for the sale of an orphan drug....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
Due to the COVID-19 emergency and the consequent lockdown that is affecting non-essential services in Italy, including some health care services, on March 12, 2020 the Italian Medicines Agency ("AIFA") issued a Guidance,...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
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
A paper published in the Generics and Biosimilars Initiative Journal reports on “an overview of the available real-world data about the pattern of use and the comparative effectiveness of biosimilars and originator biological...more
The possibility for the patent owner to prevent the reimbursement of medicinal products before expiry of patent protection is still an open issue. While the law covers prohibition of reimbursement for medicinal generic...more
On December 14th, 2017, the Italian Senate passed a long-awaited bill (DDL no 2801) governing the informed consent to medical treatments, which also allows individuals to express their wishes on medical treatments in the...more
Fast track for orphan diseases and rare forms of cancers - By Ministerial Decree of 7 September 2017 (DM 7 September 2017), published in the Italian Official Journal on 2nd November2017, the Ministry of Health enacted new...more
A recent decision by the Italian Council of State (CS) comes as welcome news for the innovative pharmaceutical industry as it sets important boundaries to the initiatives that regional authorities can take in the attempt to...more
The Court of Milan held in a Judgment recently handed down in the proceedings brought by Bayer S.p.a. against the generic manufacturer DOC Generici S.r.l. that online publication of over-the-counter (OTC) medicinal products...more
By Law passed today, August 2nd, 2017 (Law for the improvement of the competition on the market), further to a recommendation of the Italian Competition Authority (“ICA“), the Italian legislature enacted provisions for the...more
The Board of Appeal of the Italian Patent Office (Commissione dei Ricorsi), by decision published on June 26, 2017, acknowledged the right of the patent holder to ask the Italian Patent Office for the limitation of the...more
By order issued on June 18, 2017, in summary proceedings brought by Teva against Mylan and Synthon for the alleged infringement of EP 2 361 924 (covering a manufacturing process for the active ingredient glatiramer acetate),...more
In the European Union, Big Pharma has been operating with a target on its back for the best part of the last decade. Following its 2008 sector inquiry into the pharmaceutical sector, the Commission vowed to clamp down on...more
A Dutch court has backed the local Akzo Nobel in a bid by Elliot Mgmt to remove Akzo’s chairman after ignoring multiple overtures from PPG for the pain and chemicals giant. Elliot had hoped to force a special shareholder...more
The EU Medicines Agency (EMA), the most sought after EU regulator, is looking for a new home. 900 jobs will move from London to an EU Member State when Brexit is complete. In a series of blog posts, our European life science...more
Transfer of a MA, its subsequent revocation and compensation for damages - What happens if you purchase a marketing authorisation and that is then revoked for serious non-compliances with the Good Clinical Practice...more