News & Analysis as of

Italy Pharmaceutical Industry

Hogan Lovells

Market Access in Europe: Navigating Pricing & Reimbursement Pathways

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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

Goodwin

Global Biosimilar Updates - Spring 2025

Goodwin on

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

Morrison & Foerster LLP

Quarterly Cartel Catch-Up: Summer Surge Foreshadows Enforcement Intrigue

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

Fish & Richardson

Should the Experimental Use Exception Be Broadened?

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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

Hogan Lovells

MedTech companies’ hopes betrayed: Italian Constitutional Court confirms medical device payback

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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

Hogan Lovells

Payback and Health Technology Assessment in Italy: a new governance for medical devices?

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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

A&O Shearman

Italy fines Leadiant EUR3.5 million for charging excessive prices for an orphan drug

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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

McDermott Will & Schulte

Investing in European Healthcare - What's on the Horizon for 2022? - Regulatory and Legal Changes

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

Hogan Lovells

Combating COVID-19: Government powers for safeguarding supply of critical products and potential conversion of production – Italy,...

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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

Hogan Lovells

AIFA provides guidance on critical aspects relating to the management of clinical trials in Italy during the COVID-19 emergency

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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

Hogan Lovells

The Italian Supreme Court rules on the liability of broadcasters for unlawful advertising of medical devices

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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

Hogan Lovells

The Italian Supreme Court upholds the first class action relating to medical devices

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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

Goodwin

GABI Publishes Data on Italian Biosimilar Landscape

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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

Hogan Lovells

Italy: Formulation patents may prevent reimbursement of generics… but, are you innovative enough?

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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

Hogan Lovells

Italy approves new provisions on informed consent and advance decision of medical treatments – Why it matters for clinical trials...

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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

Hogan Lovells

New rules for expanded access in Italy

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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&O Shearman

Italian Regions cannot recommend against use of costly medicines – says highest administrative court

A&O Shearman on

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

Hogan Lovells

Pharma advertising in Italy – Online publication of OTC medicinal products list, prices and reimbursability

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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

Hogan Lovells

Italy opens the door to corporate ownership of pharmacies – a revolution for the Italian Pharma distribution

Hogan Lovells on

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

Hogan Lovells

Italian time-machine : Limitation of the duration of an SPC may be decided by the Italian Patent Office

Hogan Lovells on

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

Hogan Lovells

Court of Milan rules on interim measure ordering the halt of the pricing and reimbursement procedure of a generic product

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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

Jones Day

European Commission Sets its Sights on Allegedly Excessive Drug Prices

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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

Robins Kaplan LLP

Your Daily Dose of Financial News

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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

Hogan Lovells

Relocation of the EU Medicines Agency: Italy

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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

Hogan Lovells

NEWSFLASH: What happens if you purchase a marketing authorisation then revoked for serious noncompliances with the Good Clinical...

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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

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