Covington & Burling LLP (LexBlog Italy)

On 1st August 2022, the Italian Competition Authority (“AGCM”) published its decision where it ruled that the NutriScore labelling must be discontinued in Italy because it deceives consumers.  The authority further held that products meant for the French market, where the NutriScore is allowed, and which are distributed also on the Italian market may keep...

On 9 December 2021, Advocate General (“AG”) Rantos delivered his Opinion in Servizio Elettrico Nazionale (Case C‑377/20), a request for a preliminary ruling from the Italian Consiglio di Stato. The case concerns the conduct of the ENEL Group (“ENEL”) in the context of the liberalisation of the electricity market in Italy. ENEL, the incumbent, allegedly...

On 9 December 2021, Advocate General (“AG”) Rantos delivered his Opinion in Servizio Elettrico Nazionale (Case C‑377/20), a request for a preliminary ruling from the Italian Consiglio di Stato. The case concerns the conduct of the ENEL Group (“ENEL”) in the context of the liberalisation of the electricity market in Italy. ENEL, the incumbent, allegedly...

The Italian Legislative Decree 196/2021 (“Italian Decree”) implementing the Single-Use Plastic Directive (“SUPD”) will enter into force on January 14, 2022.  The Italian Decree diverges from the SUPD on significant aspects: it provides a more flexible definition of plastic; delays the entry into force of the ban on prohibited SUPs; and exempts from such ban...

The Italian Legislative Decree 196/2021 (“Italian Decree”) implementing the Single-Use Plastic Directive (“SUPD”) will enter into force on January 14, 2022.  The Italian Decree diverges from the SUPD on significant aspects: it provides a more flexible definition of plastic; delays the entry into force of the ban on prohibited SUPs; and exempts from such ban...

The Italian Legislative Decree 196/2021 (“Italian Decree”) implementing the Single-Use Plastic Directive (“SUPD”) will enter into force on January 14, 2022. The Italian Decree diverges from the SUPD on significant aspects: it provides a more flexible definition of plastic; delays the entry into force of the ban on prohibited SUPs; and exempts from such ban...

On March 12, 2020, the Italian Medicines Agency (“AIFA”) has provided guidance on the management of clinical trials due to the COVID-19 emergency.  The Guidance, which is addressed to CROs, Sponsors and non-profit organizations involved in clinical trials, allows for some derogations to support them face the criticalities.  The Guidance is intended to ensure that...

On March 2, 2020, the Italian Supervisory Authority (“Garante”) published a “statement” in which it clarifies how companies should process personal data in the context of their efforts for preventing a spread of the coronavirus disease (“COVID-19”) among their employees and others in Italy (see here, in Italian). The Garante made clear that companies must...

On September 5, 2018, a first instance Administrative Court in Italy decided that a public company cannot reject an application for the position of data protection officer (“DPO”) on the basis that the applicant is not a certified ISO 27001 Auditor / Lead Auditor (decision available here). ISO 27001 is an international information security standard....

Recently, the Council of State (i.e., the Italian supreme administrative court and consultative body) adopted an important advisory opinion, which allows for improved access to investigational medicines by patients in Italy.  In particular, the Council of State found that patients may be enrolled in compassionate use programmes or supplied with a medicine listed in the...

On 28 November 2016, the Italian Chamber of Deputies approved the Draft Budgetary Law of 2017.  Among other things, the Draft Law introduces new rules on the substitutability of biologics and the procurement of biosimilars. In particular, Article 59(11) of the Draft Law provides that: two products enjoy a biosimilarity relationship only where this has...

The Italian Autorità Garante della Concorrenza e del Mercato (“AGCM”) has fined Aspen over €5 million for having abused its dominant position – in violation of Art. 102 of the Treaty on the Functioning of the European Union – by increasing prices of its anti-cancer drugs Alkeran (melphalan), Leukeran (chlorambucil), Purinethol (mercaptopurine) and Tioguanine (thioguanine)...

The Italian Autorità Garante della Concorrenza e del Mercato (“AGCM”) has fined Aspen over €5 million for having abused its dominant position – in violation of Art. 102 of the Treaty on the Functioning of the European Union – by increasing prices of its anti-cancer drugs Alkeran (melphalan), Leukeran (chlorambucil), Purinethol (mercaptopurine) and Tioguanine (thioguanine) by up...

Recently, the Italian Medicines Agency (AIFA) has published a new Concept Paper on Biosimilars.  The Concept Paper outlines the regulatory status of biosimilars in Italy as well as their importance for the Italian healthcare sector. The new Concept Paper constitutes a revision of AIFA’s Position Paper on Biosimilars of 13 May 2013.  Overall, the Concept...

The Italian Medicines Agency (AIFA) has announced that, as of 22 July 2015, it makes available on its website the Public Assessment Reports (PARs) of medicinal products authorised in Italy through the national procedure. For the medicines authorised from 2015 onwards, AIFA will publish the full PARs together with a summary understandable to a lay...

By Dan Cooper and Oliver Grazebrook On 20 June 2103, the Court of Rome in Italy ruled that the Wikimedia Foundation (the charitable organisation that operates Wikipedia) could not be liable for defamatory content posted by users on its site.  The court deemed that Wikimedia fell within the exemptions in the Italian transposition of Articles...

By Ezra Steinhardt and Fredericka Argent InfoCuria has released information about a case recently referred to the Court of Justice of the European Union (CJEU) from Tribunale di Milano in Italy.  While the Court has yet to provide detailed underlying factual information, the case appears to raise issues that will be important to companies that...