Covington & Burling LLP (LexBlog Italy)

19 results for Covington & Burling LLP (LexBlog Italy)

  • Italy Proposes New Artificial Intelligence Law

    On May 20, 2024, a proposal for a law on artificial intelligence (“AI”) was laid before the Italian Senate. The proposed law sets out (1) general principles for the development and use of AI systems and models; (2) sectorial provisions, particularly in the healthcare sector and for scientific research for healthcare; (3) rules on the national strategy...

  • Italy Proposes New Artificial Intelligence Law

    On May 20, 2024, a proposal for a law on artificial intelligence (“AI”) was laid before the Italian Senate. The proposed law sets out (1) general principles for the development and use of AI systems and models; (2) sectorial provisions, particularly in the healthcare sector and for scientific research for healthcare; (3) rules on the...

  • NutriScore Halted In Italy As Italian Competition Authority Deems It Misleading

    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...

  • Advocate General Rantos Provides Sound Guidance for Non-Pricing Abuse of Dominance Analysis (Case C-377/20)

    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...

  • Advocate General Rantos Provides Sound Guidance for Non-Pricing Abuse of Dominance Analysis (Case C-377/20)

    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...

  • Italy Transposes into National Law the EU Single-Use Plastic Products Directive

    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...

  • Italy Transposes Into National Law The EU Single-Use Plastic Products Directive

    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...

  • Italy Transposes into National Law the EU Single-Use Plastic Products Directive

    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 Medicines Agency publishes Guidance on the management of clinical trials in Italy during the COVID-19 emergency

    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...

  • Italian Supervisory Authority Publishes COVID-19 Guidance

    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...

  • Italian court decides that a data protection officer does not have to be a certified ISO 27001 Auditor

    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....

  • Italian Council of State Improves Access to Investigational Medicines

    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...

  • Upcoming Changes to Italy’s Biosimilar Landscape

    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...

  • Italy’s AGCM Fines Aspen EUR 5 Million for Excessive Pricing

    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)...

  • Italy’s AGCM Fines Aspen EUR 5 Million for Excessive Pricing

    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...

  • Italian Medicines Agency Publishes New Concept Paper on Biosimilars

    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...

  • Italian Medicines Agency Publishes Public Assessment Reports of Medicines Authorised Through the National Procedure

    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...

  • Italian Court Finds that Wikimedia is Not Liable for Defamatory Comments

    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...

  • Italian Court Refers Question to the CJEU Regarding Circumvention of Technological Copyright Protections

    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...

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