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In Antitrust / Competition

European Union: Consultation on revision of abuse of dominance guidelines at a critical juncture

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An important policy debate is underway on how EU competition law should apply to exclusionary conduct by dominant undertakings under Article 102 TFEU, against a backdrop of geopolitical tensions on antitrust enforcement, and an urgent need to simplify the regulatory environment and boost Europe’s competitiveness.
In August 2024, the Commission issued a set of draft guidelines for public consultation. These were broadly criticized as rowing back on the economics based approach enshrined in earlier guidance and case law, giving the Commission too much enforcement discretion and providing insufficient practical guidance to business.

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In Cybersecurity, Data and Tech

European Union: DORA update – Upcoming designations of critical third-party providers

by , and 4 Mins Read

The European Supervisory Authorities are preparing to designate critical third-party service providers under the Digital Operational Resilience Act (DORA). DORA, which came into force on 17 January 2025, enables the ESAs to designate key ICT providers to the EU financial services sector as critical, subjecting them to direct supervisory and oversight obligations. The ESAs have recently published a roadmap indicating their expected timeline for designations – with the final designations expected to be in place by the end of this year.

In ESG

European Union: Commission proposes Simplification Omnibus package and Clean Industrial Deal

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On 26 February 2025, the European Commission published multiple policy documents and legislative proposals, following through on its commitment to improve the EU’s competitiveness under the European Commission’s Competitiveness Compass published on 29 January 2025.

In Corporate Compliance

European Union: Implications of the US Executive Order on Artificial Intelligence for European Businesses

by , , , and 3 Mins Read

President Biden’s issuance of the Executive Order on Artificial Intelligence (AI) on 30 October 2023 marks a significant legislative stride in AI regulation. This directive, extending beyond the US, has profound implications for European businesses and the EU’s regulatory landscape on AI.

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In ESG

European Union: Provisional agreement reached on the Corporate Sustainability Due Diligence Directive

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On 14 December 2023, the Council of the EU and the European Parliament reached a compromise on the Corporate Sustainability Due Diligence Directive (CSDDD), paving the way for its formal adoption by both institutions and thus the CSDDD’s entry into force before year end. The CSDDD is intended to significantly reshape corporate due diligence obligations regarding human rights and environmental standards in the EU and beyond. With its imminent enactment, the EU Member States will have two years to enact national laws providing for respective corporate due diligence obligations, similar to that already provided for by the German Supply Chain Act in its current form.

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EU Reaches Agreement on Landmark AI Regulation

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After three days of extensive final debate the EU Parliament, Council and Commission finally announced provisional agreement on the EU AI Act, the bloc’s landmark legislation regulating development and use of AI in the European Union. It is one of the world’s first comprehensive attempts to regulate the use of AI.
The EU AI Act awaits formal adoption by both Parliament and Council before it will become EU law.

In ESG

European Union: Deforestation Regulation – New due diligence requirements to tackle deforestation and forest degradation

by , and 5 Mins Read

The new EU Deforestation Regulation (2023/1115/EU) will impose due diligence obligations from 30 December 2024 aimed at tackling deforestation and forest degradation. The Regulation will require companies dealing in in-scope products to undertake due diligence into the source of a wide range of commodities, including cattle, cocoa, coffee, palm-oil, rubber, soya and wood, to ensure that they have not been obtained as a result of deforestation.

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In Product Regulation & Liability

European Union: The distinction between medical device and medicinal product

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On 19 January 2023, the Court of Justice of the European Union specified that Art. 2(2) of Directive 2001/83/EC, pursuant to which, in case of doubt on the classification of a product as a medicine or a medical device, the provisions on medicinal products shall apply, covers both “medicinal products by function” (i.e., substances exerting pharmacological, immunological or metabolic action) and “medicinal products by presentation” (i.e., substances presented as having properties for treating or preventing disease).

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