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In Product Regulation & Liability

EU: New developments in breeding products, animal health and traceability requirements

by 4 Mins Read

The new Delegated Regulation (EU) 2023/647 has amended the former Delegated Regulation (EU) 2020/686, which in turn complemented Regulation (EU) 2016/429, on the prevention and control of transmissible animal diseases, animal health requirements and traceability of animal reproductive products. The new Regulation complements the rules laid down in the original regulation as regards animal health issues of traceability and certification of movements of captive breeding products of terrestrial animals. Furthermore, the main objective of the regulation is to unify the different regulations applicable on this matter in order to improve their application and to avoid duplication or cross-references.

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In AML & Financial Services Regulatory

European Union: AIFMD II state of play – preparing for change

by 2 Mins Read

On 25 November 2021, the European Commission published its long-awaited proposals to amend the Alternative Investment Fund Managers Directive (AIFMD), along with changes proposed to the UCITS Directive and ELTIF Regulation (AIFMD II). The Commission’s proposals follow ESMA’s August 2020 letter of recommendations for changes that could be made to the AIFMD framework. Tripartite negotiations on AIFMD II are ongoing, following agreement by the Council of the EU on its general approach in June 2022, and adoption by the European Parliament’s Economic and Monetary Affairs Committee of its negotiating position in January 2023.

In Product Regulation & Liability

EU: A New Dawn for the Pharma Regulatory Regime?

by 5 Mins Read

On 26 April 2023, the European Commission finally published its Proposal to revise the EU Pharmaceutical legislation, the most momentous reform for over 20 years. This is an eagerly anticipated overhaul of the EU’s pharmaceutical system that has generated a lot of debate and concern since earlier leaked documents showed the far-reaching effect of the measures that were being considered and the impact these could have on the industry. The review is part of the EU’s Pharmaceutical Strategy for Europe, and its aim is to make medicines more available, accessible and affordable whilst at the same time supporting innovation and boosting the competitiveness of the EU pharmaceutical industry.

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In Employment

European Union: Equal Pay and the Pay Transparency Directive – more than just transparency – Baker McKenzie InsightPlus

by 9 Mins Read

The European Parliament has now formally adopted the Pay Transparency Directive having reached political agreement on its provisions with the Council of the EU at the end of 2022. Its provisions are likely to enter into force in most EU member states in 2026. The measures in the Directive are significant and touch on many aspects of the employment lifecycle.

In Product Regulation & Liability

UK vs EU Approach to Regulating AI: From One Extreme to Another?

by 5 Mins Read

In its white paper published last month, the UK Government set out its principles-based, adaptive approach to regulating AI. The UK approach stands in stark contrast to the more static and prescriptive approach of the EU AI Act. Instead of assigning responsibility for AI governance to a new single regulator, the UK Government is empowering existing regulators to come up with tailored approaches for specific sectors. The aim is to ensure that the UK remains a flexible and innovation-friendly jurisdiction for AI developers. The flipside is that the UK approach may leave gaps between regulators, by failing to take a more holistic approach along the lines of the EU.

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In Antitrust / Competition

European Union: Merger control below merger control thresholds

by 4 Mins Read

On 22 March 2023, the Belgian Competition Authority published a press release according to which it investigates whether Proximus had abused a dominant position by acquiring edpnet. Although the acquisition did not have to be notified, the BCA feels compelled, with reference to the European Court of Justice’s (ECJ) landmark Towercast judgment, to review the transaction under abuse of the aspect of dominance. The BCA is thus following up on recent considerations regarding more effective control of so-called “killer acquisitions”, i.e., the protection of competition against innovation-inhibiting mergers of large, strong companies with small, innovative competitors, which do not require merger control notification due to the low turnover of the target company.

In Trade and Foreign Investment

European Union: EU releases draft act to introduce binding valuation decisions

by , , and 1 Min Read

The European Commission previously announced plans to include binding valuation information decisions in its customs legislation. The Commission has published the draft Delegated Regulation and obtained feedback from a public consultation, which ended on 18 January 2023. The Commission describes this move as the completion of an already well-established legal and operational framework for issuing decisions relating to binding tariff classification information and binding origin information.

In Trade and Foreign Investment

European Union & Indonesia: EU increases actions against Indonesian imports

by and 3 Mins Read

The European Union actively uses anti-dumping and anti-subsidy (or countervailing duty) investigations to protect the EU industry. Imports from Indonesia are a prime target for these investigations. Since 2003, imports from Indonesia were targeted in 15 anti-dumping and anti-subsidy investigations, and four of these investigations were initiated in the last three years.

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