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In Product Regulation & Liability

United Kingdom: MHRA publishes “roadmap” for AI and software as a medical device

by , and 3 Mins Read

The UK government has recently published its roadmap for regulating AI as a medical device (AIaMD) and software as a medical device (SaMD). This will form part of the basis of the upcoming UK Medical Device Regulation reforms in 2024. In light of the operational difficulties faced by the NHS, AIaMD and SaMD are attractive solutions to alleviate pressures on the UK health system. Yet these products are complex and require a high level of regulatory scrutiny to ensure effectiveness and protect the safety of patients.

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In Ukraine

Ukrainian Laws in Wartime

by and 2 Mins Read

We’re pleased to present the eighth edition of Ukrainian Laws in Wartime: Guide for International and Domestic Businesses, a brief overview of the key features of wartime legislation.
This issue contains updated responses to the most common questions raised and considered by international and Ukrainian businesses.

In

European Union: New EU rules on mandatory disclosure of cross-border tax arrangements by EU intermediaries

by and 7 Mins Read

On 25 May 2018, the Council of the European Union adopted a directive on the mandatory disclosure and exchange of cross-border tax arrangements. This is the sixth update of the Directive on Administrative Cooperation, therefore referred to as ‘DAC6’ and the disclosure regime is now live.
Under the new rules, intermediaries such as lawyers, tax advisors, and accountants that design, promote or implement certain ‘arrangements’, or that provide advice in relation to such arrangements, are required to report them to tax authorities.

In Antitrust / Competition

Multijurisdictional: The burden of proof in competition cases

by 3 Mins Read

Regulators and courts in common law jurisdictions around the world are being given significant and increasing powers to impose financial penalties without traditional criminal law safeguards. Competition law has been particularly susceptible to arguments that traditional safeguards should be discarded to aid regulators in securing convictions. In the first competition case to go to trial in Hong Kong, the Competition Tribunal held in 2019 that in competition proceedings seeking financial penalties, the authority had the burden to prove its case beyond reasonable doubt. This article considers the approach taken in other common law jurisdictions and scope to argue for increased safeguards and human rights protections for clients facing financial penalties.

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In Product Regulation & Liability

European Union: Telemedicine stays a national issue? European Council scraps key telemedicine provision in European Health Data Space

by and 2 Mins Read

In a draft compromise text obtained by Politico, the European Council has dropped a key provision seeking to harmonize telemedicine from the draft European Health Data Space. The (now-removed) Article 8 was aimed at encouraging the cross-border provision of telemedicine services across the EU. However, the reality is that there are vast national differences between Member States on telemedicine-related laws. It is going to require a far more concerted legislative effort to harmonize this area of law across the EU.

In AML & Financial Services Regulatory

Luxembourg: New procedure of administrative dissolution without liquidation

by and 4 Mins Read

The forthcoming visit to Luxembourg of the Financial Action Task Force, the global money laundering and terrorist financing watchdog, is certainly not unrelated to the recent adoption of the law creating a new procedure of out-of-court dissolution without liquidation for certain commercial companies. That law is the first part of the more ambitious reform aiming at preserving businesses and modernizing bankruptcy law, currently pending before the Luxembourg Parliament. Its objective is to remove, in a quick and cost-efficient way, dormant and empty shell companies without economic reality and in breach of applicable laws to prevent them from being used for criminal purposes.

In Product Regulation & Liability

Multijurisdictional: 2022 Chambers Advertising & Marketing Practice Guide

by , , , , , , , , and 1 Min Read

Baker McKenzie was invited to serve as the global editor of the Chambers Advertising & Marketing 2022 Practice Guide which features 8 high-profile jurisdictions and provides the latest legal information on the impact of the COVID-19 pandemic, advertising claims and clinical studies, comparative advertising, social/digital media, influencer campaigns, consumer promotions, sports betting/gambling, and cryptocurrency and non-fungible tokens.

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In Trade and Foreign Investment

United Kingdom: The TP/Customs Saga continues: new valuation guidance issued by UK Customs

by , , , and 2 Mins Read

Hot on the heels of the German Federal Fiscal Court’s publication of its final decision in the Hamamatsu case, UK Customs (HMRC) have today published updated guidance on the customs valuation of imports, replacing its previous guidance (Notice 252).
What jumps out at first glance is a seeming change in policy with regards to the valuation of goods sold between related parties, with HMRC advising “you will not usually be able to use Method 1 [Transaction Value] with a margin-based transfer pricing model.”

In Sanctions

European Union: The Combined Nomenclature has been updated by the European Commission and is applicable as of 1 January 2023

by and 2 Mins Read

On Monday 31 October 2022 the European Commission published the updated Combined Nomenclature (CN) for 2023. The declaration of goods upon import, export, or when subject to intra-Community trade statistics between EU Member States is based on the CN. This sets the customs duty rate that is applicable as well as determines how the products are handled for statistical purposes. Thus, the CN is an essential working instrument for industry and the customs departments of the EU Member States.

In ESG

Germany: New German Supply Chain Due Diligence Act — The early bird catches the worm

by and 6 Mins Read

After the introduction of the UK Modern Slavery Act, the French Duty of Vigilance Law, Germany also followed by adopting the Act on Corporate Due Diligence Obligations in Supply Chains (Lieferkettensorgfaltspflichtengesetz or “LkSG”). The LkSG lays down extensive obligations for companies with regard to their own business area, but also their direct and indirect suppliers. Many of the necessary measures require preparation. Therefore, companies should finalize their preparation in the coming weeks as the LkSG enters into force in 2023.

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