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Client Alerts 533 results

Client Alert | 7 min read | 05.21.26

A New Playbook for M&A in the EU: The European Commission's Draft Merger Guidelines - 10 Key Changes

On 30 April 2026, the European Commission published draft merger guidelines that will replace both the 2004 Horizontal Merger Guidelines and the 2008 Non-Horizontal Merger Guidelines, consolidating them into a single analytical framework.
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Client Alert | 6 min read | 05.12.26

EU Pharma Package: Advertising Compromise Proposal

In our ninth alert in this EU Pharma Package Series, we discussed the proposals of the Commission, Council, and Parliament with respect to advertising of medicinal products.
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Client Alert | 5 min read | 05.12.26

The International Claims Commission for Ukraine (ICCU): What Claimants Need to Know

The ICCU is poised to become one of the most significant international compensation mechanisms of this generation. Crowell & Moring has the experience to help with your claim.
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Client Alert | 4 min read | 05.11.26

New Temporary State Aid Framework Throws A Lifeline To Sectors Hit By The Middle East Crisis

On 29 April 2026, the European Commission adopted the Middle East Crisis Temporary State Aid Framework (METSAF), a temporary framework relaxing the conditions under which EU Member States can support companies in sectors particularly affected by fuel, fertilizer, and electricity price surges driven by the Middle East crisis.
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Client Alert | 7 min read | 05.06.26

Artificial Intelligence and Human Resources in the EU - Part 2: AI Literacy - Employer AI Literacy Obligations under the EU AI Act

The EU AI Act defines ‘AI literacy’ as the skills, knowledge and understanding to enable the informed use and operation of AI systems and increase awareness of the opportunities, risks and possible harm that AI systems may present — with the ultimate purpose being to ensure that staff (and other relevant individuals) are able to take informed decisions in relation to AI, such as how to interpret AI output and decision-making processes and their impact on natural persons.
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Client Alert | 13 min read | 05.06.26

EU Pharma Package: Interplay with the Critical Medicines Act – Status Update

In our eighth alert in this EU Pharma Package Series, we took a “detour” to discuss the interplay between the measures proposed in the Pharma Package and those contained in other important EU initiatives such as the proposed Critical Medicines Act (CMA), and the Medicinal Countermeasures and EU Stockpiling Strategies.
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Client Alert | 4 min read | 05.04.26

Decentralized Clinical Trials: Key Sponsor Considerations Under FDA and EMA Guidance

The FDA and the European Medicines Agency (EMA) (jointly with the European Commission and Heads of Medicines Agencies) each have issued or updated their respective guidance addressing decentralized clinical trials (DCT), i.e., clinical trials that include trial-related activities conducted at locations other than the traditional investigative site.
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Client Alert | 8 min read | 04.27.26

Deadlock Broken: EU Adopts 20th Russia Sanctions Package

The EU has adopted its 20th package of sanctions in connection with Russia's ongoing war against Ukraine, resolving a prolonged internal political deadlock that had been caused by vetoes from Hungary and Slovakia. The package amends Regulations 833/2014, 269/2014, and 765/2006 and the respective Council Decisions and Implementing Regulations. The texts entered into force on 24 April 2026. They are available through this link.
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Client Alert | 11 min read | 04.27.26

The New EU "Pharma Package": Access Conditionalities and Shortage Measures Compromise Proposal

In our seventh alert in this EU Pharma Package Series, we provided an analysis of the increasing focus on shortages of medicinal products in the EU and the prevention and mitigation measures as proposed by the EU institutions.
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Client Alert | 10 min read | 04.22.26

The EU Industrial Accelerator Act Proposal’s Significance for the Automotive Industry

On March 4, 2026, the European Commission proposed the Industrial Accelerator Act (IAA), a draft regulation that aims to reverse the decline of the EU’s manufacturing sector while supporting the adoption of cleaner technologies. This client alert is the third in a three-part series dedicated to the IAA. In our first alert, we provided an overview of the draft regulation. In a second alert, we took a closer look at the new foreign direct investment (FDI) review framework that the IAA would establish for certain strategic sectors. In this third and final instalment of the series, we focus on the implications of the proposal for the automotive industry.
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Client Alert | 7 min read | 04.20.26

The New EU Pharma Package: The “Bolar” Exemption Compromise Proposal

In our sixth alert in this EU Pharma Package Series, we provided an analysis of the history and interpretation issues for another highly debated topic: the “Bolar” exemption.
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Client Alert | 5 min read | 04.13.26

The New EU "Pharma Package": Global (Orphan) Marketing Authorization Compromise Proposal

In our fifth alert in this EU Pharma Package Series, we provided an analysis of the background and ongoing legal debates regarding the concept of the global marketing authorization (GMA). We discussed in particular the missed opportunities in the Pharma Package to further codify and clarify the GMA, in view of its central role in determining the regulatory data protection (RDP) rights of a medicinal product.
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Client Alert | 3 min read | 04.07.26

The New EU "Pharma Package": Fiscal Imports in the Supply Chain Compromise Proposal

In our fourth alert in this EU Pharma Package Series, we provided an analysis of the long-standing but increasingly debated issue of fiscal imports in the pharmaceutical supply chain and the EU’s evolving approach to this issue.
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Client Alert | 7 min read | 04.01.26

Proposed EU Industrial Accelerator Act Would Introduce New Conditions for Foreign Direct Investments in Strategic Sectors

On March 4, 2026, the European Commission proposed the Industrial Accelerator Act (IAA), a draft regulation that aims to reverse the decline of the EU’s manufacturing sector while supporting the adoption of cleaner technologies. This client alert is the second in a three-part series dedicated to the IAA. In our first alert we provided an overview of the draft regulation. In this second alert, we take a closer look at the new foreign direct investment (FDI) review framework that the IAA would establish for certain strategic sectors.
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Client Alert | 5 min read | 03.30.26

The New EU "Pharma Package": The Transferable Exclusivity Voucher Compromise Proposal

In our third alert in this EU Pharma Package Series, we provided a detailed overview of the diverging positions of the European Commission, the European Parliament , and the Council of the European Union on the transferable exclusivity voucher (TEV) for priority antimicrobials.
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Client Alert | 5 min read | 03.22.26

The New EU "Pharma Package": Regulatory Data Protection Compromise Proposal

In our second alert in this EU Pharma Package Series, we provided a detailed overview of the diverging positions of the European Commission (Commission), the European Parliament (Parliament), and the Council of the European Union (Council) on one of the most debated and anxiously anticipated topics, the regulatory data protection (RDP). While all EU institutions proposed a modulation system, they differed significantly in terms of the baseline period and the structure of the possible extensions.
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Client Alert | 9 min read | 03.18.26

The Belgian Competition Authority's 2026 Priorities: What In-House Counsel Need to Know

The BCA 2026 Priorities Paper sets out the sectors in which the authority will exercise particular vigilance, and outlines its strategic policy priorities for the year, including the development and deployment of its enforcement instruments. For in-house counsel, the document is an important roadmap: it signals where investigations are most likely to originate, what new tools the BCA is acquiring, and which compliance initiatives deserve immediate attention. The most prominent change in the 2026 paper is the replacement of the construction sector, considered a priority sector in 2025, with sport, media and entertainment.
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Client Alert | 9 min read | 03.16.26

Proposed EU Industrial Accelerator Act Aims to Shore Up Declining EU Manufacturing Sector

On March 4, 2026, the European Commission proposed the Industrial Accelerator Act (IAA), a draft regulation that aims to reverse the decline of the EU’s manufacturing sector while supporting the adoption of cleaner technologies. The proposal introduces “Made in EU” and low-carbon requirements in public procurement and public support schemes, to create lead markets for European industrial products. The proposal also seeks to increase value creation in the EU and bolster the EU’s economic security by setting conditions for major foreign direct investments (FDI) in strategic sectors.
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Client Alert | 2 min read | 03.12.26

The New EU "Pharma Package": Formal Adoption in Sight

The EU Pharma Package represents the most significant reform of EU pharmaceutical legislation in over two decades, setting the stage for a new era in medicine regulation. Introduced by the European Commission back in April 2023, the proposals are designed to promote innovation, strengthen medicine availability and affordability, reduce regulatory burdens, ensure a fair and competitive European pharmaceutical market, and modernize the EU's pharmaceutical framework. The EU Pharma Package will replace the more than twenty-year-old Directive 2001/83/EC and Regulation 726/2004, and incorporates the separate regulations on orphan and pediatric medicines, thereby bringing the entire regulatory framework up to date.
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Client Alert | 4 min read | 03.11.26

CJEU Sets the Bar Low for Evidence Disclosure in Competition Damages Litigation

The Court of Justice of the European Union (CJEU) has delivered a significant ruling that clarifies the rules governing evidence disclosure in competition damages litigation. The judgment addresses three critical questions: (1) whether pre-action disclosure falls within the scope of the EU Damages Directive, (2) what evidence is needed to establish that there is a plausible damages claim, and that therefore a disclosure request should be granted, and (3) how the plausibility threshold should be assessed.
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