Insights

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.

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.

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.

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.

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.

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.

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.

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.

On 26 February 2026, the EU published Directive (EU) 2026/470 (the Omnibus I Directive). Adopted as part of the European Commission's (Commission) simplification agenda and after a year of debates and negotiations between the Commission, the Council, and the European Parliament, this text effectuates far-reaching changes to both the Corporate Sustainability Reporting Directive (CSRD) and the Corporate Sustainability Due Diligence Directive (CS3D).

The year 2026 marks a major regulatory turning point for European companies using or considering the use of artificial intelligence in their human resources (HR) processes. The Regulation (EU) 2024/1689 on artificial intelligence (the AI Act) is entering a critical implementation phase, while the European Commission's "Digital Omnibus" package will clarify several obligations and modify certain deadlines.

The Court of Justice of the European Union (CJEU) recently delivered its judgment in the CeramTec case (C-17/24).

On 9 January 2026, the European Commission published its Guidelines on the application of Regulation (EU) 2022/2560, also known as the Foreign Subsidies Regulation (FSR).

On February 3, 2026, the Belgian government submitted a draft law containing various labor-related provisions. The draft legislation aims to modernize Belgian labor law and includes significant changes to work regulations, minimum working time for part-time employees, night work restrictions, and notice period rules.

On 30 December 2025, the Belgian Official Gazette published the Act of 19 December 2025 implementing a strengthened return-to-work policy in case of work incapacity, and the Royal Decree of 17 December 2025 amending the Code of Well-being at Work, commonly referred to as "Reintegration Trajectory 3.0".

On December 16, 2025, the European Commission published its proposal for a regulation establishing a European Biotech Act to strengthen the EU's biotechnology and biomanufacturing sectors with a primary focus on health.

The European Commission has proposed targeted amendments to the Medical Devices Regulation 2017/745 (MDR) and the In-Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR). The amendments are intended to simplify the rules, reduce the administrative burden, and enhance the predictability and cost-efficiency of notified body certification, while maintaining high public health and patient safety standards.

On 27 November 2025, the European Commission adopted the EU Bioeconomy Strategy 2025 (the Strategy), confirming the bioeconomy as a central pillar of Europe’s industrial, sustainability, and competitiveness agenda. The bioeconomy covers activities that deliver sustainable solutions based on biological resources, including biomass, residues, byproducts, and biogenic carbon, across sectors such as agriculture, forestry, fisheries, biomanufacturing, food, health, energy, materials, and construction.

On December 11, 2025, the Council of the European Union and the European Parliament reached provisional agreement on the long-awaited “Pharma Package,” (see the announcement here). The Pharma Package is a comprehensive and major overhaul of the EU legislative framework for pharmaceuticals, which replaces the more than 20-year-old Directive 2001/83 and Regulation 726/2004 and incorporates (and updates) the separate regulations on orphan and pediatric medicines (Regulations 141/2000 and 1901/2006 respectively).

On November 12, 2025, Judge King in the U.S. District Court for the Western District of Washington granted in part Haldiram India Ltd.’s (“Plaintiff” or “Haldiram”) motion for a preliminary injunction against Punjab Trading, Inc. (“Defendant” or “Punjab Trading”), a seller alleged to be importing and distributing gray market snack food products not authorized for sale in the United States. The court found that Haldiram was likely to succeed on the merits of its trademark infringement claim because the products at issue, which were intended for sale in India, were materially different from the versions intended for sale in the U.S., and for this reason were not genuine products when sold in the U.S. Although the court narrowed certain overbroad provisions in the requested order, it ultimately enjoined Punjab Trading from importing, selling, or assisting others in selling the non-genuine Haldiram products in the U.S. market.

Major changes have been proposed to EU AI, data and wider digital laws. On 19th November 2025, the European Union Commission issued its much anticipated Digital Omnibus Regulation Proposal, (the “Digital Omnibus”) and also its Digital Omnibus on AI Regulation Proposal, (the “AI Omnibus”). The mooted changes potentially impact the “Brussels effect” seen post GDPR and add potential complexities to the compliance efforts of businesses.