Insights

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.

On November 13, 2025, the president of the French-speaking Brussels Enterprise Court ruled in the long-running battle between Sandoz and Regeneron about the correct interpretation of the EU’s Supplementary Protection Certificate (SPC) Manufacturing Waiver Regulation regarding exports to a non-EU market. The Brussels Court dismissed Regeneron’s claim that Sandoz had provided a defective notification and agreed with Sandoz’s interpretation of the Regulation.

As part of a comprehensive plan to ensure that EU Member States achieve “defense readiness” by 2030, the European Commission has proposed a package of measures to facilitate public and private investments in defense by simplifying legal frameworks relevant to defense. In a previous alert, we provided an overview of the Defense Readiness Omnibus and examined its implications for defense procurement. In this alert, we focus on its implications for the enforcement of competition law.

On October 16, 2025, the European Commission and the High Representative of the Union for Foreign Affairs and Security Policy presented their Defense Readiness Roadmap 2030 to the EU Member States. This comprehensive plan aims to strengthen European defense capabilities. It follows, and should be read together with, the Commission’s Defense Readiness Omnibus that was published in June 2025. The Omnibus contains a set of proposals to facilitate defense investments and boost EU Member States’ responsiveness to today’s security challenges.

In June 2025, the European Commission adopted its first-ever measures under the International Procurement Instrument Regulation (IPI), restricting access to the EU public procurement market for medical devices for economic operators and medical devices from the People’s Republic of China. This is the first application of the IPI, a new trade instrument aimed at tackling lack of reciprocity in access to public procurement in third countries.

The Court of Justice of the European Union (CJEU) recently issued a landmark judgment in the LEGO Group case (C-211/24) concerning the scope of EU design protection for modular systems. This recent judgment addresses fundamental questions regarding the protection and enforcement of Community designs for modular products, specifically the LEGO Group’s iconic toy building blocks and parts:

The UK’s increased defence spending and zero-tariff trade on aircraft parts with the US is generating broad interest in the UK defence sector.

Belgian labor law fixes the maximum margin by which labor costs may increase in any given period (the “wage norm”). The reason for this wage norm framework is to preserve the country’s competitiveness in the international market.

In recent years, there has been a wave of new legislation impacting contracts and contractual terms. The Belgian legislator is gradually adopting the different Books of the Belgian Civil Code, and the Belgian Code of Economic Law has been updated several times. These changes impact the drafting of contracts and contractual terms, not only between companies but also with consumers.

About one year ago, the European Court of Justice (CJEU) ruled in its landmark Illumina/Grail judgment that the European Commission could not accept merger referrals from national competition authorities under Article 22 of the EU Merger Regulation (EUMR) unless those authorities had jurisdiction to review the transaction themselves (see our previous alert).

In this ninth and final alert in our weekly series on the EU Pharma Package, we consider the proposals of the European Commission, European Parliament and the Council of the EU as regards the advertising of medicinal products and we conclude by suggesting various ways in which pharmaceutical companies can already prepare for the upcoming changes.

In this eighth alert in our weekly series on the EU Pharma Package, we continue our overview of initiatives with respect to security of supply and shortage prevention and mitigation. Our last alert looked at how the Pharma Package seeks to address these issues. However, the Pharma Package does not exist in isolation, and in this alert we will discuss the interplay between its measures and those contained in other important EU initiatives such as the proposed Critical Medicines Act (CMA), and the Medicinal Countermeasures Strategy and the EU Stockpiling Strategy.

In this seventh alert in our weekly series on the Pharma Package, we will discuss the increasing focus on shortages of medicinal products in the EU and the prevention and mitigation measures as proposed by the European Commission, the European Parliament and the Council of the EU.

In this sixth alert in our weekly series on the EU Pharma Package, we focus on the proposals of the European Commission, European Parliament and Council of the EU for another topic with a highly debated scope and with diverging interpretations across EU Member States: the “Bolar” exemption.

The Belgian federal government has taken two decisive steps in the implementation of its reform agenda. First, the adoption of the so-called Summer Agreement on July 21 outlines an ambitious fiscal and social overhaul. Second, the long-awaited Program Act was approved during the night of July 17 to July 18 and introduces a historic limitation on unemployment benefits. Together, these measures significantly redefine the Belgian labor market ecosystem.