Insights

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.

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.

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 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.

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

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.

On June 4, 2025, after nearly two years of intense debate and negotiation between the 27 EU Member States, the Council of the European Union adopted its position on the proposed overhaul of the EU general pharmaceutical legislative framework known as the new Pharma Package.

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 our new Belgian Civil Code, such as Book VI. Last February, a new proposal for Book VII on special contracts, including sale and loan agreements was submitted. Additionally, the Belgian Code of Economic Law has been updated several times, impacting the drafting of contracts and of contractual terms, not only between companies but also with consumers.

Under its new leadership, the Belgian Competition Authority (BCA) has stepped up its enforcement activities and launched a number of initiatives and investigations that put it at the forefront of competition law developments in the European Union.

On 8 May 2025, the European Commission published new lists of products potentially subject to EU rebalancing measures in retaliation to U.S. tariffs. The proposed measures would apply if EU-U.S. trade negotiations fail. They are designed to stand alongside previously adopted EU countermeasures, which are currently suspended until 14 July 2025.

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 our new Belgian Civil Code. Last February, a new proposal for Book VII on special contracts, including sale and loan agreements was submitted. Additionally, the Belgian Code of Economic Law has been updated several times, impacting the drafting of contracts and of contractual terms, not only between companies but also with consumers.

On March 5, 2025, the European Commission presented a comprehensive Action Plan to boost the global competitiveness of the European Union’s automotive industry and support its transition to zero-emission, connected, and automated vehicles.

On February 27, 2025, the Court of Justice of the European Union (“CJEU”) issued a ruling about the requirements on data controllers to respond to data access requests regarding an automated decision-making system. In particular, the CJEU interpreted the meaning (under Article 15(1)(h) GDPR) of the phrase “meaningful information about the logic involved” in automated decision-making. Importantly, the ruling also separately addressed how to balance data access rights with the protection of the controller’s trade secrets, when the protection of trade secrets is invoked under Article 15(4) as a reason not to disclose a copy of personal data in an access request.

On 26 February 2025, the Commission proposed a sustainability simplifications package, commonly referred to as the Omnibus package. Among the sustainability reporting and due diligence provisions, the Omnibus package would also bring about changes to the EU’s unilateral environmental measure, the carbon border adjustment mechanism (CBAM). CBAM entered into application in its transitional phase in October 2023 and is now halfway towards its definitive implementation. The proposed deregulation brings about improvements in several CBAM areas, including scope, and reporting and procedural requirements. In this alert, we outline those suggested amendments that are likely to be of most importance to businesses involved in trading in CBAM goods.

After months of negotiations, Belgium’s new federal government has reached an agreement introducing significant changes to labor law, employment flexibility, and social security. These reforms aim to boost employment rates, simplify regulations, and reduce labor costs for employers.  

On October 4, 2024, the Court of Justice of the EU (CJEU) ruled in the Diarra case that the transfer rules of the Fédération Internationale Football Association (FIFA) regarding the termination of player contracts without just cause were incompatible with EU internal market and competition laws. Following this landmark ruling, FIFA published temporary changes to its transfer rules on December 23, 2024. This judgment could have a significant impact on the economic model for football in Europe, and on the balance of power both between clubs, and between clubs and their players.

Since Donald Trump’s election to a second term as President of the United States, the possibility of U.S. trade measures against the European Union became more tangible. The new administration is reportedly considering imposing sanctions on certain EU Member States and imposing additional tariffs on EU exports to the U.S.

Collective Bargaining Agreement (CBA) 32bis applies in Belgium in the event of a transfer of undertakings. It establishes the legal framework that protects employees’ rights during such a transfer.