Insights

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. 

Following the February announcement of the Omnibus package, the European Commission, Council, and Parliament have made several decisions indicating ways in which EU ESG laws are likely to be streamlined. This alert provides a high-level summary of the most significant proposed changes to existing and draft ESG legislation.

In this fifth alert in our weekly series on the EU Pharma Package, we will delve into the global marketing authorization (GMA) concept which has largely remained untouched in the legislative proposal – aside from an important introduction of the notion of a GMA for orphan medicinal products. We will discuss the missed opportunity to codify existing case law and provide further clarification in this respect.

On July 24, the European Commission announced the imposition of new EU countermeasures in response to U.S. tariffs further to an agreement reached among EU Member States. These measures are adopted through Commission Implementing Regulation (EU) 2025/1564 and take the form of additional customs duties on U.S. products as well as export restrictions for certain EU products. In total, these measures concern about EUR 93 billion ($109 billion) worth of customs duties, the highest volume of bilateral trade caught by the EU so far. The EU countermeasures are set to enter into force as of August 7.

In our first alert in this weekly series on the EU Pharma Package, we provided some important background and general information about the status of the Pharma Package and how the trilogues work. In the second alert, we discussed the proposed changes to regulatory data protection. Our third alert delved into the different proposals of the European Commission, Parliament, and the Council regarding the transferable exclusivity voucher (TEV) for priority antimicrobials.

On 11 July 2025, the European Commission published the final version of its Code of Practice for General-Purpose Artificial Intelligence (GPAI). This Code is meant to serve as a tool for GPAI model providers, helping them to comply with the transparency, copyright and security provisions governing general-purpose AI models as set out in the AI Act (arts. 53 and 55), which will become applicable on 2 August 2025. Adherence to the Code is on a voluntary basis.

Since taking office earlier this year, the Trump administration has reignited tariff disputes between the European Union and the United States. The US has reimposed US Section 232 measures on steel and aluminum, extended the scope of these measures, and, on April 2nd, imposed IEEPA tariffs on EU products under the International Emergency Economic Powers Act. These IEEPA tariffs were then reduced to 10% until July 9th.

In our first alert in this weekly series on the EU Pharma Package we provided some important background and general information about the status of the Pharma Package and how the trilogues work, and in the second alert we discussed the proposed changes to regulatory data protection.

On June 25, 2025, the European Commission adopted a new framework that simplifies EU State aid rules to make it easier for Member States to support the development of clean energy, industrial decarbonization and clean technology. This Clean Industrial Deal State Aid Framework (CISAF) will be in place until December 31, 2030 and replaces the Temporary Crisis and Transition Framework (TCTF), which was introduced in March 2023 to address the economic impact of the war in Ukraine and reduce the EU’s dependence on imported fossil fuels.

On July 9, 2025, the Directorate-General for Competition within the European Commission issued two informal guidance letters, both intended to bring increased clarity on competition law compliance to companies in the transport sector.

In our first alert in our new weekly series on the EU Pharma Package, we provided some important background and general information about the status of the Pharma Package and how the trilogues work. In this second alert, we will discuss the respective positions of the European Commission, the European Parliament and the Council of the European Union with respect to one of the most debated and anxiously anticipated topics on the table, the regulatory data protection (RDP).

Last week, artificial intelligence companies won two significant copyright infringement lawsuits brought by copyright holders, marking an important milestone in the development of the law around AI. These decisions – Bartz v. Anthropic and Kadrey v. Meta (decided on June 23 and 25, 2025, respectively), along with a February 2025 decision in Thomson Reuters v. ROSS Intelligence – suggest that AI companies have plausible defenses to the intellectual property claims that have dogged them since generative AI technologies became widely available several years ago. Whether AI companies can, in all cases, successfully assert that their use of copyrighted content is “fair” will depend on their circumstances and further development of the law by the courts and Congress.

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.

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.