Insights

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.

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.

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 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.

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 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.

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.  

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.

On 23 October 2024, the European Parliament adopted Directive (EU) 2024/2831 (“the Directive”), aimed at improving conditions for individuals working for digital platforms.  The Directive introduces comprehensive measures to: address the employment status of digital platform workers, ensure transparency and fairness in algorithmic management, and strengthen the protection of personal data. The Directive came into force on 1 December 2024, and Member States are required to adopt the necessary measures for transposition into national law by 2 December 2026.

There is currently a deluge of new EU law being finalized and adopted – particularly on environmental and sustainability issues. At times it may seem overwhelming – with certain new EU laws being overlooked.  However, when serious environmental problems come to light within companies – the first major concern is normally criminal liability. That includes potential criminal liability of the company itself, but also of the CEO, Board Members and other persons leading it. With that in mind – top of a company’s ‘to-do’ list should be ensuring compliance with the new EU Environmental Crime Directive.

On September 3, 2024, the EU Court of Justice overturned the first-instance judgment of the EU General Court, which had held that the European Commission could review transactions that fall below EU and Member States' merger control thresholds through referrals by national competition authorities under Article 22 of the EU Merger Regulation (Case C-611/22 P, Illumina v Commission).

Cattle, cocoa, coffee, oil palm, soya, wood, rubber?  Do you sell any of these commodities? Do you sell any products derived, containing or using any of these commodities? Are there any companies in your supply chain which sell or use these commodities, or derivative products?  Do you (or others in your supply chain) sell products in the EU/EEA, or export products from the EU/EEA?  If so, you – and your supply chain – must likely comply with the Deforestation Regulation.[1] And getting ready is no easy feat – even despite the recent actions to postpone some of the application deadlines of concern. 

On August 1, 2024, the European Commission published its draft Guidelines on abusive exclusionary conduct by dominant undertakings. Their adoption would mark the first major update in over 15 years of the Commission’s guidance on the application of the prohibition of abuse of dominance laid down in Article 102 of the Treaty on the Functioning of the European Union (TFEU). The Commission’s 2008 Guidance on enforcement priorities in applying Article 82 of the EC Treaty to abusive exclusionary conduct by dominant undertakings, which received only a limited update in 2023, were once hailed as a welcome move away from a legalistic, form-based approach to an effects-based approached informed by economics. Is the pendulum now swinging back to a more formalistic approach based on presumptions, shifting the burden of proof onto dominant undertakings and heralding an era of stricter enforcement?

The EU Institutions are currently adding the finishing touches to the new Packaging & Packaging Waste Regulation (“PPWR”) which is expected to be adopted in Q4 2024 or Q1 2025. While many companies are fully preoccupied with preparing for other EU legislation (e.g. the Deforestation Regulation) – companies will ignore the PPWR at their peril. The PPWR contains a host of ambitious legal targets and requirements – which industry will find it difficult to achieve in practice. And the deadlines to comply – are perhaps even more challenging. Companies will need to start preparing for the EU PPWR now, to avoid serious problems – including supply-chain disruption, penalties and litigation – in the future.

Earlier this week, another case of apparent Modern Slavery and Forced Labour came to light in the UK. [1]  According to media reports, the former UK Prime Minister, Baroness Teresa May of Maidenhead, now Chair of the Global Commission on Modern Slavery and Human Trafficking[2] – described the case as “shocking” and showed “large companies not properly looking into their supply chains”. The UK Government is now contemplating further steps to strengthen UK Modern Slavery and Forced Labour laws. This recent UK case, follows a number of other cases in Europe – particularly the EU – including those involving high profile Italian fashion houses.[3] In all these cases, the ethical and social responsibilities – including the legal obligations – incumbent on large companies to root-out modern slavery and forced labour concerns in their supply chains, have been focused on. This comes in the wake of, a number of concerns in the same area with, for example, a United Nations Working Group recently noting a general lack of understanding in the banking and investment community that ESG data and information requires undertakings to provide information and data on the “S” – including, therefore, on human rights issues.[4]

The amount of litigation regarding environmental and climate change issues is, perhaps unsurprisingly, growing worldwide.[1] A significant portion of that litigation relates to so-called ‘greenwashing’, ‘climate-washing’ or ‘social-washing’ disputes. In other words, legal cases where people or organisations (often NGOs and consumer groups) accuse companies, banks, financial institutions or others, of making untrue statements. They argue these companies or financial institutions are pretending their products, services or operations are more environmentally-friendly, sustainable, or ethically ‘good’ for society – than is really the case. Perhaps more interestingly, of all the litigation in the environmental and climate change space – complainants bringing greenwashing and social washing cases have, according to some of these reports, statistically the most chance of winning. So, in a nutshell, not only is greenwashing and social washing litigation on the rise, companies and financial institutions are most likely to lose cases in this area.