Insights

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 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 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.

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 February 26, the European Commission presented its Clean Industrial Deal (CID). As a follow-up to the European Green Deal, the CID aims to strengthen the competitiveness of European industry while at the same time accelerating the decarbonization of the economy.

Just over a year ago, the notification obligations under the EU Foreign Subsidies Regulation (FSR) became applicable. Since then, M&A transactions and bids for government contracts above certain thresholds must be notified to the European Commission. Pending the Commission’s review, the transaction cannot be completed, or the contract cannot be awarded. What lessons can be learned from the application of the FSR to date? Has the FSR proved to be an effective tool in leveling the playing field, or has its main effect been to burden companies with red tape, at the risk of discouraging investment in Europe?

On July 2, 2024, the Belgian Competition Authority (BCA) found that three security companies, Seris, G4S and Securitas, had participated in serious cartel practices within the private security services sector from 2008 to 2020. The practices consisted of price-fixing, bid rigging, and no poach agreements. This decision is important for two reasons: because the fines imposed by the BCA amount to a substantial EUR 47 million and because this is the first time that the BCA has fined companies for a no poach arrangement.

Over the 2024 summer, new EU rules entered into force regarding unsold consumer products under the new ESPR (i.e. the Ecodesign for Sustainable Products Regulation – Regulation (EU) 2024/1781).  The legal obligations themselves are relatively concise and short in number and therefore perhaps easy to overlook.  However, companies selling or supplying consumer products in the EU/EEA – particularly companies in the clothing, footwear, apparel, textile and retail sectors – should beware and not underestimate their importance or impact.

The EU legal and policy framework regarding critical medicines and medicine shortages is rapidly changing.  In the past 12 months alone, there have been numerous developments: from the ‘Non-Paper’; to the Communication on ‘Addressing medicine shortages’; and the launch of the Critical Medicines Alliance.  In the next 12 months, there is likely to be similar developments – including a possible draft proposal for a ‘Critical Medicines Act’.  As the new regulatory framework becomes clearer, pharma companies will need to understand it, and prepare for the impact it will have.

In response to the ongoing conflict in Ukraine and to exert further pressure on Russia, the EU enacted its 14thsanctions package against Russia on June 24, 2024. The new package comes after months of negotiations between Member States, and follow, but in many ways expand upon, those passed by the United States and the UK last week (see Crowell’s Alert on those developments here). 

Now more than a year ago, on November 28, 2022, the long-awaited act on the protection of persons who report violations of EU or national law detected within a legal entity in the private sector, the so-called the "Whistleblowing Protection Act", was adopted in Belgium.

As from October 2023, companies receiving financial contributions from third countries will have to report these to the European Commission when engaging in M&A transactions or bidding for public contracts above certain thresholds. This alert guides you through the new notification obligations under the EU Foreign Subsidies Regulation (FSR): first, we situate these obligations within the overall set-up of the FSR; then we go into the detail of the notification obligations themselves; before concluding with practical advice on how to meet these new obligations.

Last year, the European Union (EU) legislature adopted a far-reaching regulation aimed at tackling the distortive effects on EU markets of financial support provided by non-EU countries to undertakings active in the EU (Foreign Subsidies Regulation or FSR). However, the FSR left many procedural details to be hammered out by the European Commission (EC) in an Implementing Regulation, to be adopted before the FSR itself starts to apply in July 2023. On 6 February 2023, the EC launched a much-anticipated public consultation regarding its draft Implementing Regulation, including two annexes containing notification forms for concentrations and public procurements. Stakeholders have until 6 March 2023 to submit comments.

On 28 November, the European Union adopted the Corporate Sustainability Reporting Directive (hereafter: “CSRD”), succeeding the Non-Financial Reporting Directive (hereafter: “NFRD”) and ushering in the next era of sustainability reporting. Here are seven questions and responses to help your company prepare in the countdown to CSRD implementation.

On October 28, 2022, the European Commission adopted a second amendment to its Temporary Framework for State aid measures to support the economy following Russia’s aggression against Ukraine (“TF”). The TF was set to expire on December 31, 2022. As the war in Ukraine continues to affect companies in the EU, the Commission has extended its application until December 31, 2023. In addition, the second amendment to the TF raises the ceilings for limited amounts of aid and provides for additional flexibility for liquidity support to energy utilities for their trading activities and for companies affected by rising energy costs. It also introduces means to support electricity demand reduction, in line with the recent Regulation (EU) 2022/1854 on an emergency intervention to address high energy prices. The changes reflect the growing concern of the EU institutions about the security of gas and electricity supply in Europe.

As we wrote in an earlier client alert, the European Commission proposed the FSR in May 2021 to close a regulatory gap and level the playing field between undertakings receiving subsidies from EU Member States, which are subject to strict state aid rules, and recipients of third-country subsidies, which so far escaped scrutiny. The proposal followed a public consultation on the European Commission’s June 2020 White Paper on Foreign Subsidies.

On Tuesday, July 5th, the European Parliament adopted the Digital Services Act (DSA) with a resounding 539 votes in favor, 54 votes against and 30 abstentions. The DSA is but one part of the multifaceted European digital strategy and, together with the Digital Markets Act (DMA), makes up the Digital Services Package, initially proposed by the European Commission in December 2020 (see our previous alert of January 12, 2021). The DSA takes the form of a Regulation, directly applicable in all EU Member States, and will amend (but not fully replace) the 2000 e-Commerce Directive (Directive 2000/31/EC).

On May 3, 2022, the European Commission published a proposed regulation (the “EHDS Proposal”) for the establishment of a European Health Data Space (or “EHDS”). This is the first proposal for establishing domain-specific common European data spaces following the European strategy for data and an important step in building a European “Health Union”.

Businesses distributing goods and services in the EU often rely on the Vertical Block Exemption Regulation (VBER) for legal certainty. The VBER and the accompanying guidelines set out the conditions under which distribution agreements are presumed to comply with EU competition law. To be covered by the VBER, the parties’ market shares may not exceed 30% and the agreement may not include so-called hardcore restrictions. Above the market share threshold, the parties will need to self- assess their agreement based on the guidelines. Over the past few years, the Commission has been working with stakeholders to assess, update and amend the existing rules to take account of market developments, including the emergence of online platforms and e-commerce (see also our Client Alert of August 24, 2021). The most important changes can be summarized as follows:

On March 24, 2022, the European Union (EU) co-legislators (the European Parliament and the Council) reached political agreement on the final provisions of the Digital Markets Act (DMA). The DMA aims at ensuring fair and contestable markets in the digital sector by imposing specific regulatory obligations on so-called “gatekeepers,” i.e., major digital platforms with a powerful and entrenched position which act as important gateways for businesses to reach end users. The European Commission (EC) will act as the central enforcer of the DMA. It will have extensive investigative powers and be able to impose hefty fines as well as behavioral and structural remedies (including the breaking up of companies). As an instrument of ex ante regulation, the DMA is designed to complement (not replace) the ex post enforcement of competition law, which is often viewed as too slow to effectively rein in the market power of “Big Tech” players.