Week Ahead (17 August)

Tuesday, 18 August – EU e-Evidence regulation becomes applicable, expanding authorities’ cross-border access to data held by technology companies

Tomorrow, the EU's new e-Evidence regulation will become applicable following a 3-year transition period, introducing a new framework allowing judicial authorities to obtain electronic evidence directly from technology and communications providers located elsewhere in the EU. The rules represent a significant change to the way cross border requests for digital data are handled, replacing reliance on often lengthy cooperation between national authorities with a considerably faster mechanism for obtaining information directly from service providers.

At the centre of the framework are European Production and Preservation Orders. Production Orders will allow authorities in one member state to require a service provider, or its designated representative, in another member state to provide electronic evidence relevant to criminal proceedings, including subscriber, traffic and content data. Companies will generally have ten days to respond, falling to eight hours in emergency cases. Preservation Orders will meanwhile allow authorities to require providers to retain specified data while a subsequent production request is prepared. 

Importantly, the regime also applies to companies headquartered outside the EU where they offer relevant services within the bloc. An accompanying Directive requires covered providers to maintain a designated establishment or legal representative in the EU through which orders can be received and enforced, making the framework particularly relevant for cloud providers, communications services, social media platforms and other digital businesses holding user data.

The Regulation responds to the growing importance of digital information in criminal investigations, particularly where data is stored or controlled across different jurisdictions. From a business perspective, Tuesday therefore marks an important operational change, with technology companies now facing a more standardised and considerably faster system for responding to cross border law enforcement requests, including particularly demanding timelines in emergency cases.

Friday, 21 August – Commission market test closes on Sanofi commitments aimed at settling Efluelda antitrust investigation

On Friday, the European Commission's market test of commitments offered by Sanofi will close, potentially paving the way for an early settlement of its investigation into whether the pharmaceutical company abused a dominant position through allegedly misleading communications concerning rival influenza vaccines.

In late June, DG COMP opened a formal investigation into Sanofi's commercial practices surrounding Efluelda, its high dose influenza vaccine targeted particularly at older and vulnerable patients. The investigation followed unannounced inspections carried out at the company's premises in September 2025 and focuses on whether Sanofi sought to undermine competing vaccines by disseminating potentially misleading information to healthcare professionals in France and Germany. 

The case principally concerns Efluelda's competition with Fluad, an enhanced influenza vaccine produced by CSL Seqirus. DG COMP is examining whether Sanofi, potentially dominant in the relevant markets, engaged in an exclusionary disparagement strategy designed to weaken perceptions of Fluad's safety or effectiveness and thereby restrict its uptake. The investigation follows a growing line of EU pharmaceutical antitrust cases in which the Commission has used Article 102 to examine whether dominant drugmakers have sought to impede competitors through communications concerning rival medicines rather than through pricing or contractual conduct alone. Recent examples include the Commission's Vifor Pharma case and its €462.6 million fine against Teva in 2024.

At an early stage of the investigation, Sanofi has offered commitments intended to address the Commission's preliminary concerns. These include corrective communications concerning the assessments and recommendations of French and German vaccination authorities, alongside changes to the way the company presents comparisons between Efluelda and Fluad to healthcare professionals. If accepted, the commitments would become legally binding while allowing the Commission to close the investigation without reaching a finding that Sanofi infringed EU competition law.

Friday's deadline will therefore provide competitors, healthcare organisations and other interested parties with their final opportunity to comment on whether the proposed safeguards adequately address DG COMP's concerns. Subject to the feedback received, the Commission could subsequently make the commitments binding and close the case, providing another example of DG COMP using Article 102 to address potentially exclusionary disparagement practices in pharmaceutical markets.

Friday, 21 August – Commission faces revised deadline in Orange/APG-Nexera fibre acquisition following national referral request

Also on Friday, the European Commission faces its revised Phase I deadline for its review of Orange and Dutch pension fund APG's proposed acquisition of Polish fibre network operator Nexera, after the original 7 August deadline was extended following a referral request from a national competition authority. 

The transaction would bring Nexera together with Swiatlowod Inwestycje, the Polish wholesale fibre joint venture already controlled by Orange and APG. Nexera operates an extensive fibre-to-the-home network covering close to 800,000 households, primarily across less densely populated parts of Poland, while Swiatlowod Inwestycje has itself developed into an important wholesale fibre platform since its creation was approved by the Commission in 2021.

The Commission initially began its Phase I assessment in July but subsequently extended the review until 21 August after receiving a request from a national competition authority for the transaction to be referred under the EU Merger Regulation. The procedural development does not in itself indicate that DG COMP has identified substantive competition concerns. Rather, the referral mechanism allows national authorities to seek jurisdiction where they consider that a transaction may particularly affect competition within a distinct national market.

Nevertheless, the transaction is likely to attract attention given the growing importance of wholesale fibre infrastructure and the potential implications of combining two significant Polish network platforms. Any substantive assessment is likely to focus on whether the enlarged network could reduce infrastructure competition, alter wholesale access conditions for rival telecom operators or affect incentives for future fibre deployment.

Friday's deadline could therefore result either in the Commission retaining jurisdiction and proceeding with its assessment or in all or part of the transaction being transferred to the relevant national competition authority. The latter outcome could lengthen the regulatory process and shift the substantive review towards the transaction's effects specifically within the Polish telecoms market.

Overall, the case comes as European policymakers seek simultaneously to accelerate investment in high capacity networks and encourage greater scale across the telecom sector. This approach is in line with the bloc’s evolving goals around competitiveness as advocated by the Draghi report, yet at the same time, competition authorities continue to scrutinise consolidation in infrastructure markets where alternative networks can be limited.  

The referral request itself should not necessarily be read as evidence that the transaction is heading towards a difficult regulatory process, but the outcome on Friday should provide a clearer indication of where, and potentially how intensively, the deal will ultimately be reviewed.