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The EU Commission has published its proposal for the “Digital Omnibus” aimed to simplify and streamline the EU rules governing artificial intelligence, data protection, cybersecurity, and data use more broadly. The proposal seeks to amend several cornerstone EU regulations, including Regulation (EU) 2016/679 (GDPR), Regulation (EU) 2024/1689 (AI Act), Regulation (EU) 2023/2854 (Data Act), Directive 2002/58/EC (e-Privacy Directive) and Directive (EU) 2022/2555 (NIS2). The proposal also foresees the repeal of the fairly recent Regulation (EU) 2022/868 (Data Governance Act).

Below is a high-level snapshot of the proposal, ahead of a more detailed advisory we will publish.

The proposal will now moves through what is expected to be a challenging legislative procedure and policy and political discussions with the European Parliament and the Council.

Below we set out a quick overview of the most relevant elements for companies, including medical device manufacturers and other Life Sciences companies – e.g., changes to the AI Act, updates to the GDPR, reform of the EU cookie and tracking rules, data-sharing rules, and the new single-entry point for cybersecurity and data protection incidents reporting.Continue Reading Digital Omnibus: The European Commission published its proposal to amend the GDPR, AI Act, Data Act and other related frameworks

On 23 October 2025, Advocate General (“AG”) Emiliou delivered his opinion in Case C-118/24: Laboratoires Eurogenerics and Theramex France.[1]

The AG opines on three key questions regarding the use of the decentralised procedure for generic medicinal products:

(i) The national courts of the EU Member States are allowed by EU law to judicially review the legality of a marketing authorisation (“MA”) granted via the decentralised abridged procedure where it is alleged that the medicinal product in question does not meet the criteria of a generic medicinal product. This is applies even if the judicial review is conducted by a national court in an EU Member State other that the reference Member State for the decentralised marketing authorisation procedure.

(ii) The applicant seeking such judicial review does not need to be the marketing authorisation holder for the reference medicinal product or the applicant for the generic marketing authorisation. The applicant could also be a third party with a vested interest, such as the marketing authorisation holder for a biosimilar medicinal product which will be competing with the newly authorised generic medicinal product. This conclusion by the AG remains unaffected by the fact that such applicant  may not be admissible if the action was brought at EU level to the Court of Justice of the European Union (“CJEU”) if the direct and individual concern of the applicant is not demonstrated. According to the AG, it is for the EU Member States in the framework of their procedural autonomy to decide whether a right to challenge an MA exists in these circumstances.

(iii) Chemically synthesised products are not precluded from meeting the criteria to be a generic of a reference biological medicinal product.

This third finding will, if followed by the CJEU, also apply to the centralised marketing authorisation procedure and arguably facilitate market access for synthetic copies of biological medicinal products. It would mean that, in practice, applicants for generics of biological medicinal products would not be required to submit additional pre-clinical and/or clinical data (as opposed to biosimilar applicants) and may potentially benefit, once authorised, from more advantageous pricing and reimbursement conditions (e.g., substitutability at pharmacy level which may not be available for biosimilar medicinal products).Continue Reading Can a chemically synthesised medicine be authorised as a generic of a biological medicine? And who can challenge this?

Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during September and early October 2025 from the the United Kingdom, and European Union.

This month, the EU and UK have been actively processing the future of AI development and regulation in life sciences and health care through a combination of legislative initiatives, opportunities for stakeholder engagement, and investment in infrastructure. In the EU, the European Commission has published draft guidance on reporting serious AI incidents under the AI Act, and the European Medicines Agency has initiated a stakeholder survey to define AI priorities in medicines regulation. In the UK, the UK government has announced a National Commission on the Regulation of AI in Healthcare and a new AIR-SP cloud platform. These developments signal a shift from theoretical regulation to practical implementation. There have also been two important decisions from the Court of Justice of the European Union refining the legal boundaries of digital health services and data protection.Continue Reading Virtual and Digital Health Digest – October 2025

Article 22 and the Pharma Context

Competition authorities in Europe have for years grown increasingly concerned about so-called “killer acquisitions,” particularly in life sciences where targets often have high innovation potential but little or no turnover. These are transactions where the acquired company’s competitive significance lies in its pipeline, R&D or intellectual property rather than its financials. Such deals can escape traditional turnover-based merger control thresholds, yet – the authorities argue – may still raise serious concerns about future (i.e., potential) competition and innovation. That said, the label “killer acquisition” is something of a misnomer. In practice, transactions undertaken solely to eliminate innovation from a smaller rival are exceedingly rare.

To address this risk, the European Commission has encouraged greater use of Article 22 of the EU Merger Regulation (EUMR), which allows Member States to refer cases for EU review even if they do not meet EU thresholds. Subject to potential further developments, two recent judgments, the Court of Justice’s ruling in Illumina/GRAIL and the General Court’s decision in Brasserie Nationale, now provide the leading interpretation of how Article 22 operates in practice, particularly in relation to call-in powers and timing of referrals.Continue Reading Article 22 Trends in Pharma M&A: Call-In Powers and Timing

The European Commission has published new Guidelines on the details of the various categories of variations (to the terms of marketing authorisations (“MA”) for medicinal products) (“Variations Guidelines”).

The new 2025 Variations Guidelines replace the older 2013 Variation Guidelines, and support the implementation of the amended Regulation (EC) No 1234/2008 (“Variations Regulation”) (see our BioSlice blog post), which entered into force in January 2025. The Variations Guidelines provide detailed guidance for marketing authorisation holders (“MAH”) on modifying and updating their MAs, the procedures to follow and the related requirements.

Overall, the new Guidelines provide greater flexibility and clarity in certain aspects of the variation procedures. At the same time, they introduce new obligations for MAHs that should be taken into account by pharmaceutical companies going forward.

In this blog, we highlight some of the key changes introduced by the Variations Guidelines.Continue Reading European Commission Publishes New Variation Guidelines for Medicines

On 8 September 2025, the European Commission published a call for evidence on “the targeted revision of the EU rules for medical devices and in vitro diagnostics”. This is part of the Commission’s on-going “targeted evaluation” of the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR), with the aim of identifying methods to tackle critical issues experienced throughout the industry caused by the regulations.Continue Reading European Commission’s call for evidence on the revision of the MDR/IVDR

On 2 July, 2025, the European Commission published its EU Life Sciences Strategy (the ‘Strategy’), setting out a roadmap to position the European Union (EU) as a global leader in life sciences by 2030.

For pharmaceutical, MedTech, and biotech companies, the Strategy may, at least in theory, represent a positive shift towards a more innovation-driven environment for research and development (R&D) and market access in life sciences. This will, however, depend, to a great extent, on the practical impact and implementation of the other policy and legislative initiatives in the EU (e.g., the reform of the EU pharmaceutical legislation (see our latest blog), Biotech Act, Critical Medicines Act (see our blog)).

The Strategy presents concrete EU level actions to address long-standing challenges in life sciences in the EU, such as regulatory fragmentation across EU Member States, as well as the barriers to multi-country clinical trials and to the market access of advanced therapies and novel technologies.

A new Life Science Coordination Group within the European Commission will oversee the implementation of the Strategy and ensure that EU policies are consistent and supportive of innovation.

This blog highlights key elements of the Strategy of relevance to pharmaceutical, MedTech, and biotech companies.Continue Reading The European Commission Publishes an EU Life Sciences Strategy

On 22 July 2025, the European Commission adopted Implementing Regulation (EU) 2025/1466 (“Regulation”), updating the EU pharmacovigilance (or “PV”) rules by way of amendments to Implementing Regulation (EU) No 520/2012. The changes aim to clarify and strengthen certain pharmacovigilance obligations (some of which arguably reflect what is already the current practice and expectations of the EU PV inspectors).

The Regulation introduces a number of new compliance expectations and requirements for applicants and marketing authorisation holders (“MAHs”), some of which will start to apply before mid-August.Continue Reading Updates to the EU Pharmacovigilance Rules: Key Takeaways for Marketing Authorisation Holders

On 13 June 2025, the European Commission launched the first phase of a pilot project under its COMBINE programme (the pilot project), aiming to streamline the authorisation process for combined studies involving both clinical trials of medicinal products and performance studies of in vitro diagnostic medical devices (IVD) (referred to as combined studies below).

The pilot project represents a significant step towards addressing the complex and fragmented regulatory landscape that sponsors currently face when submitting applications for combined studies across multiple EU countries. Although its practical effectiveness remains to be seen, the pilot project represents a positive development that should facilitate the approval of combined studies in the EU.

The pilot project is the first initiative under the COMBINE programme, with additional projects planned to launch in the coming years.Continue Reading European Commission launches COMBINE pilot to streamline approval of studies involving medicinal products and in vitro diagnostic medical devices

On 21 May 2025, the European Commission published its Proposal for a Regulation (“Proposal”), amending several existing regulations, including the General Data Protection Regulation (EU) 2016/67 (“GDPR”), to simplify obligations for small and medium-sized enterprises (“SMEs”) and extend certain mitigating measures to small mid-cap enterprises (“SMCs”).Continue Reading Proposed GDPR Simplifications for SMEs and SMCs