Following a two year investigation, the UK’s Competition and Markets Authority (“CMA”) has issued its provisional findings in which it proposes to impose significant obligations on veterinary business.
Continue Reading The Dog That Barks: The UK’s CMA is proposing major reforms to Veterinary BusinessesMHRA and NICE launch aligned approvals pathway
On 10 October 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) announced the early launch of the “Aligned Pathway”. This is a joint initiative designed to streamline the scheduling of the regulatory approval and health technology assessment processes in order to reduce the time before a new medicine is available on the NHS following the grant of the marketing authorisation (MA). The pathway supports the UK Government’s ambitions outlined in the 10-Year Health Plan for England and the Life Sciences Sector Plan to accelerate access to medicines and reduce regulatory burden, as discussed in our blog here.
Continue Reading MHRA and NICE launch aligned approvals pathwayCJEU to Clarify Rules on Packaging Requirements in Parallel Trade of Medicines
On 8 September 2025, the Court of Justice of the European Union (CJEU) received a preliminary request from the Bundesverwaltungsgericht, the German Federal Administrative Court BVerwG, referring a series of questions seeking interpretation on the applicability of certain rules to parallel trade of medicines, including whether German language and packaging requirements are proportionate or compatible with EU law. The request follows an order for a preliminary reference made by the BVerwG in March 2025. Notably, the request does not disclose the identity of the parallel importer, the manufacturer of the medicinal product, or the name of the product itself.
Continue Reading CJEU to Clarify Rules on Packaging Requirements in Parallel Trade of MedicinesArticle 22 Trends in Pharma M&A: Call-In Powers and Timing
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 TimingEuropean Commission Publishes New Variation Guidelines for Medicines
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 MedicinesEuropean Commission’s call for evidence on the revision of the MDR/IVDR
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/IVDRUK government and pharmaceutical industry fail to reach agreement on amendments to medicines pricing scheme
The Association of the British Pharmaceutical Industry (ABPI) and the Department of Health and Social Care (DHSC) have confirmed that they have ended negotiations on amendments to the 2024 Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG). The breakdown of the talks between the government and the ABPI mean that the pharmaceutical industry will continue to pay annual rebates on sales calculated by the current mechanism under VPAG, which produced a repayment rate of 22.9% on “newer” medicines for 2025.
Continue Reading UK government and pharmaceutical industry fail to reach agreement on amendments to medicines pricing schemeCJEU clarifies the concept of pseudonymised data
On 4 September 2025, the Court of Justice of the European Union (“CJEU”) delivered a notable judgment on what is considered pseudonymised personal data under EU data protection law. While, technically speaking, the judgment concerns the interpretation of Regulation (EU) 2018/1725 (which governs the processing of personal data by the EU institutions and bodies), it fully applies to the interpretation of the concepts of personal data and pseudonymised data under Regulation (EU) 2016/679 (“GDPR”).
This question is essential for many companies operating in the EU, and in particular Life Sciences companies handling key-coded or otherwise pseudonymised patients’ personal data in the context of research and development, supply of healthcare products and related safety monitoring.
Continue Reading CJEU clarifies the concept of pseudonymised dataVirtual and Digital Health Digest – August 2025
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 July and early August 2025 from the the United Kingdom, and European Union.
The UK government has published a number of initiatives and responses to consultations this month that have included important proposals for devices and digital health. The 10 Year Health Plan and Life Sciences Sector Plan both refer to integration of digital health into the National Health Service. Further, the Medicines and Healthcare products Regulatory Agency’s statement on the future regulation of devices makes some key changes relevant to software, including that the proposed international reliance pathways will include software. There has also been some useful guidance on synthetic data, and on reporting adverse events for software devices. These initiatives continue to demonstrate that digital technologies are seen as a growth area and are important for delivering the government’s long-term healthcare plans.
Continue Reading Virtual and Digital Health Digest – August 2025Commission guidelines for providers of general-purpose AI models
On July 18, 2025, the European Commission released its guidelines on the obligations for providers of general-purpose AI (GPAI) models under the European Union’s AI Act. This is an important development for companies, including in the Life Sciences sector, building their own GPAI models, as well as using, integrating and/or further developing third-party GPAI as part of their activities.
The Guidelines answer some of the outstanding questions around the application of the EU AI Act to GPAI models in practice. Our advisory discusses in detail the key elements of the guidelines and highlight that both the EU AI Act and the guidelines apply to Life Sciences companies not in the EU if the GPAI model is placed on or put into in the EU market or its output is used in the EU.