The EU institutions have now published the updated text on the reform of the EU pharmaceutical legislation and the new Directive [link] and Regulation [link]. Formal adoption by the European Parliament and the Council is expected
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Virtual and Digital Health Digest – January 2026
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 December 2025 and early January 2026 from the the United Kingdom, and…
EU Digital Omnibus: What the Proposed Reforms Mean for Pharma and MedTech
On 19 November 2025, the European Commission published two legislative proposals – the Digital Omnibus on AI Regulation Proposal and the broader Digital Omnibus Regulation Proposal (“Proposals”) – as part of a wider initiative to simplify and streamline the EU’s…
UK PMCPA publishes revised guidance for the use of social media
The Prescription Medicines Code of Practice Authority (PMCPA) has published revised guidance on social media.
Social media has remained a significant focus for the PMCPA in recent years, with numerous companies found in breach of the ABPI Code (the…
MHRA Launches Targeted Consultation on Indefinite Recognition of CE‑Marked Medical Devices
Today, 16 February 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) opened an important consultation seeking views on proposed changes to the recognition of CE‑marked medical devices in Great Britain (GB). The initiative forms part of the UK’s…
UK government sets out 2026 branded medicines Statutory Scheme repayment rate
The UK Department of Health and Social Care (DHSC) has proposed to set the repayment percentage on sales of branded “newer” prescription-only medicines to the NHS at 16.5% for 2026, a significant reduction on the current rate of 24.3%. The…
UK’s Data (Use and Access) Act: What Life Sciences Companies Need to Know
The Data (Use and Access) Act 2025 (“DUAA”) represents the UK’s first major reform of data protection law since leaving the EU. The Act aims to modernise the UK’s data protection framework by reducing administrative burdens on businesses, supporting innovation…
The EU Medical Device Shake‑Up: What International Companies Should Prepare For
Global manufacturers placing medical devices or IVDs on the EU market are facing a pivotal moment. Our latest advisory sets out details on the most significant reforms to the EU framework since the MDR and IVDR took effect, with particular…
UK PMCPA releases new guidance on Package Deals: key takeaways for industry
The Prescription Medicines Code of Practice Authority (PMCPA) has published new guidance to provide clarity on the disclosure obligations and commercial governance expected from companies in relation to package deals (Guidance). The Guidance responds to analysis conducted by PMCPA in…
Is change on the horizon for the UK product liability regime? [Updated]
The Law Commission, an independent organisation established to keep the law of England & Wales under review and recommend reform, has announced a review of the law in relation to liability for defective products.…