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R (Greyhound Board of Great Britain Ltd) v Welsh Ministers [2026] EWHC 670 (Admin) What are the practical implications of this case? The ruling reinforces the constitutional divide between the courts and the legislature. It explains that the scheme and framework of the Government of Wales Act 2006 (GWA 2006) embody that separation of powers, and that any judicial attempt to recognise and enforce a common law obligation on Welsh Ministers to consult prior to introducing legislation in the Senedd would trespass upon that boundary. This is not a departure from established principle; case law has already upheld comparable rules for lawmakers in Scotland and at Westminster. However, this is the first express confirmation of the position for Welsh lawmakers, and the first time this dimension of the GWA 2006 has been analysed in such depth. The court examined earlier
The solution arrived through the United Nations Compensation Commission (UNCC), a quasi‑judicial body handling mass claims, created under UN Security Council Resolution 687. By addressing environmental harm—most notably via its ‘F4’ claim class—the UNCC set a seminal benchmark shaping how international law and contemporary arbitral panels allocate financial responsibility for wartime ecological devastation. With present-day wars in areas such as Eastern Europe and the Middle East bringing dam breaches, strikes on chemical facilities, and the burning of farmland, the UNCC’s legacy endures as an essential reference point for states, global investors, and companies engaged in post‑conflict arbitration. The F4 claims: Quantifying the unquantifiable Prior to the 1990s, mechanisms in international law for war reparations overwhelmingly favoured property loss, foregone earnings, and bodily injury. The natural world was commonly treated as a mute, non-compensable victim of armed hostilities...
Understanding the farming business as a business Many farms still use long-standing structures that arose by habit, not strategy. Sole traders, informal partnerships and outdated partnership deeds are common. While once effective, such setups can cause major issues around succession, tax planning and involving the next generation. A corporate team can take a fresh, business-led view of the farm, asking: Who owns the land and other critical assets? Who manages daily operations? Who carries the risk and who enjoys the return? What is the enduring plan for succession? From this review, the team can confirm whether the current setup is fit for purpose or if an alternative — for example an updated partnership agreement, a company, a limited liability partnership, or a blended model — would better meet the family’s aims. Tax efficiency through joined-up advice Tax sits at the centre of most
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Emotional Perception vs Comptroller of Patents UKIPO [2026] UKSC 3 What are the practical Implications of the case? To displace what had been viewed as an arbitrarily administered and subjective assessment (the now disapproved Aerotel approach that muddles the inquiry into inventiveness), the ruling holds that a claim need only specify any form of hardware — for example, the use of a computer, a computer-readable storage medium, or another technical means — to avoid the statutory bar in s.1(2) UK Patents Act ‘ UKPA’. That threshold is strikingly low. This wholesale shift in method opens avenues to secure protection for innovations across other fields, provided there is a technical consideration that yields some kind of technical advantage. Yet what counts as ‘technical’ or ‘technology’ still demands careful articulation within the application’s description when setting out the invention. Where the technical...
In this issue: Disputes and regulatory enforcement Medical devices Research and development Post-market Daily and weekly news alerts New and updated content Trackers Useful information Disputes and regulatory enforcement Judgment Alert: AA v The Human Fertilisation and Embryology Authority [2026] EWHC 317 ( Fam) The Family Division issued declaratory relief in 14 of 15 applications seeking to extend consent for the storage of gametes and embryos beyond the statutory time limits. The court concluded that, where clinic errors or systemic failings meant applicants were denied a fair and reasonable chance to renew consent, it was appropriate, by virtue of section 3 of the Human Rights Act 1998, to read in a further opportunity to renew so as to prevent a breach of Article 8 rights. It held that this interpretive approach accords with the grain of the legislation, whose central objective is the protection of patient autonomy through informed consent. The court applied a test...
The European Commission has set out this year’s slate of priorities, and what should be set aside, for secondary legislation to implement the EU AI Act, according to an internal note viewed by MLex. Secondary legal acts are commonly used in EU lawmaking to confer powers on the Commission to amend or add non‑essential elements of a law via a delegated act, or to secure uniform application through an implementing act. Where the basic law is silent, the EU executive may decide when to adopt such secondary measures, enabling it to order its own regulatory agenda. In a list compiled earlier this month, the Commission detailed its priorities for implementing the EU AI Act in 2026. It also pointed to a set of ‘de‑prioritised’ items, although it is still uncertain whether that implies they are not due to be adopted this...
In this issue: Data protection and life sciences Research and development Medical devices Pharmaceuticals—regulatory framework Advertising of medicines Post-market Lex Talk®Life Sciences: a Lexis®Nexis community Daily and weekly news alerts New and updated content Trackers Useful information Data protection and life sciences EU Cybersecurity Package 2026: Cybersecurity Act 2 and targeted NIS2 amendments On 20 January 2026, the European Commission unveiled a new ‘ Cybersecurity Package’ comprising a draft Regulation, styled ‘ Cybersecurity Act 2’ or the ‘ Revised EU Cybersecurity Act’, set to replace Regulation ( EU) 2019/881, the current EU Cybersecurity Act ( CSA), together with a draft Directive to amend Directive ( EU) 2022/2555, the EU NIS 2 Directive ( NIS 2). The initiatives are designed to tackle non-technical ICT supply-chain risks, reshape the EU Cybersecurity...
RMK Maritime ( Europe) Ltd and another company v CMB. Tech NV (formerly known as Euronav NV) [2025] EWHC 2739 ( Comm) What are the practical implications of this case? The judgment has notable consequences for commercial lawyers advising on professional services contracts, M& A advisory mandates, and restitutionary claims. Prevalence of contract over restitution The court confirmed that unjust enrichment is a fallback doctrine, ordinarily inapplicable where a binding contract regulates the parties’ dealings. Even where certain services might be said to sit beyond the precise contractual remit, a restitutionary claim will fail if it would cut across the contractually agreed allocation of risk and remuneration. Legal force of NOM clauses and variation provisions The advisory agreement required any change to scope to be recorded in writing and signed by authorised representatives. The court regarded this as compelling evidence that informal...
Background and purpose of the proposal The existing CSA reinforced the EU Agency for Cybersecurity (‘ ENISA’) and established the European Cybersecurity Certification Framework (‘ ECCF’) to enable voluntary, EU-wide cybersecurity certification. After NIS2 was adopted in 2022, the EU legislator introduced compulsory cyber risk management and incident reporting duties for critical sectors. In light of escalating cyber threats and geopolitical shifts, the new Cybersecurity Package proposes updates to the CSA and NIS2 to: strengthen the protection of critical Information and Communication Technologies (‘ ICT’) supply chains within NIS2 sectors streamline use of EU cybersecurity certifications under the ECCF make NIS2 compliance easier while bolstering ENISA’s cross-border supervision support What are key changes in the EU Cybersecurity Act 2? The proposed Revised EU Cybersecurity Act, or EU Cybersecurity Act 2 (‘ CSA2’), would fully replace the CSA and introduces the following new...
For more on significant movements in Information Law, consult Trackers—overview and, in particular, these key Practice Notes: Data ( Use and Access) Act—tracker UK e Privacy law reform—tracker The UK NIS Regulations—timeline ICO consultations tracker 2025 Additional trackers can be found within our EU Law practice area, including the following Practice Notes: EU GDPR—cross-border enforcement reforms—tracker EU e Privacy Directive—tracker EU Cybersecurity initiatives tracker The EU NIS 2 Directive—timeline EU GDPR— EDPB supranational level guidance tracker Further commentary and updates are delivered via our current awareness alerts and highlights. Select ‘ Create Alert’ on your ‘ Alerts’ tab and adjust your personal settings to subscribe. Confidential information What were the key developments in 2025? In the UK, section 17 of the Victims and Prisoners Act 2024 ( VPA 2024) commenced on 1 October 2025. This provision places on a...
Pharmaceuticals—regulatory framework In this issue: Intellectual property Research and development Medical devices Commercialisation Daily and weekly news alerts New and updated content Trackers Useful information Life Sciences UK—key developments in 2025 and horizon scanning for 2026 This News Analysis compiles the key shifts across UK Life Sciences in 2025 and flags what lies ahead in 2026. It covers clinical trials, medical devices, the pharmaceutical regulatory environment, AI and digital health, pricing and reimbursement, significant IP and competition law litigation, and data protection in life sciences, among other updates. See News Analysis: Life Sciences UK—key developments in 2025 and horizon scanning for 2026. UK refreshes its collection of ILAP guidance The MHRA has updated its guidance suite for the Innovative Licensing and Access Pathway ( ILAP), created to quicken patient access to medicines. From 2025, ILAP was widened to include...
Abbott Diabetes Care Inc and others v Dexcom Inc and others [2025] EWCA Civ 1633 What are the practical implications of this case? This decision adds little to the law on inventive step, yet it does spotlight several best‑practice lessons. The court applied the orthodox Pozzoli framework. The appeal succeeded because the judge did not apply their own construction of the claims, and there was no evidence showing that a specific embodiment could render the invention obvious. Taken together, these points emphasise that parties should: Settle claim construction carefully at the outset Advance alternative obviousness lines where appropriate Avoid blending distinct embodiments within a prior art disclosure Secondly, although the dispute had settled, Abbott still pursued an appeal against revocation of its patent. With the CGM market valued at many billions of pounds, safeguarding and enforcing its rights—and weighing whether to...
In this issue: Clinical trials Medical devices Pharmaceutical legislation Pricing and reimbursement AI and digital health Intellectual property Competition in life sciences Data protection and life sciences Other key developments This News Analysis summarises significant UK life sciences developments from 2025 and anticipates what lies ahead in 2026, offering a concise overview across the sector. The edition spotlights a range of clinical trials, medical devices, the pharmaceutical regulatory regime, AI and digital health, pricing and reimbursement, notable life sciences disputes in IP and competition law, plus data protection and life sciences, alongside other updates of note......
Abraaj Investment Management Ltd (in liquidation) and other companies v Kes Power Ltd and others [2026] EWHC 65 ( Comm) What are the practical implications of this case? The recent High Court judgment in Abraaj Investment Management v Kes Power closely analyses assignment principles within secured lending. In particular, the court considers when estoppel can aid a lender confronted with defective or uncertain security. The ruling also explores several adjacent issues: the potential for assignments to be implied, whether ‘no assignment’ clauses are tempered by a reasonableness qualification, and matters of consideration in acknowledgements of notice. While estoppel provided the lender with a solution on the facts, the decision emphatically reinforces a fundamental point: only the entity to which the debt is actually owed should be the assignor. The realities of group operations can obscure the true creditor, meaning it is not always obvious which...
The ten statements are wide-ranging and address shared priorities for regulators in the fast-moving AI arena, yet taken together they show both agencies are receptive to AI, able to collaborate, and are getting ready for its broader application in drug research, clinical trials, manufacturing and monitoring, observers said. Industry consistently seeks greater predictability, noted Elizabeth Mulkey, a partner in the technology and life sciences groups at Goodwin Procter LLP, who added that the joint publication signals that regulators globally are aiming to approach the issue in a similar way. On 14 January 2016, the US Food and Drug Administration ( FDA) and the European Medicines Agency ( EMA) issued common principles, describing them as the bedrock for more detailed guidance that each jurisdiction will produce independently. The statements emphasise ethical use of AI, clear explanations of what the technology does and for what...
Introduction For more information and to monitor the progress of core initiatives in detail, consult the following Practice Notes for comprehensive coverage: Life sciences tracker— EU European Health Data Space ( EHDS) tracker The EU MDR and IVDR implementing acts and guidance tracker Health Technology Assessment in the EU — Horizon scanning—2026 and beyond Agriculture/ Food— EU Regulatory tracker Patents tracker— EU — Legislation, consultations, guidance and reports To horizon scan developments in UK life sciences for 2026, and to view a succinct summary of the major developments in 2025, see News Analysis: Life Sciences UK—key developments in 2025 and horizon scanning for 2026. For a broader discussion of earlier years’ developments, or the status of other related life sciences matters, including significant EU litigation and UK developments, see our collection of available trackers and horizon scanners: Trackers ( Life...
Telecom operators and other priority sectors such as cloud service providers, medical device manufacturers and chipmakers According to an EU proposal unveiled on 20 January 2026, telecoms, alongside key industries including cloud providers, makers of medical devices and semiconductor firms, will be subject to mandatory measures to separate their supply chains from high-risk suppliers. The updated Cybersecurity Act ( CSA 2) sets out a mechanism enabling critical entities to bar from their IT supply lines any vendors tied to hostile states — for example China’s Huawei — to avert espionage threats, hidden kill-switches and harmful strategic reliance. Since 2020, the European Commission has urged Member States to phase out lower-cost equipment suppliers like Huawei and ZTE from next-generation mobile networks through a voluntary instrument dubbed the 5G toolbox. However, the Commission’s top brass, including Executive Vice- President Henna Virkkunen, became...
Pharmaceuticals—regulatory framework European Parliament adopts Critical Medicines Act proposal to address supply shortages The European Parliament has endorsed plans to bolster the availability and supply of essential medicines across the EU, approving the proposals by 503 votes in favour, 57 against and 108 abstentions. The package seeks to lessen the EU’s reliance on non‑ EU countries and strengthen pharmaceutical competitiveness by backing strategic industrial projects to expand and modernise manufacturing capacity within the Union. Under the proposals, contracting authorities would be required to apply procurement criteria that favour manufacturers producing a significant share of critical medicines in the EU, with price no longer the sole determinant for contract awards. The measures also lower the bar for joint cross‑border procurement from nine to five countries and create an EU co‑ordination mechanism for national stockpiles of critical medicines, empowering the Commission, as a last resort during...
In this issue: Pharmaceuticals—regulatory framework Research and development Advertising of medicines Borderline products Medical devices Intellectual property Daily and weekly news alerts New and updated content Trackers Latest Q& A Useful information Pharmaceuticals—regulatory framework EU Life sciences—key developments in 2025 and horizon scanning for 2026 This News Analysis offers a concise survey of the main EU life sciences developments throughout 2025 and flags what to expect in 2026. For more, see News Analysis: EU Life sciences—key developments in 2025 and horizon scanning for 2026. Research and development UK clinical trial applications and activity significantly increase in advance of regulatory reforms to take effect from April 2026 The Medicines and Healthcare products Regulatory Agency ( MHRA) has issued data indicating ‘a sharp rise’ in UK clinical trial applications and activity in 2025, ahead of new clinical trial rules set to apply from 28...
GXD‑ Bio lost UPC infringement case against Myriad Genetics GXD‑ Bio, a South Korean biotech, saw its Unified Patent Court infringement bid against Myriad Genetics and its European affiliates fail, after the court struck down the breast cancer testing patent and rejected the infringement allegations. In a ruling issued by the Munich Local Division on 19 December, the patent—directed to a method for analysing gene expression data in breast cancer tissue samples—was found to include added subject‑matter and could not be upheld, even in amended guise. Relying on the UPC’s established approach to construing claims and assessing added matter, the court underlined that patent claims must not extend beyond what a skilled person would derive directly and unambiguously from the original application......
In this issue: Medical devices Post-market Commercialisation Intellectual property Advertising of medicines Research and development Daily and weekly news alerts New and updated content Trackers Useful information Medical devices Digital omnibus on AI regulation—considerations for Life Sciences companies The European Commission has issued its Digital Omnibus on AI Regulation Proposal, a law-making initiative introducing focused measures to support effective practical roll-out of the EU Artificial Intelligence Act (‘ AI Act’). Hélène Boland and Fabien Roy at Hogan Lovells outline key points for life sciences businesses in this piece. See News Analysis: Digital omnibus on AI regulation—considerations for Life Sciences companies. Medical devices to get softer AI compliance regime, European Commission proposes MLex: Under a European Commission plan, medical device makers would face lighter compliance with the EU AI Act’s high‑risk framework. As part of wider revisions to medical device rules, it addresses long‑standing sector concerns and, if endorsed by the European Parliament and the Council of the EU, would...
The case for reform The To R begin by asserting that the existing framework under the Consumer Protection Act 1987 (the CPA) ‘…is no longer fit for purpose…’. This is expressed more emphatically than earlier communications from the Law Commission. At this preliminary stage, its stance appears to be that the issue is not ‘if’ reform is required, but ‘how’ it should be achieved. Clear echoes to the EU reforms The To R carry unmistakeable parallels with the recent EU overhaul set out in the new Product Liability Directive ( EU) 2024/2853 (currently in the implementation phase across EU Member States—read more here): Of particular note, the Law Commission indicates it will consider whether: the ‘burden of proof for claimants to bring a successful claim is too onerous’—might the Law Commission also be contemplating introducing ‘rebuttable presumptions’ regarding defect and/or causation?......
The Commission has set out revisions to multiple rules overseeing medical devices, featuring an amendment aimed at easing EU AI Act compliance for producers. See: LNB News 17/12/2025 28. Released on 16 December 2025, the package reshapes device regulations and clarifies how such products are handled under the EU AI Act. Central to the law’s risk-based model is a rigorous due diligence framework for AI systems tagged ‘high-risk’, given their potential to seriously and directly impact people’s health, safety and fundamental rights. A key pathway to the high-risk class is where an AI system forms a product, or a product’s safety component, governed by existing EU sectoral safety regimes, for example those covering toys, lifts and industrial machinery specifically set out in Annex I......
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This Practice Note This Practice Note reviews mechanisms used in settling litigation. A Tomlin order consists of a consent order paired with a schedule. It operates to stay proceedings on terms that have been agreed. The provisions contained in the schedule may remain confidential. This Practice Note describes the scope of confidentiality attaching to the schedule and sets out how it differs from a standard consent order. Sample wording for a Tomlin order is included, alongside links to precedents, as well as guidance on court approval. It also addresses varying, setting aside and enforcing a Tomlin order, including the considerations the court will take into account when handling applications for each. Further guidance is provided on interpreting and applying the relevant provisions of the CPR; however, some courts and divisions impose very specific requirements for both drafting and approval, and for approaching the schedule and confidentiality issues. Accordingly, you must consider the particular rules and court guide provisions in the forum where your claim is proceeding when drawing up the Tomlin order...
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