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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 Sole traders, informal partnerships and outdated partnership deeds are common.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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Deal headlines Zero tariffs on UK pharmaceutical exports to the US will continue until 2028 The UK reports it has secured ‘mitigations’ under the US ‘ Most Favoured Nation’ ( MFN) drug pricing initiative, though what these entail remains unclear Plans are underway to raise the thresholds used by the National Institute for Health and Care Excellence ( NICE) to assess whether new medicines are cost-effective for NHS use by 17%–25%. In principle, this should lead to more favourable reimbursement outcomes in the UK at prices that better reflect the substantial R& D investment required to bring novel therapies to market The agreement also introduces, for 2026 to 2028, a 15% cap under the ‘ VPAG’ scheme on rebates payable by pharmaceutical firms to the UK government on net NHS sales of newer medicines Over the next decade, the UK...
The ASA has published its final guidance on the promotion of less healthy food and drink. This version is largely unchanged from the earlier draft that was previously issued. For fuller detail, see Practice Note: Food advertising— New TV and online HFSS advertising restrictions and News Analysis: The implementation of advertising restrictions for less healthy food and drink on television and online, which analyses the updated Consultation response. Notably, it explains how the new rules apply to influencers, including that ‘gifted’ items fall within the paid-for online restrictions set out. It also notes that fleeting mentions of less healthy products—such as within a supermarket’s Christmas ad—are less likely to be caught in practice. When is a product identifiable and in scope of the restrictions? The statutory question is whether people in the UK could reasonably be expected to recognise an...
In this issue Pharmaceutical regulation Advanced therapeutics Medical devices Data protection and life sciences Advertising of medicines Daily and weekly news alerts New and updated content Trackers Useful information Life Sciences Highlights 2025/2026 Pharmaceutical regulation Council and Parliament reach political agreement on pharmaceutical legislation reform package The Council of the EU and the European Parliament have struck a provisional political deal on the EU’s extensive overhaul of medicines legislation, the ‘pharma reform package’. It prioritises patient access, regulatory streamlining, industry competitiveness and secure medicinal supplies, while adding incentives to tackle antimicrobial resistance. The accord preserves the familiar baseline exclusivity of nine years: eight years of regulatory data protection followed by one year of market protection. A new Article 56a would permit Member States to require companies to keep adequate stocks to satisfy national demand,...
Earlier this year, the decision in Macdonald Hotels v Bank of Scotland unsettled lenders and their advisers, with obiter observations intimating that, for the ‘face value’ test to be satisfied for a deed, the document, on its face, must make plain that all parties expressly intended it to operate as a deed, rather than only those executing it as a deed. That stance differs from common practice in certain finance instruments, notably intercreditor agreements, which frequently state that only specified parties execute and deliver them as deeds and, unlike security documents, are ordinarily styled as ‘agreements’ in many instances. The City of London Law Society ( CLLS) subsequently released a note expressing its view on the comments and on how to comply with the face value test, confirming that, in its opinion, there is a measure of flexibility in the ways the face value...
In this issue: Medical devices Commercialisation Pharmaceuticals—regulatory framework Research and development Advertising of medicines 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 unveiled its Digital Omnibus on AI Regulation Proposal, a draft law with targeted measures aimed at smoothing the practical roll-out of the EU AI Act. Hélène Boland and Fabien Roy of Hogan Lovells set out key points for life sciences companies. See News Analysis: Digital Omnibus on AI Regulation—considerations for life sciences companies. EU countries question proposed approach for delaying AI Act’s key duties MLex reports that plans to postpone core EU AI Act obligations face scrutiny from Member States, who caution that the Commission’s method lacks clear benchmarks, predictability and adequate participation of national regulators. Even backers of a pause voiced reservations, and others queried what ensues if compliance tools remain...
According to an internal memo, EU capitals have challenged the Commission’s method for deferring the start of key obligations under the bloc’s AI rulebook. Their concerns focus on suggested postponement of the entry into application of core legal requirements. Previous month, Commission unveiled a bundle of tweaks to the EU AI Act—dubbed the digital omnibus on AI—which in turn would push back the moment when duties for providers of high‑risk AI systems begin to apply. This long‑anticipated hold‑up stems from setbacks in drafting the technical standards needed to operationalise the rules for companies, and from slow progress in setting up competent national authorities. Yet the Commission’s chosen route has prompted a series of pressing and urgent queries, signalling increased legal uncertainty for businesses......
On 19 November 2025, the European Commission unveiled its Digital Omnibus on AI Regulation Proposal, a package of targeted measures designed to smooth the practical rollout of the EU Artificial Intelligence Act ( AI Act). At its core sits a conditional deferral tool that permits high‑risk AI duties to be postponed until the requisite harmonised standards, common specifications and Commission guidance are in place. For Annex III high‑risk AI systems, obligations would start six months after a Commission decision confirming the availability of such standards or guidance. For Annex I systems, including those within the MDR and IVDR, obligations would commence 12 months after that decision. If no decision is issued, the long‑stop dates are 2 December 2027 for Annex III and 2 August 2028 for Annex I. Impact on MDR/ IVDR—regulated AI systems The proposal directly affects AI‑enabled medical devices and IVDs. Because AI systems covered by the MDR and...
Two recent instances where claims breached the CAP code concern: (i) assertions about the health benefits of sunbeds; and (ii) whether you can state you are the number one recommended skincare brand. Together, they highlight the dangers of making health claims without substantiation and of not clearly signposting proof for comparative statements. Case 1: Sun Retail Ltd t/a Indigo Sun The ASA upheld a complaint from an NHS doctor that Indigo Sun’s advertising was misleading and irresponsible, and that it cited research out of context. On its website, Indigo Sun hosted a video titled ‘ The Health Benefits of Tanning’ which asserted that moderate, responsible sunbed use delivers significant health advantages, such as vitamin D generation and lower mortality than in people who had never used sunbeds. To support its mortality claims, the ad referred to a University of Edinburgh study. The ruling found the ad...
In this issue: Data protection and life sciences Research and development Intellectual property Medical devices Pharmaceuticals—regulatory framework Advertising of medicines Daily and weekly news alerts New and updated content Trackers Useful information Data protection and life sciences Digital Omnibus proposal—re-writing the EU’s digital rulebook In recent years, the EU has introduced digital laws at almost the same speed as the technologies they are intended to govern have evolved. Worries about excessive regulation and rules that overlap or even clash have prompted the European Commission to reconsider its strategy and seek to lighten the load of digital compliance. On 19 November 2025, the Commission unveiled its Digital Omnibus proposal. It sets out two principal proposals: the first delivers ‘quick fixes’ to address several pressure points in the EU AI Act; the second, a more extensive package, updates the data...
European Union Dual regulatory framework The MDR and IVDR set out requirements addressing risks linked to medical device software; yet they do not expressly cover risks unique to AI systems. The AIA complements the MDR/ IVDR by introducing obligations that target hazards and risks to health, safety, and fundamental rights that are specific to AI. This combined application obliges manufacturers to achieve compliance with both frameworks concurrently. Manufacturers of MDAI may choose, where appropriate, to incorporate the necessary testing and reporting activities, as well as the information and documentation required for their MDAI, into the documentation and procedures already established under the MDR/ IVDR. In practice, alongside the MDR/ IVDR and the AIA, numerous other EU regulations will often apply to these devices. With this in mind, streamlining and aligning the various processes is of paramount...
Igors Veliks, formerly at Playtech, and his current employer, Realtime Latvia, persuaded the appeal court that the betting company lacks any entitlement to sue them in England. The judges held that any harm arising from the supposed commercial deception occurred beyond the UK, and they set aside a High Court ruling that had favoured Playtech. The court concluded that most of the loss said to stem from Veliks’ alleged misuse of trade secrets took place in Latvia, where Playtech is headquartered. As a result, assessment of damage falls to the Latvian courts, not to the English courts. Playtech maintained it had suffered a downturn in UK licensing income because of the alleged misappropriation of trade secrets, but the appeal court rejected that contention. The court noted: “ This pleading is concerned only with the indirect consequences for Playtech of the...
On 19 November 2025, the Commission unveiled its Digital Omnibus proposal. It comprises two principal strands: one delivering ‘quick fixes’ to pain points in Regulation ( EU) 2024/1689, the EU AI Act, and another, more intricate, amending the data acquis, most notably Regulation ( EU) 2016/679, the EU General Data Protection Regulation ( EU GDPR), Directive 2022/58/ EC, the e Privacy Directive, and Regulation ( EU) 2023/2854, the EU Data Act. The headline items are delays to the high-risk AI rules under the EU AI Act, and a fresh EU GDPR lawful basis of legitimate interest for processing personal data when developing or operating AI systems (with safeguards). There is much to absorb—just as we get to grips with the new regime, changes are proposed, some bound to be disputed while others will be seen as eminently sensible. Here we outline the key...
In this issue: Confidentiality Data protection and life sciences Intellectual property Research and development Medical devices Pharmaceutical framework Daily and weekly news alerts New and updated content Trackers Useful information Confidentiality Court of Appeal sets out the approach to confidentiality and corrections in FRAND litigation ( Inter Digital Inc v Optis Cellular Technology LLC) This Court of Appeal ruling explains how UK courts should treat confidentiality in patent disputes, particularly in fair, reasonable and non‑discriminatory ( FRAND) matters. Notably, it accepts that affected non‑parties, such as third‑party licensees, have a right to be heard on confidentiality questions. The court confirmed that a wide range of confidential material may properly be redacted, and emphasised that a licence’s age or expiry does not, of itself, remove commercial value or the need for protection. Such material can be protected where a balancing exercise shows a likelihood of commercial harm from disclosure. It also articulated a single legal test for...
In this issue: Confidential information Medical devices Pharmaceuticals—regulatory framework Research and development Commercialisation Daily and weekly news alerts New and updated content Trackers Useful information Confidential information Company Director held personally liable for misuse of confidential information ( Kieran Corrigan v One E Group) This High Court ruling followed a claim for misuse of confidential information against a company and three of its directors. At first instance, the court found the company and two directors liable, while the remaining director, Mr Timol, was not. Owing to late disclosure of pertinent documents, the Court of Appeal directed a re‑trial of the claim against Mr Timol. At the re‑trial, he was held personally responsible for breach of confidence. The court determined that, having obtained confidential material in circumstances creating a duty of confidence, any subsequent misuse breached that duty, even if he was...
What are the practical implications of this case? Inter Digital Inc and other companies v Optis Cellular Technology LLC and others [2025] EWCA Civ 1263 delivers clear direction for those engaged in patent litigation, extending to third parties with a stake in confidential material at issue. Notably, it was the non-parties—rather than Apple and Optis—who sought permission to appeal the High Court decision. The court’s acknowledgement of third-party rights may prompt greater participation by non-party stakeholders where disputes turn on third party licences. By backing a single approach to redactions and outlining how factual mistakes can be corrected, the court has sharpened understanding of the treatment of confidential information in UK proceedings. Even so, the judgment stresses that any departure from open justice must be exceptional and justified by compelling reasons, so applicants must articulate and justify their proposals. Citing his reasoning in Unwired Planet v...
In this issue: Pharmaceuticals—regulatory framework Medical devices Pricing and reimbursement Research and development Advertising of medicines Intellectual property Lex Talk®Life Sciences: a Lexis®Nexis community Daily and weekly news alerts New and updated content Trackers Useful information Pharmaceuticals—regulatory framework The Medicines and Healthcare products Regulatory Agency ( MHRA) has released a policy paper setting out plans for a new regulatory model to accelerate the development and authorisation of rare disease treatments. Created with input from the newly formed Rare Disease Consortium, the framework is due to be finalised in 2026, following a public consultation slated for early 2026. See: LNB News 05/11/2025 60. The European Federation of Pharmaceutical Industries and Associations ( EFPIA), together with eight other healthcare associations, has challenged the European Chemicals Agency’s ( ECHA) approach to its proposed universal...
In this issue: Competition in life sciences Medical devices Research and development Commercialisation Disputes and regulatory enforcement Daily and weekly news alerts New and updated content Trackers Useful information Competition in life sciences Teva, Cephalon cannot overturn €60m fine in pay‑for‑delay case Law360, London: On 23 October 2025, Europe’s highest court confirmed a €60.5m penalty against Teva and its acquired business Cephalon, holding that their pay‑for‑delay accord curtailed competition by preventing a lower‑priced generic for a blockbuster narcolepsy medicine from reaching the market. See: Teva, Cephalon cannot overturn €60m fine in pay‑for‑delay case. Judgment Alert: Teva Pharmaceutical Industries Ltd v Cephalon Inc, ECLI: EU: C:2025:825 The Court of Justice of the European Union ( Fourth Chamber) rejected the appeal brought by Teva Pharmaceutical Industries Ltd and Cephalon Inc against the General Court’s ruling, which had refused their...
The European Court of Justice upheld the General Court’s view that a value transfer from Cephalon to Teva, arising from an agreement concluded before Teva’s 2011 acquisition of the branded drugmaker, served as an inducement for Teva to delay launching its generic modafinil, used to treat sleep disorders such as narcolepsy. The ECJ stated that the General Court was entitled to classify the arrangement as a restriction of competition by object. In 2020, the European Commission imposed fines on Teva and Cephalon after determining in 2017 that they had entered a pay-for-delay deal, which postponed the introduction of Teva’s generic version of modafinil, sold as Provigil......
The Commission is considering changes to how products regulated under EU sectoral product safety laws are covered by the EU’s AI law As part of a broader effort to streamline digital rules, MLex has learned that the Commission is weighing revisions to the AI law’s treatment of goods already subject to EU sectoral product safety regimes. The potential adjustment, being worked into the Commission’s planned digital ‘omnibus’ package due on 19 November 2025, may reduce compliance obligations for areas such as medical devices and industrial machinery. The EU’s AI Act sets a rigorous due diligence framework for AI systems that present significant risks to people’s health and fundamental rights......
In this issue: Disputes and regulatory enforcement Medical devices Pharmaceuticals—regulatory framework Commercialisation Research and development Advertising of medicines Daily and weekly news alerts New and updated content Trackers Useful information Disputes and regulatory enforcement Judgment Alert: R (on the application of Medis Pharma Ltd) v NHS Resolution [2025] EWHC 2616 ( Admin) In the King’s Bench Division, Administrative Court ( London), the Claimant’s judicial review of a Primary Care Appeals decision—provided by the Defendant—was dismissed. The claim targeted the 25 November 2024 decision declining inclusion in the pharmaceutical list for distance selling premises under the National Health Service ( Pharmaceutical and Local Pharmaceutical Services) Regulations 2013, SI 2013/349, reg 25. The court concluded the committee’s decision was neither irrational nor inadequately reasoned. It was open to the committee to find the application failed to set out sufficient safeguards for the safe delivery of...
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When evaluating a general damages claim, the practitioner ought initially to refer to the Judicial College Guidelines (JCG)...
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...
Date [ date ] Parties [ name of Landlord ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Landlord) [ name of Tenant ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Tenant) [ [ name of Guarantor ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Guarantor) ] [ [ name of Mortgagee ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Mortgagee) ] Definitions Within this Deed, the terms below shall be interpreted as follows: [ Annual Rent • the annual sum reserved under the Lease; ] [ Insurance Rent • the Tenant’s share of the Landlord’s costs of insuring the Property (as set out in the Lease); ] Lease • the lease of the Property dated [ date ], entered into between (1) [ the Landlord OR [ name ...
I, [ name ], of [ address ], solemnly and sincerely state that: [ Matters to be verified, set out in numbered paragraphs ] I make this solemn statement in good conscience, believing it to be true, and pursuant to the provisions of the Statutory Declarations Act 1835. DECLARED at [ details ] this [ day ] day of [ month and year ] Before me ................................................................................ [ signature of the person before whom the declaration is made ] A [ commissioner for oaths OR [ solicitor OR [ insert other qualification ] ] authorised to administer oaths ]...
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