Featured documents
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 Sole traders, informal partnerships and outdated partnership deeds are common.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
Most recent News
The Health Research Authority ( HRA) has unveiled its 2026–28 strategy, outlining how it will support AI use across health and social care research, whilst ensuring suitable protections and safeguards are appropriately maintained......
Med Tech Europe has issued its reply to the European Commission’s consultation on revising the EU Cybersecurity Act, endorsing enhanced EU cybersecurity resilience overall whilst urging an appropriately balanced framework tailored to the healthcare sector......
The European Commission’s Joint Research Centre ( JRC) has released three complementary studies on bioinformatics quality assurance for genomic surveillance, highlighting ramifications for nascent regulatory frameworks. The JRC noted that the COVID-19 pandemic revealed rapid genome sequencing often put speed before consistency, elevating the likelihood of flawed outcomes that might impact diagnostics, epidemiological modelling, and vaccine development......
Section 6 of the Victims and Prisoners Act 2024 supersedes VPA 2024, s 17, scrapping the prior constraint that protected disclosures had to be made to particular recipients for specified purposes. Any term in any agreement, including commercial non-disclosure agreements ( NDAs), is void to the extent it seeks to stop a victim, or someone who reasonably believes they are a victim, from revealing relevant criminal conduct-or the counterparty’s reaction to it-to anyone, for any purpose. The new provision binds the Crown, subject only to a tightly drawn national security exception. This analysis examines how these reforms align with existing common law limits on confidentiality and their consequences for standard commercial NDA templates. It is written by Richard Hanstock, a barrister at Cornerstone Barristers and the founder of Deeptech Legal, an SRA-authorised firm specialising in cybersecurity, artificial...
The European Medicines Agency ( EMA), the European Commission, and the Heads of Medicines Agencies ( HMA)-the collective bodies behind the Accelerating Clinical Trials in the EU ( ACT EU) initiative-unveiled an updated ACT EU workplan......
In this issue: Pharmaceuticals-regulatory framework Medical devices Research and development Daily and weekly news alerts New and updated content Trackers and horizon scanning Useful information Pharmaceuticals-regulatory framework MHRA launches consultation on draft rare disease therapies framework The Medicines and Healthcare products Regulatory Agency ( MHRA) has opened a consultation on a draft Rare Disease Therapies Regulatory Framework. The plans would establish an Investigational Marketing Authorisation to permit controlled early access to rare disease treatments while further clinical and real‑world data are collected. The consultation closes on 30 July 2026. See: LNB News 21/05/2026 31. Commission publishes analysis proposing Biotech Act measures The European Commission has issued a staff working document outlining the analysis supporting its proposed Biotech Act, first unveiled in December 2025. Aimed at reinforcing Europe’s biotechnology and biomanufacturing base, with a strong emphasis on health, the Act intends to...
The European Commission has issued an internal working paper outlining the rationale that supports its planned Biotech Act, first unveiled in December 2025......
Global Health Resilience Initiative The European Commission has launched the Global Health Resilience Initiative, outlining a strategic blueprint for forthcoming EU measures aimed at delivering swifter reactions to worldwide health risks and emergencies......
Legal expert opinion on MDR Article 50 Team- NB, the European Association of Medical Devices Notified Bodies, has released a legal expert assessment finding that the draft Article 50 in the update to Regulation ( EU) 2017/745 ( Medical Device Regulation, MDR) would unlawfully encroach on the freedom to conduct a business guaranteed by Article 16 of the Charter of Fundamental Rights of the European Union ( CFREU). The assessment says that the contemplated measures-compulsory fee cuts, delayed payment terms and a potential duty on notified bodies to take on conformity‑assessment applications-are disproportionate and surpass what the Charter allows, even though they aim to assist small and medium‑sized enterprises, foster innovation, secure device supply and safeguard public health. It further maintains that the proposal transfers the financial load of these public‑policy aims to private notified bodies without compensation or sufficient cost...
In this issue: Intellectual property Data protection and life sciences Research and development Disputes and regulatory enforcement Medical devices Commercialisation/ Pricing, reimbursement and imports Daily and weekly news alerts New and updated content Trackers and horizon scanning Useful information Intellectual property Article 3(d) entitlement of an uncombined medicinal product (drospirenone) to an SPC ( Laboratorios Leon Farma SA v Comptroller) The court had to decide whether the Court of Justice’s ruling in Medeva ( Case C-322/10) prevents a supplementary protection certificate where the product was previously authorised only within a combination. It held that it does. Endorsing the IPO’s stance, the court found that an SPC for drospirenone could not be granted: because an earlier marketing authorisation covered drospirenone with oestrogen, the subsequent authorisation for drospirenone alone was not the first MA for that active. This...
Laboratorios Leon Farma SA v The Comptroller- General of Patents [2026] EWHC 663 ( Ch) What are the practical implications of the case? The outcome confirms that patentees still struggle to argue that a patented medicinal product merits an SPC where its active ingredient has already been the subject of an MA, even when that earlier authorisation related to a combination product. The judgment reaffirms the construction of Article 3(d) of Regulation ( EC) 469/2009 (the SPC Regulation). Notably, the court held that the converse of Medeva produces the same position: an earlier MA for a product containing ingredients A+B prevents a subsequent MA for ingredient A alone (and likewise B alone) from fulfilling the criteria for an SPC. In short, a prior combination MA blocks reliance on a later mono‑ingredient MA for SPC purposes, so the statutory requirements under Article 3(d) are not met in these...
In this issue: Commercialisation/ Pricing, reimbursement and imports Pharmaceuticals—regulatory framework Medical devices Research and development Advertising of medicines Daily and weekly news alerts New and updated content Trackers and horizon scanning Useful information Commercialisation/ Pricing, reimbursement and imports UK Government agrees US pharmaceutical partnership with tariff-free exports and pricing reforms The UK Government has settled the full text of a US– UK pharmaceutical partnership, spanning medicines and innovative medical devices and detailing changes to trade, pricing and access arrangements. The deal ensures UK pharmaceutical exports to the US—worth at least £5 billion each year—enter the US free of tariffs for a minimum of three years, making the UK the only country to secure 0% tariffs on pharmaceutical exports to the US, and brings stronger incentives for pharmaceutical companies to introduce new treatments in the UK. The agreement also extends preferential terms to medical device exports, with no additional new tariffs on medtech for at least three...
In this issue: Medical devices Research and development Pharmaceuticals—regulatory framework Competition in life sciences Data protection and life sciences Advertising of medicines Commercialisation Lex Talk®Life Sciences: a Lexis®Nexis community Daily and weekly news alerts New and updated content Trackers and horizon scanning Useful information Medical devices European Parliament adopts Digital Omnibus AI proposal on amending EU AI Act The European Parliament has set out its stance on revisions to the EU Artificial Intelligence Act, endorsing a postponement for certain high-risk AI obligations and backing a prohibition on AI ‘nudifier’ tools. To provide certainty and clarity, MEPs fix application dates: high-risk AI listed in the regulation applies from 2 December 2027; AI falling under EU sectoral safety and market surveillance regimes applies from 2 August 2028; and providers must meet...
In this issue: Intellectual property Data protection and life sciences Commercialisation Pharmaceuticals—regulatory framework Research and development Advertising of medicines Daily and weekly news alerts Trackers and horizon scanning Useful information Intellectual property KEY CASE Judgment Alert: Laboratorios Leon Farma SA v The Comptroller- General of Patents [2026] EWHC 663 ( Ch) The Chancery Division rejected Laboratorios Leon Farma SA’s ( Leon) appeal against the UK Intellectual Property Office ( UKIPO) decision refusing SPC application SPC/ GB22/02 for the oral contraceptive ‘ Slynd’, which has drospirenone as its sole active substance. The Recorder concluded the Hearing Officer was right to find Leon’s filing did not meet Article 3(d) of Regulation ( EC) 469/2009 (the SPC Regulation), which requires the marketing authorisation ( MA) relied on to be ‘the first authorisation to place the product on the market as a...
In this issue: Data protection and life sciences Medical devices Research and development Post-market Pharmaceuticals—regulatory framework Intellectual property Daily and weekly news alerts New and updated content Trackers and horizon scanning Useful information Data protection and life sciences MLex: The EU’s forthcoming biotech legislation must not dilute data protection standards for clinical trial participants, according to two EU data protection authorities. In a joint communication, the European Data Protection Board ( EDPB) and the European Data Protection Supervisor ( EDPS) endorsed efforts to harmonise clinical trial requirements and to establish a single legal basis for processing personal data under the European Biotech Act. However, they also outlined a range of measures to safeguard sensitive health and genetic information, such as clarifying codes for controllers, setting limits on data retention, ensuring coherence with the EU’s AI law, and...
Statement follows. EDPB and EDPS support harmonisation of clinical trials under European Biotech Act, but call for specific safeguards for sensitive health data Brussels, 12 March 2026— The European Data Protection Board ( EDPB) and the European Data Protection Supervisor ( EDPS) have issued a Joint Opinion on the European Commission’s Proposal for a European Biotech Act. The Proposal aims to reinforce Europe’s biotechnology and biomanufacturing sectors, particularly in health, by simplifying the regulatory landscape and updating the framework for clinical trials. The EDPB and the EDPS back the Proposal’s objective of strengthening the EU’s competitiveness and tackling existing fragmentation in the implementation of the Clinical Trials Regulation ( CTR). Notably, they welcome the intention to create a single legal basis for sponsors and investigators to process personal data, which would greatly improve legal certainty across Europe......
The UPC's Court of Appeal On 6 March 2026, the UPC’s Court of Appeal paused the patent infringement proceedings that Dyson Technology Ltd ( Dyson) had initiated against Hong- Kong-based rival hairdryer maker Dreame International ( Hongkong) Ltd ( Dreame) and a Spanish business acting in the EU as its ‘authorised representative’, in order to obtain guidance from the Court of Justice of the European Union on how the actions should progress. Dyson had requested that the UPC grant a preliminary injunction preventing Dreame from marketing hairdryers said by Dyson to infringe one of its patents across UPC territory, and also in Spain, which has never acceded to the EU’s patent court. The UPC’s Hamburg Division then issued an injunction restraining two Dreame companies, together with Eurep Gmb H ( Eurep) — described as an authorised representative for Dreame in Europe — from...
In this issue: Commercialisation Pharmaceuticals—regulatory framework Medical devices Data protection Research and development Lex Talk® Life Sciences: a Lexis®Nexis community Daily and weekly news alerts Useful information Commercialisation DHSC publishes response to NICE cost-effectiveness threshold consultation The DHSC has issued its reply to the consultation on proposed changes to the National Institute for Health and Care Excellence ( NICE) rules on cost-effectiveness thresholds. Released alongside the National Institute for Health and Care Excellence ( Amendment) Regulations 2026 and the accompanying explanatory memorandum, the amendments give ministers a narrow power of direction to set the standard cost-effectiveness threshold applied by NICE when preparing guidance, including technology appraisals and evaluations of highly specialised technologies. The revisions also remove the need for NICE to consult on procedural changes arising from ministerial directions. These measures will take effect on 24 March 2026. See: LNB News...
In this issue: Intellectual property Pharmaceuticals—regulatory framework Research and development Disputes and regulatory enforcement Daily and weekly news alerts Trackers and horizon scanning Useful information Intellectual property Medical device maker can’t revive stoma bag patent case Law360, London: On 19 February 2026, an ostomy care business was unable to resurrect its patent infringement claim, with the appellate court finding that a competitor’s drainable pouch for colostomy patients lacked key features protected by the patent. See: Medical device maker can’t revive stoma bag patent case. Tenets of patentability affected by the UK Supreme Court ( Emotional Perception v Comptroller of Patents UKIPO) On 11 February 2026, in a seismic ruling, the UK Supreme Court recalibrated how exclusions from...
The Court of Appeal rejected Salts Healthcare Ltd’s renewed bid to hold Pelican Healthcare Ltd responsible for infringing one of its ostomy bag patents, finding that the rival’s Moda Vi range did not include weld portions that run all the way to the base. Nonetheless, Justice Richard Arnold allowed Salts’ appeal on the novelty of one claim (which the earlier judge had set aside) and on pre‑transfer costs in the Intellectual Property Enterprise Court before the matter was then moved to the Patents Court. Salts began proceedings against Pelican in 2022, and later challenged a decision that had thrown out its allegation that the competitor was infringing one of its patents via its Moda Vi pouches. The trial judge also determined that one of Salts’ patented claims was invalid, but approved Salts’ amendments, the judgment records. Salts maintained that the......
Popular documents
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 ]...
Discover more from LexisNexis
