Life Sciences Law

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......

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...

This Practice Note is designed to monitor the advancement of UK legislative proposals, consultations, and other significant regulatory and governance updates affecting the life sciences sector at large. Alongside this, there are separate, topic-focused trackers covering developments on medical devices; pricing, reimbursement and commercialisation; UK block exemptions; and AI and digital health in the UK. For matters in these areas, refer to the trackers below: UK medical devices regulatory horizon scanner and tracker AI in life sciences and digital health tracker-UK UK pricing and reimbursement-horizon scanner and tracker UK block exemptions revision-tracker For a summary of key Life Sciences developments in the UK in 2025 and a forward look to 2026, see News Analysis: Life Sciences UK-key developments in 2025 and horizon scanning for 2026. For a consolidated view of all life sciences trackers, see: Trackers (Life...

This Practice Note outlines the law on product liability and defective goods under the Consumer Protection Act 1987 (CPA 1987). The Act places liability on producers of defective products. It examines what amounts to a defect for the purposes of the CPA 1987, which parties in the supply chain may face liability, the extent of that liability and any contributory negligence considerations, the categories of damages recoverable, and the defences available to a producer. It also reviews leading case law affecting the meaning of defect and the burden of liability under the CPA 1987, namely Wilkes v DePuy and Gee v DePuy, and notes plans for future reform in this field. Statutory framework CPA 1987 gave effect in UK law to Council Directive 85/374/EEC on liability for defective products (the EU Product Liability Directive or EU PLD). Part I of the CPA 1987 imposes strict...

This Practice Note tracks the development of UK cases of interest to the life sciences sector. Jump to: Judgments-Patents Judgments-Supplementary protection certificates Judgments-Medical devices and medicinal products Judgments-Trade marks For archived material on life sciences, see Practice Note: Life sciences tracker [Archived], and for UK cases from 2020 to 2022, see Practice Note: 2020–2022 [Archived]. For an exploration of the extent to which UK courts and tribunals remain bound by EU case law after the transition period, see Q&A: Are UK courts and tribunals bound by decisions of the Court of Justice of the European Union post-Brexit? Judgments-Patents For archived patents judgments, see Practice Notes: Life sciences tracker [Archived]-Judgments-Patents and 2020–2022 [Archived]. Supreme Court UKSC 2021/0209 Appeal from: FibroGen Inc v Akebia Therapeutics Inc; Astellas Pharma Inc v Akebia Therapeutics Inc [2021] EWCA Civ 1279 March 2024: Supreme Court hearing...

Confidentiality letter—private M&A—asset purchase—corporate seller Strictly private and confidential To: [ insert buyer name ] [ insert buyer address ] Date: [ insert date ] Dear [ insert buyer contact name ], Proposed acquisition of the business of [ insert name of business being acquired ] 1 Introduction 1.1 Further to our recent conversations, this letter concerns the intended disposal detailed herein by [ insert seller name ] (the Seller) of [ insert description of the business being sold ] (the Business), which trades under the name [ insert name of business being sold ] (the Business Name), on a going concern basis, together with [ insert description of the assets being sold ] (the Assets), to [ insert buyer name ] (or any member of its group of companies) (the Buyer) (the Proposed Acquisition). Each of the Seller and the Buyer constitutes a party and,...

STOP PRESS: On 19 June 2025, the Data (Use and Access) Bill secured Royal Assent, becoming the Data (Use and Access) Act 2025 (DUAA 2025), with parts of the legislation commencing on that day. Provisions of DUAA 2025 addressing issues such as dealing with data subject access requests, and conferring powers to make further regulations, began immediately on 19 June 2025, without any transitional period. Other sections, including notices issued by the Information Commissioner and selected elements of law enforcement processing, took effect accordingly on 19 August 2025 (two months after Royal Assent). For the most part, DUAA 2025’s measures will only commence once additional regulations, in the form of statutory instruments, are made to bring them into force. Parts 5 and 6 of DUAA 2025 introduce amendments to aspects of data protection and ePrivacy law in the UK, including the United Kingdom General Data...

[ insert address of sender ] Our ref: [ insert reference ] Your ref: [ insert reference ] [ insert address of recipient ] Date: [ insert date ] Dear [ insert organisation name ], 1 Further to our recent conversations concerning your assessment and appraisal of our [ patent application, (enclosed as Schedule 1 to this letter) and related material AND/OR know-how, (as described in Schedule 2 to this letter) ] ( Confidential Information ) for the purpose of [ insert purpose of discussions ] ( Purpose ). In consideration of our providing the Confidential Information to you and your directors, employees and professional advisers ( Authorised Persons ) [ and our payment to you of the sum of £1, receipt of which you acknowledge, ] you (for yourself and on behalf of your Authorised Persons) agree to the terms contained in this letter......

This Q&A proceeds on the basis that: the question relates to a business-to-business transaction the question relates to a contract drafted and negotiated in the conventional manner and is not an e-commerce transaction entered into between the parties via website terms and conditions the question relates to the execution of a simple contract the question relates to the law of England and Wales Contract formation General contract law principles apply to agreements formed virtually......

Brexit—Commercial For help with your query, please refer to the following: Brexit—contract clauses and resources—checklist [Archived] Clause: Brexit—warranty for commercial contracts clause [Archived] Clause: Territory definition For additional guidance, see: Brexit collection......

Background A statutory declaration is a solemn, formal affirmation of fact made other than for judicial proceedings. In practical application, the making of a statutory declaration is a recognised means of proving or evidencing matters of fact, and it is employed in non‑litigious proceedings, where, for those purposes, it fulfils the same role as affidavits do in litigious proceedings. Making a declaration We have been unable to identify any authority suggesting that statute sets restrictions on the person who may make a declaration......