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This Practice Note outlines the law concerning criminal recklessness. The subjective test for recklessness Certain statutory and common law offences allow the prosecution to prove mens rea through ‘recklessness’. Put simply, recklessness is where the accused takes an unjustified risk that results in unlawful harm or damage. The House of Lords in R v G reaffirmed the subjective approach to recklessness. Before R v G, two distinct tests were used, depending on the offence charged: Subjective recklessness from R v Cunningham: the prosecution had to establish that the accused personally foresaw the risk. Objective recklessness from R v Caldwell: the prosecution only needed to show that the risk would have been obvious to a reasonable person, without proving the accused themselves foresaw it. In R v G, the House of Lords concluded that the objective test could operate unfairly where a defendant did not foresee the
This Practice Note examines the remedy of rescission, explaining when and in what manner a contract can be unwound (at common law, in equity and under statute) and thereby terminated and brought to an end. It covers the consequences and effects of rescission, the principal grounds for setting aside an agreement (misrepresentation, mistake, undue influence, duress, non‑disclosure, fiduciary misdealing and bribery) and the main obstacles to claiming rescission—affirmation, the intervention of third‑party rights and the impossibility of restitution. For further guidance on rescission in the context of misrepresentation, see Practice Note: Misrepresentation—rescission as a remedy. There are many ways in which a contract may reach its end; see: Terminating contracts—how and when a contract ends—overview for a brief and accessible summary, with links to the related further practical guidance, including Practice Note: Termination and expiry of contracts. For a table
What is a res judicata? A res judicata is a determination by a court or tribunal with jurisdiction over the cause of action and the parties, which finally disposes of the issues decided so they cannot be litigated again by those bound, save on appeal. Final judgments entered by default or by consent fall within this concept, whereas rulings on purely procedural points and any decision lacking finality do not. The doctrine’s aim is to bring litigation to an end and shield parties from being harassed by the same dispute twice. in personam—binds the parties and their privies in rem—binds all persons, privy or otherwise (ie a judgment binding the whole world) A party may rely on res judicata: as an estoppel to defeat an opponent’s claim or defence; and/or as the basis of their own claim or
The offence of causing grievous bodily harm with intent Wounding or causing grievous bodily harm (GBH) with intent can be tried solely in the Crown Court on indictment. Elements of the offence Under the Offences against the Person Act 1861 (OATPA 1861), the prosecution must establish that the defendant unlawfully and maliciously: wounded with the intention of causing GBH, or caused GBH with that intention, or wounded intending to resist or prevent the lawful arrest or detention of any person, or caused GBH intending to resist or prevent the lawful arrest or detention of any person ‘Unlawfully’ and ‘maliciously’ Unlawfully The wounding or causing of GBH must be unlawful. Such conduct may be lawful if used: in self-defence in defence of another in defence of property for the prevention of crime where the victim gave express or implied consent For further information on these defences, see below:
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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 De Puy and Gee v De Puy, 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...
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: Fibro Gen Inc v Akebia Therapeutics Inc; Astellas Pharma Inc v Akebia...
This Practice Note is designed to monitor the progress of EU cases relevant to the life sciences industry. For earlier life sciences materials, see Practice Note: Life sciences tracker [ Archived]... Judgments- Supplementary protection certificates For archived supplementary protection certificate ( SPC) judgments, see Practice Note: Life sciences tracker [ Archived]- Judgments- Supplementary protection certificates... Court of Justice of the European Union What's happening? When? Find out more Teva BV and Teva Finland Oy v Merck Sharp & Dohme LLC; Merck Sharp & Dohme LLC v Clonmel Healthcare Limited - Joined Cases C-119/22 and C-149/22 19 December 2024: preliminary ruling of the Court of Justice ( Third Chamber) issued. 6 June 2024: Opinion of the Advocate General ( AG). 21 February 2022: reference made to the Court of...
This Practice Note This Practice Note monitors the development of amending legislation, implementing acts, core guidance and initiatives introduced to help stakeholders apply the EU regime for medical devices and in vitro diagnostic medical devices ( IVDs) contained in Regulation ( EU) 2017/745 (the Medical Devices Regulation, MDR) and Regulation ( EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation, IVDR) (together, the MD Regulations) across all EU Member States as well as Norway, Iceland, Liechtenstein and Turkey. For a high-level overview of the MD Regulations and their obligations, see Practice Note: Introduction to the EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation. This tracker draws on material hosted on the European Commission— Public Health website— Medical Devices sector, comprising: guidance documents endorsed by the Medical Device Coordination Group ( MDCG) MDCG guidance in progress the rolling plan of implementing measures under the MDR and IVDR (the...
This Practice Note monitors the development of UK legislation brought forward under the legislative programme linked to the UK’s departure from the EU. It also features a Brexit SI database that compiles details of both draft and made secondary legislation related to Brexit. Quick links Use the links below to go directly to the relevant section or tracker. Practice area trackers Follow the links below for trackers focused on Brexit legislation across specific practice areas: Commercial Corporate Crime Dispute Resolution Employment Energy Environment Financial Services Information Law Intellectual Property Life Sciences Local Government Pensions Property R& I Tax For further updates and guidance tailored to individual practice areas, see: Brexit collection......
Under English law, binding agreements may arise orally, in writing, or by deed. This Practice Notice explores when a deed is required or preferable, and the formalities that must be observed to ensure validity. What is a deed? When a deed is required Formalities (1): in writing Formalities (2): face value Formalities (3): execution Formalities (4): delivery Escrow Witnessing Variation Failure to comply with formalities and other defects Reform For details on executing deeds in jurisdictions outside England and Wales, see Practice Note: Execution of deeds—jurisdictional guide. We have created a comprehensive, interactive collection to help users identify and navigate concepts and common issues in executing documents, including deeds. Each phase includes practical guidance, precedent clauses and Q& As relevant to that stage. For further information, see: Execution...
This Practice Note outlines how the UK regulates artificial intelligence ( AI) under its National AI Strategy, spotlighting the proposed pro-innovation approach to AI regulation set out in the UK White Paper, and providing an overview of the relevant approach and guidance across key sectors. For more on AI and its regulation, see Practice Notes: Artificial intelligence and machine learning—an introduction to the technology Artificial intelligence—data protection Artificial intelligence—explainability Artificial intelligence—intellectual property Artificial intelligence in the workplace Artificial intelligence in the EU—the key legal issues Contractual considerations for the procurement of artificial intelligence—checklist To track major legal developments relating to AI, see Practice Notes: UK artificial intelligence—tracker and EU Artificial intelligence—tracker. The UK’s National AI Strategy AI is a swiftly developing technology with significant potential to reshape industries, drive economic growth, and influence many parts of society. The...
Practice Note This Practice Note monitors and distils EU regulatory law, guidance and wider policy activity across the agriculture and food arena. Specifically, it captures every open, concluded and forthcoming consultation, evaluation and proposal linked to guidance, code of practice and legislation in the agriculture and food sphere. Priority files include overhauls of the EU Geographical Indications regime for wine, spirits and agricultural products; updates to EU marketing standards for agricultural products; changes to the EU Food Information to Consumers ( FIC) Regulation; and a review of promotion policy for EU agri-food products. It further tracks Court of Justice matters relevant to agriculture and food. EU food policy seeks to deliver robust food safety and strong animal and plant health across the EU. Through the Common Agricultural Policy ( CAP), agricultural policy likewise supports food safety, affordable food for EU citizens, fair incomes for farmers and the...
This Practice Note functions as a reference point to contrast the principal provisions of the current UK framework for medical devices; the EU framework as set out in the Medical Devices Regulation ( MDR), Regulation ( EU) 2017/745, and the In Vitro Diagnostic Medical Device Regulation ( IVDR), Regulation ( EU) 2017/746, respectively; and the proposed UK reforms. On 25 November 2021, the Medicines and Healthcare Products Regulatory Agency ( MHRA) closed its public consultation on proposed updates to UK medical device regulation (see: LNB News 16/09/2021 90). The government’s reply was published on 26 June 2022. It also confirmed an intention to advance the vast majority of proposals, which collectively underpin the comparisons in this Practice Note. See News Analysis: A closer look at MHRA’s proposals on future regulation of medical devices in the UK. Progress in laying the new...
Patents can be revoked (ie struck from the patents register) if, in any respect, they are found invalid. Once revoked, a patent is treated as though it never existed. The statutory grounds are prescribed in section 72 of the Patents Act 1977 ( PA 1977). One such ground is that the invention is not patentable. Under PA 1977, s 1, an invention is patentable only if it: is novel (ie not ‘anticipated’) entails an inventive step (ie not ‘obvious’) can be applied industrially is not excluded under PA 1977, s 1(2)–(3) or s 4A This Practice Note focuses on invalidity arising from a lack of inventive step, often called patent obviousness. For guidance on other revocation grounds, see the Practice Notes: Patent invalidity—grounds of revocation Patent...
The criminal regulatory landscape How does criminal law intersect with the life sciences industry? The points of contact are numerous. Beyond offences against the person and controlled drugs offences, a range of corporate or ‘white collar’ crimes can affect both individuals and companies, such as counterfeiting, criminal cartel offences, money laundering, fraud and bribery. Breaches of the sector’s regulatory framework-including rules on medical devices, and on inducements and hospitality-can equally give rise to criminal liability. Criminal investigations and prosecutions may, though do not invariably, follow. This Practice Note outlines how criminal law may operate in the life sciences arena. It addresses corporate crime liability, money laundering, fraud, anti-bribery, and inducements and hospitality in the promotion of medicinal products and medical devices, as well as enforcement. It also examines the effects of, and duties created for, life sciences businesses by the Economic Crime and...
What are pharmaceutical incentives? In the EU, protection mechanisms and incentives for medicinal products, grouped under the term pharmaceutical incentives ( PIs), are in place. PIs comprise legislative measures that give originator pharmaceutical companies (originators) a degree of advantage over companies selling medicines with the same active substance at far lower prices (generic or biosimilar companies)-ranging from market protection ( MP), through extensions of patent rights, to several years of market exclusivity for a medicinal product. Rationale behind PIs PIs were introduced in the EU to encourage and support originators in discovering and developing new medicinal products. While innovation and discovery typically require considerable time and financial investment, only limited effort is needed to use the knowledge generated afterwards. When a generic or biosimilar company reproduces an invention, it often does not bear the substantial research and development ( R& D) costs of creating it and can...
Also produced in partnership with contributions from Marylis Clerc of Bird & Bird and Sapna Palla of White & Case LLP. What are paediatric medicines and why do we need them? Paediatric medicines are medicinal products intended for children from birth up to, but not including, 18 years of age. For decades, research and development in this field was minimal. Numerous medicines were neither studied nor authorised for paediatric use, leaving clinicians to modify adult formulations and doses using their own judgement. Unsurprisingly, such widespread off‑label prescribing brought a higher risk of poor efficacy and adverse reactions in children. According to a report by the European Medicines Agency ( EMA), despite limited available data, harm did occur and was frequently underreported. Several factors explain the lack of paediatric R& D, including the view that enrolling children in clinical trials was unethical. Creating medicines for younger patients is also far more...
ARCHIVED: This Practice Note is archived and is not being maintained. It acted as a reference resource to track EU– UK divergence in legislation and guidance relevant to the life sciences sector from the close of the Brexit implementation period (eg 31 December 2020) following the UK’s decision to leave the EU, through to 2023. Where relevant, it also highlighted principal areas of divergence within the UK itself (between Great Britain ( GB) and Northern Ireland ( NI)). For the purposes of this Practice Note, ‘divergence’ means differences in legislation, guidance or mandated standards arising after IP completion day (11 pm on 31 December 2020). A parallel framework that is identical or materially the same would not amount to ‘divergence’. See also the related Practice Notes: Post- Brexit transition period-the regulation of medicinal products What does IP completion day mean for Life...
Post-market surveillance Post-market surveillance refers to manufacturers’ ongoing oversight of medical devices to confirm they remain safe and effective for patients once authorised and placed on the market. Its aim is to detect whether corrective or preventive safety actions are needed. While the former regulatory framework under the medical device directives did impose compliance duties, it faced criticism for lacking rigour in tracking safety when products are actually used by patients, and for failing to feed that experience adequately into the official safety profile and continuing authorisation. The device scandals involving Poly Implant Prothése ( PIP) breast implants in the early 2000s, followed by a widespread hip implant crisis that harmed hundreds of thousands of patients across multiple countries, exposed the shortcomings of a safety certification regime unevenly carried out by different Notified Bodies, and triggered a comprehensive overhaul of medical device...
This Practice Note Use this Practice Note to monitor the status of EU legislative proposals and active consultations impacting the life sciences sector. For matters focused on the medical devices regulatory regime, its guidance and continuing reform, refer to the Practice Notes: The EU MDR and IVDR implementing acts and guidance tracker, and Medical devices- UK and EU regimes comparison. For pricing and reimbursement developments for medicines and innovative technologies under the Health Technology Assessment ( HTA) Regulation ( EU) 2021/2282 (the HTAR)-which has applied on a rolling basis since 12 January 2025-and for ongoing implementation via secondary legislation, guidance and industry input, see Practice Note: Health Technology Assessment in the EU, especially the sections: Horizon scanning-2026 and beyond, Tracker-log of HTA reform developments and important dates by reverse chronology, and Rolling implementation overview... Other related specific and topical trackers not covered here...
This Practice Note offers guidance on the EU regulatory landscape and the developing UK framework for vapour products and e‑cigarettes in the wake of Brexit and after IP completion day (eg 31 December 2020, the close of the Brexit implementation period). What are vapour products? Under EU and UK law, vapour products (often referred to as ‘e‑cigarettes’ or ‘e‑cigs’, ‘vapourisers’ or ‘vapes’) are characterised as products that can generate an inhalable aerosol containing an active ingredient, typically nicotine or a cannabinoid ( CBD), through a mouth piece. Vapour products function by heating a solution (e‑liquid) that generally contains nicotine, propylene glycol and/or vegetable glycerine, flavourings, and the active ingredient (eg nicotine, CBD). E‑cigarettes do not contain tobacco (ie leaves and other natural processed or unprocessed parts of tobacco plants), and do not burn or produce the products of combustion associated with smoking, including carbon...
What is a technology transfer agreement? The phrase ‘technology transfer agreement’ operates as a catch-all for numerous contractual forms designed to govern the handover of ownership, or permission to use, a specific technology from one entity to another. Such agreements are essential mechanisms to enable the efficient utilisation of established technologies and to foster the creation of new ones through collaboration among academic and commercial organisations across the life sciences sector. This Practice Note examines technology transfer agreements, with particular attention to additional clauses that hold special relevance for life science industries. It therefore concentrates on supplementary provisions that are especially significant for stakeholders active in this space. A wide range of life science outputs can be protected by patents. Illustrations include biological materials, manufacturing methods, and their therapeutic applications, among other relevant examples in this domain. Given the...
This archived case hub captures the position as at the decision of 3 February 2022; it is no longer maintained. See further: timeline, commentary and related cases. Case facts Outline CMA Article 101 TFEU/ Chapter I inquiry into Alliance, Focus, Lexon and Medreich, concerning an alleged non-compete arrangement for the supply of prochlorperazine 3mg buccal tablets in the UK. Latest developments On 18 October 2022, the High Court ordered that the competition law issues in the CMA’s director disqualification proceedings be transferred to the CAT. The High Court will await the CAT’s decision before advancing the CMA’s disqualification case. At a case management conference on 14 November 2022, the CAT made case management directions addressing the transferred part of the disqualification proceeding. Parties Alliance Pharmaceuticals Limited and Alliance Pharma plc (together, Alliance). Alliance is an international pharmaceutical company listed on AIM. Alliance’s expertise lies in acquiring and...
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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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