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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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What is personalised medicine Personalised medicine has been part of clinical practice for quite some time. Clinicians have, to differing degrees, tailored care to individual patients using information gathered about them. Over the last decade and a half, however, the emergence of systems biology has markedly broadened its scope; in contemporary practice it depends on collecting as much data as possible about a specific biological system under study. The aim is to interpret these collected datasets in ways that enhance understanding of a living system and its pathologies, ultimately enabling targeted interventions that are responsive to an individual patient or to groups of patients. It is often characterised as care that is ‘custom‑made’, set against the more traditional, ‘one size fits all’ model. Although many cell therapies, gene therapies and other advanced therapy medicinal products ( ATMPs) are regarded as...
Introduction to patent proceedings In England and Wales, patent disputes sit within the civil jurisdiction of the courts, which apply the substantive statutory framework — the Patents Act 1977 ( PA 1977), as amended — together with the common law, and decide cases in accordance with the procedural regime of England and Wales, as set out in the Civil Procedure Rules ( CPR). Actions for patent infringement are brought before the Patents Court or the Intellectual Property Enterprise Court ( IPEC), both of which are part of the Business and Property Courts of the High Court ( Chancery Division). The courts of England and Wales may grant remedies in patent matters at the pre-litigation stage, during proceedings, or on final disposal, and such relief may stem from powers granted by PA 1977, the common law, or by procedural rules. In awarding remedies, the courts must also...
Grounds of patent revocation Patents can be revoked (ie taken off the patents register) where they are found invalid in some respect. A revoked patent is treated as though it never existed. The statutory bases for revocation are contained in section 72 of the Patents Act 1977 ( PA 1977). These include that the invention is not patentable (eg it lacks novelty, inventiveness or industrial applicability) and that the specification fails to disclose the invention with sufficient clarity and completeness for a person skilled in the art to put it into effect. This deficiency is called ‘insufficiency’. This Practice Note focuses on patent invalidity arising from insufficiency. For details on other invalidity grounds, see the following Practice Notes: Patent invalidity—grounds of revocation Patent invalidity—obviousness Patent invalidity—lack of novelty Claim...
ARCHIVED —this archived case hub sets out the position as at the judgment dated 7 May 2021; it is no longer updated or maintained. See the timeline and related cases for detail and context. Case facts Outline Generics UK Limited v CMA (1251/1/12/16), Glaxo Smith Kline PLC v CMA (1252/1/12/16), Xellia Pharmaceuticals APS and Alpharma LLC v CMA (1253/1/12/16), Actavis UK Limited v CMA (1254/1/12/16) and Merck KGa A v CMA (1255/1/12/16) – all appeals before the CAT arising from the CMA’s decision of 12 February 2016 in Glaxo Smith Kline and others (paroxetine) ( CE/9531-11). Latest development On 10 May 2021, the CAT handed down a supplementary judgment which affirmed the CMA’s infringement finding, namely that: Generics ( UK) Limited and Alpharma were potential rivals of Glaxo Smith Kline PLC at the point they entered the settlement agreements; the settlement agreements were...
( OMPs) are medicines that help prevent, identify or treat rare illnesses and medical conditions. Because the number of people affected is very small, without incentives, pharmaceutical companies may doubt whether sales would cover the research and development ( R& D) costs of medical products to detect, prevent and treat such disorders. In the relevant EU law, 'rare' is defined as affecting fewer than five in 10,000 people in the EU. Yet most rare conditions impact fewer than one in 100,000 people. Although each individual rare disease is uncommon, they carry major public health importance and significance. There are thought to be more than 6,000 distinct rare diseases; so, while each is infrequent on its own, together they account for a substantial patient population, roughly one in every 12 people in the EU (all rare diseases combined). In the absence of...
FORTHCOMING CHANGE: On 19 June 2025, the Data ( Use and Access) Bill obtained Royal Assent, becoming the Data ( Use and Access) Act 2025 ( DUAA 2025) and coming partly into force on that date. Parts 5 and 6 serve to amend aspects of UK data protection and e Privacy law, including the United Kingdom General Data Protection Regulation, Assimilated Regulation ( EU) 2016/679 ( UK GDPR), the Data Protection Act 2018, and the Privacy and Electronic Communications ( EC Directive) Regulations 2003, SI 2003/2426. Some DUAA 2025 provisions, covering matters such as dealing with data subject access requests and the conferring of power to make further regulations, came into immediate effect on 19 June 2025. Other provisions, addressing notices from the Information Commissioner and certain aspects of law enforcement processing, will take effect on 19 August 2025 (being two months from the date of...
Developers, manufacturers and distributors in digital health—spanning m Health apps and any associated Software as Medical Device ( Sa MD), artificial intelligence ( AI) system or Artificial intelligence as a Medical Device ( AIa MD)—must meet stringent data protection regulations in tandem with regulatory compliance across the entire lifecycle, from development through to commercialisation This Practice Note concentrates on data protection and privacy issues for m Health (mobile health) and also considers the tighter safeguards governing the collection of an individual user’s health data. It does not cover broader life sciences regulatory matters, such as those relating to medical devices What is m Health? For related guidance, see: Practice Note: Digital health—regulation of m Health apps and medical software. Practice Note: Mobile app development and data protection. Practice Note: Digital health—data protection and privacy case studies, including wearables and AI...
This Practice Note summarises the ( MMDA 2021). In short, it establishes a Commissioner for Patient Safety for matters concerning human medicines and medical devices, enables post-implementation updates to UK regulatory frameworks for medicines and devices, consolidates device enforcement, and permits information-sharing on devices. It sets out the legal context and objectives of MMDA 2021, charts its legislative progress, and reviews the principal provisions on human medicines, clinical trials and medical devices: Background and purposes of the Overview of the Part 2— Human medicines Part 4— Medical devices Timeline of legislative procedure and commencement This Practice Note does not detail the stages of secondary legislation made under MMDA 2021. For further analysis, see News Analysis: Analysing the . For notable secondary legislative developments under MMDA 2021, see Practice Note: Life sciences tracker— UK. Background and purposes of the A...
This Practice Note outlines the law on marketing authorisations ( MAs) for medicinal products intended for the UK market following the close of the Brexit transition period (11 pm ( GMT) on 31 December 2020, termed in UK law ‘ IP completion day’). It covers: exemptions from the need to hold an MA (eg ‘specials’, investigational medicinal products ( IMPs), and the Early Access to Medicines Scheme ( EAMS)) the various categories of MA the licensing pathways to secure an MA in the UK, Great Britain ( GB), or Northern Ireland ( NI) (eg Northern Ireland Medicines and Healthcare products Regulatory Agency ( MHRA) Authorised Route ( NIMAR), Innovative Licensing and Access Pathway ( ILAP), unfettered access, the 150‑day accelerated national procedure, rolling review, the reliance routes on EU authorisations now integrated into the...
This Practice Note outlines and explores the overarching principles that govern the advertising and promotion of medicinal products, together with the associated rules on how the pharmaceutical industry engages with healthcare professionals ( HCPs). Introduction to the advertising and promotion of medicinal products To safeguard public health, the advertising and promotion of medicinal products is subject to strict regulation and close oversight. The general rules for advertising and promoting medicinal products are: it is forbidden to advertise any medicinal product that does not hold a marketing authorisation ( MA) promotion of an authorised medicinal product must align with the particulars in the summary of product characteristics ( Sm PC) linked to the MA promotion of authorised medicinal products must not mislead and should foster the rational use of the product, presenting information objectively and without overstating its...
CASE HUB ARCHIVED This archived case hub sets out the position as at the judgment date of 8 September 2016 and is no longer being maintained. See further: timeline commentary relevant/related cases NOTE—appeals lodged by Lundbeck and others at the Court of Justice (see below) Case facts Outline Actions before the General Court seeking annulment and/or a cut in the fines levied following the Commission’s 19 June 2013 decision which found four breaches of Article 101 TFEU and Article 53 of the EEA Agreement, and imposed total penalties of €146m on Lundbeck and generic manufacturers for concluding agreements that postponed the market entry of generic citalopram in the EEA (“pay-for-delay”). On 8 September 2016, the General Court rejected in full the claims brought by Lundbeck and the generic companies, thereby upholding the Commission’s infringement findings and the combined €146m fines on Lundbeck and the...
A– B | C– D | E– H | I– N | Q– V. Officinal formula Some medicinal products are exempt from the rule that an MA must be secured before marketing. An MA is unnecessary for medicines prepared within a pharmacy, in line with a pharmacopoeial prescription, which are intended for direct supply to patients served by that pharmacy. This is referred to as the officinal formula. See also: Magistral formula Practice Note: Unlicensed medicinal products and off-label use of medicinal products— Exemptions under Article 3 of the Pharmaceutical Code and equivalent provisions of the Medicines Act 1968 and Human Medicines Regulations 2012 Off-label The deliberate use of an authorised medicinal product outside the conditions of its MA (for example, a different indication, an alternative dose, or in another patient population). For medical devices, use is off-label where the device is employed in a manner other than that set...
A– B | C– D | I– N | O– P | Q– V. Early access to medicines scheme Through the early access to medicines scheme ( EAMS), the Medicines and Healthcare products Regulatory Agency ( MHRA) permits patients with life‑threatening or seriously disabling conditions to obtain medicines that do not yet possess a marketing authorisation ( MA) (or are not authorised for that use) where there is a clear and evident unmet medical need. For further details, consult Practice Notes: UK marketing authorisations for medicinal products— Early access to medicines scheme ( EAMS)—exemption, and Unlicensed medicinal products and off‑label use of medicinal products— Early access to medicines scheme ( EAMS)— UK regime, plus MHRA guidance: Apply for the early access to medicines scheme ( EAMS). EFPIA Code The EFPIA Code is a set of industry self‑regulatory ethical standards that govern the promotion of...
A– B | C– D | E– H | I– N | O– P. Qualified person ( QP) The qualified person ( QP) must confirm that every batch of medicinal products is manufactured and checked in line with UK or EU Member State law and in keeping with the marketing authorisation ( MA) terms. See also: batch release marketing authorisation ( MA) medicinal product Practice Note: Manufacturing of medicinal products for human use Qualified person for pharmacovigilance ( QPPV) A qualified person for pharmacovigilance ( QPPV) is the individual who, by law, holds personal responsibility for the safety of a human medicinal product. See also: adverse reaction marketing authorisation ( MA) medicinal product Practice Note: Pharmacovigilance Rare disease See: orphan medicinal product ( OMP)......
This Practice Note looks at product liability in the life sciences sector It centres on the strict liability framework in Directive 85/374/ EEC (the Product Liability Directive ( PLD)), its update by Directive ( EU) 2024/2853 taking effect from December 2026, and the Consumer Protection Act 1987 ( CPA 1987), and explores how these interact with the pharmaceutical and medical devices regulatory regimes. The proposed EU AI Liability Directive ( AILD) and its implications are addressed. The Note outlines the statutory elements for establishing liability for defective products, the statutory defences available, and the forms of redress open to an injured party. It further examines responsibility arising from off‑label use of medicines and medical devices, and liability issues in the context of clinical trials. The UK’s product liability architecture predominantly originates in EU law. Numerous EU-derived principles and obligations have been carried over into UK...
The life sciences arena sees substantial, high-value merger and acquisition ( M& A) activity. This Practice Note outlines the factors fuelling deal flow and highlights the principal issues legal counsel should consider when advising parties to such transactions. For these purposes, the life sciences sector is taken to include pharmaceuticals, health-focused biotechnology products and medical devices. This Note concentrates on issues that recur in life sciences M& A and on matters that typically carry more significance here than in other industries. Industry-specific considerations shape almost every element of a life sciences M& A transaction, including: due diligence structuring the deal consideration the purchase agreement transition arrangements Before examining these aspects, it is useful to reflect on the elements that have supported robust deal activity in the industry in recent years. Drivers of M& A...
New starter guide This introductory guide sets out the Life Sciences practice area, the legislative and regulatory architecture governing the sector, and the range of matters life sciences lawyers handle. It is designed for trainee solicitors and newcomers to the field. It includes: An overview of the life sciences sector Life sciences glossary What do life sciences lawyers do? Core topics in life sciences Q& As Further reading materials Key external links for life sciences lawyers The guide is intended to help you get the best from Lexis®+ UK life sciences resources by showing you how to locate them, register for daily and weekly news alerts, access Q& As and submit a question to the Lexis Ask team. If something is not addressed by this basic guide, use the Topics tab or Topics dropdown to explore...
ARCHIVED : This Practice Note has been archived and is not maintained. This Practice Note examines how the UK’s departure from the EU influences the application of Regulation ( EU) 1215/2012, Brussels I (recast), when determining jurisdictional disputes. It addresses: the applicable provisions in the Withdrawal Agreement between the UK and the EU; relevant domestic legislation, including, where relevant, transitional provisions, together with the position of the EU Commission; the implications of the UK becoming a third state as a consequence of leaving the EU. It should also be noted that other jurisdictional regimes are affected by the UK leaving the EU. For guidance, see Practice Note: Brexit post implementation period—considerations for dispute resolution practitioners— Jurisdiction. For specific guidance on the position during the implementation period, see Practice Note: Brexit implementation period—jurisdiction [ Archived]......
This Practice Note explores jurisdiction agreements (choice of court agreements): what they achieve, why they are adopted, and comparable arrangements pursuing the same objective. It outlines the main categories of jurisdiction agreement together with remedies available if one is breached. For assistance distinguishing the different types, see: Determining court jurisdiction—overview. It is likewise essential to grasp the operation of any formal jurisdictional regime. For insight into which regimes may apply, see Practice Note: Jurisdiction rules. A principal regime is the Hague Convention on Choice of Court Agreements. That convention applies between the UK and other contracting states in proceedings where the parties have entered into an exclusive jurisdiction agreement... What is a jurisdiction agreement? A jurisdiction agreement is the parties’ undertaking specifying which court(s) will have authority to determine disputes that could arise between them. For clarity on the concept of...
Contract Where an agreement is entered into by two or more parties, it may include a promise or obligation undertaken by two or more of them. Any such promise may be: joint several joint and several Whether an undertaking in contract is joint, several, or joint and several is a matter of construction, depending on the parties’ intention as revealed by the terms of the contract. For example, in Rhinegold Publishing v Apex Business Development, statutory demands were issued against Rhinegold Ltd and a related company, Tannhauser Ltd, for approximately £22,000 and £31,000 respectively. A settlement agreement followed under which the parties agreed to pay the sums due, but Tannhauser did not fully comply. Although the agreement was silent on liability, the High Court decided that, on a proper reading, the parties were jointly and severally liable. As a result, Rhinegold had to meet the...
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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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