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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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ARCHIVED : This Practice Note has been archived and is not maintained. This Practice Note examines how Brexit has influenced UK cybersecurity, with particular emphasis on the network and information systems legislation. It addresses: a snapshot of UK cybersecurity regulation before the end of the implementation period the origins of Directive ( EU) 2016/1148, the Network and Information Systems Directive ( NIS Directive), and how it was implemented in the UK the broad consequences of Brexit for the UK’s application of the NIS Directive what the end of the transition period means for relevant digital service providers ( RDSPs) a summary of effects on qualified trust services under Regulation ( EU) 910/2014 (the e IDAS Regulation) the impact of the transition’s end on UK– EU cooperation on cybersecurity The prominence of cybersecurity has been underlined by recent high-profile incidents affecting companies and public services. These have involved a wide array of attack...
This Practice Note outlines the UK regime governing cosmetics. It defines what counts as a cosmetic product and details the conditions for placing such products on the market in Great Britain ( GB) while safeguarding their safety. It also covers limits on particular ingredients, the prohibition on animal testing, the criteria for making cosmetic product claims, which bodies enforce the rules in the UK, and the applicable oversight mechanisms. The Practice Note further addresses the situation in Northern Ireland ( NI), which follows EU cosmetics requirements, insofar as that position diverges from the approach in the EU, where relevant. UK regulatory framework for cosmetics The UK framework largely stems from Regulation ( EC) 1223/2009 on cosmetic products, commonly referred to as the EU Cosmetic Products Regulation ( EU CPR). For material on the EU cosmetics regime, see Practice Note: Regulation of cosmetic products in the EU. The EU CPR...
This Practice Note This Practice Note is aimed at commercial lawyers who are not specialists in intellectual property ( IP). It introduces copyright and related rights in the UK, outlining what copyright is, how it comes to exist, and how to protect, transact, manage and exploit it. If you are a specialist IP lawyer, refer instead to the Copyright & associated rights—overview and Copyright disputes—overview, together with the documents they reference. Using this Practice Note This Practice Note is broadly arranged into five principal sections covering: Subsistence of copyright (copyright is not a registered right): eligibility of works, qualifying categories and qualification generally Maintaining copyright: the term of protection, copyright notices and policies Dealing with copyright in agreements: assignments, licences and collective licensing Asserting copyright: disputes, exceptions (permitted acts), defences and remedies for infringement Rights associated with copyright: moral rights and...
This Practice Note This Practice Note monitors how retained EU competition law is being superseded in the UK. It specifically addresses: the retained Vertical Block Exemption Regulation, Retained Regulation ( EU) 330/2010 (retained VBER), which has been replaced by The Competition Act 1998 ( Vertical Agreements Block Exemption) Order 2022, SI 2022/516 ( UK VABEO); the retained Motor Vehicle Block Exemption Regulation, Retained Regulation ( EU) 461/2010 (retained MVBER), now replaced by The Competition Act 1998 ( Motor Vehicle Agreements Block Exemption) Order 2023 SI 2023/586 ( MVBEO); the assimilated Technology Transfer Block Exemption Regulation, Assimilated Regulation 316/2014 (assimilated TTBER); the retained Research and Development Block Exemption Regulation, Retained Regulation ( EU) 1217/2010 (retained R& D BER), replaced by the Competition Act 1998 ( Research and Development Agreements Block Exemption) Order 2022, SI 2022/1271 (the UK R& D BEO); and the...
CASE HUB NOTE—appeals lodged before the CMA in Intas Pharmaceuticals Limited & Others v CMA (1414/1/12/21), Allergan plc v CMA (1407/1/12/21), Auden Mckenzie ( Pharma) Limited & Another v CMA (1413/1/12/21), Cinven ( Luxco 1) S.a.r.l (formerly Cinven ( Luxco 1) S. A.) & Others v CMA (1412/1/12/21) and Advanz Pharma Corp v CMA (1411/1/12/21) ARCHIVED —this archived case hub reflects the position at the date of the decision of 15 July 2021; it is no longer maintained. See further, timeline, commentary and related cases. Case facts Outline The CMA undertook a Chapter I and Chapter II investigation into suspected anti-competitive arrangements and abuses of dominance that encouraged postponed market entry and resulted in excessive and unfair pricing for hydrocortisone tablets (50277). Latest developments On 15 July 2021, the CMA issued an infringement decision, finding that: (i) Auden Mckenzie and Actavis UK abused a dominant position by...
CASE HUB ( Appeals lodged at the Competition Appeal Tribunal–see Glaxo Smith Kline and other v CMA (paroxetine)) ARCHIVED – this case hub records the position as at the 12 February 2016 decision and is no longer being maintained. For more detail, please consult the timeline, commentary, and related cases. Case facts overview: CMA investigation under Articles 101 and 102 TFEU/ Chapters I and II into Glaxo Smith Kline and generic manufacturers about pay-for-delay arrangements concerning anti-depressant medicines, specifically paroxetine ( Case CE/9531-11)......
The Competition and Markets Authority ( CMA) serves as the UK’s principal competition regulator, tasked with probing suspected anti-competitive conduct that could affect the UK. Its Guidance on investigation procedure in Competition Act 1998 matters ( CMA8) (the Guidance) outlines how the CMA applies its powers and the processes it follows. Brexit As to substantive rules, the UK reflects the EU framework in Articles 101 and 102 TFEU, and both regimes are expected to stay closely aligned for a time, even after the transition period concluded on 31 December 2020. Procedurally, the UK rules in the Competition Act 1998 ( CA 1998) resemble EU law but include notable distinctions. Up to the close of the transition, section 60 CA 1998 required UK law to track, where feasible, EU competition principles and jurisprudence. That consistency obligation covered both substance and procedure. EU procedural...
CASE HUB ARCHIVED This archived case hub sets out the position as at the decision dated 4 March 2020; it is no longer kept up to date. NOTE—appeals were filed with the CAT in Lexon ( UK) Limited v CMA (1344/1/12/20) and Amit Patel v CMA (1348/2/12/20). See further, timeline, commentary and related cases... Case facts Outline CMA Article 101 TFEU/ Chapter I investigation into Alissa Healthcare Research, Auden Mckenzie, Accord- UK, King Pharmaceuticals, Praze Consultants and Lexon regarding an infringement of competition law relating to the supply of the antidepressant Nortriptyline... Latest developments On 11 January 2022, the CMA stated it had obtained a legally binding director disqualification undertaking from Mr Pritesh Sonpal, formerly of Lexon. Mr Sonpal has undertaken not to serve as a director of any UK company for four years... Parties Alissa Healthcare Research Limited ( Alisa). Alissa focuses on licencing, marketing and...
CASE HUB ARCHIVED This archived case hub reflects the position as at the decision of 8 October 2021; it is no longer maintained. See the timeline, commentary and related cases. Case facts Outline CMA Article 101 TFEU/ Chapter I probe into AMCo (now Advanz Pharma Services ( UK) Limited), Morningside Healthcare Limited, Morningside Pharmaceuticals Limited and Alliance Healthcare ( Distribution) Limited concerning an alleged breach of competition rules linked to the supply of the antibiotic Nitrofurantoin. Latest developments On 8 October 2021, the CMA stated it had closed the investigation on the basis of administrative priorities. Parties Advanz Pharma Services ( UK) Limited ( Advanz): Advanz is a wholly owned subsidiary of Mercury Pharma Group Limited, incorporated in the UK. It primarily provides support services for the group headed by Concordia International Corp. (formerly Concordia Healthcare Corp). Mercury Pharma Group Limited ( Mercury): Mercury is a wholly owned subsidiary of...
This Practice Note Introduces the testing of medicinal products in people, commonly called clinical trials, and outlines the UK regime governing such studies. It explains the amendments made to domestic rules relating to clinical trials by the Medicines for Human Use ( Clinical Trials) ( Amendment) Regulations 2025 ( UK CTR 2025), SI 2025/538. Practical points are examined too, covering, how to seek authorisation to run a clinical trial, how to manage and bring a trial to a close, how to draft a clinical trial protocol, and links to a range of clinical trial agreements ( CTAs). It also charts the stages of clinical trials (phases I, II, III and IV), identifies the parties involved, addresses informed consent, and highlights specific provisions for children and adults lacking capacity. The note briefly reviews trials undertaken beyond the UK and, as well as this, touches on...
ARCHIVED: This Practice Note has been archived and is no longer maintained. 11 pm ( GMT) on 31 December 2020 signalled the close of the implementation period, introduced to help the UK shift away from the EU’s laws and institutions. From that moment (described in this note as ‘ IP completion day’), the UK’s legal regime underwent an immediate and notable change. This Practice Note sets out the consequences of that shift for clinical trials, covering the detailed topics listed below: Overview—what occurred on 31 December 2020 How does Brexit affect clinical trials? Which legal authorities are central in this field? What guidance has the UK government provided? What guidance has the EU provided? Which elements of retained EU law are key, and are they open to modification from IP completion day? What core...
CASE HUB ARCHIVED This archived case hub records the position as at the judgment dated 7 June 2018 and is no longer maintained. Note — on 20 December 2018, the Court of Appeal granted the CMA permission to appeal the CAT’s judgment of 7 June 2018. See the timeline, commentary and related cases. Case facts Outline Flynn Pharma Limited and Flynn Pharma ( Holdings) Limited v CMA (1275/1/12/17), and Pfizer Inc. and Pfizer Limited (1276/1/12/17) — appeals before the CAT concerning the CMA’s decision of 12 February 2016 in Case CE‑9742‑13 regarding phenytoin sodium capsules. Latest development On 25 July 2018, the CAT ruled that: (i) both Flynn and Pfizer were refused permission to appeal the CAT’s 7 June 2018 judgment; (ii) the question of abuse was remitted to the CMA for reconsideration consistent with that judgment; and (iii) the remittal should proceed...
This Practice Note outlines the law governing the use of boilerplate provisions in business-to-consumer ( B2C) contracts. In addition to summarising the Consumer Rights Act 2015 ( CRA 2015), which polices unfair terms in B2C agreements, it also considers the Competition and Markets Authority guidance ‘ Unfair contract terms: CMA37’ ( CMA Guidance). For analysis of particular boilerplate terms used in B2C arrangements—adjudication, alternative dispute resolution ( ADR), arbitration, assignment, definitions and interpretation, entire agreement, force majeure, governing law, jurisdiction, variation and waiver—see Practice Note: Boilerplate clauses in business-to-consumer contracts—specific clauses. For wider material on standard terms and conditions in B2C contracts, see the following Practice Notes: Consumer standard terms and conditions—the business context Consumer standard terms and conditions—the advertising and marketing context Consumer standard terms and...
ARCHIVED : This Practice Note has been archived and is not maintained This Practice Note reviews the rules for identifying the applicable law, also described as governing law, as they operate between the UK’s exit from the EU on 31 January 2020 and the conclusion of the implementation period, which the EU refers to as the transition period. It addresses whether the implementation period can be extended, whether the applicable law frameworks in Regulation ( EC) 593/2008, Rome I, and Regulation ( EC) 864/2007, Rome II, continue to apply during that period, and what is expected at its end. For a quick reference Brexit research aid answering key questions on Brexit and offering useful Brexit updates, research tips and resources, see: Brexit Bulletin—key updates, research tips and...
Patents for small molecules or ‘new chemical entities’ ( NCEs) This Practice Note explores matters unique to patents covering small molecules, or ‘new chemical entities’ ( NCEs), which are a subset of the materials or methods capable of being protected by pharmaceutical patents. For further detail on pharmaceutical patents, see Practice Note: Pharmaceutical patents. Brexit did not change the patent protection available in the UK at all. The UK remains firmly within the European patent system and can still be designated in European patent applications, since the European Patent Office ( EPO) and the European Patent Convention ( EPC)—the international treaty that sets out the procedure for granting European patents by the EPO—are independent of the EU. The UK has simply become another non- EU contracting state to the EPC, alongside Norway, Switzerland and Turkey. In proceedings before the EPO (eg those...
This Practice Note examines unlicensed medicines and the routes by which they can reach patients across the EU and the UK, such as via the UK Specials regime. It then looks at deploying authorised medicines beyond the scope of their licence (commonly termed off-label use). Lastly, the Practice Note addresses liability questions linked to using medicines without a licence. The UK’s regime governing unlicensed products is largely rooted in EU legislation. Numerous EU-derived principles and obligations remain in UK domestic law, save where particular measures provide otherwise. The Note surveys both EU and UK frameworks: analysis of EU requirements should be treated as relevant to the UK system unless distinct UK rules departing from EU law are set out separately. It also summarises pertinent EU case law; for guidance on the extent to which UK courts and tribunals are bound after the Brexit...
C– D | E– H | I– N | O– P | Q– V. Accelerated assessment Many countries provide a regulatory route that speeds up the appraisal of certain medicinal products, helping them reach patients sooner. In the EU, this accelerated assessment significantly shortens the period for the European Medicines Agency’s ( EMA) Committee for Medicinal Products for Human Use ( CHMP) to examine a marketing authorisation ( MA) application from 210 to 150 evaluation days overall. An application can be considered for this pathway where the CHMP judges the product to be of major relevance for public health and therapeutic innovation. See Practice Note: Marketing authorisations in the EU—regulatory procedures for approval of medicinal products— EU centralised authorisation procedure. In the UK, the Medicines and Healthcare products Regulatory Agency ( MHRA) provides a 150-day review for all high‑quality new MA...
Design rights before and after Brexit The aim of this Practice Note is to provide a concise overview of the different UK design rights available both before and after Brexit. In brief, the UK’s departure from the EU means that, from IP completion day (11.00 pm on 31 December 2020), the UK stopped being subject to the EU design framework, which at that time covered registered Community designs ( RCDs) and unregistered Community designs ( UCDs). The UK is excluded from the territorial scope of those unitary rights (and from international design registrations designating the EU) and is no longer bound by Regulation ( EC) 6/2002. Consequently, the UK implemented arrangements under which the proprietor of an RCD or a UCD on IP completion day automatically became the owner of an equivalent UK design right. Designs safeguarded as RCDs were cloned into a new UK right...
This Practice Note sets out an overview of what constitutes borderline products, explains how the regulatory status of these items is assessed across the EU and the UK, and looks at several prominent borderline questions, outlining key considerations. UK post- Brexit position in relation to EU law and judgments The UK’s regulatory regime for these categories firmly stems from EU legislation. Following Brexit, the corpus of EU-sourced rules was largely kept and carefully transposed into domestic UK law with effect from IP completion day (11 pm on 31 December 2020). Numerous EU-derived principles and obligations continue to apply in UK law, unless specific provisions expressly state otherwise. Further, under the Ireland/ Northern Ireland Protocol (the Windsor Framework), EU law requirements remain directly applicable in Northern Ireland ( NI). Consequently, guidance from the European Commission may still be pertinent when interpreting and applying those...
This Practice Note tracks key legislative and regulatory developments, government initiatives and strategies, and consultations relating to the use of artificial intelligence ( AI) in life sciences and digital health in the UK. The rapid acceleration of AI within life sciences and digital health is spotlighting its power to transform research, fuel innovation and enhance patient care, whilst at the same time presenting intricate regulatory challenges. Across the UK, AI cuts across multiple established legal and regulatory frameworks, with the Medical Devices Regulations 2002 ( MDR 2002), SI 2002/618 (as amended) being a central point of intersection. The UK Medicines and Healthcare products Regulatory Agency ( MHRA) is advancing a suite of reforms to the UK medical device framework, with notable consequences for AI and digital health—particularly for Software as a Medical Device ( Sa MD), AI as a Medical Device ( AIa MD) 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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