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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 is archived and not maintained. It considers the Public Bodies Act 2011 ( PBA 2011) and the contractual effects that should be assessed where a public body or business is impacted by it. Background On 14 October 2010, Francis Maude, the Minister for the Cabinet Office, set out in a written ministerial statement that the arrangements for public bodies required radical reform to enhance transparency and accountability, eliminate duplicated activity, and bring to an end work that is no longer necessary. In response, the PBA 2011 received Royal Assent on 14 December 2011. The Act is intended to enable the government to simplify the landscape of public bodies by, among other measures, abolishing so‑called quangos (ie quasi‑autonomous non‑governmental organisations). Quangos include non‑departmental public bodies ( NDPBs), a term commonly used by the government......
Boilerplate provisions in public sector contracts This Practice Note examines freedom of information clauses in public sector contracts. For further detail on what contracting authorities and other interested parties should be aware of when deploying boilerplate terms in public sector agreements, see Practice Note: Boilerplate provisions in public sector agreements: general considerations. Public procurement reform The Procurement Bill secured Royal Assent on 26 October 2023, becoming the Procurement Act 2023 ( PA 2023). See: Procurement Bill [ HL]— LNB News 12/05/2022 14 and Procurement Bill receives Royal Assent— LNB News 26/10/2023 81. From 24 February 2025, the principal provisions of PA 2023 are in force, and procurements commenced on or after that date must proceed under PA 2023. Earlier procurements remain governed by the existing public procurement framework, including: Public Contracts Regulations 2015 ( PCR 2015) and Procurement Practice Notes ( PPNs) Utilities...
CASE HUB ( Appeals lodged at the General Court in Cases T- 460/13 ( Sun Pharma), T- 467/13 ( Arrow), T- 469/13 ( Generics UK), T- 470/13 ( Merck), T- 471/13 ( Xellia) and T- 472/13 ( Lundbeck)–see Cases T- 472/13 Lundbeck v Commission, et al ( Pay-for-delay) [ Archived]) ARCHIVED – this case hub, preserved as of the decision dated 19 June 2013, captures the position then and is no longer actively maintained. See timeline, commentary and related cases. Case facts An Article 101 TFEU investigation by the European Commission concerning Lundbeck and others regarding Citalopram (case reference COMP/39.226). Latest development On 19 June 2013, the Commission adopted its decision, imposing fines of €146m......
CASE HUB NOTE—appeal lodged before the General Court in Case T‑74/21 ARCHIVED – this archived case hub reflects the position at the date of the decision of 26 November 2020; it is no longer maintained. See further, timeline, commentary and related cases. Case facts Outline European Commission Article 101 TFEU investigation into Teva Pharmaceuticals Industries Limited and its subsidiary Cephalon Inc., regarding a pay‑for‑delay arrangement relating to the Modafinil sleep‑disorder medicine (case number AT.39686). Latest development On 26 November 2020, the Commission adopted an infringement decision against Teva Pharmaceuticals Industries Limited and Cephalon Inc., imposing combined fines of €60.5m for infringing Article 101 TFEU. The decision concerned a ‘pay‑delay’ deal by which Teva undertook not to introduce a cheaper generic of Cephalon’s Modafinil for sleep disorders after patent expiry, in exchange for cash payments and additional...
European Commission investigations The European Commission ( Commission) examines indications or allegations of anti-competitive behaviour by companies that affect more than one EU Member State—for instance, international price-fixing cartels and other collusive practices prohibited by Article 101(1) TFEU, or situations where a company seems to misuse a dominant position contrary to Article 102 TFEU. Note—criminal action against individuals can be pursued in some Member States, but not by the Commission... Investigations may begin in one of four ways: an implicated party coming forward as a whistleblower, a complaint submitted by a third party, the Commission obtaining market intelligence suggesting a breach of competition law—for example, press reports or informal customer complaints, or the Commission identifying suspected infringements during a sector inquiry (see EU Sector...
This Practice Note This Practice Note clarifies the meaning of applicable law—sometimes, depending on context, called governing law, proper law or the choice of law—namely the law applied to resolve a dispute between parties. It does not encompass procedural law. It identifies which applicable law regime operates in the courts of England and Wales ( English courts). The regime engaged will differ according to whether the dispute is contractual or non-contractual and, for contractual matters, whether the parties selected the applicable law via a choice of law (governing law) clause, including any subsequent variation of that agreement. In a world where international travel, trade and communication are routine, cross-border complications arise with ease. Parties conclude contracts daily across different countries and continents. Goods and services move across frontiers, and individuals suffer accidents outside the states where they ordinarily live and work. When a claim has a...
This Practice Note offers practical guidance on executing simple contracts and deeds by third-party individuals or bodies corporate (chiefly companies formed under the Companies Act 2006 ( CA 2006)) acting pursuant to a power of attorney, and outlines how such parties should sign in this context. It considers the following: who can grant a power of attorney, who can act as an attorney, the formalities for executing simple contracts or deeds under a power of attorney. It does not cover: the execution of powers of attorney themselves (see Precedent: Power of attorney for commercial transactions); the execution of documents by other authorised signatories of organisations (see Practice Note: Executing documents—deeds and simple contracts). We have created a comprehensive, interactive collection to help users identify and work through the concepts and common issues when executing documents. Each section or phase contains practical guidance, precedent clauses and Q& As relevant to that section, helping users work...
This Practice Note reviews the Hague Convention on Choice of Court Agreements, which governs both jurisdiction and the recognition and enforcement of judgments. It outlines the scope of the Hague Convention on Choice of Court Agreements and the need for an international case anchored by an exclusive choice of court agreement. It also examines issues lying outside the Convention’s reach, whether by specific exclusions within the text or through declarations made by contracting states. The Practice Note considers how the Hague Convention on Choice of Court Agreements applies in the UK. An explanatory report on the Hague Convention on Choice of Court Agreements by Trevor Hartley and Masato Dogauchi supplies detailed commentary on each article. When did the Convention come into force? The Hague Convention on Choice of Court Agreements was concluded on 30 June 2005 and was first ratified by Mexico, followed by the EU. In...
CASE HUB ARCHIVED —this archived case hub reflects the position at the date of the decision to accept commitments on 22 July 2024; it is no longer maintained. See further, timeline and commentary Case facts Outline Article 102 TFEU probe into Vifor regarding alleged denigration of the closest rival therapy in Europe for intravenous iron treatment, Pharmacosmos’ Monofer ( AT.40577). Latest development On 22 July 2024, the Commission accepted Vifor’s commitments (see details below) and accordingly brought its inquiry to a close. Parties Vifor Pharma Ltd ( Vifor). Vifor is a global pharmaceutical company within the biotechnology group CSL, which develops, manufactures and markets pharmaceutical products worldwide to treat iron deficiency, as well as nephrology and cardio‑renal conditions. Background On 20 June 2022, the Commission initiated a formal antitrust investigation to evaluate whether Vifor restricted competition by unlawfully disparaging its nearest competitor in Europe in the...
CASE HUB ARCHIVED —this case hub reflects the position at the date of the decision of 4 July 2025; it is no longer maintained. See further, timeline and commentary Case facts Outline An Article 101 TFEU inquiry by the European Commission into cartel behaviour involving a key pharmaceutical input ( N- Butylbromide Scopolamine/ Hyoscine). Latest development On 4 July 2025, the Commission adopted a second infringement decision, imposing a €489,000 penalty on Alchem. Alchem chose not to enter into a settlement with the Commission. Parties C2 PHARMA Transo- Pharm Linnea Alkaloids of Australia Alkaloids Corporation Boehringer Alchem Background Commission’s 2023 infringement decision The investigation commenced in April 2019 when C2 PHARMA submitted a leniency application under the Commission’s 2006 Leniency Notice. After inspections in September 2019, Transo- Pharm and Linnea subsequently filed applications seeking reductions in fines......
In the EU, a medicinal product may only be supplied and used in line with the terms and conditions of its approval, known as a marketing authorisation ( MA). The MA decision and its contents are set according to the requisite information and data the marketing authorisation holder ( MAH) provides during the marketing authorisation application ( MAA) process... Extensive guidance on EU MAA procedures and on what MAs contain is given in Practice Notes: Marketing authorisations in the EU—regulatory procedures for approval of medicinal products, and Marketing authorisations in the EU—content and form of the application and other practical considerations... For discussion of the impact of Brexit on authorisations of medicines for the EU and UK, including Northern Ireland, see Practice Notes: UK marketing authorisations for medicinal products, particularly the MA variations...
CASE HUB NOTE—appeals lodged before the General Court in Cases T- 227/21, T- 23/22 and T- 755/21 ARCHIVED — this archived case hub reflects the position as at the decision date of 06/09/2022; it is no longer maintained. See further, timeline and commentary. Case facts Outline: European Commission merger review concerning the acquisition by GRAIL, Inc. of Illumina, Inc. ( M.10188). The deal features a vertical overlap in the market for the development and supply of cancer detection tests based on next generation sequencing ( NGS). Latest developments On 6 September 2024, the Commission announced the withdrawal of its decision in M.10188 (and its decisions in M.10493, M.10483, M.10938 and M.10939) following the Court of Justice’s judgment in Case C-611/22. Parties Illumina, Inc. ( Illumina): a global genomics company, incorporated and headquartered in the US, primarily engaged in developing, manufacturing and...
CASE HUB ARCHIVED –this archived case hub reflects the position at the date of the decision to accept commitments on 10 February 2021; it is no longer maintained. See further, timeline and commentary. Case facts Outline: The European Commission opened an Article 102 TFEU inquiry into Aspen, assessing whether it exploited a dominant position in various national markets by imposing excessive prices for the supply of off-patient cancer medicines ( AT.40394). Latest development On 10 February 2021, the Commission accepted Aspen’s commitments and, as a result, terminated its investigation. Aspen will cut prices across Europe for six cancer medicines by an average of about 73% (on average below the prices seen in 2012, ie before Aspen began raising them). These figures will act as the price cap for the next ten years and had already started to apply from October 2019. Aspen will secure the...
Data—and by extension, adherence to data protection rules—sits at the heart of clinical research, whether for clinical trials, pharmacovigilance activities or wider scientific inquiry. This Practice Note examines the data protection ramifications of running clinical research. In particular, it addresses who is accountable for compliance, the lawful bases relied upon, and how transparency should be delivered in this context... Allocation of responsibility for data protection compliance in clinical research Appropriate legal grounds for processing personal data for research purposes Transparency duties owed to participants and other data subjects Collaborative research arrangements and data sharing practices Derogations from data subject rights when processing for research A practical checklist of data protection points to consider when planning research activities The GDPR regimes On 25 May 2018, the General Data Protection Regulation, Regulation ( EU) 2016/679 ( EU GDPR) became directly...
In recent years, interest in information on medicines has risen steadily among a wide range of stakeholders, including the general public, patient associations, physicians, the pharmaceutical industry and academia. In response, legislators and medicines regulators have embraced a more open stance, enabling access to a broader set of documents and data on the quality, safety and efficacy of medicinal products than at any time before. Within the EU, the European Medicines Agency ( EMA) is the authority charged with protecting and promoting human and animal health. Among the EMA’s core duties are the scientific assessment of applications for marketing authorisation ( MA) via the centralised procedure, and the co-ordination of the EU pharmacovigilance system to monitor the safety of medicinal products. Consequently, the EMA holds extensive scientific and clinical data on medicines. There are multiple channels through which documents and information on medicinal products can be...
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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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