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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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IP disputes arise where one side—typically the claimant in this note—asserts that its patent has been infringed, while the defendant contests the patent’s validity. These matters are commonly resolved through settlement, yet such arrangements can themselves fall foul of Article 101(1) TFEU. The European Commission (the Commission) has provided guidance addressing this point. NOTE— Although the Brexit transition period ended on 31 December 2020, this Practice Note continues to cite EU and UK competition law side by side. That is because, even though UK regulators and courts may now depart from EU jurisprudence, any divergence between the two systems is expected to be incremental and progressive, as such, over time, since: (i) the UK competition framework is strongly grounded in concepts honed and refined over many years in EU case law (concepts which the UK courts were required to apply in harmony with UK...
STOP PRESS From 24 February 2025, the principal provisions of the Procurement Act 2023 ( PA 2023) now apply. Any procurement launched on or after that date must proceed under PA 2023, while procurements started under earlier regimes must continue to be run and administered under those rules, including: Public Contracts Regulations 2015 Utilities Contracts Regulations 2016 Concession Contracts Regulations 2016 Defence and Security Public Contracts Regulations 2011 The Cabinet Office has refreshed its standard contract suites, templates and guidance for the government’s Model Services Contract, Mid- Tier Contract and Short Form Contract, issued alongside the PA 2023 ‘go-live’ on 24 February 2025. This Practice Note will be updated shortly to capture these changes. In the interim, see News Analysis: Procurement Act 2023 ‘go live’—what happens next?, Government model contracts updated for Procurement Act 2023 ‘go-live’— LNB News 24/02/2025 29, and Cabinet Office updates PPN 013: Using standard...
CASE HUB ARCHIVED This archive captures the position as at the date of the decision and is no longer maintained. NOTE Appeals were lodged before the General Court in Cases T-755/21, T-23/22, T-5/23 and T-591/23. See the timeline, commentary and related/relevant cases for further details. Case facts Outline European Commission inquiry into whether, amongst other matters, Illumina’s completion of its acquisition of GRAIL while the Commission’s in-depth review of the notified deal was still underway breached the standstill obligation under Article 7 EUMR ( M.10493). Latest development On 6 September 2024, the Commission announced the withdrawal of 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): Illumina is a global genomics business, incorporated and headquartered in the US, which primarily develops, manufactures and commercialises next-generation sequencing ( NGS) systems for genetic and genomic analysis. GRAIL, Inc. (...
CASE HUB See further, timeline. Case facts Outline Appeals contesting the General Court’s judgment in Case T‑227/21, which rejected an action seeking annulment of the Commission’s decisions of 19 April 2021 to accept a referral request under Article 22 EUMR concerning Illumina, Inc.’s acquisition of GRAIL, Inc. ( M.10188). Outcome On 21 March 2024, Advocate General Emilious delivered an opinion advising the Court of Justice to set aside the General Court’s judgment and annul the Commission’s acceptance of requests by France and five other Member States for referral, under Article 22 EUMR, of Illumina, Inc.’s proposed acquisition of GRAIL, Inc. He considers that Member States cannot request the Commission to review a concentration lacking a Community dimension, even where they have no power to assess such a concentration under national law. Parties Applicants: Illumina, Inc. ( Illumina) Applicants: GRAIL, In ( GRAIL) Defendant: European...
STOP PRESS From 24 February 2025, the core provisions of the Procurement Act 2023 ( PA 2023) are in effect. Procurements launched on or after that date must proceed under PA 2023, while those initiated under earlier regimes must continue to be run and managed under those rules, including: Public Contracts Regulations 2015 Utilities Contracts Regulations 2016 Concession Contracts Regulations 2016 Defence and Security Public Contracts Regulations 2011 The Cabinet Office has also refreshed its standard contract document suites, templates and guidance for the government’s Model Services Contract, Mid‑ Tier Contract and Short Form Contract. These updated materials were released to coincide with the PA 2023 ‘go‑live’ on 24 February 2025. This Practice Note will be updated shortly to reflect these changes. In the meantime, see: News Analysis: Procurement Act 2023 ‘go live’—what happens next? Government model contracts updated for...
ARCHIVED —this archived case hub captures the position as at the decision date of 21 July 2022; it is no longer being maintained. NOTE—appeals were lodged before the CAT by Pfizer and Flynn Pharma following the CMA’s 2016 decision (1525/1/12/22 and 1524/1/12/22). Subsequent appeals were also lodged by Pfizer and Flynn Pharma following the CMA’s 2022 decision (1525/1/12/22 and 1524/1/12/22). See further, timeline, commentary and related cases. Case facts Outline CMA Article 102 TFEU/ Chapter II investigation into Pfizer and Flynn Pharma concerning an alleged abuse of a dominant position through charging excessive and unfair prices for an anti-epilepsy drug, namely phenytoin sodium capsules ( Case CE/9742-13). Latest developments On 21 July 2022, the CMA issued its infringement decision and imposed the following fines: Pfizer—£63.3m Flynn—£6.7m (representing 10% of Flynn’s global...
CASE HUB NOTE—appeal lodged before the General Court in Case T- 19/25 ARCHIVED—this archived case hub records the position as at the final decision of 31 October 2024; it is no longer updated. See also timeline and commentary. Case facts Outline European Commission Article 102 TFEU probe into Teva, examining whether it abused a dominant position by pursuing conduct designed to postpone competition to its multiple sclerosis treatment, Copaxone ( AT.40588). Latest development On 31 October 2024, the Commission adopted an infringement decision and imposed fines totalling €462.6m on Teva. Parties Teva is a global pharmaceutical group headquartered in Israel, operating through a number of subsidiaries within the EEA. Background In October 2019, the Commission carried out unannounced inspections at the premises of several Teva subsidiaries in the EEA, followed by continued inspections at the......
The Technology Transfer Block Exemption ( TTBE, Regulation 316/2014) offers a safe harbour for certain intellectual property rights ( IPRs) licences—technology transfer agreements—that might otherwise restrict competition (see also: The technology transfer block exemption). If an IP-related arrangement falls outside the TTBE, this does not automatically imply a breach of Article 101 TFEU. First, other block exemption regulations may still apply. Accordingly, consider whether the following block exemptions are relevant: the Research and Development ( R& D) Block Exemption Regulation (the R& D Block Exemption, Regulation 2023/1066) the Specialisation Block Exemption Regulation (the Specialisation Block Exemption, Regulation 2023/1067) the Vertical Block Exemption Regulation ( VBER 2022, Regulation 2022/720) If none of these fit, the IP-related agreement will then be examined on an individual basis under Articles 101(1) and 101(3) TFEU to determine whether there is an...
STOP PRESS : On 30 April 2026, the European Commission approved an updated Technology Transfer Block Exemption Regulation ( TTBER) together with accompanying Guidelines, supplanting the 2014 framework. The updated TTBER took effect on 1 May 2026. This Practice Note cites the TTBER and the Guidelines and is in the process of being refreshed to mirror these amendments. Finding equilibrium between intellectual property rights ( IP/ IPRs) and competition law is a longstanding issue. At a glance, the objectives of IPRs and competition law can seem at odds. In broad terms, IPR owners are entitled to govern access to, and seek payment for, exploitation of their exclusive rights. By contrast, competition law pursues open markets and restrains the misuse of market power. The Commission has acknowledged that the interplay of IPRs and competition law can raise concerns and create apparent friction. It has equally...
CASE HUB ARCHIVED This archived case hub sets out the position as at the decision dated 9 July 2020 and is no longer updated. For more, see the timeline, commentary and related cases. Case facts Outline: CMA investigation under Article 101 TFEU/ Chapter I and Article 102 TFEU/ Chapter II into Aspen’s suspected infringement of competition law regarding the supply of fludrocortisone acetate tablets in the UK. Latest developments On 9 July 2020, the CMA issued an infringement decision, concluding that Aspen unlawfully agreed to pay two rival firms, Amilco and Tiofarma, to refrain from entering the UK market for fludrocortisone acetate tablets, enabling Aspen to remain the sole UK supplier of fludrocortisone and increase prices by 1,800%. The CMA levied a penalty totalling £2.3. Aspen has also paid £8m to the NHS. Parties Aspen Pharmacare Holdings Ltd, Aspen Global Inc., Apsen Pharma Ireland Ltd, and Aspen Pharma...
CASE HUB ARCHIVED This archived case hub captures the position as at 25 March 2021, the date of judgment; it is not being updated. For further information, see the timeline, commentary and related/similar cases. Case facts Outline Appeals to the Court of Justice stemming from the General Court’s judgments in Cases T-460/13, T-467/13, T-469/13, T-470/13, T-471/13 and T-472/13, which rejected applications to annul the Commission’s decision of 19 June 2013. That decision identified four infringements of Article 101 TFEU and Article 53 of the EEA Agreement and imposed fines totalling €146m on Lundbeck and certain generic manufacturers for ‘pay‑for‑delay’ arrangements postponing the market entry of generic citalopram in the EEA ( AT.39226). The appeals were lodged in: C‑586/16 Sun Pharmaceutical Industries and Ranbaxy ( UK) v Commission C‑588/16 Generics ( UK) v Commission C‑591/16 P Lundbeck v...
FORTHCOMING CHANGE: On 24 May 2024, the Digital Markets, Competition and Consumers Bill secured Royal Assent, was enacted as the Digital Markets, Competition and Consumers Act 2024 ( DMCCA 2024), with some provisions commencing immediately. The unfair commercial practices regime in DMCCA 2024, Part 4, Chapter 1 took effect on 6 April 2025, disapplying and substituting the equivalent rules in the Consumer Protection from Unfair Trading Regulations 2008, SI 2008/1277 ( CPUTR 2008) from that date. However, sections 232, 234 and 235, which concern consumers’ rights to redress, have not commenced; until they do, Part 4A of CPUTR 2008 continues to regulate redress. The strengthened consumer protection enforcement powers likewise began on 6 April 2025. Measures still pending include the repeal of the Alternative Dispute Resolution for Consumer Disputes ( Competent Authorities and Information) Regulations 2015 ( Consumer ADR...
Intellectual Property Rights ( IPRs) give proprietors the practical ability to bar others from exploiting the protected subject matter. Blocking, or even threatening to block, third parties in this manner usually raises no issues under competition rules. Yet, in the relatively rare scenario where the IPR holder occupies a ‘dominant position’—that is, economic strength allowing it to operate, to a large degree, without effective competitive constraints—use of such exclusionary powers can sit uneasily with competition law. IPRs appear in several guises (eg trade marks, copyright, patents) and frictions may surface in multiple settings. Flashpoints most often involve patents and software copyright. Abuse of dominance under Article 102 TFEU EU case law recognises that dominance carries a special responsibility for the dominant undertaking. That responsibility obliges it to avoid forms of rivalry that are not ‘on the merits’. Because the contours of this notion are...
Practice Note This Practice Note sets out the principal updates to the mandatory clinical evaluation and performance evaluation pathways for medical devices under the EU regime brought in by Regulation ( EU) 2017/745 (the Medical Devices Regulation, MDR) and Regulation ( EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation, IVDR), together termed the MD Regulations. The MD Regulations represent a substantial shift in how the health and safety of devices are appraised, requiring a structured, rigorously evidenced clinical/performance evaluation that starts with the conformity process ( CE marking) and carries on throughout the entire life cycle of a device. This Practice Note examines the practical consequences of the revised definitions and obligations for clinical data, clinical evidence and, notably, clinical investigations. For further information on: an introduction to the MD Regulations, see Practice Note: Introduction to the EU Medical Devices Regulation and In Vitro...
ARCHIVED This archived case hub records the position as at the decision date of 12 December 2018; it is no longer being maintained. NOTE — appeals were lodged before the Court of Justice in the following cases: C-144/19 P C-151/19 P C-164/19 P C-166/19 P C-176/19 P C-197/19 P C-198/19 P C-201/19 P C-207/19 P See further: timeline and commentary. Case facts Outline Appeals were brought before the General Court seeking annulment and/or a reduction of fines arising from the Commission’s decision of 9 June 2014. That decision found breaches of Article 101 and Article 102 in so far as they concerned Servier, and levied penalties totalling €427.7m on Servier and five manufacturers of generic drugs for delaying the entry of perindopril......
What is digital health? Digital health is a broad umbrella describing how information and communication technologies are used to enhance prevention, diagnosis, treatment, monitoring, and the management of health conditions and lifestyle habits that influence wellbeing. Its rise reflects the coming together of healthcare and technology, and a move away from provider‑focused, ‘one size fits all’ delivery towards personalised, patient‑centred care. This Practice Note explores data protection considerations across three digital health use cases: Wearables Use of artificial intelligence ( AI) in medical diagnostics Digital health records Unlike mobile health (m Health), which is limited to care delivered via mobile devices, digital health is wider in scope. It encompasses modern care models such as digital therapeutics, telemedicine, digitised health systems and electronic health records, as well as AI, machine learning and data analytics. For more on m Health, see Practice Notes: Digital...
Practice Note This Practice Note sets out the principal issues in research services contracts from the standpoints of both the provider and the commissioning party. It assesses matters concerning the project scope and key staff, who secures regulatory permissions or approvals, any required third-party licences, available resources, the agreed reporting arrangements and process, fees, confidentiality, background and foreground intellectual property rights ( IPRs), handling of research outputs, trade marks, warranties, indemnities, limitations on liability and termination. These agreements are needed where a business is outsourcing research to a third party with specialist knowledge and skills. In practice, the research services provider might be a university or other academic institution, or a contract research organisation whose sole activity is delivering research services. For example, such arrangements are particularly prevalent in the pharmaceutical and biotechnology sectors, though they may equally be adopted in other areas. They are...
Practice Note Within the EU, medical devices are strictly overseen by legislation that manages safety and performance throughout the whole lifecycle and across the full product lifetime, spanning pre- to post-market stages. This Practice Note outlines the regime established by Directive 93/42/ EEC on medical devices ( MDD), Directive 90/385/ EEC on active implantable medical devices ( AIMDD), which applied until 25 May 2021, and Directive 98/79/ EC on in vitro diagnostic medical devices ( IVDD), which remained in force until 25 May 2022; collectively, the MD Directives. The MD Directives continue to matter for ‘legacy’ devices that were authorised under them for placement on the EEA market before the new rules started to apply. They will also persist as points of reference for several years for particular legacy devices, for differing durations, pursuant to transitional provisions. This Practice Note sets out how devices were...
This Practice Note summarises Regulation ( EU) 2017/745, the Medical Devices Regulation ( MDR), and Regulation ( EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation ( IVDR), along with the steps for placing a device on the EU market, including how the intricate transitional rules apply to ‘legacy’ devices certified under the former directives system For fuller analysis of how the MD Regulations affect related topics, see the following Practice Notes: The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—scope, classification of devices and Notified Bodies Clinical evaluation and performance evaluation of medical devices in the EU Post-market surveillance of medical devices in the EU The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation— EUDAMED and economic operators The EU MDR and IVDR implementing acts and guidance tracker Medical devices— UK and EU...
This Practice Note outlines the breadth and categorisation of devices governed by 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), along with conformity assessment routes and the designation and oversight of Notified Bodies... For information on: key provisions of the MDR and IVDR — see Practice Note: Introduction to the EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation clinical evaluation and investigation of devices — see Practice Note: Clinical evaluation and performance evaluation of medical devices in the EU post-market surveillance — see Practice Note: Post-market surveillance of medical devices in the EU European database on medical devices ( EUDAMED) and the obligations of economic operators — see Practice Note: The EU Medical Devices...
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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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