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This Practice Note outlines the law concerning criminal recklessness. The subjective test for recklessness Certain statutory and common law offences allow the prosecution to prove mens rea through ‘recklessness’. Put simply, recklessness is where the accused takes an unjustified risk that results in unlawful harm or damage. The House of Lords in R v G reaffirmed the subjective approach to recklessness. Before R v G, two distinct tests were used, depending on the offence charged: Subjective recklessness from R v Cunningham: the prosecution had to establish that the accused personally foresaw the risk. Objective recklessness from R v Caldwell: the prosecution only needed to show that the risk would have been obvious to a reasonable person, without proving the accused themselves foresaw it. In R v G, the House of Lords concluded that the objective test could operate unfairly where a defendant did not foresee the
This Practice Note examines the remedy of rescission, explaining when and in what manner a contract can be unwound (at common law, in equity and under statute) and thereby terminated and brought to an end. It covers the consequences and effects of rescission, the principal grounds for setting aside an agreement (misrepresentation, mistake, undue influence, duress, non‑disclosure, fiduciary misdealing and bribery) and the main obstacles to claiming rescission—affirmation, the intervention of third‑party rights and the impossibility of restitution. For further guidance on rescission in the context of misrepresentation, see Practice Note: Misrepresentation—rescission as a remedy. There are many ways in which a contract may reach its end; see: Terminating contracts—how and when a contract ends—overview for a brief and accessible summary, with links to the related further practical guidance, including Practice Note: Termination and expiry of contracts. For a table
What is a res judicata? A res judicata is a determination by a court or tribunal with jurisdiction over the cause of action and the parties, which finally disposes of the issues decided so they cannot be litigated again by those bound, save on appeal. Final judgments entered by default or by consent fall within this concept, whereas rulings on purely procedural points and any decision lacking finality do not. The doctrine’s aim is to bring litigation to an end and shield parties from being harassed by the same dispute twice. in personam—binds the parties and their privies in rem—binds all persons, privy or otherwise (ie a judgment binding the whole world) A party may rely on res judicata: as an estoppel to defeat an opponent’s claim or defence; and/or as the basis of their own claim or
The offence of causing grievous bodily harm with intent Wounding or causing grievous bodily harm (GBH) with intent can be tried solely in the Crown Court on indictment. Elements of the offence Under the Offences against the Person Act 1861 (OATPA 1861), the prosecution must establish that the defendant unlawfully and maliciously: wounded with the intention of causing GBH, or caused GBH with that intention, or wounded intending to resist or prevent the lawful arrest or detention of any person, or caused GBH intending to resist or prevent the lawful arrest or detention of any person ‘Unlawfully’ and ‘maliciously’ Unlawfully The wounding or causing of GBH must be unlawful. Such conduct may be lawful if used: in self-defence in defence of another in defence of property for the prevention of crime where the victim gave express or implied consent For further information on these defences, see below:
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This Practice Note explores the European database on medical devices ( EUDAMED) and the obligations on economic operators, including manufacturers, distributors and importers of medical devices, arising under Regulation ( EU) 2017/745, the Medical Devices Regulation ( MDR), and Regulation ( EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation ( IVDR). For guidance on: key provisions of the MDR and IVDR, refer to Practice Note: Introduction to the EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation scope and classification of devices, conformity assessment procedures and Notified Bodies, see Practice Note: The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—scope, classification of devices and Notified Bodies clinical evaluation and investigation of devices, consult Practice Note: Clinical evaluation and performance evaluation of medical devices in the EU post-market...
Practice Note: Marketing authorisations in the EU—regulatory procedures for approval of medicinal products As outlined in Practice Note: Marketing authorisations in the EU—regulatory procedures for approval of medicinal products, a medicinal product cannot lawfully be marketed unless prior approval, termed a marketing authorisation ( MA), has been secured in advance. An MA specifies the therapeutic indications, target patients and dosing for which the medicine is authorised, together with any obligations placed upon the marketing authorisation holder ( MAH) as part of the approval process. In the EU, an MA application may rely on several distinct legal bases. This Practice Note considers the available categories of marketing authorisation applications ( MAAs) in the EU and the underlying legal grounds, and also addresses practical aspects, including the required content and presentation of an application for an MA, the format of an...
ARCHIVED: This Practice Note has been archived and is no longer maintained. It monitored the progress of EU legislative proposals and consultations pertinent to the life sciences sector across 2019–2022, independent of and excluding issues specifically connected to the coronavirus ( COVID-19) pandemic and Brexit during that time, which were covered by dedicated, archived trackers of their own throughout that period. This tracker is organised into the following sections: Legislation Consultations To follow the progress of current EU legislative proposals, consultations and developments, as well as notable cases, which are relevant to the life sciences sector, see Practice Notes: Life sciences tracker— EU, Life sciences cases tracker— EU and Patents tracker— EU. To follow the progress of current UK legislative proposals, consultations and developments, as well as notable cases, which are relevant to the life sciences sector, see Practice Notes: Life sciences tracker— UK and Life...
ARCHIVED This Practice Note is archived and no longer maintained. It monitored EU cases pertinent to the life sciences sector during 2020–2022. To follow EU case progress from 2023 onwards, including live matters, see Practice Note: Life sciences cases tracker— EU. For current EU legislative proposals, consultations and developments relevant to life sciences, see Practice Note: Life sciences tracker— EU. For current UK legislative proposals, consultations and developments, as well as notable UK cases relevant to life sciences, see Practice Notes: Life sciences tracker— UK and Life sciences cases tracker— UK... Judgments— Supplementary protection certificates For archived supplementary protection certificate ( SPC) rulings, see Practice Note: Life sciences tracker [ Archived]— Judgments— Supplementary protection certificates... Court of Justice of the European Union Santen SAS v Directeur général de l’ Institut national de la propriété industrielle ( Case C-673/18, ECLI: EU: C:2020:531) — judgment delivered on 9 July...
Pricing and reimbursement decisions for new healthcare technologies and treatments begin with a health technology assessment ( HTA). The EU’s Health Technology Assessment Regulation ( EU) 2021/2282—often called the HTA Regulation ( HTAR)—marks a significant change in the appraisal of medicines and specified medical devices for clinical value at EU level. Finalised in December 2021 after lengthy talks, HTAR sets up a standing system for joint clinical assessments ( JCAs) of emerging health technologies, replacing the earlier model of voluntary, project-led collaboration. Its objectives are to streamline evidence development, prevent duplicative national HTA activity, and ultimately enable swifter, more evidence-driven access to cutting-edge medicines and devices across Europe. In essence, HTAR provides a harmonised framework for evaluating the clinical effectiveness and safety of new medicines and certain high-risk medical devices throughout the EU. HTAR entered into force on 11 January 2022, with...
This Practice Note delivers a succinct overview of cybersecurity challenges for life sciences businesses, coupled with practical guidance for EU-based organisations. It charts the EU regulatory landscape for cybersecurity, including the NIS 2 Directive, Medical Devices Regulations ( MDR and IVDR), the EU AI Act, the EU Cyber Solidarity Act, the EU Cyber Resilience Act, and the European Health Data Space Regulation ( EHDS), and outlines compliance duties alongside the sanctions or enforcement outcomes for non-compliance. It also identifies key regulatory authorities and industry bodies, and closes with insights into legislative trends and the likely direction of travel... The cybersecurity landscape in the life sciences sector The life sciences sector—covering R& D of pharmaceuticals, medical devices and biotechnology; clinical trials; and healthcare services—now embeds digital technologies such as telemedicine, health apps and artificial intelligence to enhance operations and drive innovation. This digital shift, however, brings...
CASE HUB (appeals lodged at the General Court in Cases T- 680/14 ( Lupin), T-682/14 ( Mylan), T-679/14 ( Teva), T-6824/14 ( Krka), T-701/14 ( Niche Generics) and T-701/14 ( Unichem)) ARCHIVED –this archived case hub reflects the position at the date of the decision of 9 July 2014; it is no longer maintained. See the timeline, commentary and related cases for further detail. Case facts outline: The European Commission pursued an Articles 101 and 102 TFEU inquiry into Servier and others concerning Perindopril ( COMP/39.612), issuing fines totalling €427.7m on 09/07/2014. On 9 July 2014, sanctions were imposed on Servier and five generic manufacturers, amounting in aggregate to €427.7m. Servier was ordered to pay €330.9972m for breaches of both Articles 101 and 102 TFEU. For the generic companies: Niche and Unichem were fined €13,968,773 (jointly and severally liable), Matrix was fined...
Intellectual property ( IP) agreements IP arrangements—such as technology licensing or collaborating on the creation of new technologies—can restrict competition. Yet their pro‑competitive advantages are acknowledged through block exemptions that offer a ‘safe harbour’ from Article 101, TFEU. Where a deal sits squarely within a relevant block exemption, only a brief review of Article 101, TFEU concerns is typically required. In practice, though, multiple block exemptions may seem to apply, and confirming that an agreement truly benefits from a safe harbour can be challenging—so a more pragmatic assessment of everyday commercial deals is often warranted. Most block exemptions share a common framework, and understanding this helps with application of the rules. Recitals: set out the overarching aim and rationale of the instrument. Definitions: clarify key terms that shape how the exemption should operate. Scope of the ‘safe harbour’:...
This Practice Note looks at Regulation ( EU) 536/2014, the EU Clinical Trials Regulation ( CTR), which governs clinical trials in the EU. It outlines the principal features of the CTR that trial sponsors and pharmaceutical businesses need to understand in practice and keep in view for compliance, and to keep abreast of. Taking effect on 31 January 2022, the CTR applies directly across every EU Member State and the EEA, marking the most significant overhaul of the EU’s clinical trial legal framework since 2001, and is now in force without exception. Its reach is truly global: any interventional study conducted even in part within an EU Member State or the EEA must follow this regime throughout the entire trial life cycle, at all times, from start to finish. Because the UK had exited the EU before it became operative, the CTR does not extend to...
This Practice Note explores the regulatory treatment of ‘m Health’ software products (including apps), centring on medical device software within the EU, while also noting the position for m Health software in Great Britain ( GB) and the wider UK. It provides a high-level outline of medical device controls, health and social care regulation, product safety and consumer protection regimes, as well as data protection and privacy duties as they apply to m Health software products... What is m Health? Medical software, including m Health, describes a broad range of healthcare services delivered using information and communications technology, often termed e Health or digital health services. These digital health offerings are becoming an ever more significant element of healthcare systems across the EU and internationally... In particular, m Health (or ‘mobile health’) relates to delivering healthcare through portable and smart devices—such as mobile phones, smart watches and other...
EU and UK legal framework governing medicinal products A detailed network of obligations and guidance at EU, EU Member State and UK levels governs critical aspects of medicinal products, including: clinical investigation (clinical trials) market entry (marketing authorisation ( MA), approval procedures and variations to those MAs) protection of pre-clinical and clinical data (regulatory data protection) manufacture and importation labelling and the package leaflet advertising and promotion wholesale distribution and brokering pharmacovigilance pricing and reimbursement falsified medicines medicines for rare diseases (orphan medicinal products ( OMPs)) paediatric medicines advanced therapy medicinal products ( ATMPs) unlicensed medicines and off-label use of authorised medicines EU legislation in these fields has expanded rapidly, resulting in greater harmonisation across numerous areas. Nevertheless, requirements and guidance at the level of individual EU Member States remain fundamental to the overall regulatory framework. Notably, there are significant variations between Member States in how they interpret, apply and enforce these rules......
General Data Protection Regulation ( EU GDPR) and UK GDPR The General Data Protection Regulation, Regulation ( EU) 2016/679 ( EU GDPR), became enforceable across the EEA (which then included the UK) on 25 May 2018. Life sciences organisations frequently collect and/or process substantial amounts of personal information, including health-related data, about individuals (or ‘data subjects’) such as patients and clinical trial participants. As a result, the relevance of the EU GDPR and the United Kingdom General Data Protection Regulation, Assimilated Regulation ( EU) 2016/679 ( UK GDPR) (which applies after the UK’s withdrawal from the EU) for life sciences companies cannot be underestimated. Assimilated law is the term used for retained EU law ( REUL) that remains operative after the end of 2023. The reclassification of REUL (and related terminology) as assimilated law marks a change in its status and handling under UK law, in that it is...
STOP PRESS From 24 February 2025, the core provisions of the Procurement Act 2023 ( PA 2023) have taken effect. Competitions started on or after that date must proceed under PA 2023, while procurements commenced under the earlier regime ( Public Contracts Regulations 2015, Utilities Contracts Regulations 2016, Concession Contracts Regulations 2016, and Defence and Security Public Contracts Regulations 2011) must continue to be run and administered under those rules. The Cabinet Office has refreshed its suites of standard contract documents, templates and guidance for the government’s Model Services Contract, Mid‑ Tier Contract and Short Form Contract. These revised materials were released to coincide with the PA 2023 “go‑live” on 24 February 2025. This Practice Note will be revised shortly to take account of these changes. For further detail, see: News Analysis: Procurement Act 2023 “go live”—what happens next?, and Government model contracts updated for...
Boilerplate provisions in public sector contracts This Practice Note examines audit clauses within public sector agreements. For additional insight into what contracting authorities (and other interested parties) should understand 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 initiated on or after that date must proceed under PA 2023. The existing public procurement regime—including the Public Contracts Regulations 2015 ( PCR 2015) and Procurement Practice Notes ( PPNs), the Utilities Contracts Regulations 2016, the Concession Contracts Regulations 2016, and the Defence and...
STOP PRESS As at 24 February 2025, the core provisions of the Procurement Act 2023 ( PA 2023) have commenced. Competitions launched on or after that date must proceed under PA 2023, while procurements started under earlier regimes must continue to be run and administered in line with 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 collections, 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 revised shortly to reflect these developments. In the interim, see News Analysis: Procurement Act 2023 ‘go live’—what happens next?, and Government model...
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ARCHIVED: This Practice Note is archived and not maintained. The implementation period that allowed the UK to disengage from the EU’s laws and institutions ended at 11 pm ( GMT) on 31 December 2020. At that time (described in this Practice Note as ‘ IP completion day’), the UK’s legal framework altered immediately and markedly. This note outlines the consequences for distribution. How does Brexit impact distribution? The appointment of a distributor in the UK is governed principally by the common law of contract and will, in large part, be unaffected after IP completion day. However, where business is conducted across borders with distributors in other jurisdictions, including EU Member States, those distributors may benefit from local rules that provide stronger protections than those under UK law. For further information see: Lexology Panoramic: Distribution and...
Declaration of a director's interests Any director who, whether directly or indirectly, has an interest in either of the following must, subject to limited exceptions, disclose to the other directors the nature and extent of that interest in line with the Companies Act 2006 ( CA 2006): a proposed transaction or arrangement with the company of which they are a director; or a transaction or arrangement already entered into by the company of which they are a director. For more detail, refer to the comprehensive Practice Note: Declaration of a director's interests—the statutory provisions. For practical help in determining precisely when an interest requires disclosure, see Flowcharts: Declaration of a director's interests—proposed transaction or arrangement and Declaration of a director's interests—existing transaction or arrangement. Some or all of the statutory rules on declaring a director's interests could also potentially extend to other companies and entities of various types;...
This Practice Note outlines the range of intellectual property ( IP) protections available for a digital health product. It further explores ancillary IP issues, including safeguarding as a trade secret, incorporation of open-source software, possible ownership conflicts with staff and contractors, IP licences, and safeguarding patient information. The Practice Note additionally reviews IP planning throughout digital health product creation, from ideation and early research through advertising, marketing and sale, and on to later enhancements and upgrades. What is digital health? Digital health sits where healthcare IT meets medical devices, and encompasses the use of data to support diagnosis, treatment, prevention and monitoring of disease, as well as providing support to healthcare practitioners. Using digital health devices to track patients can widen access to healthcare services without markedly raising costs. Such devices can feed back to clinicians in real time, enabling swift...
This Practice Note explores what is meant by advertising within the regulatory regime governing the advertising and promotion of medicinal products. It reviews which kinds of activity may amount to advertising and therefore fall under the strict rules that regulate the advertising and promotion of medicinal products. Note that this Practice Note cites case law of the Court of Justice of the European Union. For guidance on whether judgments of the Court of Justice are binding on UK courts, see Practice Note: Assimilated law— Assimilated case law. Advertising within the regulatory framework in the UK and EU Not every item of information referring to a particular medicinal product is promotional or qualifies as advertising, but the boundary is narrow and can be difficult to identify, with potentially serious repercussions for pharmaceutical companies and others involved in communicating information about medicines. For further details on...
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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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