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PRACTICE NOTES
When an organisation obtains a sponsor licence it must comply with a number of duties and responsibilities to the Home Office. When it applies for the licence it is declaring that it understands and is capable of complying with all of these. The consequences of failing to comply with the duties can be serious, including the licence being revoked, with a cooling-off period of 12 months imposed before it can apply for a fresh licence, and the permission of existing sponsored employees being cancelled. In some circumstances where there have been repeated breaches, there can be a longer cooling-off periods of 24 months. The details of the sponsor duties and responsibilities are not contained in the Immigration Rules or any legislation, but instead in the Workers and Temporary Workers Sponsor Guidance. In R (New London College Ltd) v Secretary of State for the Home Department (SSHD); R (West London Vocational Training College) v SSHD, the Supreme Court held that the Immigration Act 1971 provides a general statutory
PRACTICE NOTES
Scope of this Practice Note This Practice Note outlines the Financial Conduct Authority’s (FCA) custody rules found in the Client Assets sourcebook (CASS), which forms part of the FCA Handbook, with which regulated firms must comply when they are safeguarding and administering investments. The rules apply to custody assets, which include safe custody investments (which are designated investments which a firm receives or holds on behalf of a client), and any other assets that are held in the same portfolio as safe custody investments for the same client. What do the FCA custody rules cover? The custody rules contained in chapter 6 of the Financial Conduct Authority's (FCA) Client Assets sourcebook (CASS) provide details on what a firm must do when it carries on the regulated activity of safeguarding and administering investments. See Practice Note: Safeguarding and administering investments for more information on this activity. The rules apply to custody assets, which include safe custody investments (which are designated investments which a firm receives or holds on behalf of a client), and any other assets that are
PRACTICE NOTES
This Practice Note considers the key issues in relation to the enforcement of guarantees in the context of a financing transaction, specifically, a transaction where a lender (which is most likely to be a bank) has made a loan to a corporate borrower which is guaranteed by a corporate entity in the borrower’s group (eg the parent company of the borrower or a subsidiary of the borrower). This Practice Note considers the following issues: • what is the nature of claim that a lender has against a guarantor? • how does a lender enforce a guarantee? • how do you enforce under a multi-guarantor guarantee? • are there any specific issues to note in syndicated transactions? • are there any specific issues when dealing with guarantees from individuals? The law governing guarantees is complex and sometimes inconsistent, accordingly this Practice Note is intended to provide a starting point from which a more detailed analysis can be undertaken. What is the nature of claim that a lender
PRACTICE NOTES
This employment consultation tracker details consultations, calls for evidence and inquiries (collectively referred to here as ‘consultations’) conducted by the UK government (and other bodies) that have an impact on employment law, which have closed and for which responses have been published between 2016 and 2024. Consultations are listed by topic, in reverse chronological response date order, ie the consultation which has the most recent response or outcome date will appear at the top of the relevant topic table. For details of the status of open consultations, and closed consultations for which responses are still being analysed, see: Consultation tracker—Employment. For details of consultations issued relating to the Employment Rights Act (ERA 2025), see: Employment Rights Act 2025—tracker—Consultations issued relating to the ERA 2025. For a summary of current key legal developments generally, including consultations, that are expected to impact employment lawyers, see: Employment—horizon scanner. This Tracker is not maintained. Government departments and other bodies move historical materials to The National Archives website on a regular basis. If you encounter any broken links to consultation documents or
NEWS
Restructuring & Insolvency analysis: The High Court of Justice sanctioned a scheme of arrangement for Light SA (the Scheme), a Brazilian company, under Part 26 of the Companies Act 2006 (CA 2006). The Scheme involved two groups of creditors holding notes issued by Light SA's subsidiaries, Light Energia SA (Light Energia) and Light Serviços de Eletricidade SA (Light SESA) (together the Note Issuers) with Light SA acting as the guarantor. Both Note Issuers are regulated entities in Brazil, and their business is the generation (in the case of Light Energia) and distribution (in the case of Light SESA) of electricity in Brazil. The restructuring, approved by 99.4% of voting creditors and effective in Brazil, aims to facilitate new capital raising and note exchanges to address financial challenges, including losses incurred due to widespread energy theft and the coronavirus (COVID-19) pandemic. The Scheme offers benefits over the Brazilian judicial restructuring process, including options for New York law securities and international enforceability. Mr Justice Trower found sufficient connection to the UK jurisdiction and anticipated international recognition, particularly in Brazil, thus sanctioning the scheme. Written by Brian Rostron, associate at Addleshaw Goddard LLP.
NEWS
The Health and Safety Executive (HSE) has published its annual statistics, reporting 126 worker fatalities in Great Britain (GB) between April 2025 and March 2026. Excluding the years affected by the coronavirus pandemic, HSE says this is provisionally the lowest annual total on record. HSE has also published new international analysis comparing fatal workplace injury rates across 35 countries, concluding that GB continues to be one of the safest places in the world to work. Construction recorded the highest number of worker deaths (25), followed by agriculture, forestry and fishing (22), while agriculture, forestry and fishing continued to have the highest fatal injury rate per 100,000 workers. Falls from height remained the leading cause of fatal injuries, accounting for 31 deaths. An additional 104 members of the public died in work-related incidents during the same period. The HSE has also published annual mesothelioma statistics, showing 2,146 deaths in GB in 2024 due to past asbestos exposure. This represents a decrease of 109 compared with 2023 and is below the 10-year average of 2,508 deaths per year between 2011 and 2020. HSE expects annual mesothelioma deaths to continue declining as cases increasingly reflect historical exposure to asbestos before the 1980s.
NEWS
Life sciences analysis: This case concerned the messenger RNA (mRNA) technology used to develop BioNTech and Pfizer’s Cominarty coronavirus (COVID-19) vaccines. BioNTech and Pfizer (together, BioNTech/Pfizer) issued proceedings to revoke two of CureVac’s patents, EP (UK) 3 708 668 and EP (UK) 4 023 755 (together, ‘the Patents’). There was no dispute that the Cominarty vaccines infringed these Patents, if they were valid. The Patents concerned ‘split poly(A) tails’ in mRNA and their use to produce vaccines. CureVac asserted that the invention claimed by the Patents improved protein expression, which ultimately enabled the use of mRNA to formulate vaccines. The judge found that the patents were invalid for insufficiency owing to (1) lack of plausibility and (2) because the technical effect did not exist across the scope of the claims. The patents were also found to be obvious over a prior art citation called Thess. A further attack on the basis of added matter failed. Written by Dr Amanda Easey, senior associate at Penningtons Manches Cooper LLP.
NEWS
This week's edition of Life Sciences weekly highlights includes news that the EU AI Act has received its final approval by the Council of the EU and the UK Department for Science, Innovation and Technology (DSIT) has released the interim International Scientific Report on the Safety of Advanced Artificial Intelligence (AI) amidst nations meeting in Seoul at the AI Summit. Also included, is medical device news that the MHRA proposed a new regulatory certification pathway for medical devices via UK reliance on authorisations by certain international regulators and it launched a consultation on whether to introduce proposed common specification requirements for high-risk in vitro diagnostic (IVD) devices into the Medical Devices Regulations 2002 in alignment with the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) while the EMA updated guidance on drug-device combination products. Further included is news that a UK report was released highlighting the effects of the current economic instability on life sciences companies, the UK government has provided £85m to help tackle global antimicrobial resistance (AMR) including £1.8m to establish a dedicated regulatory support team for AMR innovators, Moderna has successfully defended a key patent underpinning its coronavirus (COVID-19) vaccine to the European Patent Office (EPO) and the UK Court of Appeal allowed an appeal against a judge’s decision to suspend a medical device’s certification for sale in British Standards v RRR Manufacturing, among other news.
NEWS
The International Medical Device Regulators Forum (IMDRF) has published its strategic plan for 2026–2030, outlining measures to accelerate global regulatory convergence for medical devices and strengthen governance. The plan sets out five strategic focus areas: (1) modernising governance to support sustainable and transparent growth; (2) reinforcing foundational regulatory principles by converting legacy Global Harmonization Task Force (GHTF) documents into updated IMDRF guidance; (3) addressing regulatory challenges posed by innovative technologies through the development of new technical documents and joint workshops with the IMDRF Industry Group; (4) expanding stakeholder engagement through new and enhanced mechanisms for participation and outreach; and (5) strengthening support for the implementation of IMDRF documents through training and practical guidance. To support consistent application across jurisdictions, the plan also calls for a more systematic and structured approach to IMDRF training programmes. The plan builds on progress made during the 2021–2025 strategic period, which was marked by rapid technological innovation, increased use of regulatory reliance mechanisms and significant regulatory disruption arising from the coronavirus (COVID-19) pandemic. During this time, regulators faced accelerating technological developments, including artificial intelligence (AI), machine learning (ML) and digital therapeutics, while adapting regulatory systems to pandemic-related pressures. IMDRF responded by issuing guidance on personalised medical devices, Software as a Medical Device (SaMD), AI-enabled medical devices and cybersecurity, and by developing the Reliance Playbook to promote more efficient and coordinated regulatory cooperation.
NEWS
This week's edition of Life Sciences weekly highlights includes news that the EU AI Act has been published in the Official Journal on 12 July 2024 meaning its impact on digital health regulation will begin as a gradual roll-out of application of certain sections from the date of its entry into force on 2 August 2024 until full application on 2 August 2027. Also, His Majesty King Charles III included among the government’s priorities and proposed policies that he set out in his first State Opening of Parliament speech, the Tobacco and Vapes Bill and the Digital Information and Smart Data Bill impacting e-cigarette/vaping and digital health and data regulation. Further news included is that the European Commission issued a statement in response to the General Court’s ‘access to documents’ decisions in relation to public access to the coronavirus (COVID-19) vaccine agreements it negotiated, the UK Office for Life Sciences (OLS) published its Life sciences competitiveness indicators reports for 2024 drawing a critical response from the British pharmaceutical industry and the European Economic and Social Committee (EESC) urged the European Commission to prioritise nuclear medicine and reduce barriers to the cross-border supply of radioisotopes, among other stories.
NEWS
Local Government analysis: The Court of Appeal in this case considered and upheld the Lower Court’s earlier conclusions rejecting two claims for a statutory review and a judicial review in respect of three Experimental Traffic Orders (ETOs) made by the respondent, the London Borough of Lambeth Council, as local traffic authority (LTA), for three Low Traffic Neighbourhoods (LTNs) in its area. The ETOs had been brought forward in the particular context of the coronavirus (COVID-19) lockdown and new government statutory guidance at that time which enjoined local authorities to introduce measures to give more road space to cyclists and pedestrians, including LTNs ‘as swiftly as possible, and in any event within weeks, given the urgent need to change travel habits before the restart takes full effect’. This meant ETOs being introduced promptly and full equality impact assessments (EqIAs) under the carried out Equality Act 2010 (the EqA 2010) but on a ‘rolling basis’, taking into account the further information gained about the measures when in place. The decisions which gave rise to the challenged orders were made by the council’s Strategic Director: Resident Services under delegated powers, on 9 October 2020. The central question in the appeal was whether the LTA had discharged its ‘public sector equality duty’ (PSED) under EqA 2010, s 149 and whether what had been done was sufficient to pass the test of having ‘due regard’ to the equality objectives in EqA 2010, s 149(1) objectives. Written by Celina Colquhoun, barrister at 39 Essex Chambers.
NEWS
Dispute Resolution analysis: This topical case arose from the failure (due to flight restrictions resulting from the coronavirus (COVID-19) pandemic) of Travelex Banknotes Ltd (TBL) to provide banknotes to Rawbank SA (the largest bank in the Democratic Republic of Congo), resulting in a claim for $US 60,072,000. The court subsequently considered on an application for summary judgment the rate of pre-action interest, whether a Part 36 offer was genuine and if so, the consequences, and whether damages should be payable immediately, in circumstances where Travelex Banknotes Ltd presented no defence and were restructuring to avoid insolvency. Mr Justice Zacaroli granted judgment. Rejecting Rawbank SA’s argument for interest at a commercial borrowing rate, the court awarded pre-action interest at the contractual rate of 2% above Barclays Bank base rate up to the end of the relevant Part 36 period for acceptance (25 May 2020) and 8% judgment debt interest thereafter, costs of the action and application awarded on the standard basis to 25 May 2020 and indemnity costs thereafter, with payment of damages within 14 days. Written by Richard Allen, costs lawyer and senior pricing consultant with Burcher Jennings, validatum and virtual pricing director.