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NEWS
The European Association of Medical devices Notified Bodies (Team-NB) has released a position paper proposing  the reclassification SARS-CoV-2 diagnostic tests from Class D to a lower-risk medical device class post-pandemic. Currently, coronavirus (COVID-19) tests are classified and regulated in the EEA as Class D in vitro diagnostic (IVD) devices according to Medical Device Coordination Group (MDCG) Classification guidance 2020-16 Rev. 2 further to Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation (IVDR)), Annex VIII Rule 1, 2nd indent.  In the paper, it considers the impact of reclassifying these tests as Class B according to IVDR Annex VIII rule 6 or Class C device according to Annex VIII Rule 3c, concluding that a reclassification to Class C would be recommended at this time given the limited availability of post-pandemic data. This would protect patient safety as stricter post-market surveillance (PMS) and performance evaluation/clinical evidence for these IVDs are applied. It further suggested that later reclassification to Class B could be considered once more data on the post-pandemic phase, especially regarding the long Covid syndrome, are gathered.
NEWS
HM Treasury has launched a voluntary repayment scheme, effective from 12 September 2025 until December 2025, allowing individuals and businesses to return funds received under coronavirus (COVID-19) schemes—including loans, grants, social security, and tax benefits—without any questions asked. This initiative is part of a wider effort to recover over £10bn lost due to pandemic-related fraud, flawed contracts and mismanagement, with £1.54bn already recovered.
PRECEDENTS
ARCHIVED: This archived Precedent clause is not maintained and is for background information only. 1 Definitions Completion Date • (a) [insert date]; or (b) if a Delay Notice has been served in accordance with clause 2.2, the date determined in accordance with clause 2.4; Coronavirus • severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the disease known as COVID-19; Coronavirus Event • any event or delay arising as a result of the Coronavirus pandemic which prevents
Q&As
The timetable for Budgets was, in theory, reformed in autumn 2017. Under that timetable, a non-general election year should only contain one ‘major fiscal event’, ie an Autumn Budget. However, due to the impact of general elections and the coronavirus (COVID-19) pandemic since 2017, there have been various Spring Budgets either as well as or instead of Autumn Budgets in 2019, 2020 and 2021. The last Budget took place on 27 October 2021. In a calendar year without a general election or other major disruptive event, the annual Budget cycle announced in 2017 is
PRACTICE NOTES
This Practice Note considers how directors convene board meetings under the model articles for private companies limited by shares and public companies limited by shares (Model Articles). It covers giving notice, content requirements of notices, attendance and attendees at board meetings. It also considers corporate governance requirements under the UK Corporate Governance (UKCG) Code. For details on the power and authority of directors to make decisions, whether as a full board or as part of a committee, directors’ duties considerations when making decisions, and decision-making in group companies, see Practice Note: Directors’ decision-making—power, authority and duties. For information on typical conduct at board meetings, including the role of the chair, quorum and voting requirements, declaring interests in transactions, consideration of board papers and debate, see Practice Note: Directors’ decision-making—conduct at board meetings. See also Practice Note: Directors’ decision-making—post board meeting formalities for an examination of preparing board minutes and administrative requirements following board meetings. For details on decisions taken by using the written resolution method and for decision-making by sole directors, see Practice Note: Directors’ decision-making—written
PRACTICE NOTES
As a result of coronavirus (COVID-19) pandemic, investment funds have faced challenges both operationally and as a result of significantly increased volatility in global markets. The pandemic, in combination with high volatility and inherent valuation issues that it has triggered, has led to large market corrections and a deterioration of liquidity risks, which in turn has prompted stress in different parts of the financial system, including in some segments of the investment fund sector. These issues are summarised in a joint committee report on risks and vulnerabilities in the EU financial system, which was published by the European Securities and Markets Authority (ESMA) and the other European Supervisory Authorities (ESAs) in September 2020. The Financial Conduct Authority (FCA) has published guidance setting out its expectations regarding funds in light of coronavirus. While it acknowledges the significant challenges firms are facing in the current environment, it nevertheless expects them to continue to uphold the best interest of their investors at all times. ESMA and the Investment Association (IA) have also published guidance, and
PRACTICE NOTES
ARCHIVED: This Practice Note has been archived and is not maintained. This Practice Note is a summary of the key legal developments of relevance to personal injury and clinical negligence practitioners as of 16 December 2020. For the most recent horizon scanner, reference should be made to PI and Clinical Negligence horizon scanning—overview. Coronavirus (COVID-19) To stay ahead of the fast-moving changes in the courts’ processes and procedures necessitated by the pandemic and for industry guidance on how to manage cases during the pandemic including medical examinations, service and limitation, see Practice Note: Coronavirus (COVID-19) implications for PI and clinical negligence [Archived]. For details on recent developments in this area for Pi and clinical negligence claims, see: • Association of British Insurers and Association of Consumer Support Organisations further extend Statement of Intent to 15 January 2021​—see: LNB News 02/12/2020 24 • Coronavirus (COVID-19)—Foreign Process Section’s availability update (November 2020) • RCJ fees office to reopen to public from 7 December 2020—LNB News 27/11/2020 57 • In-person medical examinations
PRACTICE NOTES
This Practice Note considers the Self-Employment Income Support Scheme (SEISS) under which self-employed individuals and members of partnerships who had been adversely impacted by the coronavirus (COVID-19) pandemic could claim a grant from HMRC. The scheme ended on 30 September 2021 when the claims process for the fifth and final grant payment (SEISS 5) closed. This Practice Note sets out the position in relation to SEISS 5 claims that applied immediately prior to the scheme’s closure. The SEISS was announced by the government on 26 March 2020, and the online application service for the first grant payment (SEISS 1) was available from 13 May–13 July 2020. The SEISS was subsequently extended three times: • on 29 May 2020 it was announced that the SEISS would be extended (first SEISS extension) to make provision for a second grant payment (SEISS 2). Applications for SEISS 2 were open from 17 August–19 October 2020 • on 24 September 2020 the government announced a further extension to the SEISS (second SEISS extension). The second SEISS extension provided for two taxable grant
PRACTICE NOTES
The rapid global spread of coronavirus (COVID-19) and the steps taken to limit contagion are having a significant impact on the global economy and, consequently, on the financial system. Insurers are exposed on both sides of their balance sheets; on the liability side because of changes to interest rates as well as the potential increase in claims, and on the asset side due to market volatility. Insurers are generally well-capitalised, with sophisticated risk management capabilities which should help the sector as a whole to withstand the shocks associated with coronavirus. Insurance has an essential role to play during a pandemic event, providing protections to individuals, households and businesses. Insurance supervisors have pursued a range of regulatory and supervisory measures to provide operational relief to insurers in the wake of the coronavirus outbreak and to provide appropriate flexibility to help insurers maintain their safety and soundness and deliver the essential services they provide to policyholders and the economy. Authorities have also adopted measures to support fair treatment of customers, including clear disclosure
PRACTICE NOTES
ARCHIVED: This Practice Note is archived and is no longer maintained. Lawyers across the world have been grappling with many common areas of concern in connection with the coronavirus (COVID-19) pandemic. There are a number of areas that are particularly relevant to banking and finance lawyers. For more detail and analysis on these, see Practice Note: Coronavirus (COVID-19) implications for Banking & Finance lawyers, which contains news, practical guidance and analysis covering the impact of COVID-19 developments and considers subjects such as force majeure, execution of documents, Brexit and LIBOR as well as setting out the implications for different types of banking and finance transactions. See also, Practice Note: Coronavirus (COVID-19)—implications for lending transactions which focuses on the governmental and regulatory responses to the pandemic from a lending perspective, implications for facility agreements, both from a borrower and lender perspective, and various practical implications in relation to deal execution. We have also put together a set of COVID-19 FAQs, which comprise a number of questions that might arise on a lending transaction
NEWS
The Chair of the UK Covid-19 Inquiry, Baroness Hallett, has announced plans for the public hearing dates in three further investigations that will take place from autumn 2024 until spring 2025. Module 3 public hearings will investigate the impact of the pandemic on healthcare systems and will run from 9 September 2024 until 28 November 2024, with a two week break between 14 and 25 October 2024. Baroness Hallett plans to hear evidence for Module 4 (examining vaccines, therapeutics and anti-viral treatment) from 14 January 2025 and for Module 5 (exploring pandemic procurement) from 3 March 2025.  Hearing dates for Module 6 (examining the care sector) will be announced later in 2024. Baroness Hallett has said that the report for Module 1 will be published in mid-2024 and that she aims to conclude public hearings by summer 2026.
NEWS
The European Parliament has approved revised rules on package travel aimed at enhancing protection for holidaymakers by drawing lessons from the pandemic and high-profile bankruptcies. The updated directive clarifies the definition of a travel package, introduces rules governing the use of vouchers and allows travellers to cancel trips without penalties in cases of unavoidable and extraordinary circumstances affecting the destination or point of departure.