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PRACTICE NOTES
The National Health Service (NHS) England and Wales have a publicly funded health system. The Department of Health and Social Care (DHSC) controls the provision, and the government pays for it from tax and National Insurance collected centrally. The health care is free to residents of England and Wales. Some charges are levied in politically less sensitive areas such as dentistry and eye care. The National Health Service Act 2006 (NHSA 2006) consolidates previous legislation relating to the NHS and the provision of healthcare. The provisions of NHSA 2006 primarily apply in England. The NHS has undergone significant operational reform in the last two decades. In particular, the Health and Social Care Act 2012 (HSCA 2012) came into force in April 2013 and brought major reforms to the NHS. The Health and Care Act 2022 (HCA 2022) then saw the introduction of further wide-ranging changes. The structure of the NHS in England The below provides an outline of the structure of the NHS in England,
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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.
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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.
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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.
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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.
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This week's edition of Life Sciences weekly highlights includes analysis by Gill Jennings & Every LLP of the impact of the UK Intellectual Property Office’s (UK IPO) statutory guidance on changes to marketing authorisations and SPCs for medicines from 1 January 2025 and case analysis by Penningtons Manches Cooper LLP of the BioNTech & Pfizer v CureVac patent dispute that revoked CureVac’s patents on ‘split poly(A) tails’ mRNA technology used to develop coronavirus (COVID-19) vaccines. Also included, is news that the MHRA published guidance on implementing changes to the advertising and promotion of medicines authorised in the UK after 1 January 2025 further to the Windsor Framework, the European Commission has issued guidance on implementing the mandatory notification system for medical device shortages and it substantively revised its vigilance guidance for medical devices, the World Medical Association adopted the 2024 revision of the Declaration of Helsinki for medical research ethics, the UK HRA welcomed the Sudlow Report reviewing the UK health data landscape and released a draft model Commercial Chief Investigator Agreement for consultation, among other stories.
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The Crown Prosecution Service (CPS) has reported that Harman Banger and his wife Neena Kumari have been convicted for attempting to exploit a coronavirus (COVID-19) bounce back loan scheme. According to the CPS, Banger used knowledge from having Cabinet responsibility at Wolverhampton City Council to cheat the system. His wife submitted an application for a small business grant of £10,000 for Pizza Plus, a business they shared ownership of, on 24 April 2020 claiming that it had been operating since October 2019. An investigation by Wolverhampton Council’s counter-fraud team and West Midlands police found no records of electricity being supplied to the business address until 16 May 2020 and that the property had been boarded up and was in a state of disrepair showing that the business was not in fact operating as the pair had fraudulently claimed when applying for financial assistance. They were both found guilty on 17 December 2021 at Wolverhampton magistrates’ court of fraud by false representation and will be sentenced at Birmingham Crown Court on 14 January 2022.
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Public Law analysis: The court found that a decision by the Minister for the Cabinet Office to directly award a contract for research to inform the government’s communications strategy during the coronavirus (COVID-19) pandemic to the interested party, Public First, was unlawful. Public First had personal and professional connections to both the Minister himself and to Dominic Cummings (then special adviser to the Prime Minister). The judge accepted that the defendant had been entitled to rely on the truncated procedure under regulation 32(2)(c) of the Public Contracts Regulations 2015 (PCR 2015) to make the award, and accepted that the term of six months was not disproportionate. However, the use of regulation 32(2)(c) did not relieve the defendant of the requirement to conduct the procurement so as to demonstrate a fair and impartial process of selection. In the circumstances, the failure to consider any other research agency by reference to objective criteria gave rise to an appearance of bias. Written by Siân McGibbon, barrister at 4-5 Gray’s Inn Square.
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Public Law analysis: The current Prime Minister’s long running battle with the Seven Principles of Public Life continues to gather pace. Johnson’s actions relating to the coronavirus (COVID-19) pandemic ‘partygate’ scandal have arguably violated each of the principles established by the Nolan Committee in 1995: selflessness, integrity, objectivity, accountability, openness, honesty and leadership. The Prime Minister’s full house of ethical violations concerning his attendance and subsequent denials of social gatherings held in Downing Street, contrary to lockdown restrictions, have also yielded Fixed Penalty Notices from the police for him, his Chancellor, his wife, and other government officials, with the prospect of more to follow. Yet the Prime Minister remains committed to staying in post and has refused to resign. Mike Gordon, Professor of Constitutional Law at the University of Liverpool, considers whether the Ministerial Code is the best reference point by which to assess the Prime Minister’s actions, and what impact its central status could have on the debate around whether the Prime Minister should resign.
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Public Law analysis: On 15 February 2022, the High Court handed down judgment in a judicial review claim brought by two public interest groups, the Good Law Project (GLP) and the Runnymede Trust, against an alleged government policy or practice of making appointments to coronavirus (COVID-19) taskforces without open competition. The claimants argued this gave rise to discrimination. The court did not consider that the alleged policy existed and the claim failed on grounds 1 (indirect discrimination) and 3 (apparent bias). The court nonetheless found that the specific appointments identified by the claimants (Baroness Harding as Interim Chair of the National Institute for Health Protection in May 2020 and Mr Coupe as Director of Testing for NHS Test and Trace in August 2020) breached the Public Sector Equality Duty (PSED), which requires public authorities to take reasonable steps to enquire about the potential impact of a proposed decision or policy on people with protected characteristics (as identified in the Equality Act 2010). However, only one of the claimants (the Runnymede Trust) succeeded on the PSED ground, as the court found that GLP lacked standing to bring any of the grounds of challenge, noting that it does not have a carte blanche to bring judicial review claims. The court dedicated one third of its judgment to the issue of GLP’s standing which, according to an earlier judgment, had been ‘ripe for review’. Written by Tom Cassels, Jonathan Jones, Alexander Fawke and Emma Kate Cooney of Linklaters LLP.
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Pensions analysis: The First-Tier Tribunal (‘the Tribunal’) has ruled that the Pensions Regulator (TPR) acted ‘unfairly’ in issuing a penalty to a building company (‘the Appellant company.’) for failing to comply with its automatic enrolment duties in compliance with workplace pension law under the Pensions Act 2008 (PA 2008). The Tribunal found that having satisfied itself that the precondition for issuing a penalty had been met, TPR then declined the opportunity to consider the evidence and argument put forward on behalf of the Appellant company. The Tribunal commented that TPR entirely discounted the alleged facts without either seeking confirmation of the facts as alleged, nor querying their veracity and weight. In taking this approach, TPR was said to have ignored the newness and scale of the company, the possible impact of the ‘extraordinary’ coronavirus (COVID-19) pandemic on such a small, new organisation, as well as ignoring the statement of the impact of a bereavement. Written by Rowena Wisniewska Sethi, barrister at 4-5 Gray’s Inn Square Chambers.
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The European Commission has, as part of the Pharmaceutical Strategy, adopted the new Variations Regulation which amends Regulation (EU) 712/2012 and makes the lifecycle management of medicines more efficient by adapting the current system for variations to marketing authorisation. The new Regulations will be updated in line with recent scientific and technological developments and a rise in number of variation requests, facilitating a quicker post-authorisation process of medicines, quicker processing of variations and more efficient lifecycle management of medicines. Key changes include: the removal of the default type II classification for quality/manufacturing changes for biological products (including advanced therapies), the formalisation of the legal basis for the use of existing additional regulatory tools, the extension of Influenza vaccines approaches to Coronavirus vaccines, and reference to annual updates for all minor variations whilst retaining the flexibility of immediate submission in some cases. Proposed revisions to the classification of variations guideline is expected later this year which will complete this initial update of the variation framework.