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.

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.

Dispute Resolution analysis: His Honour Judge (HHJ) Hacon addressed the precise procedure to be followed when a decision is handed down remotely, the parties do not attend, and one or more of the parties then wishes to appeal. The judge made it very clear that the procedure has not been altered by the coronavirus (COVID-19) protocol (the Protocol). The date of the decision for the purposes of CPR 52.12 (which sets time running for the 21-day period in which an application for permission to appeal must be made) is the date of the hearing, referred to as the ‘decision hearing’, at which the decision is given, regardless of whether the decision is ex tempore or whether there is a formal hand down of a reserved judgment. A party who wishes to apply to the lower court for permission to appeal should do so at the decision hearing and, where counsel have been excused from attendance, that application should be made in advance of the decision hearing. If no permission application is made at the decision hearing, and there has been no adjournment, the lower court is no longer seized of the matter and cannot consider any retrospective application for permission to appeal. Written by Oliver E Browne, partner and chair of the London Litigation & Trial Department, at Latham & Watkins.

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.

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.

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.

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.

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.

This week's edition of Life Sciences weekly highlights includes Law360 discussion of the Unified Patent Court ruling that Amgen’s patent covering Repatha, a cholesterol drug, was not valid in the EU and News Analysis by Covington & Burling LLP about the European Commission’s publication of the NIS 2 draft Implementing Regulation in June that regulates the security of digital network and information systems such as critical healthcare systems and devices. Also included, is news that the Re-elected European Commission President, Ursula von der Leyen, proposed two legislative priorities, a European Biotech Act in 2025 and a Critical Medicines Act, as part of the Commission’s five-year plan, the Court of Justice held that the Commission did not give the public sufficiently wide access to the purchase agreements for coronavirus (COVID-19) vaccines, the EU pharmaceutical industry have released a detailed position paper on the European Health Data Space (EHDS), MedTech Europe has urged the Commission urgently to further amend the medical devices regulations which it feels have proven not fit for purpose as it stands, meanwhile, Q&A guidance was released on the most recent legislative amendments to the medical devices regulations, a PRO-MaP initiative launched to enhance the methodological reporting and transparency in scientific publications and the FDA will establish a Rare Disease Innovation Hub dedicated to significant unmet needs, among other news.

This week's edition of Life Sciences weekly highlights includes news analysis on ESG trends emerging from the UK’s commitments to tackle antimicrobial resistance (AMR) by Freshfields Bruckhaus Deringer LLP. Also included is news that the Council of the EU formally approved the Regulation on Substances of Human Origin (SoHO) to expand and improve the safety and quality of blood, tissues and cells for use in humans and their cross-border movement, the European Commission adopted new rules for joint clinical assessment of medicines for the implementation of the new Regulation (EU) 2021/2282, Health Technology Assessment (HTA Regulation), WIPO Member States approved the world’s first Treaty about intellectual property based on genetic resources and associated traditional knowledge, NICE and NHS England have jointly opened a consultation on a new fast-track for MedTech developers to access NHS funding, the first UK Government Champion for Personalised Prevention published his report, the Data Protection and Digital Information Bill has been lost in the ‘wash-up’ period ahead of the UK general election, the Council of the EU adopted new rules revising the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) to prevent shortages of medical devices and enhance transparency and accessibility to information and, Moderna has successfully defended a key patent underpinning its coronavirus (COVID-19) vaccine, among other news.

This week's edition of Life Sciences weekly highlights includes an analysis by Freshfields LLP on the UK Law Commission’s review of the product liability regime, with a focus on AI technologies and recent EU developments, an analysis by Pinsent Masons of the High Court’s ruling in Samsung Bioepis v Alexion, which invalidated Alexion’s eculizumab patent and found no infringement, underscoring the importance of precise drafting in biologic patents and a Law360 story on the Court of Appeal’s ruling in a long-running patent infringement dispute between coronavirus (COVID-19) vaccine developers, upholding Moderna’s mRNA patent against Pfizer/BioNTech. Also included is news that the MHRA has been designated as a WHO-Listed Authority, launched a consultation seeking UK stakeholder feedback on the revised ICH M4Q(R2) and announced that UK licence holders must now independently monitor US FDA Warning Letters, the EMA updated its guidance on paediatric submissions, as well as news that the European Commission published a study on legal and regulatory challenges to AI deployment in healthcare across the EU, the MHRA launched a stakeholder survey on the health institution exemption for medical devices and updated guidance on adverse event reporting requirements for digital mental health technologies, following the implementation of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, and the DHSC dispute resolution panel ruled that Haleon must remain in the voluntary branded medicines pricing scheme (VPAG) for 2024, despite its claim of administrative error in joining, among other stories.

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.