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.

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.

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.

Competition analysis: In his Opinion in the Tondela Case delivered on 15 May 2025, Advocate General (‘AG’) Emiliou at the Court of Justice of the EU argues that no-poach agreements entered into between competitors have all the characteristics to be considered prima facie restrictive of competition ‘by object’, unless the content, the legal and economic context and the objectives of the specific agreement at issue cast doubt on the harmful nature of the agreement or if the no-poach agreement is ancillary to a transaction which is itself not anti-competitive. In application of the Meca-Medina case law, AG Emiliou argues that the objective of the no-poach agreement in question (ensuring a fair and orderly end of the 2019/2020 football season during coronavirus (COVID-19) pandemic) was worthy of protection under EU law and absent any equally effective and less restrictive measures necessary and proportionate to that objective. Written by Peter Giese, Kirsten Baubkus-Gérard, Elisa Götz, lawyers at CMS.

The European Medicines Agency (EMA) has published guidance on how to comply with the provisions of the amended Regulation (EU) 2024/1701 (the amended Variations Regulation), which will apply to new variation applications implemented and submitted to the EMA from 1 January 2025, in hopes to make lifecycle management more efficient. The guidance provides information on the implementation of the amended Variations Regulation, which includes amendments to the Article 5 procedure, the annual update for minor variations of Type IA, the procedure for grouping and super-grouping of Type IA variations, the annual update of a human influenza or human coronavirus (COVID-19) vaccine, the mandatory and voluntary use of the work sharing procedure, the variations to human medicines for public health emergencies and to the Annexes. The guidance also provides recommendations on unforeseen variations. Any variation applications submitted before 1 January 2025 should follow the current provisions set out in Regulation (EC) 1234/2008, as amended by Commission Delegated Regulation (EU) 2021/756.

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.

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.

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.

A letter from the Counsel General for Wales, Mick Antoniw MS, has resulted in a day of resignations for Welsh politics on 16 July 2024, including the First Minister's (FM) resignation. Just after 9.30 am on 16 July 2024, Antoniw posted a letter on X (formerly known as Twitter) in which he called on Vaughan Gething to resign as First Minister of Wales, drawing attention specifically to the Senedd's vote of no confidence in the FM in early June 2024. Antoniw wrote, 'you have lost a vote of confidence in the Senedd. That is something I regard as being of major constitutional importance.' Gething had refused to resign following the vote, which was not legally binding and was passed with a majority of two, as two Labour members of the Senedd had been absent with illness. The background is a series of troubles for the FM, including a row on political donations and reports that, as health minister, he had deleted chat messages during the Coronavirus (COVID-19) pandemic. Shortly after the Counsel General published his letter, it was reported that he had resigned, together with three other Welsh ministers, including Julie James, Lesley Griffiths and Jeremy Miles. The FM announced his own resignation a few hours later.