This week's edition of Life Sciences weekly highlights includes news that the European Parliament adopted its position on the Digital Omnibus amendments to the EU AI Act, including revised timelines for high-risk systems and the European Consumer Organisation (BEUC) expressed concerns regarding the impact on consumer protection of many consumer-facing AI systems being removed from the high-risk classification under the AI Act, the DHSC published an explanatory memorandum on proposed reforms of the EU MDR and IVDR, the MHRA published a collection of guidance on clinical investigations for medical devices and the Commission updated its Q&A on the obligation to inform of interruptions in the supply of medical devices, together with a decision tree diagram. Further news included is that the MHRA published draft guidance on ICH E6 good clinical practice compliance and new guidance on phasing out animal testing in medicines development, with the EMA also consulting on a draft opinion on virtual control groups to reduce animal use in medicines testing, the UK government published a new pandemic preparedness strategy, the Human Medicines (Amendment) Regulations 2026, SI 2026/381 came into force on 31 March 2026, amending the Human Medicines Regulations 2012 (HMR 2012) to allow pharmacist preparation without a manufacturer’s licence and extend vaccine flexibilities, as well as news that the UK confirmed a Technology Transfer Block Exemption Order under the Competition Act 1998, replacing the assimilated TTBER from 1 May 2026 with a UK regime, the EMA published the data quality framework for EU medicines regulation, to support regulatory decision-making, the Commission updated its FAQ guidance on EHDS regulation implementation and opened a consultation on draft Guidance on EU Cyber Resilience Act, among other stories.

ARCHIVED: This Practice Note has been archived and is not maintained. Coronavirus (COVID-19) presents an unprecedented challenge to the global life sciences industry. The UK and EU regulators are working to provide continually reviewed up-to-date guidance in response to the evolving crisis, as well as to support research and development (R&D) that they hope will contain the impact of the spread. This Practice Note provides guidance as to the response of UK and EU regulators in the areas of clinical trials, inspections and the continuity of supply in medicinal products and medical devices, as well as the postponement of the implementation of Regulation (EU) 2017/745 (consolidated version 24.04.2020), the Medical Devices Regulation (MDR). It also summarises key R&D initiatives at a UK and EU level and European Commission guidance on the collection and transfusion of convalescent COVID-19 plasma. For a summary of developments and updates on coronavirus that relate to the life sciences sector,

A round-up of EU competition law developments, including (amongst other things) (1) the General Court issues judgment dismissing Ryanair’s actions regarding the Commission’s decisions approving Italian compensation scheme for airlines in the context of COVID-19 pandemic and amended scheme, (2) the General Court issues judgment dismissing Apple’s actions regarding its designation as a gatekeeper in relation to App Store and iOS, and (3) the Commission launches consultation on commitments offered by Sanofi over possible anticompetitive conduct regarding the promotion of a flu vaccine for vulnerable patients.

The Financial Conduct Authority (FCA) has published the results of its final Financial Resilience Survey issued in October 2023. Over the last three years, the FCA has collected financial resilience data from approximately 23,000 regulated firms. This has helped develop the FCA’s understanding of financial resilience, which is measured by assessing whether a firm holds enough resources to meet their ongoing obligations.  This includes insight into the impact of recent crises, ranging from the Coronavirus (COVID-19) pandemic to cost-of-living pressures. The FCA says that using the data from the survey has helped it respond to risks faster and that it has identified and addressed concerns in hundreds of firms.

The Chancellor of the Duchy of Lancaster, Michael Gove, has responded to a joint letter from First Minister of Scotland, Nicola Sturgeon, and First Minister of Wales, Mark Drakeford, which they sent to Prime Minister Boris Johnson on 25 May 2021. In the letter, Gove highlighted the importance of cooperation in the response to the latest phase of the coronavirus (COVID-19) pandemic, comprising the vaccine production and rollout throughout the UK. Gove notified Sturgeon and Drakeford that the Prime Minister has agreed to delay the COVID Recovery meeting to allow for additional preparations to take place, but ‘remains keen to meet as soon as possible’.

The Lord Chief Justice, Lord Burnett of Maldon, has released a message on the return of in-person court hearings after the lockdown measures imposed due to the coronavirus (COVID-19) pandemic necessitated the use of online video platforms for remote hearings. Lord Burnett stated that there will be a continuing role for those involved in the courts’ operation, including the enforcement of and adherence to social distancing guidelines, hygiene practices and the use of face coverings. It is expected that remote hearings will still be used to manage footfall, but Lord Burnett described the return to in-person hearings as ‘desirable’.

HM Treasury (HMT) has published the independent report of the Covid Counter Fraud Commissioner, which found that the previous government’s pandemic support schemes exposed the public purse to £10.9bn in fraud and error. Commissioner, Tom Hayhoe, concluded that programmes such as Bounce Back Loans, Eat Out to Help Out and large-scale PPE procurement were launched at speed with inadequate safeguards, weak data, limited oversight and inconsistent controls, enabling extensive abuse. The report highlights that over-ordering of PPE, reliance on self-certification in business support schemes and uneven capability across departments and delivery partners contributed significantly to losses.

The European Parliament has adopted its negotiating position on the reform of the Package Travel Directive (EU) 2015/2302 on package travel and linked travel arrangements (the Package Travel Directive), with the aim of strengthening traveller protection in cases of travel disruption and tour operator bankruptcy. MEPs endorsed the European Commission’s proposal to update the rules, reflecting lessons from the COVID-19 pandemic and recent high-profile bankruptcies. The position, prepared by the Committee on the Internal Market and Consumer Protection, was adopted with 535 votes in favour, 36 against and 47 abstentions. Interinstitutional negotiations on the final rules are scheduled to start on 24 September 2025.

The Charity Commission for England and Wales has launched its strategy for 2024-2029 including its core purpose and five strategic priorities of fairness, balance, independence, digital and data, and people. The priorities were informed and guided by challenges such as the cost-of-living crisis and the disruption that resulted from the coronavirus (COVID-19) pandemic. Financial resilience was said to be a central issue in the upcoming five years. The strategy further anticipates the opportunities, risks and challenges associated with rapidly changing technology and shifting social norms.

The Ministry of Housing, Communities & Local Government has published guidance on the new Housing Possession Mediation Service for landlords and tenants undergoing possession proceedings. The service, which is free to use for all landlords and tenants currently undergoing possession proceedings, was created as part of the government’s work on new court arrangements to support parties during the ongoing coronavirus (COVID-19) pandemic. It has been designed to help landlords and tenants to resolve cases without the need for a face to face court hearing, and will see parties work alongside a neutral mediator to identify issues and work to resolve them.

The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) published their joint EU medicines agencies' network strategy to 2028 on 18 March 2025. The strategy outlines six focus areas including AI implementation, regulatory science and antimicrobial resistance. During consultation, concerns were raised about the regulatory network's capacity to implement the strategy, though 19 out of 24 responses were positive, with two trade groups expressing neutral views. The strategy aims to address post-pandemic challenges and prepare for upcoming pharmaceutical legislation reforms, with emphasis on EU competitiveness in medicines development and manufacture.

The Crown Prosecution Service (CPS) has published an update on the legal case involving Aftab Baig, who defrauded Leeds City Council of over £710,000 intended to support small businesses during the Covid-19 pandemic. Baig was sentenced to four years in prison after being found guilty on 12 February 2025 at Leeds Crown Court of three counts of fraud under s 1 of the Fraud Act 2006. The fraud was committed by making fraudulent grant claims against thirty-two Greggs properties and diverting the funds into a business account. The investigation was conducted by the National Investigation Service (NATIS), and the CPS plans to recover any assets obtained through this criminal activity.