Covington & Burling LLP (LexBlog United Kingdom)

On 22 July 2025, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) published the outcome of its most recent medical device-related consultation.  The MHRA also announced its intention to consult further on the indefinite recognition of CE-marked medical devices in Great Britain, with this consultation expected to take place later in 2025. Background The...

On June 5, 2025, the UK’s Information Commissioner’s Office (“ICO”) launched its new AI and biometrics strategy. The strategy aims to increase its scrutiny of AI and biometric technologies focusing on three priority situations, namely where: stakes are high; there is clear public concern for the technology; and regulatory clarity can provide immediate impact. The...

The UK Parliament has passed emergency legislation to enable the government to direct the use of assets of British Steel, and to take control of assets if directions are not followed. The government’s stated intention is “continuing the support of steel production in the UK [which] involves preserving current production capacity to ensure resilience in the...

The UK Parliament has passed emergency legislation to enable the government to direct the use of assets of British Steel, and to take control of assets if directions are not followed. The government’s stated intention is “continuing the support of steel production in the UK [which] involves preserving current production capacity to ensure resilience in...

In November 2024, the UK’s High Court (the “Court”) issued its judgment on the first appeal of a Final Order (“Order”) imposed by the UK government (acting through the Secretary of State) under the UK’s National Security and Investment Act 2021 (the “NSIA”). Under UK public law, decisions such as the Order can only be...

On November 8, 2024, the UK’s communications regulator, the Office of Communications (“Ofcom”) published an open letter to online service providers operating in the UK regarding the Online Safety Act (“OSA”) and generative AI (the “Open Letter”).  In the Open Letter, Ofcom reminds online service providers that generative AI tools, such as chatbots and search...

On 29 January 2025, NHS England (“NHSE”) published an updated Commercial Framework for New Medicines (the “Commercial Framework”). The Commercial Framework, first published in 2021, sets out NHSE’s approach to commercial activity in relation to new branded medicines and is a key document in the UK’s pricing and reimbursement landscape. The Commercial Framework clarifies and...

On 30 January 2025, the UK Government announced the re-launch of the Innovative Licensing and Access Pathway (“ILAP”) for medicines. The ILAP is an “end-to-end” access pathway offering a unique opportunity for a medicine’s developer to engage with: (i) the UK’s medicines regulator – the Medicines and Healthcare products Regulatory Agency (“MHRA”); (ii) England’s HTA...

The UK Information Commissioner’s Office (“ICO”) recently announced a new online tracking strategy, which aims to ensure a “fair and transparent online world where people are given meaningful control over how they are tracked online.” Online advertising is one of the ICO’s current areas of strategic focus (others areas of focus include AI and children’s privacy). The ICO has...

The UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) is seeking industry feedback on its new draft guideline on individual messenger ribonucleic acid (“mRNA”) cancer immunotherapies (the “Draft Guidance”).  Building on the success of mRNA vaccine technology in response to the Covid-19 pandemic, the technology is now being adapted to target diseases such as cancer.  The MHRA aims...

The UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) is seeking industry feedback on its new draft guideline on individual messenger ribonucleic acid (“mRNA”) cancer immunotherapies (the “Draft Guidance”).  Building on the success of mRNA vaccine technology in response to the Covid-19 pandemic, the technology is now being adapted to target diseases such as cancer. ...

The UK Information Commissioner’s Office (“ICO”) recently announced a new online tracking strategy, which aims to ensure a “fair and transparent online world where people are given meaningful control over how they are tracked online.” Online advertising is one of the ICO’s current areas of strategic focus (others areas of focus include AI and children’s...

On 23 January 2025, we hosted the 2025 edition of the Covington European Life Sciences Symposium. The Symposium brought together colleagues from London, Brussels, Frankfurt and Dublin with our industry connections to explore the evolving challenges and opportunities facing the European life sciences sector. Throughout the day our speakers shared their perspectives on a range...

Economic Turmoil in the UK The rate on the 10-year benchmark UK government bond has reached levels last seen in 2008. The rate on the 30-year bond stands at a 27-year high. Today, the Government sold £1 billion of bonds at the most expensive terms since 2004 – albeit with apparently good market demand. Sterling...

In case you missed it before the holidays: on 17 December 2024, the UK Government published a consultation on “Copyright and Artificial Intelligence” in which it examines proposals to change the UK’s copyright framework in light of the growth of the artificial intelligence (“AI”) sector.    The Government sets out the following core objectives for a new...

On November 6, 2024, the UK Information Commissioner’s Office (ICO) released its AI Tools in recruitment audit outcomes report (“Report”). This Report documents the ICO’s findings from a series of consensual audit engagements conducted with AI tool developers and providers. The goal of this process was to assess compliance with data protection law, identify any risks or...

On November 6, 2024, the UK Information Commissioner’s Office (ICO) released its AI Tools in recruitment audit outcomes report (“Report”). This Report documents the ICO’s findings from a series of consensual audit engagements conducted with AI tool developers and providers. The goal of this process was to assess compliance with data protection law, identify any...

In recent weeks, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published further guidance relating to the implementation of the Windsor Framework.  From 1 January 2025, changes due to the Windsor Framework for the licensing, labelling and wholesale dealing of human medicinal products in the UK will become effective.  The new measures require,...

Last month we provided an update on the UK Government’s draft post-market surveillance statutory instrument (“PMS SI”) and the UK Medicines and Healthcare products Regulatory Agency’s (“MHRA’s”) intention to run a further public consultation on proposed changes to pre-market medical device regulation under an upcoming statutory instrument (“Pre-Market SI”). On 14 November 2024, the MHRA launched...

Last month we provided an update on the UK Government’s draft post-market surveillance statutory instrument (“PMS SI”) and the UK Medicines and Healthcare products Regulatory Agency’s (“MHRA’s”) intention to run a further public consultation on proposed changes to pre-market medical device regulation under an upcoming statutory instrument (“Pre-Market SI”). On 14 November 2024, the MHRA...

On 21 October 2024, the UK Government laid the draft Post-market Surveillance statutory instrument (“PMS SI”) before Parliament (see the UK Medicines and Healthcare products Regulatory Agency’s (“MHRA’s”) press release here).  Once implemented, the PMS SI will further amend the UK’s Medical Devices Regulations 2002 (“UK MDRs”) by introducing new vigilance requirements for medical devices...

On 21 October 2024, the UK Government laid the draft Post-market Surveillance statutory instrument (“PMS SI”) before Parliament (see the UK Medicines and Healthcare products Regulatory Agency’s (“MHRA’s”) press release here).  Once implemented, the PMS SI will further amend the UK’s Medical Devices Regulations 2002 (“UK MDRs”) by introducing new vigilance requirements for medical devices already...

The UK Government has announced that it intends to introduce the Cyber Security and Resilience Bill (the “Bill”) to Parliament in 2025. Formally proposed as part of the King’s Speech in July, this Bill is intended to strengthen the UK’s cross-sectoral cyber security legislation to better protect the UK’s economy and infrastructure. This Bill will update the existing NIS...

The UK Government has announced that it intends to introduce the Cyber Security and Resilience Bill (the “Bill”) to Parliament in 2025. Formally proposed as part of the King’s Speech in July, this Bill is intended to strengthen the UK’s cross-sectoral cyber security legislation to better protect the UK’s economy and infrastructure. This Bill will...

The Digital Markets, Competition and Consumers (“DMCC”) Act received Royal Assent on 24 May 2024 (the final text is now available here). The DMCC Act will only enter into force, however, when secondary commencement legislation has been enacted (with some minor exceptions). This is expected to occur in Autumn 2024, but it could be delayed...

This year, the UK’s Competition and Markets Authority (“CMA”) is set to gain a range of new enforcement powers under the Digital Markets, Competition and Consumers (“DMCC”) Act (the final text is now available here). The DMCC Act received Royal Assent on 24 May 2024. However, with certain exceptions, the Act’s provisions will not come...

On May 21, 2024, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) published a statement of policy intent for UK recognition of international regulatory approvals of certain medical devices (the “Statement”).  The Statement follows the Government response to the 2021 consultation on the future regulation of medical devices in the UK that details an...

On April 25, 2024, the UK’s Investigatory Powers (Amendment) Act 2024 (“IP(A)A”) received royal assent and became law.  This law makes the first substantive amendments to the existing Investigatory Powers Act 2016 (“IPA”) since it came into effect, and follows an independent review of the effectiveness of the IPA published in June 2023. The most...

On April 30, 2024, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) outlined its strategic approach (“Approach”) to artificial intelligence (“AI”).  The Approach is a response to the UK Government’s white paper: a pro-innovation approach to AI regulation and subsequent Secretary of State letter of 1 February 2024, and is the culmination of 12...

Last week (28 March 2024), the UK Health Research Authority (“HRA”) published a draft model investigator-initiated study agreement (“mIIS-CTA”) to govern investigator-initiated clinical studies (“IIS”) that involve NHS patients and receive support from commercial partners.  The HRA is calling for comments on the draft mIIS-CTA by 13 May 2024. An IIS is a clinical study...