Following a public consultation, the UK government has outlined plans to publish guidance on disclosing payments made by the medicines and medical devices industries to the healthcare sector. While some stakeholders favour a legislative approach, the government believes that a guidance-based model will enable patients to benefit from industry reporting more quickly, avoiding delays that could arise from introducing legislation and establishing a formal compliance system.Continue Reading UK Government to Issue Guidance on Industry Payment Transparency
UK Law
UK proposes Early Access Service for innovative medical devices
By Jackie Mulryne, Eleri Abreo & Emma Elliston on
On 31 July 2025, the UK government published a statement of policy intent, setting out its initial thinking on an Early Access Service (EAS) for innovative medical devices. The intention is for this to first focus on innovative diagnostic devices, particularly those supporting the NHS’s most urgent needs and financial sustainability in the NHS. It is hoped this will lead to quick market access of such devices, by addressing challenges associated with generating sufficient evidence to obtain regulatory approval.Continue Reading UK proposes Early Access Service for innovative medical devices
Is change on the horizon for the UK product liability regime?
By Libby Amos-Stone on
The Law Commission, an independent organisation established to keep the law of England & Wales under review and recommend reform, has announced a review of the law in relation to liability for defective products.Continue Reading Is change on the horizon for the UK product liability regime?
Recent updates on reform of UK clinical trial landscape
By Jackie Mulryne & Eleri Abreo on
On 11 April 2025, the MHRA announced that the much anticipated changes to the clinical trial rules in the UK, the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 (the new Regulations), have been signed into law.
In January, we posted a detailed blog on the upcoming changes to the UK law governing clinical trials, noting that this had been described as the “biggest overhaul of the clinical trial regulations in 20 years”, and is intended to cement the UK as a world-class destination for conducting international clinical trials, to “support [a] more streamlined and flexible regulation of clinical trials, removing unnecessary administrative burdens on trial sponsors, whilst protecting the interests of trial participants.”
The new Regulations will come into effect on 10 April 2026, following a 12 month roll out period. The MHRA states in its announcement that it is “committed to implementing a flexible and risk-proportionate regulation of clinical trials, which accelerates patient access to potentially life-saving medicines without compromising safety.”Continue Reading Recent updates on reform of UK clinical trial landscape
New Year Update: incoming changes to UK regulation of clinical trials
By Jackie Mulryne, Eleri Abreo & Mimi Simmons on
2025 promises to be a year of further advancements in the UK’s life sciences sector and one important area of on-going development is the regulation of clinical trials.
After some delay, the much anticipated Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 (the new Regulations) were laid before Parliament on 12 December 2024, intended to amend the current UK framework governing clinical trials. This has been described as the “biggest overhaul of the clinical trial regulations in 20 years”, and is intended to cement the UK as a worldclass destination for conducting international clinical trials, to “support [a] more streamlined and flexible regulation of clinical trials, removing unnecessary administrative burdens on trial sponsors, whilst protecting the interests of trial participants.”
Key changes proposed by the new Regulations are discussed below. While certain regulatory requirements will be set out in the legislation, the aim is to move away from a “one-size-fits-all” approach, allowing for a more proactive response to innovation. This is in line with the new streamlined notification scheme for lowest risk clinical trials, which the MHRA introduced in October 2023, as discussed in our previous blog post. As such, the new Regulations have been described as “as future-proof as possible and […] responsive to different types of trials and innovative ways of carrying out trials.”
The new Regulation will be debated in Parliament in early 2025 and, after a 12 month implementation period, the aim is for the new Regulations to come into force in early 2026. In addition, guidance, which is already under development, will be used for specific details, rather than the new Regulations being too granular and prescriptive. The aim is for the guidance to become ‘live’ in January 2026, to coincide with the new Regulations. Continue Reading New Year Update: incoming changes to UK regulation of clinical trials
New Year, New UK-Wide Licensing Regime
By Jackie Mulryne & Libby Amos-Stone on
On January 1, 2025, new UK-wide arrangements for the supply of medicines came into effect on account of the “Windsor Framework.” The overarching aim is to secure the long-term stability of the supply of medicines to Northern Ireland (NI), ensuring that medicines will be available at the same time, and on the same basis, across…
Windsor Agreement changes to UK Assimilated SPC Regulation
Following the implementation of the Windsor Agreement, a new framework is coming into effect in the new year affecting the UK licensing regime for medicinal products, giving the Medicines and Healthcare products Regulatory Agency (MHRA) the exclusive authority to licence medicines across the whole of the UK. The changes to the UK licensing regime will have knock-on effects on the Supplementary Protection Certificate (SPC) framework. To accommodate for this, The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 (the Windsor Framework SPC Regulations) were laid before Parliament on 31 October 2024 to come into force on 1 January 2025. This will amend the existing assimilated Regulation (EC) No 469/2009 as it applies in the UK.
Although the UK SPC application process will eventually be simplified, the Windsor Framework SPC Regulations insert new definitions and additional provisions, as well as an Annex setting out transitional arrangements to address issues relating to territorial scope, validity, duration, expiry and paediatric extensions.Continue Reading Windsor Agreement changes to UK Assimilated SPC Regulation
The King’s Speech: Product Safety and Metrology Bill
By Tom Fox & Libby Amos-Stone on
Following the outcome of the national election on 4 July 2024, on 17 July 2024, King Charles III gave a speech to the UK Parliament in which, as directed by the new Government, he outlined the key points of its legislative and policy agenda.
The agenda includes a Product Safety and Metrology Bill. Some form of legislation to address UK product regulation was expected in order to take account of market developments and new technologies, such as online selling and AI. We set out below a brief summary of the Bill.Continue Reading The King’s Speech: Product Safety and Metrology Bill
What does the new UK government mean for life sciences?
By Adela Williams & Jackie Mulryne on
In the UK General Election on 4 July, the Labour Party won 412 of the 650 seats, giving it a comfortable majority. Its leader, Sir Keir Starmer, became Prime Minister, meaning a change of government from Conversative to Labour for the first time in 14 years.
In its campaign, Labour focused on the need to deliver economic growth and innovation in critical industry sectors. It also placed considerable emphasis on addressing the problems facing the National Health Service (NHS), such as long waiting lists for treatment, old equipment and an increasingly ageing population.
The government’s economic priorities were further set out in the first major speech delivered by the new Chancellor of the Exchequer Rachel Reeves on 8 July, in which she said that growth “is now our national mission”. The Health Secretary Wes Streeting also noted his intention of making the Department of Health and Social Care a department for economic growth. While each of these are statements of intent and not binding on the new government, they provide valuable insight into what industry can expect over the next 5 years. We set out below some of the most relevant initiatives that could impact the industry.Continue Reading What does the new UK government mean for life sciences?
Court of Appeal rules on suspension of UKCA certificates
On 15 May 2024, the Court of Appeal (CoA) handed down a unanimous judgment that a medical device manufacturer could not obtain interim relief to prevent its UK Approved Body (UKAB), BSI, suspending a certificate on grounds of safety and non-conformities before a substantive decision in the manufacturer’s judicial review claim. The judgment overturns the first instance decision granting the manufacturer an injunction and mandatory order against BSI.
The CoA judgment emphasises courts’ deference to expert regulators, particularly in matters of public health, and that courts are unwilling to restrain a public authority in exercising its powers in good faith, particularly when there is an argument concerning public health. The judgment also reaffirms the principle that the burden is on the manufacturer to demonstrate to the satisfaction of the UKAB the safety and performance of a device. Given this is the first decided case challenging the decision of an Approved Body, there are a number of implications for the UK framework and the relationship with the EU.Continue Reading Court of Appeal rules on suspension of UKCA certificates