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?

This digest covers key virtual and digital health regulatory and public policy developments during May and early June 2024 from United Kingdom, and European Union.

Of interest, artificial intelligence (AI) safety has been in focus over the past month, including with the publication of the Interim International Scientific Report on the Safety of Advanced AI. International collaboration in this area is increasing as world leaders met at the AI Summit in Seoul, and the UK government recently announced a collaboration on AI safety with Canada, supplementing its existing commitment with France. Further, the UK launched the AI safety evaluations platform, which is available to the global community. In the meantime, the EU has established an AI Office to oversee the implementation of the AI Act and the Medicines and Healthcare products Regulatory Agency (MHRA) has published its AI Airlock to address novel challenges in the regulation of artificial intelligence medical devices (AIaMD).Continue Reading Virtual and Digital Health Digest – June 2024

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

This digest covers key virtual and digital health regulatory and public policy developments during April and early May 2024.

You will note that France has set out new pricing rates for innovative digital therapeutic medical devices under the accelerated market access pathway, known as PECAN. While the pathway was set out in February 2023, the lack of reimbursement rates means up-take has been low. The order of April 22, 2024 introduces the new pricing structure, with the maximum amount of financial compensation set at €780 per year, per patient. This is an important step in ensuring digital therapeutic products can be widely available in France while also ensuring that developers can obtain appropriate reimbursement.Continue Reading Virtual and Digital Health Digest, May 2024

On 21 May 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a statement of policy intent (the Statement) setting out its proposals for international recognition of regulatory “approvals” of medical devices. Under the proposed scheme, medical devices will be subject to limited pre-market requirements where they are already “approved” in a trusted jurisdiction. This will replace the current provisions, which permit recognition of EU CE marks, and will expand recognition to a wider set of trusted regulators, including the US in certain cases. This has long been an intention of the MHRA, and follows a similar procedure for medicines announced last year, although the practicalities of how this will work for devices and the role of the relevant stakeholders has been difficult to resolve.

The proposals are intended to avoid duplication of assessments for medical devices and it is hoped this will lead to quicker access to new devices in Great Britain. It will also allow the MHRA to meet its stated aim of focusing resources on innovative devices, particularly artificial intelligence medical devices (AIMD) that are excluded from the scheme.  However, the Statement is silent on who will undertake the reviews required under the access routes. This is subject to ongoing consultation, though it seems likely that any reviews would be conducted by UK Approved Bodies. This will require coordination between Approved Bodies and the MHRA, which will be an important step in ensuring this scheme operates as intended.

The MHRA intends that the new recognition scheme will come into force at the same time as the future core changes to the medical devices regulatory framework in Great Britain, discussed in a previous post. It is expected the draft regulations implementing that scheme will be published later this year, with the regulations coming into force in 2025.Continue Reading MHRA outlines proposals for international recognition of medical devices

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its strategic approach to artificial intelligence (AI). The publication is in response to the request from the Secretaries of State of DSIT and DHSC dated 1 February 2024, in which the MHRA was asked to provide details about what steps it is taking in accordance with the principles and expectations of the Government’s pro-innovation approach set out in the white paper published in 2023. Further information is set out in our previous post.

The strategy provides information on how the MHRA views the risks and opportunities of AI from three perspectives:

  • MHRA as a regulator of AI products
  • MHRA as a public service organisation delivering time-critical decisions
  • MHRA as an organisation that makes evidence-based decisions that impact on public and patient safety, where that evidence is often supplied by third parties

The document is likely to be of particular interest to AIaMD manufacturers as it sets out in detail current and proposed regulations and guidance, and areas where this is likely to be tightened. Following the launch of the strategic approach, the government also published details of the AI Airlock regulatory sandbox, discussed in another post.

With a raft of measures relating to AI being published and additional measures expected in the next couple of years, pharmaceutical and medical device companies operating in the UK need to continually review how they will be impacted and respond appropriately.Continue Reading MHRA sets out its AI regulatory strategy

In our blog post on 22 February 2024 we reported on the Medicines and Healthcare products Regulatory Agency (MHRA) announcement that it intended to launch a regulatory sandbox for software and AI medical devices called the “AI-Airlock”. The pilot project went live on 9 May 2024, and government sources are citing it as a key component of the MHRA’s strategic approach to AI, published on 30 April 2024 (discussed in a separate post).Continue Reading The MHRA’s “AI Airlock” – what do you need to know?

On 5 April 2024, the MHRA updated various guidance documents on the impact of the Windsor Agreement (the Agreement) on parallel imports into and within the UK. Since the end of the Brexit transition period, EMA-issued parallel distribution notices (PDNs) ceased to be valid in Great Britain (GB). A PDN must be obtained by a parallel distributor prior to engaging in parallel distribution in the EU. In GB, PDNs were replaced by Parallel Import Licences (PLPIs), which allowed distribution of products in GB only; while PDNs continued to be valid in Northern Ireland (NI).

As of 1 January 2025, when the Agreement is due to take effect, PDNs will no longer be valid in NI. All parallel imports into GB and NI will require a PLPI from the MHRA that will apply across the whole UK, and any PLPIs that were previously limited to GB will automatically convert into UK-wide PLPIs from this date.Continue Reading Brexit update: Changes to parallel imports in the UK

A version of this article was first published in Life Sciences IP Review

There is currently no specific legislation in the UK that governs AI, or its use in healthcare. Instead, a number of general-purpose laws apply that have to be adapted to specific AI technologies. As a step towards a more coherent approach, the government recently published its response to its consultation on regulating AI in the UK.  This maintains the government’s “pro-innovation” framework of principles, to be set out in guidance rather than legislation, which will then be implemented by regulatory authorities in their respective sectors, such as by the MHRA for medicines.  The MHRA has already started this process and signalled itself as an early-adopter of the UK government’s approach. The hope is that this will lead to investment in the UK by life science companies as the UK is seen as a first-launch country for innovative technologies.Continue Reading The UK’s pro-innovation approach to AI: What does this mean for life science companies?

In a previous blog post, we discussed the UK government’s proposed changes to the regulatory framework governing clinical trials. Marking the start of this legislative change is a new notification scheme for the lowest-risk clinical trials (the scheme), published on 12 October 2023. The scheme is based on the proposal set out in the Medicines and Healthcare Regulatory Agency’s (MHRA) consultation earlier this year, which was supported by 74% of respondents.

The scheme allows for the processing of eligible clinical trials by the MHRA in less than 14 days, instead of the statutory 30 days. The scheme currently only applies to clinical trial authorisation (CTA) applications for Phase 4 and certain Phase 3 clinical trials deemed as low risk, and provided they meet the MHRA’s eligibility criteria, set out below. Initial “first in human” Phase 1 or Phase 2 trials and clinical trial amendment applications will not be eligible.

The scheme aims to reduce the time taken to get lowest-risk clinical trials up and running, to give UK patients quicker access to potentially life-saving medicines, without undermining patient safety. The MHRA encourages clinical trial sponsors to use the scheme for all eligible trials and estimates that this will include 20% of UK initial clinical trial applications.Continue Reading UK clinical trials – new notification scheme for lowest-risk clinical trials