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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

We set out in a previous post that the UK Medicines and Healthcare products Regulatory Agency (MHRA) intends to introduce a new international recognition procedure (IRP) for medicinal products, whereby decisions taken in certain countries could be recognised by the MHRA to fast-track approval in the UK.

On 30 August 2023, the MHRA published detailed guidance on how it will use the IRP for medicinal products. The IRP will be open to applicants who have already received an authorisation for the same product from one of the MHRA’s specified Reference Regulators (RRs) in Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States. However, the MHRA retains the right to reject the IRP and conduct a full assessment if considered necessary.

This procedure will operate in parallel to the MHRA’s current national procedures, including the shortened 150-day timetable, offering applicants a range of authorisation routes depending on the status in other countries and type of application. The hope is that this will allow the MHRA to be able to use the decisions in other countries, while still being able to conduct its own assessment where necessary for the UK market.

The IRP will be available from 1 January 2024. However, until the Windsor framework is in place on 1 January 2025, discussed here, products falling within the scope of the EU Centralised Procedure can only be authorised in Great Britain (England, Scotland and Wales).Continue Reading New UK International Recognition Framework for Medicines

On 19 September 2023, the UK Government launched the pilot phase of the Innovative Devices Access Pathway (IDAP), an initiative to help bring innovative technologies to the NHS where there is an unmet medical need. As discussed in a previous post, IDAP has been designed to accelerate the development of innovative medical devices, with the aim of taking delays and uncertainty out of the route to market. IDAP will provide an integrated support service for medical device developers that will include enhanced opportunities for engagement with the regulatory authorities and a streamlined adoption process.

Companies of all sizes are being invited to apply, both internationally and in the UK, where they intend to launch a device for the UK market. 8 products will be selected during the pilot phase, which is designed to test the main elements of the pathway to inform how best to build the future IDAP.

Applications for the pilot phase are open and will close after 29 October 2023; they can be made via an online application form and associated guidance.Continue Reading UK Government launches Innovative Devices Access Pathway (IDAP)

At the beginning of July, the MHRA published its 2023 – 2026 Corporate Plan, which highlights, amongst many other topics, the importance of introducing new legislation and guidance on clinical trials in the UK to help provide the “stable and predictable regulatory environment that companies require”. The intention is that by 31 March 2026, the MHRA will implement a revised regulatory framework for clinical trials.

Work on a new clinical trial framework is already underway. On 21 March 2023, the MHRA published its response to the UK consultation (which ran from 17 January to 14 March 2022) on legislative proposals for changes to the law governing clinical trials, namely the Medicines for Human Use (Clinical Trials) Regulations 2004.

Responses demonstrated strong support to update and improve the legislation governing clinical trials, with most respondents agreeing that patient safety should remain the focus of the legislation, but with a more flexible and risk proportionate approach to decision-making. In line with responses to other recent consultations, the MHRA is looking to align with international standards rather than be limited by alignment with the EU. It is hoped that the implementation of the proposals will make it easier and more efficient to run trials in the UK, enabling greater patient access to new, safe and life-changing treatments, while retaining the UK as an attractive place for trials.

In terms of next steps, the drafting of the statutory instrument to update the clinical trials legislation is expected to be laid before parliament in the Autumn of 2023. Comprehensive guidance will also accompany the legislation.Continue Reading Legislative change is afoot for clinical trials conducted in the UK