Arnold & Porter Kaye Scholer LLP (LexBlog United Kingdom)

The Association of the British Pharmaceutical Industry (ABPI) and the Department of Health and Social Care (DHSC) have confirmed that they have ended negotiations on  amendments to the 2024 Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG). The breakdown of the talks between the government and the ABPI mean that the pharmaceutical industry...

Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during June and early July 2025 from the United Kingdom and European Union. There has been a flurry of new guidance from the Medical Device Coordination Group this month, including guidance...

The UK Government has recently published plans for the Life Sciences Sector and the NHS in England. In this blog post, we summarise these plans and some of the initial feedback that has been published by ABPI.  It is not surprising that there is a large amount of overlap between the two plans, albeit that...

Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during May and early June 2025 from the United Kingdom and European Union. There has been a lot of focus on AI this month. The European Commission has launched...

On 16 June 2025, the UK Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 came into force, marking the first step in the reform of the UK legislation for medical devices. The regulations apply to Great Britain (England, Wales and Scotland), and medical devices placed on the market in Northern Ireland must follow...

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...

On February 24, 2025, new rules came into force in the UK transforming the public procurement landscape. The new regime aims to provide a simplified and flexible framework for contracting authorities when conducting procurement processes, including the purchase of medicinal products by the National Health Service (NHS). Under the new Act, a number of elements...

We recently published this Advisory for our US clients, but thought it may be a useful reminder for UK and EU teams given the number of updates in this area. We are sure that you are aware that the European Union (EU) medical devices framework has been subject to significant changes over recent years. However,...

UK Prime Minister Kier Starmer announced yesterday that NHS England will be abolished to “cut bureaucracy” and bring management of England’s health service “back into democratic control”. NHS England will be brought back into the Department of Health and Social Care (DHSC) over the next two years. The Government aims to remove a “burdensome layer...

The ICO recently announced its plan to bring the UK’s top 1,000 websites into compliance with applicable data protection law, in relation to their use of cookies. At the time of the announcement, the ICO had already checked 200 websites, and communicated its concerns to 134 of their operators. This suggests a prevalence of non-compliant cookies...

Clinical research studies within the NHS in England and Wales require Health Research Authority (HRA) approval, which brings together the HRA’s assessment of governance and legal compliance with the independent ethical opinion by a Research Ethics Committee (REC). The HRA has recently changed the requirements for the UK GDPR transparency wording in new health and...

On 3 February 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) launched a consultation asking for stakeholders’ views on  draft guideline in relation to the regulation of individualised mRNA cancer immunotherapies (Draft Guideline). The aim of the proposed guideline is to establish a clear and streamlined regulatory pathway to authorisation so that these...

The UK’s General Pharmaceutical Council (GPhC) has published new guidance for registered pharmacies providing pharmacy services at a distance, including on the internet. The GPhC is the pharmacy regulator for Great Britain. Pharmacies and pharmacists, including those operating online, are required to be registered with GPhC and follow the standards it sets. The prevalence of...

PAGB published its updated Professional Code for Medicines (the Code) on 12 February 2025. PAGB is the UK trade association that represents manufacturers of branded over the counter (OTC) medicines, self-care medical devices and food supplements. PAGB publishes two codes: the Code, which concerns advertising of OTC medicines to persons qualified to prescribe or supply...

As set out in our previous post, the Innovative Licensing and Access Pathway (ILAP) is an initiative aimed at bringing innovative medicines to the UK market more quickly. On 30 January 2025, the MHRA launched a new version of ILAP in response to feedback from stakeholders. The first version was launched in January 2021, shortly...

Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during December 2024 and early January 2025 from the United Kingdom, and European Union. In this issue, we feature the emerging trends in digital health in 2024 that...

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...

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...

Welcome to the last 2024 installment of Arnold & Porter’s Virtual and Digital Health Digest! This digest covers key virtual and digital health regulatory and public policy developments during November and early December 2024 from the United Kingdom and European Union. Of note, health authorities in the EU continue to develop methods to assess and...

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...

This digest covers key virtual and digital health regulatory and public policy developments during October and early November 2024 from the United Kingdom and European Union. Regulatory and legislative reform is on the horizon in both the UK and in the EU, which will impact software and artificial intelligence (AI) medical devices. The UK government recently published...

The current version of the Innovative Licensing and Access Pathway (ILAP) was first launched by the UK government in January 2021, shortly after the Brexit transition period came to an end. Its aim was to be a new, accelerated route to bring innovative medicines to the UK market, through facilitating a streamlined and efficient collaboration...

On 21 October 2024, the UK Government laid before Parliament the draft statutory instrument setting out proposed new post-market surveillance (PMS) requirements for medical devices in Great Britain (the PMS SI). The PMS SI will significantly enhance the PMS requirements for manufacturers of medical devices placed on the market or put into service in Great...

On 21 October 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) announced that the UK will be the first country in the world to introduce a tailored framework for the manufacture of innovative medicines at or close to the location where a patient receives care. A new statutory instrument was laid before the UK...

On 14 October 2024, the day of the International Investment Summit, the UK government published its green paper ‘Invest 2035: The UK’s Modern Industrial Strategy’, a ten-year plan designed to promote growth in the UK, with a focus on growth-driving sectors, including the Life Sciences and the Digital and Technologies sectors. The Industrial Strategy will...

This digest covers key virtual and digital health regulatory and public policy developments during September and early October 2024 from the United Kingdom and European Union. Guidance on AI continues to be published. In the EU, the European Medicines Agency (EMA) has published its Reflection Paper on the use of AI throughout the medicines life...

On 8 October 2024, the UK government launched the new Regulatory Innovation Office (RIO), which aims to “reduce the burden of red tape” faced by businesses when bringing innovations to market, including artificial intelligence (AI) healthcare technologies and engineering biology products such as vaccines and cultivated meat. The RIO, established within the Department of Science,...

This digest covers key virtual and digital health regulatory and public policy developments during August and early September 2024 from United Kingdom, and European Union. There have been some important reimbursement updates this month. In France, the French health regulator has issued a negative opinion on the first digital therapeutic that sought reimbursement through the PECAN pathway. This...

This digest covers key virtual and digital health regulatory and public policy developments during July and early August 2024  from United Kingdom, and European Union. Following the UK national elections on July 4, 2024, which brought in a new government, the King delivered a speech to Parliament setting out the government’s key legislative and policy...

This digest covers key virtual and digital health regulatory and public policy developments during June 2024 from United Kingdom, and European Union. While it has been a relatively quiet month in the EU given elections in the European Parliament and in the UK (as well as other countries across the EU), agencies across the globe have published...