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The UK government has published its first major update to the NHS Intellectual Property (IP) guidance in over two decades. Developed by the Department of Health and Social Care (DHSC) and NHS England with support from the National Institute for Health and Care Research (NIHR), the framework aims to remove long-standing barriers to innovation and accelerate the adoption of new technologies.

The previous guidance, dating back to 2002, was designed for a pre-digital era and struggled to accommodate modern technologies such as AI and machine learning. As a result, innovators and NHS partners often faced prolonged negotiations and unclear ownership rules, delaying patient access to life-changing solutions. In some cases, promising collaborations collapsed after years of legal uncertainty, highlighting the urgent need for reform.Continue Reading Updated NHS IP Guidance: Unlocking Healthcare Innovation

The UK and US governments have announced that they have reached an agreement on pharmaceutical pricing and tariffs. Under the arrangement, the tariffs charged by the US government on imports of pharmaceutical products from the UK will remain at zero for three years, in exchange for the UK agreeing to pay higher amounts for innovative medicines and reducing the rebates payable by pharmaceutical companies on newer branded medicines.

The changes to UK pricing of medicines have been welcomed by industry, which has criticised the UK environment for supply of and access to medicines.Continue Reading US-UK Pharmaceutical Pricing Deal: UK agrees increase in amounts it can pay for innovative medicines and reduction of rebate rates

A new policy paper released on 2 November 2025 sets out the MHRA’s proposals on overhauling and transforming the UK regulation of rare therapies.

The intention is for a “bold new rulebook for rare therapies” to be published in 2026. Rare therapies is defined as medicinal products intended to treat rare diseases, specifically, conditions with a prevalence of no more than 5 in 10,000. The Medicines and Healthcare products Regulatory Agency (MHRA)’s press release on the matter provides the concerning statistic that, while ≈3.5 million people in UK are affected by rare diseases (equivalent to one child in every classroom), and many more if carers are taken into account, only 5% of rare diseases have approved treatment. An intention of the reform is therefore to shorten the time for development of therapies for such conditions from initial discovery through to the stage of delivery to patients.

The MHRA aims to position the UK as a global leader in developing, regulating, and integrating rare therapies into healthcare. This policy paper outlines a new regulatory framework designed to accelerate access to innovative treatments for rare diseases while maintaining safety and evidence standards.

The initiative is supported by the newly formed Rare Disease Consortium, a collaborative effort made up of various different stakeholders including the MHRA, NICE, DHSC, NHS England, as well as patients and their representatives, academia and research institutions and industry.

A draft of the framework is anticipated to be available by Spring 2026, with external review in the first half of the year. A public consultation will also be conducted in 2026.Continue Reading Rewriting the Rulebook: MHRA’s Vision for Rare Disease Therapies

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 September and early October 2025 from the the United Kingdom, and European Union.

This month, the EU and UK have been actively processing the future of AI development and regulation in life sciences and health care through a combination of legislative initiatives, opportunities for stakeholder engagement, and investment in infrastructure. In the EU, the European Commission has published draft guidance on reporting serious AI incidents under the AI Act, and the European Medicines Agency has initiated a stakeholder survey to define AI priorities in medicines regulation. In the UK, the UK government has announced a National Commission on the Regulation of AI in Healthcare and a new AIR-SP cloud platform. These developments signal a shift from theoretical regulation to practical implementation. There have also been two important decisions from the Court of Justice of the European Union refining the legal boundaries of digital health services and data protection.Continue Reading Virtual and Digital Health Digest – October 2025

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 the NHS 10 Year Plan is more rooted in the public sector. Both plans send a clear message: the Government recognises the vital role that life sciences companies must play in order to improve the UK’s standing as a centre for life sciences. The impact these plans will have on the Life Sciences industry, and whether they are enough to realise the Government’s ambitions, remains to be determined.Continue Reading The UK Government has plans: what does this mean for the Life Sciences Sector?

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 of bureaucracy” and “put an end to the duplication resulting from 2 organisations doing the same job”. In doing so, the intention is to save hundreds of millions of pounds, enabling funds to be channelled towards enhancing patient care, reducing waiting lists and increasing staff salaries.  However, exactly how this will be done and what impact this will have on patients, staff and the many partners of the NHS in England, including pharmaceutical companies, is not yet known.Continue Reading UK Prime Minister Announces that NHS England will be abolished

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 after the end of the Brexit transition period. It enabled developers to work collaboratively with the NHS, MHRA, and UK Health Technology Assessment (HTA) bodies to bring their product to the UK market in a more streamline and efficient way, benefiting from tailored guidance and support as well as shorter timelines. The scheme saw high levels of applicants, but also faced criticism from stakeholders for a lack of clarity, overly permissive entry criteria and a lack of direct NHS involvement.Continue Reading The new UK Innovative Licensing and Access Pathway – relaunched, refined, refreshed

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 between developers, regulators, the UK Health Technology Assessment (HTA) bodies and the NHS, and facilitating enhanced patient access to medicines.

While ILAP has received an unprecedented number of applicants, with 166 Innovation Passports having been awarded since its launch, there have also been criticisms, including delays in considering applications and limited coordination with the NHS and HTA bodies, which slows the adoption of ILAP products. The Medicines and Healthcare products Regulatory Authority (MHRA) is therefore relaunching a renewed version of the scheme to “refine and refresh” the process.

It is hoped that the improvements will make for a quicker and more effective path for transformative medicines to be adopted into the UK market, reducing time to patient access and making the UK a more desirable market to launch innovative products.Continue Reading The UK Innovative Licensing and Access Pathway (ILAP) to enter a new era

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?

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?