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The Association of the British Pharmaceutical Industry (ABPI) has published a report (the Report) setting out its members’ concerns regarding the operation of the 2024 Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG).

VPAG is an agreement between the Department of Health and Social Care (DHSC), NHS England and ABPI, which came into effect on 1 January 2024.  It is the latest in a series of voluntary schemes, intended to manage NHS expenditure on branded health service medicines and operates by controlling prices, limiting profits and, importantly, by imposing a requirement for scheme members to make repayments to Government, reflecting NHS expenditure on medicines in excess of permitted growth and calculated as a percentage of eligible sales.  A key driver for changes introduced in VPAG was recognition that the level of repayments under the previous scheme had become unsustainably high (21.2% in 2023).  Therefore, while industry accepted what is described in the Report as an “exceptionally tough deal” this was in the expectation that the new scheme would, over time, bring repayment rates for newer medicines down to below 10%, consistent with the position up until 2021. However, while the repayment rate for newer medicines was set at 15.1% in the first year of VPAG, the rate for 2025 is 22.9% (with an additional 0.6% payable under an investment programme). The Report describes rates of this magnitude as “unsustainable”.

The Report analyses the reasons that repayment rates for newer medicines have ended up so much higher than predicted under VPAG, and calls for the Government to work with industry on its proposed solutions. It also sets out the consequences of requiring industry to pay such high repayments rates, including worse access to medicines for UK patients and lower investment by industry in the UK.Continue Reading ABPI calls for changes to “unsustainable” medicines pricing scheme

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 of the procurement processes have changed, and we set out the background in our previous post. For tenderers, the changes are mainly procedural, including the framework for the tender process and the timelines, rather than fundamental changes to how the procurement will operate. Nevertheless, it is important to take note of the new procedures. We set out some of the key aspects in our Advisory. Continue Reading UK Public Procurement Landscape Transformed: What Does It Mean for Medicines?

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

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?

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)

The procurement landscape in the UK is due to change next year. A draft procurement bill (Bill) seeks to consolidate a number of different procurement regulations that originate from EU legislation, including the Public Contracts Regulations 2015 (PCR), into a single revised regime. The aim is to modernise and unify procurement systems and processes into a single piece of legislation and to develop the regime specifically for England, Wales and Northern Ireland.

In addition to the Bill, a proposed Provider Selection Regime, introduced by regulations made under the Health and Care Act 2022, will create a new set of rules for arranging healthcare services in England, and take NHS healthcare services outside the scope of the Bill. That said, some services of relevance to the NHS may still fall under the Bill, in particular, the procurement of goods and medicines.

The aim of both the proposed Bill and the Provider Selection Regime is to give more flexibility to procurers to adapt the procurement process to the services and goods being procured, and to make it easier for the most suitable bidders to win the bid, while at the same time maintaining transparency. Neither the Bill nor the Provider Selection Regime apply in Scotland given that these are devolved matters and the pre-existing regime will remain in place there. Since the existing procurement regime originated in European law, there is currently little, if any, divergence between Scotland and the rest of the UK. The new changes will bring about the potential for divergence.

In this post, we have set out some key takeaways about the new procurement regime under the Bill and the proposed Provider Selection Regime.
Continue Reading Adoption of New Procurement Regulations in the UK

In February 2018, the Integrated Research Application System (IRAS) issued revised versions of the template model Clinical Trial Agreement (mCTA) and Clinical Research Organisation model Clinical Trial Agreement (CRO-mCTA, used where clinical research organisations undertake site management responsibilities on behalf of the sponsor). The new mCTAs are designed to be used without modification for industry-sponsored trials in the national health service (NHS), and have been updated to reflect current practice and regulations. The new mCTAs should be used from 1 March 2018.
Continue Reading Revised model Clinical Trial Agreements applicable across the UK