NEWS
Life Sciences Sector Plan launched
The Government has launched its new Life Sciences Sector Plan as part of its flagship Industrial Strategy, setting out a ten-year mission to harness British science and innovation to deliver long- term economic growth and a stronger, prevention-focused NHS.
The UK is already a
global leader in life sciences, with the sector worth around £100 billion to the economy, and employing around 300,000 people. The new Life Sciences Sector
Plan sets out a comprehensive roadmap built around three core pillars: 1 Enabling world-class R&D – strengthening the UK’s leadership in science and discovery.
2 Making the UK an outstanding place to start, scale and invest – growing homegrown companies and attracting global capital.
3 Driving health innovation and NHS reform – delivering better outcomes for patients and a more modern, preventative healthcare system. The Plan will be supported over the lifetime of the Spending Review by Government funding of over £2 billion, alongside funding from UK Research and Innovation and the National Institute for Health and Care Research. Actions include: n Unlocking NHS data to find new cures. n Speeding up clinical trials. Cutting red tape so patients can join trials sooner – and get access to life-changing medicines quicker.
n Backing British manufacturing. n Getting new treatments to patients faster.
n Helping doctors use cutting-edge tech. n Backing UK firms to grow. The Plan was shaped with input from over 250 organisations including doctors, scientists, NHS leaders and industry experts to ensure it delivers real impact. It builds on the Chancellor’s commitment to reduce regulatory costs by a quarter, with increased investment in the MHRA to accelerate approvals and improve efficiency. It aims to streamline MedTech market entry through closer coordination between the MHRA and NICE. The Government is also focused on
strengthening the UK’s clinical research infrastructure by improving trial delivery, expanding patient access, and embedding research more effectively within the NHS.
EDITOR’S COMMENT We have a plan
So far this summer has seen plenty to think about, not least the long-awaited 10 Year Plan being published. Much of the content was heavily trailed ahead of its launch of course. But new neighbourhood health centres attracted most of the headlines, although keener observers were wondering what had happened to the final chapter on delivering the plan, written by former Health Secretary Alan Milburn but mysteriously missing from the final document. With a few weeks’ worth of water under the bridge since it was published it would be fair to call the overall reaction ‘mixed’. There are many measures which have been received positively, not least the plans for more healthcare to take place away from hospital and closer to the community, or even via the NHS app – an area of debate has been just how these will sit alongside general practice, as well as questions over just how Foundation Trusts and the proposed Integrated Health Organisations will develop and / or sit together.
One of the most positively received aspects has been the measures introduced around the shift to digital – more AI to be used, more functions for the NHS app, an increasing focus on genomics, and, importantly for the diagnostics sector, significantly easier
adoption of new technology. Still to come there will be a workforce plan due to be published later in 2025. Disappointingly, but perhaps not surprisingly, there was scarce mention of pathology in the document. With an expected increase in demand for diagnostic services from new community settings, it is hoped that the future will see more focus on pathology, diagnostics and point-of-care testing. Bodies including the IBMS, RCPath and BIVDA have welcomed the plan, albeit with caveats (see our News section for further details).
The biggest question is still how ambitious changes will be delivered – and a big part of ‘delivered’ translates directly to ‘funded’. With little money in the pot, resident doctors striking, and the economy on a knife edge, it seemingly wouldn’t take much to scupper the laudable aims contained in the plan. We will wait and see.
In the meantime, IBMS Congress gets ever closer – if you’re beginning to plan your visit, our preview starts on page 35 with further details of the scientific programme on offer, and continues with a look at some of the suppliers attending the trade exhibition (a section which will continue into our September issue). You’ll be able to find Pathology in Practice in the foyer area on Stand F10.
andymyall@pathologyinpractice.com
UK to align with Europe on high-risk IVDs
The Government has announced its intention to amend the Medical Devices Regulations 2002 for Great Britain to incorporate EU Common Specifications for high-risk in vitro diagnostic (IVD) devices. The specifications will establish standards for high-risk diagnostic tests while creating consistency with European regulations and reducing the regulatory burden for UK firms. Respondents overwhelmingly supported
a recent MHRA consultation to repeal the current CTDA process for COVID-19 devices and to replace current requirements with Common Specifications. In the interim, an accelerated CTDA process will be introduced for COVID-19 devices that have CE marking under the European IVD regulations (EU IVDR) and meet Common Specification requirements.
The Common Specifications will also enhance performance standards for IVD
WWW.PATHOLOGYINPRACTICE.COM AUGUST 2025
devices related to infectious diseases including Hepatitis B, C and D, HIV and Syphilis, as well as devices for blood grouping and tissue typing. The move aims to ensure these vital IVD devices meet high standards of performance backed by robust clinical evidence.
These new specifications will be
introduced in regulations expected to be published later this year as part of the Government’s broader programme of medical devices regulatory reform, which supports the NHS transformation. The changes reinforce the Government’s commitment to reduce regulatory burden and balance robust patient safety measures with support for innovation in the medical technology sector. Coronavirus Test Device Approvals have also been repealed, removing a regulatory stage for devices which test for COVID-19.
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