In this blog, our Life Science Solicitors consider the state of play for the Life Sciences sector in the UK as 2024 draws to a close by providing an update on developments regarding the schemes and initiatives we have discussed throughout the year.
Medicines Manufacturing Skills Centre of Excellence, and Support for Engineering Biology
Unsurprisingly, in light of the sector's value to the UK economy, promoting growth in Life Sciences has remained a key priority despite the change in Government.
Indeed, Labour was keen to stress in its pre-election plan for the Life Sciences sector, titled 'A Prescription for Growth', that it was a previous Labour government that established the cross-departmental Office for Life Sciences in 2009, which forms part of the Department for Science, Innovation and Technology.
We previously discussed the last Government's 'Life Sci for Growth' fund and noted its intention to create a Medicines Manufacturing Skills Centre for Excellence designed (among other things) to address the skills gap in this field.
October 2024 saw the establishment of The Resilience Centre of Excellence for UK Medicines Manufacturing Skills.
Funded by the Office for Life Sciences, managed through Innovate UK, and delivered by its core partners – the University of Birmingham, University College London, Heriot-Watt University, Teesside University and Britest Limited – the Centre aims to bring together 'leading regional training providers to support the UK life sciences workforce by delivering high-quality training and outreach, spanning the entire careers pipeline for industry, academia, and the NHS'.
For businesses looking to recruit employees with the skills needed to thrive in the Life Sciences sector, it will be interesting to observe the impact this coordinated approach to training has on those entering the jobs market in the coming years.
The year has also seen the announcement of some of the projects that will benefit from the funding promised in the 'National Vision for Engineering Biology'.
In March 2024, UK Research and Innovation announced forty-eight successful engineering biology R&D projects, with funding totalling £13.5 million for studies into a wide range of topics including engineering red blood cells to unlock new therapeutic treatments, making a sustainable alternative to palm oil and engineering animal stem cells to cultivate meat production.
Branded Medicine: NHS Spending Rule Changes
However, not every planned development relevant to the life sciences sector was unaffected by the general election.
In the case of the review of the branded medicines pricing regime - while the intended alignment of pricing between the 'statutory' scheme and the 'voluntary' scheme, which we discuss in that blog, is still going ahead, the election caused a delay in the implementation of the changes that will apply to the statutory scheme.
Originally intended for implementation in July 2024, using revised pricing models based on sales data available at the time of consultation in early 2024, the process of rolling out these changes was paused earlier this year following the announcement of the general election.
The delay in implementation meant that the changes will now take effect from Q1 2025 as opposed to Q3 2024. Because of that delay, sales data for Q1 2024 have become available, resulting in further changes to the revised payment mechanisms that the Department of Health and Social Care intends to apply when the changes come into effect.
As discussed in our previous blog, the branded medicines pricing regime is designed to ensure a steady (but not unsustainable) year-on-year increase in NHS spending on these products.
The upcoming changes should help life science businesses that are not part of the voluntary scheme and who, therefore, participate in the statutory scheme by bringing their pricing regime more closely in line with that which applies to businesses that participate in the voluntary scheme.
Government Plans for Regulation of Digital Mental Health Technologies
The Government'sGovernment's investigation into how best to regulate digital mental health technologies – as led by the Medicines and Healthcare Products Regulatory Agency (MHRA) was planned from the outset as a multi-year project, which will continue through to 2026.
Our blog in May 2024 covered the most substantial update on progress since the project commenced in 2023, but since then the MHRA has published a webinar (available as a recording on their website) on the topic of 'Clarifying DMHT Qualification as Software as Medical Device (SaMD)', and there have been further updates on the developing regulatory treatment of SaMDs more generally.
Earlier this month, for example, the MHRA announced the first projects which will be trialled through its 'AI Airlock' project, a scheme designed 'to help test and improve the rules for AI-powered medical devices to ensure they reach patients quickly, safely and effectively'.
These pilot projects are five AI-powered medical devices, including a tool designed to predict serious outcomes for patients with Chronic Obstructive Pulmonary Disease, another to improve the efficiency and accuracy of radiology reporting, and a 'large language model (LLM)'-based assistant to support clinical decision-making using guidance produced by the National Institute for Health and Care Excellence (NICE).
The progress of the AI Airlock trials will be watched with interest by any life science business that might intend to capitalise on the power of AI in bringing future medical devices to market, as will the developing picture concerning the regulation of Digital Mental Health Technologies for those operating in that space.
It was also interesting to note that, although there is a long way to go with the three-year project for developing regulation of Digital Mental Health Technologies, this type of technology nevertheless made it into the MHRA's user-friendly annual update titled 'Medicines and medical devices: Six tips for staying healthy and safe this festive season', published on 11 December 2024.
The MHRA noted in this regard that 'while there are some apps out there which many will find beneficial and helpful, not all of them have been created with input from healthcare professionals or those with lived experience of mental health' and took the opportunity to draw readers' attention to the fact that apps registered with the MHRA will be CE or UKCA marked.
While this is, of course, true, for the individual wishing to use one of the many apps available over the festive period, having to find one which is UKCA- or CE-marked may, for the time being, tend to reduce their options significantly.
Contact Our Life Science Solicitors
If you would like to discuss any of the matters considered in this article, our Life Sciences specialists would be happy to advise.