Life Sciences and the Law - August 2023

8 August 2023

Welcome to the summer edition of our newsletter. We hope that you find it informative and insightful.

It has been another busy quarter in terms of developments in the sector. Our experts discuss a number of these in our news and views section including a summary of the new Value Sharing Framework released by NHS England at the end of July, further detail of the future regime for medical devices, a focus on occupational lease issues for life sciences companies, and consideration of delisting options and opportunities.

Our industry news in brief provides some short updates on a variety of recent developments in the sector and our Meet the Team section this edition features a Q&A with Hill Dickinson’s Head of Corporate Healthcare, Monica Macheng who discusses trends, challenges and opportunities for our clients in the life sciences sector.

If you have any questions, please get in touch. Enjoy the read and if you do have any comments or requests for future editions do please let us know – feedback is always welcome.

News and views – what you need to know

Value Sharing Framework released by NHS England – new principles for data sharing collaborations
NHS England’s Transformation Directorate has launched its Value Sharing Framework for NHS data partnerships – a set of guiding principles regarding data sharing collaborations. The aim of this new guidance is to help set up data sharing collaborations between NHS organisations and private sector… Read more
Medical Devices – Implementation of future regulations
The UK government has set out further detail of the future regime for medical devices, which will fully apply from 1 July 2025. Most significantly, it intends to extend the acceptance of CE devices on the UK market, so that they can continue to be placed on the market beyond 30 June 2023…. Read more
Occupational Leases: The issues Life Sciences companies need to know about
On 25th May, the Chancellor reported that the Life Sciences sector employs over 280,000 people and contributes £94 billion to the UK economy. He also unveiled a ‘growth package’ of £650m to ‘fire up the UK’s life sciences sector.’ The Government’s proposals include an intention to reform planning rules to speed up development of more lab capacity, but at present, demand for high quality life science… Read more
Cyber security in the NHS
The impact of a cyber attack (which can take may forms, including phishing emails, malware and ransomware) can be far-reaching, resulting in financial loss, reputational damage, loss of data, and outages/disruption to systems and services. In recent years, there have been a number of cyber attacks on the health sector both in the UK and abroad, which have, in addition to these risks, also led… Read more
AI in the UK healthcare sector – a round up
As in every other sector, developments in AI in the UK healthcare sector continue at pace. Here we round up a few items of interest… Read more
Delisting - An option and opportunity for some
In a curious trend, many listed companies are experiencing a significant disparity between their share price and underlying value. This intriguing phenomenon sees share prices lagging behind the true potential of companies, which subsequently opt for delisting as a strategic move… Read more
Q&A with Monica Macheng

Introducing Monica Macheng (Head of Corporate Healthcare)
Monica Macheng (Head of Corporate Healthcare) gives us her thoughts on what current trends, opportunities, and challenges she is seeing in life sciences through our life sciences work at Hill Dickinson LLP… Read more
Client news

HIC and Hill Dickinson partner to drive digital transformation in health and social care
Hill Dickinson has formed a strategic partnership with Healthcare Innovation Consortium (HIC), in order to offer a comprehensive and tailored solution to NHS clients, as they support the UK government’s move towards digital health and social care… Read more
Yorkshire & Humber Academic Health Science Network relaunches its digital health accelerator programme
We were delighted to see YHAHSN announcing the launch of its digital accelerator programme, Propel@YH for its fifth year, at the start of July 2023. YHAHSN provides healthtech innovators from the UK and abroad with a structured course of advice and guidance helping them to navigate the NHS increasing their presence in the region. The programme is this year looking for innovations in a range of areas including workforce, waiting lists, early diagnostics, and patient empowerment. Full details of this year’s programme together with information on how to apply can be viewed on YHAHSN’s website.
Upcoming events
12 October 2023 - We’re delighted to host the Digital Health and SamD seminar in our London Office - Register your place here
3 November 2023 - SEHTA Expo – We’re pleased to be sponsoring this year’s event; to register please click here
In case you missed it, access the recording of our recent How to be confident in your green claims webinar here.
Industry news in brief

Additional tax reliefs for research and development intensive SMEs
The Government has published draft legislation setting out further tax relief for Research & Development (R&D) intensive small and medium-sized enterprises and a potential merged R&D scheme. This additional support will be worth over £1.8 billion over the next 5 years and will provide eligible R&D intensive loss-making SMEs with support worth £27 per £100 of R&D expenditure. The Government announcement detailing these measures can be viewed here.
Measures announced to increase biotech/life science investment opportunities
On 10 July 2023 the Chancellor and the Mayor of London announced a series of measures aimed at increasing pension fund investment into growth industries such as life sciences and biotech. Included in the package is the Mansion House Compact, an agreement from pension providers to invest a minimum of 5% of funds to unlisted equities via defined contribution pension funds, which will include venture-capital backed biotech companies and those life science companies on the AIM stock exchange. The Government’s press release announcing the measures can be viewed here.
New government partnership to improve access to latest cancer therapies
The Government has entered into a long-term partnership with German-based company BioNTech that will hope to provide cancer patients with improved access to the latest treatments and therapies in development, which will include the goal of providing up to 10,000 patients with precision cancer immunotherapies by 2030. A recent Government press release announced that as part of the arrangement, BioNTech will set up new laboratories in the UK with capacity for around 70 scientists – the Government’s press release announcing the partnership can be viewed here.
MHRA requests views on changes to Good Clinical Practice guidelines
The Medicines and Healthcare products Regulatory Agency (MHRA) is seeking the views of those involved in clinical trials of medicines (such as manufacturers, sponsors and healthcare professional) on the recent updates to Good Clinical Practice (GCP) guidelines. The consultation ends on Thursday 31 August – to give your views, please click here.
New guidance on the labelling of medicinal products for human use
Following on from the Windsor Framework – the deal struck between the UK and EU earlier this year – the MHRA has now published guidance introducing new UK-wide rules on labelling medicinal products. The guidance deals with products available in Northern Ireland but also introduces new UK-wide rules. A ‘UK Only’ label requirement will be introduced from 1 January 2025 and will enable medicines (Prescription Only Medicine and Pharmacy and General Sales List) to use the same packaging and labelling across the UK,
The Windsor Framework had been agreed between the EU and the UK in order to revise the Northern Ireland Protocol and enable the MHRA to grant UK-wide approvals for medicines with the same packaging and labelling to be used across the UK. Further detail on the latest guidance is available here.