Life Sciences and the Law - November 2022

21 November 2022

This time of year is always especially busy and from legal perspective there are regulatory and compliance changes ahead that business owners need to be aware of.

Free sustainability masterclass series. With that in mind, we’re excited to be launching a series of masterclasses in the new year as part of a Sustainability Support Programme delivered jointly with Yorkshire & Humber AHSN. The programme is for health and life sciences businesses including those who supply to the NHS. The programme will offer insights and also networking opportunities, including with NHS partners, and will be free to attend – no catches. Do join us for our launch event on Wednesday 14 December to find out more. Details below.

In this month’s issue, we outline the five steps you need to take to prepare your company for investment, congratulate the 11 SMEs we’ll be working with as part of PropelYH’s 2022/23 support programme for digital health companies and point you towards news from the MHRA relating to adverse incidents reporting.

We also look at how political disruption has impacted the progress of data protection and digital information legislation in an article by legal director Richard Parker for Life Sciences Industry magazine.

In client news, we share details of a number of recent sector transactions on which we have advised, including an investment into a pathology services provider, a major IT project we recently completed for an NHS hospital’s new Electronic Patient Record System and the set-up of a new Community Diagnostic Centre in Oldham, Lancs. Both deals highlight the evolving approach of the NHS in partnering with healthtech and medtech businesses to deliver on current government policy initiatives.

Finally, our Meet the Team spot introduces you to corporate partner Michael Corcoran, who talks about his work with a range of life sciences clients, career highlights and what it takes to get him on the dancefloor.

Enjoy the read and if you have any comments or requests, please get in touch – your feedback on the newsletter is also always welcome.

News and views – what you need to know

Alternative Proteins: regulatory approvals imminent – five steps to attract investment or prepare for sale
Investment in companies creating sustainable alternatives to conventional animal-based foods is estimated to have hit over $3 billion in 2020, with year-on-year growth of 300%. An imminent wave of regulatory approvals has also given alternative protein businesses greater confidence that they can access the necessary growth capital and benefit from the opportunity. Here, we detail five key steps you need to take to prepare. Read more
Data: Which direction? – the current reforms and how we got here!
In an article published on 3 November in Life Sciences Industry, Richard Parker of our Health and Life Sciences team, delves into some of the detail behind the UK government’s new Data Protection and Digital Information Bill and whether the reality is likely to match up to the rhetoric that ‘everyone can take back control of their personal data’ and an end to ‘pointless paperwork’. Read more
Client news

Hill Dickinson advises ITS Technology Group on major ‘Build and Buy’ acquisition
Our Corporate team has advised wholesale full fibre provider ITS Technology Group on the acquisition of a ‘dark fibre’ firm as part of its multimillion-pound ‘build and buy’ strategy. Read more
Investment into pathology services provider
We recently advised SME investment business Seneca Growth Capital VCT on a £500,000 investment in pathology services provider Alderley Lighthouse Labs. The investment will help facilitate the roll out of a commercial model by the team responsible for the UK’s largest diagnostic lab network project set up during the Covid-19 pandemic. Read more
Hydrogen Future Industries acquires international patents
Read how we advised green energy company Hydrogen Future Industries plc on the acquisition of a suite of international patents that will significantly enhance the company’s IP around systems it is developing. More here
Palatine PE invests in Redmoor Health
We were pleased to act as legal adviser to Palatine Private Equity on a ‘significant’ investment in digital healthcare services partner Redmoor Health. Read more
Hill Dickinson advises RJAH Orthopaedic Hospital Trust on 10-year EPR deal
Jamie Foster and Christiana Demetriou of our Life Sciences team recently advised The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust (RJAH) on a new Electronic Patient Records system that will enable the delivery of electronic notes to wards, electronic prescribing, ordering and receipt of tests and improvement of patient care. More here
“The Hill Dickinson team added real value to the process. We found it extremely beneficial to have them alongside us throughout the negotiations, ensuring that schedules were clearly understood and that they maintained the purpose for which they were intended.”
Simon Adams, RJAH Digital Director
Northern Care Alliance: Community Diagnostics Centres
Jamie Foster of our Healthcare and Life Sciences team recently advised the Northern Care Alliance NHS Foundation Trust on the construction of a new Community Diagnostic Centre (CDC) in Oldham, Lancs. The CDC is one of 40 across the UK set up to help achieve the NHS objective of providing more testing in the community, which in turn will help to tackle the elective care backlog and drive down waiting lists. More here
Events

Coming up – events for your diary
Sustainability Support Programme – the masterclass series
Delivered in partnership with Y&H AHSN
Launch event: Wednesday 14 December
We’re delighted to announce the launch of our sustainability masterclass series for businesses operating in the healthcare and life sciences space. The programme is free of charge and designed to help companies of all sizes improve their performance on the ESG agenda and gain competitive advantage in response to growing pressure from customers, investors and regulators. Please register for our launch event on 14 December to come along and find out more
Events
What we’ve been up to
The Agricultural Revolution: alternative proteins investment event – webinar now available
If you missed our recent event, Introduction to Cellular Agriculture and the Investment Opportunity, you can now listen to the webinar, here. An excellent line up of speakers included Marcus Stuttard of the London Stock Exchange, Seren Kell of the Good Food Institute, Antony Chow, co-founder of Agronomics, Pasi Vainikka, CEO and co-founder of Solar Foods, Alex Neves, co-founder of the Clean Food Company and Stephanie Haszczyn of the Jeremy Coller Foundation. If you’d like further advice on capital raising, ESG, investment or regulatory aspects, please get in touch
Propel@YH – Digital Health Accelerator 2022 cohort announced
We’ve reported previously about our involvement as legal adviser to Yorkshire & Humber AHSN’s Propel Digital Health Accelerator Programme, an initiative that provides structured support to health and medtech SMEs. Now in its fourth year, we’ve been inspired already by the quality of the applicants and look forward to working with the 11 innovative startups who’ve been selected as this year’s cohort. More here
IDF medical cannabis event
We were pleased to host a network event in our London offices on 1 November on behalf of the Independent Doctors Federation with guest speaker Dr Mikael Sodergren of Sapphire Medical Clinics. Dr Sodergren gave an update on medical cannabis for GPs and was joined by Jamie Foster of our Health and Life Sciences team, focusing on the status of medical cannabis in the UK, treatment evaluation and a market update on capital raising and investment options. More on Sapphire Clinics here.
Hill Dickinson and SEHTA
Our partnership with the South East Health Technologies Alliance (SEHTA) continues to flourish. Recent events have included SEHTA’s Medtech Expo on 13 October at which Richard Parker, legal director in our Health Commercial team, provided an update on development in data regulation and their effect on health technology providers. Key points from his presentation are summarised here.
We are also involved in delivering SEHTA and London South Bank University’s EU-co-funded Simulation for Digital Health (SimDH) programme, supporting healthtech start-ups and SMEs to innovate, develop and deliver products and services. Details of the programme and how to apply here.
Meet the team

Introducing Michael Corcoran, Corporate Partner
Meet Michael Corcoran, a partner in our Corporate team, who works with many high growth private companies and small-cap listed companies and whose clients include many leading names in the Life Sciences space. Read more
Industry news in brief
NHS report calls for artificial intelligence training for all staff
The pressing need to build a digital-ready workforce within the NHS and specifically the adoption of AI within a healthcare setting, is supported in a new report published by the NHS AI Lab and Health Education England. The report, Developing healthcare workers’ confidence in AI, calls for all health and care staff to receive training in AI and builds on an earlier report which recommended that educational pathways and materials should be deployed to support healthcare professionals in using AI.
More broadly, the MHRA is continuing its work to build the UK’s regulatory framework for medical devices, which encompasses software, including artificial intelligence. It has recently released details of its planned work packages forming part of its Software and AI as a Medical Device Change programme which aims to clarify regulatory requirements and ensure that patients are protected while also promoting the UK on the global stage as a leader in responsible innovation for medical software. More here
MHRA makes changes to submission of adverse incidents involving medical devices
Changes to the way that manufacturers of medical devices must report adverse incidents to the Medicines and Healthcare products Regulatory Agency take effect from 21 November 2022. The agency has produced a webinar as part of its updated guidance, with information on:
When and how to report
Registration
Information on the MHRA’s new MORE portal and API interface
Availability of the AICxml mailbox, which will still accept submissions until 30 April 2023
API set up
More here