Life Sciences and the Law - April 2023

Hill Dickinson advises PAM Group on health screening business acquisition 

Hill Dickinson’s Manchester corporate team advised occupational health and wellbeing specialist PAM Group on the acquisition of mobile health screening business MedProtect. PAM Group is one of the largest occupational health, employee assistance programme and wellbeing providers in the UK, employing more than 700 people and backed by private equity firm LDC. Read more

We have recently advised Scotland’s first medical cannabis production facility on a £2 million fundraise from UK investment house Traditum Private Equity and a number of private investors. The funding enables Hilltop Leaf to scale its infrastructure for the specialist prescription market and to begin commercial sales. Read more about the work and the Hill Dickinson team involved here.

Our London corporate team, with international support from our Piraeus office advised the board of Hellenic Dynamics plc (formerly UK SPAC plc) on its successful acquisition of Hellenic Dynamics SA, a Greek company involved in the cultivation and production of THC-dominant strains of medical cannabis flowers. The deal represents a landmark development, as Hellenic Dynamics will become the first medical cannabis cultivator to obtain a Main Market listing. Read more

A multidisciplinary team of Hill Dickinson lawyers recently advised Liverpool School of Tropical Medicine (LSTM) on its purchase of a key life science building in the city’s health campus. The high-spec Accelerator building will add significant capacity to LSTM’s existing research capability as well as offering lettable space to inventors, enterprises and entrepreneurs engaged in research and development activity in the fields of medical and life sciences. Read more about the acquisition and its benefits here.

Members of Hill Dickinson’s healthcare commercial and property teams recently advised the Clatterbridge Cancer Centre NHS Foundation Trust on its acquisition of the formerly privately-run Rutherford Cancer Centre in Liverpool. The transaction provides the trust with additional state-of-the-art capacity, and the local population with earlier access to vital diagnostic services. Read more about the acquisition and our work on this here.

We are delighted to announce that we have been shortlisted for HealthInvestor’s Private Legal Advisors of the Year award! The awards evening is in June where we will find out if we have made the top spot – if you are going to be there, please reach out to Jamie Foster so that we can make sure to say hello. More details about the event here.

Update on extension of EU Medical Device Regulations transition period

The European Parliament will extend the transition period for the EU Medical Device Regulation, introducing more time to certify certain devices. This responds to challenges in capacity avoiding shortages of medical devices. The MHRA intends to publish guidance on the implications of these revisions for acceptance of CE marked devices on the Great Britain market. More here

Following his March 2023 report as part of the Pro-Innovation Regulation of Technologies review, the Government’s Chief Scientific Adviser, Sir Patrick Vallance is expected to report separately on regulatory changes for the life sciences sector in May. In the meantime, in a recent letter to the Chancellor in advance of the spring budget (see our update below), he recommended that the MHRA and NICE “adopt a broader approach to the mutual recognition of products already approved by trusted international partner organisations, particularly for well-established technologies”. According to Sir Patrick, the approach should operate in tandem with the domestic approval route and will enable the MHRA and other bodies to focus efforts on supporting other innovation. 

The March 2023 budget announced £10 million of extra funding for the MHRA across the next two years to “maximise its use of Brexit freedoms and accelerate patient access to treatment”. It is expected to put in place a “fully operational swift approval process for the most impactful medicines and technologies”. According to the budget announcement the MHRA will also explore partnerships with agencies in the US, Europe and Japan to “provide simple, rapid approvals for medicines and technologies from 2024”. The Chancellor’s statement expanded on this to confirm that the MHRA’s new model, in place from 2024 will involve providing “near automatic” sign off for technologies already approved by “trusted regulators” abroad. 

Following public consultation, a Government press release has confirmed plans for the MHRA to introduce a series of measures via legislative changes to make it faster and easier to gain approval and run clinical trials in the UK. The announcement pitches these changes as the “biggest overhaul in UK clinical trials regulation in over 20 years” and notes that under a new framework, the clinical trials application process will be “more proportionate, streamlined and flexible” without safety compromises. The aim is to cement the UK as an attractive destination for trials. Plans include the MHRA being required to complete its application review within a maximum of 30 days in general, and 10 calendar days for a decision once any final information has been received. 

Separate from the above announcement regarding legislative change to the clinical trial process, but aligned with it, is a review led by former health Minister Lord O’Shaughnessy looking at the commercial clinical trials landscape. A press release by the Office for Life Sciences confirms that the review, expected this spring will “offer recommendations on how commercial clinical trials can help the life sciences sector unlock UK growth and investment opportunities” and will also advise on resolving “key challenges in conducting commercial clinical trials in the UK.”