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The fertility sector is likely to present growing opportunities for PE as an emerging, multifaceted industry.

By Heather B. Deixler, Tom D. Evans, Elizabeth M. Richards, Linzi Thomas, Eveline Van Keymeulen, David J. Walker, Betty C. Pang, Stuart McRobbie, and Catherine Campbell

The global fertility sector, which has grown significantly in recent years as demand continues to soar, is expected to be valued at more than US$30 billion by 2023, up from approximately US$16 billion in 2016. While the global market is growing, fragmented European fertility regulatory regimes and complex US regulations necessitate specialised legal counsel to successfully deliver deals. Recent transactions highlight the breadth and international reach of the investment opportunities that exist, from clinic-focused businesses to those that specialise in medical device development.

In Lexology’s Getting the Deal Through: Digital Health 2021 (UK) Latham & Watkins considers the key regulatory and transactional issues faced by market players and practitioners.

By Frances Stocks Allen, Oliver Mobasser, Sara Patel, Mihail Krepchev, and Samantha Peacock

The UK has an active digital health market comprising both the private and public sectors. Venture capital funding in the digital health sector has increased significantly in recent years, with the majority of investment appearing to come from private investment firms. However, public financing through IPOs is also on the rise. The COVID-19 pandemic has further heightened the positive and dynamic investment climate for digital health technologies in the UK. In particular, the pandemic has highlighted the need for resilience in healthcare systems, including through digital health solutions. As a result, the pandemic has significantly accelerated uptake of digital health solutions in the UK and related investment opportunities, as well as challenging structural barriers that had previously slowed investment in digital health innovations.

Digital health in the UK is currently governed by a patchwork of different legal regimes, rather than bespoke legislation, while various regulatory and enforcement bodies have jurisdiction over the digital health sector.

UK companies interested in producing ventilators and other critical equipment may benefit from regulatory exemptions and use government product specifications.

By Frances Stocks Allen and Oliver Mobasser

On 16 March 2020, Prime Minister Boris Johnson called on the UK’s leading manufacturing businesses to help the UK step up production of vital medical equipment to combat the COVID-19 crisis.[i]

With no proven COVID-19 treatment or vaccine to date, ventilators are a critical piece of equipment to help treat patients with acute symptoms of the disease. The UK industry has responded to the government’s call, with a number of companies in the aerospace and automotive sectors reportedly working on plans to lend capacity to manufacture ventilators. Meanwhile, a number of newly designed ventilators and breathing aids have reportedly gained regulatory approval and are either undergoing trials or are already subject to orders from the UK government.

[i] https://www.gov.uk/government/news/pm-call-with-uks-leading-manufacturers-16-march-2020.

European Commission proposes one-year postponement in light of the COVID-19 crisis.

By Frances Stocks Allen and Oliver Mobasser

On 25 March 2020, the European Commission announced that it was working on a proposal to postpone the date of application for the new EU Medical Devices Regulation (MDR)[i] for one year, in light of the COVID-19 crisis. The MDR had been due to become fully active on 26 May 2020.

The Commission’s Directorate-General for Health and Food Safety noted in a press release that the Commission was working to submit this proposal in early April, for swift adoption by the European Parliament and the European Council. The proposed postponement aims to relieve pressure on national authorities, notified bodies, manufacturers, and others, allowing them to focus fully on urgent COVID-19-related priorities.