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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.

The agency’s consultation on the post-Brexit regulatory framework for medical devices and diagnostics aims to support innovation and sustainability, among other goals.

By Eveline Van Keymeulen, Ranulf Barman, Oliver Mobasser, and Frances Stocks Allen

A 10-week consultation launched by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on the future regulation of medical devices, including in vitro diagnostics (IVD), will close on 25 November 2021 at 11:45 p.m. GMT.

The backdrop for the consultation is the…

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 Robbie McLaren

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. Consequently, the pandemic has significantly accelerated uptake of digital health solutions in the UK and related investment opportunities, as well as challenged structural barriers that previously slowed investment in digital health innovations.

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.

By Frances Stocks Allen and Oliver Mobasser

Recent legal and regulatory developments pave the way for an increased commercialisation opportunity in cannabis-based medicines, but complex rules require careful navigation.

The National Institute for Health and Care Excellence (NICE) recommended the reimbursement of two plant-derived cannabis products for the first time on 10 November 2019. This follows Epidyolex becoming the first cannabis-derived medicine to be granted a marketing authorisation by the European Commission when it was approved for the treatment of…

The guidance provides helpful clarity on key regulatory changes impacting life sciences companies in the event of a no-deal Brexit.

By Frances Stocks Allen, Oliver Mobasser, Héctor Armengod, Gail E. Crawford, Christoph W.G. Engeler, Robbie McLaren, and Henrietta J. Ditzen

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published a significant volume of guidance documents on various aspects of the post-Brexit life sciences regulatory landscape in the UK, including in the event of a no-deal Brexit. The guidance provides helpful clarity to life sciences companies operating in the European Economic Area (EEA) and the UK, which continue to face significant uncertainty about how they will be impacted by Brexit — particularly given the ongoing risk of a no-deal Brexit. (For detailed analysis on how a no-deal Brexit scenario would impact life sciences companies, please see this prior Latham blog post.)

Background

On 29 March 2017, the UK Prime Minister gave the European Council formal notification under Article 50 of the UK’s intention to leave the EU, setting the default withdrawal date for the UK’s withdrawal from the EU to 11 p.m. GMT on 29 March 2019. The UK Prime Minister requested an extension to the original withdrawal date in light of the UK Parliament’s failure to approve the withdrawal agreement agreed between the UK Prime Minister and the European Commission. On 21 March 2019, the European Council approved the UK government’s request, permitting an extension of the Article 50 period until either:

  • 22 May 2019, if the UK Parliament approves the withdrawal agreement by the end of the week commencing 25 March 2019
  • 12 April 2019, if the UK Parliament does not approve the withdrawal agreement by the end of the week commencing 25 March 2019, with this period capable of further extension by agreement between the European Council and the UK government, provided that the European Council expects the UK to indicate “a way forward” prior to 12 April 2019

Latham lawyers explain the impact of a no-deal Brexit scenario and how it will impact life sciences companies operating in the UK

By Frances Stocks Allen, Hector Armengod, Christoph Engeler, and Robbie McLaren

There are now fewer than three months to go until the United Kingdom’s exit from the European Union on March 29, 2019. On Jan. 15, 2019, the UK government rejected the provisional deal proposed by the prime minister and accepted by the EU which…