Last week, Jeremy Hunt, Chancellor of the Exchequer, published his Spring Budget for the UK.  It identified life sciences and digital technologies as “high growth sectors,” which the UK Government wishes to prioritize.  Among other things, the Budget outlined the Government’s plans to simplify medicines and technology approvals, plus changes to the regulation and support of digital technologies and artificial intelligence (“AI”).  Essentially, the Government wants “the UK to be the best place in Europe for companies to locate, invest and grow” and has announced plans to “strengthen [our] technology and life science sectors.”  The Government intends to support those working in these sectors through regulatory changes, as well as better infrastructure and additional funding.  This blog post summarizes some of the key announcements.

Quick and simple medicines and technologies approvals

First, the Government’s ambition is for the UK to have the “quickest, simplest, regulatory approval in the world.”  Mr Hunt envisions achieving this through two key changes to UK medicines and technology regulations:

  1. Reliance on foreign approvals.  
    • The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) will implement “rapid, often near automatic sign-off” for medicines and technologies approved by other trusted regulators, such as the United States, Europe and Japan.  
    • Going forwards, developers of medicines may be able to prioritize their regulatory approvals in the United States, EU or Japan, rather than preparing a standalone marketing authorization application (“MA”) for the UK.  The UK currently has reliance procedures in place for medicines that are centrally authorized by the European Commission or authorized in the EU through decentralized and mutual recognition procedures.  The new Government policy will significantly expand the scope of the MHRA’s reliance procedures so that it includes other foreign regulators, potentially increasing the speed to market for pharmaceutical products.
    • These new policies will also extend to “technologies.”  Given the MHRA has little involvement in the pre-market approval of medical devices, it is unclear to what extent this term includes medical devices.  However, we assume there would be scope for the UK to automatically recognize a regulatory approval of a medical device in the United States (such as a 510(k)) or an EU CE-mark for the purpose of obtaining a UKCA mark.  It might also give software medical devices benefiting from innovations in regulation, such as the U.S. FDA’s Software Pre-Cert Pilot Program, rapid access to the UK market. 
    • In any event, the intended upshot of these proposals is that global developers of medicines and technologies will be able to avoid UK-specific regulatory procedures, associated costs and concerns about navigating unique regulatory requirements for the UK market.  
    • Absent mutual recognition of UK approvals by other regulators, of course, a potential downside of more expansive reliance by UK is that this could limit the MHRA’s opportunities to be a truly innovative regulator.  Mindful of this risk, the Chancellor announced some rapid review initiatives. 
  1. Accelerated approval process.
    • From 2024, the MHRA will also implement a “swift approval process” for the most impactful new medicines and technologies, such as “cancer vaccines and AI therapeutics for mental health.”  In respect of medicines, we note that the MHRA currently offers a 150-day assessment route for high-quality national MA applications and the option for applications to be fast tracked if there is compelling evidence of benefit in a public health emergency or if there is a shortage of supply of an essential medicine.  We will need to wait for further detail before we know whether the MHRA will be able to accelerate these timelines even further and what the specific product criteria will be for this accelerated assessment route.

The Government announced £10 million extra funding for the MHRA over the next two years to implement the above ambitions.

The UK also announced its intent to do more to promote innovation and the digital economy.  It highlights Patrick Vallance’s Pro-Innovation Regulation of Technologies Review: Digital Technologies Report, noting that the Government accepts all nine of Sir Patrick Vallance’s recommendations.  Notably, for those in the life sciences sector, these include the implementation of: (1) regulatory sandboxes (to allow innovators and entrepreneurs to experiment without the heavy burden of regulation and the risk of fines); (2) a clear policy position on the relationship between intellectual property law and generative AI (to provide confidence to innovators and investors); and (3) greater industry access to public data.

The Budget also highlights a number of specific ways it will support AI and digital technologies:

  • Investment in infrastructure.  “AI needs computing horsepower.” As such, the Chancellor committed to investing around £900 million to build an exascale supercomputer and to establish a new AI Research Resource.  This should provide significant computer power for the UK AI community and allow researchers to work on areas such as new drug discovery.
  • Quantum Strategy.  The UK launched its Quantum Strategy, which includes a research and innovation programme and £2.5 billion of Government investment over 10 years.
  • Funding innovation accelerator programmes.  The Government will provide £100 million funding for the Innovation Accelerators programme (which covers 26 transformative R&D projects).
  • Critical areas of AI.  The Government will award £1 million every year for 10 years to researchers that drive progress in critical areas of AI.  There is currently no detail of what these areas are nor what is considered as “driving progress.”
  • Taskforce on foundational models.  The Government acknowledges the importance of foundation models and will establish a taskforce to advance UK sovereign capability to ensure the UK is at the cutting edge of the technology.
  • Metaverse.  The Government plans to lead the way on regulation of AI and the future of web technology.

The Government’s announcements are a positive step in the right direction.  However, as always, the devil will be in the detail.  The Covington Life Sciences team is following these developments and will provide further updates in due course.

Tags: Artificial Intelligence (AI), Medical Devices, Medicinal Products, MHRA, Spring budget, UK Government
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Photo of Grant Castle Grant Castle

Grant Castle is a partner in London, Brussels, and Dublin practicing in the areas of EU, UK, and Irish life sciences regulatory law. He supports innovative pharmaceutical, biotech, medical device and diagnostics manufacturers on regulatory, compliance, legislative, policy, market access and public law…

Grant Castle is a partner in London, Brussels, and Dublin practicing in the areas of EU, UK, and Irish life sciences regulatory law. He supports innovative pharmaceutical, biotech, medical device and diagnostics manufacturers on regulatory, compliance, legislative, policy, market access and public law litigation matters in the EU, UK, and Irish Courts.

He is one of the Co-chairs of Covington’s Life Sciences Industry Group and is Head of Covington’s European Life Sciences Regulatory Practice.

Grant regularly advises on:

  • EU and UK regulatory pathways to market for pharmaceuticals and medical devices, including in vitro diagnostics and on associated product life cycle management;
  • Pharmaceutical GxPs, including those governing pharmacovigilance, manufacturing, the supply chain and both clinical and non-clinical research;
  • Medical device CE and UKCA marking, quality systems, device vigilance and rules governing clinical investigations and performance evaluations of medical devices and in vitro diagnostics;
  • Advertising and promotion of both pharmaceuticals and medical devices; and
  • Pricing, reimbursement and market access for both pharmaceuticals and medical devices.

Grant also handles procedural matters before EU, UK and Irish regulators and UK and Irish market access bodies, where necessary bringing judicial reviews for his life sciences clients before the EU, UK and Irish Courts.

Chambers UK has ranked Grant in Band 1 for Life Sciences Regulatory for the last 18 years. He is recognized by Chambers UK, Life Sciences as “excellent,” “a knowledgeable lawyer with a strong presence in the industry,” who provides “absolutely first-rate regulatory advice,” according to sources, who also describe him as “one of the key players in that area,” whilst Chambers Global sources report that “he worked in the sector for many years, and has a thorough understanding of how the industry ticks.” He is praised by clients for his “absolutely first-rate” European regulatory practice. Legal 500 UK notes that he is “highly competent in understanding legal and technical biological issues.”

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Photo of Sarah Cowlishaw Sarah Cowlishaw

Advising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and technology companies on regulatory, compliance, transactional, and legislative matters.

Sarah is a partner in London and Dublin practicing in the areas of EU…

Advising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and technology companies on regulatory, compliance, transactional, and legislative matters.

Sarah is a partner in London and Dublin practicing in the areas of EU, UK and Irish life sciences law. She has particular expertise in medical devices and diagnostics, and on advising on legal issues presented by digital health technologies, helping companies navigate regulatory frameworks while balancing challenges presented by the pace of technological change over legislative developments.

Sarah is a co-chair of Covington’s multidisciplinary Digital Health Initiative, which brings together the firm’s considerable resources across the broad array of legal, regulatory, commercial, and policy issues relating to the development and exploitation of digital health products and services.

Sarah regularly advises on:

  • obligations under the EU Medical Devices Regulation and In Vitro Diagnostics Medical Devices Regulation, including associated transition issues, and UK-specific considerations caused by Brexit;
  • medical device CE and UKCA marking, quality systems, device vigilance and rules governing clinical investigations and performance evaluations of medical devices and in vitro diagnostics;
  • borderline classification determinations for software medical devices;
  • legal issues presented by digital health technologies including artificial intelligence;
  • general regulatory matters for the pharma and device industry, including borderline determinations, adverse event and other reporting obligations, manufacturing controls, and labeling and promotion;
  • the full range of agreements that span the product life-cycle in the life sciences sector, including collaborations and other strategic agreements, clinical trial agreements, and manufacturing and supply agreements; and
  • regulatory and commercial due diligence for life sciences transactions.

Sarah has been recognized as one of the UK’s Rising Stars by Law.com (2021), which lists 25 up and coming female lawyers in the UK. She was named among the Hot 100 by The Lawyer (2020) and was included in the 50 Movers & Shakers in BioBusiness 2019 for advancing legal thinking for digital health.

Sarah is also Graduate Recruitment Partner for Covington’s London office.

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Photo of Ellie Handy Ellie Handy

Working with companies in the life sciences and technology sectors, Ellie Handy focuses on EU, Irish, and UK life sciences regulatory and commercial matters.

Ellie advises clients on regulatory issues including classification, biologics, orphans, paediatrics, GxP, market and data exclusivity, clinical research, labelling…

Working with companies in the life sciences and technology sectors, Ellie Handy focuses on EU, Irish, and UK life sciences regulatory and commercial matters.

Ellie advises clients on regulatory issues including classification, biologics, orphans, paediatrics, GxP, market and data exclusivity, clinical research, labelling and promotion, reporting obligations, medical devices, and digital health. Ellie also advises companies in the food, cosmetic and consumer products sectors regarding regulatory compliance and borderline issues. Ellie provides advice in relation to corporate transactions and restructuring, in particular performing regulatory due diligence.

Ellie represents and works with a wide range of clients working in the life sciences and technology sectors on both contentious and non-contentious regulatory matters.

Ellie’s pro bono work includes assisting charities. In addition to her role at Covington, Ellie spent three years working life sciences regulatory practice in London.

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Photo of Roderick Dirkzwager Roderick Dirkzwager

Roderick Dirkzwager advises clients in the life sciences sector on a broad range of regulatory, transactional and intellectual property matters relating to the discovery, development and commercialization of their products.

Roderick is a member of Covington’s Diversity and Inclusion Committee and is a…

Roderick Dirkzwager advises clients in the life sciences sector on a broad range of regulatory, transactional and intellectual property matters relating to the discovery, development and commercialization of their products.

Roderick is a member of Covington’s Diversity and Inclusion Committee and is a co-lead of the LGBT+ Affinity Group in London.

With a broad life sciences practice, Roderick regularly advises on:

  • EU, Irish, and UK regulatory issues relating to pharmaceutical products and medical devices;
  • commercial agreements that span the product life-cycle in the life sciences sector, including collaborations and other strategic agreements, clinical trial agreements, distribution arrangements and manufacturing and supply contracts;
  • regulatory and commercial due diligence for life sciences transactions; and
  • intellectual property issues arising in corporate transactions and IP-related contracts.

Roderick is also a member of Covington’s Life Sciences in Africa team and advises clients on regulatory and commercial strategies for the supply of medical products across Africa, including through international recognition procedures such as WHO pre-qualification. Prior to joining the firm, Roderick completed his Ph.D. in Biochemistry, focusing on the development of novel, low-cost malaria diagnostic technologies using DNA aptamers.

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