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UK’s MHRA Seeks “Bold New Regulatory Regime” for Medical Devices and Diagnostics

Posted in Life Sciences

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 UK Medicines and Medical Devices Act 2021 (the Act), which came into force on 11 February 2021 and paved the way for new regulations to shape the post-Brexit landscape for medicines and medical devices in the UK. The Act introduced extensive delegated powers in favour of the Secretary of State or an “appropriate authority” to amend or supplement regulations in the area of human medicines and medical devices.

This Client Alert analyses the most substantive proposed changes and includes an Appendix that provides a detailed summary, as well as commentary on whether the proposal aligns with or diverges from the EU regulatory framework.

Private Equity Market Study, Eighth Edition

Posted in M&A and Private Equity

By Tom D. Evans, David J. Walker, and Catherine Campbell

Current Trends

The M&A market is constantly evolving — from the predominantly seller’s market of H2 2019, through the tumultuous times of H1 2020, to the strong rebound of H2 2020 and to the highly competitive seller’s market of H1 2021 — deal dynamics are shifting. Deal terms vary by transaction size, industry sector, and jurisdiction. Having a thorough knowledge of market trends is critical to negotiating and executing a successful deal.
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Private M&A Market Study, Eighth Edition

Posted in M&A and Private Equity

By Robbie McLaren and Catherine Campbell

Current Trends

The M&A market is constantly evolving — from the predominantly seller’s market of H2 2019, through the tumultuous times of H1 2020, to the strong rebound of H2 2020 and to the highly competitive seller’s market of H1 2021 — deal dynamics are shifting. Deal terms vary by transaction size, industry sector, and jurisdiction. Having a thorough knowledge of market trends is critical to negotiating and executing a successful deal. Continue Reading

US DOJ Emphasises Importance of Corporate Culture

Posted in Dispute Resolution

UK companies should be aware of the increasing focus on corporate culture by regulators on both sides of the Atlantic.

By Nathan H. Seltzer, David Berman, Stuart Alford QC, Christopher M. Ting, and Nell Perks

In a recent speech that has garnered significant attention, US Deputy Attorney General Lisa Monaco highlighted several important changes in how the US Department of Justice (DOJ) will pursue corporate crime during the Biden Administration. (Read Latham’s in-depth Client Alert analysing the speech and its potential impact, and Latham’s blog post highlighting matters of particular relevance to UK PLCs.)

This post highlights the DOJ’s particular emphasis on the importance of “corporate culture”. Continue Reading

Senior US DOJ Official Sets Forth New Priorities for Pursuing Corporate Crime

Posted in Dispute Resolution

The priorities will impact non-US companies who may face a US DOJ with a renewed emphasis on combating corporate crime.

By Stuart Alford QC, Nathan H. Seltzer, and Christopher M. Ting

In a recent speech that has garnered significant attention, the Deputy Attorney General of the United States, Lisa Monaco, highlighted several important changes regarding how the US Department of Justice (DOJ) will pursue corporate crime during the Biden Administration. Latham’s in-depth analysis of the speech and its potential impact can be found here.

In addition to reinforcing prior statements that the Biden Administration will prioritise the prosecution of corporate and white collar crime, the speech touched on several areas that may be of particular relevance to UK and other non-US companies. This blog post highlights some of those areas. Continue Reading

Truly Green? CMA Continues to Evolve Guidance and Metrics for Companies’ Environmental Claims

Posted in Environment

Businesses must review the Green Claims Code and accompanying guidance to determine whether their environmental claims are in compliance.

By David Little and Anuj Ghai

Background: The need for a Green Claims Code

The Competition and Markets Authority’s (CMA’s) recent publication of the Green Claims Code (the Code) and its final guidance (the Guidance) in respect of environmental claims represents the culmination of extensive consultation and investigation into claims about “green” goods and services.

In recent years, consumers have paid greater attention to the environmental footprint of the products and services that they buy and consume. In 2019, UK consumers spent £41 billion on ethical goods and services — almost four times the amount spent two decades previously. In light of increasing demand for green goods and services, in 2020 the CMA launched an investigation under its consumer protection powers into the impact of green marketing on consumers and carried out inquiries into potentially misleading environmental claims. At the end of its investigation, the CMA found that up to 40% of online green claims could be misleading. As a result of these findings, the CMA published draft guidance on environmental claims on 21 May 2021, and the final Guidance on 20 September 2021. Continue Reading

UK Net Zero Strategy: Understanding the Impact on Key Sectors

Posted in Environment

The strategy sets out plans to reduce emissions from key sectors of the UK economy to ensure that the UK remains on track for net zero by 2050.

By Conrad Andersen, John Balsdon, David Berman, Paul A. Davies, Nicola Higgs, Sam Newhouse, Simon J. Tysoe, Michael D. Green, James Bee, and Anne Mainwaring

On 19 October 2021, the UK government published its climate change strategy, “Net Zero Strategy: Build Back Greener” (the Strategy), which outlines plans to support the UK economy’s transition to a greener and more sustainable future. On 31 October, the UK will host the 2021 United Nations Climate Change Conference, COP26, in Glasgow.

Last year, Prime Minister Boris Johnson set out a 10-point plan for a “green industrial revolution”, which laid the foundation for a green economic recovery from the impact of COVID-19. The Strategy builds on that approach to align the UK with its carbon budget and nationally determined contribution to the Paris Agreement, both of which aim to reduce economy-wide greenhouse gas (GHG) emissions by at least 68% by 2030 and 78% by 2035, compared to 1990 levels. Further, the Strategy details the UK’s vision for a decarbonised economy by 2050. Continue Reading

Filter Future? Updates on the Copyright Directive and Platform Liability

Posted in Dispute Resolution, EU and Competition

Recent developments at the CJEU give some shape to the practical implications of Article 17 of the Copyright Directive.

By Jean-Luc Juhan, Susan Kempe-Mueller, Deborah Kirk, Elva Cullen, Alex Park, Pia Sophie Sösemann, Victoria Wan, and Amy Smyth

7 June 2021 was the implementation deadline for the Copyright in the Digital Single Market Directive (EU) 2019/790 (the Copyright Directive), yet just four EU Member States (including Germany and the Netherlands) have fully transposed the Copyright Directive, whilst four others (including France and Denmark) have transposed only parts of the Copyright Directive. The delay in implementation is perhaps unsurprising given the controversial nature of certain of the Copyright Directive’s provisions, in particular Article 17.

Recent developments have started to add colour to how Article 17 may work in practice, and how it might align with the broader regulation of platform liability for infringing content. This blog post will discuss these developments and analyse the implications for platforms and rights holders. Continue Reading

Could PE Benefit From the Universal Adoption of “Super Senior” RCFs in Leveraged Financings?

Posted in Finance and Capital Markets, M&A and Private Equity

By Francesco Lione, Charles Armstrong, Tom EvansDominic Newcomb, David Walker, and Catherine Campbell

Undrawn credit lines are essential to private equity but in short supply from banks.

Undrawn revolving credit facilities (RCFs) are essential to private equity. They are a backup in the event of mismatches in the working capital cycle, provide comfort for a rainy day, and preserve swift access to deal-making when other financing sources are unavailable, or less easily accessible. The COVID-19 pandemic could not have proved the importance of undrawn RCFs more clearly. Within a few weeks of the onset of the pandemic, as credit markets gummed up and businesses worldwide grappled with evaporating liquidity, leveraged companies dashed for cash and drew revolving lines.

PE firms may be able to persuade banks to offer RCF commitments more freely by transcending the limitations of current transactional templates and allowing banks to consistently provide undrawn revolving credit in its most secure form — alongside all leveraged loans and secured bonds, rather than just on bond backed deals, as is current practice. Continue Reading

ESG Toolkit Expands for European PE

Posted in Environment, M&A and Private Equity

By Paul A. Davies, Tom Evans, Nicola Higgs, Farah O’Brien, David Walker, Michael Green, Hannah Berdal, Anne Mainwaring, and Catherine Campbell

Green shoots emerge as PE firms consider new ways to incorporate ESG into dealmaking.

Market sentiment and the increasing importance of environmental, social, and governance (ESG) to firms’ competitiveness across the market, combined with wide-ranging and rapidly developing ESG regulatory reforms, are driving increased focus on ESG at both LP and GP levels across Europe. As a result, the market is showing demand for enhanced diligence, and a wider range of deal provisions are being considered in light of their potential to enhance the ESG outlook of PE investments. Continue Reading

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