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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.

Companies must mitigate risks to antitrust privilege posed by cross-border megadeals and increased regulatory demand for documentation.

Richard Butterwick, John Colahan, Martin Davies, Jonathan Parker, Oliver Middleton, Gregory Bonné, and Catherine Campbell

A strong M&A market has driven a high volume of megadeals across the globe in recent years, with acquirers turning to ambitious transactions. Antitrust issues frequently arise on such complex deals, and in an evolving antitrust environment, taking a planned and strategic approach to privilege during the deal process is crucial. Balancing the need to run a thorough due diligence exercise and transparent deal process with the need to maintain confidentiality and privilege can be challenging. In our view, practical planning for privilege issues forms a key part of successfully navigating international M&A deals.

10 Key Regulatory Focus Areas for UK/European Wholesale Markets in 2019

By David Berman, Carl Fernandes  Nicola Higgs, Rob Moulton, and Charlotte Collins

The fourth post in this 10-blog series considers the latest developments in relation to the Market Abuse regime. This is taken from our wider publication: 10 Key Regulatory Focus Areas for UK/European Wholesale Markets in 2019 – Progress Report. Read the full publication here.

10 Key Regulatory Focus Areas for UK/European Wholesale Markets in 2019

By David Berman, Carl Fernandes  Nicola Higgs, Rob Moulton, and Charlotte Collins

This blog post explores developments relating to the EU Benchmarks Regulation and the transition away from LIBOR. This is the third blog of this series, which has been taken from our wider publication: 10 Key Regulatory Focus Areas for UK/European Wholesale Markets in 2019 – Progress Report. Read the full publication here.

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…

Landmark ruling requires the European Commission to disclose impact assessments used as a basis for its legislative decision-making process.

By Antonio Morales and Rosa Espín

The Grand Chamber of the Court of Justice of the European Union recently issued a landmark judgment finding that impact assessments should be considered public documents. This decision sets a legal precedent in connection with the transparency, accountability, and decision-making processes of European institutions.

Case Background

A non-profit organization active in the field of environment protection had sought to access two impact assessment reports, which had played an influential role in the proposals of certain environmental laws.

By Paul Davies, Michael Green and Ei Nge Htut

On 26 June 2017, the European Commission (the EC) published non-binding guidelines on the methodology for reporting non-financial information by certain large companies and groups (the Guidelines) as required by Article 2 of the Directive 2014/95/EU amending the Accounting Directive on the disclosure of non-financial and diversity information (the Directive). The EC intends the Guidelines to help companies disclose high quality, relevant, useful, consistent, and more comparable non-financial information in a way that will encourage growth and provide transparency to key stakeholders.

The Directive was published in the Official Journal on 15 November 2014, entered into force on 5 December 2014, and Member States were required to adopt the necessary measures transposing the Directive into national law by 6 December 2016. Article 2 of the Directive requires the EC to publish the Guidelines, including non-financial key performance indicators (KPI) (both general and sectoral). The EC consulted on the format of the Guidelines in January 2016.

Driving these Guidelines is the principle that appropriate non-financial disclosure is a vital way of ensuring sustainable finance. This builds on the EC’s goal to develop a comprehensive EU strategy on sustainable finance as part of the Capital Markets Union, and forms part of the ongoing work of the High Level Group on Sustainable Finance as established by the EC. Both the Directive and Guidelines reflect the current best practices and most recent developments at international level, including key elements from the UN Sustainable Development Goals, the Paris Climate Agreement, and the industry-led Task Force on climate-related financial disclosures set up by the Financial Stability Board.

By Paul Davies and Michael Green

On 16 June 2017, the Member State Committee (MSC) of the ECHA unanimously agreed to identify BPA as a substance of very high concern (SVHC) under the REACH regime. BPA is common in a variety of household products, typically used in the manufacture of plastics and resins found in insulation, reusable containers and bottles, kettles, and DVDs. This identification follows the 2011 EU ban on BPA as an ingredient in babies’ bottles.

At the end of 2015, the European Commission (EC) proposed a roadmap — Proposal for a new measure on bisphenol A (BPA) in food contact materials — to harmonise BPA classification. Further, the British Plastics Federation (BPF) contributed to the Joint Value Chain Input to DG Health & Food Safety in support of option 3 of the roadmap, which proposed a decrease in the migration limit from 0.6mg/kg to 0.05mg/kg. This new Specific Migration Limit (SML) came into force in March 2016, and is applicable to plastics, coatings, and varnishes for metals and other food contact sources of BPA. In addition, in October 2016, the European Food Standards Agency (EFSA) published a review of two 2014 studies, concluding that “New data confirm EFSA’s previous conclusion that BPA might affect the immune system in animals but the evidence is too limited to draw any conclusions for human health.” As a result, EFSA stands by its original position of January 2015 that there is “no consumer health risk from BPA exposure at current exposure levels.” Some argue that, as BPA is one of the most researched chemicals in the industry, and as there are safety measures such as the new SML in place, both the public and the environment are adequately protected. The risk of BPA has also been extensively assessed within the areas of consumer, worker, and environmental safety to ensure that there is no health risk at current exposure levels.

By Jörn Kassow and Eun-Kyung Lee

On June 9, 2017, the European Commission (EC) published its Action Plan to Streamline Environmental Reporting (COM(2017) 312), summarising the findings of its review of reporting requirements following the 2015 ‘Better Regulation Initiative.’

As part of this 2015 Initiative, the EC carried out a fitness check focused on assessing environmental reporting and monitoring. While environmental as well as regulatory monitoring and reporting provide essential facts for informed decision-making and implementation review, the EC acknowledges the need to balance the demand for better information with the related costs for Member States and businesses. The estimated cost of reporting obligations — solely for the authorities involved — amounts to approximately €22 million a year.

In its recently published action plan, the EC summarised the findings of its fitness check and outlined a roadmap for action. In summary, the EC found that there is room for improvement, particularly in terms of effectiveness, efficiency, and coherence of reporting obligations. The EC also concluded that the content of environmental reporting could focus more on strategic, quantitative, and regulation-driven information, e.g., by using key indicators to reduce the amount of textual information currently requested.

By Paul Davies, Elisabetta Righini and Rosa Espin

Shiny transparent capsule filled with colorful spheresOn 28 April 2017, the European Commission (the EC) published a “roadmap” on the strategic approach to pharmaceuticals in the environment, particularly in the aquatic environment.

Concurrently, the EC launched a 12-week open public consultation to address the environmental pollution caused by human and veterinarian pharmaceutical substances.

Under the title “Strategic approach to pharmaceuticals in the environment”, the EC aims to implement Article 8c of Directive 2008/105/EC, as amended by Directive 2013/39/EU, according to which the strategic approach shall include proposals to improve the procedure for placing medicinal products on the market more effectively to reduce the environmental impacts of medicines. In addition, by September 2017, the EC shall propose measures at the EU and/or Member State level recommending the reduction of discharges, emissions, and losses of such substances into the aquatic environment.

This initiative aims to:

  • Identify remaining knowledge gaps and uncertainties, and present possible solutions for filling them
  • Explore how to address the challenge of protecting the environment (and human health via the environment), while safeguarding access to effective and appropriate pharmaceutical treatments for human patients and animals, considering inter alia opportunities for innovation