Life Sciences & Healthcare

Subscribe to Life Sciences & Healthcare
Search by Life Sciences & Healthcare

The new draft guidelines depart from decades of practice by introducing novel presumptions that could make it harder for mergers to obtain regulatory clearance from the agencies.

On July 19, 2023, the FTC and DOJ published draft merger guidelines.[1]  Historically, the purpose of these guidelines has been to provide the public, including companies whose transactions are potentially subject to agency review, with information about how the agencies analyze mergers to identify potential competitive harm.  The guidelines have no force of law and are not binding on the courts, though courts have relied on them as persuasive authority to varying degrees.  Past iterations of the guidelines have therefore provided a neutral explanation of the agencies’ approach, including descriptions of the economic tools that they and the courts can use to assess a merger’s likely competitive effects.

On July 5, 2023, the German Parliament (Bundestag) passed the Competition Enforcement Act, amending the German Act Against Restraints of Competition (“ARC”) for the 11th time (“11th Amendment”).  This comes only two and a half years after the last significant amendment in 2021, which granted the Federal Cartel Office (“FCO”) unprecedented investigative powers.[1]  The 11th Amendment once again equips the FCO with additional enforcement powers.

On 11 July 2023, the UK Government published its second Annual Report on the National Security and Investment Act 2021 (the “Act”).

The Annual Report begins with an introduction by Oliver Dowden MP, the Deputy Prime Minister, who is the formal decision-maker under the Act in his role as the Secretary of State in the Cabinet Office.  This introduction seeks to reassure investors that the Act is a “light-touch, proportionate regime that offers companies and investors the certainty they need to do business, while crucially protecting the UK’s national security in an increasingly volatile world.”

On May 26, 2023, the first reading of the Government’s amendment to the draft of the Competition Enforcement Act dated April 5, 2023 (“Government Draft 11th Amendment”) was held in Parliament.  The Competition Enforcement Act will amend the German Act Against Restraints of Competition (“ARC”) for the 11th time.[1]  The Government has proposed further changes to the Federal Ministry for Economic Affairs and Climate Action’s draft published in September 2022 (“Draft 11th Amendment”).[2]  This blog post outlines the changes proposed by the government to the Draft 11th Amendment, following on from an earlier blog post on the Draft 11th Amendment (available here).

The explosion in the development of generative AI has been referred to as an “Oppenheimer” moment.  Just last week, a group of more than 350 executives and scientists jointly stated that “[m]itigating the risk of extinction from AI should be a global priority alongside other societal-scale risks such as pandemics and nuclear war.”  And more than 1,000 tech leaders have called for a moratorium on AI development until regulations governing its safe use are devised. 

On June 1, 2023, the Commission published revised Research & Development and Specialization Block Exemption Regulations (“R&D BER” and “Specialization BER”, together the “HBERs”)[1] , as well as revised Guidelines on Horizontal Cooperation (“Horizontal Guidelines”).[2]  The new HBERs exempt certain agreements from the prohibition of Article 101(1) of the Treaty on the Functioning of the EU (“TFEU”), subject to specific conditions, and accordingly create a so-called “safe harbor” for certain forms of horizontal cooperation.  Relatedly, the Horizontal Guidelines aim to guide undertakings in the interpretation and application of the revised HBERs, and thereby in their assessment of “various common types of horizontal cooperation agreements.”[3]

The UK Competition and Markets Authority (CMA) has identified “roll-up” acquisitions (the acquisition of several targets in the same sector) by financial investors, such as private equity firms, as an enforcement priority.  In this post, we discuss the CMA’s enforcement focus, its recent decisional practice, and implications for merging parties.  The main takeaways are:

On April 20, 2023, the Commission adopted the 2023 Merger Simplification Package (the “2023 Package”) designed to streamline its procedure under the EU Merger Regulation.[1]  In particular, the 2023 Package (1) expands the types of concentration eligible for treatment under the simplified procedure, (2) streamlines the review of both simplified and non-simplified cases, and (3) simplifies the notification process.

On March 27, 2023, the European Commission (the “Commission”) announced it would revise its 2008 Guidance on enforcement priorities regarding Article 102 TFEU[1] (the “2008  Guidance”).  The Commission has amended its 2008 Guidance in a Communication and Annex.  It has also launched a consultation seeking feedback on the adoption of new Guidelines on exclusionary abuses of dominance that the Commission intends to adopt in 2025 after publishing a draft in 2024.  While the amendments in the 2008 Guidance bring it closer to the case law, they show the Commission seeking more discretion and leeway in its investigations.