Global Antitrust in 2024: 10 key themes
In focus: life sciences
conduct and commercial practices under the microscope
2023 has seen significant regulatory interest in the commercial practices and conduct of companies operating in the life sciences sector, with renewed focus on traditional conduct-based theories of harm relating to companies’ pricing and distribution strategies as well as an increased appetite of regulators to pursue novel abuses and theories of harm too. Such scrutiny is set to continue throughout 2024.
Consolidation among pharmaceutical companies can facilitate collusion, distort incentives to research and develop new drugs, increase the bargaining leverage of large incumbents, and reduce potential entrants’ access to capital.
Chair, US Federal Trade Commission – September 2023
Life sciences has been – and is likely to remain – an enforcement priority for antitrust authorities across the globe
Antitrust authorities worldwide have pursued an aggressive enforcement agenda in the life sciences space in recent years. Sustained political focus on affordable access to medicines, budget pressures on national health services and a desire to enable innovative biotechs and generics to compete head-on with big pharma companies means that we expect regulators to continue to pursue enforcement action in the life sciences sector in 2024. Regulatory enforcement in the industry spans both exploitative and exclusionary practices. We have seen regulatory interest in, for example, traditional patent settlement cases (in particular “pay for delay” arrangements) and pricing abuses, as well as novel patent misuse concerns and denigration/disparagement cases. For example, the European Commission (EC) is investigating Teva for allegedly misusing the patent system and disparaging its competitors to protect its multiple sclerosis medicine Copaxone and is investigating Vifor Pharma for the dissemination of misleading information on competitor products. In the US, the Department of Justice (DOJ) Antitrust Division’s and Federal Trade Commission’s (FTC) attention to the life sciences space remains robust, with both agencies emphasizing the importance of the pharmaceutical sector to consumers. In China, the life sciences sector continues to be a prominent focus on the enforcement agenda of the State Administration for Market Regulation (SAMR), with heightened scrutiny of pricing-related conducts.
Life sciences is still very much front of mind for regulators, despite their simultaneous focus on digital markets. Businesses in the life sciences sector should continue to expect authorities to dedicate significant resources to enforcement in this space.
Antitrust Partner, Düsseldorf
Resurgence in conduct-based antitrust enforcement
Commercial practices are coming under increasing scrutiny, with regulators across Europe, the US and Asia initiating proceedings focused on traditional antitrust practices, including unfair and excessive pricing, particularly in the wake of significant concerns as to the affordability of medical services and products. In the UK, a series of excessive pricing cases brought by the Competition and Markets Authority (CMA) have recently been upheld by the first instance specialist appellate court (the Competition Appeal Tribunal) with respect to liothyronine tablets and hydrocortisone tablets. Given that excessive pricing cases are notoriously difficult to bring for regulators, the CMA’s recent wins on appeal are expected to embolden it to continue to pursue enforcement in this area.
The excessive pricing of essential medicines can have a significant impact on the [National Health Service] and on patients, and we will continue to take action in the public interest where we see companies abusing their market power.
Chief Executive, Competition and Markets Authority – August 2023
In the US, perceived high drug prices – including for generics – have prompted continued DOJ enforcement action against generic drug price-fixing, potential FTC challenges to Orange Book patent listings under the Food and Drug Administration’s regulatory process, and increased attention to bundling and bundled discount practices. In China, SAMR has persistently pursued enforcement action with respect to excessive pricing of active pharmaceutical ingredients (APIs), such as levocarnitine API, as well as resale price maintenance in the distribution of drugs and medical devices such as dental implants. This resurgent interest in traditional antitrust theories of harm means companies should ensure that their commercial practices and conduct continue to be compliant with antitrust rules.
Competition authorities have raised behavioral antitrust considerations in merger reviews, with the risk of triggering standalone antitrust investigations
The revised Merger Guidelines in the US (US Merger Guidelines), finalized by the DOJ and the FTC in December 2023 (see Theme 2), make clear that the agencies will consider both prior antitrust violations or allegations of the merging parties and the potential for a merger to entrench or extend a dominant position, including via conduct such as bundling across the parties’ portfolios. While ultimately settled, the FTC’s challenge to Amgen’s acquisition of Horizon exemplifies these themes in the life sciences sector.
Antitrust compliance is increasingly relevant for merger review. While the agencies historically would pursue potential antitrust violations identified during a merger review independently, today they are increasingly considering parties’ course of conduct as relevant to the merger assessment itself.
Antitrust Partner, Washington, DC
What this means for life sciences and pharmaceutical companies
Companies should revisit their compliance policies to ensure that these account for “traditional” antitrust risk areas as well as novel theories of harm, including regular updates to reflect evolving rules and antitrust enforcement trends. This includes, for example, ensuring that policies are in place to ensure that antitrust risk is mitigated across all aspects of day-to-day operations, including with respect to pricing and discounting, patent strategies and settlements, and agreements with distributors and competitors for the purposes of jointly developing new products. Awareness of these issues across core business teams (e.g., go-to-market and pricing teams, sales representatives, and patent attorneys) is key to mitigating risk. Similarly, these teams should ensure clear and appropriate communications in dealings with counterparties to avoid inadvertently raising antitrust concerns (e.g., disparagement-type concerns).
Artificial intelligence: the interplay between life sciences and digital markets
The crossover between antitrust compliance and compliance with other areas of regulation is becoming increasingly important for life sciences companies, particularly as data and AI are increasingly important components of the R&D and product marketing life cycle. Companies will need to ensure that compliance is assessed holistically, bringing in expertise across all areas including antitrust, data protection and IP.
Antitrust Partner, London
Companies should also ensure that compliance policies consider the interplay with other laws and regulations, such as IP and patent laws, and in Europe, the General Data Protection Regulation, the Data Act and the AI Act. Applications using AI technology are becoming increasingly commonplace across all industries, and the life sciences sector is no exception. For all the promise that AI holds for the sector, there are several legal challenges and risks that businesses should be aware of. For example, final adoption of the EU’s long-anticipated AI Act – which will have a significant impact on the ongoing use and development of AI in the industry – is expected imminently. In particular, companies that develop or operate medical devices – which are expressly covered by the AI Act – will become subject to far-reaching requirements, including compliance with self-assessment processes, testing procedures and the creation of technical documents. Regulators around the world are alive to the disruptive impact that AI technology can have across the economic value chain, and we expect that the use of AI technology by life sciences and pharmaceutical companies will be subject to close regulatory scrutiny (see Theme 4).
AI represents a huge opportunity for collaborations between life sciences, medtech and tech businesses. Making a success of these collaborations means understanding who takes responsibility for emerging regulatory risks, as well as a clear allocation of rights in data inputs and outputs. Putting in place AI governance that spans the AI life cycle – and the various regulatory, IP and contractual regimes that it engages – is no longer optional.
IP/Tech Partner, London
Looking ahead in 2024
- Expect antitrust authorities to aggressively enforce antitrust rules in the life sciences sector space. Agencies will continue to focus on promoting innovation and ensuring that consumers have access to innovative, safe and affordable products and services.
- Anticipate a greater focus on the interplay between life sciences and other policy areas. The intersection with data protection/privacy and AI will be heavily scrutinized as they become increasingly central to the R&D and commercialization life cycle.
- Proactive steps can mitigate risk exposure. Ensure that internal compliance policies are updated to reflect emerging areas of concern and that clear escalation mechanisms to in-house counsel are in place.
With thanks to Jake Bullock, Alexandra Forrest, Laura Onken and Enrica Schaeffer for their contributions to this theme.
- 01. Taking center stage global antitrust for the mid-2020s
- 02. Merger enforcement the path to clearance gets even tougher
- 03. Investing across borders in 2024 – strengthened controls to protect domestic capabilities
- 04. Digital markets antitrust and artificial intelligence – the next frontier?
- 05. Consumer driven enforcement consumer facing businesses in the regulatory spotlight
- 06. In focus: life sciences and pharma – conduct and commercial practices under the microscope
- 07. Antitrust and sustainability will 2024 bring regulatory alignment or will the chilling effect of uncertainty persist?
- 08. Dominance and monopolization back to the future?
- 09. Antitrust investigations uptick in enforcement with tougher powers and increased interagency cooperation
- 10. Cross-border claimant strategies – focused on investigations and litigation
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