Competition in life sciences

Copyright © 2025 LexisNexis

Competition enforcement in life sciences

Competition law applies to the life sciences sector and a distinct type of regulatory action that may be taken by competition authorities against companies operating in the sector, especially pharmaceutical companies, for competition law infringement.

Practice Note: Competition law in the pharmaceutical sector covers the application of EU and UK competition law to common practices that take place within the pharmaceutical sector. After explaining the definition of market as it applies to the sector, it considers reverse payment patent settlements, pricing strategy, parallel trade, misleading conduct, misuse of regulatory procedures, research and development (R&D) collaboration agreements as well as mergers and acquisitions (M&A).

Article 102 of the Treaty on the Functioning of the European Union (TFEU) prohibits undertakings that (individually or collectively) hold a dominant position within the EU or a substantial part of it from abusing their dominance (without objective justification) insofar as it may affect trade between Member States. The provision is mirrored in the national competition legislation; in the UK, for example, in section 18 of the Competition Act 1998 (CA 1998). For more information on the

To view the latest version of this document and thousands of others like it, sign-in with LexisNexis or register for a free trial.

Existing user? Sign-in TAKE A FREE TRIAL
Powered by Lexis+®
Latest Life Sciences News

EMA annual report presents key highlights on evaluation and monitoring of medicines

The European Medicines Agency (EMA) has published its 2024 annual report, outlining its evaluation and monitoring activities for human medicines across the EU. Executive Director Emer Cooke confirmed that EMA recommended 114 medicines for authorisation in 2024—the highest number in 15 years—with 46 containing new active substances and 16 intended to treat rare diseases. Notable approvals included treatments for early Alzheimer’s disease, haemophilia B, ALS, and the first adult Chikungunya vaccine. Cancer remained the leading therapeutic area, with 28 recommendations, including biosimilars addressing various oncological and immunological conditions.

MHRA launches digital hub in Leeds to boost healthcare innovation

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a new digital hub in Leeds to advance healthcare technology and support regional growth. The MHRA selected Leeds because of its strong digital health expertise, robust academic base, and thriving technology community. The hub will be located at Wellington Place in Leeds city centre and aims to enhance regulatory agility and strengthen collaboration with NHS organisations, academic institutions, and digital health networks. The MHRA plans to create approximately 30 highly skilled roles in digital delivery, software development, and data science, with further expansion planned. These roles will be part of the Digital and Technology Group (DTG), which is responsible for optimising infrastructure and ensuring the secure use of data to deliver world-class services, while keeping regulatory processes in step with technological advancements and contributing to improved patient care and public health outcomes.

EMA opens consultation on ICH guideline for pregnant and breastfeeding trial participants

The EMA has published a draft guideline, ICH E21, to promote the inclusion and retention of pregnant and breastfeeding individuals in clinical trials. Developed with global regulators through ICH, the guidance aims to address the lack of safety and efficacy data for this population, who are often excluded from trials despite frequent medicine use. Public consultation runs until 15 September 2025.

Commission seeks views on high-risk AI classification and obligations

The European Commission has launched a public consultation to inform the implementation of the EU AI Act's provisions on high-risk artificial intelligence systems. The consultation, conducted by the Commission, aims to gather practical examples and clarify the application of rules concerning high-risk systems, which include those critical to product safety under EU law and those significantly impacting health, safety, or fundamental rights. The feedback will support the development of Commission guidelines on classifying such systems and specifying corresponding responsibilities along the AI value chain. Stakeholders such as developers, users, public authorities, academia, civil society, and citizens are encouraged to participate. The consultation runs until 18 July 2025.

View Life Sciences by content type :  
News
Practice notes
Precedents
Q&As

Popular documents

If a rentcharge is shown as being informally exonerated on title information, does this apply to the

If a rentcharge is shown as being informally exonerated on title information, does this apply to the current registered owner? Or does the informal exoneration only apply to the parties to the document which informally exonerated the rentcharge?This Q&A considers the situation where, at some

Late payment penalties—inheritance tax

Late payment penalties—inheritance taxWhile interest often accrues on overdue tax, the late payment of certain taxes may also attract a penalty. For information on the interest accruing on overdue tax, see Practice Notes: IHT—payment deadlines on death—Interest on IHT and Interest on late paid

Contributory negligence in personal injury claims

Contributory negligence in personal injury claimsContributory negligence is a partial defence which can lead to a discount in damages.Other defences may also be relevant. See Practice Notes: Did the claimant consent to the risk of injury? and Was the claimant involved in an illegal activity?If a

Template for regulatory references given by SMCR firms and disclosure requirements

Template for regulatory references given by SMCR firms and disclosure requirements[Insert addressee details]Dear [insert name][It is our understanding that [insert name of prospective employee] [was an employee of yours between the dates of [insert dates as appropriate] OR is a current employee of
If a rentcharge is shown as being informally exonerated on title information, does this apply to the

If a rentcharge is shown as being informally exonerated on title information, does this apply to the

If a rentcharge is shown as being informally exonerated on title information, does this apply to the current registered owner? Or does the informal exoneration only apply to the parties to the document which informally exonerated the rentcharge?This Q&A considers the situation where, at some

Late payment penalties—inheritance tax

Late payment penalties—inheritance tax

Late payment penalties—inheritance taxWhile interest often accrues on overdue tax, the late payment of certain taxes may also attract a penalty. For information on the interest accruing on overdue tax, see Practice Notes: IHT—payment deadlines on death—Interest on IHT and Interest on late paid

Contributory negligence in personal injury claims

Contributory negligence in personal injury claims

Contributory negligence in personal injury claimsContributory negligence is a partial defence which can lead to a discount in damages.Other defences may also be relevant. See Practice Notes: Did the claimant consent to the risk of injury? and Was the claimant involved in an illegal activity?If a

Template for regulatory references given by SMCR firms and disclosure requirements

Template for regulatory references given by SMCR firms and disclosure requirements

Template for regulatory references given by SMCR firms and disclosure requirements[Insert addressee details]Dear [insert name][It is our understanding that [insert name of prospective employee] [was an employee of yours between the dates of [insert dates as appropriate] OR is a current employee of