Competition in life sciences

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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

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Latest Life Sciences News

Life Sciences weekly highlights—6 November 2025

This week's edition of Life Sciences weekly highlights includes news that the MHRA plans to overhaul rare disease regulation, the EFPIA and eight other healthcare associations raised concerns that the European Chemicals Agency (ECHA) will not conduct individual sector assessments for medicines as part of its proposed universal restriction on PFAS chemicals, the EMA launches a new Combination Products Operational Group (COMBO), MedTech Europe submitted a critical response to the EU consultation on Regulation (EU) 2024/1157 harmonising the classification of certain waste types for cross-border shipment, and MedTech Europe and other trade bodies called on the European Commission and EU legislators to permit non-essential information about medical devices to be provided by digital label. Also included, is news that the Commission published a comprehensive package of updated clinical trials guidance, the Notified Body trade group unanimously adopted a comprehensive position paper to identify significant changes affecting companion diagnostic devices, and the EU Pharma industry calls for greater HTA clarification in supporting guidance to implement Joint Clinical Assessments of medicines, among other stories.

ASA rulings—5 November 2025

One complaint was received by the Advertising Standards Authority (ASA) about advertisements by On The Beach Ltd concerning claims that customers booking certain holidays would receive free airport lounge access. The ASA upheld the complaint.

MHRA publishes policy paper on regulatory approach to rare disease therapies

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a policy paper outlining proposals for a new regulatory framework to support the development and approval of rare disease therapies. Developed in collaboration with the newly formed Rare Disease Consortium, the framework is expected to be finalised in 2026, following a public consultation planned for early 2026.

Calls to reform medical device legislation to permit non-essential information via a digital label

MedTech Europe and other trade bodies have called on the European Commission and EU legislators to revise the medical device legislation currently under review to permit additional non-essential information about medical devices to be provided by digital label, such as for the importer and authorised representative information. Ultimately, the position paper endorses that all medical device information that is not essential for the device's safe use should be provided in a digital format pending the outcome of the IHI Call 10 Digital label project

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