Disputes and regulatory enforcement

Regulatory enforcement and actions against regulators

The highly regulated nature of the life sciences industry gives rise to the potential for a myriad of regulatory enforcement action for breach of the strict rules governing the sector. Similarly, organisations affected by decisions taken by the regulators responsible for regulating the sector may also wish to take action against those decisions. Regulatory enforcement and action against regulators is possible at both at UK and EU level, depending on the nature of the issue in dispute.

Disputes arising out of the EMA’s approach to transparency

Article 15 of the Treaty on the Functioning of the European Union (TFEU) requires EU institutions, bodies, offices, and agencies to conduct their work as openly as possible and extends the public right of access to documents of all the Union institutions, bodies, offices and agencies. This is often referred to as the principle of transparency. Transparency can be pursued by institutions either by granting access to documents or information upon request (reactive disclosure) or by making documents and information publicly available on their own motion, mainly by publishing it on their websites (proactive disclosure).

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Latest Life Sciences News

Commission publishes updated clinical trials guidance package

The European Commission's Directorate-General for Health and Food Safety has published a comprehensive package of updated clinical trials guidance documents, all endorsed by the Clinical Trials Coordination and Advisory Group (CTAG) on 15 October 2025. The package includes new recommendations on criteria for selecting a reporting Member State under Article 85(2)(c) of the Clinical Trials Regulation, establishing a workshare criterion when proposed reporting Member States decline the role, which occurs in approximately 30% of applications. The Commission has updated its recommendation paper on decentralised elements in clinical trials (Version 02), superseding the December 2022 version, with revised national provision overviews and guidance on informed consent, investigational medicinal product delivery, and remote monitoring. A new recommendation paper addresses frequent issues identified during Part I and Part II assessments, based on feedback from national competent authorities and ethics committees, covering investigational medicinal product dossiers, protocols, and safety reporting. The package also includes revised guidance on auxiliary medicinal products, effective 1 December 2025 for new applications, featuring an updated classification system distinguishing between authorised, modified authorised, and unauthorised auxiliary medicinal products with corresponding application and safety reporting requirements.

Life Sciences weekly highlights—30 October 2025

This week's edition of Life Sciences weekly highlights includes a Law360 analysis of the Court of Justice upholding a €60.5m fine against Teva and Cephalon in a long-running pay-for-delay case involving a generic version of a blockbuster narcolepsy treatment, and an MLex analysis reporting that the European Commission is considering changes to how the EU AI Act applies to products regulated under sector-specific legislation, such as medical devices, as part of a wider digital ‘omnibus’ package expected on 19 November 2025. Also included is news that MedTech Europe has called for EU rules changes to permit electronic instructions for use (eIFUs) for near-patient testing devices, also known as point-of-care (POC) testing, the MHRA announced a new AI-driven project to predict drug interaction side effects, and together with the Health Research Authority (HRA) outlined preparations for clinical trials reform due to take effect from 28 April 2026, including the establishment of an advisory group on simplified arrangements for consent in low intervention clinical trials, the EMA opened a consultation on the use of non-human primates in safety testing and implementation of the 3Rs (replacement, reduction and refinement) principles, as well as news that the Health Economics Methods Advisory (HEMA) has published its first draft report for public comment on the factors that should be considered in health technology assessment (HTA) and the MHRA Criminal Enforcement Unit dismantled the UK’s first major illicit manufacturing facility distributing unlicensed weight loss jabs, among other stories.

Team-NB adopts position paper on IVDR changes to companion diagnostic devices

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MLex: The European Commission is considering changes to how products regulated under EU sectoral product safety laws are covered by the EU’s AI law as part of its wider drive to streamline digital regulations, MLex has learned. The move, which is being considered as part of a digital ‘omnibus’ package due 19 November 2025, could ease obligations for sectors such as medical devices and industrial machinery.