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

AI developers, users to see guidelines on EU AI Act interplay after legal deadline

MLex: The European Commission will issue guidelines on how the EU AI Act interacts with other EU laws such as the EU GDPR, product safety legislation, platform regulations and copyright rules only around the third quarter of 2026—meaning just before or just after the law’s high-risk obligations will take effect. The delay adds pressure on the commission as it weighs whether to pause the EU AI Act’s high-risk requirements.

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Life Sciences weekly highlights—9 October 2025

This week's edition of Life Sciences weekly highlights includes analysis by Taylor Wessing LLP of damages quantification methodologies in the long-running Merck v Merck Sharpe & Dohme trade mark infringement case. Also included, is several stories covering the European Commission announcing its bold Apply AI and AI in Science strategies to advance the adoption of AI in scientific research, the Commission also has launched the AI Act Service Desk and Single Information Platform to support implementation of the AI Act, the EMA has launched a survey to identify key research priorities for AI in the development and evaluation of medicines and published its European Medicines Agencies Network Data Strategy, MedTech Europe published a reflection paper responding to the Commission’s Chemicals Industry Action Plan calling for realistic transition pathways and continued access to essential chemicals like PFAS in their downstream use for critical medical technologies and the DHSC launched a consultation to shape new regulations on the sale and composition of tobacco, vape and nicotine products. Further news includes stories that the British health technology industry body (ABHI) published its response to an EU consultation on proposed revisions to the EU medical device legislation, the EU pharmaceutical industry called for refinement of certain provisions in the EU’s General Pharmaceutical Legislation reform package, the UK High Court found that the DHSC was still entitled to some damages for Medpro’s breach of contract despite the DHSC failing to reject the PPE gowns within time, the MHRA halved clinical trial approval times to 41 days following regulatory reforms and digital platforms introduced in 2023, and the Commission has formally withdrawn the AI Liability Act; among other stories.

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