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

Life Sciences weekly highlights—11 December 2025

This week's edition of Life Sciences weekly highlights includes analyses of the European Commission’s published Digital Omnibus on AI Regulation Proposal and an MLex analysis of Member States criticisms of planned delays for key EU AI Act duties. Also included, is news that the UK government has reduced the 2026 Voluntary Scheme for Branded Medicines Pricing and Access (VPAG) rebate rate for newer medicines to 14.5% (from 22.9% in 2025) with a total 2026 rebate for newer medicines at 15.5%, the UK and EU welcome the establishment of the world’s first global carbon footprint standards framework for assessing the environmental impact of pharmaceutical products, an EFPIA report highlights governance challenges and the policy actions needed to implement AI regulation across medicines’ lifecycles and the DHSC launched a consultation on proposed changes to give ministers limited powers to set NICE cost-effectiveness thresholds for health technology assessments. Further news included is that Medicines for Europe has called for urgent drug pricing reform to address antibiotic shortages caused by low national price caps of off-patent antibiotics despite increasing production costs, the BIA has called for a new pathway to improve UK patient access to rare disease medicines, the EMA updated its guidance on stepwise paediatric investigation plans (sPIPs), MedTech Europe supports the Commission’s proposal for a European Competitiveness Fund to support scaling up innovative digital health tech and the ASA has upheld a series of complaints in its crackdown on online advertising for food supplements claiming to alleviate medical conditions or diseases, among other stories.

Commission launches consultation on European Health Data Space Board operations

The European Commission has published a draft implementing regulation establishing the operational framework for the European Health Data Space (EHDS) Board under Regulation (EU) 2025/327. The draft sets out the Board’s governance arrangements, its cooperation with the eHealth Network during the transition period, and the actions it may take to ensure consistent application of the EHDS rules. These include issuing technical implementation guides, non-binding guidelines, and other written contributions to support the exchange and use of electronic health data, as well as facilitating cooperation, peer learning, and the sharing of best practices among Member States, the Commission, and invited bodies.

EFPIA endorses PAS 2090:2025 pharmaceutical carbon footprint assessment standard

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has endorsed PAS 2090:2025, published on 30 November 2025, as the most robust approach for harmonised Product Carbon Footprint (PCF) frameworks for pharmaceuticals. The specification, sponsored by NHS England, the Office for Life Sciences (OLS) and the Pharmaceutical LCA Consortium, represents the first publicly available standard establishing harmonised, internationally applicable Product Category Rules for Life Cycle Assessments (LCAs) and PCFs of pharmaceutical products. PAS 2090 sets requirements for data quality, methodological consistency and transparent reporting to address the previous absence of pharmaceutical-specific standards that had led to divergent methodologies and inconsistent results across the sector. EFPIA member companies have committed to collaborate with stakeholders and global authorities to implement the framework, with the organisation acknowledging stakeholder interest in product environmental data to support climate goals.

ABPI announces 2026 VPAG payment rate reduction to 14.5% for newer medicines

The Association of the British Pharmaceutical Industry (ABPI) has announced that the government has set the 2026 payment rate for newer medicines under the Voluntary Scheme for Branded Medicines Pricing and Access (VPAG) at 14.5%, down from 22.9% in 2025. This decline reflects slower growth in NHS use of newer medicines during 2025, meaning the rate calculated under the existing VPAG formula fell below the 15% ceiling agreed in the recent UK–US trade deal. Payment rates for older branded medicines will remain between 10% and 35%, and companies will continue to pay a further 1% voluntary contribution to support investment in UK life sciences infrastructure, bringing the total 2026 rebate for newer medicines to 15.5%.