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—13 November 2025

This week's edition of Life Sciences weekly highlights includes analysis on the UK High Court’s decision arising from a tax scheme dispute linked to an early-stage pharmaceutical business (Nemaura Pharma) and involving a claim for misuse of confidential information brought against a company and three of its directors. Also included is news that the European Commission has launched a pilot programme for the co-ordinated assessment of medical device clinical investigations, enabling a single application process for multinational studies to streamline regulatory processes, MedTech Europe has published a position paper calling for a more pragmatic, risk-based approach to post-market clinical follow-up requirements under the Medical Devices Regulation (MDR), the MHRA has announced the closure of its RegulatoryConnect programme to develop a central portal for tracking regulatory assessments, and has published an international study revealing significant variability in global microbiome research methods, as well as news that the NHS Health Research Authority (HRA) has launched a consultation on proposed changes to the model Clinical Trial Agreement (mCTA) and the Association of the British Pharmaceutical Industry (ABPI) has published its pre-Budget submission urging the government to reform NICE’s cost-effectiveness thresholds and the Voluntary Scheme for Branded Medicines Pricing, Access, and Growth (VPAG) rebate system to address declining life sciences investment.

MHRA launches pilot fee waiver programme for small medical device clinical investigations

The Medicines and Healthcare products Regulatory Agency (MHRA) announced its pilot programme offering clinical investigation application fee waivers to micro and small UK enterprises developing innovative medical devices. The programme, running from 4 January 2026 to 31 March 2026, provides ten waivers for Class I, IIa, or Class IIb applications. Eligible devices must be new or represent novel modifications with no existing UK-approved solution for the same clinical need, and they must demonstrate scalability potential. To qualify, applicants must obtain MHRA small enterprise status and include specific documentation in their cover letter that confirms their eligibility and explains how their device meets the innovation criteria.

Court of Appeal clarifies the approach to confidentiality and corrections in FRAND litigation (InterDigital Inc and other companies v Optis Cellular Technology LLC and others)

Information Law analysis: This Court of Appeal decision clarifies the approach of UK courts to confidentiality in patent litigation, in particular FRAND cases. Significantly, this judgment recognises the rights of affected non‑parties (eg third party licensees) to be heard by courts on issues of confidentiality. The court clarified the broad scope of confidential information which may qualify for redaction and made clear that licence age or expiry does not automatically negate its commercial value and need for protection. Such information should be eligible for protection, provided that the balancing test can show likely commercial harm resulting from disclosure. A further clarification made by the court was the correct approach for determining the scope of redactions: a single legal test involving a fact‑sensitive balancing exercise between open justice and the risk of real commercial harm. The judgment also addressed corrections of factual errors post‑judgment, confirming that ‘slip‑rule’-based correction requests may be granted in the absence of unanimous party agreement and where the changes involve targeted deletion or substitutions which does not require rewriting of the judgment’s substantive conclusions. Written by Marija Nonkovic, associate at Kemp IT Law LLP.

EFPIA and Vaccines Europe urge EU to adopt innovation-led EU Biotech Act to boost Europe’s global competitiveness

EFPIA and Vaccines Europe (VE) have urged the European Commission to ensure that the forthcoming EU Biotech Act delivers clear, predictable and supportive legislation to strengthen Europe’s competitiveness, attract global investment, and reverse the decline in research, innovation and clinical trials.