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United Kingdom
NEWS
HRA 2026–28 AI plan for UK health research: when activities require review, lawful data use for recruitment, and consistent, rigorous ethics oversight
The Health Research Authority (HRA) has unveiled its 2026–28 strategy, outlining how it will support AI use across health and social care research, whilst ensuring suitable protections and safeguards are appropriately maintained......
NEWS
Revised ACT EU 2026–27 workplan: regulatory priorities for EU clinical trials covering CTR operation, public health emergencies, patient involvement, inclusive access, analytics, training and timely submission of results
The European Medicines Agency (EMA), the European Commission, and the Heads of Medicines Agencies (HMA)-the collective bodies behind the Accelerating Clinical Trials in the EU (ACT EU) initiative-unveiled an updated ACT EU workplan......
NEWS
UK and EU life sciences regulatory update: MHRA rare disease framework consultation, EU Biotech Act developments, medical devices reforms, wastewater EPR referral, global health resilience, MHRA-NICE RWE guidance
In this issue: Pharmaceuticals-regulatory framework Medical devices Research and development Daily and weekly news alerts New and updated content Trackers and horizon scanning Useful information Pharmaceuticals-regulatory framework MHRA launches consultation on draft rare disease therapies framework The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation on a draft Rare Disease Therapies Regulatory Framework. The plans would establish an Investigational Marketing Authorisation to permit controlled early access to rare disease treatments while further clinical and real‑world data are collected. The consultation closes on 30 July 2026. See: LNB News 21/05/2026 31. Commission publishes analysis proposing Biotech Act measures The European Commission has issued a staff working document outlining the analysis supporting its proposed Biotech Act, first unveiled in December 2025. Aimed at reinforcing Europe’s biotechnology and biomanufacturing base, with a strong emphasis on health, the Act intends to...
NEWS
NDAs after the Victims and Courts Act 2026: voiding clauses that restrict disclosures of criminal conduct or responses, interaction with the iniquity rule, and drafting steps for commercial agreements
Section 6 of the Victims and Prisoners Act 2024 supersedes VPA 2024, s 17, scrapping the prior constraint that protected disclosures had to be made to particular recipients for specified purposes. Any term in any agreement, including commercial non-disclosure agreements (NDAs), is void to the extent it seeks to stop a victim, or someone who reasonably believes they are a victim, from revealing relevant criminal conduct-or the counterparty’s reaction to it-to anyone, for any purpose. The new provision binds the Crown, subject only to a tightly drawn national security exception. This analysis examines how these reforms align with existing common law limits on confidentiality and their consequences for standard commercial NDA templates. It is written by Richard Hanstock, a barrister at Cornerstone Barristers and the founder of Deeptech Legal, an SRA-authorised firm specialising in cybersecurity, artificial intelligence, defence technology and national security...
Disputes and regulatory enforcement—overview
Regulatory enforcement and actions against regulators
The life sciences sector’s stringent regulatory framework gives rise to a wide array of enforcement measures whenever the exacting rules governing the field are breached or otherwise not complied with. Equally, entities impacted by determinations made by the authorities overseeing the industry may seek to challenge those outcomes. Options for regulatory enforcement, as well as avenues to contest decisions taken by regulators, exist at both UK and EU level, subject to the nature of the dispute in question and the specific circumstances involved.
Disputes arising out of the EMA’s approach to transparency
Article 15 of the Treaty on the Functioning of the European Union (TFEU) obliges EU institutions, bodies, offices and agencies to operate as openly and transparently as possible in their work and broadens the public’s right of access to documents held by all Union institutions, bodies, offices and agencies. This is commonly known as the principle of transparency. Institutions may advance transparency by publicly disclosing documents or information on request (reactive disclosure), or by releasing material of their own accord, predominantly through publication on their websites (proactive disclosure). Within the EU, the European Medicines Agency (EMA) serves as the regulatory body responsible...
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