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United Kingdom
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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...
Definitions—overview
This subtopic focuses on definitions in the context of drafting for contracts.
For guidance on boilerplate clauses in business-to-business arrangements, see: Boilerplate clauses-overview. For boilerplate in business-to-consumer contracts, see Practice Notes: Boilerplate clauses in business-to-consumer contracts-general principles and Boilerplate clauses in business-to-consumer contracts-specific clauses. For commercial clauses for business-to-business contracts, see: Commercial clauses-overview. The definitions and interpretation section of an agreement ought to set out every individual defined term used in the agreement, together with all provisions that govern the general interpretation of the agreement and, where necessary, of specific phrases used with it. Usually, the defined terms and the interpretative provisions are set out in two distinct sub-clauses. Defined expressions are listed in one, and interpretation provisions appear in another. The definitions and interpretation clause will usually...
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