United Kingdom: Life Sciences, Biotechnology & Nanotechnology

The UK's medicines regulator is proposing fundamental changes to how gene therapy products are defined, shifting from origin-based classifications to mechanism-driven frameworks. This consultation raises critical questions about where regulatory boundaries will be drawn for synthetic biology, genome editing platforms, and engineered cell therapies as biotechnology advances beyond traditional biological manufacturing.

Artificial intelligence is transforming how pharmaceutical companies identify new therapeutic uses for existing drugs, but this acceleration creates complex intellectual property challenges. As computational methods rapidly generate repurposing candidates, innovators must navigate the tension between filing early to secure priority and waiting for sufficient validation data, while ensuring their second medical use patents provide meaningful commercial protection in an increasingly competitive landscape.

Launching a product while a patent dispute remains unresolved has never been risk‑free, but many companies have taken the view that the commercial upside justified it.

The European Data Protection Board has published draft guidelines clarifying how the GDPR applies to scientific research, addressing longstanding uncertainties around data processing flexibilities, consent models, and compliance requirements. These guidelines establish six key factors for qualifying as genuine scientific research and outline when organisations can benefit from research-specific derogations under EU data protection law.

Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments...

Assays used in clinical trials vary widely in complexity and regulatory status.. They may be fully developed and marketed as in vitro diagnostic medical devices (IVDs), including companion diagnostics (CDx)...

The Data (Use and Access) Act 2025 ("DUAA") represents the UK's first major reform of data protection law since leaving the EU.

The Law Commission, an independent organisation established to keep the law of England & Wales under review and recommend reform, has announced a review of the law in relation to liability for defective products.

European real estate investors are preparing for more activity in 2026, with an acceptance that macro headwinds are now risk-allocated like any other underwriting consideration.