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UK and EU life sciences weekly regulatory update: data protection (Digital Omnibus), R&D (Budget), IP (SPC waiver), medical devices (MHRA/EU), pharmaceuticals (EMA/EU4Health), advertising—27 November 2025

Published on: 27 November 2025

Published by a LexisNexis Life Sciences expert
Legal News
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Article summary

In this issue:

  • Data protection and life sciences
  • Research and development
  • Intellectual property
  • Medical devices
  • Pharmaceuticals—regulatory framework
  • Advertising of medicines
  • Daily and weekly news alerts
  • New and updated content
  • Trackers
  • Useful information

Data protection and life sciences

Digital Omnibus proposal—re-writing the EU’s digital rulebook

In recent years, the EU has introduced digital laws at almost the same speed as the technologies they are intended to govern have evolved. Worries about excessive regulation and rules that overlap or even clash have prompted the European Commission to reconsider its strategy and seek to lighten the load of digital compliance. On 19 November 2025, the Commission unveiled its Digital Omnibus proposal. It sets out two principal proposals: the first delivers ‘quick fixes’ to address several pressure points in the EU AI Act; the second, a more extensive package, updates the data acquis—most prominently the EU General Data Protection Regulation (EU GDPR), the ePrivacy Directive and the EU Data Act. Authored by Debbie Heywood and Alexander Schmalenberger of Taylor Wessing. See News Analysis: Digital Omnibus proposal—re-writing the EU's digital rulebook...

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