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Life sciences regulatory update: NICE cost-effectiveness threshold direction, rare diseases action plan, device reforms, Cyber Resilience Act guidance, diagnostic reference levels, HRA information governance pilot, and EPR wastewater obligations

Published on: 05 March 2026

Published by a LexisNexis Life Sciences expert
Legal News
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In this issue:

  • Commercialisation
  • Pharmaceuticals—regulatory framework
  • Medical devices
  • Data protection
  • Research and development
  • LexTalk® Life Sciences: a Lexis®Nexis community
  • Daily and weekly news alerts
  • Useful information

Commercialisation

DHSC publishes response to NICE cost-effectiveness threshold consultation

The DHSC has issued its reply to the consultation on proposed changes to the National Institute for Health and Care Excellence (NICE) rules on cost-effectiveness thresholds. Released alongside the National Institute for Health and Care Excellence (Amendment) Regulations 2026 and the accompanying explanatory memorandum, the amendments give ministers a narrow power of direction to set the standard cost-effectiveness threshold applied by NICE when preparing guidance, including technology appraisals and evaluations of highly specialised technologies. The revisions also remove the need for NICE to consult on procedural changes arising from ministerial directions. These measures will take effect on 24 March 2026. See: LNB News 04/03/2026 49.

Pharmaceuticals—regulatory framework

DHSC publishes fifth England Rare Diseases Action Plan 2026

The Department of Health and Social Care has released the England Rare Diseases Action Plan 2026, detailing progress under the UK Rare Diseases Framework and setting out priorities ahead of its extension to January 2027...

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