15th July 2026 Update

Advertising

UK

• The Medicines and Healthcare products Regulatory Agency (MHRA) has published May decisions made by it following investigations into advertising reported to have breached the legislation on advertising medicines. See here for further information.
  
  

Artificial Intelligence (AI)

EU

• • The European Commission has published the Code of Practice on marking and labelling of AI-generated content. See European Commission press release and Code of Practice for further information.

• • The European Commission has appointed a scientific panel and advisory forum to support enforcement of the EU AI Act. See European Commission press release for further information.
  • The European Commission is running a stakeholder survey to map how AI is used across healthcare and pharmaceuticals. The survey is open for responses until 26 June 2026. See here for further information, including how to respond to the survey.
  • MedTech Europe has published its response to the European Commission’s provisional agreement on the Digital Omnibus on AI. See MedTech press release for further information.
  • The International Medical Device Regulators Forum (IMDRF) has opened a public consultation on its draft Technical Framework for Artificial Intelligence Life Cycle Management Document (Document N93). The consultation is open until 10 July 2026. See here for further information, including how to respond to the consultation.

UK

• • The MHRA has published two reports following a public consultation undertaken to inform future rules on how AI can be used safely in healthcare. See MHRA press release for further information, which includes links to the Research and Engagement Report and findings from the Call for Evidence.
  • The MHRA has launched an AI sandbox to give researchers and companies a controlled testing environment to work with regulators to explore how AI tools could be used to better understand medicines safety and predict potential side effects. See MHRA press release for further information.
  • The MHRA in partnership with NHS England and the London Health Innovation networks has announced a new regulatory sandbox to test AI-enabled medical devices. See here for further information.
  • The MHRA has published the recording of the National AI Commission Ask Me Anything event on the future regulation of AI in healthcare. See here for further information, including link to the recording.
  • The MHRA’s AI Airlock sandbox phase 2 programme report has been published. The report also summarises the key technical and regulatory insights and recommendations for changes to the regulatory and support framework for AI as a medical device. See here for further information.
  • The Department for Science Innovation and Technology (DSIT) has published the AI Adoption Plan: Life Sciences, setting out recommendations from the AI Champions, to accelerate AI adoption in the life sciences sector. See here for further information. See also here for further information on the interim government response to recommendations set out in the sector AI Adoption Plans and here for further information on the recent AI Adoption Summit.
  • Science Minister Lord Vallance delivered a speech to London Tech Week on 9^th June. See transcript of his speech here. See also press release from the London Tech Week event for further information.
  • The UK Government has launched a new AI growth project to fast-track innovation. Legal services have been chosen as the first sector for the advisory Growth Lab. The Solicitors Regulation Authority (SRA) has joined the newly announced Advisory AI Growth Lab. See Ministry of Justice press release, SRA press release and Information Commissioner’s Office (ICO) press release for further information.

   

Animal Testing

EU

• The European Commission has presented a roadmap for the phasing out of animal testing for chemical safety assessments. See European Commission press release for further information. See also European Federation of Pharmaceutical Industries and Associations (EFPIA) response for further information.
  
  

Biotech Act

EU

• EFPIA has set out its position on the Biotech Act, including a comprehensive impact assessment on the European Commission’s proposals. See EFPIA press release for further information.
  

Clinical Trials

UK

• The MHRA has updated its Guidance Clinical trials for medicines: modifying a clinical trial approval. See here for further information.
  
  

Competition Law

Italy

• The Italian competition authority is investigating Biogen and its Italian subsidiary for allegedly abusing its dominant position to protect its multiple sclerosis drug from cheaper biosimilar competition. See here for further information.
  

UK

• The Competition and Markets Authority (CMA) is consulting on draft revised guidance on its approach to assessing rivalry-enhancing efficiencies in mergers. The consultation is open until 1 July 2026. See here for further information.

Cybersecurity

EU

• The European Union Agency for Cybersecurity (ENISA) has published its NIS360 report showing cybersecurity maturity of EU critical sectors under the NIS2 Directive. See here for further information.

Data Privacy

EU

• The European Data Protection Board (EDPB) has published for consultation the template for personal data breach notification. The consultation is open until 5 August 2026. See here for further information.

France

• The French data protection authority, CNIL, has fined IQVIA €5 million for health data violations. See CNIL press release for further information.
  
  

Market Access

UK

• Following consultation, The Department of Health and Social Care (DHSC) has announced it is cutting the headline payment for newer branded medicines to 16.5 % from July. See consultation outcome here for further information.
  
  

Medical Devices

EU

• The Court of Justice of the European Union (CJEU) has defined the limits of distributors’ due care obligations under the Medical Devices Regulation. See judgement in C-10/24 for further information.
  
  

Policy, Strategy and Trade

International

• The International Federation of Pharmaceutical Industries and Associations (IFPMA) has called on the G7 to invest in pharmaceutical innovation to drive competitiveness. See IFPMA press release for further information.

EU

• • The United States Trade Representative (USTR) has placed the EU on the 2026 Special 301 Watch List (page 83) for failure to give adequate protection to innovative medicines. See 2026 Special 301 Report for further information.
  • The Central and Eastern Europe (CEE) Patient Engagement Community representing patient organisations and national trade associations across 12 countries has set out five priority actions to improve investment and outcomes across CEE countries. See EFPIA press release for further information.
  • The final version of the European Union Framework for Science Diplomacy was adopted by the European Council on 29 May 2026. See here for further information.

UK

• The UK Government has announced £20 million to improve prostate cancer research and treatment. See DHSC press release for further information.
  

Procurement

UK

• The DHSC has published guidance for NHS procurement professionals to assess non-financial value when buying medical technology. See Guidance for further information.
  
  

Regulatory

EU

• The European Medicines Agency (EMA) has published its Annual Report for 2025. See here for further information.
• The EMA has published its Human Medicines Highlights for June, setting out details of new information on approved medicines and new medicines recommended for approval. See here for further information.