7th November 2025 Update

Advertising

UK

• The Medicines and Healthcare products Regulatory Agency (MHRA) has published decisions of investigations following complaints about advertising for licensed medicines for October 2025. See here for further information.

Artificial Intelligence (AI)

EU

• At the European AI in Science Summit on 3^rd November, the European Commission launched a new initiative called Resource for AI Science in Europe. The new initiative will bring together essential resources for developing AI with the aim of driving transformative scientific breakthroughs, such as improving cancer treatments. See here for further information.
• The European Commission has launched work on a code of practice on the marking and labelling of AI generated content. The obligations on transparency of AI generated content become law in August 2026. See European Commission press release for further information.
• The European Data Protection Supervisor (EDPS) has published revised and updated guidelines on the use of generative AI. See press release and guidelines for further information.

Clinical Trials

UK

• The Health Research Authority (HRA) has published a blog article on the countdown to the UK clinical trials regulations coming into force in six months’ time. See here for further information.

Competition Law

France

• The French competition authority has imposed a fine of more than EUR 4.5 million on a telemedicine firm, Doctolib, on account of its abusive conduct. Doctolib was held to have a dominant position in two markets and its practices, tying healthcare professionals to its services and acquiring the only other competitor in the market, were deemed abusive. See press release of the French competition authority for further information.

UK

• The Competition and Markets Authority (CMA) has published its updated mergers guidance on jurisdiction and procedure and updated merger notice template. It has also made corresponding changes to its guidance on the mergers intelligence function
• The CMA has updated its guidance on the principles and process of applying for leniency and no-action in cartel cases. See here for further information.

Data Privacy

EU

• The Court of Justice of the European Union (CJEU) has published the Advocate General’s Opinion on whether there is a right to the protection of personal information in competition investigations. The Opinion makes clear that compliance with the right to the protection of personal data does not require prior authorisation by a judicial authority in competition investigations. See CJEU press release for further information.

UK

• The Information Commissioner’s Office (ICO) has opened a consultation to call for views on enforcement procedure guidance. The consultation will be open until 23 January 2026. See here and here for further information, including how to provide feedback.

Intellectual Property

EU

• The EU Intellectual Property Office (EUIPO) has launched a new AI powered pre-assessment tool to screen trade marks before filing. See EUIPO press release for further information.
• The European Patent Office (EPO) Board of Appeal has found that an invention must be sufficiently disclosed at the priority date for a valid priority claim. It determined that a mere study protocol without supporting data proving the technical effect was deemed insufficient, even if the eventual patent was saved on the basis of inventive step grounds. See EPO Decision T0883/23

Market Access

EU

• The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published a blog article with reflections on the new EU HTA Scoping guidance and PICO exercises. See EFPIA blog article for further information.

UK

• The Association of the British Pharmaceutical Industry (ABPI) has published an article detailing the findings of a report by IQVIA, which shows how the UK’s spending on medicines compares internationally. See here for further information, including link to the report.
• The ABPI and the government have agreed a further two-week extension to the deadline by which companies must give notice if they intend to leave the 2024 voluntary scheme for branded medicines pricing, access and growth (VPAG). See ABPI press release for further information.

Regulatory

UK

• The MHRA has announced major reforms to accelerate the development and approval of rare disease treatments, aiming to address the significant unmet needs of people affected. Central to these changes is the adoption of innovative approaches, including the use of gene-based therapies such as CRISPR. See MHRA press release for further information.
• The MHRA has updated its regulatory guidance on therapeutic use of bacteriophages in the UK. See updated guidance here for further information.

Research and Development

UK

• The UK government has announced a £55 billion research and development funding boost for science and technology breakthroughs. The Department for Science Innovation and Technology (DSIT) announced the funding allocations for the UK’s research agencies and bodies. Further information will be published later in the year on the outcomes the funding will support. See DSIT press release for further information.
• The UK government has announced that Scottish patients will be placed at the heart of a multi-million pound government funded study of weight loss medicines. See DSIT press release for further information.

Veterinary Medicines

EU

• The European Commission has published implementing regulations on Good Manufacturing Practice for veterinary medicine products and active substances. See Commission Implementing Regulation 2025/2154 and Commission Implementing Regulation 2025/2091 for further information.