12th September 2025 Update

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UK

• The Prescription Medicines Code of Practice Authority (PMCPA) has published new Guidance on clauses 3.1 and 11 of the Code of Practice, covering activities conducted by medical, science liaisons (MSLs), legitimate exchange of scientific and medical information during the development of a medicine and advance budgetary notifications. See here for further information on the Guidance.

Artificial Intelligence (AI)

EU

• The European Commission has launched a public consultation to create guidelines and a voluntary Code of Practice for AI transparency, under the EU Artificial Intelligence Act (AI Act). See here for further information including how to contribute to the consultation.

UK

• The Department of Science, Innovation and Technology (DSIT) has published a policy paper on a trusted third-party AI assurance roadmap, which aims to ensure the trusted adoption of AI across the UK. See here for further information.

Clinical Trials

UK

• The Health Research Authority (HRA) has announced an online event on Thursday 2 October to support researchers to provide good quality feedback to participants of clinical trials and explain the new research transparency regulations which come into force in April 2026. See here for further information, including how to register for the webinar.

Competition Law

Belgium

• The Belgium Competition Authority (BCA) has published new guidelines for pharmaceutical firms that seek to exchange information for the purposes of applying for the reimbursement of a combination therapy, where the marketing authorisations are held by different companies. See here for further information.

EU

• The European Commission has launched a public consultation to invite comments on draft revised competition law rules for technology transfer agreements. The consultation on the draft revised Technology Transfer Block Exemption Regulation is open until 23 October 2025. See European Commission press release for further information.

France

• The French Supreme Court has annulled the judgement of the Paris Court of Appeal and reinstated fines of Euros 444 million on Novartis, Roche and Genentech imposed by the National Competition Authority for abuse of dominance. See decision of the French Cour de cassation (in French) for further information.

UK

• The Competition and Markets Authority (CMA) has published new guidance on competition law considerations when recruiting workers and setting pay and other working conditions. See Guidance for further information.

Critical Medicines

EU

• The European Commission has published a document summarising evidence supporting the legislative proposal for strengthening the availability, supply and production of critical medicines within the EU. See here for further information.

Global

• The World Health Organisation (WHO) has released updated editions of its Model Lists of Essential Medicines and Essential Medicines for Children, adding new treatments for various types of cancer and for diabetes with associated comorbidities such as obesity. Medicines for cystic fibrosis, psoriasis, haemophilia and blood-related disorders are among the other additions. See WHO press release for further information.

Data Privacy

EU

• The Court of Justice of the European Union (CJEU) has clarified the scope of the concept of personal data in the context of a transfer of pseudonymised data to third parties. See Judgement of the CJEU for further information.

• The European General Court has confirmed the validity of the EU-US data privacy framework. See Judgement of the General Court in Case T-553/23 for further information.

• The European Commission has drafted an adequacy decision for Brazil, recognising its data protection framework as equivalent to the EU’s GDPR. See here for further information.

UK

• The Information Commissioner’s Office (ICO) has opened a consultation on how it handles data protection complaints. The consultation is open until 31 October 2025. See here for further information, including how to respond to the consultation.

• The ICO has published final guidance on encryption. See here for further information.

Intellectual Property

EU

• The Unified Patent Court (UPC) Court of Appeal has confirmed a ‘lowered’ test for imminent infringement in Boehringer Ingelheim v Zentiva UPC_CFI_41/2025 reversing a previous decision of the Lisbon Local Division from May 2025 in which that court considered that there wasn’t a likelihood of imminent infringement and set a high bar to stop generic market entry. The Court of Appeal has set out the legal standard and confirmed that imminent infringement may be present when the potential infringer has set the stage for infringement to occur, but marketing authorisation and grant alone are not sufficient for that.

UK

• The High Court has dismissed Dr Thaler’s appeal against a UKIPO decision and confirmed that Dr Thaler could not now claim to be the inventor of the inventions that he previously claimed were actually invented by the AI machine, DABUS. The decision follows a number of challenges by Dr Thaler around whether an AI system can be credited with a patent invention, including the landmark Supreme Court decision in December 2023, which confirmed that only humans can be named as an inventor of a patent, not an AI system. The latest High Court judgement can be accessed here

Market Access

UK

• The National Institute for Health and Care Excellence (NICE) has announced new draft guidelines for the treatment of type-2 diabetes, moving away from a one-case-fits-all approach to treatment. See NICE press release for further information.

Medical Devices

EU

• The European Commission has published a call for evidence seeking input on the targeted revision of the rules for medical devices and in vitro diagnostics to simplify the regulatory framework. The current call for feedback follows on from the previous consultation and is open until 6 October 2025. See here for further information.

UK

• The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance to provide information and recommendations for manufacturers on the preparation and presentation of a post market surveillance report (PMSR). See guidance for further information.

• The MHRA has opened a call for evidence on the use of designated standards for medical devices and in vitro diagnostic devices. The call for evidence is open until 30 September 2025. See here for further information, including how to provide feedback.

Policy, Strategy and Trade

EU

• On 10^th September 2025, the European Commission President, Ursula von der Leyen gave the State of the Union speech, outlining the key priorities, proposed initiatives and recent achievements of the EU. See here for further information. Commenting on the speech, the European Federation of Pharmaceutical Industries and Associations (EFPIA) gave the following response.

• EFPIA has welcomed the forthcoming EU Cardiovascular Health Plan and published a position paper with Vaccines Europe setting out detailed proposals for improving cardiovascular health. See here for EFPIA statement and position paper.

UK

• There has been considerable media coverage after numerous pharmaceutical companies, including Merck, AstraZeneca, Sanofi and Eli Lilly have halted investments in the UK amounting to nearly £2bn, citing a challenging operating environment and lack of decline in NHS spending on medicines, making the UK an unattractive market. At the same time, The Association of the British Pharmaceutical Industry (ABPI) has published a report showing how the UK has fallen down the global rankings for pharmaceutical investment and research. See ABPI press release and report for further information. The Science Minister, Patrick Vallance has issued a statement expressing deep concern over the UK’s declining investment in new medicines, and stating the government must reverse this trend.

Regulatory

EU

• The European Medicines Agency (EMA) has issued pre-authorisation procedural advice for users of the centralised procedure. The guidance document addresses a number of questions which users of the centralised procedure may have and provides an overview of EMA’s position on issues, which are typically addressed during the course of pre-submission meetings. See here for further information.

Safety

UK

• The MHRA’s Criminal Investigation Unit has launched a number of criminal investigations following several hospital admissions linked to the use of unlicensed botulinum toxin products. See MHRA press release for further information.

• The MHRA has published its safety round-up for August 2025. See here for further information.