24th October 2025 Update

Advertising

UK

• The Prescription Medicines Code of Practice Authority (PMCPA) has ruled that Astra Zeneca has breached clauses 2 (bringing discredit upon and reducing confidence in the pharmaceutical industry), 5.1 (failing to maintain high standards), 6.1 (making a misleading claim) and 6.2 (making an unsubstantiated claim) of the ABPI Code of Practice. See AstraZeneca – Case/0387/12/24 for further information.
• The PMCPA has ruled that Organon has breached clauses 2 (bringing discredit upon and reducing confidence in the pharmaceutical industry), 5.1 (failing to maintain high standards) and 11.2 (promoting a medicine outside the terms of its marketing authorisation) of the ABPI Code of Practice. See Organon – Case/0262/08/24 for further information.

Artificial Intelligence (AI)

EU

• The European Commission has launched the Apply AI Alliance to act as a single governance structure to coordinate and shape AI policy. See the European Commission press release for further information.
• The European Commission has launched a new initiative, COMPASS –AI to increase the safe and effective use of AI in healthcare. This is one of the new measures in the Commission’s Apply AI strategy. See the European Commission press release for further information.
• The European Commission has launched an AI service desk and single information platform to ensure effective implementation of the EU AI Act. The platform will serve as a single hub where stakeholders can access all relevant information. See European Commission press release for further information.

UK

• The government has announced a new blueprint for AI regulation to help drive growth and innovation. AI Growth Lab sandboxes will support AI innovation by allowing innovators to test AI products in controlled testing environments. These will be set up for key sectors, including healthcare, to accelerate responsible development of AI products. See the UK government press release. The government has also opened a call for evidence on the AI Growth lab, which is open until 2 January 2026. See here for further information including how to provide feedback.
• The government has set aside a fund of £1 million to support the Medicines and Healthcare products Regulatory Agency (MHRA) to pilot projects using AI assisted tools. These projects are aimed at making medicines safer and bringing treatments to patients more quickly. See MHRA press release for further information.

Competition Law

Spain

• The Spanish competition authority, Comisión Nacional de Los Mercados Y La Competencia (CNMC) has issued its first ever prohibition on merger control grounds blocking an acquisition in the radiopharmaceuticals sector. See CNMC press release for further information.

UK

• The Competition and Markets Authority (CMA) is consulting on proposed changes to its approach to merger remedies and has published revised merger remedies (CMA87) guidance for consultation. The consultation is open until 13 November 2025. See here for further information on how to provide feedback and CMA press release
• The CMA has published its provisional decision in its market investigation into the veterinary services market. It has proposed twenty-one measures including better information on prices, treatments and medicines. See CMA press release for further information.

Data Privacy

EU

• The European Data Protection Board (EDPB) is organising a stakeholder event to collect stakeholder input on anonymisation and pseudonymisation. For further information on the event and how to take part see here
• During its October plenary, the EDPB picked the topic for its fifth coordinated enforcement action, which will concern compliance with the obligations of transparency and information under the General Data Protection Regulation (GDPR). See EDPB press release for further information.
• The EDPB has adopted two opinions on the European Commission’s draft decisions on the extension of the validity of the UK adequacy decisions under the GDPR and the Law Enforcement Directive until 2031. See here for further information.
• The European Parliament has adopted (on 21 October) the final text on the procedural rules for the cross-border enforcement of the GDPR. See here for further information.

Germany

• The German data protection conference of federal and state data protection authorities has published new guidelines and recommendations for international transfers of health data in medical research. See guidelines and recommendations (both in German) for further information.

Market Access

EU

• The European Commission has completed the regulatory framework for its Health Technology Assessment (HTA) Regulation by adopting the final implementing Regulation for medical devices. See here for further information.

UK

• The Association of the British Pharmaceutical Industry (ABPI) has published a blog article setting out arguments why the government must urgently raise the National Institute for Health and Care Excellence (NICE) cost-effectiveness threshold. See here for further information.

Medical Devices

UK

• The MHRA AI Airlock programme report has been published which summarises the key technical and regulatory insights and recommendations for changes to the regulatory and support framework for AI as a medical device. See report for further information. Key insights from the AI Airlock simulation workshops are also available The MHRA has also announced that phase 2 of the AI Airlock will include seven additional technologies. For further information on the AI Airlock Phase 2 cohort see here and here
• The UK government has announced increased collaboration with the United States on med tech regulation aimed at enhancing innovation and accelerating patient access to the latest technology. See MHRA press release for further information.

Regulatory

EU

• The European Medicines Agency (EMA) has published a draft reflection paper on non-human primates in safety testing of human medicinal products and opportunities for 3Rs implementation. The consultation is open until 31 January 2026. See here for further information including how to contribute.
• The EMA has published its Human Medicines Highlights for October 2025, with information on new medicines recommended for approval and new information on approved medicines. See here for further information.

UK

• Three potential therapies have become the first to enter the new Innovative Licensing and Access Pathway (ILAP). See MHRA press release for further information.
• The MHRA and NICE have launched an aligned pathway offering companies access six months earlier than normally projected. See MHRA Press release and NICE press release for further information.

Wastewater

EU

• The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published an article on concerns with the Urban Wastewater Treatment Directive. The concerns are raised in advance of the European Commission preparing to publish a long-awaited study on the costs associated with implementing treatment upgrades under the Directive. See EFPIA article for further information.