30th March 2026 Update

Advertising

UK

• The Prescription Medicines Code of Practice Authority (PMCPA) has updated its Q&A document on arm’s length arrangements based on recent case precedent. See here for further information.
• The PMCPA is intending to publish on-demand webinars on hot topics and has announced that the first webinar will cover arm’s length arrangements and look at recent cases. The PMCPA is inviting questions before 31 March 2026 which can be addressed in the webinar. See here for further information.
• The PMCPA has ruled that Bayer PLC has breached the ABPI Code of Practice for the Pharmaceutical Industry (Code) and brought discredit upon the pharmaceutical industry for promoting an unlicensed medicine prior to the grant of its UK marketing authorisation. See Case/0216/06/24 for further information.
• The Medicines and Healthcare products Regulatory Agency (MHRA) has published February decisions made by it following investigations into complaints about advertising for licensed medicines. See here for further information.

Artificial Intelligence (AI)

EU

• The Council of the European Union has agreed its position on the proposed rules regarding AI as part of the Digital Omnibus package. Following the approval, negotiations will now commence with the European Parliament. See here for further information.

Ireland

• The Irish Minister for Health has published a new national ‘AI for Care’ strategy aimed at integrating AI into the health and social care system, with a view to enhancing patient outcomes and efficiency. See here for further information.

UK

• The Department of Science, Innovation and Technology (DSIT) has published a report and impact assessment on the use of copyright works in the development of AI systems. See here for further information.

Clinical Trials

UK

• The Association of the British Pharmaceutical Industry (ABPI) has published a new report setting out industry’s view on adopting data-enabled clinical trials, clarifying that such methods would improve predictability and accuracy of carrying out trials in the UK. The report also sets out recommendations to create a UK-wide data-enabled clinical trial capability. See ABPI press release with link to the report, for further information. The Health Research Authority (HRA) has also published a response to the ABPI report. See here for further information.
• The MHRA has updated its Guidance on labelling of medicinal products used in clinical trials. See here for further information.

Competition Law

UK

• The Competition and Markets Authority (CMA) has published its final report with its remedies and recommendations, following its market study of the veterinary services sector. See here and here for further information.
• The CMA has responded to the Department for Business and Trade consultation on proposals to improve the UK’s competition regime. See CMA response here.

Competitiveness

EU

• The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published research undertaken on its behalf, providing an overview of the EU’s attractiveness as a destination for pharmaceutical investment. The research analyses twenty performance indicators across key areas to attracting interest. See here for further information, including link to the report.

UK

• The UK government has published data on the life sciences sector in the UK, ‘Life Sciences competitiveness indicators 2026’. See here for further information.

Data Privacy

EU

• The European Data Protection Board (EDPB) and the European Data Protection Supervisor (EDPS) have published a joint opinion on the European Biotech Act proposal, calling for specific safeguards for sensitive health data. See here for further information.
• The EDPB has launched its Coordinated Enforcement Framework action for 2026, with its focus on transparency and information obligations under the GDPR. See here for further information.
• The EDPB and EDPS have adopted a joint opinion on the Commission’s proposal for a Cybersecurity Act 2. See here for further information.
• The EDPS together with the Free State of Bavaria to the European Union is hosting a high-level debate on the European Commission’s Omnibus proposals and their implications for the GDPR. The event is being held in Brussels on 8 June 2026. Further details on how to register will be available shortly. See here for further information.
• The Court of Justice of the European Union (CJEU) has issued its judgement in Case C-526/24 Brillen Rottler GmbH & Co KG, clarifying the rules on access rights and when they may be considered abusive. The decision clarifies that companies may refuse an access request as excessive, but only where an abusive intent on the part of the data subject can be demonstrated. The burden of proof lies with the controller. See judgement for further information.

Market Access

UK

• National Institute for Health and Care Excellence (NICE) and the MHRA have launched a new aligned pathway to help bring NICE’s decision-making process forward to run alongside the MHRA’s, resulting in decisions on licensing and value being made at the same time. The pathway launches on 1^st April 2026. See NICE press release and MHRA press release for further information.

Patients

UK

• The MHRA has launched the ‘Improving Patient Information Project’, aiming to modernise how medicines product information is delivered. The project will work with stakeholders to understand barriers and how information can be made more accessible. See here for further information.

Regulatory

EU

• The European Medicines Agency (EMA) has launched three new tools as part of its PRIME scheme, to support the development of medicines targeting an unmet medical need. See here for further information.

UK

• The MHRA has published the latest blog article in its series, which explores how expanding medicine reclassification could improve access to treatments and reduce pressure on NHS services. See here for further information.

Research and Development

UK

• The MHRA has published a press release highlighting that new analysis shows the Clinical Practice Research Datalink run by the MHRA has supported groundbreaking research across 29 countries with close to 3,800 published studies. See press release for further information.