7th March 2025 Update

Advertising

EU

• In long-running litigation between the online pharmacy DocMorris and the German Pharmacists’ Association, the Court of Justice of the European Union (CJEU) has recently issued a judgment that clarifies the concept of ‘advertising of medicinal products’ and sheds light on the margin of appreciation of EU Member States in prohibiting specific advertisement schemes. See CJEU judgement here

UK

• The Medicines and Healthcare products Regulatory Agency (MHRA) has published its advertising investigation decisions for February 2025. See here for further information.

Artificial Intelligence (AI)

UK

• The Information Commissioner’s Office (ICO) has published its response to the government consultation on AI and copyright. See response for further information.
• The government has published an AI Playbook for the UK government, which updates and expands the earlier Generative AI Framework for HMG. The AI Playbook will support the public sector in better understanding what AI can and cannot do, and how to mitigate the risks it brings. See here for further information.
• The UK Artificial Intelligence (Regulation) Bill has been reintroduced to parliament. The Bill seeks to introduce AI specific legislation in the UK. See here for further information.

Ireland

• The Ireland government has announced a regulation of artificial intelligence bill. See press release for further information.

Brexit

UK

• The MHRA has updated its Guidance for wholesalers and manufacturers following agreement of the Windsor Framework. See updated Guidance here

Clinical Trials

EU

• The European Medicines Agency (EMA) has launched a new clinical trials map, designed to provide patients and healthcare professionals easy access to comprehensive, real-time information about clinical trials conducted in their area. See EMA press release for further information.

UK

• The Health Research Authority (HRA) has responded to the consultation on a new revision to the International Council for Harmonisation (ICH) E6 (R3) Good Clinical Practice (GCP). See the HRA press release for further information.

Critical Medicines

EU

• The European Commission will adopt a proposal for a new Critical Medicines Act on 11th March 2025. See here for further information.
• The European Commission Critical Medicines Alliance Report recommends priority actions to strengthen the supply of medicines in the EU and prevent shortages. See here for further information. See also the European Federation of Pharmaceutical Industries and Associations (EFPIA) response to the publication here

Data Privacy

UK

• The ICO has updated its guidance on keeping employment records. See here for further information.
• From 1 April 2025, the new HRA GDPR template should be used for all research applications submitted via IRAS. See HRA guidance for further information.

Health Data

EU

• The Regulation on the European Health Data Space (EHDS) was published in the Official Journal on 5th March 2025 and enters into force on 26th March 2025. See European Commission press release for further information.
• A conference on the EHDS- unlocking Europe’s health data future together will take place in Brussels on 18th March 2025 – see here for further information and conference details.
• EFPIA has called for effective stakeholder engagement and capacity building during the implementation of the EHDS. See EFPIA article here

Market Access

UK

• National Institute for Health and Care Excellence (NICE) has published further draft guidance for public consultation that continues to not recommend Alzheimer’s treatments donanemab and lecanemab. The consultation is open until 27th March 2025. See NICE press release for further information.

Medical Devices

UK

• A new UK wide scheme has been set up to improve patient access to innovative health technologies – the Medicines and Medical Devices Access Initiative (MMD). The group will aim to ensure good connectivity between regulatory, health technology assessment, and commercial processes. See NICE press release for further information.
• The MHRA has published the Medical Devices Regulations: Routes to market and in vitro diagnostic devices consultation response to the proposal regarding assimilated EU law. The response to proposals regarding international reliance, UKCA marking and in vitro diagnostic devices will be published separately in due course. See here for further information.

Rare Diseases

EU/UK

• To coincide with Rare Disease Day on 28th February 2025, a number of articles and materials were published. The Association of the Bristish Pharmaceutical Industry (ABPI) published an article, arguing that the UK needed to do more on access to rare disease medicines. See ABPI article here. The European Commission published two new factsheets explaining how it is delivering on rare diseases for patients and families. See EU publication here

Regulatory

EU

• EMA has opened a public consultation on its Guideline on the clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome. The consultation is open until 31 May 2025. See here for further information.

UK

• The government has announced that Lawrence Tallon has been appointed as the new Chief Executive of the MHRA. See MHRA press release for further information.

Supply

UK

• The General Pharmaceutical Council has updated its Guidance for registered pharmacies providing pharmacy services at a distance, including on the internet. See updated guidance here

Urban Wastewater Treatment Directive

EU

• The European pharmaceutical industry is set to challenge the legality of the EU Urban Wastewater Treatment Directive. See EFPIA press release for further information.

For further information on these developments and how it could affect business, please contact us, we are always happy to provide our insights.

You can also stay informed and ahead of the curve by subscribing to our newsletter and following us on LinkedIn.