26th February 2025 Update

Advertising

UK

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

• The Prescription Medicines Code of Practice Authority (PMCPA) has published advertised sanctions including: i) pre-licence promotion in social media – AUTH/3729/1/23 – Complainant/s v AstraZeneca ; ii) pre-licence promotion to the public in social media – AUTH/3774/6/23 – Complainant v AstraZeneca ; iii) promotion of a pre-licence medicine/promotion inconsistent with summary of product characteristics/payment of a pecuniary advantage or inducement to prescribe – AUTH/3783/6/23 – Complainant v Moderna ; iv) making a misleading claim and failing to disclose company’s involvement – AUTH/3815/8/23 – Complainant v Moderna; and v) failing to accurately disclose transfers of value – Novo Nordisk – Case AUTH/3876/2/24

• PAGB the Consumer Health Association has published a new edition of its Code for Medicines Advertising, setting out the rules that apply to advertising materials aimed at consumers for OTC medicines. See new edition of Code here

Artificial Intelligence (AI)

EU

• The European Commission has withdrawn the EU AI Liability Directive from consideration, citing no ‘foreseeable agreement’. It seems that pressure from industry may be behind the u-turn as the technology industry has pushed for simpler regulations. The Commission will assess whether another proposal should be tabled.

Clinical Trials

Switzerland

• Swissmedic has updated their position paper on decentralised clinical trials for medicinal products. See Swissmedic press release for further information.

Data Privacy

EU

• In its judgement of 13 February 2025, the Court of Justice of the European Union (CJEU) clarified the basis for calculating fines under art. 83 of GDPR. The CJEU ruling suggests that while group turnover may be used as a relevant factor for considering the specific circumstances of the case in order to calculate the actual amount of the fine, it cannot serve as the basis for such calculation.

The ruling also stressed the need to apply the principle of proportionality when assessing fine levels under GDPR. See CJEU judgement for further information.

France

• The French data protection authority, CNIL has published new recommendations on AI and GDPR. See here for further information.

Global

• Data protection authorities in Australia, Korea, Ireland, France and the UK have signed a joint declaration to create a governance framework for AI. See joint statement here

UK

• The Data (Use and Access) Bill was introduced to parliament in October 2024 and has now completed its passage through the House of Lords and reached the committee stage in the House of Commons. The Information Commissioner’s Office (ICO) has now updated its response to the Bill. See information on the Bill here and ICO response here

Health Data

UK

• The Association of the British Pharmaceutical Industry (ABPI) has published an article setting out what the pharmaceutical industry needs in order to fully access National Health Service (NHS) data. See ABPI article for further information.

Market Access

UK

• National Institute for Health and Care Excellence (NICE) has joined an international collaboration on health technology assessment (HTA) methodology. See NICE press release for further information.

• The ABPI has published a blog article on the NHS England update to the commercial framework for new medicines. See blog article for further information.

Medical Devices

EU

• The European Medicines Agency (EMA), in collaboration with the European Commission, has established a standard procedure for manufacturers of certain high-risk medical devices to request scientific advice on their intended clinical development strategy and proposals for clinical investigation. See EMA press release for further information.

UK

• The MHRA has published guidance on registration of certain in vitro diagnostic devices reliant on expired or expiring CE certificates or declarations of conformity. See MHRA guidance for further information.

• The MHRA has published guidance on registration of medical devices that are reusable or upclassified Class I devices, and/or reliant on expired or expiring CE certificates. See MHRA guidance for further information.

• The MHRA has updated its guidance on regulating medical devices in the UK, including what you need to do to place a medical device on the market in Great Britain, Northern Ireland and the European Union. See updated guidance for further information.

Pharmacovigilance

UK

• The MHRA has updated its guidance clarifying the expectations on the application of the EU guidance on good pharmacovigilance practices. See here for further information.

Regulatory

EU

• The EMA has published its Human Medicines Highlights for February 2025, setting out new information on medicines and approvals. See here for further information.

• The EMA has published a reflection paper on the current regulatory testing requirements for medicinal products for human use and opportunities for implementation of the 3 Rs. The consultation is open until 30 June 2025. See here for further information.

Research and Development

EU

• The EMA has published a concept paper for consultation on the development of a Guideline on assessment and reporting of mechanistic models used in the context of model informed drug development. The consultation is open until 31 May 2025. See here for further information.

Supply

UK

• The MHRA has published an update of its guidance on importing investigational medicinal products into Great Britain from approved countries, which outlines the principles for the management and oversight of the import of investigational medicinal products to Great Britain. See updated guidance 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.

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