23rd June 2025 Update

Advertising

UK

• The Prescription Medicines Code of Practice Authority (PMCPA) has published a new Q&A on using artificial intelligence to assist in the review of promotional materials and activities covered by the ABPI Code. See here for further information.

• The PMCPA has published two new policies: i) Managing Persistent Contact and Unreasonable Behaviour and ii) a Pilot Limitation Period Policy in relation to historical complaints. See policies and PMCPA press release for further information.

• The PMCPA has ruled that Novartis Pharmaceuticals UK Limited has breached the following clauses of the ABPI Code: Clauses 2, 5.1, 5.5, 11.2, 12.1, 12.10 and 15.6 for the cumulative effect of incorrectly using the EMA SPC, circulation of a disguised promotional email and failures of the company’s internal governance processes. See AUTH/3861/12/23 – Complainant v Novartis Pharmaceuticals for further information.

• The PMCPA has ruled that Theramex has breached the following clauses of the 2021 ABPI Code: Clauses 2, 5.1, 6.1 and 11.2 for promoting a medicine for an unlicensed indication. See CASE/0270/08/24 – Complainant v Theramex for further information.

Artificial Intelligence (AI)

EU

• The European Parliament has released an AI Act implementation timeline factsheet. See here for further information.

• The European Commission has launched a public consultation on high-risk AI systems. The consultation is open until 18th July 2025. See European Commission press release and consultation document for further information.

UK

• The Department of Science Innovation and Technology (DSIT) has published details of a new project aimed at making the UK a leader in AI driven drug discovery. See DSIT press release for further information.

Biotech Act (EU)

EU

• The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published its response to the European Commission call for evidence on the EU Biotech Act. See here for further information.

Clinical Trials

EU

• The European Medicines Agency (EMA) has published a consultation on a new Guideline on the inclusion of pregnant and breastfeeding individuals in clinical trials. The consultation is open until 15 September 2025. See EMA press release for further information including details of Guideline ICH E21 and how to provide feedback.

UK

• The Association of the British Pharmaceutical Industry (ABPI) and the Association of Medical Research Charities (AMRC) have published a report calling for improvements to inclusivity in clinical trials. See ABPI press release and AMRC press release for further information. The Health Research Authority (HRA) has also published its response to the report.

Competition Law

UK

• The Competition and Markets Authority (CMA) has published information for advisers who provide guidance to businesses on competition issues. See here for further information and detailed guidance.

• The CMA has published guidance for businesses on competing fairly and engaging with the CMA. See guidance for further information.

Data Privacy

EU

• The European Data Protection Board (EDPB) has published final guidance on data transfers to third country authorities and a report on practical compliance with privacy and AI legislation. See here for further information.

UK

• The Data (Use and Access) Bill has now passed through both Houses of Parliament. Both Houses have agreed on the text of the Bill which now waits for the final stage of Royal Assent when the Bill becomes an Act of Parliament (law). See here for further information.

Decentralised Manufacturing

UK

• The Medicines and Healthcare products Regulatory Agency (MHRA) has published detailed information and guidance on the new regulations for decentralised manufacture including point of care and modular manufacture. The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 come into effect on 23 July 2025. See Statutory Instrument 2025 No 87 for legislation and MHRA information hub for detailed guidance.

EU Pharmaceutical Law Reform

EU

• The Council of the European Union has agreed on a position on the pharmaceutical reform package, paving the way for the trilogue negotiations. The Council’s mandate for the negotiations introduces several amendments to the proposed legislation. See EU Council press release for further information. See also EFPIA commentary on the announcement here

Market Access

UK

• NICE has updated the recommendations in its clinical guideline on diagnosis and management of chronic heart failure. The updated guideline reflects a change in clinical practice over the timing of drug treatments and recommends medicines be given up to a year earlier. See NICE press release for further information.

• The UK government has doubled the statutory scheme payment rate for newer branded medicines from 1 July 2025 following a consultation. The industry considers the new rate to be unsustainable and will have a significant impact on innovation in the UK. See ABPI commentary here and here

• The ABPI has commented on the government spending review. See here for further information.

Medical Devices

EU

• The European Commission has launched a public consultation on joint clinical assessments of medical devices and in vitro diagnostic medical devices under the HTA Regulation. The consultation is open until 25 June 2025. See here for further information including how to provide feedback in the consultation.

UK

• The MHRA has published guidance on documentation for implementation of data requirements under the new Post-Market Surveillance regulations. See here for further information.

Policy, Strategy and Trade

Global

• In an open letter the global pharmaceutical industry has called on G7 leaders to recognise the strategic value of the innovative pharmaceutical industry and place health and innovation at the top of their agenda. See International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) press release for further information.

EU

• The EMA has published its annual report 2024 setting out its strategic priorities and contributions to public and animal health in the European Union (EU). See EMA press release for further information.

Regulatory

UK

• The MHRA has published guidance on regulatory considerations for therapeutic use of bacteriophages in the UK. See MHRA press release for further information including the Guidance.

• The MHRA has published updated guidance on the safe and effective use of GLP-1 medicines for weight loss and diabetes. See updated guidance here

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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