PMCPA PRESS RELEASE 2 June 2025 - Case ruled in breach of Clause 2
NOVARTIS PHARMACEUTICALS UK LIMITED has breached the ABPI Code of Practice for the Pharmaceutical Industry and brought discredit upon, and reduced confidence in, the pharmaceutical industry.
Press Release 02 June 2025
Novartis Pharmaceuticals UK Limited– Case AUTH/3861/12/23
For the cumulative effect of incorrectly using the EMA SPC, circulation of a disguised promotional email, by a third-party medical publisher, in November 2023 and failures of the company’s internal governance processes. Novartis was ruled in breach of the following clauses of the 2021 Code:
Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Clause 5.1 - Failing to maintain high standards
Clause 5.5 - Failing to be sufficiently clear as to the company’s role and involvement
Clause 11.2 -Promoting a medicine for an unlicensed indication
Clause 12.1 -Failing to include up-to-date prescribing information
Clause 12.10 -Failing to include a black triangle adjacent to the first mention of the product in digital material
Clause 15.6 - Disguising promotional material
The case report is available at www.pmcpa.org.uk.
Ends
Notes to Editors:
Notes to Editors:
The advertisement will appear in the BMJ and the Nursing Standard in June 2025.
Media Contacts:
For more information contact Alex Fell afell@pmcpa.org.uk 0207 747 8878
The Prescription Medicines Code of Practice Authority (PMCPA) was established by The Association of the British Pharmaceutical Industry (ABPI) to operate the ABPI Code of Practice for the Pharmaceutical Industry independently of the ABPI. The PMCPA is a division of the ABPI. The Code covers the promotion of medicines for prescribing to health professionals and the provision of information to the public about prescription only medicines.
If you have any concerns about the activities of pharmaceutical companies in this regard, please contact the PMCPA at 2nd Floor, Goldings House, Hay’s Galleria, 2 Hay’s Lane, London, SE1 2HB, email: complaints@pmcpa.org.uk, or visit www.pmcpa.org.uk/complaints-procedure/make-a-complaint.
The Code and other information, including details about ongoing cases, can be found on the PMCPA website: www.pmcpa.org.uk.
The PMCPA is a division of the ABPI which is a company limited by guarantee registered in England & Wales no 09826787. Registered office 2nd Floor Goldings House, Hay’s Galleria, 2 Hay’s Lane, London, SE1 2HB.