AUTH/3861/12/23: Novartis – third‑party “conference update” email and webpage found to disguise promotion and use EU (not UK) prescribing context

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Key facts

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Case number	AUTH/3861/12/23
Company	Novartis Pharmaceuticals UK Limited
Complaint source	Anonymous, contactable complainant (doctor based in the UK)
Complaint received	11 December 2023
Case completed	23 April 2025
Applicable Code	2021
Appeal	No appeal
Material/channel	Third-party publisher email and linked webpage with embedded videos, banner ads and resources
Medicine	Pluvicto (lutetium (177Lu) vipivotide tetraxetan)
Key compliance issues	Disguised promotion; insufficient sponsor declaration; EU (not UK) prescribing context shown to UK HCPs; missing UK PI and black triangle; promotion inconsistent with UK SPC particulars; governance/contract clarity and targeting controls
UK exposure noted	Webpage accessed by 60 unique viewers from within the UK (per Novartis’ understanding from the publisher)
Sanctions	Undertaking received; Additional sanctions: Advertisement

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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A UK doctor received a third-party medical publisher email (21 Nov 2023) with the subject “ESMO 2023: Prostate Cancer Update”, implying an unbiased conference update.
The email’s “Watch now” link led to a webpage that integrated: (a) a third-party “practice-changing data” conference video and article, and (b) Novartis-controlled promotional elements for Pluvicto (banner ads, a “Vision study” promotional video, and a “Resources/Information from Industry” section).
The email only stated it was a “promotional communication” at the very bottom in very small font and did not identify Novartis as sponsor.
Novartis-controlled materials on the webpage used EU context (EU SmPC/indication) and did not include UK prescribing information (including UK cost) or the inverted black triangle.
Targeting error: Novartis Global instructed the publisher to target “Europe” (understood to include the UK), rather than the European Union only; Novartis UK was not consulted for local review/approval.
Novartis Global removed the Novartis-controlled content after the complaint; the webpage had been accessed by 60 unique UK viewers before removal (per Novartis’ understanding from the publisher).

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Breach of Clause 2 Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Breach of Clause 5.1 (x2) Failing to maintain high standards
Breach of Clause 5.5 (x3) Failing to be sufficiently clear as to the company’s role and involvement
Breach of Clause 11.2 (x2) Promoting a medicine for an unlicensed indication
Breach of Clause 12.1 Failing to include UK prescribing information
Breach of Clause 12.10 Failing to include a black triangle adjacent to the first mention of the product in digital material
Breach of Clause 15.6 (x4) Disguising promotional material
No Breach of Clause 6.1 Requirement that information must be accurate, up-to-date and not misleading
No Breach of Clause 11.2 Requirement not to promote a medicine for an unlicensed indication

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Clause 2 Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Clause 5.1 (x2) Failing to maintain high standards
Clause 5.5 (x3) Failing to be sufficiently clear as to the company’s role and involvement
Clause 6.1 Requirement that information must be accurate, up-to-date and not misleading (No breach)
Clause 11.2 (x2) Promoting a medicine for an unlicensed indication
Clause 11.2 Requirement not to promote a medicine for an unlicensed indication (No breach)
Clause 12.1 Failing to include UK 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 (x4) Disguising promotional material

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