Novartis: Pluvicto third‑party promotional email to UK HCPs (geo-targeting error) breached multiple clauses incl. disguised promotion and missing UK PI (AUTH/3860/12/23)

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Key facts

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Case	AUTH/3860/12/23
Company	Novartis Pharmaceuticals (Novartis UK responsible for Novartis Global affiliate activity)
Product	Pluvicto (lutetium-177 vipivotide tetraxetan)
Channel/material	Promotional email sent by a third-party medical publisher platform
Audience impacted	UK health professionals (email opened by 44 unique UK recipients)
Core issue	EU-intended campaign mistakenly targeted “Europe” (EFPIA definition incl. UK), so UK received non-UK-compliant promotional email
Key compliance gaps	Disguised promotion; unclear company involvement at outset; misleading/ambiguous “novel/FIRST and ONLY” impression; EU indication/SPC used; missing UK prescribing information; INN not adjacent to first/most prominent brand mention; black triangle not at first mention
Applicable Code	2021
Complaint received	9 December 2023
Case completed	23 April 2025
Appeal	No appeal
Breaches	Clauses 5.1, 5.5, 6.1, 6.2, 11.2, 12.1, 12.3, 12.10, 15.6
No breach	Clause 2
Sanction	Undertaking received

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

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An anonymous UK doctor complained about a promotional email for Pluvicto sent by a third-party medical publisher on behalf of Novartis Global.
The email’s sender/subject line did not make clear it was promotional from a pharmaceutical company; sponsorship was only apparent at the end.
The email was intended for an EU audience but was sent to “Europe” due to a Novartis Global associate using “Europe” (EFPIA definition, including the UK) instead of “European Union”.
The email included EU indication and a link to the EU SPC, not the UK licence/SPC.
The inverted black triangle appeared only at the bottom of the scrolling email, not adjacent to the first mention of the product.
The non-proprietary name/active ingredient was not immediately adjacent to the first/most prominent brand name (including the subject line).
Claims and framing (including “FIRST and ONLY…” and “novel approach”) were considered to create an ambiguous impression that the product was new.
Novartis instructed the third party to cease distribution after the complaint; Novartis understood the email was opened by 44 unique UK recipients.

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Breach of Clause 5.1 Failing to maintain high standards
Breach of Clause 5.5 Failing to be sufficiently clear as to the company’s role and involvement
Breach of Clause 6.1 Making a misleading claim
Breach of Clause 6.2 Making an unsubstantiated claim
Breach of Clause 11.2 Promoting a medicine for an unlicensed indication
Breach of Clause 12.1 Failing to include UK prescribing information
Breach of Clause 12.3 Failing to include the non-proprietary name of the medicine immediately adjacent to the most prominent display of the brand name
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 Disguising promotional material
No Breach of Clause 2 Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry

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