Novartis: Leqvio online supplement—missing black triangle on standalone articles and printed versions lacked prescribing information (AUTH/3626/3/22)

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Key facts

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Case	AUTH/3626/3/22
Company	Novartis Pharmaceuticals UK Ltd
Product	Leqvio (inclisiran)
Material	Four articles in an online supplement: “2021, Volume 28, Supplement 2: Inclisiran▼ – its clinical position in lipid management” (ref 133819; date of preparation: September 2021)
Channel	Online supplement hosted on The British Journal of Cardiology platform; included email/share and print functionality
Key compliance issues	Standalone article pages omitted black triangle; printed/downloaded versions appeared not to include prescribing information
Complaint received	31 March 2022
Case completed	29 March 2023
Applicable Code year	2021
Breach clauses	Clause 5.1; Clause 12.1
No breach clauses	Clause 2; Clause 5.1; Clause 8.1; Clause 13.7; Clause 15.5
Sanctions	Undertaking received; Additional sanctions: Not stated
Appeal	No appeal

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

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What happened

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An anonymous health professional complained about four articles in an online supplement: “2021, Volume 28, Supplement 2: Inclisiran▼ – its clinical position in lipid management”, initiated and funded by Novartis (ref 133819; date of preparation: September 2021).
The supplement was hosted on The British Journal of Cardiology platform and included functionality to email/share and print the articles.
The complainant alleged (among other points) that: the articles were promotional; emails could be sent without recipient permission and without an unsubscribe option; the materials were not properly certified; the black triangle was missing next to inclisiran; and printed versions lacked prescribing information.
Novartis stated the supplement was certified as promotional under one job code; the platform’s email/print functionality was standard; and prescribing information was available via a single-click link on every page of the online supplement.
The Panel considered Novartis responsible for the supplement as promotional material, including the context in which it appeared.
The Panel found each article could be accessed directly (without viewing the landing page that contained the black triangle), so each article should have included the black triangle (the relevant requirement being Clause 12.10, though not raised; the Panel addressed it under Clause 5.1).
The Panel also considered that downloadable/printed articles were standalone items and appeared (from Novartis’ response) not to include prescribing information.

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Outcome

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Breach of Clause 5.1 (Requirement to maintain high standards) in relation to the online articles (omission of black triangle on each article when accessible standalone).
Breach of Clause 5.1 (Failing to maintain high standards) in relation to printed articles.
Breach of Clause 12.1 (Failing to include up-to-date prescribing information) in relation to printed articles.
No breach of Clause 2 (Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry).
No breach of Clause 8.1 (Requirement to certify promotional material).
No breach of Clause 13.7 (Requirement to show an inverted black equilateral triangle when required by the licensing authority on abbreviated advertisements) (Panel said it was not relevant to the supplement articles).
No breach of Clause 15.5 (Requirement to obtain permission from the recipient of promotional digital communications) (complainant did not provide evidence that any of the articles had been shared as alleged).

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Clauses

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Breach of Clause 5.1 Requirement to maintain high standards
Breach of Clause 12.1 Failing to include up-to-date prescribing information
No Breach of Clause 2 Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 5.1 Requirement to maintain high standards
No Breach of Clause 8.1 Requirement to certify promotional material
No Breach of Clause 13.7 Requirement to show an inverted black equilateral triangle when required by the licensing authority on abbreviated advertisements
No Breach of Clause 15.5 Requirement to obtain permission from the recipient of promotional digital communications

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Key facts

What happened

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Clauses

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