Novartis breached Clause 4.9 after Entresto sponsored BJC supplement articles omitted adverse event reporting statement

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Key facts

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Case	AUTH/3642/5/22
Company	Novartis Pharmaceuticals UK Ltd
Product	Entresto (sacubitril, valsartan)
Material type	Five promotional articles/supplements (online on BJC website; also referenced as print supplement set)
Channel / location	The British Journal of Cardiology (BJC) website (supplement archive)
Main issue upheld	AE reporting statement not included within the body of the articles/supplement (only in linked prescribing information)
Applicable Code	2019
Complaint received	05 May 2022
Case completed	04 April 2023
Breach clauses	Clause 4.9
No breach clauses	Clauses 2, 7.2, 9.1, 14.1
Appeal	No appeal
Sanctions	Undertaking received; additional sanctions: Not stated

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

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An anonymous, contactable complainant (self-described cardiac specialist) complained about five Novartis-initiated and funded promotional articles/supplements about Entresto (sacubitril/valsartan) hosted on The British Journal of Cardiology (BJC) website (archive content from 2019).
The complainant alleged: (1) Entresto was shown with a black triangle when it was not a black triangle product, (2) there was no adverse event (AE) reporting statement on the page, and (3) the articles were not certified; they also alleged broader concerns about Novartis’ compliance culture/signatory resourcing.
Each online article included a sponsorship disclaimer and a prominent link to Entresto prescribing information (PI).
Novartis accepted that the AE reporting information was not included in the main body of the articles/supplement (it was only within the PI accessible via the link) and removed the supplements from the BJC website.
Novartis stated the black triangle was correct at the time of publication (2019), and that the supplement was certified as one job (ENT19-C029) covering print and digital versions.

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Breach found: Clause 4.9 (2019 Code) in relation to each of the five articles.
No breach found: Clauses 2, 7.2, 9.1 and 14.1 (2019 Code).
The Panel considered omission of the AE reporting statement in the article body unacceptable, but noted it could be viewed via the PI link and the material had been removed; overall this did not justify a Clause 2 ruling.
No appeal.

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Breach of Clause 4.9 Failing to include information about how to report adverse events
No Breach of Clause 7.2 Requirement that information must be accurate, up-to-date and not misleading
No Breach of Clause 9.1 Requirement to maintain high standards
No Breach of Clause 14.1 Requirement to certify promotional material
No Breach of Clause 2 Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry

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