Novartis breached Code over third‑party video series seen as pre‑licence promotion of inclisiran (AUTH/3400/10/20)

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Key facts

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Case	AUTH/3400/10/20
Company	Novartis
Product	Inclisiran (Leqvio)
Issue	Promotion of inclisiran on a third-party website (video roundtable chapters)
Complainant	Anonymous health professional
Channel	Third-party cardiology website; open access; chapter-based video series
Key allegation themes	Pre-licence promotion; public accessibility; unclear sponsorship; lack of certification; high standards/Clause 2
Applicable Code year	2019
Complaint received	18 October 2020
Case completed	16 August 2021
Appeal	No appeal
Breach clauses	2; 3.1; 9.1; 9.10; 12.1; 14.1; 28.1
No breach clauses	26.1; 26.2 (very narrow technical point: no MA so not classified as POM at the time)
Sanctions	Undertaking received; Additional sanctions: Advertisement
Source	https://www.pmcpa.org.uk/cases/completed-cases/auth34001020-complainant-v-novartis

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

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An anonymous health professional complained about a roundtable video series on a UK-based third-party cardiology website that included clinical data on inclisiran (Leqvio) before it had a marketing authorisation.
The website was open access (no HCP gate), and the complainant highlighted chapters 5 (“Contemporary approaches…”) and 6 (“Summary”).
A homepage tile under “Editor’s Choice” displayed both the third party logo and the Novartis logo.
Novartis Pharma AG (Switzerland) funded the activity via an educational grant; Novartis UK said it had no input/oversight and the activity was intended for a global HCP audience.
The proposal document (signed by Novartis AG) heavily referenced inclisiran and ORION trial results and positioned inclisiran positively (eg ~51% LDL-C reduction; twice-yearly dosing; “ease of use and treatment compliance”).
The Panel reviewed all six videos and concluded chapters 5 and 6 were very positive about inclisiran and conveyed a “take home message” that inclisiran would overcome unmet need, amounting to promotion of an unlicensed medicine.
The sponsorship declaration existed on the site and at the start of each chapter, but was difficult to read and was not sufficiently clear/unambiguous about Novartis’ role and responsibility.
The material had not been certified by Novartis.

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Breach ruled: Clause 2
Breach ruled: Clause 3.1
Breach ruled: Clause 9.1
Breach ruled: Clause 9.10
Breach ruled: Clause 12.1
Breach ruled: Clause 14.1
Breach ruled: Clause 28.1
No breach ruled (narrow technical point): Clause 26.1 (inclisiran not classified as POM at the time because it had no marketing authorisation)
No breach ruled (narrow technical point): Clause 26.2 (same reason)

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