Novartis: corporate webpage pipeline table ruled to promote POMs to the public and an unlicensed medicine (AUTH/3414/11/20)

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Key facts

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Case	AUTH/3414/11/20
Company	Novartis Pharmaceuticals UK Ltd
Complaint	Alleged promotion of three pipeline products (QGE031, QMF149, QVM149) on a company webpage accessible to the public
Products mentioned	QGE031 (ligelizumab); QMF149 (indacaterol + mometasone, fixed-dose combination; Atectura Breezhaler); QVM149 (indacaterol + glycopyrronium + mometasone, fixed-dose combination; Enerzair Breezhaler)
Medium	Corporate website webpage (“Our work in Respiratory and Inflammation”) with a pipeline table
Key issue	Overall impression and context meant the page promoted two licensed POMs to the public and promoted an unlicensed medicine; content was also out of date
Complaint received	4 November 2020
Case completed	16 July 2021
Applicable Code year	2019
Panel findings (breach)	3.1, 9.1, 26.1, 26.2, 28.3
Panel findings (no breach)	2; 3.1 (for QMF149 and QVM149); 4.1; 4.3
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 challenged a Novartis Pharmaceuticals UK Ltd corporate webpage (“Our work in Respiratory and Inflammation”) that included a table of three “pipeline” products: QGE031 (ligelizumab), QMF149 and QVM149.
The table included non-proprietary names, mechanism of action, potential indication/disease area, route of administration, trial phase and planned filing dates.
The page opened with wording about researching, developing and launching “innovative therapies” to treat COPD, chronic spontaneous urticaria and severe allergic asthma, and included additional asthma-related content below the table.
The webpage had been issued in October 2016 and had not been updated; by the time of the complaint (November 2020) QMF149 (Atectura Breezhaler) and QVM149 (Enerzair Breezhaler) were licensed, but the table still presented them as Phase III with planned filing dates.
The page was not restricted to health professionals; access required clicking through three links on the corporate site and it could potentially be found via web search.
Novartis said the page was corporate, informational (not promotional), and removed the webpage after identifying it was not up to date; it acknowledged a breach of Clause 9.1.

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Breach of Clauses 26.1 and 26.2: the context of the page meant QMF149 and QVM149 (prescription only medicines at the time of the complaint) were promoted to the public.
Breach of Clause 3.1: information about QGE031, in the context of the page, was ruled to promote an unlicensed medicine.
Breach of Clause 9.1: failure to maintain high standards because the webpage had not been updated since October 2016, including after marketing authorisations were granted.
Breach of Clause 28.3: public internet information about medicines must comply with Clause 26.2; given the findings under 26.2, 28.3 was breached.
No breach of Clause 3.1 in relation to QMF149 and QVM149 (they were licensed at the time of the complaint).
No breach of Clauses 4.1 and 4.3: the page was neither directed to nor limited to health professionals/decision makers, so the allegations about advertising to that audience were not relevant.
No breach of Clause 2: although the Panel was concerned, it did not consider the circumstances warranted the particular censure of Clause 2.

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