Novartis breached Code over Kesimpta SMC “approval” stamp and UK digital ad (missing ‘adult’ + NI prescribing info) (AUTH/3643/5/22)

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Key facts

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Case	AUTH/3643/5/22
Company	Novartis Pharmaceuticals Limited
Product	Kesimpta (ofatumumab)
Channel/materials	Promotional webpage (ref 199247, April 2021) and digital banner advertisement (ref 120655, May 2021)
Complaint received	08 May 2022
Case completed	24 May 2023
Applicable Code	2021
Main issues	SMC approval stamp implied unrestricted approval; banner ad omitted “adult” from licensed indication; UK-targeted ad linked only to GB (not NI) prescribing information
Breach clauses	5.1, 6.1, 6.2, 11.2, 12.1
No breach clauses	2, 5.1, 5.2, 6.3
Appeal	No appeal
Sanctions	Undertaking received; Additional sanctions: Not stated

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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, contactable health professional complained about Kesimpta (ofatumumab) promotion on: (1) a Novartis product webpage (ref 199247, April 2021) and (2) a digital banner advertisement (ref 120655, May 2021).
Webpage imagery: the page featured a prominent image of a female gymnast; the complainant alleged it implied MS patients could perform like a gymnast due to Kesimpta.
Webpage access/reimbursement messaging: the banner included an SMC approval stamp (and a NICE approval stamp). The complainant alleged the SMC stamp was misleading because SMC approval was restricted, but the stamp did not say so.
Digital ad indication wording: the banner claim stated “Now licensed for relapsing forms of multiple sclerosis (RMS) with active disease” and omitted “adult” (and other indication detail) from the licensed indication.
Digital ad prescribing information: the ad stated it was for UK healthcare professionals, but the prescribing information link led to Great Britain (GB) prescribing information only, not Northern Ireland (NI).
Novartis said the gymnast image was brand-representative and included a disclaimer (“Not representative of an actual patient – this image is intended to depict the brand”).
Novartis said the SMC restriction details were provided further down the page (in expanded text under “NICE and SMC recommendations”).
Novartis argued the banner ad should be considered together with its links (learn more + PI), but the Panel rejected this for Code compliance purposes.
Novartis acknowledged the NI PI omission was “not adequate” and said it audited materials and corrected PI access to combined GB/NI.

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Outcome

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Webpage (SMC stamp): Breach of Clause 6.1, Clause 6.2 and Clause 5.1.
Webpage (gymnast image allegation): No breach of Clauses 2, 5.1, 5.2 and 6.3 on the narrow allegation that HCPs would think Kesimpta made MS patients able to suddenly perform like a professional gymnast.
Digital advertisement: Breach of Clause 11.2 (omission of “adult” made the claim inconsistent with the SPC in the circumstances), Clause 12.1 (missing NI prescribing information for UK-targeted promotion) and Clause 5.1.
Clause 2: No breach for both webpage and digital ad (Panel considered Clause 5.1 rulings adequately covered the issues; additional Clause 2 ruling would be disproportionate in the circumstances).
No appeal.

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Clauses

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Breach of Clause 6.1 Making a misleading claim
Breach of Clause 6.2 Making an unsubstantiated claim
Breach of Clause 5.1 Failing to maintain high standards
Breach of Clause 11.2 Promotion inconsistent with the Summary of Product Characteristics
Breach of Clause 12.1 Failing to include up-to-date prescribing information
No Breach of Clause 5.2 Requirement that all material and activities must recognise the special nature of medicines and respect the professional standing or otherwise of the audience to which they are directed and must not be likely to cause offence
No Breach of Clause 6.3 Requirement that all artwork must conform to the letter and spirit of the Code
No Breach of Clause 5.1 Requirement to maintain high standards
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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Key facts

What happened

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Clauses

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