Novartis disease awareness melanoma booklet: breach over ambiguous patient organisation involvement wording (AUTH/3394/10/20)

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Key facts

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Case number	AUTH/3394/10/20
Complainant	Anonymous, non-contactable health professional
Company	Novartis Pharmaceuticals UK Ltd
Material	Patient information booklet: “Melanoma. Let’s get under the skin of it / Understanding the BRAF mutation” (ref ONC19-C049b(1))
Channel	Public-facing Novartis UK website (also to be made available on Melanoma UK website per agreement)
Therapy area	Melanoma
Related medicines mentioned in case background	Tafinlar (dabrafenib) and Mekinist (trametinib)
Main issue	Ambiguous description of patient organisation involvement (“in association with”) making company involvement unclear
Breach clauses	Clause 27.2
No breach clauses	Clauses 2, 7.8, 9.1, 26.2, 27.9
Complaint received	04 October 2020
Case completed	22 March 2021
Applicable Code year	2019
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, non-contactable complainant (described as a health professional) complained about a public-facing melanoma patient booklet on Novartis UK’s website: “Melanoma. Let’s get under the skin of it / Understanding the BRAF mutation” (ref ONC19-C049b(1)).
The booklet was part of a 2019 disease awareness campaign aimed at melanoma patients and carers; Novartis marketed Tafinlar (dabrafenib) and Mekinist (trametinib) for certain melanoma patients with a BRAF V600 mutation.
The complainant alleged the booklet indirectly promoted Novartis medicines by emphasising BRAF testing/targeted therapy (eg “Testing for a mutation to the BRAF gene is the only way you can know if targeted therapy is an option for you…”), potentially encouraging patients to ask for targeted therapies.
The complainant also objected to an image of a woman outdoors in sunshine, suggesting it could imply patients were fine to do that once treated.
The complainant said it was unclear how Melanoma UK was involved and that “in association with” did not clearly describe both parties’ involvement.

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No breach of Clause 26.2: the Panel considered the booklet factual, balanced, and not encouraging the public to request a specific prescription-only medicine.
No breach of Clause 7.8: on balance, the image did not imply melanoma patients were fine to be out in sunshine once treated (though the Panel noted concern that the woman was not wearing a hat).
No breach of Clauses 2, 9.1, or 27.9 (27.9 deemed not relevant on the facts).
Breach of Clause 27.2: the wording “developed by Novartis… in association with Melanoma UK” was ambiguous and could mislead the public about the patient organisation’s role, making the company’s involvement unclear.

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