AUTH/1927/12/06: Doctor v Sanofi Pasteur MSD – Gardasil journal advertisement (appeal successful; no breach) | PMCPA Case

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Key facts

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Case number	AUTH/1927/12/06
Parties	Doctor v Sanofi Pasteur MSD
Material	Double-page journal advertisement for Gardasil
Product	Gardasil (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed))
Key challenged claims	“Now there’s Gardasil a vaccine that can prevent cervical cancer”; “Benefit from 4 types – before and beyond cervical cancer”; “Beyond the cervix…”; “To protect young women, children and adolescents”
Clauses considered	Clause 7.2 and Clause 7.4
Panel decision	Initially ruled breaches for “Benefit from 4 types – before and beyond cervical cancer” (Clauses 7.2 and 7.4), but this element was appealed
Appeal outcome	Appeal successful; Appeal Board ruled no breach of Clauses 7.2 and 7.4
Final outcome	No breach of the Code
Complaint received	8 December 2006
Case completed	22 February 2007
Applicable Code year	2006
Source	https://www.pmcpa.org.uk/cases/completed-cases/auth19271206-doctor-v-sanofi-pasteur-msd

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

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A doctor complained about a double-page journal advertisement for Gardasil (HPV vaccine types 6, 11, 16, 18) issued by Sanofi Pasteur MSD (ref 10/06 09214c).
The complainant challenged multiple claims, including:
- “Now there’s Gardasil a vaccine that can prevent cervical cancer”.
- “Benefit from 4 types – before and beyond cervical cancer”.
- “Beyond the cervix Gardasil can also prevent vulval pre-cancers and genital warts and reduce the incidence of vaginal pre-cancers caused by human papillomavirus types 6, 11, 16 or 18”.
- “To protect young women, children and adolescents”.
The Authority asked the company to respond in relation to Clause 7.2 and 7.4 of the Code.
Sanofi Pasteur MSD stated the ad reflected the SPC and noted the ad had been pre-vetted by the MHRA (while recognising this did not guarantee Code compliance).
The Panel initially found one claim (“Benefit from 4 types – before and beyond cervical cancer”) ambiguous in context and ruled breaches, but this element was appealed by the company.
The Appeal Board overturned the Panel’s breach finding for that claim; the appeal was successful and the final case outcome was no breach.

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Final case outcome (after appeal): No breach of the Code.
The claim “Now there’s Gardasil a vaccine that can prevent cervical cancer” was considered consistent with the licensed indication and not misleading / not incapable of substantiation.
The claim “Benefit from 4 types – before and beyond cervical cancer” was ultimately considered (on appeal) not ambiguous or misleading and capable of substantiation in context.
The “Beyond the cervix…” claim about vulval pre-cancers, genital warts and reducing incidence of vaginal pre-cancers was not considered misleading.
The claim “To protect young women, children and adolescents” was not considered a hanging comparison and was linked to the licensed indication.

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