Sanofi Pasteur MSD v GlaxoSmithKline (AUTH/1910/11/06): Cervical cancer disease awareness team ruled to be pre-licence promotion on appeal

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Key facts

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Case	AUTH/1910/11/06
Parties	Sanofi Pasteur MSD v GlaxoSmithKline
Issue	Cervical cancer disease awareness campaign (CCDAT) and whether it amounted to pre-licence promotion
Applicable Code year	2006
Complaint received	02 November 2006 (also stated as 3 November 2006 in the report)
Case completed	01 May 2007 (also stated as 2 May 2007 in the report)
Initial Panel ruling	No breach of Clause 3.1; consequently no breach of Clause 2
Appeal	Complainant appeal; appeal successful
Breach clauses (final)	Clause 2 and Clause 3.1
Product status	GSK candidate HPV vaccine not licensed at the time; Gardasil launched in UK October 2006
Scale of activity	65 CCDAT members operating throughout the UK
Sanctions applied	Undertaking received; Advertisement
Source	https://www.pmcpa.org.uk/cases/completed-cases/auth19101106-sanofi-pasteur-msd-v-glaxosmithkline

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

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What happened

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Sanofi Pasteur MSD complained about GlaxoSmithKline’s field-based cervical cancer disease awareness team (CCDAT), alleging its existence and activities breached the Code.
Both companies were developing prophylactic HPV vaccines: Sanofi’s Gardasil (HPV 6, 11, 16, 18) had launched in the UK (October 2006); GSK’s candidate vaccine (HPV 16, 18) was not licensed.
A recruitment advertisement in Pharmaceutical Field sought area managers and representatives to “shape the future for women in the UK” and described a pre-launch disease awareness role followed by responsibility for “sales performance” at vaccine launch; it required a proven sales track record and influencing/negotiation skills.
CCDAT used materials (detail aid/brochure/leavepiece/exhibition panels) focused on cervical cancer burden, screening, HPV infection, and included statements such as “Previous infection with HPV may not provide sufficient immunity to prevent another infection”, plus branding/straplines including “GlaxoSmithKline is committed to supporting you in the prevention of cervical cancer” and “Cervical cancer prevention for all women”.
GSK briefed representatives not to discuss HPV vaccination or its vaccine in development and to refer persistent product questions to Medical Information.
The Panel initially ruled the materials/activities did not identify a specific medicine or solicit enquiries about GSK’s forthcoming product (no breach).
On appeal, the Appeal Board considered the scale (65 CCDAT members), targeting of potential prescribers, the recruitment framing (disease awareness then launch), and the emphasis on HPV types 16 and 18 (aligned with GSK’s candidate vaccine) cumulatively amounted to pre-authorisation promotion.

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Outcome

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Appeal upheld: the appeal was successful.
Breach of Clause 3.1: arrangements amounted to promotion of a product prior to the grant of its marketing authorization.
Breach of Clause 2: the arrangements would bring discredit upon and reduce confidence in the pharmaceutical industry.
Panel’s original ruling of no breach was overturned by the Appeal Board.

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