AUTH/1917/11/06: Primary Care Trust Senior Pharmacist v Pfizer – Champix pre-launch presentation (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/1917/11/06
Complainant	Primary Care Trust senior pharmacist (prescribing and management team)
Company	Pfizer Limited
Medicine	Champix (varenicline)
Issue	Alleged advance notification / pre-launch presentation to stop smoking service
Key date (marketing authorisation)	26 September 2006 (EMEA)
Complaint received	10 November 2006
Case completed	29 January 2007
Applicable Code year	2006
Clauses considered	2, 3.1 and 9.1
Outcome	No breach
Appeal	No appeal

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

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A senior pharmacist in a Primary Care Trust (PCT) complained about a Pfizer presentation on Champix (varenicline) to members of a local stop smoking service.
The complainant alleged the activity amounted to advance notification because Pfizer anticipated a formal launch in December 2006 and the stop smoking service did not (in the complainant’s view) make entry/policy decisions or hold the relevant budget.
An email from the representative described the aim as modelling the financial and clinical impact of introducing Champix within a defined health economy, and invited the complainant to a similar presentation and a more detailed clinical presentation.
Pfizer stated Champix received an EMEA marketing authorisation on 26 September 2006; the meeting explained the regulatory status and that Pfizer would not generate demand or promote until after formal launch.
Pfizer said the presentation followed an unsolicited request for information; the representative referred the enquiry to the primary care account management (PCAM) team, who confirmed attendees were budget holders for smoking cessation products and reconfirmed this at the start of the meeting.
The PCAM presented a local budget impact model and left a pre-launch formulary summary and a smoking cessation backgrounder for the head of service.

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No breach of the Code.
No breach of Clause 3.1 (advance notification allegation) because Champix already had a marketing authorisation at the time of the presentation (even though Pfizer delayed formal launch).
Consequently, no breach of Clauses 9.1 and 2.

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