GSK travel health “pricing proposal” treated as promotion: uncertified material and missing PI (AUTH/2250/7/09)

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Key facts

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Case number	AUTH/2250/7/09
Company	GlaxoSmithKline UK Ltd
Material	Travel health pricing proposal to local buying group(s)
Trigger	Voluntary admission (matter brought to GSK’s attention by a competitor on 10 June 2009)
Complaint received	14 July 2009
Case completed	24 August 2009
Applicable Code year	2008
Breach clauses	4.1, 4.3, 4.10, 7.2, 7.10, 9.1, 14.1, 15.2, 18.4
No breach	Clause 2; Clause 15.10 (no breach; explanatory)
Key issues	Misleading unqualified claim (“Excellent Products”); missing PI/INN/AE statement; uncertified promotional material; reference to non-promotional medical service in promotional material
Sanctions	Undertaking received
Appeal	No appeal

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

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GSK voluntarily admitted an inadvertent ABPI Code breach relating to a travel health pricing proposal created by a field representative and provided to a local buying group.
A practice manager requested pricing information; the representative could not present in person due to timelines and produced written material within two days.
The representative compiled the document and her regional business manager reviewed and approved it locally (not via head office certification).
Three hard copies were provided (with an approved promotional item). An electronic copy was requested and circulated within the buying group.
The same (slightly edited) material was later provided to a second buying group.
Although framed as a pricing proposal, the inclusion of the claim “Excellent Products” meant it was considered promotional.
The document omitted prescribing information, non-proprietary names next to prominent brand names, and an adverse event reporting statement.
The promotional document also referred to a non-promotional nurse audit medical service (ITHENA Nurse Audit), which should not have been referenced in promotional printed material.

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Breaches were ruled for Clauses 4.1, 4.3, 4.10, 7.2, 7.10, 9.1, 14.1, 15.2 and 18.4.
No breach was ruled for Clause 2.
No breach was ruled for Clause 15.10 (noted as explanatory and not capable of infringement).
Sanction recorded: Undertaking received.
No appeal.

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