AUTH/2197/1/09: Sanofi Pasteur MSD v MASTA — Unsolicited ‘Epaxal costings’ promotional email and inadequate Code training

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Key facts

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Case number	AUTH/2197/1/09
Parties	Sanofi Pasteur MSD v MASTA
Product	Epaxal Hepatitis A vaccine
Issue	Unapproved promotional email (“Epaxal costings”) without prescribing information; inadequate representative training and high standards concerns
Complaint received	09 January 2009
Case completed	02 March 2009
Applicable Code year	2008
Breach clauses	9.1, 15.1 and 15.2
Appeal	No appeal
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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Sanofi Pasteur MSD complained about an email headed “Epaxal costings” sent by a MASTA representative to a customer in October 2008.
Although framed as cost information, the email contained multiple product claims and was considered promotional.
The email was not internally approved/certified and did not include prescribing information.
Sanofi Pasteur MSD also challenged MASTA’s follow-up actions, citing an internal email to the sales team that linked to an out-of-date (2006) Code and did not amount to adequate training.
Sanofi Pasteur MSD noted a similar prior issue (2007) and said MASTA had provided written assurances in November 2007, yet similar activity recurred.

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Breach found for the representative’s conduct: Clause 15.2.
Breach found for inadequate training and failure to maintain high standards: Clauses 15.1 and 9.1.
On the “persistent activity despite previous assurances” point, the Panel considered this was covered by the Clause 9.1 breach already ruled under the training issue.
No appeal.

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