AUTH/2392/2/11: Anonymous v Sanofi-Aventis — patients attended Multaq promotional meeting | PMCPA Case

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Key facts

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Case	AUTH/2392/2/11
Parties	Anonymous v Sanofi-Aventis
Issue	Patients attended a promotional meeting where Multaq (dronedarone) was promoted; representative conduct and hospitality concerns
Product	Multaq (dronedarone)
Meeting setting	Restaurant private room; promotional meeting for health professionals
Public attendees	Two patients (speakers) and one spouse/carer (members of the public)
Hospitality	40 set meals pre-ordered (£22.24/head); drinks £185.70
Applicable Code	2008 edition (considered under 2011 Constitution and Procedure)
Complaint received	28 February 2011
Case completed	28 April 2011
Breach clauses	15.2 and 22.1
No breach clauses considered	2, 9.1, 19.1
Appeal	No appeal
Sanctions	Undertaking received; additional sanctions not stated

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

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A Sanofi-Aventis representative organised a restaurant-based promotional meeting (Nov 2010) on “New advances in atrial fibrillation management”.
A consultant cardiologist speaker told the representatives two days before the meeting he was considering inviting patients; on the evening he confirmed he had invited two patients to attend and speak.
Two patients spoke (~10 minutes) after the consultant’s presentation (~1 hour 15 minutes). A spouse attended as a carer.
The consultant’s slides promoted Sanofi-Aventis’ product Multaq (dronedarone).
One patient left before the meal; one patient and spouse stayed and ate with health professionals. Representatives assumed the consultant had invited them to stay.
Hospitality: 40 set meals pre-ordered at £22.24 per head; drinks cost £185.70. The company had a list of 40 HCP attendees but did not appear to have a record of the 2 patients and 1 spouse.

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Breach of Clause 22.1 (promotion of a prescription only medicine to the public) because patients attended a meeting where Multaq was promoted.
Breach of Clause 15.2 (representatives must maintain high standards) due to failure to remain in control of meeting arrangements and unprofessional handling.
No breach of Clause 19.1 (meetings and hospitality) regarding the meal provided to the patient speaker and carer, in the circumstances.
No breach of Clause 9.1 (high standards) as the issue was covered by the Clause 15.2 breach.
No breach of Clause 2 (discredit to the industry) — Panel concerned but did not consider it warranted particular censure.
No appeal.

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