AUTH/2392/2/11: Patients attended Multaq promotional meeting (Anonymous v Sanofi-Aventis)

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Key facts

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Case	AUTH/2392/2/11
Parties	Anonymous v Sanofi-Aventis
Issue	Patients/public attended a promotional meeting where Multaq (dronedarone) was promoted; conduct of representatives and hospitality concerns
Product	Multaq (dronedarone)
Meeting setting	Restaurant private room; promotional meeting for health professionals
Public attendees	2 patients (speakers) + 1 spouse (carer)
Timing	Meeting held November 2010
Hospitality	40 set meals pre-ordered at £22.24 per head; drinks £185.70
Complaint received	28 February 2011
Case completed	28 April 2011
Applicable Code	2008 edition (considered under 2011 Constitution and Procedure)
Breach clauses	15.2 and 22.1
Sanctions	Undertaking received; additional sanctions not stated
Appeal	No appeal

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

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An anonymous, contactable complainant raised concerns about a restaurant promotional meeting (Nov 2010) organised by two Sanofi-Aventis representatives with a consultant cardiologist.
The meeting topic was “New advances in atrial fibrillation management”.
Two days before the meeting, the consultant mentioned he was considering inviting patients to give a patient perspective; on the evening he confirmed he had invited two patients to speak.
Three members of the public attended: two patients (speakers) and the wife of one patient (carer).
The consultant presented for ~1 hour 15 minutes using slides that promoted Multaq (dronedarone); patients then spoke for ~10 minutes about their experiences.
A set meal for 40 was pre-ordered (£22.24 per head) with drinks (£185.70). One patient left before the meal; the other patient and spouse stayed and ate with attendees.
Representatives assumed the consultant had invited the patient and spouse to stay for the meal; the Panel said representatives must remain in control of meeting arrangements.
Sanofi-Aventis accepted the arrangements technically breached Clause 22.1 because patients were present during a promotional meeting, but denied other alleged breaches.

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Breach of Clause 22.1 (advertising a prescription only medicine to the public) because patients attended a meeting where Multaq was promoted.
Breach of Clause 15.2 (high standards) due to failure to maintain control and ensure arrangements complied with the Code.
No breach of Clause 19.1 (meetings and hospitality) in relation to providing a meal to the patient speaker and carer, in the circumstances.
No breach of Clause 9.1 (covered by the Clause 15.2 breach).
No breach of Clause 2 (not considered sufficiently serious for particular censure).
No appeal.

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