Sanofi: Toujeo Coach webinar invitation briefing materials (no breach) | AUTH/3454/1/21

📅 2021 | 🖉 Dr Anzal Qurbain
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Key facts

CaseAUTH/3454/1/21
ComplainantAnonymous, non-contactable employee (described themselves as a Sanofi representative)
CompanySanofi
Material/activityBriefing materials for representatives; certified email invitation and certified briefing document for Toujeo Coach webinars aimed at health professionals
MedicineToujeo (insulin glargine solution (300 units/ml) for injection in a pre-filled pen)
Indication (as stated)Treatment of diabetes mellitus (also stated: in adults, adolescents and children from the age of 6 years)
Main allegationsCopy/paste of invitation could cause errors/missing data; tracking invites could pressure non-compliant sending; possible uncompliant reminder emails; culture/concerns ignored
Applicable Code year2019
Clauses considered9.1, 14.1, 15.2, 15.9
OutcomeNo breach
Complaint received20 January 2021
Case completed8 September 2021
AppealNo appeal

Download the full case report (PDF)


Reviewed by Dr Anzal Qurbain (FFPM) β€” ABPI Final Signatory

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What happened

  • An anonymous, non-contactable complainant (describing themselves as a Sanofi representative) raised concerns about briefing materials for Toujeo Coach, a patient support programme for adults prescribed Toujeo, and related webinar invitations to health professionals.
  • The complainant alleged that after an β€œerror” with an approved invitation, representatives were told to copy and paste the invitation content and send it themselves, which might lead to errors or missing data.
  • The complainant alleged representatives were asked to track how many invitations they sent, potentially creating pressure to send to as many HCPs as possible β€œwhether compliant or not”.
  • The complainant suggested a named colleague had possibly sent uncompliant reminder emails.
  • Sanofi stated representatives had a certified email invitation and a certified briefing document, with clear instructions that only names/email addresses could be changed and the content/subject line must not be amended.
  • Sanofi said the β€œcopy/paste” instruction was already in the certified briefing and was re-communicated after a technical issue (a greyed-out send button) was reported.
  • Sanofi said the request to report numbers invited was to gauge interest and plan attendance; there were no targets and no contact metrics tied to the activity.
  • Sanofi said it could not evidence reminder emails (no CRM record; representative had no recollection; email retention policy of 90 days; no certified reminder invites existed for the November webinars).
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Outcome

  • No breach of the Code was found.
  • The Panel ruled no breach of Clauses 14.1 and 15.9 regarding certification/briefing and the copy/paste instruction.
  • The Panel ruled no breach of Clause 15.9 regarding the request to track and report the number of invitations sent.
  • The Panel ruled no breach of Clause 15.2 regarding the allegation of uncompliant reminder emails (complainant did not discharge burden of proof).
  • The Panel ruled no breach of Clause 9.1 (high standards).
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