AUTH/3491/3/21: Complainant v Sanofi — Suliqua off-licence promotion allegation (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/3491/3/21
Company	Sanofi
Complainant	Anonymous, non-contactable (self-described health professional)
Product	Suliqua (pre-filled pen of insulin glargine and lixisenatide)
Allegation	Off-licence promotion: starting Suliqua while leaving patient on basal insulin (potential overdose risk)
Applicable Code year	2019
Clauses considered	2; 3.2; 7.2; 9.1; 15.9
Panel decision	No breach of the Code
Complaint received	15 March 2021
Case completed	6 October 2021
Appeal	No appeal
Notes on evidence	Panel did not have the information in question; nurse not identifiable; Sanofi reported no evidence in CRM/interviews of off-licence promotion
Third-party factor	Local APC formulary wording (independent of Sanofi) was inconsistent with SPC; amended 17 March 2021 after Sanofi contacted APC

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

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An anonymous, non-contactable complainant (self-described health professional) alleged off-licence promotion of Suliqua (insulin glargine/lixisenatide) by Sanofi.
The complainant said a diabetes nurse believed—based on information received from Sanofi—that Suliqua could be started while the patient remained on basal insulin.
The complainant said a BNF check indicated this was incorrect and could have led to insulin overdose; they queried whether this reflected Sanofi direction to staff.
Sanofi said the complainant provided no evidence and the allegation was based on what a third party (the nurse) supposedly received.
Sanofi noted a local Area Prescribing Committee (APC) formulary entry (set independently of Sanofi) had wording inconsistent with the Suliqua SPC and similar to the alleged approach.
Sanofi said it found no evidence in its CRM system or staff interviews of off-licence promotion; it could not investigate the specific interaction without identifiable details of the nurse.
Sanofi said representatives were trained/validated on the SPC and materials were certified; it provided SOP requirements for briefing/training customer-facing teams.
Sanofi proactively contacted the APC (via medical) about the inconsistency; the APC amended the entry on 17 March 2021.

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No breach of the ABPI Code of Practice (2019) was found.
The Panel ruled the complainant had not discharged the burden of proof that a Sanofi representative engaged in off-licence discussions.
No breach was ruled for Clauses 3.2, 7.2, 15.9, 9.1 and 2.

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