Sanofi: flu vaccine ordering emails misled on NHS reimbursement and disparaged NHS bodies (AUTH/3487/3/21)

📅 2021 | 🖉 Dr Anzal Qurbain
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Key facts

Case numberAUTH/3487/3/21
ComplainantNHS commissioning manager
CompanySanofi (Sanofi Pasteur Vaccines)
Product / contextSeasonal influenza vaccines; QIVe (egg-grown), aQIV, QIVc
Main issueEmails suggested QIVe orders were “fully reimbursable” and included disparaging statements about NHS bodies/understanding; communications not certified and one was misclassified to avoid formal review
Complaint received22 February 2021
Case completed12 August 2021
AppealNo appeal
Applicable Code year2019
No breachClause(s) 8.2, 9.2
BreachClause(s) 2, 8.2, 9.1, 9.2, 15.2
Sanctions appliedUndertaking received; Advertisement

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

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What happened

  • An NHS commissioning manager complained that Sanofi staff encouraged ordering quadrivalent influenza vaccine egg-grown (QIVe) contrary to official NHS guidance which positioned QIVe as second-line (only where QIVc was not available) for at-risk adults aged 18 to <65.
  • Official NHS England/Ireland reimbursement guidance (Powis letter, 3 February 2021) recommended:
    • Age 65+: aQIV first choice; QIVc if aQIV not available.
    • At-risk adults 18–<65 (including pregnant women): QIVc first choice; QIVe only where QIVc not available.
  • Local NHS clarification (February 2021) aimed to ensure practices ordered sufficient aQIV/QIVc and to avoid QIVe early; “not available” was unlikely before September at the earliest.
  • On 19 February 2021, Sanofi’s flu team emailed existing customers stating: “We would like to reassure you that your flu vaccine order remains fully reimbursable in line with NHS guidelines”, directing them to Vaxishop to “check” orders.
  • A Sanofi manager separately emailed an NHS manager (after a call), including statements such as: “Some CCGs… are threatening Practices with Non-reimbursement…” and “This demonstrates a complete lack of understanding of the Flu manufacturing…”; the email was not certified and was sent without company discussion/agreement.
  • The flu team email was misclassified as a purchase-related logistical email and was not formally reviewed under Sanofi’s Review and Approval SOP.
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Outcome

  • The Panel ruled the flu team email was misleading because it appeared to guarantee reimbursement for QIVe orders placed in February, whereas the NHS letter implied QIVe would only be reimbursed where QIVc was not available.
  • The Panel ruled the manager’s email contained disparaging statements and failed to maintain high standards and professional respect.
  • The Panel was concerned both emails appeared to call into question official NHS guidance and could lead to conflict between practices and commissioners, bringing discredit upon the industry.
  • No breach findings were made for Clause 8.2 and Clause 9.2 in relation to the flu team email (but breaches were found for those clauses in relation to the manager’s email).
  • Case completed 12 August 2021; no appeal.
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