AUTH/3520/6/21: NHS commissioning manager v Sanofi (flu vaccine promotion/availability) – No breach | PMCPA Case

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Key facts

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Case number	AUTH/3520/6/21
Complainant	NHS commissioning manager
Company	Sanofi (Sanofi Pasteur)
Product / area	Flu vaccines (QIVe and QIVr; references to QIVc and aQIV in NHS guidance)
Main issue	Alleged assertive pre-guidance marketing/discounting; alleged restriction of cancellations; and communications around a 30% reduction in QIVe orders with QIVr as an alternative
Key communication date	13 May 2021 (email advising automatic 30% reduction of QIVe orders)
Clauses considered	Clause 2; Clause 7.2; Clause 9.1; Clause 15.2
Outcome	No breach
Complaint received	2 June 2021
Case completed	28 September 2021
Applicable Code year	2019
Appeal	No appeal

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

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What happened

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An NHS commissioning manager complained about Sanofi Pasteur’s promotion and availability of flu vaccines for the 2021/22 season, following an earlier complaint about QIVe (egg-based) and now also concerning QIVr (recombinant).
The complainant alleged Sanofi ran an assertive pre-guidance campaign (from Sept 2020) offering significant discounts to induce GP practices to pre-order QIVe ahead of JCVI/NHS reimbursement guidance.
The complainant alleged that in Jan/Feb 2021 some practices were prevented from cancelling QIVe orders to switch to preferred QIVc (cell-based) after local clarification of the reimbursement letter.
The complainant said NHSE/I national team indicated in March 2021 that Sanofi had a shortfall of around 1 million QIVe doses and would struggle to fulfil its order book; Sanofi was advised to release practices from orders to switch to QIVc.
On 1 April 2021, updated NHS guidance expanded the programme (including ages 50–64) and added QIVr as reimbursable for certain under-65 groups; recommended vaccines were QIVc or QIVr, with QIVe as an alternative if those were not available.
On 13 May 2021, practices received a Sanofi email stating QIVe orders would be automatically reduced by 30% due to increased global demand; the email suggested contacting other suppliers or Sanofi for an alternative vaccine consistent with NHS guidance.
The complainant was concerned the reduction came shortly after the QIVc order window closed and questioned whether Sanofi’s alternative (QIVr) being ~4x the price of QIVe created an incentive to steer practices to the higher-priced product.
Sanofi denied preventing cancellations and cited certified briefing material instructing field staff to accept cancellations. Sanofi said the supply issue and mitigation discussions with government teams were confidential and not known to the representative at a 30 April meeting.

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Outcome

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No breach of the ABPI Code was ruled.
The Panel found no evidence that the representative failed to maintain a high standard of ethical conduct or misled about QIVe supply.
The Panel found no evidence Sanofi influenced QIVe supply to preferentially sell higher-priced QIVr.
The Panel noted the timing was “unfortunate” and that the 13 May email could have been clearer that demand had outstripped Sanofi’s capacity (suggesting the issue was not truly “global” in the sense implied), but this did not amount to a breach.

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AUTH/3520/6/21: NHS commissioning manager v Sanofi (flu vaccine promotion/availability) – No breach

Key facts

What happened

Outcome

Clauses

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