AUTH/3487/3/21 - NHS Commissioning Manager v Sanofi

Conduct of staff in relation to flu vaccines

  • Received
    22 February 2021
  • Case number
  • Applicable Code year
  • Completed
    12 August 2021
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

An NHS commissioning manager alleged that, with regard to the flu vaccine, a manager of Sanofi Pasteur Vaccines and the Sanofi flu team had encouraged the purchase of quadrivalent vaccine egg grown (QIVe) contrary to official guidelines which recommended the purchase of either adjuvanted quadrivalent vaccine (aQIV) or quadrivalent vaccine cell based (QIVc). Sanofi Pasteur marketed QIVe.
The complainant stated that on 3 February 2021, he/she and a colleague circulated the NHS England/Ireland (NHSE/I) flu reimbursement letter (signed by Professor Powis) to local practices and summarized the key points. This set out the vaccines for each cohort eligible for free NHS flu vaccine: it was recommended those aged 65 years and over should receive aQIV or QIVc where aQIV was not available; at-risk adults, including pregnant women, aged 18 to less than 65 years were recommended QIVc, or QIVe where QIVc was not available.

The complainant stated that in order to ensure that patients within the area had access to the most effective vaccine, additional guidance was issued to local practices in February 2021. Subsequently, a number of enquiries were received about the purchase of QIVe, as an alternative to QIVc, because a number of practices had ordered QIVe ahead of the NHSE/I reimbursement letter and now sought clarification regarding reimbursement or cancellation. As a result, further clarification was sent to practices and others in February 2021 to ensure that practices ordered sufficient stocks of QIVc and aQIV to vaccinate their eligible population to the level indicated by NHSE/I and to, as a minimum, improve on their 2020/21 uptake rates. The clarification was also intended to ensure QIVc would be ‘available’ and therefore hopefully avoid the purchase of QIVe. If later in the season, as a result of high vaccine uptake rates, further orders of QIVc were required but not available to order, it would be acceptable to order QIVe. ‘Not available’ was unlikely to be before the flu season had started, ie September at the earliest. This might have resulted in those practices that ordered ‘at risk’ before the NHSE/I reimbursement letter was published, cancelling their orders of QIVe.

The complainant was asked to respond to a telephone call and an email from a Sanofi manager and a query on behalf of a GP practice.

The complainant was concerned by both the individual’s behaviour and the flu team’s behaviour. The complainant believed these were linked and both breached the Code in spirit and in letter.

The complainant alleged that the content of the email, sent to a GP practice by the Sanofi flu team contradicted guidance given by the NHSE Regional Commissioners; the email was misleading and led the practice to believe that it would, without question, be reimbursed for its order of QIVe. Clearly the order had been placed recently, when QIVc was available in sufficient volumes to be ordered. The complainant submitted that thankfully the practice sought additional guidance from its clinical commissioning group (CCG). The complainant was concerned that if practices did not seek additional clarification and acted on the advice of Sanofi, it would lead to conflict between practice and commissioners in the next seven months.

The complainant and his/her practice had clearly stated that they currently did not support the ordering of QIVe when ample supplies of the most effective vaccine were available to order. The complainant and his/her practice did not believe QIVc would become ‘unavailable’ until later in the season, if at all.

The complainant was particularly concerned about the email from Sanofi’s manager including the purpose of his/her engagement activities with an NHS manager who was not a decision maker or a prescriber. The complainant alleged that the tone of the email was threatening, manipulative and sought to undermine confidence in the guidance issued by regional commissioners and cause fear of risk. The Sanofi manager’s advice was not accurate and was likely to underpin the comments made by the flu team and ultimately lead to conflict between GP practices and commissioners in the next seven months ie specifically when practices sought reimbursement for the purchase of QIVe vaccine orders placed when QIVc, the most effective vaccine, was available to order.

The complainant provided detail comment on the correspondence submitted that he/she would like to understand whether the Sanofi NHS manager was acting alone or in line with company policies. The complainant questioned whether the Sanofi manager’s training included acting to undermine confidence in national commissioning policy, local guidance and making threats regarding the potential consequences of such.

The detailed response from Sanofi is given below.

The Panel noted that the Powis letter (dated 3 February) sent, inter alia, to all GP practices set out the official NHS guidance about which flu vaccines would be reimbursed as part of the NHS 2021/22 flu vaccine programme for adults; the letter was signed by the national medical director for NHS England. The summary of the key points was clear that aQIV was to be used as the first-choice vaccine in patients 65 and over with QIVc to be used where aQIV was not available. QIVc was to be the vaccine of choice in at risk adults, including pregnant women, aged 18 to less than 65 years; the alternative QIVe was to be used where QIVc was not available. Sanofi Pasteur’s vaccine, QIVe, was thus recommended only for second line use in the at-risk population. The letter advised providers to plan their vaccine ordering to at least equal the high levels of uptake achieved in 2020/21. The Panel considered that the official NHS letter implied that QIVe would only be reimbursed in circumstances where QIVc was not available.

The Panel noted that Sanofi’s briefing material, issued February 2021, provided its customer facing teams with an understanding of the official NHS flu vaccine reimbursement letter. The material advised the Sanofi team to accept all customer cancellations reactively based on the guidance. On 19 February, the Sanofi flu team sent an email to existing flu customers which stated that ‘your flu vaccine order remains fully reimbursable in line with NHS guidelines’. Noting the content of the official NHS letter sent earlier in the month, the Panel queried whether that was correct so early on in the season ie when QIVc could still be ordered. In that regard, the Panel noted from correspondence provided by the complainant, that the email had caused confusion amongst some of its recipients. The Panel noted Sanofi’s submission that a link to its online ordering system ‘Vaxishop’ was provided so that customers could easily amend or cancel their orders, however it appeared that readers were only pointed in the direction of Vaxishop so that they could ‘check’ their orders. The Panel did not consider, given they had been told by Sanofi that their flu vaccine order for QIVe would be ‘fully reimbursable’, that the email would prompt customers to consider cancelling their order.

It appeared to the Panel that practices in the complainant’s remit should set out in February to order enough aQIV and QIVc to vaccinate their eligible populations to the level indicated by NHSE/I and to improve uptake in the at-risk group vs the 2020/21 uptake rates. It was made clear that practices were not expected to order QIVe before the flu vaccine season started. If, however, later in the season and not before September, and as a result of higher than planned for vaccine uptake, further orders of QIVc were required but QIVc was no longer available, then it would be acceptable to order QIVe. In those circumstances practices would be reimbursed for the purchase of QIVe.

The Panel noted that both the complainant and Sanofi were concerned to ensure that sufficient vaccines were available for the forthcoming flu vaccination programme; the difference of opinion between the parties was about the status of QIVe and how late in the flu vaccination season practices could wait before they ordered QIVe with any confidence of those orders being fulfilled. The complainant’s view was that there should be adequate supplies of aQIV and QIVc if practices ordered sufficient volumes, in excess of uptake figures from the previous flu season, at the outset. QIVe should only be ordered later in the year if more than expected QIVc was needed but was unavailable. The Panel considered that the complainant had in effect advocated that any early orders for QIVe should be switched in QIVc now so that there was unlikely to be a shortfall in the supply of that vaccine in September. However, The Panel considered that ordering in February and ensuring an adequate supply of vaccine doses once the flu vaccination season arrived was not straightforward as the manufacture and distribution of flu vaccines relied upon orders being received months in advance. It was important to Sanofi that practices and the complainant understood that, in the absence of early orders, it was unlikely that the company would have surplus supply of QIVe at the start or during the flu vaccine season and so if orders for QIVe, to be used instead of QIVc in the at risk group, were not placed before September then it was likely that they would not be filled. The email from the Sanofi manager had set out a number of reasons for that view.

Neither the email from customer services at Sanofi dated 19 February and sent to existing flu customers, which stated that ‘We would like to reassure you that your flu vaccine order remains fully reimbursable in line with NHS guidelines’, nor the email from the manager (19 February), referred to the advice that orders could be amended or cancelled. Neither email referred to the need for practices to have sufficient stock of alternative flu vaccine ordered prior to cancelling any orders for QIVe. The Panel noted that the email from the flu team to existing customers had been misclassified as a purchase-related logistical email and so had been not formally reviewed as per the company’s Review and Approval SOP. The email from the manager dated (19 February) had also not been certified; it was sent without discussion or agreement by Sanofi.

The Panel considered that the email from the Sanofi flu team was misleading in that it appeared to guarantee that orders for QIVe already placed in February would be fully reimbursable when the official NHS letter implied that QIVe would only be reimbursable where QIVc was not available. In the Panel’s view, it was not for Sanofi to appear to infer differently. Although the Panel did not consider that the email disparaged health professionals, and so in that regard ruled no breach of the Code, high standards had not been maintained and a breach of the Code was ruled. Although noting its comment and rulings, the Panel did not consider that the email did not recognise the special nature of medicines nor the professional standing of the audience to whom it was directed. No breach of the Code was ruled.

The Panel noted the content of the manager’s email and considered that statements such as ‘Some CCGs within [named area] are threatening Practices with Non‐reimbursement if QIVe is ordered/not cancelled’ and ‘This demonstrates a complete lack of understanding of the Flu manufacturing and Northern Hemisphere flu dose distribution process’ were disparaging. The Panel noted that both Sanofi and the manager recognised that some of the wording had been poorly chosen. The Panel considered that high standards had not been maintained and that the email did not recognise the professional standing of the audience to whom it was directed. Breaches of the Code were ruled including that the manager who had sent the email had not maintained a high standard of ethical conduct.

The Panel was concerned that the emails from the flu team and from the Sanofi manager appeared to call in to question the official NHS guidance with regard to the reimbursement and choice of flu vaccines. The Panel noted the complainant’s submission that both communications could have led to conflict between GP practices and commissioners. The Panel considered that such activity brought discredit upon the pharmaceutical industry and a breach of Clause 2 was ruled.