Public reprimand for Sanofi - CASE/0689/08/25

“Sanofi has been publicly reprimanded by the Code of Practice Appeal Board for its very serious breaches of the ABPI Code, related to disparaging claims and comparisons made about the UK’s RSV vaccination programme for infants, which were based on a highly misleading interpretation of data.

The Appeal Board considered the findings from Case/0689/08/25, which related to a complaint about articles in the Sunday Express and the Health Service Journal, and two related social media posts. The Panel had ruled breaches of Clauses 2(x3), 5.1(x3), 6.1(x3), 6.2(x3), 6.6(x3), 8.1(x2), 26.1(x2) and 26.2(x2) of the Code.

The Appeal Board also took account of the related Case/0518/03/25, in which the Panel had ruled breaches of Clauses 2, 5.1, 6.1(x2), 6.2(x2), 6.6, 26.1, 26.2(x3).

The Appeal Board bore in mind that the Panel decided to report Sanofi to the Appeal Board because of the cumulative and serious nature of the breaches of the Code. The Panel gave the following key reasons for its decision to report Sanofi to the Appeal Board in relation to the significant multiple breaches:

1.      Since the Covid-19 pandemic there has been a degree of public scepticism and debate about vaccine efficacy. It is therefore critical that material about vaccine efficacy (particularly in relation to public health vaccination campaigns) is accurate. Misleading claims and comparisons can undermine the public’s trust in vaccination campaigns, leading to fewer people being vaccinated and, ultimately, creating public health concerns.

2.      This was not an isolated incident but part of a broader campaign across different media outlets.

3.      The broad readership of the mainstream publications, namely:

a.     new and expectant parents and the general public (Sunday Express);

b.     health professionals, decision makers and those influencing immunisation programmes (HSJ), and

c.     the broad reach of social media (LinkedIn).

4.      The claims/comparisons (and the disparagement of Pfizer’s medicine and the UK Government’s vaccination programme) were premised on a very misleading interpretation of the data and were not substantiable.

5.      It is important that the Panel can rely upon a company’s response. Sanofi did not appear to have done its due diligence before submitting its initial response because:

a.     it implied that the reference to public dissemination in the ‘approval’ of the HSJ article also covered the LinkedIn posts, rather than an awareness that these were different materials requiring separate approval, and

b.     the true picture in relation to certification only became apparent after further enquiries from the Panel.

Further to this, the Panel also raised concerns in the report to the Appeal Board about how Sanofi had behaved both during intercompany dialogue (ICD) stage and once the complaint had been made to the PMCPA. The Panel noted that Sanofi had not provided full information to Pfizer during the ICD.

At the May 2026 Appeal Board meeting, representatives of Sanofi accepted:

1. the serious nature of the breaches,

2. the impact the company’s actions had or were likely to have on the wider vaccination programme, and

3. that there were cultural, compliance and governance issues within Sanofi at the time.

The Appeal Board wholeheartedly agreed with the concerns raised by the Panel about the nature and seriousness of the breaches. The use of thoroughly misleading data, on multiple occasions, to disparage a competitor’s medicine (and, by association, a critically important national vaccination programme) was indicative of a complete absence of appropriate compliance checks and balances and a culture within Sanofi that significantly brought the pharmaceutical industry into disrepute.

The Appeal Board was also extremely concerned by the manner in which Sanofi had engaged with Pfizer in the ICD, and with the PMCPA in relation to the complaint. The Appeal Board considered that such conduct undermined effective self-regulation, which required frankness, transparency and proper engagement at all stages of the process.

For these reasons, the Appeal Board had no hesitation in concluding that Sanofi should be publicly reprimanded as an additional sanction.

The Appeal Board also considered whether to require an audit of Sanofi’s procedures in relation to the Code, to be carried out by the PMCPA. On hearing from the representatives of Sanofi, all of whom had leadership roles, and all bar one having come to their role after the complaints were made, the Appeal Board took account of Sanofi’s submission that the new leadership was delivering a change of culture and governance.

Sanofi informed the Appeal Board that an audit by a third party was imminent, in which all procedures in Sanofi would be ‘pressure tested’.

Rather than require a PMCPA audit at this stage, the Appeal Board decided to require a senior representative from Sanofi to attend the Appeal Board in October 2026. At that meeting, the Appeal Board expected Sanofi to provide a copy of the third-party audit report and to provide details of the actions it has taken, and is taking, as a result of that audit. The Appeal Board would expect the third-party audit to assess, as a minimum, Sanofi’s culture, compliance programme, Code adherence and implementation of SOPs. The Appeal Board reserved the decision regarding the application of additional sanctions until consideration of this information.”