AUTH/3559/9/21 - Anonymous v Sanofi

Alleged promotion of Toujeo and Suliqua by health professionals

  • Received
    14 September 2021
  • Case number
    AUTH/3559/9/21
  • Applicable Code year
    2019
  • Completed
    06 June 2022
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

An anonymous complainant who described him/herself as a company employee complained about one of Sanofi’s business units (BU).

The complainant stated that he/she was a current employee of Sanofi and had become more and more concerned with the direction his/her BU was heading. Over the last 18 months or so there had been a clear driver to develop ‘advocates’ for Sanofi’s brands (Toujeo (insulin glargine) and Suliqua (insulin glargine, lixisenatide)) – those health professionals who used Sanofi’s products and were willingly to advocate them to their peers.

The complainant stated that this was normal in pharmaceuticals, however the way it had been briefed made many feel very uncomfortable. Firstly, the materials used had not been approved and constituted a briefing, with clear direction in both documents. Secondly, it was clear in the documents and in various internal conversations, for a health professional to become a DA (developing advocate) and then move to a MA (mobilising advocate), they must use either Toujeo or Suliqua. The health professional would be paid to advocate the products, which based on their qualification to become a mobilising advocate or a developing advocate, could be construed as an inducement to prescribe. There was a meeting in September 2021 with a speaker who had gone through this very process. Lastly, the complainant queried whether the health professionals in question were aware that their data was used in such a fashion and if this constituted a General Data Protection Regulation (GDPR) breach. The complainant stated that this had been raised internally by him/her and several colleagues to various members of the leadership team, all to no avail.

The detailed response from Sanofi is given below.

The Panel noted Sanofi’s submission that one of its business units introduced the term ‘developing advocate’, for health professionals who were not established users of Sanofi products, and ‘mobilising advocate’ where advocacy already existed. Sanofi developed a ‘Toujeo Advocacy Menu’ which was an internal document that listed information on the health professional’s expertise and experience with Toujeo; health professional’s consent, via a certified form, was sought prior to adding them to the advocacy menu which included their biography and area of expertise.

The Panel noted Sanofi’s submission that there were plans to develop an ‘Advocacy Menu’ for Suliqua in 2020 but this was not progressed, due to the Covid-19 pandemic. The Panel therefore only considered the arrangements in relation to Toujeo. The Panel noted Sanofi’s submission about the timing and decided to make its rulings under the 2019 Code.
1 Toujeo brand advocates

The Panel considered that there were a number of potential concerns when pharmaceutical companies developed on going relationships with health professionals who were known prescribers of the company’s medicines. There were requirements in the Code to that effect including the importance of being transparent about the relationships. It was not necessarily a breach of the Code to have such relationships. The difference here was that health professionals who were developed as advocates would be asked to present about Sanofi’s products at meetings and would be paid to do so. This in itself was not necessarily a breach of the Code.

The Panel noted that there was no expectation that any health professional would definitely be asked to be a speaker. The Panel noted Sanofi’s submission that the health professional would be paid for any presentation and that there were no fees for service associated with a health professional giving consent to be included within the ‘Toujeo Advocacy Menu’.

The Panel did not consider that the complainant had established that becoming a Sanofi developing advocate or mobilising advocate would amount to an inducement to prescribe Sanofi’s medicines as alleged and no breach of the 2019 Code was ruled.

The Panel noted that the complainant provided screenshots from a spreadsheet which he/she alleged was briefing material that had not been approved. The Panel noted Sanofi’s submission that the spreadsheet included internal use templates which were to be used in line with training to support employees with local account planning which Sanofi did not consider required separate certification.

The Panel noted that the templates, at the top of the page, had steps to developing an advocate which included identifying an innovator who was willing to prescribe Suliqua/Toujeo in a few patients to gain experience to be followed up to encourage sharing with peers and the development of case studies to use at meetings. Staff were also instructed to ask if the health professional wished to become an advocate and if so a development plan was to be agreed before the health professional moved to becoming a MA.

Sanofi submitted that one member of each diabetes sales team was selected as an advocacy champion; the templates were to be used by these sales team members to support local account planning which instructed them to identify the innovators who were willing to prescribe Suliqua/Toujeo in a few patients to gain experience. In the Panel’s view, it could not see how the material could be seen as anything other than representatives briefing material as set out in the 2019 Code. The Panel noted that the material had not been certified and a breach of the 2019 Code was ruled. The Panel ruled a further breach as the failure to recognise that the material at issue constituted briefing material that required certification meant that Sanofi had not maintained high standards.

2 Meeting

The Panel noted Sanofi’s submission that the named health professional had never consented to, nor been included in the Toujeo Advocacy Menu and was contracted as an external expert and paid in line with fair market value. The Panel considered that the complainant had not established that there was any evidence to show that the engagement of the named health professional, or the arrangements, were an inducement to prescribe a Sanofi medicine as alleged and no breach of the 2019 Code was ruled.

3 Alleged GDPR breach

The Panel noted Sanofi’s submission that all health professionals listed in the ‘Toujeo Advocacy Menu’ provided their consent to be included using a certified consent form which explained how their data would be used. Sanofi submitted that it had investigated the matters raised by the complainant and had not identified any breaches of the UK GDPR.

The Panel noted that there did not appear to have been any formal finding by any judicial authority or appropriate body charged with determining matters in relation to GDPR. The Panel did not consider that the complainant had established that Sanofi’s activities with regards to the inclusion of health professionals’ data within the ‘Toujeo Advocacy Menu’ had breached GDPR. Accordingly, no breach of the 2019 Code was ruled.

The Panel did not consider that the particular circumstances in this case warranted a ruling of a breach of Clause 2 which was a sign of particular censure and was reserved for such use. No breach of Clause 2 was ruled.