Sanofi: uncertified advocacy planning templates treated as reps’ briefing material (Toujeo) (AUTH/3559/9/21)

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Key facts

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Case	AUTH/3559/9/21
Parties	Anonymous v Sanofi
Products	Toujeo (insulin glargine); Suliqua (insulin glargine, lixisenatide)
Main issue	Alleged promotion via HCP “advocates”; alleged inducement; alleged GDPR concerns; use of uncertified internal briefing/templates
Applicable Code	2019
Complaint received	14 September 2021
Case completed	6 June 2022
Appeal	No appeal
Breach clauses	9.1; 14.1
No breach clauses	2; 1.11; 23.1
Sanctions	Undertaking received; Additional sanctions: Not stated
PMCPA summary link	https://www.pmcpa.org.uk/cases/completed-cases/auth3559921-anonymous-v-sanofi

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

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An anonymous complainant (describing themselves as a Sanofi employee) raised concerns about a business unit’s push to develop health professional “advocates” for Toujeo (insulin glargine) and Suliqua (insulin glargine, lixisenatide).
The complainant alleged: (1) materials used to brief staff were not approved/certified; (2) HCPs had to use Toujeo/Suliqua to progress from “developing advocate” (DA) to “mobilising advocate” (MA) and would be paid to advocate, potentially inducing prescribing; (3) a September 2021 meeting featured a speaker who had gone through the process; (4) HCP data (including prescribing habits/plans) was used in a way that might breach GDPR.
Sanofi explained it used “DA/MA” terminology; had a certified consent form for inclusion in an internal “Toujeo Advocacy Menu” (speaker bank) and said there were no fees for being listed and no guarantee of speaking engagements.
The Panel focused on Toujeo (a planned Suliqua advocacy menu was not progressed) and ruled under the 2019 Code.
The Panel reviewed screenshots of Excel spreadsheet tabs used as local account planning templates for “advocacy champions” and considered whether these were representatives’ briefing material requiring certification.

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No breach of inducement provisions: the complainant did not establish that DA/MA status or the September 2021 engagement amounted to an inducement to prescribe.
No breach found in relation to the alleged GDPR issue: no formal finding by an appropriate authority and the complainant did not establish a GDPR breach in relation to the Toujeo Advocacy Menu.
Breach found because the Excel templates were considered representatives’ briefing material and had not been certified.
Breach found for high standards due to failure to recognise the material required certification.
No breach of Clause 2 (particular censure) in the circumstances.

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