Sanofi: anonymous ex-employee allegations about medical team contact targets, unlicensed promotion and NICE/CDF lobbying (AUTH/2504/5/12) – no breach | PMCPA Case

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Key facts

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Case number	AUTH/2504/5/12
Parties	Anonymous ex-employee v Sanofi
Topic	Activities of sales and medical teams; contact rates; alleged promotion of unlicensed medicines; request for HCP support re NICE/CDF
Complaint received	09 May 2012
Case completed	11 July 2012
Applicable Code year	2012
Clauses considered	2, 3.1, 9.1, 15.2, 15.4 and 15.9
Decision	No breach
Appeal	No appeal
Products mentioned	Jevtana (cabazitaxel); iniparib (referred to as “parp inhibitor”); ombrabulin; larotaxel; alvocidib
Notable Panel observations	Scientific advisors had a mixed non-promotional/promotional role; lack of formal briefing documents was unacceptable/poor practice; company advised to review role in light of informal guidance on Clause 3

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

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What happened

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An anonymous, non-contactable complainant (stating they were an ex-employee) alleged Sanofi’s medical oncology team was pressured to proactively generate contacts with key oncologists and that contact rates were monitored.
The complainant alleged the medical team was sometimes asked to act like an “extra sales team” and was pushed to promote unlicensed medicines (named: “parp inhibitor” (iniparib presumed), ombrabulin, larotaxel, alvocidib; and also mentioned cabazitaxel/Jevtana).
The complainant alleged sales representatives were instructed to plan at least 12 calls per year on key customers (exceeding Code expectations).
The complainant alleged representatives were instructed to ask key customers to write to NICE to challenge a negative decision on cabazitaxel (Jevtana), and referenced an email where an oncologist described a request as unethical/unprofessional.
Sanofi denied the allegations, stated scientific advisors’ role was to provide balanced, non-promotional scientific/technical information, and said there were no contact rate targets tied to objectives or remuneration (only a broad expectation of a certain number of customer contacts per week, including face-to-face, meetings, substantive email responses or telephone calls).
Sanofi said it found no evidence of a “12 contact rule” and that such a rate would be inappropriate/non-compliant.
On the NICE-related allegation, Sanofi said the email in question related to a request for support for a Cancer Drugs Fund (CDF) application for Jevtana funding in one region, not the NICE review; the representative said they were unaware the HCP had been supported by Sanofi to attend a congress and would not have approached them if they had known.

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Outcome

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No breach of the ABPI Code was ruled in relation to the matters considered.
The Panel concluded there was no evidence to support the alleged excessive call rates, proactive promotion of unlicensed medicines, or failure to maintain high standards in the CDF-support contact.
However, the Panel stated it was unacceptable that Sanofi provided little in the way of formal briefing documents for scientific advisors, describing this as poor practice and noting the company was vulnerable under the Code due to the dual nature of the role.

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Sanofi: anonymous ex-employee allegations about medical team contact targets, unlicensed promotion and NICE/CDF lobbying (AUTH/2504/5/12) – no breach

Key facts

What happened

Outcome

Clauses

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