Sanofi Lantus rebates: employee alleged anti-competitive strategy (No breach, Clause 5.1)

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Key facts

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Case	AUTH/3549/7/21
Parties	Employee v Sanofi
Product	Lantus (insulin glargine)
Issue	Alleged anti-competitive use of rebates to limit biosimilar uptake; alleged internal concerns ignored
Applicable Code year	2021
Clause(s) considered	Clause 5.1
Decision	No breach
Complaint received	25 July 2021
Case completed	13 May 2022
Appeal	No appeal
Sanctions	None

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

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An anonymous complainant (described as a Sanofi employee) alleged Sanofi had a strategy of offering Lantus (insulin glargine) rebates to prevent uptake of biosimilar insulin, which the complainant considered potentially anti-competitive.
The complainant alleged their team was instructed to focus rebate activity on “high potential”/priority Lantus accounts and that internal reviews measured biosimilar growth before/after rebates to assess effectiveness.
The complainant also alleged they had raised concerns with superiors about anti-competitive behaviour and market-share protection vs biosimilars, but these concerns were ignored.
Sanofi explained it offered a flat-rate primary care rebate to CCGs in England and Health Boards in Wales from around 2017, calculated as a percentage of Lantus spend, and said it was available to any CCG/HB that requested it.
Sanofi stated it had procedures/training for compliant rebate discussions (eg, handled only by trained NHS KAMs; not discussed in promotional meetings; contracts in place before commencement; not an inducement; not restricting prescribing choice).
Sanofi noted that in 2021 it replaced the flat rebate offering with a list price reduction (effective 1 July 2021) following NHS stakeholder feedback.

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No breach of the Code was found.
The Panel ruled no breach of Clause 5.1 (2021 Code) regarding the allegation that the arrangements were anti-competitive, noting there was no formal finding by a competent authority that competition law had been breached and no evidence the rebate was not available to any CCG/HB that requested it.
The Panel also ruled no breach of Clause 5.1 regarding the allegation that internal concerns had been raised and ignored, because the complainant provided no evidence to support that claim.
No appeal.

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