Daiichi-Sankyo breached ABPI Code over out-of-date competitor safety symbol in Nilemdo FOC scheme material (AUTH/3396/10/20)

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Key facts

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Case	AUTH/3396/10/20
Company	Daiichi-Sankyo
Complainant	Anonymous Sanofi employee (personal capacity; Sanofi named in report per PMCPA approach)
Product promoted	Nilemdo (bempedoic acid)
Competitor product referenced	Praluent (alirocumab)
Issue	Out-of-date material showing Praluent with a black triangle after removal from SPC; considered disparaging
Material	Free of Charge Scheme Communications Document, “NILEMDO▼ (bempedoic acid) Free of charge (FOC) scheme” (ref BEM/20/0202, September 2020)
Material certified	3 September 2020
eMC SPC update (black triangle removed)	16 September 2020
Daiichi-Sankyo awareness of change	22 September 2020
Sales force instructed to stop using material	5 October 2020
Complaint received	5 October 2020
Case completed	27 May 2021
Applicable Code year	2019
Breach clauses	7.2, 8.1, 9.1
No breach clauses	2 (upheld on appeal)
Sanctions	Undertaking received; additional sanctions not stated

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

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An anonymous Sanofi employee complained (in a personal capacity) about Daiichi-Sankyo promotional material for Nilemdo (bempedoic acid) used in a virtual meeting about a free-of-charge (FOC) scheme.
The material referenced Sanofi’s Praluent (alirocumab) and showed it with a black triangle (additional monitoring symbol).
The complainant stated the Praluent black triangle was removed from the SPC on the eMC website on 16 September 2020, but Daiichi-Sankyo material still displayed it in late September 2020.
The Panel identified the material as a “Free of Charge Scheme Communications Document” (ref BEM/20/0202, September 2020), certified on 3 September 2020.
Daiichi-Sankyo said it became aware of the SPC change on 22 September 2020 and instructed the sales force to stop using the material on 5 October 2020 when updated material was issued.
Daiichi-Sankyo stated its CRM recorded that a health professional was detailed with a product, but did not record which specific materials were used in meetings.
The complainant alleged the out-of-date black triangle was inaccurate and disparaged Praluent by implying an unwarranted safety concern, and also alleged Clause 2 (discredit) due to process deficiencies.

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Breach of Clause 7.2 (material not up-to-date/accurate).
Breach of Clause 8.1 (disparagement) because associating Praluent with a black triangle implied additional monitoring was required when it was no longer required.
Breach of Clause 9.1 (high standards not maintained), including delay in becoming aware of the competitor SPC change and not withdrawing the out-of-date material promptly once aware.
No breach of Clause 2 (particular censure). The complainant appealed this point; the Appeal Board upheld no breach of Clause 2.

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