Daiichi-Sankyo: congress programme listed product-linked symposia without mandatory info or clear sponsorship declaration (AUTH/3388/9/20)

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Key facts

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Case	AUTH/3388/9/20
Complainant	Anonymous, contactable member of the public
Company	Daiichi-Sankyo UK Limited
Medicines mentioned	Lixiana (edoxaban); Nilemdo (bempedoic acid); Nustendi (bempedoic acid and ezetimibe)
Context	Congress organised by a UK patient organisation; congress website programme listed “Daiichi” live symposia agendas
Main issues	Mandatory information missing on symposia agenda webpage; insufficiently prominent sponsorship declaration; third-party control/briefing
No breach findings	Clause(s) 2, 26.1, 27.2, 27.9, 28.1
Breach findings	Clause(s) 4.1, 4.3, 4.6, 4.8, 4.9, 4.10, 9.1, 22.4
Sanctions	Undertaking received; additional sanctions not stated
Complaint received	24 September 2020
Case completed	22 April 2021
Appeal	Complainant appeal on Clause 2 only; unsuccessful (no breach upheld)
Applicable Code year	2019

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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 member of the public complained about alleged promotion of prescription-only medicines (POMs) Lixiana (edoxaban), Nilemdo (bempedoic acid) and Nustendi (bempedoic acid/ezetimibe) on a congress website run by a UK patient organisation.
The congress website’s “Live Sessions” programme listed two “Daiichi” symposia with agendas that referenced the medicines and linked them to therapeutic areas/indications (dyslipidaemia; NVAF).
The complainant said the website appeared publicly accessible and not clearly marked “for health professionals only”, and alleged missing mandatory information (prescribing information, black triangle, adverse event reporting statement, date of preparation, and generic name).
The complainant also alleged there was no clear declaration of Daiichi-Sankyo’s involvement/sponsorship for the symposia and that listing them in “live sessions” made them look like official congress content.
Daiichi-Sankyo said the congress was clearly aimed at health professionals, the link was only on the health professional section of the organisation’s site, and the symposia content itself was only accessible after registration/login; it also said it did not create or approve the organiser’s programme webpages.
The Panel considered the relationship and concluded the advertising of company symposia by the organiser was potentially covered by the Code and was the company’s responsibility; it was concerned the company had not clearly instructed/briefed the organiser on Code requirements.

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Outcome

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No breach of Clause 26.1 (promotion of POMs to the public): the Panel considered the congress website was aimed at health professionals, not the public.
No breach of Clause 28.1 (access restrictions): consequential to no breach of Clause 26.1.
Breach of Clauses 4.1, 4.3, 4.6, 4.8, 4.9 and 4.10: the symposia agenda content was considered promotional because it associated medicines with indications, but omitted required information (PI, generic name adjacency, PI location statement, date, AE reporting statement, and black triangle symbols).
Breach of Clause 22.4: no sufficiently prominent sponsorship declaration on the webpage to make clear the company’s involvement/sponsorship of the meeting as a whole.
No breach of Clauses 27.2 and 27.9: the Panel considered the Clause 22.4 breach covered the inadequate declaration issue in these circumstances.
Breach of Clause 9.1: high standards not maintained due to inadequate briefing/contracting with the organiser regarding Code requirements for presenting the symposia agenda and sponsorship declaration.
No breach of Clause 2: not warranted; upheld on appeal (complainant appealed only Clause 2).

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