Takeda Rare Disease Hub website: missing adverse event reporting statement (AUTH/3765/4/23)

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Key facts

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Case	AUTH/3765/4/23
Company	Takeda
Complainant	Anonymous, contactable complainant (described themself as a UK health professional)
Material	“Rare Disease Hub” website (certified as promotional; UK HCP attestation required)
Main issue upheld	Adverse event reporting statement not properly displayed (was one click away)
Breach clauses	Clause 12.9
No breach clauses	Clause 5.1; Clause 5.6 (x2); Clause 6.1; Clause 11.1; Clause 12.1 (x2); Clause 12.10; Clause 15.6; Clause 26.4
Sanctions	Undertaking received; Additional sanctions: Not stated
Complaint received	25 April 2023
Case completed	27 June 2024
Appeal	No appeal
Applicable Code	2021

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

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An anonymous, contactable UK health professional complained about Takeda’s “Rare Disease Hub” website (certified as promotional and gated for UK HCPs via attestation).
Concerns included: a black triangle shown with a white border on an Adynovi tile; no explanation of the black triangle; missing adverse event reporting statement; whether a “Disease Awareness” section could be used with patients and inadvertently promote medicines; a single prescribing information (PI) page containing multiple Takeda medicines; PI for Rixubis allegedly not licensed in Northern Ireland; and wording in PI (“Other serious undesirable effects”) alleged to be misleading.
Takeda accepted that, at the time of the complaint, the full adverse event reporting statement was not displayed on the homepage and relevant pages (it was “one click away”), and updated the site from 2 May 2023 to display the full statement prominently.
The Panel assessed the black triangle complaint using a previously removed certified item (C-APROM/GB/ADYN/0029, certified March 2022) that showed a black triangle with a white border on a dark background.
Takeda clarified that Rixubis had a PLGB licence for Great Britain and also a centralised licence covering the EU including Northern Ireland; supply to Northern Ireland had been discontinued for commercial reasons (not a licensing issue).

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Breach: Clause 12.9 (Failing to include the adverse event reporting statement).
No breach: Clause 5.1, Clause 5.6 (x2), Clause 6.1, Clause 11.1, Clause 12.1 (x2), Clause 12.10, Clause 15.6, Clause 26.4.
No appeal.

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Clause 12.9 Failing to include the adverse event reporting statement (Breach)
Clause 5.1 Requirement to maintain high standards at all times (No breach)
Clause 5.6 (x2) Requirement to tailor material to the audience to whom it is directed (No breach)
Clause 6.1 Requirement that information must be accurate, up to date and not misleading (No breach)
Clause 11.1 Requirement that a medicine must not be promoted prior to the grant of its marketing authorisation (No breach)
Clause 12.1 (x2) Requirement to include up-to-date prescribing information (No breach)
Clause 12.10 Requirement to include the black triangle in promotional material (No breach)
Clause 15.6 Requirement that promotional materials and activities must not be disguised (No breach)
Clause 26.4 Requirement to include the black triangle in material which relates to a medicine subject to additional monitoring and that is intended for patients taking that medicine (No breach)

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