Takeda voluntary admission: uncertified UK HCP webinar invitation and missing prescribing information (AUTH/3420/11/20)

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Key facts

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Case number	AUTH/3420/11/20
Company	Takeda UK Limited
Type	Voluntary admission (treated as a complaint under Paragraph 5.6 of the Constitution and Procedure)
Issue	Uncertified email invitation sent to UK HCPs linking to a registration page referencing darvadstrocel (Alofisel) without prescribing information
Meeting	The Gastrointestinal (GI) Summit 2020 (8 live webinars, Oct–Dec 2020)
Regional office involved	Takeda Pharmaceuticals International AG (TPIAG), Switzerland
UK HCP impact	15 UK HCPs registered before the link was disabled; 10 registered for webinar 7
Pipeline session	Webinar 7 (“Break it down now: Advances in coeliac care”) intended to be excluded for UK; UK registrants were blocked from accessing it
Complaint received	12 November 2020
Case completed	11 June 2021
Applicable Code year	2019
Breach clauses	4.1, 9.1, 14.1
No breach clauses	2, 3.1
Sanctions	Undertaking received; Additional sanctions: Not stated
Appeal	No appeal

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

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Takeda UK voluntarily admitted that UK health professionals (HCPs) were emailed an invitation to an educational webinar series (“The GI Summit 2020”) without UK certification.
The invitation was distributed by Takeda’s regional office in Switzerland (Takeda Pharmaceuticals International AG, TPIAG) and linked to a registration webpage.
Takeda UK and TPIAG had planned a UK-specific invite and UK-specific registration page (to be UK certified) because the Summit was to be treated as promotional in the UK (webinar 5 included content relating to darvadstrocel (Alofisel)).
Webinar 7 (“Break it down now: Advances in coeliac care”) was agreed to be excluded for UK HCPs due to Takeda pipeline assets in that therapy area.
Despite two planned checks, an agency provided TPIAG with a distribution list that included UK HCP email addresses and used “UK” rather than “United Kingdom” as the country code, so the wrong (TPIAG-approved, non-UK-certified) email went to UK HCPs.
Takeda UK requested the registration link be disabled; in the interval, 15 UK HCPs registered, including 10 for webinar 7.
Apology communications were sent; UK registrants for webinar 7 were blocked from accessing that session. Takeda UK ultimately decided not to invite any UK HCPs to the Summit to avoid further risk.

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Breach found: Clause 14.1 (material not certified).
Breach found: Clause 4.1 (prescribing information not provided where required).
Breach found: Clause 9.1 (high standards not maintained).
No breach: Clause 3.1 (no evidence of promotion of an unlicensed medicine to UK HCPs).
No breach: Clause 2 (Panel did not consider Takeda brought discredit upon or reduced confidence in the industry in the particular circumstances).
Sanction recorded: Undertaking received.
No appeal.

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