AUTH/3420/11/20 - Voluntary admission by Takeda

About an email invitation to a meeting

  • Received
    12 November 2020
  • Case number
  • Applicable Code year
  • Completed
    11 June 2021
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

Takeda UK Limited voluntarily admitted that an invitation to an educational meeting series (The Gastrointestinal (GI) Summit) was emailed to UK health professionals without UK certification. The invitation had been distributed via Takeda’s regional office located in Switzerland – Takeda Pharmaceuticals International AG (TPIAG).

As Paragraph 5.6 of the Constitution and Procedure required the Director to treat a voluntary admission as a complaint, the matter was taken up with Takeda.

The meeting was planned as a series of eight live webinars during October, November and December 2020. The objective of the meeting was to educate and upskill health professionals working in the gastroenterology field across Europe and Canada on the evolution of care in several specific disease areas.

An email, which had not been certified as required by the Code, was issued by TPIAG in error to the UK health professionals and included a link to a registration webpage where recipients could select which of the 8 webinars they wished to attend.

Takeda submitted that, from the outset, Takeda UK and TPIAG communicated regularly and had a clear process in place to ensure that Code requirements were fully met. Takeda had specific concerns regarding the content of the seventh webinar (‘Break it down now: Advances in coeliac care’) which focused on a therapy area in which Takeda had pipeline assets. It was agreed that that webinar would not be made available to UK health professionals. To facilitate UK health professionals’ access to the remainder of the Summit, a UK-specific email invite was planned together with a UK-specific registration webpage which would omit the seventh webinar.

Further, Takeda noted that webinar five was to include content relating to its licensed medicine darvadsrocel (Alofisel). It was therefore agreed that the entire GI Summit would be viewed as promotional in the UK and as a result the UK specific invitation and registration page, along with the slide decks used during the Summit, would be UK certified as promotional items and would include all of the obligatory information required by the Code. These requirements were set out and agreed upon by TPIAG, its appointed medical communications agency and Takeda UK and were well understood by all involved.

A list of UK health professionals was provided to the agency for the purpose of distributing the UK-specific invitation, once approved. The agency collected similar distribution lists for all other countries and provided these to TPIAG which was to send invitation emails. A TPIAG-approved email was planned for dissemination to all countries excluding the UK. Two checks were put in place to ensure the UK-specific email, and not the TPIAG-approved email, was sent to UK health professionals. Unfortunately, the TPIAG-approved, rather than UK-certified, emails were distributed to UK health professionals in error.

Takeda UK was notified of the error and requested that the registration link be immediately disabled so that no UK health professionals could proceed to the (non UK-specific) registration webpage. In the time between the emails being sent and the link being disabled, 15 UK health professionals registered for the event including 10 who registered for webinar 7. Those 15 health professionals received an apology with a clear statement that the invitation was sent in error and that webinar 7 would not be available for a UK audience. Additionally, the agency would look to manually block UK entrants from webinar 7. Furthermore, an apology email was disseminated to all the UK health professionals.

During the course of a number of subsequent discussions Takeda UK decided not to invite any UK health professionals to the GI Summit in order to avoid any risk of further breaching the Code.

TPIAG and Takeda UK dealt with the matter with the highest level of urgency and had taken corrective action. Takeda UK felt grossly let down by the agency engaged to support the event, especially considering the many hours of briefing and clarification on UK requirements which were provided over a number of months.

The detailed response from Takeda is given below.

The Panel noted that whilst the TPIAG approved invitation, that was sent to UK health professionals in error, did not mention any of Takeda’s medicines, the linked registration page stated under the description of Webinar 5 ‘In the Spotlight! Stem cells in Crohn’s perianal fistulas’ that after this session attendees would be able to: identify the challenges associated with current surgical and medical Crohn’s perianal fistula treatments; understand the mode of action of darvadstrocel▼ at a cellular level; and identify where stem cells fit in the Crohn’s perianal fistulas treatment pathway.

The Panel noted that the email invitation sent to UK health professionals, which linked to a registration page that referred to a Takeda medicine and its indication, had not been certified and a breach of the Code was ruled as acknowledged by Takeda.

The Panel noted that the prescribing information for Alofisel was not included on the registration page which could be accessed from the email invitation and a breach of the Code was ruled as acknowledged by Takeda.

The Panel noted Takeda’s submission that whilst the email invitation and linked registration page contained the title of webinar 7, (‘Break it down now: Advances in coeliac care’) which focused on a therapy area in which Takeda had pipeline assets, neither the invitation nor linked registration page detailed the pipeline products and the ten UK health professionals who registered for that session were blocked from accessing it. The Panel did not consider that there was evidence that an unlicensed medicine had been promoted to a UK health professional and no breach of the Code was ruled.

The Panel noted its comments and rulings above and considered that Takeda had been let down by TPIAG and its third party agency resulting in a promotional invitation being sent to UK health professionals without being certified and without the requisite prescribing information. In that regard high standards had not been maintained and a breach of the Code was ruled.

The Panel noted that a robust certification procedure underpinned self-regulation. The Panel noted Takeda’s submission that it had on a number of occasions clarified the UK requirements. Takeda had, however, been badly let down by TPIAG and the agency resulting in the incorrect version of the webinar invitation being sent to UK health professionals. The Panel noted Takeda’s actions following notification of the error. The Panel did not consider that in the particular circumstances of this case Takeda had brought discredit upon or reduced confidence in the industry and no breach of Clause 2 was ruled.