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.
CASE AUTH/3420/11/20
VOLUNTARY ADMISSION BY TAKEDA
Distribution of uncertified invitation to a meeting
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.
Takeda UK Limited voluntarily admitted that an invitation to an educational meeting series (The Gastrointestinal (GI) Summit) was emailed to a number of (details provided) 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.
VOLUNTARY ADMISSION
Takeda explained that, historically, TPIAG hosted an annual, standalone, face-to-face educational event – ‘The IBD [inflammatory bowel disease] Summit’. In 2020 the event was converted into ‘The GI [gastrointestinal] Summit 2020’ which widened the scope of educational content beyond IBD in order to reflect Takeda’s commitment to the wider gastrointestinal therapy area. Due to the Covid-19 pandemic, 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. Delegates could attend all webinars or a selection of their choosing. The topics of the eight webinars were provided.
An email, which had not been certified as required by the Code, was issued by TPIAG in error to the health professionals and included a link to a registration webpage where recipients could select which of the 8 webinars they wished to attend. Takeda was concerned that there had been a breach of Clause 14.1.
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 (What’s new for patients with Chronic Perianal fistulae?) was to include content relating to darvadsrocel (Alofisel) – a licensed Takeda medicine. 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.
Takeda explained that the UK-specific invitation and registration webpage were reviewed before certification in the first week of October 2020 but amends were required and as of 6 October those items had yet to be certified. On 6 October at 11:00am, TPIAG initiated distribution of email invitations across the Europe/Canada region. A list of UK health professionals, for whom Takeda had consent to send promotional emails, 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. Firstly, the agency would provide the distribution lists for all countries, excluding the UK, to the email distribution team in TPIAG. Secondly, the email system would be coded to check and exclude any email address from the distribution list with country code ‘United Kingdom’.
Unfortunately, and despite its prior agreement, the agency provided TPIAG with a distribution list that did include UK health professional email addresses – and as a second failure did not respect the country naming convention and used ‘UK’ rather than ‘United Kingdom’ as the country code. This meant that TPIAG-approved, rather than UK-certified, emails were distributed to UK health professionals in error.
Takeda UK was notified of the error at 12:50pm on Tuesday, 6 October and requested that the registration link be immediately disabled so that no UK health professionals could proceed to the (non UK-specific) registration webpage for the meeting. In the time between 11:00am and 12:50pm on 6 October, 15 UK health professionals registered for the event including 10 who registered for webinar 7. Those 15 health professionals received a personalized apology note on 9 October (copy provided) with a clear statement that the invitation was sent in error and that webinar 7 would not be available for a UK audience. Additionally, it was planned that the agency would work with the webinar platform provider to manually block UK entrants from webinar 7. Furthermore, an apology email with a statement was disseminated to all UK health professionals on 20 October 2020 as the coding and approval process took several days to complete. This stated: ‘We wish to apologise that you were sent an email in error on the 6th October 2020 related to a GI Summit series of meetings. This email was not intended for a UK or Irish audience and we greatly apologise for any inconvenience caused’.
During the course of a number of subsequent discussions with both the agency and TPIAG, Takeda UK became increasingly concerned about the operational ability of TPIAG and the agency to fulfil commitments previously given in order to meet UK compliance requirements. As a result of those concerns, on 16 October 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. The GI field teams had been instructed to directly forward any queries related to the GI summit to the medical manager (gastroenterology) to be dealt with reactively.
TPIAG and Takeda UK dealt with the matter with the highest level of urgency and had taken corrective action, not only in relation to the event, but in strengthening the overall promote-to-production process (sign-off of content, functionality, and recipient lists) as well as working with separate recipient lists for countries with unique requirements. 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.
When writing to confirm that the matter would be taken up under the Code, The Authority asked Takeda to provide any further comments it might have in relation to Clauses 2, 3.1, 4.1, 9.1 and 14.1.
RESPONSE
Takeda did not consider that it had breached Clauses 2 or 9.1 since it had maintained high standards throughout, including appropriately communicating Code requirements to TPIAG and its agency as well as taking appropriate actions as soon as the error was identified. As outlined above, every effort was made to ensure the requirements of the Code were front of mind for the event in question. Takeda UK and TPIAG communicated regularly and a clear process was in place to ensure that Code requirements would be fully met. Furthermore, when the error was disclosed to Takeda UK it was treated with the highest degree of urgency. Takeda UK and TPIAG had taken corrective action, not only in relation to the event, but in strengthening the overall promote-to-production process (sign-off of content, functionality, and recipient lists) as well as working with separate recipient lists for countries with unique requirements (copy provided). The process adopted for the meeting in question, with invitations being managed centrally using health professional details extracted from customer relations management (CRM) systems across multiple countries, was a relatively new process for Takeda. This was therefore an example of problems being encountered when a new process had been introduced, rather than persistent failures relating to a well-established process.
Takeda also denied a breach of Clause 3.1 of the Code. Although the invitation contained the title of a session on coeliac disease (‘Break it down now: Advances in coeliac care’), the 10 UK health professionals who registered for that session between 11:00am and 12:50pm on Tuesday, 6 October were blocked from accessing it and therefore no UK health professionals were exposed to any of the content of that session. This meant that in addition to being informed that they had received the invitation in error, no UK health professional was able to access any content relating or pointing to any Takeda molecule in development for the treatment of coeliac disease. Takeda did not believe that simply inadvertently allowing health professionals to see the title of the session constituted promotion of a medicine prior to the granting of marketing authorisation.
In relation to Clauses 4.1 and 14.1, Takeda acknowledged that the invitation should have been certified as a promotional item and should consequently have included links to prescribing information for relevant licensed Takeda medicines. Indeed, if the correct invitation had been issued, as prepared and approved by Takeda UK, then all of the requirements of the Code were in place. Unfortunately, and despite the best efforts of Takeda UK, the email which was erroneously disseminated had not passed through the UK approval process, which would have ensured that these elements were in place, as it was never intended to be sent to a UK audience. The root cause of this had been identified as human error on behalf of the agency, in contravention of a clear commitment it had provided to Takeda UK and despite the best efforts of the Takeda UK team.
Takeda stated that it was confident that the UK requirements were well understood by TPIAG and its agency. As described above, an email of 10 September clearly outlined the UK requirements that had been discussed on a telephone call prior to the email. Takeda provided details of the roles and status of those Takeda staff present on the call in question. Takeda UK received a response indicating that the clearly outlined requirements had been understood. Furthermore, there were numerous subsequent emails between the agency and the UK team to clarify details of UK requirements. Those emails showed the extent to which Takeda UK reinforced all finer details of the UK requirements with the agency over a prolonged period to ensure that every element was correct and understood.
Takeda stated that over time, the responses to emails sent by Takeda UK became less prompt and it became concerned about the capacity of the agency to deal with the volume of its correspondence, as well as managing the entire multinational event for TPIAG. In an email received on 14 October, the agency outlined that it would no longer support in the sending of the apology email to UK health professionals and outlined that several previously agreed tasks would take longer than it anticipated from an agency and a TPIAG IT point of view. For this reason, Takeda UK lost confidence in the capacity of the agency to meet all UK requirements as previously agreed. A copy of the covering email under which the agency provided the email addresses in question to TPIAG was provided.
Takeda UK provided a response from TPIAG as to why, irrespective of the acts/omissions of the agency, TPIAG did not notice, or otherwise undertake, its own due diligence in relation to the email addresses, given that the UK compliance matters had been brought to its attention.
With regard as to why the country code UK was not noticed at TPIAG, Takeda submitted that TPIAG had stated ‘Wrong country naming standard was used in final source list for automated email journey and that resulted in “United Kingdom” not showing up in spot-checks performed in the excel file containing more than 6,000 data sets. Neither agency nor Takeda received any official training or notification on the specific country naming standard by IT supplier’. It appeared that neither the TPIAG organizing team nor the agency were aware of this naming convention which was implemented by the external IT supplier as an extra line of defence but did not appear to have been communicated to either TPIAG team or the agency.
Takeda submitted that it and TPIAG had undoubtedly learnt a lot from this experience and as always committed to abide by the letter and spirit of the Code in its activities at all times.
PANEL RULING
The Panel noted Takeda’s submission that an email invitation to a promotional meeting, which had not been certified, was issued by Takeda’s regional office in Switzerland, Takeda Pharmaceuticals International AG (TPIAG) in error to a number of UK health professionals and included a link to a registration webpage where recipients could select which of the 8 webinars of the GI [gastrointestinal] Summit 2020 they wished to attend.
Takeda had previously communicated to TPIAG its 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 and it was agreed that that webinar would not be made available to UK health professionals. Further, Takeda noted that webinar five was to include content relating to darvadsrocel (Alofisel), a licensed Takeda medicine, and it was therefore agreed in advance that the entire GI Summit would be viewed as promotional in the UK and as a result a 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. The Panel noted Takeda’s submission that despite this prior agreement, TPIAG approved, rather than UK certified, emails were distributed to UK health professionals in error.
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 Clause 14.1 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 Clause 4.1 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 Clause 3.1 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 Clause 9.1 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 which was confirmed by TPIAG and the agency. 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 its 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.
Complaint received 12 November 2020
Case completed 11 June 2021
