AUTH/3174/3/19 - Anonymous Employees v Otsuka Europe

Conduct of Otsuka Europe

  • Received
    20 March 2019
  • Case number
    AUTH/3174/3/19
  • Applicable Code year
    2016
  • Completed
    16 October 2019
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
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  • Appeal
    Appeal by the complainant
  • Review
    Published in the May 2020 Review

Case Summary

 

A ‘group of concerned employees’ complained about the arrangements for international meetings and comments made by a senior Otsuka Europe employee at an internal meeting.

The detailed response from Otsuka Europe is given below.

The complainants alleged that previous international meetings had been misclassified and certified as non-promotional events when it was clear that such activities were promotional.  The complainants alleged that these had been classified incorrectly due to commercial pressure to get more attendees for non-promotional meetings.  Such activities were disguised promotion as health professionals thought they were attending a non-promotional meeting as part of an exchange of scientific material.  One example was a symposium at the 2018 European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) Congress.  The symposium had been certified as non-promotional when in fact it was promotional.

These concerns had been highlighted to the compliance department, but no action had been taken, probably because no-one was well versed with the ABPI Code, and Otsuka Europe had to rely on a third party for most of its compliance activities.

The Panel noted Otsuka Europe’s submission that the symposium was led by the medical department and was classified as non-promotional in the approval system.  Otsuka Europe stated that its investigation identified that the symposium slides were approved by the country of the congress affiliate (Denmark) as promotional.

The Panel noted Otsuka Europe’s submission that on review of the symposium slides it was clear to the company that it was promotional and disguised in that regard; it discussed treatment with tolvaptan (Jinarc marketed by Otsuka) which according to Otsuka Europe was the only medicine licensed for the indication.  The Panel noted Otsuka Europe’s submission that the materials used to advertise the symposium all referred to a discussion of the ERA-EDTA guidelines on Autosomal Dominant Polycystic Kidney Disease (ADPKD), which were in fact guidelines on the use of tolvaptan in ADPKD.

The Panel noted that the symposium slides included multiple references to tolvaptan.  It was difficult for the Panel to understand how Otsuka could have classified and treated this meeting as anything but promotional.  It had been classified as promotional by the Danish affiliate.  In this regard, the Panel ruled a breach of the Code as Otsuka Europe had failed to maintain high standards.

In the Panel’s view, it was clear that the symposium was an Otsuka Europe promotional symposium.  However, the Panel considered that, on the balance of probabilities, not all health professionals, based on the materials used to advertise the symposium at the scientific congress, would have expected the symposium to be a promotional meeting.  In that regard it was disguised promotion and a breach was ruled as acknowledged by Otsuka Europe.

The Panel noted that Otsuka Europe had identified a number of other issues during its investigation into this matter including, inter alia, the symposium slides not being consistent with the tolvaptan SPC and lack of prescribing information.  Whilst the Panel was extremely concerned with regard to the issues identified, there had been no allegation on these points and therefore the Panel could make no rulings.

Whilst the Panel was concerned that Otsuka Europe classified a clearly promotional symposium as nonpromotional, it did not consider that, on balance, the particular circumstances of this case warranted a ruling of a breach of Clause 2 and ruled accordingly.  The complainants appealed this ruling.

The Appeal Board noted that the symposium at issue was led by Otsuka Europe’s medical department and was classified as non-promotional in the approval system.  The Appeal Board noted that the symposium slides included multiple references to tolvaptan.  The symposium slides were approved as promotional by the Danish affiliate.  In addition, Otsuka Europe had a promotional booth for Jinarc

(tolvaptan).  The Appeal Board agreed with the Panel in that it was difficult to understand how the symposium in question could have been anything other than promotional. 

The Appeal Board noted Otsuka Europe’s submission that its investigation indicated that the company did not properly understand the distinction between promotional and non-promotional activities as defined by the Code and this failure was at an organisational level.  Otsuka Europe submitted that it was not conscious misclassification of nonpromotional meetings, but gross incompetence caused by a lack of training, management and support.  Otsuka Europe submitted that these failings had reduced confidence in the pharmaceutical industry. 

The Appeal Board considered that such failings reduced confidence in the pharmaceutical industry and ruled a breach of Clause 2 as acknowledge by the company.  The appeal on this point was successful.

The Appeal Board noted the issues found during Otsuka Europe’s investigation and the actions taken.  It noted that some of these were identified in the recent audits of Otsuka Europe and Otsuka UK required in Cases AUTH/3041/6/18 and AUTH/3123/11/18.

The complainants provided information about an internal company meeting held in March.  It was a weekly management update meeting that focused on the Appeal Board meeting on 13 March.  There was a debrief on the presentation and the types of questions asked by the Appeal Board.

The complainants stated that attendees were informed that culture was of particular interest, especially around whistleblowing.  A senior employee at Otsuka Europe (named) went on to add that during this ‘period’ it was very easy to finger point individuals and departments.  This person then stated that there might be some individuals in the audience that wondered what he/ she was still doing in the organisation.

The complainants alleged that the senior employee then asked all present to raise their right hand and swear that they would not complain about individuals or departments to anyone for the next 6 months.  He/she added that when staff were questioned during the PMCPA audit, they had to be careful with their answers.  The PMCPA would open up with easy questions, and then tackle more difficult areas, eg were we happy with the processes and the organisation?  He/she hinted that staff would receive training to indicate their appropriate answers.

The complainants alleged that, in summary, they should not be holding each other to account (by swearing not to complain) and would receive training to provide the answers the PMCPA want to hear during the audit (lack of transparency).

The complainants alleged that it was clear that the culture in Otsuka Europe was going from bad to worse and they did not see it improving imminently.

The complainants provided a copy of an email (22 March) to staff following the meeting on 18 March which suggested that even the leadership team felt that the pledging episode was not appropriate.  The complainants wanted to find out what specific feedback had been received from the leadership team, and if a formal investigation had begun (especially as this had been brought to the attention of the PMCPA).

The complainants believed that the email was not entirely accurate (the complainants stated that they did not know what would be communicated to the PMCPA).  Before making all of the employees pledge that they would not complain, he/she shared a restaurant motto – ‘If you are happy tell everyone, if you are not tell us’.  This action was to stop disgruntled employees from going outside the company to complain about certain issues.  The complainants believed with the restaurant story in mind and the forced pledging, the direct message was not to further whistle blow.

The complainants stated that, given this evidence, the senior employee conceded that he/she was not clear with his/her messaging and that his/her actions caused certain employees to feel deeply uncomfortable.

It was not entirely clear to the Panel what exactly was said at the meeting in question.  The Panel noted the interview notes with some of the meeting attendees who were also on the leadership team.

The Panel noted that the comments were made at a meeting which was to inform staff that Otsuka UK and Otsuka Europe would be audited by the Authority later that year.  The audit was in relation to three cases and in each case it appeared that the complainant was an Otsuka employee.  The Panel further noted that at the time of the meeting in question there were ongoing Otsuka cases at the Authority where the complainant appeared to be an anonymous employee or employees.  The Panel considered that it was a critical time for the company with regard to compliance and comments made by senior members of staff at this time would be fundamental in driving the company’s compliance culture.

The Panel considered, based on the evidence before it, that the comments made at the meeting in question would, on the balance of probabilities, have been interpreted by some as saying do not complain outside the company.  In the Panel’s view, such comments from a senior employee would have a huge impact on the culture within the company at a critical time when the company ought to be actively encouraging open dialogue about compliance matters.  The Panel considered that Otsuka Europe had therefore failed to maintain high standards and a breach was ruled as acknowledged by the company.

In the Panel’s view, the implied message ‘do not complain outside the company’ was a serious matter that undermined the Code and self-regulation.  Regardless of whether or not such a message was intended or misinterpreted, the Panel considered that the comments at the meeting in question meant Otsuka Europe had brought discredit upon and reduced confidence in the pharmaceutical industry.  The Panel therefore ruled a breach of Clause 2.

With regard to the allegation in relation to training staff to ensure that appropriate answers are given during the upcoming audit, the Panel noted Otsuka Europe’s submission that audit readiness training for employees would focus on what to expect and would convey the importance of answering questions completely and honestly.  Otsuka Europe made no submission about whether such matters were within the scope of the Code.  The Panel noted that it was not inappropriate to provide training in preparation for an audit.  The training had not taken place at the time of the complaint.  The complainants had not shown that their concerns gave rise to a Code matter.  No detail was provided.  The Panel ruled no breach of the Code as the subject matter of complaint was outside the scope of the Code.