AUTH/3013/1/18 - AstraZeneca employee v AstraZeneca

Global training and advisory board and provision of incomplete and inaccurate information

  • Received
    23 January 2018
  • Case number
    AUTH/3013/1/18
  • Applicable Code year
    2016
  • Completed
    10 April 2018
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
    Public reprimand
  • Appeal
    No appeal, Appeal Board required public reprimand
  • Review
    Reprimand published in the May 2020 Review, see also May 2018 Review

Case Summary

An anonymous, non-contactable complainant, who described him/herself as an employee of AstraZeneca UK Limited’s marketing company, alleged that although one of AstraZeneca’s values was ‘we do the right thing’, over the last five years the company had become solely focussed on profits ahead of its ethical obligations. Over the last couple of years, the trend had reversed in the UK marketing company and the focus on achieving AstraZeneca’s goals through the right means had returned. However, the same was not so for AstraZeneca’s global functions.

The complainant stated that as a UK company, and with many employees in the global functions based in the UK, AstraZeneca should comply with the Code for activities led by global. However, this was not so. Global functions did not receive appropriate training on the Code and did not have regular Code case updates as in the UK marketing company. Globally led activities thus usually did not comply with the Code. In particular, the complainant referred to an unspecified global advisory board, held in October 2017, with over 15 external advisors and a similar number of AstraZeneca employees. The UK nominated signatory who was asked to approve the meeting, as UK health professionals were advisors, refused to do so due to the excessive number of people and the view that this was not a genuine advisory board. However, the UK marketing company was put under pressure to approve this and the nominated signatory was told to approve the advisory board by two other staff even though they acknowledged that it was likely to be a breach of the Code.

The detailed response from AstraZeneca is given below.

With regard to the allegations about training, the Panel noted that AstraZeneca distributed training to staff based on their role, location and responsibilities. The Panel noted that although the materials provided by AstraZeneca did not demonstrate comprehensive training on the Code, the company nonetheless trained global staff and provided more detailed training to the nominated signatories. The Panel did not consider that there was evidence to show that on the balance of probabilities, AstraZeneca had not trained relevant global staff as alleged. The Panel therefore ruled no breach of the Code.

With regard to advisory boards, the Panel noted that it was acceptable for companies to pay health professionals and others for relevant advice. Nonetheless, the arrangements for such meetings had to comply with the Code. To be considered a legitimate advisory board the choice and number of participants should stand up to independent scrutiny; each should be chosen according to their expertise such that they would be able to contribute meaningfully to the purpose and expected outcomes of the advisory board. The number of participants should be limited so as to allow active participation by all. The agenda should allow adequate time for discussion. The number of meetings and the number of participants should be driven by need and not the invitees’ willingness to attend. Invitations to participate should state the purpose of the meeting, the expected advisory role and the amount of work to be undertaken. If an honorarium was offered it should be made clear that it was a payment for such work and advice. Honoraria must be reasonable and reflect the fair market value of the time and effort involved.

AstraZeneca referred to an advisory board meeting, held in Amsterdam in November 2017, which, in the absence of details, it assumed was the one to which the complainant had referred. The Panel noted that the agenda for that advisory board, included in the presentation, started with a welcome coffee and the actual meeting started at 10.30am and ended at 5.30pm; there were breaks for lunch and tea. The meeting was co-chaired by an external speaker and a member of AstraZeneca staff. One of the two speakers in the morning session was from AstraZeneca and the moderators for the afternoon discussion groups were both from AstraZeneca.

The initial invitation described the advisory board as part of AstraZeneca’s ongoing commitment to supporting health professionals and patients. The objective of the meeting was to gain expert feedback and insights on the role of selective sodium glucose co-transporter 2 (SGLT2) inhibitors in type 1 diabetes and specifically the Forxiga (dapagliflozin) programme studies (DEPICT-1 and -2). The external speaker was asked to critically evaluate the benefit/ risk of dapagliflozin on type 1 diabetics and to provide recommendations for safe and effective use of dapagliflozin in type 1 diabetes. The UK delegates were emailed 6 published papers as pre-reading 6 days before the meeting.

There were 78 slides to be used during the day. Twenty-eight slides were presented in the first session by an external speaker, one of the investigators of the DEPICT studies. This one-hour session, which focused on the results of the two studies included two periods for discussion. The second session of seventeen slides, presented by an AstraZeneca employee, focused on the safety results of the two studies and lasted for one hour and fifty minutes. In the afternoon the group was split into two (US and EU/International) and each group, moderated by AstraZeneca, discussed as session 3 (45 mins) the efficacy results. Session 4 (90 minutes) was a discussion of the benefit/risk of dapagliflozin in type 1 diabetes. The day ended with 30 minutes for summary and closing remarks. The short agenda provided included the sub heading ‘Group discussion is 80% or more of each allocated session time and includes all participants’.

The Panel queried whether so many slides were needed on the DEPICT outcomes given the prereading included the published studies.

The Panel noted that the advisory board was to help AstraZeneca decide about an application for a new indication in the US and EU. In that regard, seven of the 16 advisors were from the US, eight came variously from five European countries (two from the UK, a doctor and a diabetes specialist nurse) and one advisor was from another country. In addition, there were 12 AstraZeneca staff.

The rationale for the attendance of AstraZeneca staff was provided. The stated business justification was to present and discuss DEPICT data, to critically evaluate benefit/risk of dapagliflozin on type 1 diabetes patients and to provide recommendations for the safe and effective use of dapagliflozin in type 1 diabetes. The business justification in this document was different to the objectives provided to the attendees. This document listed the 12 AstraZeneca staff and the rationale for their attendance. Five of the staff were to watch the first part of the advisory board via a video link and then three would actively participate in the breakout sessions. This was different to the submission from the company which stated that 9 of its staff joined the meeting and three listened in another room. Following a request for further information, the company stated that on the day there were 9 AstraZeneca staff in the room and the three listening in another room joined the main room about half way through the morning session due to a technical problem.

From the list of AstraZeneca attendees, four were assigned to participate in each of the breakout sessions; it was not stated if the other four were to participate in either session or not. The further information confirmed that all 12 AstraZeneca staff participated in the afternoon breakout sessions.

It was not clear to the Panel why AstraZeneca had not described what actually happened at the advisory board in the first instance. It was unacceptable and concerning that details of the arrangements for AstraZeneca attendees were only provided following a request for additional information.

The Panel was concerned about a number of aspects of the advisory board including the number of AstraZeneca attendees which was well outside the UK SOP. However, this did not necessarily mean that the advisory board failed to meet the requirements of the ABPI Code. The Panel was concerned to note, given the compliance difficulties that companies could experience with advisory boards and the high profile given to such in the UK recently, that it appeared that the arrangements for the meeting were only submitted for local review 12 working days before the meeting took place. The Panel was also concerned that the day before the advisory board AstraZeneca made fundamental changes to the arrangements and increased the number of its staff in the meeting room. In the Panel’s view, the timescales and last minute changes would put unnecessary pressure on the nominated signatory to approve a meeting for which all of the arrangements should have already been in place; the UK SOP stated that material should be submitted for approval at least 6 weeks before the meeting date.

The Panel noted that no evidence was supplied in relation to the alleged pressure on the UK signatory to certify the meeting. The Panel was concerned as this was a serious allegation and it was vital that signatories were free to decline certifying material if they did not think it met the requirements of the Code. It appeared from AstraZeneca’s submission that there was discussion between UK and global. This was particularly concerning given that this was ongoing so close to the date of the advisory board and that advisory boards were high risk area for companies. The Panel queried whether the certification should have been completed before the UK advisors were first approached at the end of September. If the arrangements were not capable of certification, UK health professionals should not have been approached.

The Panel noted that the advisory board which was held outside the UK and involved UK delegates had not been certified. The Panel noted AstraZeneca’s submission that this was due to a timing issue rather than because the signatory was concerned with compliance with the Code. The Panel ruled that the failure to certify was in breach of the Code as acknowledged by AstraZeneca.

The Panel noted the complainant alleged that the advisory board was not genuine. No evidence had been provided by the complainant who had not clearly identified the advisory board about which he/she was concerned. As noted above, the Panel was concerned about the advisory board identified by AstraZeneca but did not consider that the complainant had shown, on the balance of probabilities, that the advisory board held on 10 November 2017 failed to meet the requirements of the Code and thus that any payment was inappropriate. Thus, the Panel ruled no breach of the Code.

On balance, the Panel considered that the arrangements for certification and the short time frame increased the pressure on UK certifiers. This and the failure to certify meant that AstraZeneca had failed to maintain high standards and a breach was ruled.

Noting its rulings above the Panel did not consider that the circumstances warranted a ruling of a breach of Clause 2 which was used as a sign of particular censure and reserved for such use.

ADDENDUM TO SUMMARY

Following completion of this case in April 2018 and its publication on the PMCPA website in May 2018 a letter was received in June 2018 regarding the case and providing further information.  It appeared to have come from the original anonymous, noncontactable complainant, who had described him/ herself as an employee of AstraZeneca UK Limited. 

The letter appeared to provide information which had not been provided by AstraZeneca in its response to the complaint: an email from a senior UK medical department employee outlining options for the advisory board in question.  The further information was provided to AstraZeneca for comment including on Case AUTH/2793/9/15 where additional information was provided following the completion of a case.

Detailed comments from the complainant and AstraZeneca are given below.

The PMCPA decided that the original Panel should reconvene to consider the matter in relation to Paragraph 8.2 of the Constitution and Procedure which provided that the Panel might report to the Appeal Board any company whose conduct in relation to the Code, or in relation to a particular case before it, or because it repeatedly breached the Code such that it raised concerns about the company’s procedures, warranted consideration by the Appeal Board.  Such a report to the Appeal Board might be made notwithstanding the fact that a company had provided an undertaking requested by the Panel.  The Panel noted that AstraZeneca had provided the requisite undertaking.

The Panel noted that the author of the letter had provided a copy to the Medicines and Healthcare products Regulatory Agency (MHRA) as the author was concerned there appeared to be no activity and alleging that AstraZeneca was receiving preferential treatment.  The PMCPA responded to inform the MHRA that the matter had been followed up with

AstraZeneca and would be considered by the Panel shortly.  The delay was due to the number of complex cases.  AstraZeneca was not receiving any preferential treatment. 

The Panel noted the difficulties for UK companies regarding activities run by global.

The Panel noted the email trail dated 7 and 8 November 2017 provided as additional information which appeared to provide context to the discussions between the UK company and the global company about the arrangements for the advisory board held on 10 November 2017.  It was clear that the concerns raised by the UK went beyond just a difference between the UK and global SOPs.  Reference was made to advisory boards being in the spotlight in the UK over the last 18 months.  The MHRA had questioned the validity of advisory boards and that the UK position was rather sensitive at the moment due to the AstraZeneca cases at the Panel and that it was ‘… trying to ensure we do not attract an audit’.  The senior UK medical department employee stated that the need for the global advisory board was clear and the agenda was reasonable.  The ratio of AstraZeneca attendees to health professionals was high.  The situation was described as low risk but if a complaint were made it would be marginal as to whether it could be defended from a perceptual perspective.  Three options were proposed including option 1 that the extra 5 AstraZeneca attendees watched the first part of the advisory board in a separate room and then participated in the breakout sessions.  The email trail went on to state that the senior UK medical department employee wanted to avoid dropping the UK health professionals and also disrupting the plans for the proposed agenda.  He/she was happy to go with any of the three options.  He/she understood that this was frustrating but ‘we do need to be consistent in our approach to implementing the code’. 

The Panel considered that it was not clear from the email trail whether the senior UK medical department employee considered that the number of AstraZeneca attendees at the advisory board was in breach of the Code or in breach of the AstraZeneca UK SOP.  The email spelt out three options.  The Panel noted that the company had decided on option 1 although as included in the report for Case AUTH/3013/1/18 this did not happen due to technical issues.

The Panel considered the email including the context of discussions about the advisory board and the perception of the email.  The Panel considered that the reference to self-reporting was a possible reference to the need for AstraZeneca to consider making a voluntary admission about a possible breach of the Code.  Clearly it was important that companies followed their SOPs but not doing so was not in itself necessarily a breach of the Code. 

The impression of the email was that the UK company had concerns about the arrangements for the advisory board, in particular the number of AstraZeneca attendees.  Full details about the number of AstraZeneca attendees had only been provided to the Panel considering the case when it asked for further information. 

The Panel noted that clearly there were difficulties with the advisory board and breaches of the Code had been ruled and a number of concerns raised.  At that time it was also clear that AstraZeneca had not provided all the information.  In relation to AstraZeneca’s submission that as the Panel had not asked for the email of 8 November it had not provided the email, the Panel noted that self-regulation relied on companies to provide all relevant material.  As the Panel did not know of the existence of the email, it could not request it. 

The Panel noted AstraZeneca’s submission that the email represented a snapshot of the discussions that had taken place and these were explained in the company’s response to Case AUTH/3013/1/18 where it stated ‘they presented several options to resolve this, one of which was the option which was eventually settled upon’.

Now having received the email of 8 November the Panel did not consider that this additional information would have made a difference as to whether it thought the advisory board itself was in breach of the Code.  The Panel had ruled no breach in this regard based on the complainant not having shown on the balance of probabilities that there was a breach of the Code.  However, the new information which provided some insight into the company’s compliance culture was a concern as was AstraZeneca’s general approach with regard to providing information to the Panel as evidenced by the number of times recently that the company had either not provided all the relevant information or had provided misleading information.  This was set out in the Panel’s request for further information from AstraZeneca. 

Taken as a whole, the Panel considered that AstraZeneca could not clearly demonstrate its stated commitment to self-regulation in the broadest sense.  It was concerned that actions might be taken by AstraZeneca so as to ‘… not attract an audit’ rather than ensuring compliance with the Code and its own procedures.  The Panel was also concerned that it appeared from the email and other aspects of the complaint that for some staff raising concerns about activities was difficult at AstraZeneca and this contributed to the differences of opinion between UK and Global.  However, it decided that, on balance, the material before it, most of which had come to light either during the consideration of the cases or afterwards and had been the subject of a public reprimand, had been addressed and thus on balance a formal report to the Appeal Board was not needed at this stage.  The Panel’s view was that these examples should be reconsidered if there were further instances of AstraZeneca failing to provide comprehensive information.  The Appeal Board would be provided with details of the Panel’s further consideration following a similar format to the details provided for cases which concluded at the Panel level. 

The Appeal Board received the update to the case report as set out in Paragraph 13.4 of the Constitution and Procedure.

The Appeal Board considered that the additional information in this case raised serious issues including about the provision of incomplete and/ or inaccurate information.  The Appeal Board’s view was that further consideration should be given to this matter including the possibility of imposing further sanctions under Paragraph 11.1 of the Constitution and Procedure. 

The company was advised that the Appeal Board was giving further consideration to this matter including considering imposing additional sanctions and asked to respond in writing, as well as be given the opportunity to attend the Appeal Board when the matter would be considered.  AstraZeneca was provided with a copy of the papers.

The detailed comments from AstraZeneca about the possible imposition of further sanctions is given below.

The Appeal Board noted the Panel’s rulings of breaches of the Code.  The Appeal Board noted that the company had apologised and admitted that it had made errors. 

The Appeal Board noted the context in that there had been discussions between AstraZeneca UK and the global company about the arrangements for the advisory board held on 10 November 2017 right up to the meeting taking place. The UK company did not want to certify the meeting due to concerns about the number of AstraZeneca representatives attending.  The email at issue dated 8 November 2017 from a senior UK medical department employee was an attempt to overcome this issue.  The email included three options in order to enable the advisory board to go ahead.  The Appeal Board noted AstraZeneca agreed that the email of 8 November 2017 was poorly worded.  The email referred to ensuring the company did not attract an audit and mentioned a self-report to the ABPI if the meeting went ahead as planned.  The Appeal Board noted the submission from AstraZeneca that the senior UK medical department employee was new; and that the self-report was in relation to the breach of the company’s SOPs and not in relation to the ABPI Code.  The Appeal Board considered that the reference to self-report appeared to be in relation to the Code.  The Appeal Board noted that the email of 8 November 2017 had been copied to several senior AstraZeneca members and queried why nobody had replied to the email to raise their concerns.  AstraZeneca stated that there had been a discussion about the email at the time but there was no written record.  Although there was no requirement to self-report, the Appeal Board queried why the company had not self-reported a breach of the Code at this point.  This was said by AstraZeneca to be an oversight.

The Appeal Board considered that when submitting a response, companies need not include everything however the company had not provided the relevant source material it used in summarising events.  The email of 8 November 2017 was clearly central and relevant to this case and did not appear to be consistent with the summary provided.  In the Appeal Board’s view to not submit the email was inexplicable.  Effective selfregulation required companies to be open and transparent when responding to complaints; they had a duty to disclose all relevant documents and information.  When compiling its response to the complaint AstraZeneca stated that it had referred to emails.  The Appeal Board was not satisfied with AstraZeneca’s submission as to why it had not provided the email dated 8 November when responding to the complaint.

The Appeal Board considered that the email of 8 November 2017 was clearly relevant and should have been provided to the PMCPA as part of AstraZeneca’s response.  Notwithstanding AstraZeneca’s submission that it now had updated its processes, the Appeal Board noted that self-regulation relied, inter alia, upon the provision of complete and accurate information from pharmaceutical companies. 

The Appeal Board decided that in accordance with

Paragraph 11.3 of the Constitution and Procedure, AstraZeneca should be publicly reprimanded for failing to provide complete and accurate information in an open and transparent way. 

The Appeal Board was concerned to note that

AstraZeneca was also publicly reprimanded in 2016 by the Appeal Board for providing inaccurate information to the Panel (Case AUTH/2793/9/15).

The Appeal Board noted the Panel’s comments above regarding AstraZeneca’s conduct in responding to complaints.  The Appeal Board noted its concerns about AstraZeneca’s compliance culture.  The Appeal Board gave consideration to the imposition of further sanctions including whether an audit should be required.  However, on balance, the Appeal Board decided that no additional action was required.