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An anonymous and non-contactable complainant who appeared to be an employee of Astellas complained about the truthfulness of Astellas’s response to Case AUTH/2747/1/15 which concerned the arrangements for an Astellas Pharma Europe meeting held in Milan in February 2014. In that case the company was ruled in breach of the Code including Clause 2 and was required by the Appeal Board to issue a corrective statement to all UK attendees.
The complainant stated that Astellas colleagues recently provided training on the outcome of Case AUTH/2747/1/15 and its learnings and a ‘town hall’ meeting was convened, where a very senior employee (identified by job title) of Astellas Pharma Europe discussed the matter, albeit in a very dismissive manner.
The complainant stated that it was extremely alarming and concerning that the account given to the PMCPA was knowingly false and intentionally misleading. In its response to Case AUTH/2747/1/15 Astellas claimed that all invitees were identified and grouped based on their ‘clinical expertise’ and ‘experience of treating patients with mCRPC’ (metastatic castration – resistant prostate cancer). Unfortunately, nothing was further from the truth and Astellas knew that but deliberately chose to conceal it from the PMCPA. The complainant provided a copy of the briefing given by Astellas to its affiliates which stated that all 30 opinion leaders chosen by each affiliate had to be; ‘mid to top level opinion leaders with the potential to be local product champions’. Furthermore it was requested that they be ‘data naïve’. The complainant alleged that this directly contradicted the claim made that they be chosen based on their clinical expertise.
The complainant stated that it was also disappointing that Astellas had still not learnt from rulings of breaches of the Code including Clause 2, and that the company had deliberately misled the PMCPA about a very serious complaint. The complainant urged the PMCPA to consider more serious sanctions including an audit of the company’s procedures, a public reprimand and possible suspension or exclusion from membership of the ABPI.
The detailed response from Astellas Pharma Europe is given below.
The Panel noted the outcome of Case AUTH/2747/1/15 and that the Panel had ruled Astellas Europe in breach of the Code including Clause 2 in relation to arrangements for a meeting. The Panel had also reported the company to the Code of Practice Appeal Board. The Panel’s rulings were not appealed. The Appeal Board required Astellas Europe to issue a corrective statement to UK attendees. This was issued on 1 July 2015.
The Panel noted that the meeting at issue in Case AUTH/2747/1/15 had been run by Astellas Europe. The complaint concerned arrangements for UK attendees. In this regard the Panel noted that Astellas UK was responsible for the acts/omissions of its affiliates including its UK based European headquarters. In the Panel’s view this remained the position even if the UK based European affiliate had responded directly to the complaint. In its response to Case AUTH/2780/7/15 Astellas Europe explained that Astellas UK and Astellas Europe had decided that the European affiliate should respond to the complaint. Correspondence in relation to Cases AUTH/2747/1/15 and AUTH/2780/7/15 had consequently been sent directly to Astellas Europe. The Panel noted the company’s submission about the involvement of the UK company with the response to Case AUTH/2747/1/15 prepared by Astellas Europe. The Panel noted the position of Astellas UK in relation to the present complaint remained as set out above.
The Panel noted that the criteria used to select advisory board members to attend the meeting in question must stand up to scrutiny and relate solely to their ability to provide expertise to the company. The Panel considered that three emails sent in September 2013 and October 2013 were wholly unacceptable in relation to the criteria to be used to identify potential advisory board members. All the emails and/or their attachments listed above referred to invitees being-mid to top level product opinion leaders with the potential to be local product champions within the relevant market and data-naïve customers ie those who had not been involved in any Astellas Europe or national/local advisory board meetings prior to the Pan EU Expert Meeting.
A presentation to the Oncology Steering Committee (5 February 2013) referred to the success of the Pan – European Uro-oncology Advisory Board held in Barcelona in November 2012. It stated that the proposed structure of future meetings was discussed/agreed by a UK medical employee. This presentation referred to the aims and suggested target audience for 13/14 pan European advisory board meetings as:
‘Objectives for meeting
• Increase Astellas’ profile in the field of oncology• Communicate Astellas’ strategy and oncology pipeline to key target customers• Communicate Xtandi and tivozanib data and common set of messages to EU affiliates’ key target customers• Gain an increased understanding of the current landscape in RCC and prostate cancer & the challenges Astellas will face when launching Xtandi and tivozanib in the EU
Target audience for meeting
• Mid – top level product OLs – those with the potential to be local product champions within the relevant EU markets• Data – naïve customers, ie those who have not been involved in any APEL or national/local advisory board meetings prior to the pan EU ad board meeting • 10 per affiliate: 5 prostate/Xtandi and 5 RCC/tivozanib*
*Turkey – 10CRPC OLs.’
The emails sent to the UK affiliate which reflected the selection criteria set out above, the email which the UK senior employee forwarded to UK managers, and the responses from this team compounded the unacceptability of the arrangements. In that regard the Panel noted the email from one of Astellas UK staff identifying health professionals who met these unacceptable criteria included ‘[city] is one of … main key accounts’, ‘…one of our high users and would respond well to such a meeting…’, ‘… is influential at a [city] level and more and more nationally with time’ and ‘This is a business move … barely sees industry, not using prechemo abi and once using he rarely changes’. The reserve nominations included ‘… I believe he has the reputation with us for being an abi man, however, this would give us the opportunity to convert him to the new way and ‘…is on our list and is influential, and would be good to engage at this level’.
The Panel did not accept Astellas Europe’s submission in the case now under consideration that its provision of an incomplete and in the Panel’s view misleading response was unintentional given Astellas’ decision not to include the unapproved criteria following the dispatch of what Astellas described as a revised corrective email (December 2013). The Panel noted Astellas Europe’s submission that it did not include the initial unapproved criteria in its response to Case AUTH/2747/1/15 as these were not the ultimate final criteria communicated to affiliates. It further noted the company’s submission that there was no consideration at all as to whether the emails of 5 September and 17 October should be submitted as part of its response to the previous case, Case AUTH/2747/1/15. Astellas Europe acknowledged that its investigation into that complaint was inadequate.
The Panel was extremely concerned that Astellas Europe appeared to consider that ultimate revised final selection criteria had been communicated. In the Panel’s view that was not so. Neither of the two emails dated 12 December sent from Astellas Europe contained revised selection criteria. The Panel noted Astellas Europe’s submission that the teleconference held on 12 December discussed the revised selection criteria for attendees. In the Panel’s view this should have been made abundantly clear in the emails of 12 December. Astellas Europe had not provided detailed information regarding the discussion on the teleconference. Given its comments above the Panel was not at all surprised by Astellas Europe’s submission that none of its affiliates had subsequently requested any changes to those nominated as attendees. It was hard to understand why such a fundamental change to the selection criteria had not been made clear at the outset in either of the emails.
The Panel noted that the original selection criteria as set out in the three emails and the presentation to the Oncology Steering Committee dated 5 February 2013 were directly relevant to the subject matter of the complaint in Case AUTH/2747/1/15. In the Panel’s view Astellas Europe had therefore provided not only an incomplete response to that complaint but also a misleading one.
The Panel noted Astellas Europe’s submission that the final certification did not take place until the day before the meeting took place (26 February 2014) after health professionals had been selected and invitations sent.
In addition to the provision of an incomplete response, the Panel noted Astellas Europe’s submission that it was now apparent that its representatives had misled the Appeal Board when the report was considered as the UK sales force had been involved in the nomination process.
The Panel noted Astellas Europe’s submission that concerns had been raised in November 2013 and that in January 2014 it had received an anonymous complaint about the meeting which had been dealt with by the issuing of the revised selection criteria and thus no further action was taken. The Panel noted its comments above about the revised selection criteria and their communication. The Panel also noted that Astellas Europe’s response to the Panel’s request for further information was different to its initial submission in relation to whether the company knew about the emails and the changes to the selection criteria for attendees and had decided not to provide them or whether the company had not asked staff for materials etc other than those in the Zinc system. In the Panel’s view Astellas had either not paid sufficient attention to ensuring that all relevant information had been supplied in its response to Case AUTH/2747/1/15 or had made a conscious decision to omit relevant details from that response. The Panel noted Astellas Europe’s most recent submission in this regard that it had not considered the material at all.
The Panel was extremely concerned and disappointed by the conduct of Astellas Europe and Astellas UK. The integrity of self-regulation relied upon the provision of complete and accurate information by pharmaceutical companies. The Panel considered that the failure to provide all the information and the misleading nature of what was submitted in Case AUTH/2747/1/15 meant that high standards had not been maintained. A breach was ruled as acknowledged by Astellas Europe. The circumstances brought discredit upon and reduced confidence in the pharmaceutical industry. The Panel ruled a breach of Clause 2 as acknowledged by Astellas Europe.
In relation to the allegations about the discussion of the case by a very senior employee of Astellas Europe, the Panel noted the comments made by staff interviewed about meetings which this individual had attended. It appeared that these were not ‘Astellas town hall’ meetings as stated by the complainant. It was not clear what the meeting referred to by the complainant was but the complaint was clear it was a meeting where this individual discussed the matter. The Panel was concerned that the interview guide for discussion with employees appeared to be biased and designed to encourage staff to confirm that they were impressed by the training and the ‘Tone from the top’. Bearing in mind the difficulties for staff in being critical of senior management, the Panel was very concerned that a very senior employee of Astellas Europe’s comments on the outcome of Case AUTH/2747/1/15 were viewed as dismissive and/or that the matter was not taken seriously enough. This was compounded by the serious nature of that case. The details set out in the collated interview feedback master document appeared to be different to those provided elsewhere in the company’s response. Nonetheless it was clear that despite the content and tone of the interview guide, certain staff were concerned about the impression given. The Panel was also concerned that staff recalled the phrases ‘we were trying something different’ and ‘there are large grey areas in application of the code’. The Panel disagreed with the latter comment in relation to Case AUTH/2747/1/15 as the requirements for advisory boards and other such meetings were clear in the Code, supplementary information and guidance issued by the PMCPA.
The Panel considered, given the seriousness of Case AUTH/2747/1/15, it was completely unacceptable in the companies’ discussion of that case for a very senior employee of Astellas Europe to give any impression that he and/or the company was dismissive of the Panel’s rulings and the Appeal Board’s consideration of the report from the Panel. The Panel considered that in this regard high standards had not been maintained and ruled a breach. In addition the Panel considered that the circumstances brought discredit upon and reduced confidence in the pharmaceutical industry. The Panel ruled a breach of Clause 2. These rulings were upheld on appeal by Astellas Europe.
The Panel considered that the circumstances regarding the failure to provide comprehensive, accurate information, the misleading nature of the submissions in Case AUTH/2747/1/15, the relevance of the omitted material and the discussion of the outcome of the case by Astellas Europe raised serious concerns about the companies’ procedures. In this regard the Panel noted Astellas Europe’s submission about its certification of the arrangements the day before the meeting in question. It also noted the Appeal Board’s comments when considering the report from the Panel in Case AUTH/2747/1/15 that the company’s standard operating procedures were either unclear or not followed and its questions over the rigour of Astellas Europe’s certification process. This case also raised fundamental concerns regarding Astellas Europe and Astellas UK’s approach to compliance and self-regulation.
The Panel noted its comments above regarding the position of Astellas UK and Astellas Europe in relation to this case. The Panel considered that its serious concerns warranted reporting Astellas Europe and Astellas UK to the Appeal Board under Paragraph 8.2 of the Constitution and Procedure.
In relation to the report from the Panel, Astellas Europe contacted the PMCPA in September to advise that it had recently discovered information which the company wished to provide to the Appeal Board in relation to its consideration of the report from the Panel. The Chairman of the Appeal Board agreed that Astellas Pharma Europe could submit further information in relation to the report. The information did not relate to Astellas UK.
Astellas Europe stated that it had conducted a number of staff interviews as part of its continued human resources investigation and an email had been discovered which it considered to be the source of the concerns that were raised in November 2013 about the advisory board at issue in Case AUTH/2747/1/15.
The email, from a senior employee at Astellas Europe was dated 26 October 2013 and indicated that the sender was instructing the team to remove an unacceptable objective for the advisory board from the meeting agenda in order to ‘smooth the passage’ of the meeting through the approval process, but unfortunately made it clear that this was still a key objective of the advisory board.
Astellas Europe referred to the background and submitted that the email indicated that there was a conscious decision by one individual to circumvent the established approval process in order to incorporate an unacceptable objective in to an advisory board.
Astellas Europe submitted that the email appeared to be the trigger for the activities that took place in late 2013 to reassess the meeting and address the concerns raised. Two of the four members of staff in receipt of the email of 26 October 2013, whilst not sharing or discussing the email directly with anyone, raised their concerns about the meeting. The activities in November and December 2013 were as a consequence of this in an attempt to correct the issues raised eg the teleconference and emails of 12 December 2013.
Astellas Europe as an organisation stated that it was not aware of the emails until 22 September 2015 which was why they were not submitted in the company’s response to Case AUTH/2780/7/15. This was particularly disappointing, given that the individual in question was asked for all relevant information.
At the consideration of the report Astellas Europe and Astellas UK stated that the companies recognised that the investigation and response to Case AUTH/2747/1/15 was inadequate. The companies submitted that there was no dishonesty or deliberate attempt to mislead. The investigation had identified that an individual senior member of staff central to this situation withheld key information from Astellas Europe, the Panel and Appeal Board. Immediate action had been taken to address the conduct of this senior member of staff. Astellas incorrectly assumed that there was no sales involvement in nominating UK health professionals to attend the advisory board and therefore it unintentionally provided inaccurate information to the Appeal Board.
Astellas accepted the Panel’s rulings of breaches of the Code and deeply regretted that it had brought disrepute on the pharmaceutical industry.
Astellas Europe stated that it had already undertaken a number of measures and gave details of its key compliance activities since the completion of Case AUTH/2747/1/15. Details were provided.
The Appeal Board noted the Panel’s comments and rulings including its ruling of a breach of Clause 2 and the outcome of the appeal where the Appeal Board upheld a second Panel ruling of a breach of Clause 2. The Appeal Board was extremely concerned about the approach to compliance and poor communication across Astellas Europe and Astellas UK.
The Appeal Board noted the Panel’s comments that the original selection criteria for Astellas Europe’s Pan-European Uro-oncology Advisory Board Meeting were directly relevant to the subject matter of the complaint in Case AUTH/2747/1/15 yet these had not been provided by the company in its response to that case.
The Appeal Board was also very concerned about why the email dated 26 October 2013, sent by the senior employee of Astellas Europe was not previously provided. The Appeal Board noted from Astellas that two recipients of the email had raised concerns about the meeting back in 2013 but they had not disclosed the email itself. Astellas stated that the email was handed to senior management on 22 September 2015. The Appeal Board was concerned that such relevant information had not surfaced until this late stage.
The Appeal Board was very concerned about the culture of the organisations and that despite a prior internal complaint raising the issue it had taken two complaints under the Code and a late submission of evidence in the present case to produce comprehensive information concerning selection of the delegates for the meeting at issue.
The Appeal Board was concerned that the arrangements had been reviewed and approved by the UK affiliate. Astellas Europe certified the arrangements the day before the advisory board at issue took place.
The Appeal Board considered that Astellas had provided not only an incomplete response to the original complaint but also a misleading one. The Appeal Board considered that self-regulation relied upon the provision of complete and accurate information by pharmaceutical companies. Astellas’s omission was totally unacceptable. The Appeal Board decided that in accordance with Paragraph 11.3 of the Constitution and Procedure that both Astellas Europe and Astellas UK should be publicly reprimanded for this failure.
The Appeal Board noted that the UK health professionals who attended the meeting had been provided with a corrective statement and a case report which was misleading. This was totally unacceptable. Consequently the Appeal Board decided, in accordance with Paragraph 11.3 of the Constitution and Procedure, to require Astellas Europe and Astellas UK to issue a corrective statement to all the UK attendees at the meeting to clarify the position. The corrective statement should refer to both case reports. Under Paragraph 11.3 details of the proposed content and mode and timing of dissemination of the corrective statement must be provided to the Appeal Board for approval prior to use. [The corrective statement appears at the end of the report.]
The Appeal Board also decided that, given all of its concerns about the conduct of Astellas as set out above, to require, in accordance with Paragraph 11.3 of the Constitution and Procedure, an audit of both Astellas Europe and Astellas UK’s procedures in relation to the Code. The audit would take place in December 2015. On receipt of the audit report, the Appeal Board would consider whether further sanctions were necessary including the possibility of reporting the companies to the ABPI Board of Management (Paragraph 12 of the Constitution and Procedure).
Astellas Pharma Europe and Astellas UK were each audited in December 2015 and on receipt of the report of the audits, the Appeal Board was extremely concerned that despite a very critical report that highlighted numerous serious concerns including the companies’ cultures and a reference to Astellas Europe’s institutional failure with respect to compliance, neither Astellas Europe nor Astellas UK provided any detail on when and how each would address those concerns.
The Appeal Board decided that both companies should be re-audited but it deferred setting a date for such until each had provided a detailed compliance action plan and comprehensive response to the recommendations in the report of the audits. The Appeal Board discussed further sanctions including, again, whether there should be a report to the ABPI Board. The Appeal Board concluded that on receipt of the report for the re-audits it would decide whether further sanctions were necessary.
The companies subsequently provided a further detailed response as requested. The Appeal Board noted that the companies would need time for their stated compliance objectives to be completed or get underway. In that regard the Appeal Board decided that Astellas Pharma Europe and Astellas UK should each be re-audited in September 2016 by which time both would be expected to demonstrate significant improvement.
During the Code of Practice Appeal Board’s consideration of the audit reports for Astellas Europe and Astellas UK (25 February 2016) it noted a letter from Astellas Europe (17 February) which stated that new information had been discovered as a result of further investigation which would assist the understanding of the full circumstances of these cases and this would be sent to the PMCPA.
On receipt of further information from Astellas Europe the original Panel was reconvened to consider the matter.
The detailed response from Astellas Europe is given below and included a report by external counsel which was asked by Astellas Pharma Inc to conduct an investigation.
The Panel noted the circumstances surrounding Cases AUTH/2747/1/15 and AUTH/2780/7/15, the reports to the Appeal Board, the findings of the audits, particularly those relevant to Astellas Europe, and the additional information now provided by Astellas Europe. The companies were to be re-audited in September 2016.
The Panel noted that the additional information was provided by, and concerned acts and omissions by, Astellas Europe. The Panel noted that Astellas Europe was not a member of the ABPI, although it was a member of EFPIA. Astellas UK was a member of the ABPI. The Panel had previously noted that Astellas UK was responsible for the acts/omissions of its affiliates that fell within the scope of the Code including its UK based European headquarters. In the present matter, the Panel noted that the position of Astellas UK remained as set out above.
The Panel noted all the concerns and comments it had raised previously. It was appalled at the conduct of senior managers as revealed in the additional information in relation to the two cases and resulting audits. Senior managers failed to provide full and accurate details to the Panel, the Appeal Board and the Authority in relation to the audits. Some very important details, although hinted at by the Panel, the Appeal Board and by the Authority in the report of the audits, had only come properly to light as a result of the follow-up investigation ordered by Astellas Japan and carried out by an external counsel. This might, in part, have been triggered by the audits including the conversation the PMCPA had with the CEO and President Astellas Group.
The report from external counsel stated that all those involved in compiling the information and drafting the response to Case AUTH/2747/1/15 were aware of the existence of the original selection criteria, as on 30 January 2015 senior employees’ attention was drawn to the email which set out the original selection criteria. This was inconsistent with Astellas Europe’s original response.
The report from external counsel noted that the company’s investigation following receipt of the second complaint (Case AUTH/2780/7/15) was inadequate. The external counsel report noted that the failure to conduct a thorough fact-finding exercise at any time following the first PMCPA complaint was concerning and was even more troubling given the number of senior staff who knew exactly where to look for the relevant material. Further details about the content of the report from the external counsel appear below.
The Panel considered that the additional information demonstrated that a number of individuals in Astellas Europe had not provided complete and accurate information. That this included very senior employees was extremely concerning. Astellas Europe’s conduct was completely unacceptable. The report of the audits had found that there was an institutional failure with respect to compliance; a finding which, in the Panel’s view, was now compounded by the additional information including the report by external counsel. The failings of Astellas Europe, as demonstrated by the additional information, went beyond, and were arguably even more serious than, those outlined in the report of the audits. The latest information demonstrated that Astellas Europe staff had lied about the original selection criteria on a number of occasions and not limited to Astellas Europe’s response to the complaints but including when interviewed individually by members of the Authority at the audit, when they appeared before the Appeal Board in relation to the reports from the Panel in both cases and at the appeal in Case AUTH/2780/7/15. The failure to provide accurate, complete information at an audit and to the Appeal Board was a very serious matter. The truthfulness and accuracy of such comments and submissions to the Authority was fundamental to the integrity of self-regulation. It was remarkable that the individuals concerned had not provided the correct information sooner despite having had every opportunity to do so; the true position only emerged after those from the PMCPA carrying out the audits had spoken to the Japanese parent company and a report from external counsel was commissioned. The Panel was also concerned about the newly revealed breadth of compliance failures such as flawed processes including human resources processes wherein vital compliance material was not recognized as such, and the apparently unfettered influence of the named senior individuals upon matters such as disciplinary investigations. The Panel noted that very senior employees had left Astellas Europe. The Panel decided that it would report Astellas Europe to the Appeal Board under Paragraph 8.2 of the Constitution and Procedure for it to consider in relation to Paragraphs 11.3 and 11.4 of the Constitution and Procedure. Astellas UK would be advised accordingly.
The detailed comments from Astellas Europe and Astellas UK on the report from the Panel appear below.
In summary the representatives from Astellas Europe sincerely apologised for the significant cultural and compliance failings created and caused by the actions and behaviours of some of its very senior managers. Globally Astellas viewed the current position as a corporate crisis. The newly appointed President of Astellas Europe stressed his commitment to improve corporate culture such that ethics and compliance were embedded throughout the organisation. Some of that cultural change would come through the appointment of new people into key roles.
The UK company was committed to working closer with Astellas Europe to clarify responsibilities and to ensure that the UK approved and certified any activity undertaken by its European affiliates that involved a UK health professional or took place in the UK. The company would also take responsibility for any future complaints under the Code about such activities.
The Appeal Board welcomed the full apology made by the representatives of Astellas Europe at the consideration of the report, particularly as no apology was included in the papers for the case. However, the Appeal Board considered that such multiple organisational and cultural failings meant that this was one of the worst cases it had ever had to consider. There was an institutional failure with respect to compliance. Very senior staff had lied and there was deception on a grand scale. The Appeal Board was appalled and astonished that senior managers from Astellas Europe had made a concerted attempt to deceive it and the PMCPA. In that regard the Appeal Board considered the PMCPA’s foresight to interview the Global CEO and President of Astellas Inc during the audit was pivotal in bringing these failings to light. It was a truly shocking state of affairs. The Appeal Board noted that these concerns did not relate to Astellas UK.
This was the third time Astellas Europe had been reported to the Appeal Board by the Panel and the second time Astellas UK had been reported to the Appeal Board by the Panel (including Case AUTH/2747/1/15).
The Appeal Board whilst recognising the difficulties of the situation, considered that Astellas UK should have attempted to exercise greater control on compliance matters in relation to the meeting at issue, the investigation of and response to the complaints and the Panel’s reports to the Appeal Board. This was especially important given that Astellas UK was responsible for the acts/omission of its affiliates that fell within the scope of the Code including its UK based European headquarters. Given the information about the lies and deception, it was not surprising that Astellas Europe had asserted itself and taken the lead in responding to Cases AUTH/2747/1/15 and AUTH/2780/7/15.
The Appeal Board noted that Astellas Europe, as a member of EFPIA, was bound by the codes of EFPIA member associations including any applicable sanctions.
The Appeal Board considered that the integrity of self-regulation was reliant upon pharmaceutical companies providing complete and accurate information. The conduct of senior staff at Astellas Europe had been totally unacceptable and potentially harmful to self-regulation in this regard. It was also disappointing that Astellas UK had not taken firm action. There were multiple failings in these cases. The Appeal Board decided that in accordance with Paragraph 11.3 of the Constitution and Procedure that both Astellas Europe and Astellas UK should again be publicly reprimanded for this failure.
The Appeal Board noted that the UK health professionals who attended the meeting had been provided with two corrective statements and case reports which, given the emergence of new information, gave a misleading account of the arrangements for the meeting at issue. This was wholly unacceptable. Consequently the Appeal Board decided, in accordance with Paragraph 11.3 of the Constitution and Procedure, to require Astellas Europe and Astellas UK to issue a fresh corrective statement to all the UK attendees at the meeting to clarify the position. This would be the third corrective statement. [The corrective statement appears at the end of the report.]
The Appeal Board also decided, given the seriousness of the failings, its concerns about the conduct of Astellas as set out above and the responsibility of Astellas UK for its parent company, to report Astellas Europe and Astellas UK to the ABPI Board of Management. This was in accordance with Paragraph 12.1 of the Constitution and Procedure.
The ABPI Board noted that breaches of the Code had been ruled including Clause 2. The companies had been reported to the Appeal Board and both had been publicly reprimanded and required to issue corrective statements. The companies had been audited in December 2015 and were to be re-audited in September 2016.
The ABPI Board was extremely concerned at the multiple organisational and cultural failings at Astellas. There was an institutional failure. Very senior staff at Astellas Europe had lied and there was deception on a grand scale which was appalling and shocking.
The totally unacceptable behaviour of senior staff at Astellas Europe was potentially harmful to the integrity of self-regulation which relied upon companies providing complete and accurate information. The ABPI Board noted that Astellas UK was the member of the ABPI and that Astellas UK was responsible for the acts/omissions of affiliates that fell within the scope of the Code including its UK based European headquarters.
The ABPI Board decided that Astellas UK should be suspended from membership of the ABPI for a period of 12 months commencing 24 June. The ABPI Board also decided that it wanted sight of the reports of the September 2016 reaudits of Astellas UK and Astellas Europe so that it could review the position, including the length of the suspension, before the end of 2016. The reaudits must show demonstrable improvements at both companies particularly in relation to corporate culture.
Astellas UK and Astellas Europe were re-audited in September 2016 and the report of the audits was considered by the Appeal Board in November.
The Appeal Board noted that although both companies had worked hard to implement the recommendations from the previous audits and to ensure compliance was truly embedded, there was still work to do.
With regard to Astellas Europe, the Appeal Board noted that the institutional failure with respect to compliance was starting to change. Both companies had, inter alia, issues with certification. The Appeal Board decided that both should be re-audited in April 2017 and on receipt of the report for those re-audits it would decide whether further sanctions were necessary.
At its meeting in December, the ABPI Board reviewed the progress made by both companies and the work still to be completed noting that it took time to change culture and to truly embed compliance. It noted the Appeal Board’s decision that both companies should be re-audited in April 2017. Although the ABPI Board was encouraged by the improvements and progress made by both Astellas Europe and Astellas UK it decided that the suspension of Astellas UK from membership of the ABPI should continue. The ABPI Board would review the position in June after the re-audits.
Astellas UK and Astellas Europe were re-audited in April 2017 and the report of the audits was considered by the Appeal Board in May 2017.
The Appeal Board noted that Astellas UK and Astellas Europe were now working more closely and there was more open communication with staff. Both companies had been working to implement the recommendations of the previous audits and to ensure compliance was embedded. However, the Appeal Board noted the number of issues highlighted in the report and that there was still much work to be done.
The Appeal Board accepted that it took a long time to change culture but it was not convinced that progress was being made at an appropriate speed particularly given the issues that had come to light in Cases AUTH/2883/10/16, AUTH/2939/2/17 and AUTH/2940/2/17. This was particularly worrying given the level of scrutiny the companies were under. In the view of the Appeal Board, Astellas had much work still to do.
In relation to Case AUTH/2780/7/15 the Appeal Board decided that both companies should be re-audited in October 2017 at the same time as the audits required in Cases AUTH/2939/2/17 and AUTH/2940/2/17 and the re-audit in Case AUTH/2883/10/16 (Astellas UK only).
The Appeal Board noted the outcome of the audit in Case AUTH/2883/10/16 and the re-audits in Case AUTH/2780/7/15, the decisions to report Astellas UK to the ABPI Board in relation to Case AUTH/2883/10/16 and Astellas UK and Astellas Europe in relation to Cases AUTH/2939/2/17 and AUTH/2940/2/17. It also noted its concerns regarding the lamentable lack of concern for patient safety and wholly inadequate oversight and control. Whilst noting this was a matter for the ABPI Board, the Appeal Board’s view was that Astellas UK was not ready to resume membership of the ABPI and the suspension should continue.
At its meeting in June 2017 the ABPI Board agreed with the Appeal Board’s comments and concerns about the re-audits in April 2017.
The ABPI Board noted and endorsed the Appeal Board’s views about the total failure of the companies’ systems in relation to the control of prescribing information, the lamentable lack of concern for patient safety, wholly inadequate oversight and control and initial lack of urgency. It was a woeful state of affairs.
The ABPI Board gave serious consideration to expelling Astellas UK from membership of the ABPI. However, it noted the commitments from Astellas Europe, the global company and of the new UK General Manager. The companies had made voluntary admissions and it was now imperative that the October re-audits showed significant progress.
The ABPI Board decided that it would extend the suspension of Astellas UK from membership of the ABPI for another 12 months. This further period would run uninterruptedly from the initial period of suspension and would then amount to the maximum suspension (two years) allowed under the ABPI Articles of Association.
The ABPI Board also decided that it wanted sight of the report of the October 2017 re-audits of Astellas UK and Astellas Europe so that it could review the position before the end of 2017. If the report of the re-audits did not show significant improvement and progress at both companies, then the ABPI Board would consider expelling Astellas UK from membership of the ABPI. The companies should consider undergoing an external assessment of progress, particularly in relation to risk management of compliance in the broadest sense, ie including matters beyond the scope of the Code, with the outcome to be available at the time of the October 2017 re-audits.
The ABPI Board also decided that the MHRA should be advised of the ABPI Board’s very serious concerns about the conduct of Astellas UK and Astellas Europe particularly in relation to the matters concerning patient safety. EFPIA should also be updated and asked to ensure the EFPIA Board was informed of the position.