A sacked drug safety manager at pharma multinational Roche has alleged the firm’s former top manager in Ireland pressured him to lie to the State medicines watchdog about wanting a recall of marketing literature for three specialist cancer, arthritis and haemophilia medications.
The Workplace Relations Commission heard on Tuesday that the Health Products Regulatory Authority (HPRA) was in agreement with Dr Bruno Seigle-Murandi about risks to patient safety in five items of literature and ordered a recall of the items.
When the HPRA announced an audit over the issue, Dr Seigle-Murandi told the WRC, Roche’s former general manager in Ireland, Pierre-Alain Delley, told him the company’s licence to operate was “at risk” and asked him to take responsibility for an earlier letter to the regulator stating the view that ending distribution and sending medics an instruction to bin the material was enough.
Dr Seigle-Murandi’s legal team says he was ultimately penalised for having made a protected disclosure and dismissed from his role as pharmacovigilance manager and local safety representative for Ireland.
“I was asked to sacrifice myself for the sake of the team,” he told the Workplace Relations Commission on Tuesday, as the adjudication of his complaints under the Protected Disclosures Act 2014 and the Unfair Dismissals Act 1977 against Roche Products Ireland Ltd opened for hearing.
Roche denies any whistleblower retaliation and maintains the complainant’s dismissal last year was not linked to any previous disclosure.
Dr Seigle-Murandi’s barrister, Darach MacNamara, instructed by Andew Freeman of Sean Costello Sols, said his client had “literally stumbled” upon boxes of the promotional material in the Roche lobby in Citywest in May 2019, apparently having been delivered by a printer for the sales department.
In evidence, the complainant explained that the European Medicines Agency, and in Ireland the HPRA, dictate the wording of three categories of literature on medicines: the “easy-to understand” patient information leaflet included in packaging; the “full, comprehensive, more scientific” summary of product characteristics provided to healthcare professionals, and a third optional category for “tricky-to-use” products advising doctors on side effects called “additional risk minimisation measures”.
Dr Seigle-Murandi said the boxes contained promotional material for Roche sales reps – a category which did not have its wording set by the national or European regulators, but which was required to give “full comprehensive and scientific information on claims and safety”.
He said he had been seeking such material to read up on Roche products and found it hard to come by, so he opened a box.
“Gosh we’re in deep s**t. What have we been doing?” he described saying to himself, adding that he knew immediately the material was in “total infringement” of the relevant rules.
The brochures for the product were clearly advertising material as they included illustrations – but also contained a patient alert card which he said could only be issued by a pharma firm in an additional risk minimisation measures (ARMM) document with wording set by the regulators, he said.
After going to the Roche marketing department that day to investigate, he said he identified issues with promotional material for three products including a cancer therapy, a medicine for arthritis and a product for haemophilia patients.
The tribunal was shown an ARMM risk mitigation document for the cancer drug, Tecentriq, and an example of its promotional brochure which he obtained from the Roche marketing department that day.
“It has the exact title of a document approved by the HPRA. It is a lookalike, a copycat of an ARMM,” Dr Seigle-Murandi said, adding that the wording was “99.9%” identical.
The difference was that the brochure was missing safety information referring to some 62 adverse reactions to Tecentriq which had been notified to health regulators, including two fatalities from liver injuries, Dr Seigle-Murandi said.
After consulting with a colleague, the complainant said he wrote to his superiors on May 8th that year stating that he had identified a risk to patients in the distribution of the marketing material.
After writing a draft of a notification to the HPRA in which he urged a document recall, he said he was “shocked” to read the final version of the letter sent to the regulator, which was opened to the tribunal by Mr MacNamara.
“Roche does not believe HCPs [healthcare practitioners] should be instructed to retrieve information from patients,” it read.
Dr Seigle-Murandi said he did not realise the changes had been made until the HPRA replied with “very robust questions” and that he felt “betrayed” by the new wording.
“Ultimately I have the accountability to health authorities – it looks like I would allow such nonsense action from Roche.” he said.
In correspondence from early June 2019 opened to the tribunal, the regulator questioned why Roche thought it was appropriate not to retrieve the cards in view of what it regarded to be “patient level safety concerns”.
It was the complainant’s evidence that the regulator took issue with five items of literature associated with Tecentriq and two other Roche products – the arthritis drug RoActemra and Hemlibra for the treatment of haemophilia A – and instructed the company to draft a letter to healthcare professionals recalling the material.
Dr Seigle-Murandi said it was “false, dangerous information” and that there ought to be “no cutting corners” when a patient risk was identified.
Mark Connaughton SC, appearing for Roche instructed by McCann Fitzgerald, raised an objection and said that assertion had not come up before.
The complainant said that was his assessment as a healthcare professional.
“There’s no indication in the HPRA document of that,” Mr Connaughton said.
“Let me replace ‘dangerous’ with ‘presenting a risk to patient safety’,” Dr Seigle-Murandi replied.
The HPRA then notified Roche it would carry out a two-day inspection at the end of July 2019.
The complainant said he was called to a meeting a week and a half before this, on July 18th, with Roche Ireland’s then-general manager, Pierre-Alain Delley and other members of the pharmacovigilance team.
He described taking a seat at a table and having the other five attendees sit down on the opposite side.
“I felt immediately oppressed, ostracised ... I immediately felt it was a court, like I was at trial,” he said.
He said Mr Delley told him: “You are probably aware we have our licence to operate at risk. You don’t want to jeopardise our licence to operate.”
The complainant said he was told he “needed to be part of the team” and to “go along, collaborate, sign off” on an “alternative storyline” put together by a colleague.
Dr Seigle-Murandi said the options given to him were to either stand over the original letter stating that the literature should not be recalled or accept that it should be recalled and say it was his mistake.
“Pierre-Alain Delley asked me to back [the colleague’s alternative] story ... I was asked to sacrifice myself for the sake of the team,” he said.
“There is no way that I would not be fully truthful to a health authority inspection,” he recounted telling the meeting.
He added that Mr Delley told him: “The company’s future was at stake but so was mine.”
“How could the general manager of one of the biggest pharma firms ask me to lie to the HPRA,” the complainant said. “I said: ‘No way am I signing that,’” he told the tribunal.
He added that there were no minutes taken.
Dr Seigle-Murandi said he was subjected to exclusionary treatment leading up to the HPRA audit less than a fortnight later.
The extent of his involvement with the inspection was to make a “very short comment” at the request of the investigators with Roche deciding who would make presentations to answer their questions, he said.
Dr Seigle-Murandi replied affirmatively when asked by his counsel if the literature was recalled.
Mr Connaughton asked how the complainant had knowledge of this. Mr MacNamara then asked his client whether he was involved.
“No, which is mad,” Dr Seigle-Murandi replied, before adding: “I was involved to a minimal degree.”
Mr Connaughton said Roche had acted “immediately” in response to the issues raised by Dr Seigle-Murandi and notified the matter to the HPRA, and that the regulator’s inspectors “closed their file to their satisfaction” in February 2020.
He said certain allegations raised by the complainant’s legal team had only been aired for the first time in legal submissions shared with the firm on Monday, the day before the hearing, and objected to these as they arose.
“It is a red herring to suggest there was something he disclosed or discovered that he’s being punished for when the company dealt with that,” Mr Connaughton continued, adding that there had been “no subsequent protected disclosures”.
“Contrary to Dr Seigle-Murandi’s assertion that he was motivated by issues of patient safety, he did not use the internal policies. He chose not to follow those policies,” Mr Connaughton said. He said Roche had a “very well developed ‘speak up’ policy” and that its independence is “guarded very, very carefully”.
“It means any employee who has a concern and raises it through policy is guaranteed an examination of the issue. That’s what makes it all the more astounding. That policy would have allayed any concerns – any legitimate concerns – that he had,” Mr Connaughton added.
He said it was Roche’s case that Dr Seigle-Murandi “was a very difficult man to work with” and had “relationship issues” with colleagues during his employment. The company supported the complainant with a coaching programme, but he “railed against that”, Mr Connaughton said.
Counsel said the sacking was a fair and a reasonable sanction for gross misconduct after Dr Seigle-Murandi admitted to investigators that he had sent company documents to personal email accounts – and that the firm had followed fair procedures.
“He didn’t just send emails to himself. He sent hundreds of emails concerning the confidential business of the company to a number of email addresses which he alleged were under his control – but we never got to the bottom of it,” Mr Connaughton said.
Mr MacNamara said his client would continue with his evidence in chief on the next date, when further matters including the disciplinary process would be addressed.
Adjudicating officer David James Murphy closed the hearing and adjourned the matter. The matter will resume on a date yet to be fixed by the WRC.