Global pharma giant Roche has been ordered to pay a whistleblower €8,000 in compensation for penalising him after he made a protected disclosure to the State medicines regulator.
Ruling on statutory complaints by the whistleblower, a Workplace Relations Commission adjudicator said it was "concerning" that the penalisation occurred "as there are few private sector organisations which can have a greater impact on public safety and welfare than a pharmaceutical company".
He wrote it was also "concerning" that the ex-CEO of its Irish subsidiary tried to get staff to "agree on a version of events" with an inspection looming "rather than recognise that [they] had an individual obligation to engage with the regulator truthfully".
Dr Bruno Seigle-Murandi had claimed he was pressured by the ex-Roche Ireland boss, Pierre-Alain Dellay to "lie" to the HPRA and take responsibility for an earlier letter in which the firm said there was no need to recall non-compliant marketing literature in which he had identified a patient safety risk – something he insisted he would "never" put his name to.
However, the WRC found the CEO's actions could not be an act of penalisation after accepting the evidence of two former colleagues who said that the whistleblower had been directly involved in formulating the wording of the initial letter to the regulator.
Dr Seigle-Murandi was eventually sacked by the firm two years later for emailing hundreds of documents to email addresses controlled by his brother and parents – a bid to preserve evidence following an alleged campaign of "moral harassment" by his colleagues for his stance on the noncompliant documents, he said.
The tribunal heard that after Dr Seigle-Murandi "stumbled" across a consignment of documents from a printer, he identified marketing material for three specialist drugs that had used "copycat" wording to tightly-regulated additional risk minimisations measures (ARMM) documents.
The key difference was that the marketing brochures were missing a sentence referring to adverse reactions to the drug, including two fatalities, he said in evidence last year.
He said his initial reaction was: "Gosh, we’re in deep s***."
He uncovered the same problem with materials produced for Roche’s specialist cancer drug Tecentriq as well as its arthritis product RoActemra and Hemlibra for haemophilia, the tribunal was told – ultimately discovering in a long-term review that there were 93 documents with the issue.
"This is widespread, not a mistake, this is made with a commercial purpose. 93 materials were sent to patients and healthcare practitioners in Ireland that were noncompliant," he said.
The firm’s regulatory affairs manager Kim Kirwan said in evidence that it was an "error" as Roche was unaware the practice wasn’t allowed, and that it had been going on since before she joined the firm in 2010.
Dr Seigle-Murandi accused ex-colleagues of altering a document which went to the regulator late on Friday 24 May 2019 without his knowledge to state Roche "did not believe the material had to be recalled" – a claim denied in evidence by company witnesses.
The firm’s compliance manager Pat Lennon said he, Dr Seigle-Murandi and Ms Kirwan all "saw that [wording] going into that document".
Ms Kirwan said Dr Seigle-Murandi only later expressed concerns referring his "up to now 100% safety record" and alleged he had been put under "pressure" from Mr Lennon.
"He was regretful that he didn’t challenge the team decision we made," she said.
With a HPRA inspection on the noncompliant brochures just days away on 18 July that year, former Roche Ireland CEO, Pierre-Alain Delley, said he chaired a meeting of the core compliance group Dr Seigle-Murandi worked with on 18 July in an effort to "align on a story".
Dr Seigle-Murandi said Mr Delley told him the: ""The company’s future was at stake but so was mine" – and pressed him to "go along, collaborate, sign off" on an "alternative storyline" by either standing over the original letter or accept that it should be recalled and say it was his mistake.
"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.
In his evidence, Mr Delley said: "The problem I see with Bruno, he was forgetting a little the enterprise mindset… He was acting a bit as an external auditor rather than a Roche employee."
"I do not understand how he could be threatened. It was an alignment meeting in relation to the story flow," Mr Delley said. "I never used any pressure point because he was part of the team. We didn’t have any reason to threaten him," he added.
He called it "critical and very important" that Dr Seigle-Murandi raised the issue.
"That’s what I expect of any compliance person," he said.
Roche’s barrister, Mark Connaughton SC, appearing instructed by McCann Fitzgerald, said Dr Seigle-Murandi’s claims were "false allegations" – telling the complainant directly at the end of his primary evidence: "You cannot continue to traduce or defame the reputations of people by making false allegations which contradict what was written."
Dr Seigle-Murandi said he made a second notification to the HPRA – described by Mr Connaughton as a "unilateral" action – in July 2020 concerning the documents issue, after the company said the regulator had closed its file on the matter to its satisfaction.
He claims the firm penalised him in later dealings with him, including reductions of 25% to his 2019 bonus and 50% in 2020, attempting to have him complete a performance improvement plan, and other matters, all of which Roche denies were connected to any protected disclosure.
Further claims of "moral harassment" by a line manager of Dr Seigle-Murandi in the form of "micromanagement" and a performance improvement plan were also denied when the manager in question, Patrick Weston gave evidence.
Closing out his case, Dr Seigle-Murandi said: "Roche tried to protect themselves before patients. The clique did not like that I tried to disrupt the status quo."
The complainant, who spent the last three days of the case cross-examining company witnesses personally after dismissing his legal team on cost grounds, said he had been left "blacklisted" and unemployed.
"I was the snitch to be managed out. In this company, Roche, when you have the courage to speak up and make protected disclosures, you are only met with investigators searching your emails," he told the tribunal as the case concluded.
In decision documents released today by the Workplace Relations Commission, adjudicator David James Murphy said Mr Lennon and Ms Kirwan had been "convincing" in their accounts of how the wording of the letter to the HPRA was formulated compared with "vague" testimony from Dr Seigle-Murandi on that point.
The complainant "was involved in the initial decision not to recommend a recall," Mr Murphy concluded.
It followed from this that he could not find Mr Delley’s actions at the 18 July meeting were penalisation as they were not linked to a protected disclosure, he wrote.
However, Mr Murphy said Mr Delley’s own evidence "largely supported" what Dr Seigle-Murandi had alleged – and called it "concerning" that the CEO "sought to get employees to agree on a version of events… rather than recognise that each had an individual obligation to engage with the regulator truthfully".
The adjudicator also rejected the company’s argument that there had been no subsequent protected disclosure by Dr Seigle-Murandi, accepting that the complainant had made a protectected communication to the HPRA in July 2020.
The complainant’s then-line manager, Patrick Weston, considered this "unilateral" contact with the HPRA to be "unprofessional", the tribunal heard.
Mr Weston was "clear" in his evidence that the email was taken into account for Dr Seigle-Murandi’s performance review that year, when the complainant’s communications skills were rated as "needs improvement", Mr Murphy wrote.
Although Dr Seigle-Murandi "did display poor communication skills" which were legitimately factored in, the protected disclosure was still a factor in the poor rating – making the bonus cut which followed "an act of penalisation", Mr Murphy concluded.
"It is concerning that this occurred in the context of the respondent’s business as there are few private sector organisations which can have a greater impact on public safety and welfare than a pharmaceutical company," Mr Murphy wrote.
In a separate decision on Dr Seigle-Murandi’s Unfair Dismissals Act complaint over the circumstances of his sacking from Roche, Mr Murphy wrote that the complainant presented "no cogent argument" that emailing documents to outside addresses was a necessary act.
Mr Murphy said there was "a question… as to how serious the breach was" as there was "no question" of Roche intellectual property being sent to a competitor or personal benefit, and the documents involved mostly concerned Dr Seigle-Murandi’s grievances and penalisation claims.
However, he said the complainant’s refusal to delete the emails or say who had access to them put the dismissal "squarely within the band of reasonableness".
He rejected the dismissal complaint on that basis.
