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 (WRC) 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 Health Products Regulatory Authority (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.
Buying a new car in 2025? These are the best ways to finance it
The best crime fiction of 2024: Robert Harris, Jane Casey, Joe Thomas, Kellye Garrett, Stuart Neville and many more
We’re heading for the second biggest fiscal disaster in the history of the State
Housing in Ireland is among the most expensive and most affordable in the EU. How does that happen?
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 e-mailing 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 for 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 May 24th, 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 per cent 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 July 18th 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 July 18th in an effort to “align on a story”.
Dr Seigle-Murandi said Mr Delley told him: The company’s future was at stake but so was mine”. He said he 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, said Dr Seigle-Murandi’s claims were “false allegations”. “You cannot continue to traduce or defame the reputations of people by making false allegations which contradict what was written,” he said.
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 per cent to his 2019 bonus and 50 per cent in 2020, while also attempting to have him complete a performance improvement plan.
Further claims of “moral harassment” by a line manager in the form of “micromanagement” were also denied by the manager in question, Patrick Weston.
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.”
He said he was treated like “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 said.
On Thursday 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.
He could not find Mr Delley’s actions at the July 18th 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.,
In a separate decision over the circumstances of his sacking from Roche, Mr Murphy wrote that the complainant presented “no cogent argument” that e-mailing documents to outside addresses was a necessary act.
He rejected the dismissal complaint on that basis.
