A drug safety manager at international pharma giant Roche has alleged before the Workplace Relations Commission that there was widespread non-compliance in marketing materials distributed by its Irish arm – not in error, but "with a commercial purpose".
Dr Bruno Seigle-Murandi has alleged that after a review in 2019, some oncologists received letters from Roche to "throw in the bin all literature they had on products and to contact patients to say they should come to the practice [sic]".
He claims that Roche retaliated against him when he challenged this alleged "ongoing noncompliance", telling the WRC that there are "rotten elements" in the firm and that he believed there had been a "cover-up" to protect the marketing and medical departments at the Irish firm.
Roche, which denies Dr Seigle-Murandi's allegations of whistleblower retaliation and unfair dismissal, accepts that he raised issues but says the company acted "immediately" in response and notified the matter to the State medicines regulator, who "closed their file to their satisfaction" in February 2020.
It is their case that Dr Seigle-Murandi "was a very difficult man to work with"; had "relationship issues" with colleagues during his employment, and was guilty of gross misconduct for sending "hundreds" of Roche documents to personal email accounts.
It was the second day of Dr Seigle-Murandi’s direct evidence on his complaints under the Unfair Dismissals Act 1977 and the Protected Disclosures Act 2014 against Roche Products Ireland Ltd, where he was the pharmacovigilance manager for the Irish market.
At the opening of proceedings yesterday, the company’s barrister, Mark Connaughton SC, told the tribunal that the complainant had made some "outrageous claims" in his evidence to a previous hearing in November, "purely to damage my client", adding that the complainant should withdraw them.
Previously, Dr Seigle-Murandi said he had been pressured by Roche Ireland’s ex-general manager, Pierre-Alain Delley, to lie to the State medicines regulator, the Health Products Regulatory Authority, by taking responsibility for a company recommendation that non-compliant marketing documents did not need to be recalled from patients by healthcare practitioners.
The complainant said he had wanted the documents recalled as he believed there were patient safety risks – but that his recommendation was changed in a letter sent to the HPRA by his colleagues.
The HPRA ordered five items of marketing literature for three specialist cancer, arthritis and haemophilia medications made by Roche to be withdrawn and carried out a regulatory inspection in July 2019.
Dr Seigle-Murandi told the WRC yesterday that following a HPRA audit in July 2019, he continued his investigations into the autumn of that year, working with an external consultant.
"Most of my time was to review marketing materials – over 500. I ended up with 93 distinct materials – so 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.
After accounting for brochures which were either redundant or out of circulation, Roche issued 20 more recall notices for the literature.
"Everyone was unhappy with me in the field… During that time, some oncologists received three letters from Roche to throw in the bin all literature they had on products and to contact patients to say they should come to the practice," he said.
He said that from September 2019, the company structure changed and he was no longer reporting to medical director Dr Michel Starnowsky but instead to a new line manager, Patrick Weston.
"I was not supported. I was micromanaged. Every single thing was second-guessed," Dr Seigle-Murandi said.
"It was obvious to me that other members of the team gave negative feedback," he said.
At his next performance review, his bonus was reduced to 75%, he said, adding that he believed the negative feedback was motivated by his having taken a "very strong" stance on the regulatory matters.
He said Mr Weston told him at a review meeting in October or November 2019 that the two main issues were "communication style" and "lack of trust with the team".
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.
Dr Seigle-Murandi said the criticism against him was coming from the "core team" involved with the regulatory matters, which he said had removed his original recommendation that the regulator recall the literature because he had patient safety concerns.
"I was not happy with this. Of course, when you express your displeasure to them, it's rocky, it’s vivid," he said.
He said his colleagues were "not happy" to make admissions to a senior drug safety manager at Roche headquarters and wanted to "cover up the infringements perpetrated by marketing and medical in the Irish affiliate".
Dr Seigle-Murandi said he initially believed senior drug safety management in Roche’s headquarters knew about the issues and would address them, and knew that there was retaliation against him in the Irish firm.
"I was a snitch of them [sic]. I was a bad guy coming to expose their bad practices that are going on, that are widespread," he said.
The complainant's account was that interpersonal difficulties persisted within that core team up to and into the period of Covid-19 restrictions, during which he returned to his home in Strasbourg, France and worked remotely.
In a 20 October 2020 letter to the Roche group compliance officer, he made two allegations of breaches of the company’s business ethics rules against a group of colleagues who had been involved in initial dealings with the HPRA and against the former general manager of Roche Ireland, Pierre-Alain Delley.
The complainant’s barrister, Darach MacNamara BL, said it was his client’s case that this was the second time his client made a protected disclosure.
Asked Mr MacNamara why he had not previously said something about the meeting with Pierre-Alain Delley during his ongoing dealings with human resources, Dr Seigle-Murandi said: "I got very scared. When you have the GM of an extremely powerful organisation like Roche threaten you, that is very scary... I didn't know who I could trust."
Dr Seigle-Murandi said that he was taken off duty and locked out of company systems on 8 February 2021 because he refused to tell an internal drug safety audit group that a compliance plan to deal with the brochures issue was working.
Roche Ireland’s general manager, Alison Muir, told him in a telecall that he was being placed on administrative leave pending an investigation into "flows" of email from his company address, he said.
"After 30 seconds my computer closed down and I was denied any access to Roche systems," he said.
"On the previous Friday we had an audit preparation meeting – it’s Roche checking how we’ve worked with HPRA outcomes," he said.
He said it was stated at the meeting that there had been a "successful" outcome in the area he had identified.
"I said: 'I disagree, that I was in disagreement to tell to them, audacious, the folly, [to say] that we were successful in the measures after the inspection and that I was ready to tell why," he said.
Having been placed on leave, he went on to send an email to a number of Roche staff from a personal email account outlining his concerns, and was subsequently suspended until the investigation could be completed.
He was investigated and ultimately sacked on foot of a finding of gross misconduct, with the sanction confirmed on appeal, the WRC was told today.
"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 last year.
At the opening of a hearing today, the complainant was accused by Mark Connaughton SC, counsel for Roche, of making "outrageous remarks" in evidence to the Workplace Relations Commission last year "purely to damage my client".
The company accepts Dr Seigle-Murandi raised issues in May 2019 but says the company acted "immediately" in response and notified the matter to the HPRA.
Last year Mr Connaughton said the regulator’s inspectors "closed their file to their satisfaction" in February 2020.
"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 said.
"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.
"As a pharmacovigilance professional I had to speak up… Roche is a good company made up of mostly good people, but there are some rotten elements. In Dublin there is a group; the clique is protecting themselves and making me pay," Dr Seigle-Murandi said.
At the conclusion of proceedings, Dr Seigle-Murandi said he had remained out of work since his appeal to the company was rejected in March 2022 despite being shortlisted for similar pharmacovigilance roles at Roche’s competitors.
He said he was down to the last two for one such role in spring 2022 when he had a meeting in Paris with the senior executive who was to pick the candidate in Paris.
Dr Seigle-Murandi said the executive, referring to the pharmacovigilance sector, told him "bluntly" in French: "It’s a small world. We all know each other. You were in Ireland. I know what you’ve done. You’re not getting the job."
The complainant said that it was only on foot of a previous press report on his case that he had been in a position to fully explain to prospective employers why he was no longer working for Roche.
"It’s very difficult to sustain to a HR department that you’ve been reporting your own company to the regulator. Pharmacovigilance professionals understand, but the HR department – it’s really tough to go through this stage," he said.
Adjudicating officer David James Murphy has adjourned the case until Friday.
