Drug safety manager alleges ‘cover-up’ at pharma giant Roche

A sacked drug safety manager at Roche claims there was widespread non-compliance in marketing materials distributed by its Irish arm – not in error but “with a commercial purpose”.

He told the Workplace Relations Commission (WRC) on Wednesday that there are “rotten elements” in the company and that there was a “cover-up” to protect the marketing and medical departments at its Irish arm.

Roche, which denies Dr Bruno Seigle-Murandi’s claim of whistleblower retaliation under the Protected Disclosures Act 2014, and of a breach of the Unfair Dismissals Act 1977 in his sacking, accepts that he raised issues but says the company acted “immediately” and notified the matter to the State medicines regulator, who “closed their file to their satisfaction” in February 2020.

The firm argued Dr Seigle-Murandi “was a very difficult man to work with”; had “relationship issues” with colleagues, and was guilty of gross misconduct for sending “hundreds” of Roche documents to personal email accounts.

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Dr Seigle-Murandi said he had to retain them to substantiate his claims, and that it had been a protected act.

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Counsel for Roche, Mark Connaughton SC, said on Wednesday that the claims made up to that point by Dr Seigle-Murandi were “outrageous” and were “purely to damage my client”.

The complainant said he was seen as a “snitch” by some of his colleagues, and that this drove complaints against him in the autumn of 2019 – leading to a performance review rating him down for his “communication style” and having his bonus cut.

The complainant said he was “micromanaged” by a new line manager at this time and had “every single thing second-guessed”.

However, he said he continued to find non-compliant brochures, identifying 93, with recall notices issued for 20 of them.

“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 non-compliant,” he said in evidence.

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.

However, in a 20th October, 2020 letter to the Roche group compliance officer, he alleged breaches of the company’s business ethics rules against a group of colleagues who had been involved in initial dealings with the Health Products Regulatory Authority (HRPA) and against the former general manager of Roche Ireland, Pierre-Alain Delley.

He said Mr Delley pressured him to agree to an “alternative storyline” in which he took responsibility for an earlier letter to the HPRA on the brochures issue stating there was no need to recall non-compliant material from patients.

Asked by his barrister, Darach MacNamara BL, why he had not complained sooner, Dr Seigle-Murandi said: “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.”

Mr MacNamara said this letter amounted to a fresh protected disclosure. Mr Connaughton, counsel for Roche, said there had been no second protected disclosure.

Dr Seigle-Murandi said he was taken off duty and locked out of company systems on 8th February, 2021 because he had just told colleagues he could not agree to tell auditors that a compliance plan to address the brochures issue was working.

He said Roche Ireland’s current general manager, Alison Muir, placed him on administrative leave pending an investigation into “flows” of email from his company address – and that within “30 seconds” of the telecall ending, his computer was shut off remotely.

He was then suspended with pay before being investigated, brought through a disciplinary process and sacked on foot of a finding of gross misconduct, the tribunal heard.

“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.

Adjudicating officer David James Murphy has adjourned the case until Friday.