Roche drug safety manager accuses former Ireland chief of pressuring him to lie to regulator

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Roche drug safety manager accuses former Ireland chief of pressuring him to lie to regulator
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Complainant alleges he was penalised for protected disclosure and ultimately sacked in row stemming from wording of letter to regulator over recall of promotion literature for medicines

“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.

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”. 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.

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. 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”.

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. 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.

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.Mr Connaughton asked how the complainant had knowledge of this. Mr MacNamara then asked his client whether he was involved.

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