Earlier this year in June, Roche’s name hit the headlines after a pharmacovigilance inspection discovered around 80000 safety reports that had not been evaluated by the company to determine whether they should be reported as adverse drug reactions. Included in the reports were approximately 15161 deaths, although the European Medicines Agency explained at the time that the actual number of reports could be lower once verified. EMA also added that the deaths may not have a casual link to the medicine. Either way, it’s still a huge number of reports that should have been assessed.
Today, the case accelerated as the European Medicines Agency launched an infringement procedure against Roche to investigate the alleged pharmacovigilance deficiencies.
The procedure means that EMA will be able to investigate Roche within the legal framework of Europe’s Regulation (EC) No 658/2007, which concerns financial penalties. The case could mean fines or periodic penalty payments being imposed upon Roche if the company is found to have failed to comply with its pharmacovigilance obligations. EMA will report the outcomes of the investigation to the European Commission.
The reports were originally identified by the UK’s Medicines and Healthcare products Regulatory Agency during a pharmacovigilance inspection. Many of the unevaluated reports came from a US-patient support programme, but MHRA also identified other deficiencies related to evaluating and reporting suspected adverse reactions from Roche’s own reporting systems and clinical trials.
Following the inspection, Roche was ordered to take corrective actions to ensure the correct processing of reports. EMA’s Pharmacovigialnce Risk Assessment Committee is currently reviewing data to evaluate whether the reports will have any impact on the overall risk–benefit balance for any of the medicines involved. According to an EMA statement, the reports concerned 19 centrally authorised medicines.