The European Medicines Agency (EMA) has announced the start of an investigation into Roche Registration-the EU subsidiary of Roche-after UK regulators conducting an inspection found, "Serious shortcomings" in the company's pharmacovigilance processes.
The investigation could be the first major test of the EU's recently passed pharmacovigilance legislation. EMA has previously blasted the company in a June 2012 statement regarding the same incident, saying the company had a cache of approximately 80,000 potential adverse event reports which had not been submitted to EU regulators.
Those findings were the result of a May 2012 inspection by the UK's Medicines and Healthcare products Regulatory Agency (MHRA), which was conducting a routine inspection of the company's UK facility. Among the tens of thousands of adverse event reports were more than 15,000 reports of patient deaths, 23,000 suspected adverse reactions and 600 clinical trial-related adverse events. Regulators cautioned that the reports did not imply causation, and were not necessarily even associated with the drug product being taken by consumers.
Still, regulators were furious. EMA's Committee on Medicinal Products for Human Use (CHMP) demanded the company turn over, "All known reportable events … in accordance with [the company's] legal obligations" and "submit a revised comprehensive action plan" by the end of June 2012.
EMA is now initiating what it is calling an "infringement procedure"-an investigation into whether Roche broke European Commission (EC) rules by failing to comply with its pharmacovigilance obligations for 19 medicines approved by EMA's centralized procedure.
The results of the investigation will be reported to the EC, which in turn may impose fines or other penalties. Those penalties, according to (EC) No 658/2007, should be "effective, proportionate and dissuasive, having regard to the circumstances of the specific case."
Those fines could ultimately be substantial for Roche. Article 16.2 of EC No 658/2007 allows for the EC to impose a penalty of up to 5% of a company's revenue for the preceding year. Continued non-compliance can lead to an ongoing, periodic fine of 2.5% of the company's daily revenues until compliance is assured.
Roche did not have any statement on the investigation available at press time, but it has previously said it was cooperating with regulatory authorities, including US regulators at the Food and Drug Administration (FDA), to evaluate the scope and impact of the adverse event reporting deficiencies and whether any of its medicines require reevaluation.