The European Medicines Agency is investigating whether Roche Holding AG met its legal responsibilities to report drug side effects, a review that may lead to fines of as much as 5 percent of the company’s sales in the European Union.
The agency will decide whether Roche properly monitored the safety of the 19 drugs it markets in the EU, according to a statement today. The case is the first of its kind, Martin Harvey Allchurch, a spokesman for the London-based agency, said in a telephone interview.
“As of today, there is no change in the benefit-risk of the products currently on the market,” he said. “We don’t want people to stop taking their medicines based on what we currently know today.”
The agency began a review in June of the public-health implications of Roche’s failure to evaluate 80,000 reports of potential safety issues to determine whether they should have been flagged to the EU as suspected adverse reactions. The two investigations are now running in parallel, as the EMA probes the case’s legal and public-health implications, Allchurch said.
The EMA is required to make a recommendation to the European Commission by April 2014, Allchurch said. The commission would then rule on the case and may levy a fine of as much as 5 percent of Roche’s EU sales in the preceding year.
Roche reported 12.8 billion Swiss francs ($13.7 billion) in EU sales last year.
“We’re working together with the authorities on this,” Daniel Grotzky, a spokesman for Basel, Switzerland-based Roche, said by phone. “We’ve been in close contact.”
The reports had come from a support program run out of the U.S. for patients who couldn’t afford medicines, not a clinical trial, Grotzky said. The reports hadn’t been processed inside a Roche database, and therefore hadn’t been passed to EU authorities. According to the EMA, the reports included 15,161 patient deaths.
“What we’re doing now is basically going through all these cases and seeing which ones of these might be potential adverse events, and as we’re updating our database, we’re reporting back to health authorities,” Grotzky said. “At this point in time we have not seen any change to the safety profile of the drugs.”
Roche dropped 2 percent to 182.20 Swiss francs in Zurich.