Roche Withholding Data Didn’t Harm Patients: EU Agency

Roche Holding AG’s failure to disclose some safety data on medicines didn’t put patients at risk, European regulators said today in a decision that leaves open whether the Swiss drugmaker will be fined for not initially providing the information.

The risk-benefit profile of 19 Roche drugs approved in Europe hasn’t changed, and patients should continue taking their medicines as prescribed, the European Medicines Agency said in a statement.

The agency started reviewing the drugs after an inspection early last year found that Roche didn’t evaluate reports from the U.S. about potential safety issues to determine whether they had been flagged to the EU as suspected adverse drug reactions. Still open is a separate review begun in October 2012 into whether Roche met its legal responsibilities, with potential consequences of fines totaling as much as 5 percent of the drugmaker’s EU sales, which were 12.2 billion Swiss francs ($13.4 billion) last year, according to data compiled by Bloomberg.

“These two strands run parallel,” Monika Benstetter, a spokeswoman for the EMA, said in a telephone interview. The EMA didn’t say today when it expects the legal review to finish.

Roche and the agency revised the number of unprovided reports down to about 23,000 from the original 80,000 estimate while taking corrective action, spokesman Daniel Grotzky said.

When the legal assessment started last year, the agency said it’s required to make a legal recommendation to the European Commission by April 2014.

Roche has taken steps with the EMA’s approval “concerning the collection, processing, evaluation and reporting of adverse event data,” the Basel-based company said in an e-mailed statement today.

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