Medicines agency sends report on Roche to EU Commission
LONDON, April 14
LONDON, April 14 (Reuters) - The European Medicines Agency (EMA) said on Monday it had concluded an inquiry into lax drug-safety reporting at Roche and sent its report to the European Commission for the next steps.
The European Commission will decide whether the matter should be pursued and financial penalties should be imposed.
The process could potentially lead to hefty fines for the Swiss drugmaker for breaching EU rules but the agency gave no further details on its conclusions because the procedure is considered confidential.
The EMA previously said in November it had not uncovered any new safety issues connected with Roche's drugs as a result of the shortcomings in reporting adverse events.
EMA launched its probe into Roche in 2012 after a routine inspection found the firm had failed to properly assess tens of thousands of cases of possible adverse drug reactions, involving 19 drugs, several of which were for cancer.
Drugmakers are required to evaluate problems reported by doctors and patients after taking their drugs and then pass on any serious cases to regulators. The inspection found many of these reports had not been properly assessed by the company.
Roche could face fines for failing to comply with so-called "pharmacovigilance" obligations under EU rules of up to 5 percent of its annual EU turnover, which totalled 12.8 billion Swiss francs ($14.6 billion) in 2011. ($1=0.8791 Swiss francs) (Reporting by Ben Hirschler; Editing by Greg Mahlich)