[April 15, 2014]LONDON (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 totaled 12.8 billion Swiss francs ($14.6 billion) in
2011.
($1=0.8791 Swiss francs)
(Reporting by Ben Hirschler; editing by Greg Mahlich)
