* Infringement procedure launched by EU medicines agency
* Drugmaker may face fine of up to 5 pct of its EU turnover
* First time such proceedings taken against a drugmaker
* EMA and Roche say no evidence to date any drugs unsafe
By Ben Hirschler
LONDON, Oct 23 Europe's drug regulator has
started an infringement procedure against Switzerland's Roche
to investigate its alleged failure to properly report
tens of thousands of potential drug side effects.
If found guilty, the world's biggest maker of cancer
medicines could be fined up to 5 percent of annual EU turnover
which totalled 12.8 billion francs ($13.8 billion) in 2011, or
640 million francs.
It was first time the London-based European Medicines Agency
(EMA) has launched such proceedings since legislation came into
force five years ago.
"The agency will report the outcome of its investigation to
the European Commission who may impose fines or periodic penalty
payments ... if it finds that Roche has committed an
infringement of its obligations," the EMA said on Tuesday.
The issue of drug-safety reporting by Roche was first
highlighted by the agency in June after a routine inspection by
British investigators found it had failed to fully assess up to
80,000 cases of possible adverse drug reactions.
There were some 15,000 deaths among the reports, which may
have been due to natural disease progression but may have been
connected to the drugs.
That led to an immediate probe into public health
implications. The latest investigation is into the separate
matter of whether Roche complied with its legal obligations. The
two inquiries will run side by side, an EMA spokeswoman said.
The issue relates to medicines from across the Roche product
range that were part of a financial reimbursement system
designed to help U.S. patients who could not afford to pay for
Roche's drugs without outside assistance.
Roche said it was cooperating with health authorities,
adding that, to date, no impact on the safety profiles of any of
its products had been found.
The EMA also said all Roche's medicines remained authorised
without changes to the treatment advice for patients and
doctors, since there was no indication of "a negative impact on
the benefit-risk balance" of the drugs.
The agency's investigation affects 19 Roche drugs that have
been centrally authorised by the EMA - including blockbuster
cancer treatments like Herceptin and Avastin and its popular flu
drug Tamiflu - as well as some medicines that were approved by
Roche said it was going through all the cases to check which
incidents should have been classified as possible adverse
reactions, adding that some may already have been submitted to
regulatory authorities through different channels, including by
doctors looking after patients.
A company spokesman said it was premature to speculate on
the outcome of the EMA investigation and the possibility of a
fine, but he noted that Roche had provisions for various risks.
Roche stock was 2.1 percent lower by 1400 GMT,
underperforming a 1.4 percent decline in the European drugs
Adverse drug reporting is designed to catch potential
problems with medicines by setting a requirement for
notification when a patient dies or suffers a medical setback -
even if this may be due to their underlying disease.
The EMA - the equivalent of the U.S. Food and Drug
Administration - routinely carries out so-called
pharmacovigilance inspections to make sure drug companies are
reporting incidents properly.