Irish Times: Viagra now available as EU moves to license it
Saturday, September 12, 1998: IRELAND
By Kevin O'Sullivan
The anti-impotence drug Viagra is about to be licensed by the
EU, which will immediately allow it to be sold on prescription
in Ireland. It is expected to be authorised after the European
Commission ratifies the findings of its expert group on new
drugs, possibly on Tuesday, The Irish Times has learned.
The blue, diamond-shaped drug, whose active ingredient is
manufactured in Ringaskiddy, Co Cork, by the multinational
Pfizer Pharmaceutical Corporation, has rarely been out of the
news since its US launch in April.
While it is not available routinely on prescription in the
Republic, doctors have been able to prescribe it on "a named
patient basis" if it is considered the most effective option
available to treat a condition.
The Dublin Medical Centre has been selling Viagra to 150 of
its patients since May as it has passed all relevant tests in the
US, and may be imported from there. If problems arise with an
unlicensed drug, however, the doctor, as opposed to its
manufacturer, can be held responsible.
Pfizer, which was precluded from speaking publicly about the
drug in Europe prior to it being licensed, has a massive
"information" campaign (including expert medical opinion)
primed, though such is the scale of Viagra hype it has already
become the most talked-about new drug to come on the
market on either side of the Atlantic.
A company spokeswoman said this would be started
simultaneously in Ireland and Britain within 24 hours of the
European Commission in Brussels ratifying the view of the
European Medicines Evaluation Agency.
All queries raised by the agency had been satisfactorily
answered by the company. It is understood a decision was
"imminent . . . possibly Tuesday". She added: "It is simply a
matter of the European Commission ratifying the licence."
Pfizer chose to seek "quick route" approval for Viagra by an
application to the EU, which means authorisation in all 15
member-states. In countries where the drug is imported by
doctors, it costs œ200 for 10 tablets.
Viagra's arrival on the market has led to predictions that it will
add huge costs to public health services. The Department of
Health has yet to decide if it will be available on the medical
card or if users will be able to avail of the drugs refund scheme.
A consultant urologist, Mr Ted McDermott of St James's and
Meath Hospitals in Dublin, who has conducted trials on the
drug over three years, said: "An awful lot of people in Europe
are waiting for it."
An estimated 10 per cent of the Irish male population suffers to
varying degrees from erectile problems.
He said it was a very exciting drug as it was the first of a new
group that can be taken orally, when 10 years ago there were
no drugs for treating the problem. Viagra was a drug that could
be taken orally with comparatively few side effects.
Deaths caused by heart attack which had been linked to Viagra
use were not yet proven, and have been reported among older
people for whom activity like sexual intercourse could put a
strain on their heart. The most common side-effect is minor
headaches.
The Advertising Standards Authority in the UK this week
warned companies against advertising unlicensed imitations of
Viagra. One product is under investigation after it appeared in
advertising under the heading: "Finally available in the UK. The
potency pill that swept America".
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