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 £200 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".
