An expert committee is to examine whether the anti-impotence drug, Viagra, which was cleared yesterday for sale throughout the EU, should be made available free to medical-card holders.
The Minister for Health, Mr Cowen, announced the establishment of the committee after the pharmaceutical company which manufactures Viagra said it would be applying immediately to have it included in the General Medical Services (GMS) scheme.
If the drug is covered by the State's various drugs schemes, the cost to the Exchequer could reach £20 million a year, the Minister said.
He said the committee would monitor the demand for the drug, the prescribing pattern of doctors, the results obtained and any problems with the control of the drug.
Pfizer, which makes the drug for worldwide distribution at its plant in Ringaskiddy, Co Cork, said it would be available in the Republic on prescription from the end of the month.
But Mr Cowen said more information was needed before any decision could be made on including Viagra in the GMS scheme or reimbursing users under any of the community drugs schemes.
He said it was very difficult to estimate the potential cost to the State, but international figures indicated a cost of between £7 million and £20 million. He was also concerned the drug might be seen as a "lifestyle" or "recreational" drug by some people.
However, at a press conference in Dublin announcing the availability of the drug in the Republic, Pfizer denied it had any recreational benefits.
Dr Tony Whitehead, the company's medical director for Ireland and Britain, said the drug, which is used to treat erectile dysfunction (ED), had no effect on sexual desire. The company said the drug was designed to help those with ED and would have no beneficial effect for non-sufferers.
He added that the drug, which improves blood flow to the penis, had been shown to restore sexual function in most men, no matter what was the cause of their ED.
Pfizer has set a trade price for the drug in the Republic of £5.56 per 50mg tablet, but the retail price is likely to be about £9.
Welcoming the "cautious approach" taken by Mr Cowen, a Fine Gael spokesman said account had to be taken of the potential abuse of the drug, and its use would have to be monitored closely.
Ms Roisin Shortall, Labour's health spokeswoman, said the cost of the drug to the GMS scheme would have to be limited. But she added that sexual dysfunction was a serious problem, and medical card holders were entitled to an early decision.
The European Commission's formal approval yesterday for the sale of Viagra followed approval of the drug by the EU's standing committee on medicines three weeks ago.
The committee, made up of expert representatives of the member-states, had endorsed the product with the proviso that certain labelling changes be made: a warning that the drug could cause "prolonged and painful" arousal and that a doctor should be consulted if this lasted more than four hours.
An explanatory note will also warn of possible side-effects including headaches, hot flushes, indigestion, panic attacks, blocked noses and problems with vision. The committee made it clear that Viagra is not intended for women and must not be administered to patients under 18 or to those with severe heart or liver problems or low blood pressure.
The British Health Secretary, Mr Frank Dobson, announced the government's decision to temporarily ban Viagra earlier this week amid fears that the National Health Service will not be able to afford the drug. The drug will be available by private prescription for those who can afford it, but NHS patients may have to wait for many months to receive the drug.
Ms Ann Craig, a spokeswoman for the Impotency Association, said the organisation had received many calls from people who believed the drug had been banned indefinitely: "A lot have been waiting patiently for the decision. They are diabetic or suffering from some related ailment, and I am sure they will be fed up that it will be available in Europe and not here."
