SOME Irish fertility clinics say they face closure because of a new EU directive forcing them to introduce stringent standards of sterility and air quality.

Ireland’s eight clinics estimate they will have to pay about €150,000 a year to implement administrative and clinical standards being set down by the EU. For those based in older buildings, the structural costs could be as high as €500,000.

Most of the cost is likely to be passed on to IVF patients, who already pay an average of €3,000-€4,000 per cycle. Martine Millett Johnston, medical director of the Kilkenny fertility clinic, said: “Assisted reproduction is in danger of becoming affordable only to higher-income couples.”

The EU directive on tissues and cells, agreed in 2004 but becoming part of Irish law on Friday, is designed to ensure high quality and safety in the procurement, storage and use of human tissues and cells. It covers bone marrow, skin, eyes, embryos, sperm and eggs.

Irish fertility clinics will have to implement the highest standards of sterility and ensure Grade D air quality, the level used in hospital operating theatres. Clinics currently operate under sterile laboratory conditions, but staff will now have to wear gowns and masks, and patients will have to be treated in theatre conditions for even the least invasive procedures.

Clinics will also have to fulfil complex reporting procedures to show that standards are kept. Most say they have hired extra staff and installed new IT systems to meet their obligations. It is estimated that these measures will cost each clinic €150,000-€200,000 per annum.

“The directive is built on an industrial model rather than a clinical one,” said Mary Wingfield, clinical director of the Merrion fertility clinic. “There is a huge emphasis on administrative paperwork which will bring staff away from patient care.”

Wingfield warns that patients will end up bearing the cost of the new measures, possibly working out at between €500 and €1,000 per couple, per treatment. “A lot of the clinics are registered charities. They’re non-profit making and self-funding. The money has to come from somewhere,” she said.

Several clinics provide subsidised treatment to medical card patients but none receives state funding. Wingfield says the Merrion knows of couples remortgaging their homes in order to pay for treatment, and every month one or two customers stops treatment for financial reasons.

Millett Johnston believes that, without public funding, some clinics will be forced to close. She was part of a delegation which met Mary Harney, the health minister, to voice concerns. The Department of Health would not comment last week on the possibility of funding.

Harney has asked the Irish Medicines Board to ensure that the standards required by the directive are met in Ireland.

“We will technically be breaking the law from Friday,” said Mary McNeaney of the Morehampton clinic, which specialises in male infertility and believes it is under the greatest threat from the financial burden of the directive. “We hope that things won’t be as hard as they seem now, but this will be an impossible situation without some kind of funding.” The clinic has run at a loss for the past four years.

“If we are forced to go ahead with the air-quality changes it will mean a huge increase in fees,” said McNeaney. “Most of the couples who come to us are stretched as it is. The really worrying thing about all of this is that people will not be able to have treatment.

“It’s very dispiriting to think in economic terms when you’re dealing with such an emotive issue. I feel very determined that this is not going to stop us.”

Ireland is not the only country to be concerned about the affect the directive will have on fertility clinics. Both the UK and Denmark have an extension until 2007 before they have to implement it, but the Irish government has shown no sign of lodging a similar appeal.

Helen Browne of the National Infertility Support and Information Group says that callers to its helpline are concerned. “People are worried about the cost implications. They don’t understand why the changes are needed because all the clinics have very good standards already,” she said.

Karen and Bernard from Portarlington in Co Laois say they plan to fund IVF treatment with the proceeds of their SSIAs.

“We had no idea we’d be using the money for this when we opened the accounts,” said Karen, 30. “We had enough for a couple of tries but the fees going up would limit us to one try for the immediate future.”

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