The National Drugs Advisory Board licensed a non-heat-treated blood product in 1985 after itself recommending that only heat-treated blood products be used on haemophiliacs, it emerged yesterday.
Mrs Mary Rafter, a pharmacist with the Irish Medicines Board, formerly the National Drugs Advisory Board (NDAB), said the issuing of the licence to the Cutter pharmaceutical company in March 1985 was unfortunate.
She told counsel for the tribunal, Mr John Finlay SC, that it was a "mystery" how it happened. "Yes, I'm afraid it's very unfortunate that it did happen, but I had certainly no knowledge that this had happened until commencing the review of documents for this tribunal," she said.
Mrs Rafter worked with the NDAB from January 1983 to October 1987, vetting applications for product authorisations. She left and returned to the renamed IMB in 1995. She was under the impression that all products issued should be heat-treated, which would mean they would be virally inactivated to protect against the risk of HIV transmission.
Despite the issuing of the licence, no non-heat-treated Cutter clotting agent was issued on foot of the licence.
It seemed strange, Mr Finlay said, that the licence was issued, given that the leading treater at the time, Prof Ian Temperley, former director of the national haemophilia treatment centre, had written to the NDAB in December 1984 saying he wanted to use only heat-treated products. The NDAB also recommended in December 1984 that heat-treated products be used.
Mrs Rafter emphasised that she had finished her involvement with the licence application when the decision was made.
She attended a meeting between the Blood Transfusion Service Board and the Armour pharmaceutical company in June 1987 about the making of blood products from Irish plasma. Mrs Rafter confirmed that no applications for authorisations were received from either the blood bank or the commercial company for products made from the plasma, but she said it was not within her remit to go out looking for them.
Earlier, the Department of Health's chief pharmacist, Mr Thomas McGuinn, said customs officials were relied on to police the importation of medical products in the 1980s. He said their surveillance worked only 60 per cent of the time in the case of policing blood product importations. There were some "serious omissions" that were not picked up by customs and he couldn't understand it.