Regulations governing the sale and distribution of blood products in the State were flouted for several years, and the Department of Health did nothing to enforce them, the tribunal heard yesterday.
Mr Thomas McGuinn, the Department's chief pharmacist, said many of the blood products issued to haemophiliacs between 1975 and 1990 were never authorised for use in the State. These included the Blood Transfusion Service Board's Factor 9 clotting agent which went on to infect seven haemophiliacs with HIV, five of whom have since died and one of whom went on to infect his partner.
He said the BTSB product should have had an authorisation licence. "That would have been the view if we'd spotted it. For some reason we did not spot it," he said. Mr McGuinn said the ultimate responsibility for ensuring products were authorised lay with the Minister for Health, but for whatever reason no steps were taken to enforce the requirement.
He added that the non-compliance with the 1932 Therapeutic Substances Act, under which products for sale or supply required a product authorisation licence, never came to the attention of the Department.
The regulations in place until 1984 were largely ineffective, with vague standards and no inspectors to police them for most of the time.
However, when the Department became aware of the ineffectiveness of the legislation in the 1970s it decided at principal officer level, rather than amending it which would be a long process "of last resort", to rely on EU regulations governing medical products, but which did not govern the sale and supply of blood products. Mr McGuinn agreed it was strange to rely on regulations which did not cover the area but it was "an attempt in the right direction".
Mr George Durcan SC, for the tribunal, said this meant there was no effective control mechanism in place for blood products to be used in the State. Mr McGuinn agreed. This situation continued until 1984, by which time haemophiliacs were showing symptoms of AIDS which they had contracted from contaminated blood products.
Counsel put it to Mr McGuinn that because no standards were in place the commercial companies who did seek product authorisation licences before 1984 could suggest their own standards. He suggested the National Drugs Advisory Board, to which applications for licences were made, had to "make it up as it went along" in the absence of standards.
Mr McGuinn agreed this was the case. He continues his evidence on Monday.