THE licensing arrangements of the Blood Transfusion Services Board for the manufacture of the blood product Anti D would have been challenged in court by Mrs Brigid McCole.
It is understood that Mrs McCole would have alleged that the BTSB was making Anti D for years without the licence required by law.
Mrs McCole, who was infected on October 2nd, five days before her High Court case against the State was due to start. In a letter to the Minister for Health, Mr Noonan, her family has questioned whether the BTSB manufactured Anti D without a licence under the Therapeutic Substances Act between 1970 and 1984.
A BTSB spokesman said he was unable to comment on the allegation but he referred to the finding of the expert group, chaired by Dr Miriam Hederman O'Brien, that the board had been licensed from 1975.
A manufacturer's licence is a fundamental requirement under the 1932 Act and is issued directly by the Minister for Health.
If it is proved that the BTSB was making Anti D without the proper licence it could implicate the State directly in the infection of the hundreds of women who were infected with hepatitis C by Anti D.
A spokeswoman for the Department of Health said the issue of licences would come under the terms of reference of the Tribunal of Inquiry.
It is believed that a main pillar of Mrs McCole's case against the State would have been that the BTSB failed to operate with a licence under the 1932 Act until 1984.
A large volume of documentation has been compiled by the legal team that represented Mrs McCole. In June she was granted the right to information about the identity of every BTSB employee who might have information on the infection of the 1976 plasma exchange donor.
In July, the High Court was told that five BTSB employees were trawling through documents nine hours a day, five days a week preparation for Mrs McCole's case.
According to a legal expert this evidence could be made available to a Government Tribunal of Inquiry if the tribunal made an order for discovery of documents from the parties to Mrs McCole's case. A great deal of work has already been done on the issues surrounding her case.
However a separate discovery order may have to be made covering the use of plasma from a donor infected in 1989. This could prove to be just as time consuming as the discovery of documents in Mrs McCole's case. And, according to one source, it is potentially a much more serious incident of contamination, as it occurred after hepatitis C was identified as a separate virus.
