A SENATOR who discovered that the Blood Transfusion Service Board's (BTSB) replacement antiD product was licensed only in its country of origin told the tribunal of inquiry yesterday that the Minister for Health appeared unaware of the product's status when she raised the matter with him.
Senator Mary Henry said she accidentally discovered that the Canadian made anti D product, called Win Rhd, was licensed only in that country and did not have US Food and Drug Administration approval in April 1994.
The product was introduced over a weekend when the hepatitis C scandal broke two months previously.
Senator Henry said that while she had no problem with the Win Rho product, alternative licensed products were available.
She raised the matter with the then Minister of Health, Mr Howlin, on April 28th 1994 but got the impression that "he did not know".
It had since emerged that the Department was informed some days previously by Mr Ted Keyes, chief executive officer of the BTSB, that the product was unlicensed in Ireland.
Senator Henry was told at a meeting in February 1994 with a former BTSB national director, Dr Terry Walsh, and Dr Niall Tierney, a former chief medical officer at the Department of Health, that the product was widely used in North America and on the Continent. But on a visit to the US in April of that, year, she called to the FDA and was told the product did not have US authorisation.
"I brought it immediately to the attention of the Minister for Health because I thought it was quite a serious matter. I knew I had not got authorisation from the National Drugs Advisory Board; (NDAB) because it was brought in over a weekend," she said.