Minister says he was surprised at licensing methods

THE Minister for Health, Mr Noonan, yesterday said he had been "extremely surprised" on discovering the licensing methods employed by the Department where blood products had been concerned. He found "all the back-dating very disturbing", and felt that "checks and balances within the system had become a rubber stamp."

Giving evidence to the hepatitis C tribunal, Mr Noonan also said he was "not aware" of what consideration the Expert Group had given the 1932 Therapeutic Substances Act, which dealt with blood product licensing.

The Act had not been commented on in the main body of the Expert Group's report, he said, but was referred to in the appendices. He was aware that following receipt of the report at the Department of Health in January 1995 an official had prepared a memo on the application of the Act where anti-D was concerned.

It detailed dates on which licences had been issued, but did not explicitly refer to the fact that the BTSB had no licence to manufacture anti-D from 1970 to 1984. Mr Noonan recalled the matter being drawn to his attention by officials in his Department "as a detail, though not significant." He had "not been told of the absence of licences," he said.

The matter only became an issue when he was served with a statement of claim in April 1996, as preparations got under way for Mrs McCole's High Court action. He then had "a full briefing" on it, but did not feel he should inform the public of what he had been told as in the circumstances the pending court action he would be the subject of criticism" for doing so.

Mr Noonan told the tribunal there was "no new medical information" concerning the hepatitis C scandal in a document discovered at Pelican House last February.

The 1976 document, about which the Department of Health was informed in March of last year, concerned patient X and described her as having "infective hepatitis."

It was claimed, following its discovery, that this information had not been available to the Expert Group, set up in 1994 to investigate the BTSB.

He said the information had been available to his Department since February 25th, 1994 when the then chief executive officer at the BTSB, Mr Ted Keyes, wrote saying patient X had had "an episode of jaundice" while undergoing plasma exchange, and had had tests for hepatitis B which proved negative.

Mr Noonan said that at that time (1976) the words "jaundice" and "infective hepatitis" were synonymous, with jaundice being understood as "both a symptom and a condition."

That was the situation as he "understood it and (as he) was briefed." He was "in no doubt" the Expert Group knew it was dealing with a case of infective hepatitis. His position was that there was "no new medical information in the file" (discovered at Pelican House in 1996).

"What was new was a new file," he said. That was his position when there was controversy over the matter last year, and "it is still my state of mind," he said. He added, "I may be wrong."

Asked if he had investigated whether the Expert Group knew the BTSB knew in 1976 that patient X had infective hepatitis, Mr Noonan said he had not.

"Were the BTSB asked by the Department whether they had told the Expert Group of the clinical diagnosis (that patient X had infective hepatitis)?" asked Mr Rory Brady, counsel for the tribunal. Mr Noonan replied "I do not know.

Pressed on his "failure" to investigate the matter, by Mr John Rogers, counsel for Positive Action and the McCole family, Mr Noonan responded angrily that in dealing with the crisis over the past two years it was to his credit that what he had done right "far outweighs what I did wrong, and I resent, Mr Rogers, your talking about the failures of the Minister for Health."

He agreed with Mr John Coughlan, counsel for the Department of Health, that the chairwoman of the Expert Group, Dr Miriam Hederman O'Brien, had written to the Dail Select Committee on Social Affairs last June saying no evidence had come to light which would lead to a change in the Group's conclusions.

Mr Brady revealed that 1,653 applications had been received by the Compensation Tribunal. To date it had dealt with 233 cases and awarded £25.9 million to victims, in sums ranging from £15,200 to £453,904.