IT WAS more like "the Starship Enterprise than a Government Department", Mr James Nugent SC, said of the way blood product authorisations were issued by the Department of Health in the late 1980s and early 1990s.
"Quite frankly, in endeavouring to untangle the events which occurred, one was hampered by the fact that the ordinary concept that the present follows the past and precedes the future does not appear to have applied in this particular case," he said.
Mr Nugent, counsel for the tribunal, was looking at how the Department of Health had been implementing EC (blood) product authorisation regulations where the Blood Transfusion Services Board (BTSB) was concerned.
From April 1st, 1983, such authorisations were required for blood products every five years. The BTSB was required to apply with all the data about the product. The National Drugs Advisory Board (NDAB) would then conduct an assessment and make recommendations to the Department of Health. It would issue the authorisation.
However "things were so chaotic" at the NDAB that although the first application (by the BTSB) for authorisation was made to it on December 12th, 1982 its recommendation to authorise the product was not made until September 5th, 1986. And when that licence came (to the BTSB) it was backdated to April 1st, 1983.
The next application for authorisation was made by the BTSB on February 2nd, 1993. By then the original authorisation had expired since April 1st, 1988. However, on March 1st, 1991, the BTSB got a letter from the Department pointing out that that authorisation - in fact already three years out of date - "would expire shortly", Mr Nugent said.
On February 2nd, 1993, the Department told the BTSB its product authorisation would expire on April 1st, 1993, "when it in fact had already expired some five years previously".
Mr Nugent said the system had so broken down between the Department of Health and the NDAB "that they had, in fact, devised a system for pretending that the system had not broken down".
They called it "the one page renewal".
Mr Nugent interpreted these efforts at post dated authorisation as designed to give the impression the products had "authorisation consistently throughout when, in fact, they did not".
However, probably the most curious episode involving this authorisation procedure took place after the anti D product was withdrawn by the BTSB on February 18th, 1994. On February 23rd, five days later, a clerical assistant at the Department of Health contacted the NDAB asking it to send a "one page renewal" for the antiD's authorisation. The clerical assistant said he did so on the instructions of his superior officer, who has said he was "unaware" this was being done.
On April 23rd, 1994, a product authorisation was issued for the (withdrawn) anti D, and represented it as having had that authorisation since April 1st, 1988.