THE Department of Health was described as being more like the Starship Enterprise than a government department at the hepatitis C Tribunal yesterday. The reference by counsel for the tribunal Mr James Nugent SC, raised a smile during the 12th day of the proceedings, but will surely be an insult to Star Trek fans, who know that the chain of command on the Enterprise is always respected and that rules are strictly followed.
A situation devoid of such checks and controls was outlined by Mr Nugent when he described the relationship between the three bodies responsible for maintaining standards in the blood service - the Blood Transfusion Service Board, the National Drugs Advisory Board and the Department of Health.
He referred to a litany of inefficiencies and inexplicable decisions relating to the granting of licences for the manufacture of blood products, the screening of donors, the viral inactivation of blood products and the eventual withdrawal and replacement of anti D immunoglobulin, which prevents haemolytic (blue baby) syndrome.
Any impression that the "worst" had already been heard by the tribunal before Christmas was quickly dispelled yesterday.
Mr Nugent said that the former Minister for Health, Mr Howlin, had declined to hold a public inquiry into the hepatitis C scandal in 1994 contrary to advice from his officials. He also told the tribunal that the BTSB had manufactured anti D without a licence for 14 years; that the replacement for anti D was produced by a Canadian company which had not received approval from the proper authority in the US; and that the Department of Health took four years before giving the BTSB approval for the introduction of a test for hepatitis C.
The manufacture of anti D was covered by the Therapeutic Substances Act of 1932 and it was an offence to manufacture it without a licence. However, that was what the BTSB had done with the knowledge of the Department of Health between 1970 and 1984.
Under EU regulations for blood products, the NDAB, which was "grossly understaffed", was responsible for BTSB inspections, but the system "did not work in any meaningful way", according to Mr Nugent. He detailed what he described as "most peculiar" practices relating to the granting and renewal of licences. It appeared that the Department had a policy of simply backdating licences to cover any breaches.
The logic was "bewildering": the BTSB applying for licence renewal which the NDAB would have already recommended before the BTSB had even applied; the Department granting that licence and putting a date on it which preceded the date of application.
Mr Nugent said that the BTSB had applied for a product authorisation for anti D in December 1982, but the NDAB had been so inundated" that this took almost four years - until December 1986 - to come through. Yet, when the licence was granted, it was dated April 1983.
Mr Nugent said that numerous letters had been sent by the BTSB throughout the four year periods during which it was awaiting approval by the Minister for Health for the "important new test for hepatitis C, but many of these letters had not been answered up to the time approval was finally given in September 1991. The test would have cost an additional £500,000 a year.
Counsel spoke of the "inability or unwillingness" to tell the story of exactly what had occurred in the BTSB to cause the infection. This had led to a "strained relationship" between the BTSB and Department officials, who felt that they were not being told the full story.
Department officials from "assistant secretary level down" had advised Mr Howlin "from the very start" that a tribunal of inquiry should be set up. Instead, he had opted for an expert group to look into the matter. The officials knew from the initial stages that the BTSB was "not co operating with the expert group", Mr Nugent said.
The tribunal also heard how there was a "feeling" in 1994 that people with hepatitis C were being "kept apart deliberately". Ms Jane O'Brien, spokeswoman for Positive Action, the organisation representing women infected through anti D, had asked the BTSB to circulate a letter to these women as she did not have their addresses.
"Initially, they seemed to agree, but subsequently there was a rowing back from the position and the board said it would be a breach of confidentiality. It is hard to see how that was the case", Mr Nugent added.