FOR some time flow it has been clear that the hepatitis C scandal has two parts. One is the infection of well over 1,000 people with an incurable illness. The other is the fact that this disaster happened without any apparent intervention by the Department of Health.
Having heard the grim details of the first story before Christmas, Mr Thomas Finlay's tribunal last week heard about the second. And what it has heard so far raises the most serious questions about the role of the State and of successive Ministers for Health. Those questions concern not just a passive failure to act but active collusion in the evasion of the regulatory procedures.
There is, already, a sure sign of alarm among officials and politicians involved with the Department, as the former Minister, Mr Brendan Howlin, and his officials at the time seek to blame each other for the decision not to establish a tribunal of inquiry in 1994 when the scandal first broke.
According to counsel for the tribunal, Mr James Nugent SC, the advice given to Mr Howlin by officials "from assistant secretary down" was that he should set up a public inquiry into the scandal. According to Mr Howlin, in a statement issued on Monday, he received no such advice from his officials.
Implicit in both claims is a recognition that the action actually taken by the Department, the establishment of an expert group, which produced a report that now seems patently inadequate, was highly questionable. The expert group operated under the aegis of the Department of Health, yet from the evidence emerging at the tribunal this week it is obvious, not only that the Department itself needed to be investigated, but that it had a lot to hide.
To understand the part played by the Department of Health it is necessary to remember that the conduct of the anti D programme was not just chaotic and dangerous, it was also illegal. Under the Therapeutic Substances Act of 1932 it is an offence to manufacture a scrum or blood product without a licence. A senior health official confirmed to the tribunal this week that the Department was fully aware that this Act applied to the BTSB.
After April 1983 it was also a breach of EU law to manufacture and use anti D and other blood products without specific authorisation from the National Drugs Advisory Board (NDAB). The BTSB flouted both of these laws.
It operated the anti D programme without a licence for 14 years, from 1970 to 1984. And it operated without NDAB authorisation for two separate periods, between April 1983 and September 1986, and again between 1988 and 1994.
Such behaviour on the part of the BTSB is, at this stage of the tribunal, unsurprising. The real cause for astonishment is the attitude of the Department of Health to these illegalities. It is not that the Department did not enforce the law, or that it was merely negligent in failing to ask whether the law was being complied with. It is that the Department actively, concluded with the BTSB in making a nonsense of the law.
This collusion involved a complex game of charades with three players, the Department, the NDAB and the BTSB. In theory, the BTSB ought to have applied every five years for authorisation, the NDAB ought to have assessed - this application and, if the NDAB - was satisfied, the Department ought to have then issued the licence. This sequence was deliberately distorted.
As Mr Nugent put it: "The ordinary concept that the present follows the past and precedes the future does not seem to have applied in this particular case." He drew an analogy with Star Trek, comparing the Department to the starship Enterprise.
What the Department did was to issue effectively fictional authorisations. The first licence it issued was in September 1986, but it was back dated to April 1983. That licence expired in April 1988. Bizarrely, the Department informed the BTSB in 1991 that this licence, now almost three years out of date, would "expire shortly". No effort was made to renew it. Even more bizarrely, two years later the Department again informed the BTSB that this same licence, now five years out of date, was due to expire in April 1993.
The Department had, as Mr Nugent put it, "devised a system to pretend that the system had not broken down". That system involved the use of a special backdated document (called a "one page renewal"), devised to disguise the absence of a licence for long periods.
Crucially, this active participation by the Department of Health in the covering up of breaches of Irish and EU law continued after Mr Howlin issued a press statement announcing the anti D crisis.
On February 23th, 1994: two days after that statement, a junior official in the public health division of the Department of Health contacted the NDAB and asked it to issue a "one page renewal" to cover the period from April 1st, 1988, to March 31th, 1993, during which the BTSB had been issuing anti D without a licence. On April 23th, 1994, an authorisation purporting to have been issued six years earlier, in April 1988, was sent to the BTSB.
It is worth noting that the expert group cleared the Department of any suspicion that the issuing of this misleading document was part of an attempt to cover up the Department's own behaviour. It was done, it said, "as part of normal procedures and was not for the purposes of deflecting attention from the previous absence of a product authorisation".
What, then, was its purpose? Since by this time the anti D had been officially withdrawn from circulation, this retrospective authorisation, unlike the previous ones, was not needed to keep the product in circulation. Nor does it seem to have been regarded internally as normal practice.
Mr Thomas McGuinn, the Department's chief pharmacist, told the tribunal on Wednesday that he was rather surprised" to find this document on file in April 1994, because it "had never happened before". He queried the matter but got no answers. Why, if it was so `normal', could no one tell him why it happened?
And if it was "part of normal procedures", it might be expected that it would be easy to identify the official in the Department - who decided to ask the NDAB to issue it. It appears, instead, that there is a conflict of evidence, with the official who made the phone call claiming to have done so on the instructions of a superior officer, and the superior telling the tribunal legal team that he was "unaware" that the "one page renewal" was being sought.
This collusion by the Department in the circumvention of the law may not have caused the debacle, but it certainly contributed to its continuation. Dr Terry Walsh, the BTSB's former chief medical consultant, told the tribunal on Thursday that, when applying for its first licence, the BTSB did not report the outbreak in 1977 of hepatitis C among women who had received anti D to NDAB, as it ought to have done under the regulations.
The reason it did not feel compelled to do so was obvious from his evidence: he expected the licences to come through "as a routine". If the law had been enforced, and the BTSB had felt obliged to obey it, the whole scandal might have come to light in 1983 rather than in 1994.
Aside from its role in this extraordinary series of deliberate fictions, the Department must have known in 1994 that any lie inquiry into its role would discover other uncomfortable facts.
Even this week, for instance, the secretary of the Department, Mr Jerry O'Dwyer, was initially unable to explain the extraordinary delay between the Department's decision in May 1991 to introduce a hepatitis C test for blood donors and the BTSB being told of this decision the following September.
During that period, six people were infected with hepatitis C by blood transfusions. Neither had he disclosed, in his written statement to the tribunal, that the Department had a £1 million contingency fund for hepatitis and AIDS testing in its 1991 budget.
The Department must also have known that a public inquiry would reveal a staggering tack of communication between itself and the BTSB. The link between the Department of Health and the BTSB ought to have been provided by the Department officials who served on the BTSB board. Instead, those officials seem neither to have been kept fully informed by their own Department nor to have told the Department everything they learned from the BTSB. Thus for instance, Mr O'Dwyer told the tribunal that Mr Frank Ahern, one of his officials who was on the BTSB board in 1991, did not know the purpose of the contingency fund.
Equally, according to Mr Nugent, the Department's medical officer, Dr Rosemary Boothman, who was on the BTSB board from August 1993, "saw her role as bringing the Department's expertise and viewpoint to the board of the BTSB, and she has a definite view that her role was not to carry information from the BTSB to the Department".
Dr Boothman told the tribunal she did not consider herself as a representative of the Department on the board but rather as a ministerial nominee.
Dr Boothman seems to have maintained this view, even when she had actually been informed that there was a strong possibility that the anti D programme had turned into a public health disaster.
