The Chairwoman of the Lindsay tribunal is due to rise today to begin the arduous task of writing a report on the matters which she has been investigating since September, 1999. At the centre of the inquiry is a devastating tragedy: an estimated 252 people infected with HIV and/or hepatitis C through blood products used for the treatment of haemophilia. Some 78 have died, six of them since the tribunal was established.
Judge Alison Lindsay must consider 186 days of evidence, thousands of documents and hundreds of witness statements, including harrowing personal testimony.
She must consider the role of a range of State agencies in the tragedy, including the Blood Transfusion Service Board (BTSB) and National Drugs Advisory Board, along with actions of haematologists, blood product manufacturers and former ministers for health.
Dozens of questions have been raised, as counsel for the tribunal pointed out in its closing submission. Yet there are only a small number to which the victims want clear and unambiguous answers. These include the following questions:
1: Was there a cover-up?
The bare facts are that senior officials in the BTSB had information in 1986 which showed its products were responsible for infecting some haemophiliacs with HIV but the agency denied its involvement, and blamed instead imported commercial concentrates for the infections.
The tribunal has seen the minutes of board meetings which record the erroneous view that BTSB products were not responsible for infections. Minutes also reveal what counsel for the Irish Haemophilia Society (IHS) described as "coded" references to the BTSB's role in the tragedy as well as a strong focus on legal and litigation considerations in the aftermath of the AIDS crisis.
All these, counsel suggested, pointed to "State-sponsored concealment" in which the Department of Health colluded by agreeing a "no fault" settlement with infected haemophiliacs in 1991.
The BTSB and the Department strongly contested the claim but the fact remains that it took the establishment of this tribunal for the BTSB to admit its role in the infection of eight people with HIV, seven through BTSB factor 9 and the other through BTSB croyprecipitate.
2 Did the BTSB put profit ahead of safety?
Attention has focused on the BTSB's seminal decision in 1974 to start distributing commercial concentrates in the State. Until then, the agency had opposed such products due to their link to "skid row" donors in the US. Their use also ran counter to the BTSB's stated aim of achieving self-sufficiency in blood products.
It was claimed the BTSB's opinion changed when it realised it could make money from acting as a distributor of imported concentrate, initially by earning a 10 per cent commission on all sales to hospitals plus a mark-up on all such sales. Among other decisions scrutinsed at the tribunal was the BTSB's decision in June, 1988, to continue supplying a product over which its manufacturers, Armour, if not the agency itself, seemed to have had serious safety concerns.
The product was to be manufactured under conventional heat-treatment procedures which by then had been discredited as a means of guarding against hepatitis C. Armour succeeded in getting the BTSB to sign a letter of indemnity, absolving the drugs firm of responsibility for the product.
The decision was taken against the background of severe financial stringency within the BTSB, and the identifying of Armour as the cheapest supplier.
3: Did the BTSB "dump" unsafe product in hospitals?
Perhaps the most serious charge against the blood bank is that it tried, against the wishes of doctors, to get rid of a large stock of non-heat-treated BTSB factor 9 in late-1985 for economic or other reasons.
The tribunal has heard that the BTSB only agreed to heat-treat its factor 9 to guard against HIV after a stormy meeting in August, 1985, with Dr Helena Daly, a locum consultant working at St James's Hospital, Dublin, while Prof Ian Temperley was on a six-month sabbatical. Following the meeting, the BTSB gave a verbal commitment that heat-treated BTSB material would be available from November, 1985.
Three days after the meeting, however, the BTSB also issued to St James's what was described by counsel for Dr Daly as a "substantial amount" of non-heat-treated product - 44,000 units to be precise, more than double the monthly average. A week later another 44,000 units were issued.
Dr Daly gave evidence that following the meeting she also had difficulty obtaining sufficient quantities of heat-treated commercial factor 9 through the BTSB.
The BTSB product continued to cause infections with HIV up to February, 1986.
4: To what extent were doctors responsible for what happened?
As concerns grew over the safety of blood products in the 1980s, treatment protocols were drawn up aimed at limiting the use of commercial concentrates. The tribunal heard, however, these were not always adhered to.
Doctors were criticised at the tribunal, not only for this but also, for the manner in which they informed patients of diagnoses for HIV and hepatitis C, and for apparent failures in communicating HIV test results which might have assisted in a withdrawal of unsafe product.
Counsel for the IHS reserved strongest criticism for Prof Temperley and Dr Paule Cotter, consultant haematologist at Cork University Hospital, both of whom it accused of "gross negligence" on numerous counts. Their legal representatives vehemently denied the claims and accused IHS counsel of engaging in "character assassination".
All sides agreed the actions of doctors should be seen against the backdrop of an under-funded and over-stretched health service, unrecognisable even by today's standards. Prof Temperley, for instance, was said to have been doing the job which is now performed by eight consultants.
5: Should there be a new inquiry into the role of pharmaceutical companies in the tragedy?
The IHS strongly criticised Judge Lindsay for refusing to investigate the actions of multinational drugs firms despite their apparent role in infecting the majority of haemophiliacs with HIV and hepatitis C.
After ruling that the inquiry's terms of reference did not allow such an investigation, she turned town a request from the Minister for Health and Children, Mr Martin, to have those terms broadened.
The tribunal has heard evidence to suggest that Armour continued to export a certain product after receiving information which cast doubt over its safety. A batch of the product infected a child in Dublin with HIV.
The inquiry also heard of a practice in the US whereby manufacturers targeted high-risk blood donors in contravention of official guidelines.
In order to get to the bottom of what happened, the IHS is seeking a fresh inquiry into these, and other allegations against the drugs companies, many of whom have offices in the Republic.
The society has urged Judge Lindsay to recommend such an inquiry. Were she not to, her report - due early next year - can expect a frosty reception.