BTSB's neutral stance on imported products causes strain

How much responsibility had the Blood Transfusion Service Board over the safety of imported commercial blood products which caused…

How much responsibility had the Blood Transfusion Service Board over the safety of imported commercial blood products which caused the majority of 260 haemophiliacs to be infected with HIV and/or hepatitis C?

This crucial question was one which counsel for the Irish Haemophilia Society, Mr John Trainor SC, returned to time and again this week. And the board's position has not once wavered from "little or none".

From her first day of evidence almost three weeks ago, Dr Emer Lawlor, deputy medical director of the Irish Blood Transfusion Service (as the BTSB is now known), has maintained a clear distinction between those products made at Pelican House, which the board stood over, and imported commercial products.

Yesterday, she spelt out this position further, saying the safety of commercial products was primarily the responsibility of the manufacturers, the physicians treating haemophiliacs and the licensing authorities, namely the National Drugs Advisory Board and the Department of Health.

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She said it would not have been the BTSB's place to interfere with such imports. If there were safety fears over them it would have been up to the Department to remove licences. It would have been "impertinent", she added, to tell treaters what products to use and even if the board had offered advice "the physicians were not going to change".

This portrayal of the BTSB as a neutral player in the use of imported products, however, is coming under increasing strain.

The tribunal has already heard that the board did not simply import and distribute the products. It was paid a commission for doing so while earning an additional profit on sales, estimated yesterday to be around £7.50 for a packet of clotting agent, "the size of a bottle of baby food".

Mr Trainor further argued that, whatever about now, the BTSB used to believe it had responsibility over the safety of all products which it handled.

A 1984 Council of Europe review of the BTSB's services, which was cleared by board officials and the Department, said the board's policy was "to protect the health of both the donor and recipient". It further stated that "the supply of blood product is a matter for clinical decision and reasoned refusal could not be regarded as a failure to provide assistance".

Mr Trainor said the document suggested two things. First, that the board felt it had the authority to intervene in the distribution of a blood product over which it had safety concerns. Second, that it did not at the time distinguish between imported and home-made products.

The matter is ultimately one on which Judge Alison Lindsay will have to decide. However, to many observers the BTSB's policy of absolving itself entirely for responsibility over imported products is becoming increasingly untenable.

Mr Trainor yesterday also strongly contested Dr Lawlor's claim, made on Wednesday, that 85 per cent of HIV infections had occurred by 1983. He said figures from the National Haemophilia Treatment Centre showed that of haemophilia A patients, who accounted for the majority of haemophiliacs, 60 per cent became infected in 1983 and 1984.

Mr Trainor remarked that relatives of victims who were attending the tribunal found it "very offensive" that the significance of the board's actions after 1983 was being played down.

One such relative was Mr Raymond Kelly, whose son, John, died in 1994, aged 13, after being infected with an imported blood product exactly 10 years earlier.

Mr Trainor noted that if the board had taken a different course of action in 1983 Mr Kelly's son would be alive today.

The exchange highlighted a degree of tension which has crept into the hearings since Dr Lawlor's cross-examination began.