BTSB did not seek safe product available in UK in late 1980s

The Republic could have obtained from Britain a supply of super-heat-treated factor 9 that was safe from both HIV and hepatitis…

The Republic could have obtained from Britain a supply of super-heat-treated factor 9 that was safe from both HIV and hepatitis C for "virgin" haemophiliacs in the late 1980s, the Lindsay tribunal was told yesterday.

However, neither the Blood Transfusion Service Board nor any treating doctor requested the product.

Dr Terrence Snape of the UK's BioProducts Laboratory, which pioneered super-heat-treatment (SHT) on UK blood products in 1985, said the technology was not easily transferable and could only have been developed by the BTSB if substantial expertise, resources and time had been invested.

Asked, however, if it would have been possible by 1988 to supply a regular quantity of British SHT factor 9 for Irish haemophiliacs who had not been previously exposed to commercial concentrates, Dr Snape replied: "I don't see why not."

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He said that to the best of his recollection no request for the product was made by any doctor or transfusion service outside the UK between 1986 and 1990.

The tribunal has heard that in June 1988 the BTSB and Prof Ian Temperley, the former medical director of the National Haemophilia Treatment Centre, decided previously unexposed, or "virgin", haemophilia A patients should receive a virally-safe pasteurised factor 8 product. However, no similar provision was made at the time for "virgin" factor 9 patients and, as a result, three children and an adult with haemophilia B were infected with hepatitis C.

At a previous sitting, Prof Temperley said the possibility of getting SHT factor 9 from the UK "escaped us" at the time.

Asked about the development of the SHT technology, Dr Snape said yesterday that the laboratory's concern was always about the "unknown virus", or "the next one round the corner", so it attempted to heat-treat its products at as high a temperature as possible. A treatment protocol of 80C for 72 hours subsequently emerged.

He said SHT factor 8 was ready for clinical trials in April 1985 and SHT factor 9 in July 1985. They were first issued in July and October 1985 respectively. The results of trials showing the technology's effectiveness in killing both HIV and hepatitis C were published in various forms in May and September 1986 and October 1988.

Dr Snape said it would not have been "practicable" to make factor concentrates solely from Irish plasma at the plant at Elstree, Hertfordshire, as it had only one fractionation stream. Irish plasma would instead have to have been mixed with UK plasma.

He said the laboratory supplied SHT factor 7, 11 and 13 concentrates to various countries as well as SHT factor 8 to Egypt from, he believed, 1990 or later. As the Elstree plant was "extremely expensive" to run, however, it was never its intention to fractionate more plasma than met demand in the UK. Only "surplus" product was exported.

He said the SHT technology was duplicated with difficulty in a small number of countries including South Africa and Australia.

On the BTSB, Dr Snape said his perception was that it was "not as well resourced" as other blood transfusion services which were fractionating similar products. Asked to comment on the BTSB's success in introducing virally-safe solvent detergent products in early 1990, Dr Snape said it seemed "quite timely" given the UK introduced such products in mid-1990.

Joe Humphreys

Joe Humphreys

Joe Humphreys is an Assistant News Editor at The Irish Times and writer of the Unthinkable philosophy column