Expert opposes production of concentrates

A retired official with the Dutch blood transfusion service told the Lindsay tribunal yesterday he would recommend against a small organisation, such as the BTSB, attempting to produce its own factor concentrates.

Prof Willem van Aken, former medical director of the CLB, the Irish Blood Transfusion Service's (as the BTSB is now known) Dutch counterpart, said home production of concentrates was a costly and complicated process and should not be undertaken without adequate funding and support.

He said between 220 and 250 people worked on the production of an intermediate purity factor 8 product in the Netherlands from 1981. This figure included quality control, research and development staff, and about 50 individuals working purely in manufacturing.

In addition, the CLB had to spend 80 million Dutch guilders (£28.6 million) on the development of a fractionation plant.

Prof van Aken said a small organisation which attempted to produce its own concentrates would encounter numerous problems, including a lack of efficiency and a difficulty in marketing the end product. In Europe, he said, there had been a consolidation of fractionation centres, as at least 300,000 litres of plasma were needed annually for them to be viable.

The tribunal has heard the BTSB tried without success to manufacture its own intermediate-purity factor 8 in the early 1980s. Just two staff members worked part-time on the re search project, which was abandoned in 1983.

The blood board has estimated that it generated a maximum of 18,000 litres of plasma a year at the time. Partly due to such inadequate supplies, the Irish agency never became self-sufficient in blood products.

Under cross-examination by Mr Frank Clarke SC, for the blood board, Prof van Aken said he strongly believed self-sufficiency was obtainable for small countries but it required a "certain effort" and investment. He said politicians often paid lip service to the notion of self-sufficiency without committing the necessary resources.

He agreed with Mr Clarke that a major factor in assisting smaller transfusion services in becoming self-sufficient was engaging in contract fractionation arrangements, whereby plasma would be sent overseas for manufacturing into concentrates. Asked whether he thought any other country was much ahead of Ireland in arranging contract fractionation, Prof van Aken replied "Certainly not."

He further agreed that rigidly adhering to a policy of self-sufficiency was not always best for patient safety. A study of HIV infections among Dutch haemophiliacs showed that in 1984, when drug companies began heat-treating their products to guard against the virus, it was safer to use commercial concentrates than non-heat-treated native concentrates. Despite this, the goal of self-sufficiency was embodied in Dutch law from the 1960s.

The tribunal continues today.