Authorising of non-heat-treated product was an `error'

A retired official with the National Drugs Advisory Board expressed her surprise yesterday at the discovery that the agency authorised the use of a nonheat-treated blood product in 1985. This was after a ban on such products was introduced.

Dr Mary McCarthy, a former medical assessor with the board, told the Lindsay tribunal that she found out about the "administrative error" only while she was preparing her evidence for the inquiry.

She said she understood the drugs board made a policy decision in January 1985, on foot of advice from Prof Ian Temperley, former medical director of the National Haemophilia Treatment Centre, to authorise only products which had been heat-treated to guard against HIV.

The tribunal heard, however, that the drugs company Cutter received clearance from the board in March 1985 for the supply on the Irish market of non-heat-treated Koate factor 8.

Dr McCarthy traced the error to a mistake in a letter from the board to the Department of Health, which had responsibility for licensing, saying the board had approved the product on March 15th, 1984.

Dr McCarthy confirmed the matter was considered by one of the drugs board's medical committees on that date, but a decision on approval had been deferred. Despite this, a letter was sent to Cutter in March 1985 enclosing authorising documentation. Records indicated that the decision-making board of the drugs board never gave approval for the product to be authorised. The board did, however, grant product authorisation for heat-treated Koate in June 1985.

Dr McCarthy stressed there was no evidence that the untreated product was marketed or used under the licence. Indeed, the tribunal saw correspondence from Cutter to the drugs board in January 1985 in which the company said it did not anticipate any future market for it.

Dr McCarthy agreed it was "unusual" and "odd", in light of this view, that Cutter continued to correspond with the late Dr Allene Scott, former medical director of the drugs board, on having the product authorised.

She agreed it was possible Dr Scott and Cutter thought that by putting through the application for untreated Koate the heat-treated product would be approved more quickly.

Later, Mr John Lynch, a pharmacist who was involved in site inspections for the drugs board, gave evidence on the agency's granting of manufacturing and wholesaling licences to the Blood Transfusion Service Board. Mr Lynch agreed with a summary of facts contained in the report of the Finlay tribunal regarding the drugs board's failure to adhere to a policy of inspecting premises.

Mr Lynch said that when he joined the drugs board in 1987 there was a "chronic backlog" of inspections. He agreed that it appeared from documentation that no inspection took place at the BTSB in a five-year period between July 1987 and May 1992.

The company Accu-Science, which supplied Cutter blood products to the board, was inspected, however, in February 1985 and July 1988. Mr Lynch said he recalled being satisfied that the operation was in compliance with good practice.