Drugs board wanted to shut down manufacturing at Pelican House

The National Drugs Advisory Board considered seeking the closure of blood product manufacturing operations at Pelican House due to the BTSB's perceived failure to adhere to licensing regulations, the Lindsay tribunal heard yesterday.

In a report in September 1991 on the blood bank's compliance record, the NDAB's former medical director, the late Dr Allene Scott, asked whether it should seek "suspension" of activities at Pelican House.

"It is suggested," she wrote, "that the NDAB should openly dissociate itself from the present situation and make it clear to the BTSB that theirs is the responsibility and risk" in manufacturing blood products.

Dr Scott's concern centred on a number of issues, including the BTSB's supply of BTSB factor 9 and custom-fractionated Octa-Pharma factor 8 without product authorisation.

Despite first indicating that it would apply for a manufacturing licence for factor 9 in 1982, "nothing has as yet been received", said Dr Scott.

In view of the events of recent years regarding the transmission of HIV to haemophiliacs, she noted: "It's surprising that such supply should be freely undertaken still." The tribunal has heard that unlicensed BTSB factor 9 infected seven haemophilia B patients, five of whom have died.

Dr Scott's report was one of a number of documents opened to the tribunal yesterday during an examination of the drugs board's dealings with the BTSB.

Dr Michael Morris, pharmaceutical director of the Irish Medicines Board, as the NDAB has become, said he understood the agency was awaiting an application for a licence from the BTSB to cover factor 9 production but none was forthcoming.

Writing to Dr Scott in December 1982, the former BTSB national director, the late Dr Jack O'Riordan, said "an application will be submitted as soon as possible". In July 1986, Dr James Wilkinson, a former haematologist with the BTSB, said it expected to finalise its application "in the near future".

The next year, Dr James Walsh, former chief medical officer with BTSB, wrote to NDAB saying it was seeking a variation on its factor 9 licence.

Dr Morris described the letter as "very strange" as it referred to an authorisation that did not exist. He believed Dr Scott had not seen the letter as she would have very quickly pointed out the error to the BTSB.

Dr Morris said it appeared the BTSB had applied for product authorisation for contract fractionated Armour factor 8 in 1988 without Dr Scott's knowledge. Dr Morris agreed the BTSB submitted the documentation to the NDAB but no assessment was made.

Dr Morris said the application would have gone into a "queue". While it did not seem to have been followed up, he said, this did not have any impact on patients as the product continued to be supplied.