THE former chief medical consultant at the Blood Transfusion Service Board (BTSB) yesterday agreed that Pelican House had breached conditions when it used patient X's plasma in the manufacture of anti D.
Dr Terry Walsh, who retired from the BTSB in 1995, was giving evidence to the tribunal for the third time. He also agreed, with Mr Patrick Hanratty, counsel for the National Drugs Advisory Board (NDAB), that the BTSB never, ever submitted "an adverse reaction report" concerning any of its products, to the NDAB, as it was obliged to do under its licensing conditions.
Dr Walsh agreed that the BTSB; should have reported the outbreak of hepatitis like symptoms in 1977 among women who had received their anti D product. It had conducted its own investigation about it at the time, he said, "and told no one about it".
He agreed that he "expected licences to come through as a routine". They "seemed to do so", he said. He also agreed that product authorisation (valid for five years) for the anti D had been issued to the BTSB by the Department of Health on October 31st, 1986, on a NDAB recommendation of September 9th, 1986, and that it had been back dated to April 1st, 1983, the date from which EC regulations stipulated such authorisation was required.
"Similarly he agreed that the BTSB had received a letter from the Department of Health on January 7th, 1992, dated December 18th, 1991, and informing him that the BTSB's production authorisation for anti D "will (stet) expire on 1st April 1988".
He further agreed that the renewal of a manufacturing licence (valid for three years) granted to the BTSB by the Department of Health, and backdated to October 2nd 1981, was not applied for by the BTSB until October 16th 1981, and had been recommended by the NDAB on October 9th 1981.
"It's quite clear the (very) first licence was granted for October 2nd," observed Mr Justice Finlay, the tribunal chairman, "and that thereafter all licences were granted from that date, irrespective of when other steps were taken."
"Yes, whatever the history" commented Mr Rory Brady, counsel for the tribunal. Earlier he had remarked of the licensing/authorisation process that "it's all over the place".
Dr Walsh also told the tribunal of a dispute between the NDAB band the BTSB in 1991, which followed a letter to the Departments of Health from Dr Alene Scott, medical director at the BTSB, saying her board was dissociating itself from the situation whereby, the BTSB was selling products which had not been "appropriately authorised".
Dr Walsh said the dispute cent red on imported blood products which the BTSB needed to use and did so often without waiting for authorisation as the authorisation process was so delayed. Later in 1991 it was agreed by "both boards that the BTSB would continue to import and use the products as necessary, and the NDAB would authorise them as soon as possible.
