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Blood: Contamination

Volume 458: debated on Thursday 22 March 2007

To ask the Secretary of State for Health what trials were conducted in the UK between 1984 and 1986 to ascertain the efficacy of heat treatment for (a) commercial and (b) non-commercial VIII blood products; and if she will make a statement. (128427)

Heat-treated Factor VIII and Factor IX produced by Bio Products Laboratory (BPL) in the mid 1980s were evaluated in several haemophilia centres in England and Wales. The results from these studies have been published by the investigators in medical journals.

BPL developed 8Y in 1985 and studies on the efficacy of BPL’s heat treatment undertaken after 1986 showed that the process was very efficacious. Clinical trials and laboratory studies reported in 1985 had previously demonstrated the safety and clinical efficacy of the heat-treated product made by the Plasma Fractionation Laboratory of Churchill hospital Oxford, which was destined to become the BPL heat treated factor VIII product (8Y).

The report “Self Sufficiency in Blood Products in England and Wales” provides a section on heat treatment which contains information on trials undertaken by a number of commercial companies. The supporting references are all in the public domain.

To ask the Secretary of State for Health (1) if she will place in the Library a copy of the Department's internal audit report referred to in the answer of 23 May 2006, Official Report, column 1742W, on destroyed documents/blood products; and if she will make a statement; (128429)

(2) by what date she expects her Department to finish its identification and review of all the documents currently held relating to the safety of blood products between 1970 and 1985; and if she will make a statement.

[holding answer 19 March 2007]: The report on the internal review of documents held by the Department relating to the safety of blood products between 1970 and 1985 is being finalised. This report will also take account of missing documents. We expect to complete the report shortly, and a copy will be placed in the Library.

The internal audit report will be referenced in the internal review of documents and we will make all reference documents available.