§ Lord Irving of Dartford
asked Her Majesty's Government:
Whether they will confirm that all plasma derived products, particularly Factor VIII and Factor IX concentrates, which are currently being distributed from blood products laboratories and commerical companies have been individually donor-screened for anti HIV; and
Whether they will state the dates from which distributed products have been manufactured from donor-screened anti HIV plasma, both in the commercial market and in British products manufactured at blood products laboratories.
§ Baroness Trumpington
It is necessary to distinguish Factor VIII and Factor IX from other plasma derived products, as these are the only ones for which Human Immunodeficiency Virus (HIV) transmission has been established.
Factor VIII and Factor IX are made by the Blood Products Laboratory (BPL) at Elstree for distribution in England and Wales, and by the Protein Fraction-ation Centre (PFC) in Edinburgh for distribution in Scotland and Northern Ireland. In addition, commercial Factor VIII is imported for distribution in England and Wales. No commercial Factor IX products are licensed for marketing in the United Kingdom. All Factor VIII and Factor IX manufactured or used in the United Kingdom is heat treated to inactivate HIV.
By the end of 1985 all licensed commercially manufactured Factor VIII released in the United 825WA Kingdom was made from individually donor-screened plasma. The heat treatment used by the BPL is more rigorous than that used in commercial processes. The BPL product has a good record of safety in clinical trials and has been shown to be safe when made from screened and unscreened plasma. All plasma processed at BPL since 2nd June 1986 has been derived from individually screened donations.
Products derived from screened plasma will become available from BPL for distribution in England and Wales during August 1986. By December 1986 all issued products will be derived from donor-screened plasma. All plasma processed at PFC since January 1986 has been derived from individually screened donations. By the end of August 1986, all products distributed by PFC in Scotland and Northern Ireland will be derived from donor-screened plasma.