§ Mr. Frank Fieldasked the Secretary of State for Social Services if, pursuant to his answer of 7 April, Official Report, column 207, on blood products, he will give the date in 1984 on which manufacturers of factor VIII initially found that heat treatment techniques inactivated HIV; if he will give details of the operation of the named patient basis used for prescription of heat-treated factor VIII; and from what date in 1984 heat-treated factor VIII could be so prescribed.
§ Mr. NewtonThe first account of experimental work which showed that HIV in factor VIII could be inactivated by heat treatment was published in October 1984(Morbidity and Mortality Weekly Report 1984, Volume 33, 589–91). This work led to the National Haemophilia Society of the United States of America advising that heat treated factor VIII should be considered for haemophiliacs even though its protection against AIDS remained to be proven.
Similar advice was published in the United Kingdom in December 1984 (Lancet 1984, Vol. 2, 1433–1435).
However, not until February 1985 (Lancet 1985, Vol 1 271–272) was evidence published which showed that heat treatment of factor VIII actually reduced transmission of HIV to haemophiliacs.
Factor VIII products which had been heat treated to prevent the transmission of hepatitis were under development by several manufacturers throughout 1984 but with limited availability. The realisation that heat treatment procedures could also inactivate HIV led to the wider availability of these factor VIII products after October 1984.
The "named patient basis" refers to section 9 of the Medicines Act 1968. This exempts a doctor from the licensing provisions of the Act in respect of a medicinal product which is specifically prepared or imported by him for administration to a particular patient of his. There is no statutory requirement to notify the licensing authority about named patient prescribing, although practitioners are encouraged to do so. It is not therefore possible to give a precise first use date for such products.