published in March 1982. The evidence from Dr. Prince and Professor Preston was, however, clear that in the period up to June 1982 the consensus or general view of NANB hepatitis remained that it was relatively mild or benign. Professor Preston stated in evidence that the general consensus at the end of the 1970s coming into the early 1980s was that while NANB was persistent and chronic, it was not considered to be dangerous or very serious and that most individuals would have been of the view that it was relatively mild, although worrying because it was there. Dr. Prince stated that in the early days it was generally concluded that it was a pretty mild infection possibly involving some kind of harmless pathogen. He expressed the view that the slow rate of progression after infection with NANB hepatitis and the absence of a specific test for hepatitis C until after 1989, were reasons for the slow development of a true appreciation of the seriousness of the condition. During the period between 1974 and 1980 it became known that persons with haemophilia who received multiple treatments with blood products were likely to develop NANB hepatitis. It was understood that the risk of infection from concentrates made from large pools of plasma was higher than the risk of infection from products made from single donations or small pools of plasma. It was probably generally thought that concentrates fractionated from donations from paid donors carried a higher risk of infection than concentrates fractionated from voluntary donors. While the risk of infection from products made from single donations or small pools was less, it was not nonexistent. NANB hepatitis was found among persons with haemophilia who had received only such products. This was particularly so where patients had received multiple treatments. Professor Mannucci referred in his evidence to a 1977 joint American and English study reported by Peter Levine & Others which showed a 48.5 per cent rate of infection among a group of English patients with haemophilia who had been treated with cryoprecipitate only.
Central Purchasing and Distribution of Commercial Concentrates by the BTSB Events in Ireland Significant quantities of commercially fractionated Factor VIII concentrate for the treatment of persons with haemophilia A were first imported into this country in 1974. Importation of commercially fractionated Factor IX concentrate for the treatment of persons with haemophilia B started in 1977. In both cases the BTSB acted as a central purchasing and distributing body. It purchased the Factor VIII and Factor IX concentrates from the commercial fractionators and it sold and supplied them to the National Haemophilia Treatment Centre, regional centres and other hospitals providing treatment to persons with haemophilia. This practice evolved on an informal basis until 1980 when a formal written policy was adopted by the National Haemophilia’s Service Co-ordinating Committee, (NHSCC). A draft policy was prepared in November 1979 and adopted with some amendments at a meeting of the NHSCC on the 29 January 1980. The policy provided that the director of the National Haemophilia Treatment Centre and the regional directors should, on an annual basis, evaluate all available products in consultation with the National Drugs Advisory Board, NDAB, and the BTSB and should then recommend to the NHSCC the Factor VIII and Factor IX product or products to be purchased for a period of one year. It also provided that the NHSCC should then recommend to the Department of Health that only the recommended products should be subsidised by the Department of Health during the specified year. The policy expressly provided that the BTSB should continue to be the central purchasing and distribution body for commercial Factor VIII and Factor IX concentrates. The procedures contemplated in this written policy were not followed precisely (see Appendix 12 for the policy adopted in 1980). In - 47 -