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A report on HIV and blood supply was critical of the FDA in the way it had managed regulation of blood and blood products in the early 1980s, and for having relied too heavily on the pharmaceutical industry.

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The Penrose Inquiry Report concluded that, in relation to blood products, "subjecting UK products to a need for approval to the FDA before introducing them for use in Scotland would not have been a rational exercise of judgement by any UK or Scottish government agency".

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Dr Thomas Cleghorn noted that plasma to manufacture initial supplies of Hemofil for the UK had not been individually RIA tested and had come from Puerto Rico, where they Hyland a blood bank.

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At a CSM(B) meeting, the Sub-Committee was informed that the manufacturer of Kryobulin PL/0215/0003 had not been visited recently, but the licensing authority intended to ask the Austrian authorities to carry out an inspection.

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The CSM accepted the recommendation from its Sub-Committee, and advised the grant of a product licence for Hemofil.

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Product licence was granted for Hemofil.

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Dr Thomas commented regarding the Kryobulin licence application that despite precautions being taken, "the risk of transmission of serum hepatitis can only be diminished and not completely eliminated.

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Austrian Inspectors conducted an inspection of the manufacturing facilities regarding the Kryobulin licence application.

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Dr Thomas visited Immuno factories in Vienna.

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In a journal article it was reported that the risk of causing hepatitis from blood taken from paid donors was markedly higher than that of blood from unpaid donors.

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"The Gift Relationship" by Richard Titmuss was published, in which it was stated that the risk of catching hepatitis from blood taken from paid donors was higher than that of blood from unpaid donors.

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In a journal article by Alter et al it was stated that the exclusion of commercial and HBAg positive blood donors had resulted in a marked reduction in post-transfusion hepatitis.

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Grady et al "Risk of Posttransfusion Hepatitis in the United States: A Prospective Cooperative Study" reported on the National Transfusion Hepatitis Study in the US, that those cases of hepatitis with which Hepatitis B antigen was associated accounted for around 60 percent of the cases of post-transfusion hepatitis which had occurred.

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Professor J. Garrott Allen of Stanford University Medical Centre concluded in a paper published in 1972 that the risk of serum hepatitis from transfusions derived from prison and Skid Row populations was at least ten times that from the use of volunteer donors.

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At an international forum reported in Vox Sanguinis in 1972, Dr Biggs and Dr Dormandy assessed that patients with haemophilia could be adequately maintained with the use of cryoprecipitate.

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Dr Peter Jones wrote in an article that "cryoprecipitate is now the product of choice in
major surgery, allowing the potent but antigenic animal fractions and expensive human
concentrate to be reserved for major complications, the emergency treatment of
patients with FVIII inhibitors, or, in the case of concentrate, for prophylaxis."

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Dr Carol K Kasper and Shelly An Kipnis concluded in an article on Hepatitis and Clotting-Factor Concentrates that single donor products were preferable for older children and adults who had little exposure to blood products.

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From a report on the progress of the MRC Cryoprecipitate Working Party Survey of the Incidence of Transfusion Jaundice, Haemophilia Centre Directors were aware that larger pools theoretically came with a greater risk of causing "clinical" hepatitis.

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Professor Edward Blackburn wrote on behalf of Haemophilia Centre Directors to the Chief Medical Officer, stating that there was "an urgent need to increase supplies of Factor VIII Concentrate."

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Dr William d'A Maycock's view was that self-sufficiency should be the aim. He stated that insufficient freeze-dried antihaemophilic globulin concentrate was made in the UK, and there was a need to supplement the existing UK supply. However, the facilities for larger scale fractionation that would become available in England and Scotland should eliminate the need to use foreign commercial preparations.

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