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In early January 1976, CSM (B) recommended the grant of a licence which was subject to conditions. It particularly sought information regarding the pool size, and the reasons for and rate of donor rejection centre by centre.

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The UK product licence for Koate stated that the presence of hepatitis should be assumed.

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The license for Koate contained no condition requiring the provision of ongoing data about donor rejections by center.

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Bayer informed Dr Andrews regarding Koate, that Cutter did not collect information about the rejection of donors. Nonetheless, they gave an assurance that "the collection of plasma is carried out according to the US Code of Federal Regulations".

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Cutter confirmed regarding the Koate licence application that the pool size was 2500 litres of plasma, but the DHSS were told that Cutter did not collect information about the rejection of donors.

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Bayer UK stated that Cutter did not collect information on the reasons for, and the rate of, rejection of donors or donations, centre by centre.

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Dr John Holgate stated regarding the licencing process that, "It is one thing to have regulations and another to learn of the enthusiasm with which they are carried through"

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NIBSC stated they would not agree to the licensing of a product unless there were batch release procedures due to bad experiences in the past where deficiencies in proper formulation of information on protocols, and unacceptable assay biometry and methods were seen.

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NIBSC offered to explain the quality control difficulties to a representative of Bayer.

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An application was made by Armour Pharmaceuticals for the importation and distribution of Factorate.

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A report produced by Dr Andrews for the CSM (B) noted there was a hepatitis risk associated with Factorate.

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In a memorandum from R E Tringham to Mr Lillywhite, Tringham made a comment in relation to the cost for supplying Factor V8 to Haemophilia Centres. He stated that he understands the Supply Division have received a "very favourable" tender from the company for the supply of Factor 8 to haemophilia centres, but of course, action on this depends upon the granting of a product license".

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The Minister of State, Dr David Owen, who authorised the importation of Factor 8, was part of the Medicines Branch of the Medicines Division. Mr Tringham was Assistant Secretary of the body.

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It was assessed that inspections were limited in their usefulness and it "seems best to assume that all blood products of this nature coming from the USA may be obtained from plasma taken under the worst circumstances and any protective measures should be achieved by other means."

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One of the proposed conditions for the submission regarding the Factorate licence application was that plasma would be obtained from only donors from USA or other countries where the licensing authority is satisfied with the donation arrangements.

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Armour confirmed regarding the Factorate licence application "that the plasma will be only from donor centres in the USA, and from USA sources" and "the rejection rate at blood collection centres [was] below 1% for accepted donors."

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Dr John Craske spoke to the UKHCDO, where he noted that of eleven hepatitis outbreak cases reported, seven suffered from hepatitis which was neither Hepatitis A nor Hepatitis B.

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Dr John Craske spoke to the UKHCDO which was where he noted that of eleven hepatitis outbreak cases reported, seven suffered from hepatitis which was neither Hepatitis A nor Hepatitis B, in which was similar to what he wrote in the Lancet.

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Dr Owen expressed his belief that the NHS should have been self-sufficient to have made treatment "more readily available to people suffering from haemophilia".

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Roger Evans discussed the relationship between the Macfarlane Trust and the Caxton Foundation in his statement, notably that after the appointment of Christopher Pond the attitude towards the Macfarlane Trust was problematic.

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