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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"

Published on: 23 July, 2024

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.

Published on: 23 July, 2024

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

Published on: 23 July, 2024

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

Published on: 23 July, 2024

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

Published on: 23 July, 2024

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".

Published on: 23 July, 2024

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.

Published on: 23 July, 2024

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."

Published on: 23 July, 2024

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.

Published on: 23 July, 2024

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."

Published on: 23 July, 2024

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.

Published on: 23 July, 2024

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.

Published on: 23 July, 2024

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".

Published on: 23 July, 2024

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.

Published on: 24 July, 2024

Roger Evans stated in his statement that Russell Mishcon drafted a letter to the Minister of Health without the knowledge of him, his CEOs or the majority of the board members and put it before him at a board meeting in an attempt to pressure him to sign.

Published on: 24 July, 2024

A letter written by Dr Caroline Coffey discussed the psychological and financial impact on the Wales Infected Blood Support Scheme clients and the lack of financial parity for clients which caused them to feel like second class citizens and an unimportant group of people.

Published on: 24 July, 2024

In his statement to the Inquiry, Charles Gore said with regards to the Caxton Foundation that he thought Peter Stevens "made every effort to ensure the Caxton Foundation was a well-run organisation."

Published on: 24 July, 2024

In her statement to the Inquiry, Sue Phipps said that Peter Stevens "never stopped working to try and protect the rights of the registrants and their access to the support that he had done so much to ensure was available to them."

Published on: 24 July, 2024

It was reported by the Oxford Haemophilia Centre that the clinical trial of prophylactic treatment in haemophilia created new problems, for example the statistical plan led to many boys being in the control group which gave the treatment a bad reputation with the boys.

Published on: 24 July, 2024

In autumn 1974 there was a hepatitis outbreak at the Lord Mayor Treloar College in which 10 boys were affected following receipt of a batch of Hemofil.

Published on: 24 July, 2024

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