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Dr Maycock observed that the prevalence of hepatitis in the UK associated with UK blood and blood products had "long been smaller" than that in the US, but added "Until concentrate prepared from UK plasma is available, I would have said the benefits attaching to Hemofil and other similar concentrates of antihaemophilic factor, used with discrimination, outweigh the risk".

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Professor Arthur Bloom expressed concerns to Dr Holgate (DHSS). Firstly that material produced by a US company had been sold "through brokerage or other means" to Speywood where it had been relabelled as a product of their own. A second concern was that it had been reported Inter-Pharma intended to market cut price Factor 8 obtained from Cutter and from Hyland".

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Dr Holgate stated (when responding to the Speywood issue): "As I am sure you are aware one of the cornerstones of our philosophy for the licensing of 'biological' products is to have detailed knowledge of and control over early stages of manufacture and in-process control - this including source material."

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Professor Garrott Allen wrote that "it appears that at least two immunologically separate agents are capable of producing hepatitis from the transfusion of blood or the administration of many of its products". He also added that it was considered 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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CSM provided a suggested Agenda for discussion on AIDS in relation to licensed blood products which was to be held on 3 July 1983. CSM explained that the discussion was to help them decide if any action was needed in respect of AIDS and licensed blood products.

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The Government announced a 10 million payment for the Haemophilia Society to establish a trust (the Macfarlane Trust). It became a separate charity.

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The National Biological Standards Board was established under the Biological Standard Act 1975 and took over management of the National Institute of Biological Standards and Quality Control ("NIBSC").

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In a paper on the Freedom of Information legislation the CSM had concerns about its secrecy of operation.

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The Public Health Laboratory Service operated 52 area and regional diagnostic laboratories in England and Wales, providing diagnostic services and support for outbreak investigation to local hospitals, public health authorities, and environmental health departments.

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When products were required under the terms of a licence to undergo a "batch release" process, manufacturers were required to submit to NIBSC protocols which described the results of in-process tests made during the manufacture and, in most cases, submit samples.

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Dr Joseph Smith was the director of NIBSC from 1976 to August 1985.

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Dr Joseph Smith was the chair of the CSM(B) from 1981 to 1986.

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Dr Joseph Smith stated that he did not have any role in advising government on the response to AIDS. The extent of his input was in the capacity as Director of the NIBSC, Chairman of the CSM(B), a member of the CSM or other relevant committees or working groups, or Director of the PHLS.

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Dr Smith regarded Dr Fowler's paper as representing the DHSS Medicines Division's evaluation of the cause of the AIDS problem.

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In Dr Smith's written evidence, he described the CSM as having gained "some comfort" from being told that efforts were being made to secure UK independence of foreign suppliers of clotting factor concentrates.

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Dr Smith recalled asking the DHSS after a couple of months about progress, and that they had remained positive about progress whilst telling him that self-sufficiency had not yet been achieved.

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Dr Smith told the Inquiry that he had "the clear impression" that the UK's self-sufficiency was expected to be achieved within approximately two more months.

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Dr Smith observed that there were occasions when the CSM(B) or the CSM considered broader issues relating to the safety of blood products in the context of AIDS. This led to advice, recommendations or "remarks" being conveyed to the Medicines Division of the DHSS for consideration by the Licensing Authority.

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Dr Smith understood from what Dr Lane and the DHSS representatives said - that self-sufficiency was expected soon, and would be achieved "within a period of months".

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There was no statutory requirement for products to be tested by NIBSC as part of the application for a product licence.

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