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Magna Carta - 15th June, 1215

 
No of entries selected: 2 of 711
1983
14 September
CSM Sub-Committee on Biological Products / Travenol - Hemofil
The CSM Sub-Committee on Biological Products declines a Product Licence to Travenol Limited for Factor VIII (PL 0116/0011 HEMOFIL). Travenol fails to present information that adequately shows the safety and efficacy of the product and that adequately characterises the product in terms of heat-treatment. They also fail to provide justification of the inclusion and choice of heat treatment process.

Note: Travenol are strongly criticised by the Sub-Committee for writing promotional letters making unjustified claims on improved safety margins in respect of AIDS infection.

Source: Link #1
Type: Product Licence Refusal
Location: UK
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1985
12 March
Mr Kenneth Clarke - Awareness that Imported FVIII was Subject to the Medicines Act
In a House of Commons debate on 12th March 1985, the subject of product licences with respect to imported heat-treated factor VIII was discussed as follows:

Dr. McDonald asked the Secretary of State for Social Services how many applications for product licences in respect of imported heat-treated factor VIII have been received by his Department; and how many were granted in 1984 and in 1985.

Mr. Kenneth Clarke: Further to my reply on 20 February at columns 498-500, to my hon. Friend the Member for Peterborough (Dr. Mawhinney), all the seven applications made since November 1984 for product licences under the Medicines Act for heat-treated factor VIII were granted earlier this year. All of these were for imported products.

Dr. McDonald asked the Secretary of State for Social Services if exactly similar tests are applied to imported factor VIII products as to Blood Products Laboratory products; and if he will make a statement.

Mr. Kenneth Clarke: The Central Blood Laboratories Authority, which is a special health authority, ensures the safety and quality of products made at its blood products laboratory. Imported, commercially manufactured factor VIII is subject to the formal licensing arrangements under the Medicines Act 1968.

Dr. McDonald asked the Secretary of State for Social Services if he will place in the Library a copy of his Department's studies of the economics of self-sufficiency against the continued importation of factor VIII products.

Mr. Kenneth Clarke: I refer the hon. Member to my reply to the hon. Member for Portsmouth, South (Mr. Hancock) on 19 February at columns 446-47.

Note: Two years earlier (Sept. 1983) Travenol were strongly criticised by the Sub-Committee of the CSM for writing promotional letters making unjustified claims on improved safety margins in respect of AIDS infection.

Source:
Type: Hansard - House of Commons Debate, 12th March 1985, vol 75, c117W.
Location: UK
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