HC Deb 13 May 1993 vol 224 cc562-3W
Mr. Galloway

To ask the Secretary of State for Health if she will place in the Library a list of all the fully completed research on the effects of AZT on patients with either ARC or AIDS distinguishing the research that shows conclusively that AZT is of benefit in such cases.

Dr. Mawhinney

The Licensing Authority receives reports of fully completed research as part of a licensing application. The information relating to licensing applications is confidential in accordance with section 118 of the Medicines Act 1968. However, most of the extensive research has been published in the scientific literature and copies will be placed in the Library.

Mr. Galloway

To ask the Secretary of State for Health on what grounds the drug AZT was given fast-track licensing by the Committee on the Safety of Medicines; and if she will make a statement.

Dr. Mawhinney

The licence application for Retrovir (AZT) was given fast-track status by the Licensing Authority on the grounds that it was considered to be a potential major advance in the treatment of AIDS patients. At the time of the decision in late 1986 there was no alternative licensed product for the treatment of AIDS. The decision to fast-track the application was made solely on public health grounds.

The fast-tracking of an application means that it is assessed out of turn, but is still subject to the full standard assessment process. The criteria for granting fast-track status to an application was set out in the reply given by my right hon. Friend the Member for Braintree (Mr. Newton). the then Secretary of State, to my hon. Friend the Member for Thanet, North (Mr. Gale) on 3 November 1987 at column 703.

Mr. Galloway

To ask the Secretary of State for Health what consideration is being given to the advertising and promotion campaign relating to AZT in respect of the application of the prescription medicines code of practice authority guidelines.

Dr. Mawhinney

The application of the code of practice is a matter for the prescription medicines code of practice authority.