§ Lord Morris of Manchesterasked Her Majesty's Government:
Further to the Written Answers by the Lord Hunt of Kings Heath on 20 January 2003 (WA 79), the Lord Bach on 9 October 2003 (WA 67) and S January 2004 (WA 54) and the Lord Warner on 8 January 2004 (WA 59), whether the Secretary of State for Health, as the licence holder, and the manufacturer of the anthrax vaccine are satisfied that the vaccine was not used for troops involved in the 1990–91 Gulf conflict, or the conflict with Iraq in 2003, outside the conditions of its marketing authorisation. [HL761]
§ The Parliamentary Under-Secretary of State, Department of Health (Lord Warner)Individuals using pharmaceutical products outside the specifications within the market authorisation are not obliged to inform the licence holder of such use. The Department of Health (DH) understands that the timings of anthrax immunisations planned by the Ministry of Defence (MoD) in 1991 were different from those in the marketing authorisation and that fewer immunisations than recommended were to be given to each individual. In preparation for the conflict in Iraq in 2003, the DH understands that personnel deploying to the Gulf region were offered anthrax vaccine in accordance with MoD policy. Variations in use, from the summary of product characteristics, when these occur, are dictated by military-specific risk assessments and are based on the best available medical advice from the Advisory Group on Medical Countermeasures (AGMC). The AGMC is an independent civilian body specifically set up to advise on these matters.