§ Sir David Priceasked the Secretary of State for Social Services whether Azidothymidine has been approved for clinical trials on acquired immune deficiency syndrome patients in the United Kingdom; and if he will make a statement.
§ Mr. NewtonAll information provided to the licensing authority in connection with applications made under the Medicines Act 1968, including clinical trial applications, is, under the Act, treated as confidential by the Department. But in this case, the company concerned has agreed that the Department should indicate that it had already applied to carry out trials under the clinical trials exemption scheme set up under the Act and that the licensing authority had agreed.
In addition, section 9 of the Medicines Act 1968 provides exemption from the licensing requirements to enable a doctor to administer an unlicensed medicinal product to a particular patient of his. Information on the availability of this drug for such use would be a matter for the supplier.