§ Mr. HarveyTo ask the Secretary of State for Health if he will list the hospitals which(a) have been, (b) are and (c) plan to be involved in trials of Misoprostol; what evidence he has collated concerning the drug's effects during the first stages of labour; what representations have been made to the Government on the subject of Misoprostal; if he will review the Government's policy on the use of Misoprostol; and if he will make a statement. [150386]
§ Ms StuartMisoprostol is not currently licensed for the induction of labour. The Department has asked the National Institute for Clinical Excellence to provide clinical guidelines on the induction of labour and their report is expected this summer.
Our view is that until such time as the NICE guidelines are issued, use of misoprostol for the induction of labour should only be administered under properly managed clinical trials where the risks and benefits of the drug are fully explained and understood by women.
Since March 1998, the Medicines Control Agency has received and approved 22 notifications for clinical trials of misoprostol in the United Kingdom from consultant obstetricians and gynaecologists. These notifications have been made under the provisions of the Doctors and Dentists Exemption Scheme. Details of clinical trials, including data collated during trials, are not normally released, without the consent of the parties concerned, as there are legitimate commercial and other confidential interests which cannot be disclosed. Such interests are recognised in the current administrative Code of Practice on Access to Government Information and also in the Freedom of information legislation.