Vol. 566 No. 2
158 Mr. Naughten asked the Minister for Health and Children prior to the introduction of the Control of Clinical Trials Act 1987, the form of controls which were in place governing clinical trials; and if he will make a statement on the matter. [12511/03]
Following the establishment of the National Drugs Advisory Board in 1966 a voluntary approval scheme for the control of clinical trials was introduced by the board with the agreement of the pharmaceutical industry and the medical and pharmaceutical professions. This informal scheme continued until the Control of Clinical Trials Act 1987 came into force: prior to this there was no statutory control of clinical trials.
159 Mr. Naughten asked the Minister for Health and Children since the introduction of the Control of Clinical Trials Act 1987, if he will supply a list of names and addresses of applicants for clinical trials; the number granted and refused; the name of the person or persons who conducted the trials and the location of such trials; the cri teria laid down for the selection of participants; the total fees paid to the Department in respect of each application and trial; the compensation and bond arrangements put in place by each successful applicant ; if the Department is sill in possession of any such securities; the number of inspections performed by the Department during and since any such trials; and if he will make a statement on the matter. [12512/03]
The information requested by the Deputy is not readily available in this Department. My officials have been in contact with the Irish Medicines Board in this matter and I will write to the Deputy when I have further information.
