Vol. 540 No. 3
149 Ms Fitzgerald asked the Minister for Health and Children if he is satisfied that international pharmaceutical companies operating here are disclosing the results of research carried out by them on drugs in full at the earliest possible time; the mechanisms here requesting them to do so; if he will list the relevant legislation and regulation; and if he will make a statement on the matter. [20547/01]
The statutory control over the conduct of clinical research in this country commenced in 1988 when the Control of Clinical Trials Act, 1987, came into force. This Act laid down strict controls on persons conducting clinical trials in this country. Under the Act, which was amended in 1990, persons proposing to arrange for the conduct of a clinical trial were required to make application to the Minister for Health for permission to conduct the trials. These permissions were granted on the recommendation of the national drugs advisory board. On the coming into force of the Irish Medicines Board Act, 1995, in January 1996, the Irish Medicines Board became the competent authority for the granting of such permissions.
The intention of the Act was to provide a framework of control within which the following two objectives could be achieved – the protection and safeguarding of the right of those participating in clinical trials, and the facilitation of clinical research. The information which must be provided in respect of each application for permission to conduct a clinical trial is laid down in the Act and this information is evaluated by the Irish Medicines Board on the basis of strict criteria. In addition, the approval of the appropriate ethics committee for the trial must also be obtained. Under the Acts it is incumbent on the applicant in making application to identify the proposed ethics committee and to provide the names, addresses and qualification of each member.
The Irish Medicines Board in its examination of applications for permissions also takes into account the appropriateness of the proposed ethics committee and of its proposed composition. Where the board is satisfied that a proposed ethics committee is competent to "consider the justification for conducting the proposed clinical trial and the circumstances under which it is to be conducted", it gives its approval for the proposed committee.
Section 11 of the Control of Clinical Trials Act, 1987 requires that –
"(1) Every person who conducts a clinical trial shall –
(a) in respect of any place under his control which the Irish Medicines Board reasonably believes is being or has been used in connection with the trial, permit any person, duly authorised by the Board, to inspect such place for the purpose of determining whether or not the permission to undertake the trial is being or was complied with,
(b) comply with any request for information in relation to the progress of the trial which the Irish Medicines Board may from time to time request, and
