asked the Minister the steps the Government are taking to ensure the continuation of essential drug testing, in view of the appointment of a receiver to the Institute of Clinical Pharmacology and to safeguard the position of the 20 volunteers for drug-testing; and if he will make a statement on the matter.
Private Notice Questions. - Clinical Trials.
asked the Minister for Health if, in view of the appointment of a receiver to the Institute of Clinical Pharmacology in Dublin, he will outline the steps which are being taken to safeguard the health of the 20 volunteers who were undergoing drug tests at the time of the appointment of the receiver; and if he will make a statement on the matter.
I propose to take both questions together.
Following the announcement of the appointment of a receiver to the Institute of Clinical Pharmacology (Ireland) Ltd., officials of the Department of Health requested and were granted an immediate meeting with the receiver.
At this meeting the officials stressed that the primary concern of the Minister for Health was to ensure that proper medical care and supervision should continue to be provided for all participants in clinical trials being conducted by the institute. It was indicated to the receiver that the trials being conducted by the institute were the subject of licences granted by the Minister under the Control of Clinical Trials Act, 1987 on the basis of agreed protocols which included appropriate provisions for the care of participants which was one of the fundamental purposes of the Act. The Minster was anxious to ensure that the terms of the licences were fully complied with. It was also indicated that there should be no unilateral withdrawal of participants from such trials except under proper medical supervision and guidance. The receiver accepted the responsibility to provide such care and indicated that he was seeking the assistance of leading specialists in the fields of medicine and pharmacology to advise him in this respect. He also undertook to keep the Department of Health advised of all developments in this matter. I am satisfied that the medical needs of the participants are being provided for.
The Government are, of course, anxious that clinical research and testing should continue to be a feature of health care in Ireland. I understand that the receiver is actively pursuing the possibility of putting together a rescue package for the institute. In so far as my Department can be of assistance to him in this, we will readily do so. I should say, however, that apart from ICP as a centre for clinical testing of drugs, much testing and research also takes place in hospitals and other centres and such testing is totally unaffected by the receivership of the Institute of Clinical Pharmacology (Ireland) Ltd.
I should like to ask the Minister if he will give an assurance to the House that all the obligations to the 20 drug-testing volunteers will be met, financial and medical? Has the Minister obtained such an assurance from the receiver? Will the Minister, and the Government, accept that their failure to amend the Control of Clinical Trials Act has meant that hospital-based and clinical research here is grinding to a halt because of insurance difficulties? Will the Minister give a commitment to the House that the new legislation will be brought forward?
I thought I had made the position clear. I should like to assure the House that all obligations, financial and medical, will be met by the receiver and we have a commitment to that effect. The receiver has appointed two eminent professors of clinical pharmacology to advise him in regard to this. He has given a commitment that 24 hour medical supervision, full nursing care and monitoring facilities are being provided for all volunteers involved. I do not accept what the Deputy has said in regard to the failure of the Government to bring forward the new clinical controls Bill. The introduction of the Control of Clinical Trials Act, 1987 in Ireland has not adversely affected the conduct of clinical research here.
That is a joke.
With reference to the Institute of Clinical Pharmacology, I should like to tell the House that that body had their own independently constituted ethics committee who met on a weekly basis. For that reason they were not under any difficulty in regard to ethics. I should like to assure the House that the Attorney General has examined the proposed new Bill and cleared it to the parliamentary draftsman. As soon as it has been cleared by that official the Minister for Health will bring it before the House.
I should like to ask the Minister to elaborate on the assurances he has given that medical care of the participants is fully provided for against the background that 168 staff were laid off yesterday. I should like to ask the Minister if he has invoked section 11 (1) (b) of the Control of Clinical Trials Act, 1987 which, I should like to remind him, enables him to require detailed progress reports from the institute concerning the progress of volunteers involved in clinical trials. Will the Minister say if the Department of Health are taking any measures to supervise or monitor the progress of those clinical trials to their termination?
I thought I had given details of what the receiver is doing. I should like to assure the Deputy, and the House, that the Department of Health have been in touch with the receiver and that we have been assured by his commitments. He has engaged eminent advisers. It is a matter for the receiver to deal with this issue and not the ICP. The interests of the volunteers, medical and financial, are being looked after by the receiver and the Department of Health will monitor this and be in constant touch with the receiver.