asked the Minister for Health the steps he will take to ensure that research carried out under the auspices of ethics committees in different hospitals will continue, in view of the recent problems arising out of the insurance difficulties concerning the implementation of the Clinical Trials Act, 1987; and if he will ensure that such research is facilitated at the earliest possible date.
Ceisteanna—Questions. Oral Answers. - Clinical Trials Act, 1987.
2.
I have already set in train steps which will ensure that clinical research will continue to take place in our hospitals.
At the outset, when the controls set out in the Control of Clinical Trials Act, 1987, became operational in December 1988 I indicated that I would be monitoring closely the implementation of this legislation. As the House will be aware, this legislation brought Ireland to the fore in terms of statutory control over clinical research and I would be most anxious to ensure that the Act is, and is seen to be, working effectively. The aim of the legislation is to provide a balanced framework within which clinical research is facilitated and those participating in clinical trials are protected.
Since the coming into force of the Act just three months ago, the concerns of certain ethics committees with regard to their potential legal liability have been brought to my attention. I have tried to allay these fears by meeting with representatives of the interested parties and conveying the legal advice available to me on the matter. I would refer the Deputy to my reply to Parliamentary Question No. 14 column 218 of the Official Report of 6 December 1988 where I set out the position about the legal advice comprehensively.
I am fully appreciative of the potentially serious effect which the present impasse might have on clinical research and, in order to expedite a resolution, I have asked representatives of the hospitals, clinical researches, Federation of Irish Chemical Industries, the Health Research Board and my Department to consider the operation of the Act with particular reference to the difficulties which have arisen in certain hospitals and clinical research in general in this country and to report to me by the end of March 1989.
On a point of order, and in relation to this question — Deputy Richard Bruton is not here and he cannot put supplementaries — I should like to point out that a similar question was answered on 6 December and I cannot understand why the Chair allowed the question to be repeated within the six month rule. I am drawing the Chair's attention to that because questions of mine on issues that have been broadly mentioned in the House are being constantly ruled out of order under the six month rule.
I note what the Deputy has said. My office is very careful in such matters but nevertheless, I shall have the Deputy's allegation investigated.