Dáil Éireann - Volume 363 - 22 January, 1986

Written Answers. - Statutory Control of Clinical Trials.

212. Mr. Prendergast asked the Minister for Health if he is aware of the growing public concern at the use of human beings in drug experiments by the chemical and pharmaceutical industries; the proposals he has for the prevention or [146] restriction of such experiments; and if he will make a statement on the matter.

Minister for Health (Mr. B. Desmond): As the Deputy will be aware, there is no provision in existing legislation for a statutory scheme to control clinical trials. However, I am very concerned that these trials should be subject to statutory control and I will be circulating a Bill in the current session with the aim of providing for such control. I have already indicated that the Bill will lay down formal conditions for all clinical trials conducted in this country involving existing or proposed new drugs. It will also control the participation of all persons in such trials.