Joan Burton (Dublin West, Labour)
Link to this: Individually | In context

Question 154: To ask the Tánaiste and Minister for Health and Children if her attention has been drawn to the decision of the Mater Hospital Dublin to defer approval of testing of an anti-cancer drug due to the fact that it required those involved to use contraception; her response to the move; the steps she will take to ensure that no woman is denied access to potentially life saving treatment through the use of such drugs; and if she will make a statement on the matter. [28784/05]

Paul Gogarty (Dublin Mid West, Green Party)
Link to this: Individually | In context

Question 189: To ask the Tánaiste and Minister for Health and Children if she has a record of the membership of ethics committees of hospitals that are in receipt of State funding; if she keeps a record of decisions taken by those committees in hospitals that are in receipt of State funding; her views on whether such committees should be selected if the patient's best interests are to be paramount; and if she will make a statement on the matter. [28967/05]

Mary Harney (Dublin Mid West, Progressive Democrats)
Link to this: Individually | In context

I propose to take Questions Nos. 154 and 189 together.

I am, of course, aware of the concerns that have been expressed about the Mater Hospital and the trial of an anti-cancer drug. Officials in my Department have written to the chairperson of the Mater Hospital ethics committee in regard to this matter and I will review the position when his reply is received.

The European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004, S.I. 190 of 2004, govern the conduct of clinical trials on medicinal products for human use. I am arranging to have copies of these regulations forwarded to Deputy Burton and to Deputy Gogarty.

Ethics committees established under the regulations are required to be independent, consisting of health care professionals and lay members and to have responsibility for protecting the rights, safety and well-being of those involved in a trial — which is a paramount consideration. They are also required to provide a public assurance of that protection by, among other things, expressing an opinion on the trial protocol, on the suitability of the investigators, on the adequacy of the facilities, on the availability of insurance, indemnity or compensation and on the methods and documents to be used to inform those participating in the trial and to obtain their informed consent.

Ethics committees are required to submit annual reports to my Department detailing their activities during the year. These reports are required to include a list of applications for opinions in respect of clinical trials and the decisions made by committees on these trials.