Vol. 557 No. 6
31 Mr. Quinn asked the Minister for Health and Children if an investigation has been held or is planned into reports that St. Vincent's Private Hospital in Dublin had charged cancer patients more than ?1 million for drugs it had received free of charge; and if he will make a statement on the matter. [22905/02]
The drug trial in question was held in a private hospital in which my Department has no function. The responsibility for clinical trials lies with the Irish Medicines Board.
I understand the Irish Medicines Board, IMB, was informed on 2 September that patients recruited into three oncology trials conducted at St. Vincent's Private Hospital may have been charged over a period of months for two particular medicines used, despite signing a consent form which stated that these medicines would be supplied free of charge. This represented a violation of the clinical trial protocols for the three trials and a breach of Article 12 of the Control of Clinical Trials Act. Under the terms of the Act, the chief investigator has full responsibility for all aspects of the conduct of a clinical trial. The IMB has suspended the recruitment of new patients to all clinical trials being conducted at the hospital concerned. In the interests of patients who may be benefiting from participation in the clinical trials those already enrolled were allowed to continue.
Officers of the IMB conducted a good clinical practice inspection of the oncology clinical trials carried out at the hospital concerned. The inspection encompassed all aspects of the conduct of clinical trials in accordance with the IMB's remit under the Control of Clinical Trials Act and international guidelines on good clinical practice. The IMB has sought clarification on a number of outstanding issues which were identified during this inspection.
