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Dáil Éireann debate -
Thursday, 6 Feb 1997

Vol. 474 No. 5

Written Answers. - Hepatitis C Research.

Liz O'Donnell

Question:

52 Ms O'Donnell asked the Minister for Health the research, if any, which is ongoing to find a treatment or cure for hepatitis C in view of the high incidence of the disease in Ireland; the efforts, if any, which have been made in Ireland and abroad to source a cure or to support clinical trials of a potential cure for hepatitis C; if he will consider the funding of a clinical trial in Ireland of a potential cure for the disease which is being developed by a company (details supplied) in Florida; and if he will make a statement on the matter. [3450/97]

Limerick East): The Health Research Board, which was established in 1986 under the Health (Corporate Bodies) Act, 1961, is the statutory agency charged with the commissioning and conduct of medical and health research in Ireland.

The health care package which I agreed in December 1995 with the four groups representing those infected with hepatitis C through the receipt within the State of blood and blood products included a commitment to establish a special research programme on hepatitis C. I have approved funding over £1 million to be made available to the Health Research Board over the next five years for such research.

In March 1996, the Health Research Board invited proposals from interested research groups for project studies into some of the key areas relating to hepatitis C infection, particularly as it relates to persons infected through the use of anti-D. In all, a total of eight projects were approved. The most significant project concerns the establishment of a special hepatitis C research unit which will involve St. Vincent's Elm Park, St. James's Hospital/Trinity College, University College, Dublin and St. Patrick's College, Maynooth. The unit will undertake a range of collaborative research activities, using an inter-disciplinary team of research investigators, which, it is hoped, will lead to the development of improved approaches to the control of the hepatitis C infection.

In addition to the new research unit, the Health Research Board has also approved projects which will be undertaken by research teams at University College, Cork, the Royal College of Surgeons in Ireland, Cork University Hospital, the Mater Hospital, a joint project between the BTSB and St. James's Hospital, and a joint project between the Royal College of Surgeons in Ireland and the Mater Hospital.

It is anticipated that these research studies will provide new insights into hepatitis C infection and lead to improvements in the care and treatment of patients.

One of the functions of the Consultative Council on Hepatitis C, which I established in November 1996, will be to advise and make recommendations to me, as Minister for Health, on developments arising from such research into hepatitis C.

The undertaking of clinical trials in Ireland is governed by the Control of Clinical Trials Acts, 1987 and 1990. The Irish Medicines Board is legally obliged to examine each application and to grant or withhold approval for such trials. In order to facilitate applicants who are seeking approval to carry out clinical trials, guidelines have been drawn up by the Irish Medicines Board which outline the information required before clinical trial approval can be considered. I understand that the person referred to in this question contacted the Irish Medicines Board last year and was given full details of the documentation which would be required for any application for approval to carry out clinical trials. The board has had no further communication from the person concerned. It is the board's understanding that the drug referred to in the question has no licence anywhere in the world, and that it is not currently approved for the understanding of clinical trails either by the FDA or by any European member state.
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