Dáil Éireann debate -
Tuesday, 16 Jun 1998

Vol. 492 No. 4

Priority Questions. - Hepatitis C Infection.

Alan Shatter

Question:

5 Mr. Shatter asked the Minister for Health and Children the proposals, if any, there are to recall for further testing those women who were assumed to show false positives in their original tests in 1994 for hepatitis C, who were tested as a result of receiving contaminated anti-D blood products; whether there is a concern that these recipients of anti-D may, as a result of their exposure to hepatitis C, have suffered liver damage; whether his Department or the Blood Transfusion Service Board has made contact with those who may be so affected for the purpose of their undergoing further examination and testing; if not, whether it is intended to do so and when this will take place; the number of women who may be recalled; and the procedures, if any, he is putting in place or has put in place to address this matter. [14109/98]

Minister for Health and Children (Mr. Cowen)

I assume the Deputy is referring to a number of anti-D recipients who tested negative in 1994 for hepatitis C antibodies on the confirmatory RIBA test following an initial positive ELISA test. In 1994, a national blood screening programme was established which offered testing for women who received anti-D immunoglobulin in order to identify those who were infected with hepatitis C. Under this programme, 165 women tested positive on the initial ELISA test and negative on the confirmatory RIBA test. International practice has been that, in the absence of RIBA positivity, the initial ELISA positive reaction probably reflected a false positive reaction. I am advised that such non-confirmed reactions to sensitive screening tests are not uncommon in the general population. Accordingly, when the general practitioners of the persons concerned were being advised of the test results, the results were reported as hepatitis C antibody negative.

In September 1997 I established an expert group comprising, among others, consultant hepatologists, a consultant haematologist, a virologist, the chairman of the Irish College of General Practitioners, and the chairperson of Positive Action. The group is chaired by the chief medical officer at my Department. The remit of this group is to advise on the clinical and non-clinical management of anti-D recipients who tested negative for hepatitis C and who received infected or potentially infected product.

The group has reviewed the position in relation to the anti-D recipients referred to by the Deputy, including the international practice already referred to. It has decided that where such recipients have been identified as having received an infected or potentially infected anti-D batch, they should be offered referral to one of the six designated hepatology units. The consultant in the unit will review the patient's clinical status and will conduct any further testing which is considered necessary. I understand that, to date, it has been confirmed that 18 of the 165 recipients did not receive infected or potentially infected anti-D.

Mr. Shatter

What has acted as the catalyst to these women being recalled for further testing? Is there is a concern that they may have suffered liver damage? Of the 165 people who initially tested positive — which result is now regarded as a false positive — has each person been communicated with on an individual basis and asked to attend for further medical testing? What is the nature of the procedures it is proposed they undergo?

Mr. Cowen

I stress that the expert group is advising that such recipients can be reassured that all the indications from their hepatitis C tests are that they are not currently infected with hepatitis C. The ELISA test may have been a false positive result, or a low antibody response. The overall experience is that such individuals do not have active liver disease, and it is unlikely that any further intervention such as liver biopsy will be required.

At its meeting on 5 June, the expert group discussed the detailed implementation of the decision to notify the women concerned, through their general practitioners — this relates to the Deputy's supplementary question. The implementation will involve the expert group issuing comprehensive advice and information to general practitioners to ensure that they are in a position to discuss fully with their patients the circumstances of their particular situation.

I emphasise that the expert group is an interdisciplinary group comprising specialists in a number of areas relevant to the clinical and non-clinical management of hepatitis C patients, including Positive Action. The approach of the group at all times is to arrive at agreed conclusions in respect of complex issues, and its primary concern is to continue to ensure maximum care for the anti-D recipients concerned. The process of notifying the women concerned, through their general practitioners, will commence this week.

Following the publication of the Finlay report, a number of outstanding issues relevant to the testing of anti-D recipients required assessment. Positive Action mentioned two distinct groups tested under the programme — first, anti-D recipients who tested negative for hepatitis C but reported suffering jaundice following administration of anti-D; and second, those who tested negative for hepatitis C but were known to have received anti-D from infected or potentially infected batches of blood. We therefore established an expert group to consider those issues in detail and to make recommendations. I have stated the group's terms of reference. They have had six meetings since November to deal with these issues in detail. The purpose is to ensure that there is a decision making process within the expert group which deals with all outstanding issues and allows for contacting people, giving proper counselling, and delivery of information in a correct and controlled manner to the people concerned, respecting the doctor-patient relationship. That has been the catalyst for the detailed consideration. In some respects public comment may not get the full message across but that is what we are doing at present.