The Blood Transfusion Service Board informed me on Thursday, 17 February 1994 that evidence had emerged that there was a possible link between the product anti-D immunoglobulin and hepatitis C. The Blood Transfusion Service Board made arrangements to change the product and this took place the following day, Friday, 18 February 1994. The board has introduced a new virally inactivated product which has been supplied to hospitals.
Rhesus haemolytic disease of the newborn is a condition that affects Rh positive babies born to Rh negative women who have developed anti-bodies to the Rhesus factor. These anti-bodies generally do not affect the first pregnancy but develop in subsequent pregnancies. The mother's anti-bodies cross the placenta while the baby is still in the womb and begin to destroy the baby's red cells. The baby can be thus affected by anaemia, brain damage or may be stillborn. Over 100 babies a year in Ireland were lost as a result of this condition. Others, less severly affected, required treatment by exchange transfusions.
In the late 1960s, it was discovered that the development of these harmful anti-bodies in the mother could be prevented by the administration of a substance called anti-D immunoglobulin. A national programme for the production of this vital substance was initiated in 1969 and has been dramatically successful in preventing the condition with now fewer than five babies per year being severely affected.
The hepatitis C virus was first described in 1989. Infection with hepatitis C may cause jaundice immediately. More usually the infected person is totally unaware of infection. In some cases, however, the virus may persist and cause chronic inflammation of the liver.
The question of introducing a screening test for hepatitis C for donations nationally had been considered in 1989 and 1990. During this period the Blood Transfusion Service Board and the Department of Health examined the possibility of introducing such a test. However, a review of international practices and discussions with medical experts abroad revealed that there was insufficient scientific information about the test to approve its routine introduction. The position was carefully monitored and when the test was considered sufficiently reliable for the purposes of screening donations, it was introduced in Ireland. This occured in 1991 at the same time as this screening was introduced in the UK. I emphasise that cost is not a factor in the timing of the introduction of such tests and, in fact, £1 million for hepatitis C testing by the Blood Transfusion Service Board has been approved to date.
In January 1994, as part of the ongoing monitoring of quality assurance procedures by the Blood Transfusion Service Board, it emerged that a disproportionate number of group Rh negative female donors had anti-bodies for hepatitis C. On further investigation it was found that nine of the ten female Rh negative donors had received anti-D in 1977. This was linked with an earlier report of six cases of jaundice which had been investigated in 1977 when no cause for the jaundice had been found. It would seem that the anti-D manufactured in 1977 is potentially the cause of this problem.
I commend the Blood Transfusion Service Board for carrying out this very thorough research which is essential in the monitoring and quality control of blood products which it produces.
When this matter was brought to my attention, my immediate concerns were: (i) the protection of all future recipients of anti-D immunoglobulin and (ii) the identification of any risk, however small, for any mothers who received the anti-D immunoglobulin product in the past. I agree, therefore, that the action taken yesterday by the Blood Transfusion Service Board was correct as the safety of blood products must be the first priority at all times.
The Blood Transfusion Service Board has announced its intention to follow up all of the mothers who may have been at risk of contracting hepatitis C from the anti-D immunoglobulin product. A special public awareness campaign has been launched to inform the public as to the possible risks.
Special arrangements have been made to provide information to general practitioners who, in many cases, will be the first point of contact for the women concerned. Free telephone lines have also been put in place by the Blood Transfusion Service Board to provide information to people who might be anxious as to whether they are in the category of those who might be at risk. The phone lines are open from 9 a.m. to 5 p.m. each weekday beginning today Tuesday, 22 February 1994.
Special arrangements for testing of women at risk have been made at the following locations throughout the country: Dublin, Galway, Limerick, Cork, Waterford, Drogheda, Sligo, Tullamore, Clonmel, Killarney, Letterkenny, and Cavan. Blood testing at the Blood Transfusion Service Boards centres and at general practitioners surgeries will be administered free of charge.
I am determined that every woman at risk will, as far as practicable, be indentified. The BTSB is making specific arrangements to trace the cohort of mothers who were given the anti-D products in 1977 and are focusing on these mothers. Because of changes of addresses it may not be possible to trace everybody and thus the public awareness campaign has been launched. Because we cannot be sure that the problem is confined to 1977, the Blood Transfusion Service Board is advising any woman who has received anti-D to be tested. Decisions on the individual follow-up necessary will be made as a result of the ongoing testing process.
It is accepted that all medical interventions, including the use of blood and blood products, carry some risks which require the balancing of the benefits and risks of particular treatments. I would like to reassure the public that there is no need for alarm. The Blood Transfusion Service Board has taken action to ensure the safety of blood and blood products as far as possible. The prevalence of hepatitis C in Ireland among blood donors is low and compares favourably with other European countries. This implies that hepatitis C is not widespread in the population.
It is estimated that approximately 100,000 women require testing, which will be provided within as short a time frame as possible.
If any of the people give anti-D immunoglobulin need medical treatment for hepatitis C as a result of receiving this product, I confirm that whatever treatment is prescribed by the clinicians will be provided by the public hospital services free of charge.