Vol. 517 No. 4
56 Mr. Penrose asked the Minister for Health and Children his views on a ban by the Blood Transfusion Service Board of 13% or 13,000 of its blood donors who lived in Britain between 1980 and 1996 at the height of the BSE scare to avoid any potential risk of contracting Creutzfeldt-Jakob disease in line with the example already set by countries such as the US, Austria, Germany, New Zealand and Japan; and if he will make a statement on the matter. [9923/00]
The question of deferring different categories of blood donors from donating blood is a matter for the Blood Transfusion Service Board. There is no proven instance of classical CJD having been transmitted through blood or blood products, but the theoretical possibility associated with variant CJD cannot be excluded at this time. There is currently no screening test to detect the presence of variant CJD. For my part, I will ensure the BTSB has adequate resources to introduce proven new technologies in this area.
Experimental animal models suggest that the infectivity of Transmissible Spongiform Encephalopathies, which include variant CJD, may be associated with white blood cells in animal systems. White blood cells can be removed from blood donations using special filters. This process is called leucodepletion, and the BTSB, as a precautionary measure to minimise the theoretical risk of transmission, introduced leucodepletion for cellular products in 1999.
The BTSB's policy is to permanently defer potential donors who may be at risk of carrying CJD, including donors who have received a dura mater transplant, human pituitary derived growth hormone or have one or more blood relatives with CJD.
The countries referred to by the Deputy recommend that potential blood donors who spent a total of six months or more in the United Kingdom between 1980 and 1996 be permanently deferred from donating blood. As part of the decision-making process, the countries in question assessed the likely effect of such decisions on their blood procurement policies. I understand the effects for those countries was in the order of a 2% reduction in supply whereas the effect in this country would be a 13% shortfall in donors.
The Council of Europe's Committee of Experts on Blood Transfusion and Immunohaematology recommend that the balance of risk between maintaining an adequate blood supply and minimising a theoretical risk has to be considered in the decision-making process and it advises that care must be taken to ensure any precautionary measure proposed will not impact adversely on the donation, safety and supply of blood necessary to meet patients' needs. Furthermore, the populations of Ireland and other European countries differ from those of countries such as North America in the extent of their exposure to UK bovine-derived material. In countries with a higher historical exposure to BSE, measures to defer donors who have spent time in the United Kingdom may reduce donor supply without enhancing safety. European countries are actively evaluating this matter at present.
The Irish Medicines Board, which is the regulatory authority, has indicated that it is anxious to consult more widely with national and international expertise and have more detailed discussions on the matter before recommending any change in the current position. It supports the BTSB's proposals to re-enforce guidelines on the optimal use of blood in hospitals.
The strategy of ongoing monitoring of the emerging scientific data will continue as a matter of priority, involving the BTSB, the Irish Medicines Board, and the CJD advisory group, which is advising me on matters relevant to CJD. I am planning to have a series of consultations with these bodies to keep the matter under constant review. The advice and evidence from EU scientific and medical experts is also being regularly evaluated to assess whether current strategies ought to be revised and this will continue to be the case. I will ensure adequate resources are available for this purpose.
I thank the Minister for his extensive reply though I am not sure how much information he gave in reply to the question which asked for his views on whether a ban would be desirable and if plans should be made to impose one. As he pointed out, certain countries have imposed a ban against donors who spent time in Britain between 1980 and 1996. Presumably he would accept those are the countries that have very low numbers of such potential donors. Does he accept that in Ireland, where a much higher percentage of donors would fall into this category, the potential risk is higher? Is it the case that he, as Minister for Health and Children, will not impose such a ban and will depend on the BTSB to ensure nobody will be at risk from blood donations from sources who could potentially carry CJD or is he saying he is actively considering the possibility of imposing a ban? His view on this matter is not clear from his reply?
What is clear from my reply is that there is a responsibility on the Minister for Health and Children of the day to be in the position to take due cognisance of expert advice on this issue nationally and internationally and to assess all the issues involved. I met representatives of the BTSB to discuss this issue, as I am concerned about it and it needs to be thoroughly teased out. My view is that we should minimise all possible risks to the people here in terms of blood transfusions and so forth, and that would be everyone's basic principle in approaching this issue.
However, the position here is different from that in North America. There are a number of other issues involved here, not least that the indigenous population has had considerable exposure over the years to British bovine-derived material through imported foodstuffs. How does one draw a distinction between those who lived in Britain between 1980 and 1996 and people who lived here who would have been exposed to food products manufactured in Britain during that period?
The BTSB advises that one could increase the risks if it deferred 13% of donors from donating blood because it would have to draw from a younger population to replace that deferred group with new donors who could have had a high degree of exposure to bovine-derived material. I have no difficulty with this advice from the BTSB being made available to the spokespersons. I am also being advised by the CJD advisory group and we have to weigh up the issues involved.
We also have to consider the immediate impact of the announcement of such a ban, which would be the responsibility of the Irish Medicines Board, the regulatory authority. If it were to announce tomorrow that a percentage of donors were excluded from donating blood, a significant number of patients would be put at risk in terms of surgical procedures, blood transfusions and so forth. It is a case of balancing the risks involved.
At present there is a theoretical risk. As I said in my reply, no one can be certain there is no risk involved. I am actively pursuing advice on the issue. I met representatives of the BTSB and I intend to consult the IMB, the national blood users group, who are advising hospitals and clinicians in terms of minimising the use of blood in various surgical procedures – something that is growing apace – and our European colleagues on the matter.
It would be safest not to get up in the morning.
That was my thought last week when I finished my meeting with the BTSB.
The time allocated for this question has expired.
I wish to ask a brief supplementary.
I will allow a brief supplementary.
The Minister will be aware that this issue was teased out with the BTSB by the Joint Oireachtas Committee on Health and Children. When might a conclusion be reached in the context of the deliberations taking place regarding whether any portion of the population should be excluded as blood donors or is the issue being left open for further consideration should other information become available at some undefined date?
The matter is being kept open for consideration and I will have further consultations to satisfy myself, as Minister for Health and Children, on the matter. At present, the IMB is not predisposed to introducing a ban and it wants to consult more widely, particularly in the European context. The European Commission's scientific committee issued advice and guidelines on this, as has the Council of Europe's expert committee.
It has no problem banning St. John's Wort.
Cardiovascular surgery is not dependent on St. John's Wort.
