Variant CJD
The next item of business is a statement by Malcolm Chisholm on variant Creutzfeldt-Jakob disease. As normal, the minister will take questions at the end of his statement, so there should be no interventions during it.
Members will recall that on 18 December I drew their attention to a single incident in England in which it appeared that, for the first time anywhere in the world, variant CJD might have been transmitted by blood transfusion. At the time, I said that the advisory committee on the microbiological safety of blood and tissues—MSBT—had been asked to consider comprehensively whether, in the light of that incident, any further precautionary measures needed to be taken. That request was made with the proviso that such measures should not have an unmanageable adverse impact on the safety or availability of essential blood supplies. The dangers of a shortage of blood will be obvious to all, so we expected the committee's recommendation to take account of the balance of risk involved.
The committee met on 22 January and discussed a number of options for further strengthening protection of the blood supply. On the basis of the evidence available, and taking a precautionary approach, the committee has recommended that UK blood services should cease to accept blood donations from people who can confirm that they have definitely received a blood transfusion in the UK since 1 January 1980—the date after which it is believed people might first have been exposed to variant CJD via the food chain.
As I indicated on 18 December, at that time I asked the Scottish National Blood Transfusion Service to anticipate such a recommendation by preparing as a matter of urgency an implementation plan. That has been done and the plan will be put into effect on Monday 5 April—the date recommended by MSBT as being the earliest date that would allow blood services to put in hand all the necessary work.
Preparatory to implementing the plan it has been necessary to undertake a considerable amount of work to ensure its smooth and safe introduction. To reassure members that we have been addressing the issue vigorously, I will outline the most important elements of that work.
Our primary concern has been to take measures to secure the blood supply, so that operations and essential treatment are not jeopardised by the loss of blood donations from the group of donors who will no longer be able to give blood as a result of our adopting the committee's recommendation. We expect that the new policy will result in the loss of around 4 per cent of current donations, but secondary effects could increase the figure to as high as 10 per cent. To take account of the loss, the SNBTS will need a large number of extra donors to come forward over the next 12 months. There will be a doubling of its normal requirement for new donors.
The SNBTS has already stepped up its existing donor recruitment campaign. In addition, it has conducted new research into the issues that motivate people to become blood donors. Based on that research, it will launch a completely new high-profile media campaign later this year. The SNBTS will write to existing donors who are unaffected by the new policy and will ask them to make a special effort at this time, with particular emphasis on the importance of maintaining the supplies of O negative blood that are so important in emergency situations. Arrangements are in hand to introduce a screening test that will allow an estimated 2,500 donors who are currently prevented from giving blood because travel abroad to certain countries can involve a risk of contracting malaria to resume giving blood.
In addition to the essential work that I have described, it has been necessary to put in place arrangements to explain the new policy to donors and to other people who may be worried about its implications. Those include the provision of counselling where it is appropriate. The SNBTS has prepared three new information leaflets specifically for that purpose and has drafted comprehensive briefing for use in call centres where calls from donors will be handled. It has also set in motion the recruitment process for the additional nurses and donor care staff who are required. In the interim, existing staff will work additional hours to meet the need. It has been necessary to provide comprehensive training for front-line SNBTS staff in both the implementation of the policy and how to inform and support donors who have concerns arising from it.
In outlining the policy and its implications, I emphasise that we are taking this approach on the basis of scientific advice and as a precaution against an uncertain but slight risk. We believe that the risk of any individual having been infected with variant CJD as a result of blood transfusion is extremely small. Nevertheless, I realise that individuals may have concerns about how the new policy affects them and may wish to seek advice. Any patient in that situation can contact the dedicated team on the national helpline number. Any donor who is deferred under the new arrangements should speak to a SNBTS member of staff at a donor centre or session or should call the SNBTS's 24-hour donor helpline. I urge people to continue to have a blood transfusion when it is really necessary. Any slight risk associated with receiving blood must be balanced against the significant risk of not receiving that blood when it is most needed.
As I explained in January, we already have in place a range of precautionary measures to reduce the possible risk of transmitting variant CJD through blood. Since 1999, those have included the leucodepletion of blood intended for transfusion and the importation from the United States and Germany of all plasma used in the manufacture of blood products. More recently, since September 2003, all the clinical fresh frozen plasma needed for the treatment in Scotland of newborns and of children who were born after 31 December 1995—the date when exposure to BSE via the food chain ceased—has also been imported from the United States and virally inactivated. That latest measure merely augments the existing measures to provide an even greater degree of safety.
In addition, we have a responsibility to donors and patients to ensure that blood is used as effectively as possible and is used only in circumstances in which the essential benefits to the patient outweigh any adverse effects. To that end the SNBTS is collaborating with health professionals in NHS Scotland to implement the better blood transfusion programme, a key initiative endorsed by the chief medical officers of all four United Kingdom Administrations. Three key areas of transfusion practice are being reviewed: blood ordering and administration; efficient management of blood components; and, crucially, clinical effectiveness and the use of the best evidence-based practice in prescribing blood so that it is used only where there is a real need.
In April 2003, we recruited a full-time programme director to implement the programme in Scotland over the next three years. Eighteen transfusion practitioners have also been recruited from various nursing and hospital backgrounds and they are being supported by a designated senior manager in each NHS board. I believe that the programme is important and every effort will be made to ensure its success.
Obviously, we are sad to be losing some of our most loyal blood donors and I thank them for their commitment to saving lives over the years. It is essential that the potential shortfall that arises from the decision is made good and that essential blood supplies are maintained. As I have already mentioned, the Scottish National Blood Transfusion Service has embarked on a new initiative to recruit additional donors and, based on new research about potential donors, the initiative will be accelerated over the coming months. The effectiveness of the new approach will be kept under close review and, if necessary, consideration will be given to other approaches, such as enhanced blood collection arrangements, more donor sessions and the use of automated blood collection equipment that allows the equivalent of more than one donation to be taken from each patient without their being exposed to any adverse health effect.
It is important not to lose sight of the key role that blood donations play in providing essential treatment and in saving lives. The statistics are compelling. Approximately 80,000 patients in Scotland receive a blood transfusion every year. At present, less than 6 per cent of the Scottish population who could give blood do so. It has never been more important for people to come forward to donate blood regularly and I urge them to do so.
I thank the minister for early sight of his statement. He seems to share the general concern that the risks that flow from blood donations from variant CJD sufferers must be tightly managed. Therefore, we welcome his early and appropriate response to managing the potential risks that arise from blood donated by previous recipients of blood and blood products.
Any reduction in the number of blood donors as a result of today's announcement is a cause for concern and a potential threat to public health in a country that has one of the poorest life expectancies in the European Union and where health care is, therefore, one of the most important services that we provide. With the introduction of a new screening test for previously excluded potential donors, I look forward to resuming my own blood donations and to making a small contribution. I hope that other members will do the same.
My questions relate to the continuity of supply of blood products. First, what proportion of donated blood is currently used for clinical purposes and what is that proportion expected to be following implementation of the better blood transfusion programme and the introduction of the new equipment, which will increase the take from donors?
In the longer term, what research to which the NHS in Scotland is party is being undertaken into the potential use of blood substitutes, which have been used for several years in South Africa and in one or two other places around the world?
Finally, in the event that we fall short of recruiting the required figure of 100,000 donors, at what point does the situation become critical and what is the back-up plan?
I thank Stewart Stevenson for his opening remarks. He has asked three specific questions, the first of which covered quite a few areas. I think that he was referring to some of the things that I mentioned in my statement, such as automated collection, which would enable more blood to be used from one individual in one session. That is certainly being considered. The other issue that he referred to was the more efficient use of blood, and Scotland certainly leads the way in that regard, although there is still further to go, so that blood is used only where appropriate during operations.
Stewart Stevenson's second point was about blood substitutes. The National Institute for Clinical Excellence is doing some work on that, and we obviously listen carefully to the views of NICE and comment on them through NHS Quality Improvement Scotland, as he knows. However, I do not think that we should hold out too much hope for that being a major alternative source of supply.
On Stewart Stevenson's third point, the figure that he quoted would, of course, be a worst-case scenario, but the Scottish National Blood Transfusion Service is clearly preparing for that. Basically, we are losing about 6,000 donors a year, so the immediate task is to replace those, but there are all sorts of uncertainties around the situation, so we are obviously aiming for a whole lot more extra donors than that. We should bear it in mind that we currently attract an extra 50,000 new donors each year, so we must have a very big increase on that. As I indicated, we are aiming to attract far in excess of 50,000.
Clearly, we must have contingency arrangements. I know that the Scottish National Blood Transfusion Service has been speaking to the Netherlands, for example, and if the worst comes to the worst, we can import blood, although that is certainly not the plan. What we want to do is to ensure that we attract more people to donate blood. In a sense, the key message from today's announcement and over the next few weeks is that we want people who have not donated before to come forward and donate blood. There will be a new advertising campaign, which will try to target some of the messages more effectively.
I, too, thank the minister for providing an advance copy of his statement. The whole issue is a matter of public confidence and I think that all members in the chamber are united in the perception that infection through transfusion—whether by HIV, hepatitis C or variant CJD—is a risk. I welcome the minister's comments about the precautionary approach and I offer any support that we can give in helping to boost public confidence.
The minister mentioned some new screening tests that will enable certain people who have been exposed to malaria to be screened. Are any other new screening tests being developed for similar conditions? If so, could he update us on those?
With regard to the increase in the requirement for donations of blood, I have recently received a number of comments, rather than complaints, about the user-friendliness of the process of donating blood—partly to do with access, partly to do with comfort and partly to do with waiting times. I know that the minister talked about increasing staffing, but will he comment on which specific aspects of the user-friendliness of the process he expects to be improved?
He also mentioned the existing foreign sources of the United States of America and Germany. What steps has he taken to ensure forward supplies until we can get our own level of blood donations in this country up?
I thank David Davidson for his opening remarks and his three questions. In answer to his first question, malaria is certainly the only disease for which I am aware that there is a new screening test, but if there are others I shall write to him about them.
His second question raises an important general point for the health service more widely, with regard to its being more patient focused, user friendly, customer friendly or whatever phrase we wish to use. Obviously that is an important area that the Scottish National Blood Transfusion Service should consider as part of its wider work. Since December, its attention has been focused mainly on assessing the situation and developing research and new advertising campaigns, but it needs also to address the area to which David Davidson refers.
I have already answered Mr Davidson's third question in my previous response, in which I highlighted the provisional arrangement with the Netherlands. He mentioned the US and Germany; however, those arrangements relate to the importation of plasma, which will continue.
I know that we have the advisory committee on the microbiological safety of blood and tissues. Given the problem of patients' being infected with HIV, hepatitis C and now vCJD through blood products, how confident is the minister that the arrangements in Scotland are robust enough to ensure that donated and transfused blood is as safe for our patients as it is humanly possible to be?
I am certainly confident that the blood is as safe as possible. As far as HIV and hepatitis C are concerned, those problems are very much in the past and reliable tests are now available for those diseases. The problem with vCJD is that no such test exists, which is why we have to take this series of other actions. As I have indicated, some actions such as leucodepletion, the importation of plasma and this new measure are already in train. Although it is very unlikely that anyone would contract vCJD in this way, we must follow the precautionary principle and the scientific advice that we have recently received. In other words, in the absence of a test for vCJD in blood, we are taking a series of actions to minimise the risk.
What information can be provided to current blood donors to ensure that they check their medical records and find out whether they received blood transfusion or infusion while they were undergoing surgery and therefore were unconscious? I ask the question to ensure that current donors can comply with the new criteria that the minister has announced today.
Margaret Jamieson's suggestion that people who are uncertain should check whether that information is available is a good one. The advisory committee on the microbiological safety of blood and tissues has taken the view that most donors who are unsure whether they have had a transfusion are unlikely to have received one. However, it will review the situation in six months' time. Obviously, we are following the expert committee's current advice in that respect.
I thank the minister for his statement, which I welcome and fully support. My question follows on from Margaret Jamieson's question. Do the measures in question apply only to people who have received whole blood or do they include people who have received blood products such as plasma or packed cells?
The minister said that the measures will be effective from 5 April. I take it that that means that they will apply to blood that is donated after 5 April and that there will be no implications for existing stocks of blood and blood products. Will there be any implications for other forms of donation such as bone marrow donation? Furthermore, has any thought been given to relaxing restrictions on becoming a blood donor such as the restriction on age?
Phil Gallie raised Eleanor Scott's final point in December and I wrote to him about it. The age limit was raised relatively recently and people can now donate until they are 70. Looking around, I think that that probably includes everyone in the chamber.
The risk posed by plasma derivatives is lower than that posed by transfusions. The CJD incidence panel is calculating the potential risk from individual batches of each plasma product manufactured from suspect plasma pools. It will then be possible to judge whether individuals have received a sufficient dose of that product for the increased risk of exposure to vCJD to be of significance. As a result, the situation is rather more complex and there is no blanket ban on people who have received plasma derivatives.
I support the minister's statement and welcome the precautionary measures that he has outlined. Will he elaborate on any chats that he has had with his European counterparts? Boundaries are easily crossed and many of us go on holiday abroad, where we might have accidents and find ourselves in hospital being given a blood transfusion. Will more information be given to travellers?
I have had no personal chats with European counterparts on that issue, although obviously, as I indicated, the SNBTS has been in contact with other countries.
I thank the minister for his statement and for his actions to secure an on-going source of blood for the SNBTS.
Will the minister also support on-going research into variant CJD and treatment for its victims? For example, is he aware of the recent confirmation of another case of variant CJD in Scotland, in a young mother with two children? Is he aware that treatment might be offered at the Western general hospital in Edinburgh, which will be the first official treatment centre in the United Kingdom for CJD patients? Is he also aware that the UK Government announced plans in December for a number of such treatment centres? I congratulate the minister on the fact that Scotland is taking the initiative and ask him to draw the matter to the attention of his colleague at Westminster, John Reid, the Secretary of State for Health.
I join Ken Macintosh in praising the Western general hospital in Edinburgh for its work in that area and, indeed, in many others. Research into the area is on-going, as I indicated in my previous statement on variant CJD, but there is no new progress to report. It is clear that, in particular because of the uncertainties around the diagnosis, there is a great need for further research.
I remind the minister of the evidence that he gave to the Health Committee on 9 September 2003 in the context of hepatitis C, when he indicated that he would not rule out an inquiry into blood and blood products if "new evidence" came to light. Therefore, in the context of the new evidence of contamination of blood from new variant CJD, will he undertake to hold an inquiry into the safety of blood and blood products, not only for Scotland's many haemophiliacs, but for the wider Scottish public?
We should not try to roll the issues of hepatitis C and variant CJD into one, as the two issues are quite separate. Obviously, we have not favoured the wider inquiry into hepatitis C to which the member refers, for reasons with which she is familiar—the matter has been considered through various reports and inquiries and fault has not been found. It is not helpful to roll the two issues together.
Over the years, it has been obvious that restrictions on blood donors have increased quite significantly, partly because of foreign travel and other such matters. Even before the problem with variant CJD, it has been difficult to secure enough donated blood. I welcome the proposals for an intensive media campaign.
Members of the Scottish Parliament are meant to be leaders in the country, but I am told that blood donor sessions are not held in the Parliament. Should we assume some leadership on the issue and instigate such sessions?
That is an entirely positive and helpful suggestion and no doubt those who have responsibility for such matters in the Parliament heard it.
I thank the minister for his statement and recognise the reasons for the precautionary steps that he has announced. I also welcome the emphasis that the minister has placed on ensuring that the public have access to the best possible advice and information on a complex and sensitive issue. However, I note that the bulk of our time this afternoon has been spent talking about the provision of information to donors and would-be donors. Will the minister elaborate further on the measures that are being taken to ensure that those who have received blood transfusions are given the information, advice and reassurance that they might need in the light of the most recent developments? Will the minister also elaborate on the steps that are being taken to advise members of the public who might need a transfusion—which could mean any of us—or whose relatives might need a transfusion in the future?
It is important to emphasise that side of the issue. In the middle of my statement, I said:
"We believe that the risk of any individual having been infected with variant CJD as a result of blood transfusion is extremely small. Nevertheless, I realise that individuals may have concerns about how the new policy affects them and may wish to seek advice. Any patient in that situation can contact the dedicated team on the national helpline number."
That number is the first point of contact for anyone who has received a blood transfusion and who has any concerns. Obviously, they can talk to their doctor as well.
That concludes questions to the minister on his statement.