| Human Tissue Bill
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Mr. Lansley: I want to ask one or two questions for the record. There is obviously a substantial relationship between the codes of practice and the activity of the NHS. Ministers will understand that point, not least because the explanatory notes set out some of the public sector financial and manpower consequences that flow from the Bill. The explanatory notes give a figure of about £2.7 million for resources and £300,000 for a central training budget. I am sure that many in the NHS are concerned to ensure that the resources for implementation and training will reflect Column Number: 192 requirements not only once the Bill is enacted. There are one-off costs even now that are associated with implementing the interim statement and introducing consent forms. It would be useful if the Minister could say something about how the Human Tissue Authority, in framing codes of practice, will reflect its understanding of the resource implications of the codes' requirements.Will the Minister state that the Department understands that implementation and training need to be properly resourced? There is, in addition, the issue of the extent to which the NHS complies. I would be the last to add to the burden of inspection and control, and the Bill is clearly designed to place a set of obligations directly on the trusts and on those who receive consent and undertake regulated activities. There are many variables, such as the extent to which existing consent forms have been adopted in the NHS; that to which those who work with consent forms secure the appropriate consent at the appropriate time; and that to which, in line with the interim statement, bereavement counsellors are appointed in accident and emergency units. There will be concern in the NHS if its procedures are not in accordance with the Bill at the point at which the Bill comes into force. In theory, criminal penalties or severe consequences would flow from a failure to take proper procedures into account. Equally, if patients and their families feel that obligations are set out in the Bill but are not being complied with in practice in the NHS, they will suspect that some of our objectives have been undermined. Many of our concerns are to do with the relationship between the codes of practice and NHS management activity. It is unfair for us to legislate—to impose codes of practice—and for the authority to promulgate codes based on the gold standard, if everybody in the NHS is then to discover that they have no resources, time or bereavement counsellors; they have not been given the consent forms in the appropriate manner; they have not had any opportunity to train, and so on. We cannot allow the strain of trying to reconcile such matters to fall wholly on a junior hospital doctor or NHS clinician who is trying to manage such things in the midst of addressing a range of other priorities. I hope that the Minister can say something about the mechanisms. We have not previously discussed the matter, but we should do so, possibly on Third Reading. When we legislate, we must be clear about the processes by which activities will be managed, so that they will be acceptable in practice to the staff who have to live with them. Dr. Harris: I was interested to hear the hon. Gentleman's closing words, because I have identified some issues that we could well leave until Third Reading. We have both been requested by the Academy of Medical Sciences and others to raise the question, perhaps under the commencement clause or now of the time lag between the promulgation of the codes of practice—in order that people get to know them—and the implementation of criminal sanctions. If the Minister can pre-empt that, it would be Column Number: 193 appreciated by both of us, and by others who are concerned that there might be a big bang that will scare people and cause paralysis.The major concern about codes of practice is how they will impact on research using retained samples following surgery. I am raising the matter under clause stand part because of subsection (2)(d), which deals with
I declare an interest as a member of the BMA medical ethics committee. One thing that it has been concerned about has been the public's understanding of the definition of death, particularly because the terms ''brain death'' and ''brain-stem death'' are unhelpful. I hope that the Minister will agree that we need people to understand that death is death and that the death that we are talking about for the purposes of transplantation—when there is a beating-heart donation—is death confirmed by brain-stem tests. That is not death by observation of a non-beating heart and lack of respiration as well as pupilary fixed dilatation. Does the Minister consider that the reference pre-empts a code of practice that will serve as a way of educating everyone in the health service, particularly patients and relatives, that just because a heart is beating on a ventilator, death is death when confirmed by brain-stem testing? Dr. Ian Gibson (Norwich, North) (Lab): Will the hon. Gentleman define how many ways we can record death? Do all doctors have different methods of recording death? Does a histopathologist have a different method from others? How many mechanisms of defining death are there? Dr. Harris: I look to my consultant colleague for correction on the matter, but generally when patients die in hospital, the junior doctor is called to verify—not certify—death by observation and examination of the body that demonstrates that life has expired. That will include monitoring the respiration and cardiac activity as well as the pupilary reflex. In the specific case of death while on a ventilator, death is verified by brain-stem testing. Sometimes that it difficult for people to understand and there have been some controversies about whether people whose death is confirmed by brain-stem testing are, in fact, dead. That can be damaging to the business and duty of the NHS to ensure that there is a transplantation service. Anything that can be done to make that point clearly, during this debate but mainly in a code of practice issued under subsection (2)(d), will be welcomed by those working in the service and by the BMA, which is particularly concerned about public understanding of the issue. Dr. Taylor: So that members of the Committee do not become worried, I wish to confirm that there are real safeguards in the rules for brain-stem death and particular exclusions in cases of people who have taken overdoses, when even some of the reflexes can be removed. I do not want people to be worried. As the Column Number: 194 hon. Member for Norwich, North (Dr. Gibson) said, it is left to pathologists to make the diagnosis, although I hope that physicians are good enough to make it before then.Ms Winterton: As for the points made by the hon. Member for South Cambridgeshire and the relationship between the Human Tissue Authority, the implementation that will be required by the NHS and those who work in it, we need to bear in mind a few issues. Over the next year, the shadow authority will be drawing up codes of practice in two ways. It will first build on best practice. The hon. Gentleman referred to gold standard. In many areas, that will conform with GMC and BMA guidelines. I do not believe therefore that, because the Bill and the codes of practice will bring such policies together and build on them, they will be new to most people in the NHS and those who work on the front line. At the same time, a common-sense approach will be taken. Before the penalties come into force, it will be important to have wide consultation as well as to build on best practice. Although the hon. Gentleman raises an important point, we must make sure that strings are not attached to the service.
3.30 pmIn a sense, the safeguard is that the health service can implement what the authority draws up while it is in shadow form and puts into practice when it comes into being. Otherwise, we would be back where we were before, with a lack of public confidence in the system. Therefore, it is vital that the authority issues code of practice that can be implemented. The hon. Gentleman asked about bereavement and other services. Funding has been included in allocations already made, so such services can be offered. As I have said, there will be consultation on the draft codes, and people will have ample opportunity to comment and contribute, and to prepare for the time when the authority comes into being. With regard to the definition of death under subsection (2)(d), I hope that hon. Members will forgive me if I do not enter into the technicalities, as others are far more capable than I am. The hon. Member for Oxford, West and Abingdon was right that the amendment gives me an opportunity to clarify some extremely important aspects of transplantation, so that people understand the difference between heart-beating donations and those when there is no heart beat. The provision sets out the means by which the fact of death is determined. The chief medical officer has already asked the Academy of Medical Royal Colleges to review the current code, and the Human Tissue Authority will pursue the matter further when it is established in shadow form. I hope that I have shown the Committee that the clause can be implemented in a way that does not shock those in the health service who currently implement guidance from the GMC and the BMA. Column Number: 195 However, they will have an opportunity to comment on and contribute to the draft code of practice that the shadow authority will draw up.Question put and agreed to. Clause 23 ordered to stand part of the Bill.
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