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Lord Clement-Jones: My Lords, I start by thanking the Minister for his very lucid exposition of, as he rightly said, a fairly complex Bill. From the outset, the Minister was right to remind us why the Bill is now before us. It is over five years since the Alder Hey inquiry was set up and some three and a half years after Mr Redfearn's report and Sir Liam Donaldson's accompanying guidelines and census were presented to this House and the other place.

Clearly, the unethical activities of Professor Van Velzen were the greatest cause for concern and demonstrated the widest gaps in the then current law, but it is clear from the census carried out by the CMO at the time that Alder Hey was just the tip of the iceberg: the scale of organ retention where consent had not been obtained was immense.
 
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The intention behind ministerial statements at the time, to which I responded positively from these Benches, and the Bill now before us, is that parents would never again suffer the anguish that they have suffered in so many cases where their children's organs were retained without their consent, but also that public trust in the post-mortem process and in medical research is rebuilt. Extraordinary collections of children's organs had been built up, not only at Alder Hey but elsewhere.

The question now before us is whether the Bill does the job Ministers promised us it would do and whether it is proportionate in its effects.

This Bill needs to strike a balance, as the Minister said, between the rights and privacy of patients and their families on the one hand, and the importance of ensuring that bio-medical research, monitoring, education and training that saves lives and cures disease on the other can take place with full public understanding of what is involved.

Throughout this process we need to consider the needs of patients, not only to have their wishes respected and consent gathered, but also to have access to the best possible treatments and care that medical research can give them.

However, if these ends are to be achieved, the fundamental provisions of the Bill relating to matters such as consent, accountability, and provisions for training, education and research must be absolutely crystal clear.

A great deal of progress has been made in the Bill since its introduction into the other place. On these Benches we now support its overall architecture and broad content, and I welcome a great deal of what the Minister had to say today.

During the passage of the Bill in the other place Ministers emphasised the golden thread contained in Part 1 requiring consent from an appropriate person for tissue usage, retention and storage except in certain defined circumstances covered by Schedule 1. These circumstances have now been broadened by amendments in the other place, so that several provisions which inhibited medical training and education and scientific research have been changed, leaving the Bill in far better shape than when it started its passage through Parliament. We welcome in particular on these Benches changes which allow tissue for living patients to be used without consent for the purposes of medical education and training.

However, there are still a large number of outstanding issues where the Bill's provisions need to be clarified. First, it is clear from exchanges on Report in the other place that there is some confusion regarding the concept of anonymisation. I accept from the Minister that Clause 1(8) does not refer to the concept. But the Government said that residual tissues could be used for research without consent if the research were approved by a research ethics committee and if the samples were anonymised prior to their use.

However, there are circumstances where it may be desirable to reverse this anonymisation if the results should be, say, communicated to an individual patient
 
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for some reason or the identity of a patient needs to be known and the individual traced. The Minister in the Commons, Ms Rosie Winterton, in response to questioning from my honourable friend Dr Harris, said:

I shall not enter into whether that is genuine anonymisation or whether it should have some other language, such as pseudo-anonymisation.

However, regardless of the correct term, the process being described has little benefit for patient privacy and negative implications for medical researchers. In that case—and I understand this is the briefing that has been given—if a researcher looking at tissue needs to collect information from a patient's clinical record, he or she must ask a third party colleague to consult the record and relay an answer. The argument is that this allows researchers to access necessary information but in reality it only allows them access if they know exactly what to ask for.

In short, the people who can put this information to the best use for medical research purposes—the researchers at the lab bench examining tissue samples—are the very people who are prohibited from having access to the necessary clinical information. So this approach achieves very little in terms of patient protection, as research being conducted on human tissue will already have been approved by research ethics committees. Moreover, researchers are medical professionals already bound by codes of confidentiality.

So, while this provision of the Bill may at face value sound as though it protects patients' rights, it adds very little. Patient protection could be achieved by giving more responsibility to the research ethics committees and allowing them to approve use of clinical records in conjunction with tissue samples when merited by the research project involved. Ms Winterton also suggested that to make use of information gained through the research process, consent would have to be obtained. She said:

The context of that discussion centred on disclosing information discovered through research to the patient, if it had a bearing on the prognosis. However, the Minister's language was unclear. If consent must be sought before information relating to the research can be used for any purpose, that would undermine the changes made to the Bill in another place that allowed for such research without obtaining consent. I hope that the Minister will be able to clarify that when he winds up.
 
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Many other points about anonymisation need clarification. One is whether any distinction will be made between what is considered to be public health monitoring and what is considered to be epidemiological research. We need greater clarification about whether, in a public health circumstance, tissue may be traced back to the individual who donated it, even where consent was not obtained but the research was being done with approval from a research ethics committee. One can think of several examples, such as the SARS virus or another emerging threat, where that might be necessary.

Other issues arise from Schedule 1. There was concern in many scientific circles about the interplay between Parts 1 and 2 when it comes to education and training about research techniques. That is specifically not included in Part 2 of the schedule, so consent will be required although, as the Minister in another place acknowledged, research ethics committees will have approved the research. Again, I should be grateful if the Minister would respond on that.

Then we come to that issue of post-mortems and coroners. There are issues about the duration and extent of the coroner's authority. The Minister, Dr Ladyman, said on Report in the other place that a coroner's authority would last only as long as his functions were required. Nevertheless, as the Bill stands, it leaves open questions about coroners and forensic investigation in to the cause of death. In a sense, that is ironic, given that some of the greatest abuses were uncovered in the Alder Hey report as a result of post-mortems. Under the Bill, it would be an offence to hold on to tissue, including slides and blocks, after a post-mortem examination is concluded, except in the case of ongoing criminal inquiry. If the coroner is satisfied with the findings and can establish the cause of death, no samples are retained.

Unfortunately, coroners are not infallible and, although a cause of death can often be initially established, later discoveries, developments or events can call the original conclusion into question. By prohibiting the retention of tissue, physical evidence of death is destroyed. Cases where such a scenario arises are not unknown; on occasion, a death that is originally ruled a suicide or result of natural causes is later questioned. That is an important area.

All that points to it being vital to align the new coroners' rules with the Bill. It is extremely unsatisfactory that that is not being done simultaneously with the Bill's passage through Parliament.

Some of the Bill's finer points were not discussed in the other place due to lack of time. One of those was concern that, where the Bill mentions DNA, it does not mention the other types of genetic material or tests that can yield the same results. The wording of the Bill should include RNA, which effectively contains the same information as DNA, as well as protein sequencing tests, from which DNA sequences can be deduced. I believe that the Government are considering that, although the Minister did not refer to it.

Those points are not exhaustive of the work remaining to be done. Concerns remain in other areas, including provisions for consent to be applied to those
 
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with diminished mental capacity. That issue is very delicate, especially as we will have to ensure that the Bill's provisions can be easily matched with what is to come in the Mental Capacity Bill. I recognise that there is provision for regulations to be made, but we need more detail about what those regulations may contain. I am not sure whether a best interests test is the correct one to apply, and those regulations should be subject to affirmative resolution of both Houses.

We also need to look ahead to the establishment of the Human Tissue Authority and its interaction with other arm's-length bodies. I note the Minister's statement about merger with the HFEA, but should there not be a limit on the size of the board of the merged authority? Why are there to be two inspectorates, the inspectorate of anatomy and pathology and that for organ tissue for human use, especially when we are trying to reduce the amount of regulation across the NHS?

In conclusion, the fact is that legislation by itself is not enough. As Sir Liam Donaldson said at the time,

I agree with those sentiments, but I am not yet sure that the Bill quite fits them.

My view is that the strongest of the guiding principles originally set out by the CMO is the aspect of a gift relationship. We must be mindful of the needs of medical training and research, but we must never take donation for granted. It follows that we need proper counselling services in place and comprehensive training in the new consent regime—a massive exercise—and a programme of communication to the public, especially about consent, research use and medical training and education. But we have a great shortage of trained pathologists. Has the cost of obtaining necessary consents been factored in? What is envisaged? Are the estimated costs of implementation of the Bill's provisions adequate in those circumstances? It would be useful to hear more about that from the Minister.

I look forward to the Minister's response and to Committee, when I shall continue to be actively involved. I also greatly look forward to the maiden speeches of my noble friends Lord Roberts of Llandudno and Lady Neuberger, and to that of the noble Baroness, Lady Murphy, from the Cross-Benches.


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