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Lord Patel: My Lords, it is always difficult to follow my noble friend Lord Winston, but I shall try.

Overall, I welcome and support the Bill. It has gone through significant changes from the original Bill, and the professional organisations and the medical and scientific research community are much happier with it. Much of the credit for those changes goes to the Minister, and I thank him for that. There remain, however, some concerns, many of which, I hope, can be alleviated by reassurance, but some may require further amendment to the Bill. I am encouraged by the comments made by the Minister in his opening presentation of the Bill, particularly in relation to anonymisation and linkage.

Much of what I have to say follows discussions with and briefs from the research councils, the Royal College of Pathologists, the Public Health Genetics Unit and medical professional organisations, all of which still have residual concerns.

The concerns that I have fall within the categories of research and anonymisation; education and training; research involving mentally incapacitated individuals; the timing of when the Bill comes into force in relation to codes of practice and clarification of some of the definitions in the Bill. I also have comments on the constitution and method of working of the Human Tissue Authority, which now, after this morning's report and the Minister's announcement, has changed somewhat.

In relation to research and anonymisation, the Bill must make it clear that reversible and linked anonymisation will be permitted, particularly to allow for epidemiological research of the kind that may well fall
 
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outside the category of public health monitoring, as already mentioned by the noble Lord, Lord Clement-Jones.

The requirement of identifying information to be withheld from the researcher has considerable practical implications if the clinician or the pathologist involved in the clinical care or the examination of the tissue is also the one involved in the research, which is not uncommon. The Minister made encouraging comments on this and we will discuss it further in Grand Committee.

The requirement for the research ethical committees to give ethical approval for the use of anonymised tissue for research has implications for the capacity and expertise required within the research ethical committees to do this, and that matter will have to be addressed.

In relation to education and training, the changes to Parts 1 and 2 of Schedule 1 are welcome. However, the distinction made between education and training relating to human health and that which relates to the functioning of the human body and disorders requires further legislative and professional guidance. Again, other noble Lords have referred to this.

The introduction in Clause 6 of a provision to enable adults who lack capacity to consent to be involved in research is welcome. However, the Bill as drafted may impede research into conditions associated with emergency medical care and critical care.

I am also concerned that inconsistencies may develop between the Mental Capacity Bill, clinical trials regulations and the Human Tissue Bill. I welcome the fact that the Bill makes consent the fundamental principle underpinning the lawful storage of human tissues. The scope and specificity of appropriate and qualifying consent established by the Bill remains unclear, notwithstanding the clarification given today by the Minister. I shall read carefully in Hansard what he had to say. A broad definition of "consent" on the face of the Bill might be more appropriate, rather than the standards of consent being part of the discretionary powers of the Human Tissue Authority.

Let me now briefly mention concerns in relation to the definitions in the Bill and inconsistencies. The noble Lord, Lord Turnberg, has already mentioned, for example, the definition of DNA and analysis. RNA analysis can yield similar information to that derived from DNA. There appears to be inconsistency in the definition of a "child" as defined in Clause 59 of the Bill and the one defined in Section 8 of the Family Law Reform Act 1969.

Clause 32, which relates to the definition of a "controlled material", excludes material which is the subject of property because of an application of human skill. The interpretation of the case law in this area is not straightforward. Importantly, Clause 11 excludes from the Bill anything done for purposes of the functions of coroners, the major issue which prompted this legislation. The House needs to be
 
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reassured that the Coroners Rules 1984 will be amended to have the same effect as this Bill, for it is important that there is consistency.

Clauses 14 and 46 relating to the import and export of tissues will be difficult to implement in practice. Histopathologists routinely exchange histological slides for expert second opinions across the UK, including Scotland, and overseas. Such practice would fall within the scope of this legislation and regulatory system. It cannot be the intention to prohibit it, otherwise it will affect patient care.

I recognise that today is not the right time to go into details of these and other concerns. I hope that we will have the opportunity to do this when the Bill is considered in Grand Committee. I am sure that many of the concerns of the research and professional communities can be alleviated by reassurance. I look forward to further discussions in the future. In the mean time, I wholeheartedly support the general tenet of the Bill and congratulate the Minister on bringing a much improved Human Tissue Bill to this House.

Lord Jenkin of Roding: My Lords, I begin by acknowledging, with thanks, the apology that the Minister made in response to my intervention at the beginning of the debate. I hope that by drawing this to the attention of the officials in his department he will make sure that we do not receive all the documents on the morning of a debate.

There have been a number of extremely expert speakers so far, not least the noble Lords, Lord Turnberg, Lord Winston, and Lord Patel. I join my noble friend Lord Newton of Braintree in addressing the House as a layman. I spent some years on the council of the Imperial Cancer Research Fund, but that was very much as a layman.

It is clear from the purport of the papers and reports that led to the introduction of the Bill that there were very serious breaches of the existing law in the two hospitals investigated—the Bristol Royal Infirmary and Alder Hey in Liverpool. I accept entirely that the practice that was there disclosed turned out to be much more widely spread than had been anticipated. These were serious breaches of the law; there were also serious breaches of best practice by the consultants concerned. That is what they were; no lives were lost as a result of that, so far as I am aware.

When the reports were published and the matter became a matter of public comment, the then Ministers at the Department of Health, by using some very unrestrained language, managed to turn the whole affair into a national horror story. I believe that this was quite unnecessary. I also believe that events subsequent to that have been coloured by those comments. The first comment on the report by the right honourable Alan Milburn, the then Secretary of State for Health, was that it was "gruesome". One wonders whether he had the slightest idea of what happens in a post-mortem examination. Perhaps modern television programmes could have shown him. The fact is that this got off on the wrong foot from the beginning.
 
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I do not doubt that many of the relatives, particularly of children who had died and whose tissues had been removed and retained without consent, were very distressed indeed to learn what had happened. I believe that in their distraught reactions, as graphically recorded in the Kennedy and Redfern reports and also in the minutes of the Chief Medical Officer's summit meeting held on 11 January 2001, these people deserve our profound sympathy. There is no doubt that they suffered grievously.

Equally, I have little doubt that it was Ministers' desire to fall over backwards to respond to that distress that led to the Bill, as originally introduced, being seriously out of balance.

The need for balance was expressly recognised on page 1 of the consultation document. I shall read the relevant paragraph because it is quite important. The consultation document emphasises,

That is a perfectly fair statement of what Ministers were aiming at. However, that is not what happened. Here I disagree with the right reverend Prelate the Bishop of Portsmouth. One only has to look at what has happened. As soon as the Bill was published, the entire research community was up in arms. As originally drafted, the Bill in a number of major respects appeared to place huge, new obstacles in the way of using tissues and organs for medical research, going far beyond what was necessary to remedy the perceived shortcomings of the existing law and practice.

Happily, as has already been mentioned in a number of speeches, amendments in another place have gone some way towards meeting those representations. However, as has been made clear in today's debate, much more needs to be done if an acceptable balance is to be struck.

With a number of your Lordships, I had the advantage of attending a meeting in the Moses Room earlier this week. It was addressed by Professor Carol Dezateux of the Institute of Child Health and the MRC, by Professor Alex Markham of Cancer Research UK, and by Dr Mark Walport of the Wellcome Trust and others. It was immediately apparent to me that a number of serious concerns remained about the Bill, which it will be for this House to address.

Also present were a number of charities representing patients' groups: the Parkinson's Disease Society; the National Kidney Research Fund; Cancer Research UK; the Primary Immunodeficiency Association; the Tuberous Sclerosis Association; the Foundation for the Study of Infant Deaths; the British Heart Foundation; the Motor Neurone Disease Association; the Genetics Interest Group; and, I have no doubt, others. I was reminded of the enormously important role that those bodies played in leading this House to a sensible conclusion on the legislation regulating stem cell research.
 
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All those groups want medical research to continue in the hope of finding the causes of diseases with which they are concerned and of discovering new treatments and new drugs. Their spokespeople echoed the concerns of the researchers and the Government must listen to them.

Most of the issues raised will be for later stages of the Bill, but I note that a number of noble Lords have already gone into detail about the various forms of consent and the issues of anonymisation, which the Select Committee on Science and Technology, chaired by the noble Lord, Lord Oxburgh, has to address in the human genetic databases report. Some noble Lords have also discussed what should be covered by the proposed licensing system and so on.

One of the major issues that we must address and on which there needs to be wide consultation with the research community—I am glad to hear that a lot of consultation has already taken place—is the proposed regulations and the codes of practice that are due to be introduced. Those regulations and codes of practice should, if possible, be agreed and in place before the commencement of the Act. We shall no doubt deal with those and other matters when we come back in September—and, I suspect, in October.

I come back to my first point. Because the Bill fell over backwards to reflect and remedy the severe distress of the relatives, the legitimate concerns of the researchers were seriously underestimated. The result has been that the passage of this Bill has taken the form of a long, hard-fought struggle on the part of the research community, supported by the medical charities and patients' groups, to redress the balance. I do not believe that that is the right way to legislate on such an immensely important matter. The process has not ended and, like other noble Lords, I hope that we shall do our best to return a better balanced Bill to another place, with many of the changes which have already been identified incorporated in it.


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