Previous Section Back to Table of Contents Lords Hansard Home Page

Lord Warner: My Lords, we did our best to recover from the situation in which I personally found myself yesterday following the telephone call from the noble Lord. My private office tried as much as we could to help him and remedy the situation. It is unfortunate that the department did not ensure that all the documents were available, and all I can do is apologise to the House. As the noble Lord said, these documents will be particularly useful in Committee. We have tried to remedy the shortcoming and make them available. If any noble Lords are having difficulties over access to the documents, perhaps they could let me know and
22 Jul 2004 : Column 366
I will try to ensure that we get them to you as quickly as possible and before the summer holidays. On that basis, I shall continue my speech.

As I said, the Bill is brought forward as a response to the scandals revealed by the Alder Hey and Bristol inquiries. There can be no doubt that many people suffered when they discovered that the organs of their loved ones had been kept without their knowledge. We must not underestimate the pain endured by those who came to realise—often many years later—that the body of the child, husband or mother whom they had buried was incomplete. We must ensure that that does not happen again, and this legislation is key to ensuring just that. However, it does much more than that. This Bill will provide the comprehensive statutory framework needed to ensure the appropriate use of human organs and tissue. It will make consent the clear controlling mechanism for the retention and use of organs and tissue and it will establish a regulatory body to oversee a range of related activity in this area such as post-mortems, tissue banking and the public display of human bodies.

At the same time, we must recognise that many important benefits accrue from the use of tissue both from living patients and following post-mortems. There has been uncertainty in recent years among researchers about whether and when they can use tissue in research, whatever its source, and this uncertainty has undoubtedly inhibited research. So we are legislating in part to provide the protection and confidence needed to support research and development in science and medicine. But this must be a partnership between medicine and society and the partnership must be built on communication, understanding and consent. The Bill will ensure that the rights and expectations of patients, families and society are met, while meeting broader social needs such as the importance of medical research, education, training and public health.

The need for this new legislation on human organs and tissue was recognised some three years ago. Before setting out the detail of the Bill, I think it would be helpful to recall some of the background. In 1999 and 2000 the inquiries at Bristol and Alder Hey left us in no doubt about the scale on which tissue and organs were being retained without the knowledge of families following post-mortems.

The practice was not limited to those particular hospitals or to children's post-mortems. The report of the Isaacs inquiry more recently confirmed that large numbers of adult brains had been retained, again without the knowledge or consent of families, following coroners' post-mortems. A census of organ retention by NHS pathology services carried out by the Chief Medical Officer in 2000 revealed that more than 100,000 hearts, brains, lungs and other organs were being kept. In Northern Ireland the Human Organs Inquiry confirmed that similar practices had occurred there. Part of the tragedy was that, ironically, in many cases the families concerned said that they would readily have accepted the use of their loved ones' tissue or organs for medical research, if only they had been asked.

In the light of all that, we asked the Chief Medical Officer, Sir Liam Donaldson, to report and make recommendations on the retention and use of human
22 Jul 2004 : Column 367
tissue and organs. One thing that had by then become clear, as the reports emerged, was that post-mortem practice had developed over many years in ways that were no longer in keeping with what we have come to expect. While practice was directed at supporting medical knowledge and research, it was, in this area, failing to respect the interests of families. It had become routine for tissue taken at post-mortem to be kept for archives, research and education but without proper discussion with those close to the deceased.

The situation was set out very clearly for us when the Chief Medical Officer reported in January 2001. Sir Liam made 17 recommendations, all of which we accepted in England and Wales. The Human Organs Inquiry made broadly similar recommendations in Northern Ireland.

In implementing Sir Liam's recommendations, we aimed to provide, first, support and advice for those affected; we put in place stabilising measures by means of advice and guidance; we set in train a review that would secure a proper framework for the future; and we are helping to develop professional and public understanding as a way of ensuring that changes in the law go hand in hand with changes in practice and culture.

Therefore, immediately following publication of the report, in April 2001 we established the Retained Organs Commission, whose task was to provide advocacy, oversee the return of organs and tissue to families and give guidance to trusts. The commission closed in April this year, having carried out its responsibilities with admirable sensitivity and commitment.

In April 2003, we published guidance and consent forms for post-mortems, together with advice that helps to clarify the law as it currently stands. We have other work in hand that includes providing information and support to bereaved families, and we are supporting further training and development for health professionals.

The Bill will support and underpin those developments. But the Bill is not just about how we deal with the deceased. The review of the law covered the whole area of the use of human tissue, from the living as well as from the deceased, and its use for transplantation, research and other purposes, such as donation for teaching and education. Those are all important matters, and it was vital that we approached this in a comprehensive, joined-up way to ensure that all research, education, transplantation and other uses can progress confidently and on a sound legal basis.

Regrettably, we have undoubtedly lost opportunities for valuable health research, partly because of the lack of confidence in post-mortem practice but also because of uncertainty among pathologists and tissue banks as to what can be used and for what purposes. The law across the field, as it stands, is unclear, out of date and close to unworkable. It is important that those working in medical research—an area well represented in this House—
22 Jul 2004 : Column 368
understand the public confidence and trust that must be established if they are to do their valuable work confidently in the future.

The proposals set out in the Bill have been prepared following extensive consultation. In July 2002, we published a major, comprehensive consultation report called Human Bodies, Human Choices. We received around 250 responses but we also held workshops and conferences with a wide range of interested groups and individuals covering consent, regulation, transplantation, next-of-kin issues and penalties.

We published the results of the consultation in April 2003, and we published the broad proposals in September, following which we held a further round of stakeholder meetings with families, clinicians, researchers, heads of Royal Colleges, anatomists and other organisations, including the BMA, ROC, Wellcome Trust, UK Transplant, Human Genetics Commission, and the Welsh Assembly's Organ Retention Advisory Group. The degree of support and consensus that we found has been hugely encouraging, and we have been able to build on that. I am grateful to all the groups and individuals—some through the pain of their own experience—who contributed to this work.

The Bill, therefore, is about balancing the rights and expectations of families with broader public health considerations. It will make consent the clear basis for the keeping and use of tissue and organs. It will restore confidence so that important health research can proceed with the support of patients, families and the public.

Part 1 of the Bill deals with the question of consent. Here, we are proposing a comprehensive framework in relation to all medical uses of human bodies, organs and tissue and in relation to public display. That should allow us to draw a line under the events of the past and be confident that proper legal and ethical standards will apply in all situations where tissue can be kept and used for the public benefit. The Bill will establish clearly that, other than in cases of a coroner's investigation, the decision about the use of tissue or organs will lie squarely with the individuals themselves. Where the individual's wishes were not given before his death, the role of the family or person closest to the deceased will also be made clear and explicit. And there will be offences relating to keeping or using tissue or organs without consent.

Clause 1 of the Bill sets out where consent will be needed for scheduled purposes. Those purposes include carrying out a hospital post-mortem and the subsequent keeping and use of tissue or organs for transplantation, research, education and training, and so on. For certain, particularly sensitive, purposes—that is, for donation of the whole body for anatomical examination and for use for public display, such as Professor von Hagen's "Bodyworlds" exhibition—the specific consent of the individuals themselves will always be required.

The Bill will not affect the coroner's authority to order a post-mortem for his purposes related to establishing the cause of death, nor his ability to ask
22 Jul 2004 : Column 369
for tissue or organs to be retained should they be needed, again, for his purposes. That is made absolutely clear in Clause 11. But once the coroner's work is complete, further retention or use of tissue or organs for scheduled purposes would be subject to the Bill and to the requirement for consent.

In the case of tissue from living patients, we recognise that some purposes are so intrinsic to general diagnostic and clinical care that the consent that the patient gives to the procedure itself can be regarded as sufficient for those other purposes. Those are set out in Part 2 of Schedule 1 and include clinical audit, quality control, education and training. Therefore, consent will not be needed in those cases, nor for public health monitoring.

Noble Lords will be aware that, following extensive discussion with the medical and research community, amendments were made in another place that made clear that health-related training and education fall squarely into Part 2 of Schedule 1. Following extensive discussion with a range of medical research interests, including many eminent people in that sphere, amendments were also made in another place to provide for the use, without consent, of residual tissue from living patients in research, provided that the tissue is effectively anonymised and the research approved by a research ethics committee.

I know that some research interests have some anxieties about what is meant here by "anonymised". In fact, the word "anonymised" is not used in the Bill. The Bill states at Clause 1(9)(b) that the person conducting the research should not be,

Clearly that does not mean that the tissue must be irretrievably unlinked from the medical record. In many cases, it will be vital to maintain that link, and the Bill allows for that.

Therefore, the amendments made were important ones that recognised the practical aspects of the use of samples recovered during diagnostic and surgical procedures. I hope that medical research interests will recognise that we have responded to their concerns in a practical way while preserving the integrity of the new consent arrangements that the public wish to see in this legislation. I would say to those who want to go further in this area that they need to reflect very carefully on how their actions will be seen by a wider public and they need to recognise that the Government must maintain a balance on this issue.

The Bill goes on to make clear that failing to obtain consent where it is required, whether from patients themselves or, in the case of the deceased, from other appropriate people, may be a criminal offence and subject to penalty. There will be safeguards to ensure that people cannot commit an offence inadvertently. For example, a researcher will receive tissue from others, perhaps a tissue bank. He will, therefore, quite reasonably be relying on the regulated system to deliver tissue that has the appropriate consent for the purpose. The "end-user" researcher would not be held
22 Jul 2004 : Column 370
responsible if, having asked for tissue with appropriate consent in place, this subsequently proved not to be the case.

The Bill does not set out the form consent should take in any particular situation. Let me state clearly that the Bill does not require consent to be specific to each research project for which tissue might be used. Consent can be broad. Consent to research can be generic and enduring.

As at present, consent can take different forms in different circumstances, and primary legislation is not the place in which to attempt to define them all. The consent arrangements provided for in the Bill will be described more fully in guidance to be issued by the new authority. This guidance will be set out in a statutory code of practice and this will be subject to parliamentary approval. Like other codes and regulations under the Bill, it will be subject to wide consultation and will clearly need to reflect the pragmatic nature of current good practice. Research ethics committees will continue to have a role in considering whether legal and ethical standards have been met in the context of the specific projects that they consider.

The Bill introduces certain new provisions with regard to consent. It provides for an individual to nominate another person to take decisions about tissue or organ retention, storage and use after his or her death. So, for example, I can either make my consent known prior to my death, such as through my donor card or by entry on the donor register, or I can nominate another person who may make those decisions when I die. It is where I have not made my own wishes known, and have not nominated another person, that my next of kin would be empowered to make those decisions and their actual consent would be needed, as opposed to the rather unclear position currently pertaining under the Human Tissue Act 1961.

There is one further important point that I should make about Part 1 of the Bill. Clause 9 deals with "existing holdings"; that is tissue and organs currently stored from a variety of sources for the purposes set out in Schedule 1. That includes all tissue banks and archives. The Bill simply provides for that to be lawfully kept and used. There will be no consent requirement for existing holdings. It has to be recognised that there is immense value in current archives. Thus it is important that we allow for research options to remain open, but for respectful and appropriate disposal to take place where necessary. We have provided for the new Human Tissue Authority to give guidance on the use and disposal of this tissue.

I turn to Part 2 of the Bill. Anything more than a cursory view of this area will show how complex, sensitive and important it is. We are, therefore, proposing a regulatory system to oversee the implementation of this overarching legislation. A new Human Tissue Authority will be created with the task of ensuring that the use of whole bodies, and of tissue and organs, is in keeping with the legal and ethical standards that we expect. The general remit is set out at Clause 14,
22 Jul 2004 : Column 371
covering the removal, retention and use for purposes set out in Schedule 1, and disposal of all tissue and organs, as well as their import and export.

Clause 16 sets out the licensing role of the authority, which will be responsible for licensing and inspecting anatomical examination, post-mortem practice, and the storage of tissue and organs, whether for research or for human application; that is, transplantation. Licensing for storage will regulate at the level of tissue banks. Licensing will not apply in the case of each researcher who holds a few samples for a particular project.

What will also need to be licensed is the use of bodies for public display. We are all aware of Professor Von Hagen's "Bodyworlds" exhibition of plastinated human bodies, and licences will in future be needed for all such displays, other than where the bodies or parts are of historic interest, being over 100 years old.

The new authority will consist of members appointed by the Secretary of State—including members appointed by the National Assembly for Wales and the relevant department in Northern Ireland—following transparent procedures in keeping with what have become known as the Nolan principles. At least half of the authority will be lay members but, clearly, professional expertise will also be needed.

The new authority will issue codes of practice and it will have the power to vary, revoke or suspend licences where the necessary conditions are not met. There will be powers to inspect premises that are licensed or where there is reason to believe that an offence may have been committed. There is considerable detail in the Bill, naturally, about the procedures for licensing, appeals, inspections and enforcement that follow current best practice in ensuring a fair, transparent and rigorous regulatory system. The licensing sanctions in the Bill are clear and strong, and they are backed with criminal sanctions for carrying on activities without a licence. But while the licensing system will be firm and clear, it will also include the flexibility, through the use of statutory codes of practice, to ensure that it is able to respond over time to technical, scientific and social developments in this area.

In proposing a new Human Tissue Authority we are already streamlining the regulatory arrangements in this area. By reviewing the law and regulation across the whole field, we have been able to bring under one agency matters that are currently dealt with under three. Currently we have the Inspector of Anatomy; the Unrelated Live Transplant Regulatory Authority (ULTRA), which regulates the donation of organs between an unrelated donor and recipient; and some of the duties of the former Retained Organs Commission (ROC). Moreover, the Bill also extends to tissue banks that are currently subject to a non-statutory, voluntary regulatory scheme. This scheme will become mandatory under the EU Tissue and Cells Directive and the new authority will be the competent authority under that directive.

With the announcement today of the next steps on the review of arms' length bodies, we will be able to go even further with streamlining the number of
22 Jul 2004 : Column 372
regulatory bodies. This will involve the new Human Tissue Authority being merged with the Human Fertilisation and Embryology Authority. The merged body will be called the Regulatory Authority for Fertility and Tissue. The merger will take place when the current review of the Human Fertilisation & Embryology Act 1990 is complete. That Act is being reviewed for other policy reasons and it will be sensible and convenient to establish the merged body at that point.

In the mean time, we will continue with the establishment of the HTA and begin work on that quickly. Work on the development of procedures, protocols, and codes of practice for consultation will go ahead as planned. A key factor here is that the EU Tissue and Cells Directive, under which the authority will be a competent authority, must be implemented by April 2006. But we will establish the Human Tissue Authority on this interim basis in a way that will facilitate the later merger. This means looking at shared back office functions, staff and premises and possibly some common membership.

In its comprehensive approach, the Bill also makes provision for dealing with human tissue in particular circumstances, and here I turn to Part 3. For example, we expect that it will play a part in expanding the scope for transplants using organs from donors who have died, where organs are retrieved quickly after death to enable transplantation to go ahead. A provision is included (Clause 44) to make it clear that steps may be taken to preserve organs while it is established, possibly from the next of kin, whether there is consent to donation for transplantation. At the same time we will make it clear—in Clause 32—that commercial dealing in all tissue for transplantation will be illegal. That extends the current prohibition under the Human Organ Transplants Act, which relates only to organs.

The Bill has in addition one provision—Clause 50—which exceptionally applies also to Scotland since it deals with genetics policy, which is wholly reserved to Westminster. This makes it an offence to have human material intending to analyse its DNA without consent or for certain specified purposes. This provision responds to a recommendation of the Human Genetics Commission, which has been concerned in particular about the emerging market for commercial DNA testing for the purposes of discovering family relationships without consent.

Finally, the Bill will allow certain national museums to remove human remains from their collections; for example, in response to claims from the descendants of indigenous people—Clause 52. The statutory constitution of these museums currently prevents them from returning these remains even where they may wish to do so. We will remove this barrier, recognising the consensus both within government and the museum community that museums should be free to respond positively to claims from those indigenous people whose ancestors' remains are currently held in our national museums. On this point, I know that concerns have very recently been raised about ancient human remains in museums—for example, Egyptian mummies—and the possibility of gratuitous claims for
22 Jul 2004 : Column 373
their return. The Department for Culture, Media and Sport will be working over the summer with interested parties to see how best to deal with these.

It has been said that this Bill is complex—some have even suggested that it is convoluted. But, as I have tried to explain, it is a Bill which covers much ground that is currently fraught with difficulties. It repeals and replaces the current incoherent set of statutes—the Human Tissue Act 1961, the Anatomy Act 1984, and the Human Organ Transplants Act 1989, as well as corresponding Northern Ireland legislation. I believe that some of the criticism that has been made is unjustified.

This Bill provides a statutory basis for the other aspects of law that currently can be managed only through common law, such as the uses that can be made of stored surplus tissue. It supports the implementation of the EU directive on tissue and cells and resolves a number of current problematic issues, taking account of distinctions between tissue from the living and deceased, coroners, and hospital post-mortems, tissue from children, adults and mentally incapacitated persons, and use for clinical and research purposes.

It establishes a single coherent regulatory mechanism and provides for a number of discrete areas such as the offence of non-consensual use of DNA, trafficking in tissue or organs, and the returning of human remains.

In conclusion, the Human Tissue Bill provides, for the first time in this area, a comprehensive and coherent approach to the use of human bodies, organs and tissue. It brings together various existing provisions of statute and common law and provides a sounds framework for the future. I believe that it will bring confidence both to those who have been affected by the failings of the past and will reassure our medical and research communities that their important work is not jeopardised. For these reasons, I commend the Bill to the House.

Moved, That the Bill be now read a second time.—(Lord Warner.)

Next Section Back to Table of Contents Lords Hansard Home Page