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Organ Retention

Volume 404: debated on Tuesday 29 April 2003

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Motion made, and Question proposed, That this House do now adjourn.— [Gillian Merron.]

7.31 pm

I am grateful for the opportunity to raise the important and sensitive issue of retained organs. For all of us, there are occasions when the experiences brought to us by constituents make us deeply sad and concerned and, sometimes, angry. The experiences of my constituents, who have discovered that the organs or tissues taken from their children or other relatives have been retained without their consent or contrary to their express wishes, have been something that I have found it distressing to hear, just as the House learned with shock of the conclusions of the Alder Hey inquiry in January 2001

It was later in 2001 that a constituent told me of her personal tragedy. She and her husband lost their son in a road accident in 1984. They said that they did not wish any organs to be removed after the coroner's post mortem, so it was 17 years after burying their son—and in the wake of the Alder Hey report—that they contacted Addenbrooke's hospital, which is in my constituency. Despite the undertaker's assurances at the time, my constituents were suspicious and they learned that organs had been kept after their son's post mortem

Initially, the hospital told my constituents that their son's appendix had been retained. Later, and after systematic collection of hospital records, they were informed that his thymus had also been retained. Inconsistencies in records and copies of the post mortem reports added to their distress. Their suspicions about examination of their son's brain may never be allayed

That family, and others in my constituency and neighbouring constituencies around Cambridge, came together in a support group in November 2001. On the occasions when we have met, I have become aware not only of how the discovery of retained organs has caused the relatives to relive all the distress of the original loss and bereavement, but of how it has made things worse. The sense of betrayal by those whom the relatives had trusted and, in many cases, valued for the care of their children or other relations has been deeply painful. The inability to account fully and quickly for retained organs has added to their distress. The relatives were upset that in the wake of the Redfern report on Alder Hey, other hospitals were not immediately ready and able to respond fully and with adequate support to requests from families for information about retained organs

More recently, I have discussed with another constituent her case, which has been investigated by the inspector of anatomy in the course of his inquiry, prompted by the case of Mr. Cyril Isaacs. As a scientist and doctor herself, my constituent has felt a sense of professional betrayal that her late husband's brain was retained despite her attempts to respect his wishes to be buried intact and her specific wish that organs should not be retained.

I know that the House and the Minister will join me in expressing our deep sympathy with, and regret for, the pain felt by my constituents. What has impressed me as well—I know that the Minister will agree—is that the families are determined to ensure that the pain that they have experienced should not be repeated in the future for other families. They recognise, as I do, that, with very few exceptions—such as those revealed by the Alder Hey inquiry—the unauthorised retention of organs did not stem from malice or improper motives

In years past, hospital staff often engaged in practices that they believed to be commonplace. Their approach to information and consent was inadequate because the law and practice were inadequate, and because a paternalistic attitude suggested that families would be saved from potentially harrowing details of postmortem practices and treatment of organs, or from the pain of a delayed burial or cremation while a brain was fixed over several weeks. Moreover, scientific rationality appeared to say to those working in the NHS, "Why should organs relevant to teaching or research not be kept?"

It is now understood and, I hope, agreed that that approach was misguided and wrong. It has given rise to specific instances of abuse, and to a general loss of trust. That loss of trust is serious and potentially damaging if it affects the availability of organs for transplantation, for teaching and research, or for public health surveillance. It would be serious, too, if it were to lead to a loss of morale and motivation in the pathology profession

It has been recognised on all sides that, in order to offer any redress, it is essential that families learn about retained organs and tissues, that those organs and tissues are dealt with according to the families' wishes, and that the families are given support. In addition, however, it is crucial to put in place a statutory and best-practice framework that establishes and maintains a high standard in dealing with families and retained organs. Such a framework would recover and retain trust between the public, the medical professions and the NHS.

It is four years since the Association of Community Health Councils first raised the issue with the Department of Health. I want to recognise the steps that the Department has taken: the chief medical officer's census, subsequent report and 17 recommendations in January 2001; the publication of draft codes of practice for families and post mortems; the piloting of standardised consent forms; the consultations last year entitled "Human Bodies, Human Choices", and the investigation by the inspector of anatomy to which I referred earlier

Not the least important element in maintaining the momentum of reform and in establishing a mechanism for families and the public to express their concerns has been the establishment of the Retained Organs Commission. The commission, which has worked to secure disclosure by trusts and the continuing audit of organs and tissues, has held meetings nationwide, including one in Cambridge last July, and has advocated the interests of the public and families.

In this context, it is especially encouraging to note that, last week, the Government published their code of practice for families and post mortems, including standardised consent forms. The Government have recognised that the issues should be differentiated according to whether the consent is related to an adult or to a child, and whether it is a coroner's post mortem or a hospital post mortem. Also, the publication of a summary of responses to last year's consultation on legislative reform and an interim statement by the Department about the use of human organs and tissues give reassurance that the Department and the NHS will actively seek to meet high standards in dealing with families in connection with the use of organs and tissues

While I welcome the publication of those documents, they are interim in nature and require further definitive action in new legislation. Like recommendation 1 in January 2001, the chief medical officer himself said that
"as an immediate measure, the Human Tissues Act 1961 should be amended to clarify that consent must be sought from those with parental responsibility for the retention of tissue or organs from the post-mortems on children beyond the time necessary to establish the cause of death. A penalty for non-compliance with the provisions of the Human Tissue Act 1961 should be introduced."
I accept that it makes more sense to legislate for a new framework than to amend the 1961 Act and enact a further framework later. However, the absence of a new regulatory framework and the lack of availability of sanctions for non-compliance are key aspects of past failures and require new legislation to be proceeded with rapidly

This is the third time that I have questioned Ministers—the first time in an Adjournment debate—about the timing of legislation. The most recent answer that I received from the Leader of the House was that draft legislation would be published in this parliamentary Session. I urge the Minister to go further. Will she commit the Government to publishing a draft Bill before the summer recess? Given the nature of the legislation and the issues that it covers, does she agree that there should be pre-legislative scrutiny? If scrutiny is to be as accessible to public and professional input as we would all wish it to be, and if a Bill is to be enacted in the next Session, I am sure that such a timetable is necessary. I know that the Minister cannot pre-empt the Queen's Speech, but she could tell the House that a draft Bill will be available within three months and that pre-legislative scrutiny will apply to it. As a veteran of the scrutiny that took place on the Communications Bill, I can vouch for the value and effectiveness of such a procedure, not least to the Government themselves

When will the Minister publish the findings of the inspector of anatomy? The sooner we see the extent and nature of the problems, the sooner we shall be able to resolve the issues leading to new legislation.

Notwithstanding the fact that the key messages for the development of new legislation are helpfully set out in the Government's summary of responses to the "Human Bodies, Human Choices" document, I want to highlight a number of conclusions that ought to be included in the legislation. First, it is vital that the terms "tissues" and "organs" are both used and are clearly distinguished from each other. The past use of "human tissues" as an encompassing term has, I am afraid, failed to make it clear to relatives that whole organs were to be removed or retained. The consent forms published by the Government last week make that distinction, but we need a clear legal basis for whether consent has been given for the removal or retention of whole organs. That is not to imply that the treatment should be different when it comes to requests or requirements for consent or for decent disposal. However, families may require different things for whole organs or may be less willing to provide consent. We must respect that

Consent should be the basis of the new legislation, and it should be informed consent. It is properly recognised that relatives or family will not wish in some instances to know all the details of a post mortem examination. For the protection of staff involved, as well as to be clear for the family, if families wish to offer consent without receiving full information, such a procedure should be explicitly provided for through the consent form. The next of kin could signify that they had declined to receive full information, but had none the less expressed their wishes

The definition of "next of kin" is also important. Clearly, the wishes of the deceased person should prevail, if known, and that should apply to all those over 16. If those wishes are not known, we need a clear procedure to determine the next of kin that does not involve hospital staff in making arbitrary decisions or prolonged investigation of family and social relationships. Clearly, the best route would be to encourage patients to nominate a next of kin and to understand the implications of that choice. People should be free to choose, regardless of specific natural relationships. However, I commend the view, given in the response to consultation from Addenbrooke's hospital, that where consensus cannot be reached between those judged to have equal rights to act as next of kin, no steps should be taken with regard to the patient's body or body parts unless a senior clinician—not the consultant for the deceased—judges that it is in the best interests of a living patient to use or transfer tissue to prevent serious deterioration or to save a life. The Addenbrooke's submission rightly states that the knowledge that relatives must agree or the matter could be taken out of their hands should ensure that that step is only rarely used. However, if an independent person from outside the hospital is also available to arbitrate or to determine next of kin, the risks and interference with the hospital should be minimised

The requirement to report back to the family should be applied in the spirit of a donation, so that it should occur if, and only to the extent that, it is requested by the family concerned

Finally, there is the issue of penalties. The availability of sanctions is an essential aspect of securing compliance and promoting confidence in the light of past events. I wish it were otherwise, but it is not. The penalties, however, should primarily apply to the organisations concerned, in so far as the non-compliance is not the result of malice, improper considerations, personal gain, or gross negligence. In the latter cases, penalties may be applied personally rather than institutionally. Our objective should be to ensure that, where NHS staff act in good faith, they will not be at risk of criminal liability, but that the systematic failure of an institution to meet its obligations to a family will not go without redress

Those are the key issues that we, as legislators, must address. I am encouraged by the fact that the Government are moving in the right direction and are minded to establish a single regulatory framework, incorporating Her Majesty's inspector of anatomy and the requirements of the Anatomy Act 1984, as well as an amended Human Tissue Act

In parallel with the preparation of legislation, the continued work of the Retained Organs Commission is needed, but I convey the view of a constituent that the commission's work should give full consideration to the concerns and needs of the families of adults whose organs and tissues have been retained without consent. Deeply distressing as the loss and bereavement of the families of children must be, I am sure that those families would not want the commission to act on their behalf to the exclusion of the interests of the families of adults

Also in parallel, we need additional support for family networks, such as the Cambridge area support network. Their courage in being prepared to turn their pain into a basis for representations and help for others, geared to preventing suffering for others in the future, is to be commended. They need practical assistance, including financial help, to make their contribution over the difficult months, or perhaps years, ahead

I must conclude. Families in my constituency who are affected by organ retention, as well as those providing care and medical services, are all clear that reform of the law and regulation is needed. They all understand that we need to carry out that reform in a way that respects the wishes of patients and their families, and which inspires trust because it is clear and understandable, practical, deliverable and enforceable. We all recognise that families would rather have the pain of knowing than to be left in ignorance. They recognise that a wider public good needs to be secured, for research, education, public health surveillance, transplantation and other reasons, but that will only happen in future if the public trust the system sufficiently to donate organs and tissues through informed consent

We all recognise that the vast majority of practitioners in the national health service and the coroner's system act in good faith, seeking to do what they believe is right and in the interests of their patients. Through reform, we must enable the public and practitioners to re-establish between themselves the sense of trust on the issue that is central to the caring work of the national health service

7.48 pm

I am grateful to the hon. Member for South Cambridgeshire (Mr. Lansley) for raising this important subject. It enables me to outline some of the steps that the Government have already taken to improve practice—he has already referred to some of them—set out our plans for the future, and respond to the specific points that he thinks should be included in the review of the legislation

I have met families who have experienced such circumstances, so I am well aware of the distress, anguish and pain that many of them have endured for a considerable time. It has always been my intention to involve families as much as possible so that, hopefully, such things as codes of practice and the piloting of forms will command the trust and respect of families as well as the professionals involved. Families must be at the heart of our policy

We are aware that, in the past, protocols for the taking, retention and use of human organs and tissue were often less than adequate. Too often, insufficient thought was given to seeking the consent of relatives at the time of hospital post-mortems. As the hon. Gentleman knows, the law governing organ and tissue retention, particularly the 42-year-old Human Tissue Act 1961, is unclear, ambiguous and outdated. The law has, in any event, been poorly understood, and, as a result, not applied well in practice. The Human Tissue Act had no regulatory framework, penalties or sanctions to support it. That was in marked contrast to the Anatomy Act 1984, which, in relation to whole body donation, has a full regulatory framework, as well as sanctions. Clearly, discrepancies existed in the law in those two areas

Custom and practice developed within this framework of law, which relied far too heavily on traditional and paternalistic attitudes under which the benefits of pathology for diagnosis, post-mortem examination, teaching and research were understood, but the wishes and feelings of families were not sufficiently recognised. In those terms, we got the balance wrong. That damaged public confidence across a wide spectrum of pathology. It must be recognised, however, as the hon. Gentleman has done, that the removal and use of tissue samples and organs for matters such as medical research and education has significant implications for everyone's health. It is an important matter, and we cannot address today's public health challenges without that facility

We have only to consider the present worldwide concerns about severe acute respiratory syndrome—SARS—to recognise that we need good research and education. We need to develop new drug therapies, so the diagnosis of existing conditions and the training of medical professionals all rely heavily on the donation of tissue and organs. Therefore, unless we rebuild confidence in the system, we will not receive those vital donations. Certainly, my experience is that families are often happy to contribute to the development of medical education and science, provided that they have been properly and fully informed at the outset

As a result of the incidents not just at Alder Hey but right across the country in relation to organ retention, there has been a damaging effect on pathology as a whole, and there have been particular problems in paediatric pathology. We now have a big programme in the NHS to try to attract more people into the paediatric pathology work force, to ensure that more people get involved and to provide more training places. We are funding a range of fellowships to try to get more people into the field, and developing guidance for the NHS on modernising pathology services in general, to try to ensure that patients have access to high-quality diagnostic services. We must not lose sight of the fact that we need good-quality pathology in the whole NHS

The hon. Gentleman mentioned the investigation that my right hon. Friend the Secretary of State asked the inspector of anatomy to carry out into the case of the late Mr. Cyril Isaacs, who died in 1987, and into the retention after coroners' post mortems that took place at that time. We expect his report to be published shortly—it is currently with the Secretary of State for consideration—and we will consider it carefully to try to make sure that we reach a balanced view in relation to the rights and wishes of families and the needs of pathology. It is imperative that we recognise the legitimate expectations of patients and families, and at the same time try to ensure that medical science is safeguarded for the long-term protection of the health of the community. Any approach that we take, however, must have the full support of patients, families and the public at large. That is how we will secure medical science for the future. Our aim is to ensure that future arrangements protect the interests of everybody involved and that we retain important medical and educational benefits

The hon. Gentleman has set out some of our reforms, which we began in March 2000 when the chief medical officer set out interim guidance stressing that valid consent would be sought for hospital post-mortem examinations and for any retention of organs. That was the first step taken to try to restore confidence in the field

Sir Liam carried out an investigation and census of retained organs to gauge the extent of the problem nationally, and he published further advice in January 2001. That included 17 recommendations to change practice and culture across many areas of clinical work. My right hon. Friend the Secretary of State accepted all the recommendations

The programme of action that has been undertaken in this arena since 2001 has already achieved significant improvements. New guidance from the Department of Health, the Retained Organs Commission, the Royal College of Pathologists and others is already supporting transparent new systems founded on consent. Major changes have been made in the way consent is sought, codes of practice have been drawn up to inform and support families, regulatory controls are being developed and a wholly revised framework of law will aim to provide a single, comprehensive statutory basis for practice in this area

I pay tribute to everyone who has been involved in that process—the professionals, pathologists, researchers and the people in a range of caring professions who have contributed. Despite their distress, many family groups have been prepared to consider the code of practice and forms to see what could be done in practical terms. I understand that family groups in the hon Gentleman's area have contributed helpfully in the consultation on the review of the law. They have been involved and have made a difference

We have issued in the past week a comprehensive interim framework of information and new guidance. We have an interim statement on the use of human tissues and organs under the current law to try to help clarify the position pending new legislation. The code of practice on families and post mortems sets out how families should be communicated with about all postmortem examinations. We have standardised forms for obtaining consent and information leaflets that set out exactly what is happening, the rights of patients and their families and what they can expect from the decision-making process. A code of practice on the import and export of human body parts deals with a significant concern, and we also have a report on the consultation that took place on the legal framework

All those materials emphasise that the wishes of the person who has died and those close to him or her should be respected—that is the overriding consideration—that organs and tissues must not be retained following post-mortem examination without consent, and that accurate records must be kept of consent and of the tissue and organs retained. A great source of distress to families has been the delay in finding accurate records so that they know exactly what has been retained, where it is and how it can be returned. Families should also be informed about post-mortem findings and about any organs or tissues retained

We are working closely with the Home Office to support the implementation of the guidance, forms and leaflets not just throughout the NHS but to encourage their use by coroners' services. We have made sure that family support groups have been involved at every step, and the documents are available on the website and in the House

Our work to progress the Government's commitment to the review of the law moved into a major new phase in July last year when we published the consultation document "Human Bodies, Human Choices". It reviewed the law in England and Wales and considered the full range of circumstances. There was a series of facilitated workshops and a major national conference in November last year. It represents a real attempt not just to come up with a proposed Bill out of the ether, but to work genuinely from people's experience. That process has made a significant contribution to our preparations for a Bill and has strengthened the way in which it will work

The Bill's objective will be to provide a more systematic and comprehensive framework. We need to have clear, unambiguous and transparent provisions so that people know exactly where they stand and what they can expect from the legal framework. We want to ensure that there will be statutory requirements about consent to underpin the legislation. There will then be a proper legal framework in which consent should be obtained for tissue or organ removal, storage and use that sets out clearly the duties and a proper regulatory framework to oversee and support compliance. Provision will be made for penalties to be introduced for certain breaches, and the hon. Gentleman made important points about the distinction between organisational and individual accountability. Codes of practice will be established for the import and export of human body parts and other issues. Such a framework will provide better protection, support the patient involvement agenda across the NHS and give clarity for professionals so that they know that they are acting properly within that legal framework. Unfortunately, as he said, sanctions and penalties will be necessary in some circumstances

I am pleased to confirm that we intend to introduce the Bill as soon as parliamentary time allows. I can give the hon. Gentleman the undertaking that we hope to publish the draft Bill for parliamentary scrutiny before the summer recess. We are anxious to get on with the process, which started with the chief medial officer's report three years ago

Some people expressed concern because we did not immediately introduce the relatively simple legislative recommendations on sanctions and legal duty. We found that the law was complex and deep ethical considerations had to be taken into account. It is right to consider the law as whole and to get a proper new regulatory framework rather than to rush into making simpler amendments that would need to be undone and incorporated into a better regulatory framework at a later stage. I am happy that we are proceeding appropriately, but I accept the hon. Gentleman's point that we need to get on with the process so that we give people the security that they require

The hon. Gentleman's points about consent, the definition of next of kin, reports to families and the essence of donation are important. They can all be raised at the pre-legislative scrutiny stage and we look forward to further discussions on them

I reiterate our commitment to the families of children and adults who have found themselves in such circumstances and we are determined to make a difference—

The motion having been made after Seven o'clock, and the debate having continued for half an hour, MADAM DEPUTY SPEAKER adjourned the House without Question put, pursuant to the Standing Order.

Adjourned at one minute past Eight o'clock.