HC Deb 28 June 2004 vol 423 cc115-24
Ms Rosie Winterton

I beg to move amendment No. 31, in clause 29, page 19, line 2, leave out from beginning to 'material' and insert 'any controlled'.

Mr. Deputy Speaker

With this it will be convenient to discuss the following: Government amendment No. 114.

Government amendments Nos. 32 to 46.

Government amendment No. 65.

Ms Winterton

In Committee, hon. Members tabled several amendments that reflected the concerns of the pharmaceutical industry. The amendments and the correspondence cast doubt on whether clinical research activities, such as indemnity payments to participants in clinical trials and payments to companies that source tissue for research projects that are at present legitimately carried on for profit, would remain lawful following the passage of the Bill as drafted. In Committee, I undertook to review clause 29.

Having examined the issue, we took the view that those concerns are justified. We understand that payments are not made in respect of human tissue itself, but that payments of the kind that I have mentioned would be within the scope of the offence as drafted. However, it was clearly never our intention to interfere with commercial activities that had been lawfully and ethically carried on for many years. We therefore propose to amend the Bill to confine the offences connected with advertising and supply of human tissue for reward to transplantable tissue only. That solution would, as we intended, extend the existing offences of commercial dealings in organs, which are transferred from the Human Organ Transplants Act 1989, to cover supply of any tissue for transplantation.

Other amendments to clause 29 will allow for the possibility of commercial tissue banks by permitting more than just expenses to be recovered in respect of the storage of tissue and for people involved in the chain of supply of transplantable tissue to pass on costs that they have incurred. Grouped with those amendments is Government amendment No. 65, which relates to the Asylum and Immigration (Treatment of Claimants, etc) Bill. The amendment is minor and consequential and is required because that measure is ahead of the Human Tissue Bill in its passage through Parliament.

It being Nine o'clock, MR. DEPUTY SPEAKER put the Question already proposed from the Chair, pursuant to Order [15 January].

Amendment agreed to.

MR. DEPUTY SPEAKER then proceeded to put forthwith the Questions necessary for the disposal of the business to be concluded at that hour.

Remaining Government amendments agreed to.

Order for Third Reading read.

9 pm

Ms Rosie Winterton

I beg to move, That the Bill be now read the Third time.

In Committee and today during Report, we have given the Bill very detailed consideration, and I hope that hon. Members and others who have shown keen interest in our deliberations will agree that we have been able to refine it in ways that will ensure that it is not only welcome and necessary—as I believe it is—but also workable and pragmatic. I am grateful to Members on both sides of the House, especially to the Members of the Committee, for the warmth with which they received the Bill, and for the unfailingly constructive way in which they have engaged with it.

I am particularly grateful to the Under-Secretary of State for Health, my hon. Friend the Member for South Thanet (Dr. Ladyman), for the help he gave me during Committee. He made several memorable comments that will be written into the Bill's history, because he brought to our discussions his particular expertise. I also thank officials for their help and I hope that Members on both sides of the House felt that that help was extended to them, too, and that we achieved consensus on the Bill and managed to reflect the views of stakeholders and others with a keen personal interest in the measure.

The process of preparing the Bill and of bringing it through the House has involved consultation, consensus and co-operation. We have been able to discuss it—I hope openly—not only with MPs but with family groups, researchers and other key stakeholders. We have had the opportunity to listen and have been able to make improvement;, which will, I hope, like the principles of the Bill, receive broad support.

In that respect, the Bill's progress has been a happy experience. But all Members will agree that what never left our minds was the appalling experience, suffered by far too many people, that led us to the awful realisation that practice in post-mortems and in tissue use had become far out of step with the public's expectations. As we said earlier, the former Secretary of State for Health, my right hon. Friend the Member for Darlington (Mr. Milburn), announced in January 2001 publication of the report of the inquiry into the Royal Liverpool children's NHS trust—the Alder Hey report—and of the report by the chief medical officer on the retention and use of tissue and organs. It is now a little over three years since that happened, and the House is ready to send to another place the Bill that has resulted from that review. Many people might say that that has taken a long time, but we have been dealing with complex. sensitive and, sometimes, very fraught issues. We have achieved a lot in drafting the Bill, and I am glad that, in the end, it has enjoyed support from hon. Members on both sides of the House.

Dr. Murrison

The Minister rightly determines that the Bill's provenance lies in the events at Alder Hey. Will she also record that, before those events, the tragic events at the Bristol royal infirmary gave rise to the revelation of what was going on at Alder Hey? It is important to record, especially for those who have been distressed by them in the south-west, that the events at the BRI gave genesis to the Bill.

Ms Winterton

Of course, and as the hon. Gentleman knows, I referred to that fact earlier in my contributions. I should like to refer not only to the Bristol inquiry report in 2000, but, of course, to the Isaacs report, which gave rise to the realisation that the uncontested retention of tissue from adult post-mortems was also a widespread practice.

What happened as a result of those terrible tragedies was not only a source of enormous distress to the families who were affected by those events, but has produced in recent years a loss of confidence and, for many, a diminution in their trust that science and medicine would respect people's interests and act only for the best. That, too, is a tragedy, as it is only with trust and confidence that we can truly progress with the important research that will support further advances in medicine. That is why it was so important in drafting the Bill that we were able to come up with proposals that will go a long way to restore that trust and confidence. I believe that they will succeed.

I have certainly met—I am sure that other hon. Members have done so—bereaved families who are still shaken by the experience that they went through, but who have been determined to play their part in helping to produce legislation that they accept will not help them but that they know will help others in the future. Their role, quite frankly, has been invaluable, and their generosity should not go unmarked today. Many in the health community have also shown remarkable commitment to and support for this reform.

In Committee, hon. Members expressed reservations about some of our proposals, but I am glad that we have been able to work with them to include some necessary safeguards, so that the research that they were concerned about can be carried on.

The Bill will provide the clarify to enable people to act and the oversight to ensure confidence. It will establish a regulatory framework with a Human Tissue Authority, so that oversight and monitoring of the new arrangements can take place. Moreover, the new authority will also be the source of advice, information and guidance that will enable people—the public and professionals—to understand fully what their rights, responsibilities and options are.

Mr. Lansley

Since we were in Committee, the Secretary of State has announced a further stage of his review of arm's-length bodies and, since the abolition of the Retained Organs Commission, the Human Tissue Authority has been included in his review. What intentions does the Secretary of State have towards the HTA under that review?

Ms Winterton

The HTA comes under the scope of the review, and that fits in with the spirit of the amendments that were proposed in Committee and that we have accepted today. We want to make sure that there is no duplication in any of the work of the arm's-length bodies, and we want to examine where it might be appropriate to put different arm's-length bodies together. However, no decisions have been made and announcements will be made shortly about that. I assure the hon. Gentleman that our vision that the authority will be independent and made up of experts and others who have an interest in the subject will be preserved.

Mr. Lansley

We observed in Committee that the structure of licensing intended for the HTA is very similar to that for the Human Fertilisation and Embryology Authority. Although the Secretary of State may not have framed it as such yet, if it is his intention to combine the work of the HFEA and the HTA, it would be certainly be advisable to say that before asking the other place to consider the matter in detail.

Ms Winterton

I will certainly pass on the hon. Gentleman's advice.

The Bill now provides the clarity to enable people to act and the oversight to ensure confidence but, most of all, it represents a move into the future. That is a future in which the relationship between patients and professionals has been redefined for the good of each and to the benefit of us all. For those reasons, I commend the Bill to the House.

9.12 pm
Mr. Lansley

I am grateful to have the opportunity to say a quick word on Third Reading. I am sure that the House will join me in thanking the Minister and the Under-Secretary of State for Health, the hon. Member for South Thanet (Dr. Ladyman), for the way in which they have conducted proceedings on the Bill. It is not a routine commendation to say that the Bill has been debated in good humour; that is true not least because of the Minister's approach to these matters.

It is not easy for a Minister to navigate from the position that she and the Under-Secretary took in Committee on some of the amendments to the points that they have made on Report. She has managed to do that without the remotest sign of embarrassment, which is commendable and bodes well for her future ministerial career.

Like the Minister, I want to thank others, not least my hon. Friend the Member for Westbury (Dr. Murrison). He has done, as they would say in the trade, the heavy lifting on our side. I am acutely conscious that, whereas the Minister has no medical qualifications but has the benefit of advice, I have no medical qualifications and relied heavily on my hon. Friend's advice. The Committee also benefited from the contributions of the hon. Members for Oxford, West and Abingdon (Dr. Harris) and for Wyre Forest (Dr. Taylor). That is an illustration of how we can bring together in the House a degree of expertise and a degree of ignorance and combine them happily.

A number of the issues that we raised on Second Reading just over six months ago have now been taken on board. I shall not repeat everything that I said when I spoke to the first group of amendments, but as I said to the Minister before Second Reading, the Bill should have been committed to a Special Standing Committee—it was a great pity that that did not happen—so that we could take evidence, even if there had not been full pre-legislative scrutiny.

It was amply illustrated in Committee that hon. Members, including my hon. Friend the Member for Westbury and me, were putting forward well-argued points made by outside organisations such as the Medical Research Council, the Wellcome Trust, the BioIndustry Association, the British Medical Association, organisations representing the family support groups and the National Committee Relating to Organ Retention. Those outside bodies used us as a mechanism to make points in Committee, but although we put their proposals on the table before Ministers we got limited shrift, as the hon. Member for Oxford, West and Abingdon suggested. However, our persistence seems to have paid off, so we can give thanks to those groups and the departmental officials for working together since the Committee to allow us to reach a more satisfactory conclusion today.

Several improvements have been made to the Bill as a result of that process. We debated widening the scope of education and training—I gave an example regarding cervical smears—and the Bill has been amended to reflect our concerns. The situation regarding the tacit consent involved in retaining residual tissue from living persons was mentioned as far back as Second Reading. We talked in Committee about the need to protect clinicians and researchers from risk if they obtained material without consent although they thought that that had been given, and I am glad that the Government have responded to our points. We suggested in Committee the requirement for regulatory best practice to cover the Human Tissue Authority, and the Government have accepted our point. We argued in detail in Committee about the requirement for codes of practice to deal with consent more explicitly, and although the Government resisted our suggestion at the time, they have now accepted it. We talked in Committee about the risk that commercial undertakings engaged in legitimate work connected with research could be criminalised as a consequence of the provisions in clause 29 on commercial trafficking, and the Government have now accepted our arguments. We had one success in Committee when the role of grandparents was recognised, although I suspect that the Minister could not think of an argument against our suggestion then because I dare say that she would have decided to go away to think about that, too.

We have made a lot of progress, so that should give a greater sense of security to those in the medical and research professions. We have tried to minimise the risks that they will face individually due to the creation of the criminal offences and the burdens that they will face collectively when trying to undertake successful research. Although a lot of our discussion in Committee and on Report was geared up to striking such a balance for those people, the Bill still provides the families who suffered from the unauthorised, and sometimes malign, retention of organs and tissues with an expectation that such things will not happen again.

The Minister and my hon. Friend the Member for Westbury mentioned the Redfern report on Alder Hey and the report on the Bristol royal infirmary tragedies. Those reports disclosed several specific incidents that occurred and the clandestine nature of the way in which tissues and organs were retained at Alder Hey. Many of us were disturbed that the reports exposed a culture in the NHS of retaining organs and tissues that often did not comply with the consent requirements in the Human Tissue Act 1961. Sometimes there was a patronising assertion that it would be better not to tell people and that what they did not know would not hurt them. Well, what they did not know did hurt them, and hurt them very deeply. It is absolutely right that, as the Minister said on Second Reading, that must not happen again.

We may be about to complete our consideration of the Bill, but it has to go to another place. Ministers may be tempted to assume that, given the positive reception that all the amendments considered today were given, it is the end of the story. There is one thing that I must raise in addition to the future of the Human Tissue Authority even before it is to be established.

Clause 9 relates to the position of coroners. It will not have escaped the Minister's notice that, in some instances, the tragic circumstances that gave rise to the necessity for this legislation included occasions on which post mortems had been carried out by or on behalf of the coroner, The case of my constituent, to whom I referred on Second Reading and whose circumstances were reported on in detail in the Isaacs report, resulted from a coroner's post mortem. My constituent can hardly feel the security about the future that she wishes to feel if the Bill simply says that anything done by or on behalf of the coroner will not be affected by the legislation and the issue is to be followed up by the Home Office at some future point.

Ms Winterton

The hon. Gentleman is right to raise the issue. As he knows, the Home Office is responsible for the coroners' rules, which set out among other things the duties respectively of coroners and of pathologists undertaking post mortems on their behalf. The Under-Secretary of State for the Home Department, my hon. Friend the Member for Wythenshawe and Sale, East (Paul Goggins), wrote to me on 22 June confirming that the rules will be revised as soon as is practicable and at the latest by the end of the year. They will be revised so that it is clear to coroners and pathologists when the coroners' jurisdiction has expired, who must communicate with families about tissue retention and when they should do so. I assure the hon. Gentleman that Home Office and Department of Health officials are and will remain in close touch on that issue.

Mr. Lansley

I am grateful to the Minister for that intervention, because it adds substantially to the point relating to coroners. I was suggesting that there was a serious deficiency. Although I have not had a chance to look at precisely what the Minister said, I think that my noble Friends will want to explore the point when the Bill reaches another place. I hope that the Minister and her Home Office colleagues will be in a position to expand on that. It was clear in Committee that, although activity carried out ultra vires by coroners or on behalf of coroners will be subject to the Bill, the matter is not confined to coroners' statutory obligations. It includes non-statutory obligations, and therefore, the scope of coroners' rules is the critical issue. I am sure that, in order to be confident that the Bill and the rules fit together to provide the necessary security for patients and families, my noble Friends will want to know more precisely what the rules will look like if they are to be amended later this year.

With those points that I have raised with the Minister, I echo my thanks to my colleagues and others for the way in which our discussion has been conducted. I hope that my noble Friends do not find that we have erred in our consideration in this place.

9.24 pm
Dr. Evan Harris

I want to start by referring to the Alder Hey and Bristol tragedies. They were the genesis of the Bill, and it is right that we remember that. Despite our heated debates about transplantation and presumed consent today, there is no doubt that significant damage was caused to families not only at those two hospitals but, as we discovered, at hospitals throughout the country. I hope that those families will take some comfort from the fact that a good Bill is now leaving this House in a decent state. They were the inspiration and, in some cases, the driving force behind putting the legislation right and recognising the need for a modern approach to the way in which the health professions and the NHS deal with the living, and with the dead and their organs. The key lesson is that although sometimes the professionals' sincere desire was to protect families from too much information, we have to beware the danger of paternalism and of acting against people's interests, their autonomy and their right to make decisions. The medical profession in particular must be wary of that, given the power relationships that arise from technical expertise and knowledge. In that respect, the Redfern report and the Bristol inquiry report were seminal and very useful in getting us to this point. The new framework, in which we have—rightly, I think—avoided putting consent on a statutory footing, but created a new statutory basis for dealing with such issues none the less, will be useful.

There is another side to the issue: the continuing ability of health professionals and medical researchers to do their job. I have always made clear my family connection in that my father was for many years professor of child health at Alder Hey and was, before leaving, involved in the appointment procedure for Professor van Velzen. In that respect, he was mentioned in the Redfern report. I do not think that that report was handled entirely satisfactorily: everyone mentioned in it who bore the title "doctor" was referred to the General Medical Council, including non-medical people for whom GMC was not responsible. My father was found to have no case to answer before the GMC. I hope that the Government recognise that a balance has to be found between the effective conduct of health care and medical research and the prime need of patients and families to have their autonomy respected.

There is an ongoing problem with the number of people who are willing to enter paediatric pathology. We have to deal with that problem. The measured tones of our debates have helped, given that there was an opportunity inadvertently to make the problem worse. The coverage of allegations surrounding child abuse and cot deaths show that paediatricians continue to receive adverse publicity, especially those working in the difficult field of child protection. We have to bear in mind that, whatever the drawbacks and problems we have encountered, the situation would be much worse without health care professionals practising in these difficult and often unrewarded fields. There is little, if any, private practice in paediatrics and in that type of research.

I endorse the observation made by the hon. Member for South Cambridgeshire (Mr. Lansley) that pre-legislative scrutiny of the Bill would have been extremely useful. The Minister of State says that Committee stage is scrutiny and she feels that there is nothing wrong with that, but it is not ideal, because one has to discuss the issues in a confrontational setting—even though we managed to do so politely and graciously—and, if messages are understood, they are taken away to a dark hole and new amendments emerge on Report. In contrast, pre-legislative scrutiny, especially if it had involved some form of Select Committee, would have allowed the representations that the Government heard, and to which they responded, to be made in the open, and our Standing Committee would not have had to dwell on some of the points that have now been corrected. I think that all members of the Committee can take some credit for the improvements to the Bill that were made at that stage. I remember suggesting that the use of anonymisation might be a way forward for research, to varying degrees of shrift, and that education and training might not necessarily be seen as they were originally. Many suggestions were made by the hon. Members for South Cambridgeshire, for Westbury (Dr. Murrison) and for Wyre Forest (Dr. Taylor), which have seen their echoes in Government amendments. I now want to mention two forty-fours.

Clause 44 is important and should not be overlooked. It provides an opportunity for us to set clearly the rules for cold perfusion, and use non heart-beating donation as a way to increase the number of organs that are available from that source. That has not had the attention that it deserves because the issue was not that contentious, but it may be significant. It is one of three sources, including live donations, from where we would hope to get more organs.

Government amendment No. 44 has, as it were, dropped off the Amendment Paper. I think that it read "leave out from 'beginning' to 'and'" in clause 29. By sheer luck, I spotted that it should have read "from 'beginning'"? to the second "and". I am sure that when the last group of amendments was moved, when the guillotine fell, the Minister was about to thank the Liberal Democrats for pointing out that new amendment No. 114 was required, to which the Secretary of State put his name, to make the provision robust so that we could send the Bill to the other place—

Ms Winterton

I can confirm to the hon. Gentleman that I was about to thank him. It was helpful.

Dr. Harris

I remember that when I asked my hon. Friend the Member for Southwark, North and Bermondsey (Simon Hughes) during the passage of the Greater London Authority Bill, which contained hundreds of clauses, whether he had had any successes in Committee, he said that he had inserted one comma, and that he felt that that was a great victory.

There is the issue of DNA and RNA. I feel guilty for the lack of attention that I paid to molecular biology when I was at university. I was out campaigning—rather hopelessly in those days—for my party. The Minister said that she would look again at whether the provisions for DNA and RNA need to be re-examined; I hope that I shall be able to wave that as a sign that I was awake at some stage of my training.

Consideration of the Bill in Committee was enjoyable. The Minister is able to say no so nicely. In contrast, her colleague, the Under-Secretary of State for Health, the hon. Member for South Thanet (Dr. Ladyman), says no rather less nicely but still in an engaging way. I think that we learned in Committee that all parties were in favour of grandparents. I expect that we shall see a commitment to have more grandparents in all our manifestos.

I thank the hon. Member for Wyre Forest, my consultant, for the advice that he gave me, which was in much more moderate terms than my consultants used to give me when I was a junior hospital doctor. I thank also those organisations that took the time to brief us, and my researcher, Laure Thomas, for her sterling efforts.

The hon. Member for South Cambridgeshire said, importantly, that the Government were keen to ensure that the Bill went to the other place with no threads hanging, because the Lords would not be able to resist the temptation to pull them. The Government have done well to cram in so many of their amendments tonight. After all, who knows what the other place would have done on these issues?

We will not all agree, but I think that there is some unfinished business on transplantation. It may be that we shall not be able to make progress on presumed consent with this Bill. However, Ministers should know that the issue will not go away. It is an important Bill and I am glad that it has left the House in its present state and not so much in the state that it came before us in Committee. The Government should be congratulated because broadly the structure is the same. Broadly, the Bill commanded cross-party support throughout, and that is indicated by the fact that none of us anticipates a Division on Third Reading, and rightly not.

Question put and agreed to.

Bill accordingly read the Third time, and passed, with amendments.