§ (First Day)
§ Wednesday, 15 September 2004.
§ The Committee met at half past three of the clock.
§ [The Deputy Chairman of Committees (Lord Brougham and Vaux) in the Chair.]
§ The Deputy Chairman of Committees (Lord Brougham and Vaux)
I am not going to remind your Lordships of the procedure; you have all been acquainted with Grand Committees for long enough. I shall simply remind you that if there is a Division in the Chamber we shall adjourn for 10 minutes straightaway.
§ Title postponed.
§ Clause 1 [Authorisation of activities for scheduled purposes]:
§ Baroness Finlay of Llandaff moved Amendment No. 1:
§ Page 2, line 20, after "imported" insert "and is subject to appropriate consent and the death has been registered in accordance with the laws of the exporting country"
§ The noble Baroness said: The amendment is remarkably simple. It seems morally wrong to expect a lower or different level of consent for imported material than for that donated in England, Wales and Northern Ireland. It is in terms of establishing equity of principle that Amendments Nos. 1 and 2 are tabled. I beg to move.
§ Earl Howe
I fully recognise the force of the moral case put by the noble Baroness, Lady Finlay, although, to be honest, I am not sure how practical are her proposals. If her amendments were accepted, we should perhaps bear in mind what would be needed in the case of the thousands of blocks and slides that are imported each year and the urgent circumstances that usually surround the importation of an organ for transplant. From those perspectives alone, I cannot see that her idea will find favour with the Minister.
Indeed, the amendment that I have tabled, I am afraid, looks at the matter of imported material from another perspective. My amendment, Amendment No. 66, has been suggested by the BioIndustry Association, which is anxious that the Human Tissue Authority lay down requirements on the consent needed for human tissue that is imported into this country.
As I read Clause 1, imported bodies and imported relevant material are exempt from the consent requirements of the Bill. However, the anxiety of the BIA—and this is the reason that I have tabled the 406GC amendment—rests on an apprehension that the HTA may take it upon itself to lay down stipulations on the consent needed in relation to imported material.
I do not know whether that apprehension is well founded but, if there is anything in it, I have sympathy with the BIA's position. Seeking to lay down what procedures should operate in other countries in relation to consent goes, I would have thought, beyond the remit of the HTA and beyond the scope of the Bill. Indeed, any attempt to go down this path would have one result—that is, to encourage research to move out of the UK. I hope the Minister can reassure me on those matters.
§ Lord Jenkin of Roding
I have added my name to Amendment No. 66. In fact, I tabled a similar amendment but, very wisely, the Public Bill Office said that it would make sense to have the two amendments rolled into one. I was very happy to agree with that
I am going to speak to Amendments Nos. 66 and 68, which stand in my name. First, I can deal with Amendment No. 68 very briefly. I believe that this is an issue which has figured in the Bill—although one is not allowed to use Latin—per incuriam. It is an accident; it should not have happened.
This is a question of transferring tissues and slides and so on between departments of universities and other researchers in different parts of the United Kingdom. The Minister will know from looking at the battery of distinguished doctors sitting along the Bench from him and on the Cross Benches that collaboration frequently exists between universities in Scotland and in England and Wales. One is increasingly struck by how many papers are published that come from several different sources within the United Kingdom. They work very closely together. Indeed, the IT revolution makes it much easier and more possible.
Therefore, it seems absolutely absurd that, as the Bill provides for its procedures to operate in all parts of the United Kingdom, as I understand it—certainly England, Scotland and Wales—it should cover the transport of tissue and other materials between different centres within the United Kingdom. We shall turn to the question of use and the need for consent later. But one assumes that these will be materials that have secured the necessary consent and are just being sent to collaborators in other UK centres. I cannot believe that the Government have intended that that should be the subject of a separate consent. It will be hugely bureaucratic.
From what I said at Second Reading, the Minister will recognise that I have the greatest sympathy with those concerned, while recognising the main purposes of the Bill and the need to remedy the shortcomings that became apparent in the various inquiries that have been held. It is also desperately important that the balance should be maintained and that the research community is not saddled with unnecessary bureaucratic hurdles. That is precisely the aim of Amendment No. 66. I hope that the Minister will be able to give us an assurance that the Government will table an amendment at a later stage in order to make that perfectly clear.
407GC Amendment No. 66 refers to similar arrangements that might exist between other countries in the European Union and the UK and between the United States and the UK. I am aware that, of course, there are collaborations and transfers that will take place on a multilateral basis right across the world. Therefore, this is a very modest amendment that is intended to deal with those countries that are likely to have similar forms of consent and procedures to those that we have.
I shall not bother to weary the Committee, but I have a substantial note here that has been provided for me to indicate that there are differences. Of course there are differences. If one takes the United States of America, it is true that in some American states there is no absolute requirement for informed consent. The equivalent of a research ethics committee—the IRB—has the legal power to waive consent to the use of tissue if it deems that there is no risk to the patient and if confidentiality is preserved. Some might argue that that would be quite a good system to have here, but I understand that the Government are now taking that much further. I am arguing that it is a sufficient condition that the importation of tissue from the USA should be acceptable for the purposes of the Bill on the question of controlling such tissue.
In the European Union, Austria and Hungary, for example, operate a system of presumed consent. I recognise that the Government have firmly turned their face against presumed consent. I do not think that my noble friends on the Front Bench will argue for that. But the fact is that they are perfectly acceptable procedures in those countries. Should we add to the bureaucratic burden of the Bill by saying that what is acceptable in some countries, with systems that are not all that different from ours but where there are differences, should be subject to all the rigours of the Bill?
In most EU countries, some form of consent is required for collection of human tissue for research and for certain other activities. To act without such consent is illegal. Well, that is at the heart of what we are about here. It seems to me that the Government owe the Grand Committee an explanation of why it is not possible, in developed cases such as the United States and the rest of the European Community, to have a system whereby there can be transfers without the necessity for all the bureaucratic controls which we have in the Bill. That matter needs to be examined closely.
I am sure the Minister will recognise that a number of the amendments on the Marshalled List, to some of which I may be speaking, are designed to try to reduce the burden of bureaucracy which the Bill imposes and to make it possible for valuable research to continue without imposing these unnecessary burdens.
The first burden—the question of transfers between different countries in the United Kingdom—is, if I may use another Latin phrase, a casus omissus. They should be perfectly possible without any of the bureaucracy. I recognise that there are differences with the European Union and America, but we could perfectly well allow them under the Bill. I shall not go 408GC through the rest of the countries because of course there are a lot of differences. But the main point is that they require consent for the use of tissues. They may have different procedures and rules, but the provision is sufficiently close to ours that we ought to be able to accept it.
§ Lord Walton of Detchant
I have a couple of questions to ask the Minister in this very complex situation. In many circumstances when a patient is suffering from a rare form of cancer and a biopsy is taken from that particular lesion, the pathologist in question may not feel that he or she has sufficient expertise to be able to determine the nature of the lesion—and this is for purely diagnostic purposes and not for research. Often those samples of tissue are sent to another centre where an expert in the field is able to give a definitive opinion. I recognise that those patients will have given consent for the removal of tissue for study by the first pathologist, but does that consent extend to the transportation of the tissue to other parts of the United Kingdom for an expert opinion?
My second question is based on personal experience. When I was in clinical practice and involved in research on muscle disease, I regularly received blocks of muscle taken from patients in many parts of the world, not just the European Union but the United States, Saudi Arabia and sometimes even Australia. I was asked to process this material in my department using the expertise we had developed over several years in order to offer a diagnosis. Is that particular process covered by the Bill as it stands or does it require these amendments in order to make that legal?
§ Lord Clement-Jones
I rise briefly to support Amendments Nos. 66 and 68. The noble Lord, Lord Jenkin, made the case extremely effectively for Amendment No. 68. Clearly, it seems anomalous if the UK is not treated as a single entity for the purpose of import and export under Clause 46. No doubt the Minister will address that particular point.
On Amendment No. 66 the situation appears fairly unclear under Clause 1. I can well understand that Amendment No. 66 has been tabled because Clause 1 does not appear to be totally clear. If it covers imported material then there is an element of extraterritoriality about this in terms of the UK—or at least England, Wales and Northern Ireland—assuming some sort of right to determine the nature of the consent obtained for that material. Basically the fundamental case being made is that any attempt to stipulate those kinds of consent requirements in other countries would simply encourage research to move out of the UK. I think that that that is at the bottom of this amendment, which I support.
§ 3.45 p.m.
§ The Parliamentary Under-Secretary of State, Department of Health (Lord Warner)
A good deal of clarification will probably be required, given what has been said by a number of noble Lords. Subsections (4) to (6) of Clause 1 have the effect that storage and use of an imported body of a deceased person or of relevant 409GC material are not subject to the consent requirements of subsections (1) to (3), as I think that the noble Earl, Lord Howe, suspected. These requirements are that appropriate consent is obtained and, if the activity in question is anatomical examination, that the death has been certified and registered. Amendment No. 1 would change that position so that it would be lawful to store and use imported bodies and material only where appropriate consent was in place and after the death had been properly registered in the country of origin.
As a number of noble Lords have suggested, it is unrealistic in particular to expect that consent regimes abroad will be the same as the requirement for "appropriate consent" under the Bill. Some countries which are much involved in exchange of research material, such as the United States, do not have obligatory consent regimes. The amendments would restrict the use of imported tissue in transplantation, teaching, research and public display. They would risk holding back valuable international research and could lead to movement of research from this country. That is certainly not the Government's wish, as, indeed, it is not the wish of other noble Lords.
It is our view that suitable control of storage and use of imported bodies and tissue can be achieved through guidance. The Human Tissue Authority is required to issue a code of practice on the import and export of tissue—I refer noble Lords to Clause 26(2)(k) on this issue—and it would, no doubt, make it clear that care should be taken on provenance of human tissue and that the relevant formalities in the country of export were adhered to. It is not for us, however, to impose our regulatory systems in this regard on other countries.
Amendment No. 66 requires the authority's code of practice on import and export of tissue to include that consent to storage and use of tissue shall be deemed to be in place where tissue is imported from America or the EU in accordance with their local law. I believe that the amendment is inconsistent with the Bill. As I have indicated, the Bill does not require consent to be in place in relation to imported tissue in any event. Moreover, it is fair to say that Amendment No. 66 in any case discriminates between tissue from the EU and the US and that from other developed countries such as Australia and New Zealand. However, as I have said, it is our view that suitable control of storage and use of imported bodies and tissues can be achieved through guidance and without the need for deeming consent to importation to be in place.
I will come to some of the points made by the noble Lord, Lord Jenkin, in a moment. As regards the point raised by the noble Lord, Lord Walton, under the Bill there would be no restriction on the movement of tissue in the first case—the cancer case—that he cited. On the imported second case he cited—I assume he meant "muscles" and was not in the fishing business—similarly, there would be no problems. The material would be covered as imported tissue under the terms of the Bill. There would be no restriction in either case.
I can reassure the noble Baroness, Lady Finlay, that the Bill covers Northern Ireland, so there is not an issue in terms of Northern Ireland.
410GC Finally, Amendment No. 68 states that the code of practice will not apply to transport within the UK. I am still not sure why we need this. There is no reason why movement of tissue in the UK should be affected in any way by the Bill. We regard the amendment as totally unnecessary. As I have said, there is no increase in the regulation of imports and exports taking place, and the Human Tissue Authority code of practice will give guidance on that. The Bill does not extend to Scotland so the question of movement of tissue between Scotland and other parts of the UK will be subject only to guidance from the HTA in the form of a code of practice. As I have said, this will not be a matter of imposing any new requirements on research collaborations. That is true, as I have tried to set out, in relation to collaborations with other parts of the world also.
In the light of my explanation, I hope that the noble Baroness will feel able to withdraw the amendment.
§ Lord Jenkin of Roding
I hesitate to take up more of the time of the Grand Committee but, in the light of debates in another place and a study that has been made of the Bill since then, bodies engaged in this work are not reassured by the statements put before us by the Minister, who says that he cannot see why these amendments are needed, particularly Amendment No. 68.
There are those who, on reading the Bill, feel that it will give the Government powers to impose, either by regulation or through the codes, restrictions on the transport of tissues within the United Kingdom. However, the Minister has said that that is not their intention. This issue will arise again and again. Is it sufficient to rely on ministerial statements? Should we have a clear statement set out in the Bill, or should the matter be dealt with in regulations? We know that United Kingdom courts will take note of statements made by Ministers during the passage of legislation, but that is not widely known in the rest of the world.
Let us consider the position of firms in the bio industry that are seeking to exchange tissues. Are we to say, "It is all right. I can quote the noble Lord, Lord Warner, speaking on 15 September in the House of Lords"? How many people will pay attention to that when it is not set out in the Bill, the regulations or the code? That is what will create difficulties.
For that reason, we need these statements, which are reassuring as far as they go, put in the Bill or in subordinate legislation. It is not enough simply to rely on Ministers giving us a view of their intentions.
§ Lord Warner
I do not quite know what one does in these circumstances. I have tried to reassure the Committee that no provisions in the Bill would enable us to impose restrictions of the kind about which the noble Lord and others are concerned. In this country we often structure primary legislation to provide for another body to produce a code of practice on some of the detailed working arrangements. That is the case here and the body is the Human Tissue Authority. It will have to operate within the framework of the legislation that has been described, outlined and agreed by Parliament.
411GC On the legal advice I have been given, I am unaware of any provisions that would enable the introduction of restrictions on the transport of tissue of the kind that the noble Lord and others fear. If he gives the names of those who are deeply concerned, I shall be happy to put those assurances on paper on behalf of the Government. However, I am not sure what more I can do because we do not have the code of practice of the Human Tissue Authority before us—the authority has not yet been set up. Unfortunately, I cannot bring forward that code as a further reassurance.
I have done my best to make it clear that it is not the Government's intention to impose such restrictions. No provision in the Bill would enable the body to impose such restrictions and, in the light of these assurances, it would be very surprising if the Human Tissue Authority, of its own volition, were suddenly to write such restrictions into its code of practice. That, I would guess, would be challengeable in law.
§ Lord Jenkin of Roding
I shall say no more than a further word or two. Certainly the BioIndustry Association has had discussions with the Minister's officials. The association was not given the kind of reassuring responses that the Minister has given Members of the Grand Committee this afternoon. It would be helpful if the Minister could write to the BioIndustry Association setting out precisely the intentions of the Bill. Such a letter would have to be taken into account by the courts in this country and may well go some way to reassuring the association.
When I discussed the matter with association representatives, they expressed their concerns. If a letter would relieve that concern, the time taken to write it would be very well spent.
§ Amendment, by leave, withdrawn.
§ [Amendment No. 2 not moved.]
§ Lord McColl of Dulwich moved Amendment No. 3:
§ Page 2, line 32, after "body" insert "(or education and training relating to such research or to research techniques)"
§ The noble Lord said: In moving Amendment No. 3, I shall speak also to Amendments Nos. 4, 13 and 15. The purpose of the amendments is to make it clear that research can never be divorced from education and training. Unlike education and training related to health, education and training related to research falls under those purposes generally requiring consent. It is not clear why that distinction has been made. We foresee considerable difficulties in making the distinction in practice.
As Members of the Committee will know, research is defined as,
the systematic investigation to establish facts or principles, or to collect information on a subject".
Academic departments in many branches of medicine and surgery throughout the world regard research and teaching merely as part and parcel of everyday
practice. If one considers training someone in cytology to read, for instance, cervical smears, is that an example of training in research or in a research technique? If tissue is anonymised, do training and research techniques require consent?
§ I remind the Committee that patients with duodenal ulcers sometimes experience a dangerous complication when the ulcer perforates and the patient develops peritonitis. Some years ago, the treatment of that complication was to open up the abdomen and plug the hole with a piece of nearby fat. One clinician was surprised when he noticed that one of his patients who had the complication never had any further trouble from the ulcer, whereas other patients in similar condition continued to have trouble for many years. That prompted him to find out what percentage of patients had no further trouble. The answer was a third of them. He then began to wonder why that was so. The probable explanation was that the antibiotics given to rescue the patient from that dangerous complication also happened to cure the infection that we now know is the cause of a duodenal ulcer.
§ The clinicians had at their disposal hundreds of biopsies of patients with duodenal ulcers, which they were then able to examine. The bacterium—helicobacter—was found in those biopsies. Later, the helicobacter was cultured by one of the doctors, who drank the broth containing it, just to make sure that it was the cause of duodenal ulcers. He developed an ulcer and then had a biopsy to prove it. We tend to experiment on ourselves, not our patients.
§ I tell that story to illustrate the fact that the clinician did not suddenly decide, in the middle of his work, "Ah—time for research", and put on a research hat. Research is merely part and parcel of the clinician's way of life. It is also worth pointing out that a patient who is part of a controlled clinical trial is managed in a very strict scientific protocol, and is therefore likely to receive better management than patients who are not in a trial.
§ We often take a three-centimetre slice of one of the minor nerves in the leg—the sural nerve—for diagnostic purposes, and we are teaching the junior staff how to carry out that procedure. It can also be for research purposes at that time, or years later the material may be invaluable in new research as more advanced techniques become available to analyse the tissue. It should be agreed that all education and training, whether it relates to health or research, is included in the purposes not normally requiring consent. As a minimum, we propose that the exemption from the consent requirement applicable to research using anonymised tissue is extended to education and training for research purposes. I beg to move.
§ 4 p.m.
§ Lord Clement-Jones
I rise not only to support Amendments Nos. 3, 4 and 13, to which I added my name, but also to speak to Amendments Nos. 9 and 16. I cannot be as graphic as the noble Lord, Lord McColl, the Committee will be glad to hear, but the argument is a strong one. 413GC Research using tissue taken ante-mortem may be conducted without consent if the research is ethically approved and the tissue is anonymous to the researcher. However, this exception to the consent requirement does not extend to education and training relating to research. There does not appear to be any justification for taking a stronger line on the former than the latter, for the reasons that the noble Lord, Lord McColl, has put forward. It would therefore seem logical, as a minimum, to extend the exception to education and training relating to research, with one modification. The requirement for ethical approval would be unnecessary and inappropriate—ethical approval is not generally required for education and training, nor do systems exist to provide this.
The subsections proposed in Amendment No. 9 would permit education and training relating to research to be conducted on ante-mortem tissue without consent if the tissue is anonymous to those using it, bringing the position on education and training relating to research more in line with the position on research itself.
I turn to Amendment No. 16. Unlike education and training relating to health, education and training relating to research currently falls under those purposes generally requiring consent. It is unclear why this distinction has been made. We certainly foresee difficulties which appear to be shared across both Opposition Front Benches in making the distinction in practice. All education and training, whether it relates to health or research, should be included in the purposes not normally requiring consent. As a minimum, we would propose in this amendment that the exemption from the consent requirement applicable to research using anonymised tissue is extended to education and training for research purposes. The requirement for ethical approval would not apply in line with the approach to training generally.
The effect of Amendment No. 16 would be that all education and training would be in Part 2 of Schedule 1 and therefore would not require consent to be conducted using tissue taken ante-mortem.
§ Lord Walton of Detchant
I support these amendments, but do so with one qualification, although again the Minister may well reassure that me that the concern I now wish to express is already covered in the Bill. However, nowhere in Schedule 1 do I find the word "diagnosis". Tissue is often removed from the human body not for research, but that is not covered in Schedule 1. Schedule 1 states that the purpose may well be to determine the cause of death or to obtain,scientific or medical information about a living or deceased person which may be relevant to any other person".I am sure that these amendments would be strengthened by the addition of the word "diagnosis", with a view to treatment. I believe that that is one of the major purposes for which tissue is removed from the body of a living person.
§ Baroness Finlay of Llandaff
First, I apologise to the Committee for not having thanked the Minister for his reply to my previous amendments. Having had a very relaxed summer, I was a million miles away.
414GC I should like to speak to Amendments Nos. 3, 4, 13 and 15, but to address my remarks particularly to Amendment No. 13. The difficulty with which we are faced in the reality of training people to become clinicians and to work and acquire the skills they need to undertake research in a clinical context is that they have to be trained in the methodology. As the Bill stands, while those in training will be able to use historical samples that are already stored, they will not be able to use samples prospectively. Therefore, they may not be able to look prospectively at new techniques or even at new syndromes as they emerge.
That is particularly important in genetics. In genetics, you have to be able to link the sample in front of you to the clinical case scenario that you are pursuing. You have to be able to identify the very specific gene changes. Junior doctors in training need to learn how to do the technique. Very often in the process of their training they will undertake a series of examinations and pull those together, out of which they will probably, it is to be hoped, get a paper. That will be for the common good, will inform the rest of the clinical community and therefore will improve patient care across the board.
However, because they are in training, they are going through quite rapidly. Unfortunately, at present the process of going to local research ethics committees is cumbersome. Because standard guidance has not been issued and is therefore not in place, ethics committees deliver different decisions in different parts of the country. Those in training need to be able to work through and learn the techniques. They need to undertake the diagnostic processes. Moreover, there is an integral link between education, research and training. It would be wonderful if we could unhook them and put them in very clear compartments, which the Bill has tried to do. However, the reality of training the next generation means that we cannot do that.
In their White Paper published in 2003 entitled, Our Inheritance, Our Future, the Government recognised the recruitment and training problems and the need to expand genetic clinical scientists in the workforce. I hope that the Minister will recognise the wisdom of the amendments and the fact that we cannot have an artificial separation which does not recognise diagnostic processes and the training of the next generation to improve services for the next group of patients.
§ Baroness Hayman
I rise briefly in support of the thrust of the amendments, in particular Amendments Nos. 3, 4 and 13. I remind the Committee of my interest as chairman of Cancer Research UK.
The case has been made that there will be enormous difficulties in differentiating between research and training in health and education and training in research techniques. To put that distinction in the Bill will be thought to cause more practical problems. However, there is a more fundamental reason for including training into research techniques within the ambit of the Bill as not needing consent.
415GC The noble Lord, Lord McColl, said that research was part and parcel of a clinician's life. Sadly, that is less the case these days. The diminution in the research capacity of many practising physicians and surgeons is a worry to us all. It has to be a concern that all clinicians are trained in research techniques in order to provide a better service to their patients. As more and more medicine is related to the assessment of the quality of research, if patients are to get good advice from their general practitioners, junior hospital doctors and those who are not going to pursue careers in academic medicine, it is vital that they are well trained and able to assess the research findings put in front of them.
It is enormously important for patients that nothing in the Bill inhibits the training of clinicians in research techniques. I always remember how the previous director-general of the cancer research campaign used to stop audiences in their tracks and say that he believed that we should get informed consent from patients for them not to be entered in clinical trials because there was so much evidence that those who were, in whatever arm of the trial, did better than those receiving standard treatment. That assertion makes one think, even if one does not subscribe totally to it. However, it underlines the importance of research techniques becoming once again part of a clinician's life. I would not like to see anything in the Bill that would inhibit that.
§ Lord Warner
I will try to take the amendments together, as they seek to achieve a similar result by different routes. I shall detain the Committee a little while by talking about the technical effects before dealing with some of the substantive arguments that underpin the ideas that lie behind the amendments.
The first two amendments seek to allow education and training in health research using material from the living—that is, residual tissue—without consent, where the same safeguards are in place as are required for use without consent of such material in research itself. The amendments to Schedule 1 do not work with the amendments to Clause 1, but seek to achieve use without consent of residual tissue for research education and training by a rather different route. They would remove the requirement for consent to the storage and use of residual tissue for education and training in research altogether, by putting all health-related education and training into Part 2 of Schedule 1. The effect of that would be that education and training in health research using residual tissue would not require consent or any other safeguards. However, the amendments to Clause 1 already propose that such use should be lawful where certain safeguards are met. Not all the amendments could work together as there are inconsistencies. That is a technical explanation of the Government's interpretation of the amendments.
I appreciate that the thinking behind the amendments is very much driven by medical scientists who maintain that it is difficult, as several Members of the Committee 416GC have said, to differentiate between research and training for research, and that they do not wish to ask for consent. To respond to the amendments, I must go back to the origins and principles of the Bill. When we first drafted the Bill, we wanted to allow education and training related to the delivery of care without consent, because patients expect that, and the Bill originally included "on the job" training in Part 2 of Schedule 1. We were told by medical educators that "on the job" training was difficult to distinguish from education in a more formal setting. We tabled amendments to ensure that all education and training related to care could be carried out using tissue from living patients without consent. We have already responded to many educationists' concerns on the issue.
Now we hear that education and training related to research is difficult to distinguish from education and training related to healthcare, and from research itself, so it should also be allowed without the patient's consent. Given the context of the Bill—that we are promoting a consent-based environment—research-related activities do not seem part of what people would expect when their tissue is taken for diagnostic or treatment purposes. I can reassure the noble Lord, Lord Walton, on diagnosis. The Bill itself does not in any way cover the removal of tissue from patients or its use for diagnosis or treatment, so there should be no concern about that. Only the usual common-law consent requirements apply, with which the Bill does not presume to interfere.
For many people, it is one thing for such material to be used for training doctors who treat people, but not quite the same for the training of researchers who may not themselves treat patients. There is a distinction in many people's minds that can fairly be made, however unacceptable the thought might be to some researchers. We have to understand the origins of the Bill. However, that does not mean that all research training is impossible unless there is consent for the purpose. Clearly, where a trainee is observing a research procedure, there is no difficulty. Equally, if a postgraduate student has a research proposal approved by an ethics committee, the learning would be part of the research and that would proceed in the usual way. However, if tissue samples—we could be talking about sizeable items—are to be used solely to teach someone how to use a piece of equipment, that is a different matter, and one where consent should be required.
We do not wish to create an environment where residual tissue can be used for all training and education irrespective of how far removed it is from the original purpose for which the tissue was taken. It would be anomalous if residual tissue could be used for education and research without consent while consent or safeguards are required for the same tissue in research. Lines have to be drawn somewhere, I would suggest, if the purposes of the reforms in the Bill—to restore public confidence—are not to be eroded.
417GC I always feel a little nervous arguing clinical matters with the noble Lord, Lord McColl, but I am still going to chance my arm a little. One of the cases he cited entered the department's top 10 list of myths in the Human Tissue Bill; it has now risen to the top 12 myths. The case he quoted is one of these myths in terms of stopping earth-shattering research. It is simply not true. Studies of the kind mentioned by the noble Lord could take place in future without patients' consent, with ethical approval and anonymisation of tissue. Use of existing holdings requires no consent and, again, services could also introduce procedures asking for generic and enduring consent to research at the time samples are taken. So I do not think we are stopping the advance of science in quite the way the noble Lord seemed to suggest with his example.
I also remind the Committee that resources of tissue will remain available for use in training and research techniques without consent following the passage of the Bill. Existing holdings of tissue—that is, tissue held for scheduled purposes—when the Bill takes effect will be available for use for any scheduled purpose without a requirement for consent and subject only to a code of practice issued by the Human Tissue Authority. There should be no difficulty about easy access to tissue for educational training related to research.
I hope the Committee will accept that we have drawn the line in a reasonable place and will feel able not to pursue the amendment.
§ Lord Winston
I wish to reply to the Minister very briefly. It is not true to say that new techniques would not be interfered with. For example, in the field of genetics, to which the noble Baroness, Lady Finlay referred, the way in which tissues are stored makes a huge difference. Now, increasingly, you can recover things that you could not recover even three years ago—for example, DNA, RNA and chromosome investigation. There are new techniques which we continue to expect in all kinds of staining of tissue which are not available, or have not been available, because of the way in which the tissue has been preserved and maintained. It is a fact that we have to face. We have to face some restriction and we should be honest about it.
§ Lord Clement-Jones
I am sure the Minister will respond and, no doubt, the noble Lord, Lord McColl, will wish to respond.
The Minister has answered on very broad policy grounds; he has not tried to unpick the amendments to any great extent. Although I understand his reasons for doing so, that is very disappointing. He clearly does not accept the concrete examples that have been given. I suspect that the proponents of a changed regime for education and training on research techniques will have to come back with chapter and verse in concrete terms to demonstrate to the Minister that there are problems which will cause difficulties, and to persuade him otherwise. It is only by sheer volume of evidence that we shall be able to persuade him. 418GC Although I do not agree with the Minister's caution, I understand it in the light of previous events. But I think he is being overly cautious. Clearly we must try harder and come back to this issue at a later stage of the Bill.
§ Lord McColl of Dulwich
I thank the Minister for his reply. Clearly, he has firmly fixed in his mind the fact that there are researchers and clinicians and that the two are divided, but that is not so. I wonder whether he thinks that it is all right for junior clinicians to do research, but that once they become established as clinicians and are no longer in training, somehow or other we move to a different scene.
I agree entirely with the noble Lords, Lord Winston, and Lord Clement-Jones. I think that the Government will eventually be persuaded on this matter because the evidence is overwhelming. Meanwhile, I beg leave to withdraw the amendment.
§ Amendment, by leave, withdrawn.
§ [Amendment No. 4 not moved.]
§ Earl Howe moved Amendment No. 5:
Page 2, line 42, at end insert—
( ) the person from whom the material has come has not withheld his consent to the research
§ The noble Earl said: This is a simple amendment but it covers an important point. When the Bill was in another place, significant changes were made to the provisions relating to consent for various activities involving tissues where the tissue comes from a living person. These changes are reflected in Clause 1. The result is that a large number of activities involving tissue taken from living persons, including certain types of clinical research, will now be exempt from the consent requirements.
§ While all that is very welcome, the Bill should not overlook the possibility that a person might object to the idea of his tissue being used for any purpose other than the diagnosis and treatment of his own condition. Not many people perhaps would adopt that sort of attitude, but it is conceivable to imagine that someone might. Simply because the Bill now says that a person's consent for a particular activity is not required, we should not thereby negate that person's right to express his wishes about the use to which his tissue is put. On the contrary, his wishes should be respected. I beg to move.
§ Lord Warner
The effect of the amendment would be to allow use of residual tissue in research without consent, where anonymised and with ethical approval, but only where the person whose tissue was concerned had not "withheld his consent to the research". Although there is no stipulation in the amendment, that implies that a person's consent needs to be asked, possibly to the particular research project envisaged, so that he could express a view. It is difficult to see how else a person would be given an opportunity to withhold consent. Getting people to respond to posters or the like by objecting would bring us to "presumed consent", but that would discriminate against certain groups of people.
419GC During the course of debates on the Bill in the other place, the research community has consistently said to the Government that a requirement always to seek consent of living patients to use their tissue in research would be a major obstacle to medical research in this country and would ultimately damage patients as a result. The Government therefore introduced amendments in another place to allow use of residual tissue without consent, provided the tissue was anonymised and the research had ethical approval. However, we believe that this particular amendment would negate the concession brought forward in another place, which has been generally accepted as a sensible way forward by the medical research community.
I would not wish to give the impression that the Government think that the views of patients should be ignored. On the contrary, we wish to enlist the support of patients in medical research for the good of us all. That is why we have made a requirement for consent the default position for using tissue for research. Ministers have made it quite clear that, notwithstanding the fact that it may be lawful to use it without consent if it is anonymised, if an individual particularly does not wish his tissue to be used in research, then it would not be good practice to do so. We would not expect tissue to be used in those circumstances. Code of practice guidance on this will be issued by the Human Tissue Authority and tissue storage facilities and their records will be licensed and inspected accordingly.
However, the practical effect of the amendment would be to bring about a situation whereby patients may have to be invited to give or withhold their consent. It would also entail an onerous process of having to check the records of all patients from whom potential research samples have come, in case they had withheld consent. That would be a considerable bureaucratic problem. I am sure that it is not what the noble Lord had in mind when he tabled this amendment, but I would ask him to reconsider the position in the light of what I have said because I think that it will add to the concerns and demands on the medical research community.
§ Baroness Finlay of Llandaff
Would a consent form completed at the time a specimen is taken, whereby patients donate tissue as part of the process before, for example, going into surgery—and donate any residual tissue to be used for education and research purposes—be a lawful consent and completely covered by this Bill? Could tissue so acquired then be used for research purposes provided that it remains anonymised? I ask this as a point of clarification.
§ Lord Warner
I think that we have always said that where a patient has given a clear consent to the use of tissue for research purposes, that is a continuing, generic consent that would endure. I hope that reassures the noble Baroness.
§ Earl Howe
I am grateful to the Minister for his reply and of course I would be the first to recognise that the 420GC amendment as drafted may not quite achieve the purpose that I had intended for it, and that there are unintended consequences. However, I am not quite reassured by his undertaking that this will be covered in guidance.
In 2001 we debated Section 60 of the Health and Social Care Act and the provisions concerning the disclosure of confidential patient information. We had long exchanges about presumed consent to the disclosure of patient data and when that might be permissible in the absence of explicit consent. This was primarily in the context of cancer registries. The Health Service (Control of Patient Information) regulations followed in 2002. Never did it occur to me during any of those debates that, where a patient had expressly objected to the disclosure of information about him or herself, that those wishes would not be respected. Both the Act and the regulations are silent on that issue, but it was one that I and, I suspect, others took as read on the basis of accepted medical practice.
The Minister may recall that I wrote to him in June this year about the case of a patient who had recorded an express wish for the details of her cancer not to be passed to a cancer registry. Despite that, the hospital did pass the details across. When the patient found out and requested the registry to delete the information it was holding about her, the registry—having taken legal advice—refused to do so. It refused on the apparent grounds that nothing set out either in Section 60 or the 2002 regulations stated that a patient has the right to object to this type of information being disclosed. The Minister may know that I am due to see his colleague, Melanie Johnson, about this case and its implications.
I am well aware that we are dealing with human tissue in this Bill, not data, but the underlying principle of patient autonomy is exactly the same. Despite what the Minister said, and I realise that he is trying to be helpful, I still think that we need somehow to make it absolutely clear, beyond argument, that if a patient articulates an express objection to his tissue being used for any particular purpose, those wishes should be respected. There should be a right in law for that to happen.
§ Earl Howe
I was referring to Clause 1(9), which, in shorthand terms, is the requirement for the anonymisation of tissue. I am one of those who find the presence of this requirement surprising and odd. At Second Reading, the Minister said that nothing in the subsection would oblige researchers to ensure that the tissue should be disconnected irretrievably from the medical record. He said that so-called reversible and linked anonymisation would be permitted.
Of course, I take the Minister's assurances at face value. But, given those assurances, it is a mystery to me why subsection (9)(b) should be worded in the way that it is. By the Minister's own admission, clearly, there are circumstances where the identity of the tissue donor may have to become known to the person carrying out the research. That is especially so in the case of epidemiological and genetic research where the results of the research have little value unless they can be correlated 421GC with clinical information about the subject—sometimes very detailed information. Indeed, it is often the little detail about someone's life or circumstances that can lead a researcher to make a connection or a discovery that is of major importance.
In certain other sorts of research the requirement for identifying information to be withheld from the researcher may be entirely acceptable and uncontentious. What is surprising is to see that requirement written into the Bill as a blanket precondition for all research of that particular kind. It seems to me that that is not a matter for the face of the Bill. If complete anonymisation is something that a research ethics committee believes is appropriate, it will be able to insist on it as a condition of approving a research proposal. On the other hand, if reversible or linked anonymisation is thought to be a necessary feature of the project, the conditions governing the linkage or the reversibility can be spelt out as a condition of the approval.
In some cases, it may be thought that no anonymisation is appropriate; for example, where it is the clinician or pathologist concerned with the clinical care of the patient or the clinical examination of the tissue who wishes to carry out research on that tissue. There will he instances of that. Therefore, just as in other areas of the Bill, we say that we cannot generalise about what must happen in all conceivable cases, so here it would be better to say that the Bill need not make any stipulation about anonymity but rather that the HTA should be charged with the task of ensuring that codes of practice and standards are in place to guide researchers and research ethics committees as to what degree of anonymity may be appropriate in individual cases.
At Second Reading, the noble Baroness, Lady Hayman, made a wise observation when she said that what mattered to patients was not anonymity but medical confidentiality. In other words, if a doctor or medical researcher had a need to know the identity of the patient, so be it as long as that knowledge was not shared indiscriminately among those who did not need to possess it. That is a common-sense approach. We do not need to write anything into the Bill about medical confidentiality because it is already inbuilt into accepted medical ethical practice.
I hope that what I have said will have some resonance with the Minister. I believe that the Bill is currently over-prescriptive. I also believe that the Government's rationale for including subsection (9)(b) has never been satisfactorily explained. It would be very good if we could resolve what, for many scientists and researchers, is a source of considerable bemusement, not to say worry. I hope that we can. Therefore, I beg to move.
§ 4.45 p.m.
§ Lord Clement-Jones
I support the amendment of the noble Earl, Lord Howe. It is very important. As the noble Earl noted, a number of noble Lords raised these issues on Second Reading. The logic of the noble Earl is incontestable, particularly his point that this is an issue for research ethic committees and a matter of medical confidentiality rather than anonymity.
422GC In many respects, the Minister repeated what Rosie Winterton said in the other place. He gave the assurance that it was not permanently unlinked but, nevertheless, he stood his ground in terms of saying that the critical issue in these circumstances is that without consent the researcher does not have the name.
The Minister conceded that practical issues may be involved. This is where the practical issues impinge on principles. I am not a clinical researcher or a medical researcher, but I have no doubt that the Minister could be more enlightened by the experience of others in the Committee.
From the exchanges in the other place, it seems that the way in which that re-linking will take place will he extremely difficult and complicated. Certainly a researcher looking at the tissue would need to consult a third party colleague—and that third party colleague would have to link the sample—but the researcher would not have the identity; and yet the identity, in certain circumstances, for the purpose of research, would be necessary.
This seems to be setting up a huge barrier on an issue which, in practical and ethical terms, could be dealt with as a matter of course on the ground for the purposes of specific research. That seems to be utterly logical as a course of action.
Having debated but four groups of amendments, I have this awful feeling that, as we go through the Bill, ministerial caution, for understandable reasons, will be a real problem and a barrier to commonsense and practical solutions.
§ Lord Walton of Detchant
under the guidance of the General Medical Council, medical confidentiality includes the requirement that it is right for a doctor to consult with and if necessary advise, in relation to the management of a patient, a professional colleague, who will also maintain confidentiality. I can think of innumerable examples from my personal clinical practice where, in the pursuit of research, I have examined tissue which had been removed from patients who were patients of another colleague, and where, some years later, things came to light which made it absolutely clear that there were important issues to be raised in relation to the management of that patient. I then consulted the doctor in charge of that individual.
That is one of the reasons why this clause simply should not be allowed to stand. I support the amendment.
§ Baroness Finlay of Llandaff
I have put my name to the amendment and I support it very strongly. Two other situations can arise, quite apart from the ones so clearly elaborated by the noble Earl, Lord Howe. In a clinical academic's routine practice, he or she will have some specialisation interest and will see patients who have been referred, possibly from all around the UK. He or she will often have undertaken a biopsy. With time, that clinical academic may well think that there is a strange subset that seems to respond differently to treatment.
423GC The clinical academic will know the names of those patients and will have been integrally and intimately involved in their care. He or she will also have looked at their histology from a biopsy taken. He or she would then need to pull these together to look at them systematically and, in a research project, quite separately. In so doing, not only does he know the identity of the patient and, indeed, all the personal details of the patient that have been disclosed; he will also know exactly what the histological specimen looks like. So to try to unlink those two becomes impossible if you want the clinical academic unit to be able to pursue the research.
The other situation that can arise quite separately is that of a pathologist who has looked at a specimen and may easily remember the visual picture of that specimen. In the process of research, he may see that slide again if it is brought out, and recognise it. Fortuitously, that pathologist will then know the patient that the specimen came from because of the clinical details attached to the original pathology request form.
As far as I can understand, and as the Bill is drafted, that pathologist is then committing an offence by having been so vigilant and so involved in his clinical diagnostic processes that the picture of that slide has remained in his memory, possibly for many years. Certainly, in clinical practice when you see something visually unusual, you remember it for many years, possibly a lifetime. If you are researching an unusual condition, you will be seeing unusual things and are much more likely to remember them.
This clause seems to cut across and hamper any kind of clinical academic service, provision and advance, which is essential for the care of patients. I sincerely do not believe that patients want to stop advances in research. They do not want pictures of their condition broadcast. Of course they require confidentiality. Any research publication must be completely anonymised so that nothing is traceable, but it becomes unrealistic to expect the clinical researcher to be able to uncouple completely any identity.
§ Lord Winston
During Second Reading I made a point about my own research, which clearly would have been possible only with the kind of linkage that pertained previously. However, I want to make a special plea to the Minister today of a really personal nature. It refers back to a clinic I did this morning. It is a general issue about confidentiality and the protection of the anonymity of patients.
§ In 1990, Parliament passed the Human Fertilisation and Embryology Act. Ever since then we have been dogged with this issue of confidentiality, which works so often against patients but is enforced by the regulatory authority in various ways. So for example, as happened this morning in my clinic, the human fertilisation and embryology notes as properly required by the regulatory authority were separate from the patient's notes. As often happens in hospitals, because these things were separated, there was a long 424GC delay in being able to treat a very anxious patient who became increasingly nervous about her fate. That kind of problem is inevitable in the service.
§ It seems to me quite inappropriate to make stringent demands of this kind in all sorts of ways, and not only because it inhibits research. I believe that it will inevitably inhibit good clinical practice—as it did on several occasions this morning in my clinic, but on one particular occasion for this one patient—as it often does. Even in the best-run services, that is inevitable when research, teaching and clinical work are separated in this way. I beg the Minister to consider this matter carefully.
§ Baroness Hayman
When we debated anonymity at Second Reading, the Minister helpfully acknowledged that there would be cases in which establishing linkage and reversing anonymity would be essential and justified and that there would be processes and procedures so to do.
§ However, the concern remains that we were setting up a system that presupposed that we had to put in place all the processes relating to anonymity and then reverse them so that there would be a system for de-identifying every sample and then a form of scrutiny to see whether it was justified to re-identify and re-link those samples. The noble Earl, Lord Howe, seems to have come up with rather an elegant solution to that problem.
§ For all the reasons given by the noble Baroness, Lady Finlay—we have had different examples of what could happen—I would be much more comfortable with placing the burden of making decisions and recommendations on whether anonymisation, which would be the norm, should take place, or whether the circumstances of a particular piece of research justified linkage and de-identification, with an ethics committee that looked at a particular project, rather than having to go through a process that presupposes anonymisation and then allows another process. That is where we come to the bureaucracies referred to by the noble Lord, Lord Jenkin, and the general disincentive to the undertaking of research that can come from overburdensome regulation that ends up not being in the patient's best interests. For that reason, I support the noble Earl's amendment.
§ Lord Warner
As a number of Members of the Committee have said, the amendment seeks to remove the requirement for anonymisation of residual tissue when it is used without consent and with ethical approval. That would make use of residual tissue for research without consent, and it would only have to acquire ethical approval.
§ As I set off along the path of arguing against the amendment, I am very conscious that I shall probably be told later how cautious I am being by the noble Lord, Lord Clement-Jones. However, I have something to say gently to him. In one of his rhetorical flights, he said that there was a huge barrier to consent. However, there is quite a simple solution—it is called asking the patient, and I shall come back to it in a while.425GC
§ I have to detain the Committee a little by going through the history of the issue. The concessions made in the other place mean that residual tissue from patients can be used in research without consent if the research is approved in accordance with regulations—we expect that to be by an ethics committee—and the researcher cannot identify the person from whom the tissue came. The researcher will therefore be able to access anonymised information from the patients' medical records, but if he wants to use residual tissue of identifiable patients he must ask the patients' consent.
§ We ended up with that formulation in the other place—it was introduced by the Government—but not because the Government had invented it merely of its own notion. It was put forward following an extensive meeting—I attended it with my good friend Rosie Winterton—with what I can only describe as the medical-scientific establishment. There was a long discussion about the uncertainties around the Bill, in terms of its impact on research, as it was then drafted. It was the Wellcome Trust that came forward with many of the ideas, and this is the kind of the wording in the legislation. When it was proposed, it was welcomed by other professional and research organisations, which perceived no difficulties with it.
§ [The Sitting was suspended for a Division in the House from 4.59 to 5.9 p.m.]
§ Lord Warner
My noble friend Lady Andrews was enjoying this so much that she suggested that I start again. I shall resist the temptation.
§ As I was saying, we have been through a process of consultation with the leaders of the medical profession and the scientific community in this area which has resulted in these arrangements on anonymisation and the consent of ethical committees. We thought that we were producing a solution here that actually was in the interests of the medical research community. Now, we hear that this will create difficulties in the case of research without consent conducted by the patient's own doctor or by a pathologist holding patient records.
§ The Government's position is that in these circumstances the clinician should seek the patient's consent or should seek the assistance of a third party in anonymising the samples if, for whatever reason, consent cannot be sought. In our view, a treating clinician is particularly well placed to obtain his patients' consent. It is difficult to see why he or she should have a major problem. If they do, then the anonymisation requirement is an important safeguard for the patients.
§ There is also some misunderstanding about the issue of confidentiality. The requirement in the Bill that the researcher should not know the identity of the patient if he or she is using the tissue without the patient's consent is really about fairness and balance. If the researcher is to use tissue without the consent or knowledge of the person from whom it came, then in fairness he should not know the identity of that person. It is inappropriate for doctors or researchers to be in a position where they hold tissue and names, and 426GC potentially discover relevant new clinical information through a research project, when the patient has no knowledge that research might be conducted using their tissue.
§ That is the principle we are seeking to enforce in this legislation. We believe that researchers need to respect it as part of—I repeat—the balance that the Bill seeks to strike in what has been an extremely contentious area.
§ If the researcher really needs to know the identity of the patient in order to access his identifiable clinical records, for example, he should ask for the patient's consent. We accept that there is a need for linkage, and we have done nothing in the Bill to prevent linkage. It would be surprising if ethical committees did not require a researcher to ask for consent in these circumstances, and a number of noble Lords have hinted that they believe that that would be the case.
§ Furthermore, this provision is in keeping with the data protection principles which require patients to be provided with information on the uses to which data they provide will be put. It also reflects the principles identified by the Patient Information Advisory Group, as the noble Earl, Lord Howe, said in an earlier debate, which include the "ask or anonymise" principle.
§ A key purpose of the Bill is to rebuild trust between the public and the medical science community so that research can go forward with public support and confidence. We believe that we have amended the Bill to take account of concerns of a major swathe of opinion in the medical research community. So although I understand where the amendments are coming from, I do not think that they would support the kind of balance that I have suggested. I hope that noble Lords will be able to reflect on this discussion and withdraw the amendment.
§ Baroness Finlay of Llandaff
Can the Minister confirm that the pathologist who fortuitously recognises and therefore knows about a specimen in the course of a research project will not be committing an offence because he remembers who that specimen came from? That is terribly important when one operates with a very small number of people with the expertise in a given field, which can itself be very small and precise. We do not want to say that a pathologist cannot be involved in a research project just in case he recognises where a sample came from. That would destroy the whole process of moving knowledge forward.
§ Lord Warner
In the circumstances which I think the noble Baroness, Lady Finlay, is outlining, if the researcher had a reasonable belief that he had conducted his research in the right and proper way, I cannot see that he would be guilty of any particular misdemeanour. No doubt there will be quirks of circumstance where someone does recognise a particular individual. However, providing that he set out on his research with the right approach—trying to adhere to the provisions on anonymity, consent and ethics committee approval, or the appropriate combination of those—I see no reason to believe there will be a misconduct problem.
§ 5.15 p.m.
§ I was very impressed by what the noble Baroness, Lady Finlay, said about the position faced by clinical academics where anonymity would make certain research unworkable. The Minister says that there is a very simple answer to all this, which is to obtain the consent of the patient. It seems to me that, given what I am led to believe is a very frequent need to identify patients in research projects, the concession made by the Government in another place is illusory because, in practice, consent will have to be obtained from living patients time and again if a researcher or clinician wants to proceed with a particular project.
I still do not understand why this cannot be a matter left to the code of practice and to research ethics committees to decide upon on an ad hoc basis. As drafted, the Bill seems to be a disincentive to certain types of research. I am still in the dark as to why, if linkage and reversible anonymisation is to be allowed, subsection 9(b) is worded as it is. It states:
Research falls within this subsection if …
(b) it is to be, or is, carried out in circumstances such that the person carrying it out is not in possession and not likely to come into possession, of information from which the person from whose body the material has come can be identified".
It is the words,
not likely to come into possession
that puzzle me if reversible and linked anonymisation is to be permitted. I simply do not understand why that wording has been put in.
§ However, I have no doubt that we shall return to this matter at a later stage. I am sure that the Minister has gone as far as he possibly can at this stage. With time moving on, I beg leave to withdraw the amendment.
§ Amendment, by leave, withdrawn.
§ Lord Jenkin of Roding moved Amendment No. 7:
Page 2, line 46, at end insert—
( ) For research that is ethically approved in accordance with regulations made by the Secretary of State under subsection (9) above, the body responsible for providing such ethical approval shall be subject to performance standards, including but not limited to expert review and fixed approval time requirements, consistent with the relevant standards specified in other codes, regulations or legislation relating to other forms of human subject research.
§ The noble Lord said: In listening to the debates that have taken place so far, I am very disturbed by the reluctance of the Minister to concede anything on any of the arguments that have been advanced, notwithstanding the huge distinction of a number of Members of the Committee who really do know what they are talking about.
§ Nearly four months elapsed between the end of Committee stage and Report stage in another place. It was during that period that intensive pressure and 428GC discussion led the Government to go part of the way to recognise the fears of the research community. We shall not have that luxury. We shall have to try to finish the Bill so that it can be completed in this Session. I really do beg the Minister, when he comes to address these matters, to recognise that given the virtual unanimity of the support which has existed for a number of the amendments as voiced in this Committee, he will find himself with amendments carried against the Government on Report and will then perhaps have very little time to try to reverse them in another place.
§ So, with that introductory plea to the Government to perhaps acknowledge that there is more to be said for what has been advanced so far than he has recognised, it would be in his and the Government's interests to make some concessions in that regard.
Amendment No. 7 covers a different matter and relates to research ethics committees. When I was deciding how I was going to introduce this matter, the noble Lord, Lord Patel, had not joined the Committee. I warned him that I was going to quote his very wise words from his speech at Second Reading. He said:
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".—[Official Report, 22/7/04; col. 388.]
This amendment and Amendment No. 65—which contains an alternative form of words and is tabled by my noble friend Lord Howe—attempt now to deal with this issue.
§ Research ethics committees may give professional opinions and views on the ethics of applications—and that can always be valuable—but one has to remember that it is a voluntary process. As I know from my experience as a health authority chairman, many of these committees are under-resourced and the doctors who sit on them are under great time pressures. As a consequence—and this is what the noble Lord, Lord Patel, adverted to—they are frequently unable to provide a professional service to applicants in terms of the time taken to turn round applications.
§ Furthermore—I do not place as much stress on this as we have a very broad range of experience across the country—it is true that there is variability between the levels of expertise of research ethics committees in different parts of the country. Some, I am told, are happy to deal with applications regarding research using human tissue, but it has been the experience of some researchers that other ethics committees find this an uncomfortable process.
§ The need for this activity—the application to the research ethics committee process—will be very substantially enhanced as a result of the Bill. This is something to which Ministers need to address themselves.
§ Turning to the issue of clinical trials, which is a different area, there are now specific performance expectations placed on research ethics committees. For example, regulation 15 of the Medicines for Human Use (Criminal Trials) Regulations 2004 implemented the 429GC European Union clinical trials directive into UK law. In those regulations, specific time limits within which an ethics committee must give its opinion were laid down. If it is right for that legislation, why is it not equally right for what the ethics committees will be asked to do under this legislation?
§ It seems to me that it would be entirely appropriate to have wording similar to those regulations placed on the face of the Bill. If this does not happen, and if this issue was, as it were, left at large, it is my fear that the situation might arise that applications for which performance criteria exist would take precedence and the referral of cases to research ethics committees would tend to take second place. Human tissue-based research might be hindered by the combination of limited capacity—and, in many cases, I fear, limited expertise—and the higher priority given where performance criteria is laid down.
§ Amendment No. 7 requires that the regulations must specify a time limit within which research ethics committees should give their views. It is quite possible that this very important part of the structure of the legislation will raise great difficulties. I beg to move.
§ Lord Walton of Detchant
These are two powerful amendments—and their importance was underlined by correspondence in last week's issue of the British Medical Journal, which the Minister may not have had an opportunity to read—demonstrating that COREC, the Central Office for Research Ethical Committees, is currently imposing such standards upon ethical committees as are extraordinarily difficult to fulfil.
§ One researcher wrote in that issue that it took him 19 hours to complete the 60-page form required to obtain ethical approval for a fairly simple piece of research. We are in danger of living in an over-regulated society. Having said that, I nevertheless feel very strongly that all research involving human subjects and tissue from human subjects requires ethical approval. The issue needs to be clarified and simplified. I therefore support the principle underlying these two amendments.
§ Earl Howe
I very much support the remarks both of my noble friend and of the noble Lord, Lord Walton of Detchant. One of the welcome policy shifts the Government have made since first introducing the Bill into another place has been to recognise the interests of the medical research community rather more full-bloodedly than perhaps it did initially.
§ The most important result of that policy shift has been the amendments to Clause 1 which exempt residual tissue from living people from the standard consent requirements in relation to research, subject to certain conditions. One of the conditions is that any research involving such tissue must be ethically approved in a manner to be prescribed in regulations. That is right and proper, as the noble Lord, Lord Walton, said. It reminds us that the role of research ethics committees in relation to all types of research involving human tissue, whether from a living or a dead donor, is now of crucial importance. It is important not only to ensure the ethical acceptability 430GC of what is proposed, but also to make doubly sure that all the legal requirements, such as those laid down in the Bill, have been adhered to.
§ Research ethics committees as gatekeepers are therefore in a responsible and powerful position. By the same token, however, they need to work efficiently, reasonably and consistently with each other if there is not to be delay and disruption to the ethical approval system.
§ I am sure that the Minister is aware of a degree of concern among researchers—partly as a result of the EU Directive 2001/20/EC, partly because of severely stretched budgets and partly because of a shortage of suitable people willing to serve on these committees—some RECs have found themselves under pressure. A number of people in the medical and scientific research community fear that lack of resources and pressure of work may lead to an absence of consistency in the decisions taken by RECs across the country.
§ At the same time we hear anecdotal evidence—we have heard another piece this afternoon—that the requirements laid down by some research ethics committees are becoming ever more burdensome and time consuming to the extent that some research proposals, especially those of fairly modest scale and cost, are not being submitted for scrutiny because the hassle of doing so is simply too great. The Human Tissue Authority will have a job on its hands It will need to confront these concerns head on and find a way to resolve them that does not compromise the quality of ethical decision making, which is what really counts.
§ The BioIndustry Association believes that when the HTA draws up standards, it absolutely must include performance expectations for research ethics committees in its approval process. This is to ensure that applications involving human tissue are subject to the same approval time requirements as other types of application, such as those specified, for example, in the Medicines for Human Use (Clinical Trials) Regulations 2004. I have much sympathy with that proposal, but I also think that, with the increasing pressure on research ethics committees, there needs to be some sort of formal evaluation by the Department of Health on how this Bill will impact on the workload of RECs and what additional resources those committees are likely to need in order to do their job satisfactorily—by which I mean in accordance with the standards imposed upon them.
§ I hope that the Minister will have a degree of sympathy with the concerns underlying these amendments and that he will have some reassuring words to impart.
§ 5.30 p.m.
§ Baroness Finlay of Llandaff
I rise briefly to support these amendments and I thank the noble Lord, Lord Jenkin, for having raised some extremely important issues that affect all those engaged in clinical research. There is a real problem regarding inconsistency in decision-making. A multi-centre research project can be completely hamstrung by the refusal of one REC when all the others have agreed. 431GC Quite apart from the burdensome forms that may need to be filled in, all produced in different formats, there are worries about inconsistency in decision-making.
§ Another issue relates to indemnity. The indemnity of the researchers and the principal investigator can be called into question. It is very difficult for NHS trusts, in whose employ are some of these researchers, to have to deal with different decisions being reached by different research ethics committees. I would make a plea that, as a result of this Bill, we see the introduction of some measure of standardisation. That is not in any way to diminish the importance of ethical scrutiny, but it is inefficient to have so many committees looking at the same piece of research over and over again. More time spent by one committee, and that decision being accepted on behalf of all the others, would be a more thorough approach to the scrutiny of research.
§ Lord Warner
The noble Lord, Lord Jenkin, and other noble Lords will be delighted to know that I have some sympathy with the sentiments behind these amendments. Indeed, some would say that there are no lengths to which I would not go to curry favour with the Grand Committee. No doubt the noble Lord will be pleased to learn that I have been listening to the advice he so kindly offered at the beginning of his remarks.
§ As a number of noble Lords have pointed out, we have to start from the position that independent ethical review is a vital safeguard for the individuals taking part in research. There is nothing between us here. We all want the ethics committee system to work as effectively as possible in the interests of research as well as of the people who take part in such research.
§ But as I go around the NHS and talk to a variety of people working in the medical research field, I have become increasingly aware of the growing concerns about the inconsistency and growing bureaucracy of this area. I am sure that we would gain wide support for ways to make this process much less bureaucratic. Indeed, a number of noble Lords may know that I am the Minister deputed as the Department of Health bureaucracy buster, so this sits fairly and squarely on my plate and there is no ducking the issue.
§ A number of noble Lords have recognised that we have already taken some steps to align the time limit for ethics committee review of all types of research with the 60-day time limit required by law for clinical trials of medicines. Ethics committees are now adopting standard operating procedures that apply to all types of research, and there is a system of quality assurance based on self-assessment and peer review that will soon help ethics committees to ensure that they are working to the same standards. It would be wrong, therefore, not to recognise that there has been some movement in this area.
§ I take the point made by the noble Earl, Lord Howe, that if one is imposing new requirements and demands on people, they need to be resourced to meet them, but there is a prior question: are they working as efficiently and effectively as they might?432GC
§ I intend to seek independent advice as part of taking a closer look at the operation of the whole research ethics committee system, including that of the Central Office for Research Ethics Committees, before this area passes to the National Patient Safety Agency as part of the arm's-length review on which we made an announcement just before the Summer Recess. I intend to make a fuller announcement about the review, but it would not be right to do that in Grand Committee. The announcement will explain in detail how it is to be conducted and will be made in the near future.
§ I hope that, in the light of those assurances, the noble Lord will withdraw his amendment.
§ Lord Jenkin of Roding
I must say, there is nothing like a punch-up for getting some results. More seriously, I am grateful to the noble Lord, Lord Warner, for his readiness to look at this again. Clearly I have touched a tender spot as regards the working of the RECs, but it is one with which he is now a great deal more familiar than I am. I welcome the measures he intends to take to standardise and speed up the whole procedure.
§ In the light of that it would be foolish to press the amendment, but I hope that by the time we reach Report, we shall have something that can be put into the Bill which will reflect the investigations being undertaken by the Minister. This is a hugely important part of the Bill and is a vital stage in the process, so we have got to get it right. The noble Lord, Lord Patel, was quite right to raise it at Second Reading and I hope he feels that it was worth doing so, given that we have pursued it at a later stage, as he suggested. I beg leave to withdraw the amendment.
§ Amendment, by leave, withdrawn.
§ Earl Howe moved Amendment No. 8:
§ Page 3, line 7, at end insert "(having consulted such persons as he shall consider appropriate)"
§ The noble Earl said: In moving Amendment No. 8 I shall speak to all the other amendments grouped with it. These amendments have the same purpose, which is to ensure that where the Bill gives powers to the Secretary of State to amend by way of regulation those parts of the Bill which cover key matters of principle or practical operation, the making of the regulations should at the very least be preceded by full consultation with the medical and scientific communities.
§ The Minister will have noted, I am sure, that I have not tabled an amendment for consultation on each and every regulation-making power. But where, for example, the Secretary of State is being given power to set aside the cardinal principle of informed consent in Clauses 6 and 7, augment the remit of the Human Tissue Authority in Clause 14, alter the list of those activities which require a licence under Clause 16, or completely change the list of purposes for which a DNA analysis may legally be carried out under Schedule 5—these are surely matters in which the medical and scientific communities have an inbuilt interest. They should be consulted automatically.433GC
Clause 34(1) is a prize example of why consultation is essential, stating:
The Secretary of State may make regulations requiring such persons as may be specified in the regulations to supply to such authority as may be so specified such information as may be so specified with respect to transplants".
That is a fun piece of drafting. The Government are effectively asking us to legislate on the clause blindfold. We do not know who is going to be affected by it or in what way. At the very least, those who are eventually affected should have the right to be consulted before regulations are published which concern them intimately.
However, if there is one part of the Bill where I feel most strongly about consultation, it is in relation to Clause 1. Subsection (11) asks us to allow the Secretary of State to "vary or omit" or add to,
any of the purposes specified in … Schedule 1".
Changing Schedule 1, in whatever way one chooses to do it, will have a far-reaching effect on those individuals who have to implement this Bill.
§ Schedule 1 is one of the linchpins of the way the Bill will operate. There are offences attached to any action that infringes or cuts across it. It serves to define what is and is not within the remit of the Human Tissue Authority, and it is a key element in determining whether an activity needs to be licensed under the terms of Clause 16.
By any standards, therefore, the power in subsection (11) is important. When the Select Committee on Delegated Powers and Regulatory Reform considered it, it commented that while the delegation was not in its opinion inappropriate,
the House may wish to see the criteria for its exercise, if such criteria can be formulated, set out on the face of the Bill".
That, I think, was an important statement. I have to say that I think that it would be extremely difficult, if not impossible, to formulate criteria for the exercise of the power to cover every type of unforeseen circumstance. We perhaps need to approach the committee's recommendation in a slightly different way. My amendment would ensure that those who are likely to be most closely affected by changes to Schedule 1 should be given an automatic opportunity to have their views heard if ever such changes were proposed.
§ I hope that the Minister will look sympathetically at all the amendments in this group, but I hope particularly that he will be sympathetic to Amendment No. 8, which to my great pleasure I see has attracted the support of the noble Lord, Lord Clement-Jones, and the noble Baroness, Lady Finlay. I beg to move.
§ Lord Clement-Jones
Having put my name particularly to Amendment No. 8, but to others as well, I support the noble Earl, Lord Howe. He has made an extremely good case. There are some extremely important sets of regulations. It is, at the very least, vital to hear from the Minister what proposals there are on consultation, but it would be even better to have provisions in the Bill. As the noble Earl pointed out, so many regulations are of crucial importance to the 434GC exercise of the Bill, such as—to name but three examples—regulations setting out circumstances where there can be deemed to be consent in relation to adults who lack capacity; regulations enabling the High Court to make exception orders for research; and regulations specifying exceptions to the licensing requirements.
§ This is a crucial issue and I very much look forward to hearing what the Minister has to say.
§ Baroness Finlay of Llandaff
I reiterate my support for the amendments, particularly Amendment No. 8. The Minister's description of the Bill's history and the previous consultation on it demonstrates the importance of those consultative processes. The different stakeholders involved in any regulation will be able to identify not only problems but solutions to issues that arise in the process. It seems essential that the consultation processes draw in for the Secretary of State the wide body of expertise that, in a rapidly changing society and world, will almost inevitably bring forward new information to inform the thinking and the making of regulations.
§ Lord Jenkin of Roding
I add one very short point. The need for consultation on the face of the Bill is essential if, when controversial regulations are being made, there is an opportunity to challenge them in the courts on the grounds that consultation did not take place. There are innumerable cases—one is going on at the moment on the totally different subject of airport runways—where it is said in the courts that consultation was required but the consultation undertaken was inadequate. That is the reason for putting it into the Bill. It is not enough for a Minister to say, "Yes, of course; we would not dream of making regulations without consulting widely all those who are going to be affected". That would not stand up in court.
§ If there is an obligation to consult, as set out in this group of amendments, then there is something which is justiciable. The noble Lord has recognised that this is a highly controversial piece of legislation, for reasons which we entirely understand. Therefore, it will be enormously important with the subordinate legislation and the codes of practice to get it right. To have a statutory obligation to consult is one of the safeguards which can be written into this Bill.
§ 5.45 p.m.
§ Lord Warner
Having won plaudits from the noble Lord, Lord Jenkin, on the previous amendment, I have an uneasy feeling that I am going to say exactly what he said I was going to say. I assure him that we will be consulting on these particular regulations and orders and consulting the key stakeholders as is appropriate, as has always been the custom under successive governments.
§ It is worth just bearing in mind that the key order and regulating powers are themselves subject to the affirmative resolution procedure. It would be a pretty brave Minister, then, who came along to move these orders and regulations in either House of Parliament and was unable to give some confidence that the key stakeholders had actually been consulted.435GC
§ I draw the attention of the noble Earl, Lord Howe, to Clause 34(1). That regulation-making power on transplants is directly lifted from the current Human Organ Transplants Act, which requires notification of transplant procedures to UK transplants.
§ We therefore accept the need for consultation. It is not in the Government's interests not to consult the key stakeholders, or make sure that the regulations or orders are in the appropriate form and have taken account fully of the views of those affected by any of those changes, particularly in relation to any that there might need to be over time to Schedule 1. Therefore, we accept the principle behind these amendments.
§ The amendments leave it to the Secretary of State to consult whoever he likes or whoever he thinks is appropriate—or, indeed, whoever he thinks is not appropriate. So the way they are framed does not in any way inhibit or determine the range of consultation that the Secretary of State could make. I am not trying to encourage Members of the Committee to table a more restrictive amendment; I merely say that, as framed, the amendments would only require the Secretary of State to make a decision about the appropriate consultation.
§ It is fair to say, if we look at the history in this and other areas, that Ministers under successive governments have consulted widely. It is in everyone's interests that they consult widely, not just because a Minister has said that they would do so when legislation was going through Parliament.
§ We are committed to consultation. We do not think these particular amendments are necessary, but we are extremely sympathetic to the thinking behind why the noble Earl has made the proposals.
§ Lord Walton of Detchant
The Minister will be fully aware that regulations under the affirmative resolution procedure cannot be amended and have to be either accepted or rejected. What is the force of his argument for rejecting them? How can one possibly object to these amendments, which seem to me to be adding to the actual nature and quality of the Bill? It seems a rather curious decision.
§ Lord Warner
I was trying to say, in as gentle a way as I could, that we do not think that they do add very much to the Bill. The consultations would be taking place with all the appropriate stakeholders on the particular order or regulations. The Minister would need to demonstrate before Parliament that that consultation had taken place. He would have a fairly rough time—and might well have to withdraw the order—if he could not show that that consultation had taken place.
§ He slightly surprised me by criticising the wording of the amendments in that he felt that they allowed rather wide scope for interpretation. I have taken my cue from other statutes where that is standard wording, as far as I am aware. As my noble friend Lord Jenkin said, the key is that there should be meaningful consultation every time. I think that a court would take a view of what that amounted to.
§ Again, as my noble friend said, the issue is not whether this particular Government say that they will consult, but whether there should be a requirement to do so in the Bill. One can accept the assurances of the Minister and still believe that the Bill needs amendment.
§ The Minister also said that we should perhaps be reassured that the regulations in question allow for the affirmative resolution procedure. But, in fact, if you look at the regulations relating to Clause 34(1), it is actually the negative procedure for that. Be that as it may. I have listened carefully to what the Minister had to say. I shall reflect on it between now and Report stage. In the mean time, I beg leave to withdraw the amendment.
§ Amendment, by leave, withdrawn.
§ [Amendment No. 9 not moved.]
§ Clause 1 agreed to.
§ Schedule 1 [Scheduled purposes]:
§ Earl Howe moved Amendment No. 10:
§ Page 39, line 10, after "Obtaining" insert "(other than as part of diagnosis and treatment)"
The noble Earl said: The Royal College of Pathologists has raised a matter which I have tried to address through the amendment. It has pointed out that the process described in paragraph 4 of Schedule 1—
Obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person"—
is an intrinsic part of the clinical practice of diagnostic histopathology. It is a process that cannot be separated from routine diagnosis.
§ The following example it gave me illustrates the point. Let us suppose that a middle-aged man is being investigated for jaundice. A liver biopsy is sent to a pathologist for diagnostic interpretation. To ensure that important causes of the patient's liver disease are not overlooked, the pathologist will routinely have the liver tissue sections stained by various methods which can reveal various inherited disorders.
§ Equally, the biopsy may also reveal evidence of a virus infection. All those conditions, if one takes the wording literally, are "relevant to another person". The inherited disorders are relevant to people genetically related to the patient; the virus infection may be relevant to those who have intimate contact with the patient.
§ My concern—and the concern of the college—is that unless paragraph 4 is amended, pathologists risk committing an offence if they perform investigations for the patient's benefit which, fortuitously, benefit the health of another person in circumstances where they 437GC do not have the person's specific consent. I hope that the Minister can provide reassurance on that point. I beg to move.
§ Lord Clement-Jones
The noble Earl, Lord Howe, has illustrated that there is a lack of precision in some elements of Schedule 1—in particular, paragraph 4. My Amendments Nos. 11, 12, 14 and 112 essentially try to achieve a greater level of precision.
§ When I thought about this issue, I nearly said that parliamentary draftsmen "strive for clarity", but I am not sure that that would be correct. "Strive for precision" probably would be closer to the mark. I hope that some of these points, which have been raised with me by the research and medical community, find some favour with the Minister.
§ The points are mostly self-explanatory. The noble Earl has pointed out that paragraph 4 lacks clarity. Amendment No. 11 tries to tighten that up. Perhaps the Minister would like to comment on whether it is preferable to Amendment No. 10; certainly, it tries to be more precise.
As to Amendment No. 12, simply referring in paragraph 6 to the "human body" does not seem to be as precise as it should be. That is why the words,
development or use of the whole or any part".
is suggested as an addition.
Amendment No. 14 seeks to insert,
other than public health monitoring",
in paragraph 6. This is because in part 2 "public health monitoring" is stated as a purpose that does not normally require consent. The amendment seeks to make that clear.
§ That general point is made by Amendment No. 112. To the experts in this area it is quite clear that some of the purposes in parts 1 and 2 of Schedule 1 overlap in the sense that they could he used to describe the same activity. This includes, for example, public health monitoring and research, research and clinical audit and drug efficacy testing and clinical audit. Where this is the case, it should he clear that only the requirements applicable to part 2 apply.
§ So the new subsection proposed by Amendment No. 112 would clarify that if an activity could be described as both a part 1 purpose—for example, research—and a part 2 purpose—for example, clinical audit—it would only be regarded as a part 2 purpose.
§ Clearly, some activities will fall into both parts. That clarity would be an advantage in view of the importance of Schedule 1, which really underpins the whole structure of the Bill.
§ Baroness Finlay of Llandaff
The group of amendments seeks clarity. I should like to focus my remarks around Amendment No. 10 and probe a little further in trying to seek clarity. Let me give an example to try to illustrate the matter.
§ A clinician who is involved in the diagnosis and treatment of patients needs to do a case series analysis. He wants to look back at the case series of, say, 100 cases. As I understand it, a surgeon would be able 438GC to review his notes—indeed, he might even write a paper and present it at a learned society based on perhaps his last 100 cases—by virtue of paragraph 8 of Schedule 3 to the Data Protection Act. That allows processing for medical purposes, if necessary, to he undertaken by a health professional or a person who owes an equivalent duty of confidentiality. "Medical purposes" in this section include medical research.
§ However, if a pathologist in the same situation wanted to review his last 100 cases, he would be prevented from doing so because he would be examining tissue in the form of slides, rather than case notes as the surgeon had. As such he would have to use this part of the Human Tissue Bill.
§ So one of the areas of clarification needed relates to clinical activities which are part of a diagnosis and treatment, but where again the information and knowledge is collective in terms of case series analysis.
§ 6 p.m.
§ Lord Warner
As Members of the Commit tee have said, the amendments are addressed at refining or clarifying the activities covered by Schedule 1, particularly in relation to research. I reassure the Committee that the structure of the schedule accommodates the kind of important research activities with which we are rightly concerned. The amendments are not really necessary and, in some respects, could be unhelpful. I shall deal with them in turn.
§ Amendments Nos. 10 and 11 are directed at altering paragraph 4 of Schedule 1. The former would allow any tissue to be used as part of treatment and diagnosis in order to obtain information which may be relevant to another person without the consent of the person from whom the tissue came. Alternatively, Amendment No. 11 would mean that the consent requirement applied only where the use of tissue would be to establish whether or how the information would be relevant to another person. It would not necessarily apply where it was known that the tissue would be used to provide such information.
§ I understand that, particularly in genetics, clinicians will often have stored tissue from a relative of their patient which could be used without the knowledge or consent of that relative, in order to assist the diagnosis of genetic disease. The Bill will require that consent be sought from such relatives before their tissue is used for this purpose. That seems right and proper. The principle of the Bill is that individuals should be able to determine what happens to their bodies and tissue from their bodies, particularly where the tissue is identifiable.
§ The point is not whether using relatives' tissue would harm those relatives, but that people should be able to say whether or not their identifiable genetic material can be used for purposes not connected with their own diagnosis and treatment. It is fundamental to the Bill that they should be able to do that. That is the context in which we would find it difficult to accept the amendments on principle. As a matter of practice, it seems unlikely that asking for relatives' consent will pose a major problem.439GC
Amendment No. 12 addresses the definition of research in paragraph 4 of Schedule 1. It is not evident that it adds anything to the meaning of that paragraph, which is intended to be all-embracing in the sense of covering research extending to all matters connected with human health and disease. The reference to:
Research in connection with disorders, or the functioning, of the human body",
is deliberately wide and would include matters concerning the development or use of all or parts of the body. If we add specifics such as those proposed, we risk making the paragraph appear to be a list. That begs the question of what might not be included. We have had the argument before on other legislation; the noble Lord, Lord Clement-Jones, smiles approvingly at that reference back to happy days. I prefer our wider approach, for the reasons that I have given.
§ The further amendments in the group—Amendments Nos. 14 and 112—seek to ensure that where an activity such as research, in part 1 of Schedule I, could also be considered "Public health monitoring", in part 2 of Schedule 1, it is treated under only part 2. Amendment No. 112 would extend the principle of mutual exclusivity to other Schedule 2 activities.
§ It is true that the Bill does not closely define each of the purposes which will come within the scheme of regulation. However, it could he dangerous to include a statutory definition purporting to give a comprehensive or exhaustive statement of the meaning of the terms, as there is always the possibility that a meaning in some context would be inadvertently overlooked. The Human Tissue Authority will have the role of monitoring the situation and providing information, advice and practical guidance to persons carrying out the activities within its remit, as well as superintending in relation to the legal requirements. Clearly those are practical issues to be worked out as the Bill is implemented, through the offices of the Human Tissue Authority.
§ That said, there is a particular point that I would add. If an activity can properly be described as "Public health monitoring", even though in some cases it may be possible to describe it as research, it would be quite proper, because it is indeed public health monitoring, to treat it under part 2 of Schedule 1.
§ I shall spare the Committee my very lengthy speaking note on particular definitions. If it would assist noble Lords, I would be happy to write to them in the hope that that would provide reassurance. On that basis, I hope that the amendment will be withdrawn.
§ Lord Jenkin of Roding
Will the Minister add to his note about definitions information on a point that was raised with me this morning by the General Medical Council? Its relevant paragraph reads:One of the most important reasons for new legislation is to improve clarity about the responsibilities of those collecting and using tissue. We agree with the BMA and others who feel that some terms in the Bill require further clarification, in particular, 'research'. 'public health monitoring' and 'clinical audit—.440GC The Minister may well already have those definitions in mind.
The GMC continues:
Boundaries between these activities are difficult to define but it is vital that all those affected by the legislation understand how distinctions are to be made since criminal offences are attached to misuse of tissue".
I will not read the rest of the paragraph. In this area, it could be very helpful if there were a definition. When a body of the status of the GMC raises the question, the Minister would do well to listen.
§ Lord Warner
I can reassure the noble Lord. Those are very much the topics that I shall cover in my letter.
§ Lord Clement-Jones
It was very helpful of the noble Lord, Lord Jenkin, to quote what the GMC had to say, as it is concerned about the issue. Overlap is important. I liked the Minister's expression, "mutual exclusivity", because that is surely what we are trying to achieve in terms of the clarity of Schedule 1 and its impact on the Bill. The GMC's views are worth considering at some length; it even goes on to say that if there is not clarity there may be a "bias toward classifying projects" in one way or another. That is of considerable importance.
§ I entirely surrender so far as the dreaded lists are concerned. When a Minister raises the fact that something may be a list, there are no other arguments left in the barrel. Paragraph 6 is important, and it is necessary to consult those who will apply Schedule 1 on a regular basis. It is all very well for us as legislators to look at the matter and talk about clarity, but if those who are to administer the legislation on a day-to-day basis have doubts about its effects, they would be important concerns.
§ No doubt the noble Earl will respond on paragraph 4. We shall need to consider carefully what the Minister had to say because the area is complex. I look forward to the Minister's letter and I am grateful to him for sparing us the full gory details at this stage.
§ Earl Howe
There is little that I wish to add, except to thank the Minister for his reply and his offer to write to Members of the Committee, which I am sure will be helpful. However, I shall have to consider carefully what he said in relation to Amendment No. 10, just to make sure that he covered the concerns that I raised. In the interests of time, I beg leave to withdraw the amendment.
§ Amendment, by leave, withdrawn.
§ [Amendments Nos. 11 to 16 not moved.]
§ On Question, Whether Schedule 1 shall be agreed to?
§ Lord Jenkin of Roding
I apologise for not having given notice that I would ask a question on whether Schedule 1 should be agreed to, but it follows on well from our previous debate. There is clearly a conflict of objective. The Minister laid great stress on flexibility, which is very important with such a complex piece of legislation. Where one is establishing new criminal offences—this picks up the point of the GMC—there 441GC is also a need for clarity. How can one combine flexibility and certainty, which is a better word than clarity?
§ What will the mechanism be for deciding purposes that normally require consent under Part 1 or do not normally require consent under Part 2? I stress the word "normally". Will it be the subject of regulations? Will it be the subject of guidance? Will codes be published? How will the exceptions to the rules in Parts 1 and 2 be determined, and how will people know in advance that they will be covered by "normally"? I understand the objectives of certainty and flexibility, but the schedule seems to carry them a little far. Can the Minister give us some explanation of how such matters will be determined?
§ Lord Warner
We have structured the Bill so that we have a clear statement in Schedule 1 of which purposes normally require consent and which do not. As I said, I will write to Members of the Committee to set out some of the definitional issues around particular words and phrases. We have also set up the Bill on the basis that there will be an authoritative body called the Human Tissue Authority, which will produce codes of practice. Those will be prepared in the normal way—after extensive consultation with a variety of stakeholders, including bodies such as the General Medical Council—to produce codes that are helpful to practitioners.
§ The intention on the Government's part—I am sure that it will be the intention on the part of the Human Tissue Authority—is, within the guidance given in the legislation by Parliament, to produce codes of practice that do not hinder research unnecessarily, but protect the interests of patients and make practical proposals so that people can get on with their jobs. In this area, we have to avoid the danger of trying to be over-prescriptive in a good cause—trying to achieve clarity in the Bill—and ending up having hamstrung practitioners as a result of putting definitions in primary legislation.
§ I understand the dilemma pointed out by the noble Lord, but the best way to proceed is as we are trying to do; that is, by ensuring that a code of practice is produced by an authoritative body. We will discuss how the Human Tissue Authority is composed, which is set out later in the Bill.
§ Lord Walton of Detchant
I want to say how much I approve of the use of "normally" in the schedule, if only because a medical practitioner might be accused of breaching the law in relation to the matters set out in Schedule 1, but could very properly argue that exceptional circumstances led to the breach. The word must remain in both parts of the schedule.
§ The Minister talks about the Human Tissue Authority's guidance. Is it likely to include the kind of definitions of research, audit and other matters to which reference has already been made, but which are not clarified in the Bill?442GC
§ 6.15 p.m.
§ Lord Warner
It would be surprising if, particularly in the light of the debates here and in another place, the Human Tissue Authority did not give guidance to practitioners and the world at large on what the terms meant in practice from day to day. It will recognise that it has to carry a wide variety of people with it in the interpretation of this legislation, and that it has to produce codes of practice that are helpful and practical for daily use.
§ Lord Jenkin of Roding
I apologise for coming back on the issue, but the Minister has not entirely answered the question asked by the noble Lord, Lord Walton of Detchant. In the absence of any clear exception made in a code of practice by the HTA, would it be open to a doctor to take refuge in "normally"? I would find that difficult. It is as long as a piece of a string. If "normally" is intended to imply that the HTA can issue codes of practice that will allow, in defined circumstances, particular exceptions from the lists in Parts 1 and 2, that is one thing. However, simply to allow a doctor to say, "This was a very strange case so I did not have to apply for consent", would be jolly difficult. Can the Minister add a word or two about that?
§ Lord Warner
This is a bit like being on "Mastermind". There is an old saying, "You don't buy a dog and bark yourself". We are getting very much into the territory of trying to do the job of the Human Tissue Authority before it has even been set up under the Bill. I have the slight sense that, whatever I say, I will not be able to satisfy the noble Lord because I will not be able to do the job of the Human Tissue Authority in the remaining course of our Committee.
§ I have offered to write to Members of the Committee with the kinds of definition that will be needed, and we will give our best thoughts on that. We are trying to set up a body of authoritative people who can produce authoritative guidance. As the noble Lord, Lord Walton, said, we need the flexibility that "normally" provides in the Bill. I have done my best to reassure the Committee, but I am running out of creative ideas for further reassurance.
§ Schedule 1 agreed to.
§ Clause 2 ["Appropriate consent": children]:
§ Lord McColl of Dulwich moved Amendment No. 17:
§ Page 3, leave out line 40.
The noble Lord said: In moving Amendment No. 17, I shall speak also to Amendment No. 18. The phrase,
where the subject-matter of the activity is not excepted material",
seems unnecessary. Excepted material is defined in Clause 12 in a way that already appears to exclude material removed from a dead body for the purposes of anatomical examination. We would be grateful for clarification. I beg to move.
§ Lord Warner
I accept that the issue is quite complicated and shall do my best to explain it to the noble Lord. Clause 2(5) deals with consent in relation 443GC to children, and Clause 3(4) with consent in relation to adults. They ensure that consent to public display of the body or parts of the body after death, and consent to anatomical examination—that is, examination by dissection of the body after death—can be given only by the individual themselves, before death. The consent must be given in writing and be witnessed. Neither a nominated representative nor the next of kin can consent to those activities if the deceased had not, while alive and competent to do so, consented in writing.
§ The purpose of this provision was to distinguish the donation of whole bodies for these particular purposes from other purposes addressed by the Bill, as it would not be appropriate for a third party to authorise the donation of whole bodies for anatomical examination or public display. We are aware, anecdotally, that on occasion some people do try to avoid funeral expenses by donating the body of a—presumably unloved—relative to medical science. Such donations are not accepted, are not acceptable, and would not be acceptable under our proposals in the Bill, in which anatomical examination as well as public display can be consented to only by the individual. That is the context.
§ In the Bill as originally drafted, there was no limit put on the material which was covered by this requirement for prior written, witnessed consent in relation to anatomical examination. However, we received representations from scientists in the pharmaceutical industry and others who said that the special consent requirements, combined with the broad definition of anatomical examination, would inhibit research. This was because any research involving examination by dissection on any material might invoke the special consent requirements.
§ We recognised their concerns and brought forward amendments on Report in another place. In addition to tightening up the definition of an anatomical examination, we introduced at Clauses 2, 3 and 12 the concept of "excepted material". It is only in relation to material which is not excepted material that the special consent requirements apply—that is, whole bodies and material which has come from whole bodies during an anatomical examination.
§ The purpose of these amendments in another place was to remove from the Bill the obstacles inadvertently placed in the way of research, and the amendments before us would have the unfortunate effect of reintroducing them. I should say to the noble Lord, Lord McColl, that they would have an adverse effect. This is because their effect would be that any act of examination by dissection for particular purposes on any material, including for example material received following surgery, may need specific written consent. This is not what is intended under these provisions and would entail a bureaucratic and unnecessary consent requirement in circumstances where none is needed.
§ I recognise that this is a rather complicated part of the Bill and a complicated set of arguments. However, I hope that noble Lords will take the time to read carefully what I have said. I have tried to put on the 444GC record the thinking behind the Bill and the amendments we moved in the other place, and why the amendments before the Grand Committee would not help. I hope that, in the light of this explanation, the noble Lord will feel able to withdraw his amendment.
§ Lord Jenkin of Roding
Before my noble friend replies, perhaps I may say once again to the Minister that he really needs to draw a distinction between an amendment moved for the purpose of seeing it put into the Bill and an amendment tabled simply as a peg for a query. There is no question that my noble friend Lord McColl is seeking to add these provisions to the Bill. He made the point in his opening remarks and finished by commenting that they would give the Minister an opportunity to explain this part of the Bill.
§ The last part of the Minister's response comprised a passionate appeal that we should not press the amendments for inclusion in the Bill, but that was never the intention. I hope that the Minister will recognise that there are different ways of doing these things, ones that are likely to speed up the activities of this Grand Committee.
§ Lord Walton of Detchant
Before the Minister responds, perhaps I may ask a question for clarification. Many years ago when I was dean of a medical school, I regularly received what were known locally as "body letters", whereby people donated in advance their bodies for anatomical examination and/or medical research. My legal advice at the time stressed that such written permission was a very important provision, but that after death the body of the individual belonged to the executors. On rare occasions the executors would give permission for a body—presumably that of an unloved relative as referred to by the Minister—to be used for that particular purpose. I take it that this provision will make that process illegal.
§ Unless an individual gives consent in advance for their body to be used after death for this purpose, no one else, even the executors, can subsequently grant that permission.
§ The Countess of Mar
Is there a definition of "excepted material"? I have found a definition of "relevant material", but I cannot work out where "excepted material" is.
§ Lord Warner
It is in Clause 12. My understanding is that the interpretation of the noble Lord, Lord Walton, is exactly right. I am grateful for the coaching offered by the noble Lord, Lord Jenkin. Perhaps I may offer him some on moving his amendments.
§ Lord Jenkin of Roding
I was once the Minister's boss, so I am entitled to offer the noble Lord some very gentle advice from time to time.
§ Lord McColl of Dulwich
I should like to thank the Minister very much for his reply. I shall not need to read it in Hansard. His reply was so lucid that I fully accept it and find it very helpful. I beg leave to withdraw the amendment.
§ Amendment, by leave, withdrawn.
§ Clause 2 agreed to.
§ Clause 3 ["Appropriate consent": adults]:
§ [Amenthnent No. 18 not moved.]
§ Clause 3 agreed to.
§ Clause 4 [Nominated representatives]:
§ Earl Howe moved Amendment No. 19:
Page 5, line 33, at end insert—
( ) Where two or more persons appointed under this section are regarded as appointed to act jointly and severally, the consent of any of them in relation to an activity shall have no legal force if another of them has actively withheld his consent to that activity.
§ The noble Earl said: Clause 4 deals with nominated representatives, which an adult may appoint to take decisions after he has died about what should happen to his organs and his body. The clause makes clear that where there is more than one such representative it will be possible to stipulate that they must act jointly. Failing such a stipulation, they will be taken as acting jointly and severally; in other words, independently from each other.
§ In the later circumstances, the obvious question arises on what happens when two or more nominated representatives, acting jointly and severally, disagree with one another. Are we to say that as long as one of them agrees to tissue or organs being taken from the body of a dead person and used for research, then it is all right for that to happen? Or, should we say that where there is a disagreement nothing can be removed?
§ The amendment I have tabled is intended to pose that question. Although I am not a lawyer, it seems to me that it is a question that needs to be resolved on the face of the Bill, unless the Minister can tell me that there are provisions in common law which cover the situation. I beg to move.
§ Baroness Finlay of Llandaff
I seek some clarification about the relationship between this Bill and the proposed mental capacity legislation. As far as I can understand from reading the draft guidance accompanying that Bill, a person will be able to appoint somebody with a lasting power of attorney to take health decisions on his behalf when he becomes incapacitated.
§ I wonder whether that lasting power of attorney will carry over to decisions after the person has died. For example, someone who is becoming demented with Alzheimer's may appoint someone with a lasting power of attorney whom he trusts to take health decisions in his best interests. However, during the course of that illness, which may be fairly long, the person with the lasting power of attorney may become aware of really ground-breaking research to which post-mortem tissue from the person for whom he is taking decisions might contribute. Aware of that person's wishes before being granted a lasting power of attorney, he may know that the person would want to support advances in medical research. Given that there is a stipulation that the patient must decide, but this patient has handed over clinical decision-making because he is no longer competent to make such decisions, what will the position be?446GC
§ Will the Bill dovetail with the other legislation? And will the lasting power of attorney need specifically and separately to stipulate the ability to donate postmortem tissues that could be used for the advancement of medical science?
§ 6.30 p.m.
§ Lord Warner
As the noble Earl, Lord Howe, said, the Bill provides in Clause 4(6) that where more than one person is nominated, they can be appointed jointly and severally or jointly. So, if the person making the appointment wants his representatives to act together, he can appoint them jointly. The appointer can also limit or specify the terms of the consent he wishes the nominated representatives to give. That is set out—this is relevant to the point raised by the noble Baroness, Lady Finlay—in Clause 4(2).
§ A further point is that if one nominated representative could veto the others where they are appointed jointly and severally, that would be out of step with the provisions for the next of kin to make decisions after someone's death. In that case Clause 27(7) provides that the consent of only one will suffice where more than one person has equal status in the hierarchy of qualifying relationships.
§ I shall have to take advice on the particular point raised by the noble Baroness, Lady Finlay. I am not a lawyer, as she is aware. My sense is that this is tied up with Clause 4(2) but I would need to take advice about the particular circumstances she mentioned. I am told that a person appointed under the Mental Capacity Bill would not automatically become a nominated representative under the Human Tissue Bill. A separate appointment as a nominated representative could be needed.
§ The Human Tissue Authority will issue a code of practice on consent in which guidance on dealing with situations where disagreements occur will be given. That is the best I can do in explaining this point in relation to the circumstances that have been raised. In a sense, the general thrust of the Bill is that where people have concerns about what will happen to their body or parts of their body after death, they need to be clear about who will take the decision on such issues when they make their own provisions. That is the encouragement that is provided in the Bill.
§ Lord Warner
The point I was trying to make is that where there are those difficult tensions we come back to issues of hierarchies of qualifying relationships. Unless the person had said that the decisions were to be made jointly, in those kinds of circumstances, if it was jointly and severally, there would be an issue as to whose decision was final. That is the kind of issue on which we would expect the Human Tissue Authority's code to give guidance.
§ Amendment, by leave, withdrawn.
§ Earl Howe moved Amendment No. 20:
Page 5, line 40, after "adult," insert—
( ) he is likely to derive direct personal benefit from the activity for which consent is sought,
§ The noble Earl said: In Clause 4(10) the Secretary of State is empowered to make regulations covering the qualifications necessary for a person to act as a nominated representative. We are given no clue as to what those qualifications might comprise, not even in the Explanatory Notes, which is a pity. The only requirement spelt out on the face of the Bill is that a representative has to be an adult.
§ Obviously, regulations present a more flexible way of dealing with this kind of issue than putting a whole lot of measures on the face of the Bill. But there is perhaps one other attribute, apart from being a minor, which should disqualify someone from exercising a decision under this type of appointment, and that is where the person is set to derive a direct personal benefit from that decision. You surely cannot have a representative consenting to the removal of an organ for transplant if the organ is destined for himself. That would obviously amount to a direct conflict of interest. There are other sorts of example, but this one is perhaps the most obvious. I hope the Minister will tell me that, at the very least, this issue will be covered in the regulations. If so, I will be content.
§ I am not sure about what other requirements the regulations are likely to lay down. If there are going to be a great many, then one has to wonder about the practicalities. Let us imagine that someone has died and his son has been appointed as the nominated representative. The doctors want a decision about the possibility of removing organs or tissue from the body. It is easy enough to establish that the dead man's son is an adult, and it should be relatively straightforward to go through a brief factual checklist to ensure that he was legally empowered to give consent. But the operating word is surely "brief". If the regulations are likely to contain a whole list of detailed matters, the bureaucratic burden placed on the doctors or hospital administrators will probably prove self-defeating.
§ So I should be grateful if the Minister could reassure me on this point and say what the Government's intentions are as regards these regulations. I beg to move.
§ Lord Warner
As the noble Earl said, there clearly could be some anxiety that someone might seek unjustifiably to exploit his position as nominated representative by consenting to scheduled activities for his own benefit. That could happen in theory. In practice, however, we do not think that that is very likely. I am still struggling to think of the kind of mischief against which we would be trying to protect, given that the deceased had clearly and deliberately made the appointment of a particular person to fulfil his wishes.
§ The noble Earl mentioned the issue of transplantation that could benefit the nominated representative. But are we really to exclude that possibility if the deceased person had appointed the person knowing full well, and possibly even wishing, that that situation could arise? Do we really want to exclude that possibility?
§ Moreover, there are scheduled purposes where we might anticipate that the whole point of the appointment of, say, a family member was so that the family could benefit from information derived from a post-mortem or from research using tissue from the deceased. It would be unfortunate if a person who could derive benefit from information obtained from the tissue of a deceased person were excluded from acting as a representative. He might be prevented, for example, from finding out about an infectious disease which threatened him, or of an hereditary condition which might be relevant to his health and that of the wider family. Although those are personal benefits, they are not benefits of which I think most of us would wish to deprive a family member.
§ If it were to come to light that there was a possibility of someone getting a benefit from consenting which he should not get—though, as I said, I cannot see such a situation at present—we could deal with this in the regulations to be made under Clause 4(10). These can specify persons who may not act under such an appointment. They could spell out the particular conditions under which someone should not act as a nominated representative.
§ As long as we cannot identify any real mischief that we are trying to address, and we have a regulation-making power that could deal with the situation were it to arise, my preference is to leave the Bill as it stands. It gives autonomy to the those who make these decisions prior to their death. We certainly do not have anything up our sleeves in terms of inserts into the regulations about who cannot be a nominated representative.
§ We have taken the view that if there is a possibility of personal gain by the nominated representative, we should rely on the person appointing his representatives to be well aware of their potential interests. As I have indicated, it could be precisely so that such people may benefit that the deceased would have made the appointment. At the moment, as I have said, we cannot see a real risk here. That is the best explanation that I can give to the noble Earl.
§ Earl Howe
Not for a minute did I want to suggest that I was against personal representatives deriving a benefit from the taking of tissue from a dead person. But the question is whether we mind or do not mind about conflicts of interest. The Minister says that he does not mind, which I am very interested to hear. I shall have to reflect on that. Of course, the person making the appointment might not be able to predict, at the time of making the appointment, that his personal representative could derive personal benefit from any decision. It is not always possible to build that into the equation.
§ Nevertheless, I am grateful to the Minister for the trouble that he has taken in his reply. He did not address the wider question about what the regulations will look like and whether they will be long and cumbersome. I hope very much that they will not be. If he has any further particulars to supply to me on that, I would be grateful to have them. In the mean time, I beg leave to withdraw the amendment.
§ Amendment, by leave, withdrawn.
§ Clause 4 agreed to.
§ Clause 5 [Prohibition of activities without consent etc.]:
§ Earl Howe moved Amendment No. 21:
§ Page 6, line 13, after "knows" insert "or should reasonably have known"
§ The noble Earl said: Clause 5 sets out the offences committed by a person if he proceeds to do any of the activities described in the first three subsections of Clause 1 without consent. It also makes it an offence to make out to someone who is about to undertake such an activity that consent for it has been obtained, when in fact it has not, or is unnecessary, when in fact it is not, in the knowledge or belief that what one is saying is untrue. While that is fine as far as it goes, the problem is that it lets off the hook someone who does not personally undertake any of the activities listed in Clause 1, but who negligently instructs someone else to do them without having obtained the proper consent.
§ I shall give an example. A doctor on a ward has a patient who dies and he believes that there are good reasons for thinking that the person's tissue may yield interesting results in the laboratory of a medical researcher or as an anatomical specimen. The doctor instructs a pathologist to remove the tissue concerned and tells him that the necessary consent procedures have been complied with. In fact, let us suppose that the consent procedures have not been properly complied with and that the doctor has simply been sloppy in the way that he has set about them, so that the consent is not valid. The pathologist has accepted the doctor's assertions in good faith on the basis of his past dealings with him and therefore reasonably believes that his actions in removing the tissue from the body are lawful.
§ In that situation, who would be committing an offence? It would not he the pathologist because he has the defence of a reasonable belief that his actions were lawful; or the doctor because he believed that what he told the pathologist was correct. If my understanding of the position is right, we need to question whether that is satisfactory, which I do through this amendment. I beg to move.
§ Lord Warner
The straight answer to the particular case raised by the noble Earl is that the doctor would be in the dock and not the pathologist. But I shall come back to the issue of what he might or might not be guilty of. Clause 5(2) makes it an offence to forcefully represent to someone else that consent exists or is not needed for an activity that a person may carry out when he knows that the representation is false or does not believe it to be true.
§ In the case raised by the noble Lord, there was an interesting issue about whether he knew that it was false or whether he was just, as the noble Earl said, "sloppy". As I understand the amendment, in effect, it extends the offence to a person who should reasonably have known that the representation was false. We intended, in drafting this legislation, to target the person who wilfully made false representations to a colleague, for example about the consent status of material required for research. As I said, this amendment extends that offence in effect to the person who is negligent.
§ We did intend the malicious person to be guilty of an offence. However, if I put it this way, we did not intend the merely stupid, casual or unthinking to be guilty of such an offence. We do not think that this is an appropriate way of dealing with such a person. This sort of case could be dealt with by the Human Tissue Authority also under the licensing regime for storage of tissue. Ultimately, the HTA could revoke a person's licence. That would come down to a judgment about what people deem to be the motives of the doctor or the person involved at the time when the activity took place. So, we are coming down to what was behind this, whether casualness or wilful intent to falsify.
§ 6.45 p.m.
§ Amendment, by leave, withdrawn.
§ Earl Howe moved Amendment No. 22:
Page 6, line 13, at end insert—
( ) In all circumstances other than those referred to in subsection (1) and sections 8,9,10,48 and 50, a person commits an offence if knowingly and without appropriate consent he stores—
§ The noble Earl said: This is purely a probing amendment to find out whether, in the Minister's opinion, the Bill covers all the bases as regards offences. My first question is why it does not appear to criminalise someone who, for example, steals a body part which falls short of being an anatomical specimen, let us suppose, and takes it home as a souvenir, or someone who stores a body or body part for no particular purpose. There are probably all sorts of ghoulish scenarios that one could construct involving the possession of bodies or body parts, but it 451GC is striking that the only activities made illegal by the Bill are those that it happens to mention and not any that it does not mention.
§ I am far from clear that Clause 30, as expressed, is sufficient to cover all contingencies which most of us would find unacceptable and repellent. I beg to move.
§ Lord Warner
Clearly, I have led a more limited life than the noble Earl! I must talk to him afterwards about these exciting circles in which he may be moving.
§ The Bill resolves significant problems that have become apparent in existing legislation relating to certain uses of human bodies and bodily material. It addresses the failings and difficulties that arose through the ambiguity and lack of regulation or sanctions in the Human Tissue Act 1961 and resolves the inconsistencies that exist between the 1961 Act, the Anatomy Act 1984 and the Human Organs Transplants Act 1989 and the relevant parts of the common law that apply to the application of human tissue in medical treatment and research.
§ In the latter case it provides for clarity and certainty that is lacking in the present situation, which leads researchers to doubt whether and when they are able to use human tissue. The Bill established the principles by which consent is needed for these various purposes, set out in Schedule 1, which we have discussed.
§ However, it also establishes offences broadly in respect of two areas. First, under Clause 5 it is an offence to carry out any of the activities for which consent is required under the Bill—that is, consent in relation to scheduled purposes—without such consent. That is fairly straightforward. It also establishes an offence under Clause 8 by which material which is donated by virtue of a consent under Clause 1 cannot be used for a purpose other than a Schedule 1 purpose; that is, diagnosis or treatment, disposal, or a purpose allowed for in the regulations.
§ So, if material falls within the scope of the Bill, it is properly and fully dealt with. The scope of the Bill extends to the regulation of storage and use of tissues for health-related purposes.
§ We have accommodated the DCMS provisions on public display and the de-accessioning of human remains from museums, but there has never been an intention as such to regulate all possible uses of human tissue per se. I seek to explain to the noble Earl the limitations in the use of human tissue that are prescribed in this Bill.
§ The effect of the amendment would be to criminalise an unspecified and unidentified range of activities, the nature and scope of which are not evident to us when the need for such criminal sanction has, to the best of my knowledge, not been raised, let alone established. So we are in a situation where there may be what might be regarded as ethically undesirable uses of bodies or parts of bodies—and I am not suggesting in any way that the noble Earl is a member of the Burke and Hare fan club. These have not been anticipated in terms of prescription and sanction under the terms of this legislation. The Bill is much more sharply focused, 452GC which is why it does not seek to deal with some of the more racy aspects of human body use, which we may leave to the conjecture of the noble Earl.
§ Earl Howe
There was a case involving the artist Robert Lenkiewicz, who stored the body of a tramp in his studio for several years as a kind of memento mori. Even though he did that without anyone's consent, apparently he was not committing an offence of any kind. I found that quite extraordinary. While he might be doing so under this Bill, I shall not second-guess the point.
§ The thinking behind the amendment is that, in reality, the only legitimate reason for anyone to store a body or body part, unless it is a museum specimen or it is being done for medical research reasons, is that the person has died and is about to be given a funeral. Surely there cannot be any other reason for having a body or body part in your possession without permission. Nevertheless, I hear what the Minister says about the selective nature of the Bill—that there is no wish on the part of the Government to introduce a blanket measure on the possession of human tissue, which is an important and interesting point and one that I note with gratitude. I beg leave to withdraw the amendment.
§ Amendment, by leave, withdrawn.
§ Lord McColl of Dulwich moved Amendment No. 23:
§ Page 6, line 43, leave out sub-paragraph (i).
§ The noble Lord said: In moving Amendment No. 23 I shall speak also to Amendments Nos. 24 and 25, 60 to 62 and 73 to 78. The idea of sending a doctor to prison for three years for this offence seems very harsh indeed. I expect that the Government have studied what kind of offences on the statute book can now result in a three-year prison sentence. They include going equipped for stealing, an affray, failure to comply with instructions set out in the Firearms Acts, possessing obscene material, and the taking or making of indecent photographs.
§ Are the Government really suggesting that the offences under consideration in this Bill are comparable with the crimes I have just outlined? Of course there is no comparison. Some people are sent to prison for three years for having committed manslaughter. The offences in this Bill certainly cause no physical harm to the body.
§ I recall a lady who came into my clinic. She sat down and asked, "Do you remember me?". "Remember you?" I replied. "With the exceptions of Sundays and holidays, I have thought of you every day for the past 22 years". This somewhat surprised the lady until I explained that, 22 years ago when she was four years old, I removed part of her intestine which was threatening her life, and the piece of intestine was kept in a bottle on my desk with her name on it. I offered it to her, but she declined and asked that I continue to use it to teach medical students.
§ These specimens are quite often taken to various universities for examination purposes. The only problem that has arisen is if the examiner has been 453GC stopped at Customs and, sometimes, the Customs officers have had a bit of a fright. Perhaps I may ask the Minister whether that practice will be made illegal with this Bill.
I was somewhat puzzled by Dr Ladyman's statement in another place. He was asked about those harsh prison sentences. He said that,
these things are judgment calls. The hon. Gentleman has clearly spoken to some people who think that the penalties are too severe; I assure him that we have spoken to people who do not think that they are severe enough".—[Official Report, Commons Standing Committee G, 29/1/04; col. 133.]
§ It would be important to know who those people were that he spoke to, their expertise and the basis of their judgment. It is not for us to question the motives of the Government, but we cannot help feeling that someone or some group of people to whom the Ministers have access possibly have a little bias against the medical profession. But whatever the motives or reasons, it is important to point out the effect that these penalties will have. They will result in fewer people going into the pathology service and the coroner's service. Moreover, there will be fewer research proposals and doctors will inevitably become more risk averse.
§ Perhaps I may point out that even now we have a dearth of paediatric and adult pathologists, which will get steadily worse. Why should doctors be subjected to such harsh treatment when there is no question of malice? We believe that if there is a need to have a prison sentence, one year is perfectly adequate. I beg to move.
§ Baroness Finlay of Llandaff
I support the amendment, which I suppose one could say that "I would, wouldn't I" because I hold a medical degree. However, I am not a pathologist. Certainly, I endorse the comments of the noble Lord, Lord McColl, that there is a shortage of people entering pathology. I support the amendments because I question the purpose of such a long prison sentence. Holding people in custody is to keep them away from others in the population to whom they could do harm, while it is hoped that they are making redress for what they have done.
§ However, if a doctor commits an offence, as outlined in the Bill, it will inevitably be reported to the General Medical Council. The GMC will take a decision and I would expect it to suspend the person's ability to practice. It would mean that they could not do what they were doing before anyway during whatever period the GMC decided to suspend their registration. That would be tantamount to a prison sentence in terms of an individual, but it would not incur an enormous expenditure to the state by holding a person in custody when we already know all the problems that relate to our prisons.
§ Therefore, while it seems reasonable to attach a fine, one has to look at the purpose of a prison sentence. If it is just to appease a perception that some people might 454GC want revenge, I would gently remind Members of the Committee that there are a lot of people out there who would still want hanging.
§ Lord Warner
In this legislation, the Government are neither picking on doctors in general nor pathologists in particular. I can reassure the noble Lord that although we have taken a note of his confession, he will not be escorted from the premises to the local police station. I am not expecting the Metropolitan Police to pursue charges under this legislation.
§ The Government have made it clear on numerous occasions that the offences and penalties in the Bill are there to demonstrate the seriousness with which we view the events that took place in the past at Alder Hey and elsewhere. I think that, under successive governments, it has always been a legitimate view that sentences have a deterrent effect as well as a conventional punishment effect.
§ 7 p.m.
§ There are already deterrents in legislation and elsewhere in the present arrangements. These include, as the noble Baroness mentioned, disciplinary processes and sanctions from professional bodies.
§ But the Bill addresses matters that could extend beyond the regulated professions; it is not only about doctors. The people whom it might concern may be outwith the health service and may be in ancillary positions. So it is important that we do not rely on disciplinary sanctions alone within the regulated or self-regulated professions.
§ I know that some pathologists, in particular, wish to see the penalties reduced as they feel that they will be vulnerable when the Bill takes effect. However, I have tried to indicate that these provisions are not directed specifically at one professional group. In any event, it is difficult to see how a professional such as a pathologist could be prosecuted for going about his proper and legitimate business. The offences and penalties are a backstop.
§ Offences and penalties already exist tinder the Human Fertilisation and Embryology Act 1990. These are for creating and using embryos without a licence and for using people's sperm, eggs or embryos without their consent. The penalties under this Act—not under this Government—range from two years to 10 years. So we already have significant penalties in other legislation.
§ There are a range of penalties under the Human Organ Transplants Act 1989 and the Anatomy Act 1984—again, not under this Government. Those are for organ trafficking and for carrying out anatomical examinations without a licence or without proper consent. Those two Acts will be repealed and replaced by the Bill. I have to acknowledge that no one has so far been prosecuted under these Acts because they simply define the limits of acceptable practice.
§ We do not expect anyone to act beyond the bounds of acceptable good practice. We do not start from the position that self-regulated professionals or others in 455GC healthcare and regulated activities do not want to conform to acceptable good practice. We have, however, introduced in the Bill penalties that apply more consistently across the range of activities involving human tissue and organs. So while there were offences under the Anatomy Act and the Human Organ Transplants Act and none under the Human Tissue Act, there will now be a consistent approach across all these areas, which are themselves coming together in EU legislation.
§ To maintain the status quo would not be an adequate response to the wrongs and failures that resulted in the problems of organ retention. Certainly in respect of post-mortem organ and tissue retention without consent, penalties of that order seem to be appropriate.
§ We have also examined the penalties that currently apply a consistent deterrent across a range of activities that fall within the Bill. In doing so we are mindful of concerns across Europe about issues of organ trafficking, for example, and the fact that strong deterrents will be needed in this area.
§ The importance of all this is that we have the means—although we hope they will never need to be invoked—of addressing the kinds of wrongs that took place through the systematic removal and storage of organs without the knowledge and consent of families. Let us not underestimate the seriousness of this as a potential offence—I emphasis "potential offence".
§ A range of penalties is also available—from a fine to imprisonment, or both—to provide for a range of criminal circumstances. Some offences, were they to occur, may well be trivial—I accept that—and some extremely serious. In the unlikely case of a prosecution, it would then be for the courts to decide the appropriate penalty from the range available. It is in the nature of things that the offence would have to be extremely serious for custodial sentences to be imposed in this particular area.
§ I hope that explanation gives the noble Lord some reassurance.
§ Lord Jenkin of Roding
While the Minister has been talking I have been listening to him with one-and-a-half ears. I have also been reading again the extract from the book of Professor Raymond Tallis, which was published in The Times under the headline "When grief turned into grievance". The professor gives a very disturbing account, from the side other than the bereaved parents, of what the appalling impact was on the two hospitals—on Alder Hey in particular—which became besieged by the press. They were unable to proceed with their appeal for a new building to treat children, all of whom come from an extremely deprived area.
§ Professor Tallis turned his considerable talent for invective—which is far stronger than anything I said at Second Reading—against those who, to use my own words, turned the situation into a national horror story. The Minister has demonstrated again this desire 456GC to appease the parents who have suffered great grief—one appreciates that; we all pay tribute to that—to the extent that the balance has got out of kilter.
§ My noble friend did not say much about Amendment No. 23, which simply seeks to remove from magistrates the power to send someone to prison. If someone is to go to prison for an offence under this Bill, the case must go before a High Court judge or equivalent. I do not believe that magistrates should have the power to do that.
§ This is evidence of the issue getting out of balance. I hope that we may be able to return to the matter. I understand the arguments that the noble Lord has advanced, but he must appreciate, from the way in which the whole matter was handled right from the beginning—and Professor Tallis has described in horrifying detail what happened—that this balance must be redressed.
§ It may be that the Minister can say, with some justice, that imprisonment would be the very last resort for the most serious kind of offence. But that is not what it looks like in the Bill. Here we have got an offence of taking organs without consent, and if an offence is committed someone can go to prison for three years. It is an extraordinary way of handling what Professor Tallis and others have described as a "medical misfortune".
§ No one doubts that it caused great grief—it was handled very badly by the doctors and the health authorities concerned—but for goodness sake let us keep a sense of proportion. If one is dealing with people who have nefarious purposes, that is a different matter which could probably be dealt with under criminal legislation; but we are trying to find an appropriate way of ensuring that the rules in the new Bill, which updates the whole process, are observed.
§ I have the greatest sympathy with the noble Lord, Lord McColl. These measures are too swingeing to go into a Bill of this kind; it gives the wrong message. It does not recognise what has happened to the profession of pathology; it does not recognise what has happened to people who have devoted their lives to the care of sick children, who have suffered grievously as the scandal has multiplied and multiplied.
§ One has got to get back to a common-sense view of what is right. The amendments would go some way to reversing a very unfortunate and unhappy episode. For a former Minister of Health to describe it as the worst disaster that ever happened to the National Health Service seems to me to be a most extraordinary statement. It should never have been made because it is not that at all.
§ Lord Clement-Jones
At this stage in Committee I do not want to go on at length. However, some of the comments of the noble Lord, Lord Jenkin, need to be redressed. I know well many of the circumstances at Alder Hey. Frankly, if I were a prosecution authority and faced with some of the matters for which Dr van Velzen was responsible, I would have wanted to prosecute him: I think many of us would have wanted to give him a gaol term.
§ We need to put into context, of course, that the culture of the time was not set in stone. Now the medical profession generally is aware that it needs to adopt sounder practices. Of course, no one wishes to tar the medical profession with a single brush, but there were people like Dr van Velzen at the time who gave rise to an absolutely legitimate public revulsion. The Alder Hey inquiry resulted, many felt that it had got it right, and this legislation has ensued.
§ I have supported many of the points made by the noble Lord, Lord Jenkin, during the passage of the Bill, but I really do not believe that we should forget the circumstances that have given rise to the legislation we are discussing at the moment.
§ Lord Warner
I shall reply as gently as I can to some of the points made by the noble Lord, Lord Jenkin. The noble Lord acknowledged that he was listening with only half an ear to the points that I was making. If the other half had been deployed, he would have noticed that I said that this was a last resort; that it was a deterrent; and that it was for serious offences. I also mentioned that there is existing legislation—I shall not go through it but I shall send the noble Lord samples—in the Anatomy Act, in the Human Organ Transplants Act and in the Human Tissue Act, where there are three-year custodial sentences as maximum sentences for these offences.
§ So we are not introducing anything new. If I may make a very narrow political point, all that legislation was introduced under a previous government, which the noble Lord served with such distinction.
§ I have to put these points on the record. We are not seeking to run around locking up doctors and pathologists. But there needs to be a deterrent in the legislation and there needs to be consistency across the legislation. So by abolishing the Acts we are incorporating greater consistency in the sentencing provisions.
§ Lord Walton of Detchant
Nevertheless, it is important to recognise that the whole issue has been clouded by an enormous range of misunderstanding. What happened at Alder Hey was quite unforgivable—the doctor concerned, who has been referred to by the noble Lord, Lord Clement-Jones, was eventually erased from the medical register by the General Medical Council—but the same strictures were applied to what happened at the Bristol Royal Infirmary, where most of the hearts that were removed from the children were removed and retained at the coroner's behest under the Coroners' Rules.
§ Here again there was a very serious misunderstanding. I think it is time to put behind us these misunderstandings and the enormous range of concern that has been expressed, and to ensure that the Bill works well.
§ I believe these penalties are potentially very savage. Nevertheless, I can understand why the Minister feels that they must be retained—although I only accept them with a very heavy heart.
§ Lord McColl of Dulwich
I thank the Minister for his reply. It is worth pointing out that we have not 458GC objected to the penalties in the Bill for trafficking under Clause 32. As far as concerns the human fertilisation scene, the potential for mischief there is far greater than the sphere to which we are referring.
§ Lastly, does the Minister really think that these penalties are comparable? They are the same as for the offences I outlined—going equipped to steal, affray, firearms, possessing obscene material. Are the offences really comparable?
§ 7.15 p.m.
§ Lord Warner
Many of these matters come down to judgment. They are also down to bodies such as the Sentencing Advisory Panel, which advises on sentences. The Government have taken what they think is an appropriate line.
§ I shall certainly look into the range of penalties in the existing legislation and I shall write to noble Lords, but there are custodial provisions. I will check that I have got my periods correct, but there needs to be a deterrent. Our motive is not a matter of vengeance. We need to have a sensible set of deterrents which apply to a range of people, not only to doctors; we are not picking on doctors in this case.
§ I have the greatest respect and admiration for the noble Lord, Lord Walton, but I should say to him that, in a way, this Bill when enacted will help to achieve some closure on the issue of Alder Hey and on some of the matters that went before. It is important that we do that in a statesmanlike way.
§ Lord McColl of Dulwich
I thank the Minister for that reply. I beg leave to withdraw the amendment.
§ Amendment, by leave, withdrawn.
§ [Amendments Nos. 24 and 25 not moved.]
§ Clause 5 agreed to.
§ Clause 6 [Activities involving material from adults who lack capacity to consent]:
§ Lord McColl of Dulwich moved Amendment No. 26:
§ Page 7, line 10, at beginning insert "the person intending to undertake the activity has taken such steps as are reasonable in all the circumstances to establish that"
§ The noble Lord said: As it stands, requiring a researcher to establish the absence of an effective decision is considered to be far too onerous, as well as counterproductive in areas such as research into emergency and critical care, where of course time is of the essence. The amendment would create a much more reasonable position and would enable the clinician to care for his patients without having the threat of the law hanging over him.
§ If the clause remains as it is, the effect on clinicians will be that they do not do anything which could possibly put them at risk. Research will be made much more difficult, or impossible in some spheres. Again the requirement in the Bill is bound to make doctors much more risk averse, inevitably resulting in less effective and less cutting-edge treatment for patients. I beg to move.
§ Lord Clement-Jones
The amendment is very important. I added my name to it as soon as it was 459GC tabled. It certainly reflects the considerable concern in a wide variety of quarters, including medical, research and voluntary organisations. There is a very widespread concern about the impact of Clause 6 as there is a strong belief that it will impede the conduct of research into medical conditions or treatments associated with emergencies or critical care. In order to rely on the clause, there should be no decision of the patient to consent or object in force. That is an absolute statement in the clause.
§ It is assumed that this will require some level of investigation on the part of the researcher to establish the relevant facts, but where time constraints are severe it might be quite impossible for these facts to be established with absolute certainty. Practically, it is essential that this requirement is qualified to recognise those constraints. The interests of the patient will be further safeguarded, in any event, by the requirement for ethical review.
§ The effect of the amendment, which is extremely well drafted, would be to qualify the requirement in Clause 6 to establish whether any existing consent or objection is in force. Clarification is certainly needed on how far researchers are required to go to establish whether a person has consented or objected to the use of his tissue in research where the person involved lacks the capacity to consent. Otherwise, this requirement could make certain research in the critical care area impossible. It seems to us that "all reasonable inquiry" is the right way to go. The amendment should be supported.
§ In addition, it is worth making the point that organisations such as the Parkinson's Disease Society are concerned generally about the operation of Clause 6 and its inter-relation with the Mental Capacity Bill. The society states in its briefing that the expectation had been that the new Mental Capacity Bill would set out a framework for proxy consent when tissue is obtained from people lacking capacity, but the provisions set out in the draft Bill were not broad enough to encompass the range of activities otherwise made criminal by the Human Tissue Bill.
§ These are considerable concerns which the Government should take into account, possibly through discussion with all those concerned. The amendment would make a good start.
§ Baroness Finlay of Llandaff
I support the amendment, which is extremely important, particularly in the area of critical and emergency care.
§ Let me outline a scenario for the Minister to illustrate why it is so important. Someone is brought into an accident and emergency department; it is thought that he needs to be given a drug very rapidly which would, for example, act as an anticoagulant factor. However, there is some suspicion that there may be a sub-group among the people who come in with an additional substance in their blood that should be identified—but the blood must be taken before the anticoagulant is given. Indeed, the processing of such blood for research purposes has to be carried out in a particular way. It must be done very rapidly because 460GC once it is out of the body and exposed to the air, there is decay. As all doctors in the Committee who know about clotting factors will be aware, the cascade will start in less than a second.
§ In that situation it is not possible to ask for consent. The process of going through all the layers of requesting consent would delay the treatment—which would be completely unethical. On the other hand, if you do not pursue that line, you will never know whether there is a better treatment and a better way of managing that sub-group of patients.
§ So, given that the research has to be carefully scrutinised by a local research ethics committee; given that you would have to try to ascertain as quickly as you can—in an emergency room situation—something about the patient's wishes; and given that you would have to go back to him afterwards—if he survives whatever brought him into casualty—to explain that you have done this research and you have the data, it is terribly important to allow for the appropriateness of the measures taken to obtain consent.
§ Ideally, if you are going to obtain consent, people should be given a cooling-off period. You should explain it to them and then go back the next day, when they have had time to think about it. However, that is completely inappropriate in an emergency situation.
The amendment goes part of the way towards helping another problem that arises. In line 10 of page 7 it states,
nor a decision of his not to consent to it, is in force".
I should like to explore the position should someone revoke his consent, not in an emergency situation but where he is part of a very large study where perhaps there has been complicated double anonymisation. There would have been two phases to the anonymisation process, which is very complex; data have been collected and are already anonymised, but the person now states that he does not want to participate in the study any longer. Is that researcher bound, as the Bill is drafted, to "unanonymise" doubly and remove all his data, or is he able to carry on using the data if the consent to do so exists, yet seek to take further blood samples or specimens from the person who was in this study in the long term? He would of course be obliged to carry on treating that person without prejudice to his treatment at the time that the patient removed his consent saying that he no longer wished to participate.
§ There is an additional complexity that could arise with very sick people. A person could say, "I really don't want to participate any more" because he is very ill, tired, has had enough and is dying. He then dies, so you cannot ascertain what his intentions were over the data that you have obtained, which is held through the doubling anonymisation process.
§ There are some real complexities. The amendment might help a bit, but clarification about revoking consent is important. As drafted, the Bill implies that you either consent or you do not but consent is an ongoing process. A person may revoke and then change his mind and say, "I feel a bit better. I am quite 461GC happy to participate again at some time in the future". However, when a patient says that he does not want his blood taken today, of course you stick by that.
I support the amendment. The reason a change is required has been put very clearly by the noble Lord, Lord Clement-Jones, and also by the noble Baroness, Lady Finlay. It will impede the conduct of research into medical conditions or treatments associated with emergencies or critical care. A great deal of important research will be impeded as the Bill stands.
§ Baroness Andrews
I am grateful to noble Lords who took part in the debate. It was very interesting and pointed out the complexities of some of these issues.
§ The amendment causes us some major problems in the context of Clause 6. It arises from fears expressed by some scientists that in emergency and acute situations involving people without mental capacity there may be no opportunity to establish whether the individual had given or withheld such consent. The amendment proposes, therefore, that the researcher should be obliged only to take "reasonable steps" to find out. The argument seems to be that this would reduce the risk. The noble Lord pointed out in graphic language that the researcher might fall foul of the law by failing to make exhaustive efforts despite the emergency nature of the situation in which the research is conducted.
§ Perhaps I can establish our case, to which we hold strongly, in terms of both the effect of the amendment and what the clause is trying to do. We want to maintain the position set out in Clause 6 in order to avoid setting a different and disadvantageous position for mentally incapacitated people compared with that pertaining to people with capacity. We must also maintain it if we are to maintain compatibility with the clinical trials directive in relation to any research involving people with mentally incapacity. I shall describe that in a little more detail later. However, we also need to ensure that what we do in the Bill is consistent with the Mental Capacity Bill and particularly Clause 33(2)(b)of that Bill. That is the purpose of the clause.
§ Clause 6 of the Bill states that there should not be a prior decision of the person whether to consent or otherwise to the use in question. As for our debates on the nature of consent and the difficulty of establishing consent, the Bill deliberately does not set out the extent to which a researcher, when seeking to establish consent, should be obliged to go to determine whether consent for any person has been given, and nor should it. The experts around this Committee table will know that that is not a matter for legislation; it is, has been and will be essentially a matter for professional judgment. As every doctor will know, those judgments are made daily and on a case-by-case basis.
§ 7.30 p.m.
§ In relation to people with capacity, there will be an absolute obligation to ensure that consent is either given or not, and people without capacity are entitled to the same protection—no more, no less. To attach a specific qualification, as the amendment does, on the lengths to which a researcher should go to establish a 462GC prior consent, but to limit that only to people with a mental incapacity would be discriminatory. I suggest that it is also unnecessary. I shall return to that point.
§ Perhaps I may restate the purpose of the clause and try to set minds to rest insofar as I can. We are not imposing impossible challenges. In Clause 6 we have provided for regulations that will cover a set of specific circumstances in which tissue from mentally incapacitated patients could be used for necessary scheduled purposes. There are three such circumstances. First, we need to be able to ensure that the consent can be deemed in cases where it would be in the patient's best interests. It is a slightly bizarre notion, but I shall give some predictable examples.
§ Without this provision it would not be possible to use tissue once removed from an incapacitated person for a scheduled purpose even where it would be in a patient's best interests. There has already been a case of a person without capacity providing bone marrow for a relative. That was considered by the court to be in her best interests. We can see why, because of the dependence relationship. We can imagine other such cases. Such cases will be rare but the provision makes such choices possible if they are in the person's best interests. There will be other cases where it is important to be able to obtain genetic information. This provision could be extremely important in those cases.
§ The second area covered by the regulations will ensure that the use is possible and consistent with the requirements of the clinical trials regulations. Under the proposed regulations we will be able to provide that where consent has been given by a proxy in accordance with Schedule 1 of the clinical trials (storage and use of materials) regulations from the adult lacking capacity as part of the trial, that should be treated as having been done with consent. We need that provision in the Bill.
§ The third purpose was alluded to by the noble Lord, Lord Clement-Jones, in relation to the Mental Capacity Bill. It is addressed to research that would be allowable under the Bill. Clauses 30 to 33 of that Bill will set out how research should be allowed in the context of a whole set of definitions, which it will also provide in terms of interests and so on. Our Bill needs to align with that so that the tissue can be used in the same circumstances.
§ Returning to an earlier debate on the nature of consultation and the case raised with the Parkinson Society by the noble Lord, we intend to consult very fully. I am sure that the medical researchers, voluntary organisations and the patients' associations also will be consulted in that context.
§ I emphasise that both Bills seek to establish the main principle that a person's prior decision regarding the use of their tissue in research should be respected. The Mental Capacity Bill does that in Clause 33(2)(b), which provides that nothing may be done to, or in relation to, a person lacking capacity in the course of research which would be contrary to an advance decision of his that has effect. That would include removing and using material of his in research. 463GC Clause 6 of the Human Tissue Bill provides that there should be no prior decision of the incapacitated person regarding such use of tissue. These two Bills must march together.
§ I should like to make two further points on the wider debate that we had on the nature of consent in emergency and critical care situations. I cannot comment on the nature of the cases to which noble Lords referred because they were clearly extremely specific and complex and I would imagine relatively rare. I say that because the argument seems in all logic to be concerned principally with the lawful removal and use of tissue in an emergency situation. Therefore, I would suggest that they probably fall primarily under the Mental Capacity Bill in relation to research rather than the sorts of conditions that we may be addressing in this Bill.
§ I can imagine few emergencies where the crucial point is to do immediate and instant research on the spot rather than longer-term research or a process towards clinical trials where the normal ethical considerations would apply.
§ On the situation described by the noble Baroness, Lady Finlay, if research is authorised under the clinical trials directive, the regulations under the Bill will follow through to allow the use of the tissue. The noble Baroness described the case of administering a trial drug. If it is part of a research study, the tissue can still be used if the research is approved by the REC. The case to which the noble Baroness referred is, especially with double anonymisation, sufficiently complex for us to look at it and write to her. I think that that would 464GC be the best thing to do in the circumstances. The Bill does not address the use of personal data in research. We would want to reflect on that issue in the letter.
§ I should like, finally, to try to offer some comfort. The concerns expressed overlook the crucial caveat in the Bill from the point of view of researchers. The defence of reasonable belief will be available to researchers. If prosecution were considered, the Bill makes it explicit, as we discussed today under Clause 5(1), that the defendant does not commit an offence if he reasonably believes that the activity in question is not one to which the consent provisions of Clause I apply. As I said, if the material is to be used anonymously in REC-approved research, no consent would be required anyway.
§ On the basis of that, and particularly in the light of my remarks on the potentially discriminatory effect of attaching a condition only to people with mental incapacity, I hope that the noble Lord will feel able to withdraw his amendment.
§ Lord McColl of Dulwich
I thank the Minister for her very detailed and helpful reply. I recognise that it is a complex business. There is, of course, very strong support for the amendment and we will revisit it later. I beg leave to withdraw the amendment.
§ Amendment, by leave, withdrawn.
§ Lord Warner
I think that this may be a convenient moment for the Committee to adjourn until tomorrow at 2 p.m.
§ The Deputy Chairman of Committees (Baroness Thomas of Walliswood)
The Committee stands adjourned until tomorrow at 2 p.m.
§ The Committee adjourned at twenty-two minutes before eight o'clock.