Human Fertilisation and Embryology Bill [HL]

– in the House of Lords at 4:50 pm on 29th October 2008.

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Moved accordingly, and, on Question, Motion agreed to.

[The page and line references are to HL Bill 70 as first printed for the Commons.]

Commons Amendment No. 1

Page 4, line 6, leave out "the keeping or using of" and insert "keeping or using"

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

My Lords, I beg to move that the House do agree with the Commons in their Amendment No. 1. I shall speak also to Amendments Nos. 1, 4, 29, 49 to 52 and 54.

Amendments in this group follow discussions in this House and relate to human admixed embryos. The Bill sets out a clear definition of human admixed embryos, and ensures that all such embryos are regulated and may not be created without a licence.

The Government have listened very carefully to arguments from the scientific community about the need to create admixed embryos for research. This matter has been closely scrutinised by parliamentary Select Committees, and voted on in both Houses. The Human Fertilisation and Embryology Authority also ran a public consultation on this issue last year.

One motivation for allowing this research to go ahead is the limited availability of human eggs for advancing techniques in cell nuclear replacement, a process used in therapeutic cloning. Scientists are hoping to use as a substitute rabbit or cow eggs, which are abundantly available. There is clearly a wide spectrum of embryos that could be created using human and animal genetic material. The Bill captures the creation, keeping and use of those embryos that are at the human end of the spectrum—in other words, with predominantly human genetic make-up. Research using embryos at the animal end of the spectrum has been undertaken for some time in this country, and regulated by the Home Office under the Animal (Scientific Procedures) Act 1986.

Amendments Nos. 50 to 52 make consequential changes to Schedule 2 to the Bill to bring the new category of human admixed embryos into line with other categories under the Bill, so that the creation, keeping and use of any admixed embryos to which the Bill applies could be licensed by the HFEA. Amendment No. 29 is consequential to Amendment No. 50.

Amendment No. 1 is minor and technical, to ensure consistent use of the term "keeping or using". This phrase is used in existing Section 3(3)(a). The amendment ensures that the term is used consistently throughout the Bill, by amending new Section 4A(3) to ensure consistency in the wording.

Amendment No. 4 relates to definitions in the Bill. The 1990 Act defines an embryo as a live human embryo. It also states that references to embryo include an egg in the process of fertilisation. The Bill defines an egg as a cell of the female germ line at any stage of maturity, but not including an egg in the process of fertilisation. This is because the definition of an embryo expressly includes an egg in the process of fertilisation. To ensure that these definitions work together, it is necessary to clarify that the general definition of an egg does not apply to the definition of an embryo. The definitions in Clause 1 do not cover the section relating to human admixed embryos. Therefore, the term "embryo" needs to be defined independently in the human admixed embryo provisions and the same exclusion of "egg" in the definition of embryo needs to be made. The Bill as it stands does not do so and Amendment No. 4 is a minor technical amendment to rectify this. This amendment ensures consistency between the definitions in the two clauses of the Bill and ensures that they work as they are intended to.

Amendment No. 54 is a technical amendment to ensure consistency. Under paragraph 2(1) of Schedule 3 to the 1990 Act, a person's consent to the use of a human embryo can specify use for the purposes of any project of research, whereas under new paragraph 2(1A) of Schedule 3, as introduced by the Bill, a person's consent to the use of a human admixed embryo must be for the purposes of use in a project of research.

Amendment No. 54 clarifies that a person can give a general broad consent to a human admixed embryo, created using their cells, being used in research, if they choose to do so. Using the word "any" makes it clear that consent does not have to be project-specific, although it can be if the donor chooses and removes any doubt about whether a general consent can be given. The amendment ensures consistency with the wording used in relation to human embryos. I beg to move.

Moved, That the House do agree with the Commons in their Amendment No. 1—(Lord Darzi of Denham.)

On Question, Motion agreed to.

Commons Amendment No. 2

Page 4, line 14, at end insert-

"(4A) A licence cannot authorise keeping or using a human admixed embryo in any circumstances in which regulations prohibit its keeping or use."

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

My Lords, I beg to move that the House do agree with the Commons in their Amendment No. 2. These amendments add powers in relation to the regulation of human admixed embryos, to provide consistency with provisions, and in particular with prohibitions, relating to the use of human embryos.

Amendment No. 2 adds a new regulation-making power. The amendment mirrors an existing power that relates to human embryos, which enables restriction of the circumstances in which human admixed embryos can be kept or used. This could be important if, for example, it became necessary to shorten the 14-day limit in some circumstances. Amendment No. 27 is a consequential amendment.

Government Amendments Nos. 2 and 27 ensure that the Bill is consistent by providing a power, which enables the restriction of the circumstances in which human admixed embryos can be kept or used which mirrors the provision for regulating human embryos. The noble Lord, Lord Alton, has tabled an amendment to Amendment No. 2 and I shall respond to it after he has spoken to his amendments.

Moved, That the House do agree with the Commons in their Amendment No. 2.—(Lord Darzi of Denham.)

Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench

moved, as an amendment to the Motion, Amendment No. 2A:

Line 3, at end insert "or in any circumstances where the purposes of the proposed research can be achieved by any method not entailing the use of human admixed embryos."

Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench

My Lords, Amendment No. 2A tabled in my name straightforwardly seeks to enshrine in the new law the principle that, before any animal-human admixed embryo is created, it must be established that alternatives do not exist. This proposition was advanced in your Lordships' House by the noble Baroness, Lady Williams of Crosby, who has a hospital appointment which coincides with this debate. It was also the subject of amendments in another place at Report stage, tabled by Mr. David Burrowes, Member of Parliament for Enfield Southgate. As the debate in another place was guillotined, the amendments were never reached, so the House of Commons did not have a chance to debate this principle. The only way in which such a debate could occur is if your Lordships agree Amendment No. 2A.

At earlier stages of our debates on this issue, the issue was often referred to as the "Hunt test". It gained that description from some words used by the noble Lord, Lord Hunt, in our debates on whether we should allow the creation of embryonic stem cells for the purposes of cloning. In that debate in 2001, the noble Lord, Lord Hunt, said that it would be licit to use embryonic stem cells only if it could be demonstrated that no other alternatives were available.

We should not underestimate the phenomenal public unease about some of the provisions of the Bill. More than 30 major public meetings have been held throughout the United Kingdom, attended by thousands of people; almost 2 million protest cards and letters have been sent to Members of another place; and many significant public figures have spoken out against the mass manufacture, manipulation and destruction of human embryos. This is not, as I know your Lordships will agree, a trivial matter.

The argument has been put persistently throughout our debates that experiments on the human embryo and admixed embryos will bring great benefits in the form of treatments for diseases which at present are incurable. Yet, since 1990 not even one treatment has materialised to help the sick, compared with more than 80 treatments using ethically acceptable adult stem cells. There has been scandalous over-hype and playing on people's fears and desperation.

Our obsession with experiments on human embryos has led to a failure properly to pursue the alternatives. That in turn is having a disastrous effect on both our ability to develop life-saving treatments and to develop good science. Some scientists have also been coming to the same conclusion. A report in last week's Sunday Timesstated:

"A leading British scientist is leaving the country to work in France after claiming that British science gives too much priority to embryo experiments over 'more ethical' alternatives".

An article in the Times Higher Education supplement of 23 October states that Colin McGuckin, professor of regenerative medicine at Newcastle University, and an expert in adult stem cells, believes that UK funding agencies and his university have prioritised embryonic stem cell research above work with adult stem cells. He said:

"You would barely know adult stem cells exist".

He added:

"A vast amount of money in the UK from the Government has gone into embryonic stem cell research with not one patient having been treated, to the detriment of (research into) adult stem cells, which has been severely underfunded".

Those are his words.

It is tragic that Professor McGuckin feels that he has to leave the UK to go to a country which he says,

"offers a much better environment"— both—

"to cure and treat more people" and "to do good work".

Amendment No. 2A simply seeks to insist on what Professor McGuckin calls,

"a much more reasoned balance", between the use of human embryos and the alternatives.

As the Bill is currently drafted, government Amendment No. 2 requires that a

"licence cannot authorise keeping or using a human admixed embryo in any circumstances in which regulations prohibit its keeping or use".

At first glance this may seem eminently reasonable, but in reality, these words merely assert in a painful piece of tautology that it is not legal to allow something that is illegal. Surely, before authorising the creation and use of animal/human hybrid embryos, we should insist on more rigorous criteria and safeguards.

I therefore propose that this should be extended to cover, in the words in the Marshalled List,

"any circumstances where the purposes of the proposed research can be achieved by any method not entailing the use of human admixed embryos".

Some may protest that the law already contains criteria that achieve this effect. However, if it does, I should be grateful if those who believe it would kindly cite the relevant clauses and demonstrate how they have been used in practice. By contrast, I remain unaware of anything in either the current Human Fertilisation and Embryology Act or this Bill that has parity with the Animals (Scientific Procedures) Act 1986, in which the relevant imperative is in the legislation, explicitly requiring,

"that the purpose of the programme to be specified in the licence cannot be achieved satisfactorily by any other reasonably practicable method".

That is a perfectly reasonable, logical thing to do. If it is right to do it in the case of animal experimentation, why is it not reasonable to ask for the same thing for human embryos?

What objective criteria are employed by the regulatory authority in determining whether the use of embryos is necessary and desirable for a particular purpose? As discussed during our earlier debates, it is especially noteworthy that the HFEA has ultimately never refused any licence application. It has therefore been argued that the HFEA may have found it very difficult to say no. Even as we have been debating the Bill over the past 12 months, there have been extraordinary breakthroughs that mercifully and happily will ensure that these dilemmas and decisions will no longer be necessary. I refer to the breakthroughs made by Jenny Thompson and Professor Shinya Yamanaka in Japan using IPS cells—induced pluripotent stem cells—and getting them to run backwards, using our skin rather than creating human embryos to manufacture embryonic stem cells, which is extraordinarily exciting science. It enables good science and good ethics to march hand in hand.

I am glad to see the noble Lord, Lord Winston, in his place. I was struck by a programme that he broadcast over the summer in which he demonstrated that a huge amount of hype has gone into the claims made about various forms of stem cell technology. We have to keep this in the kind of perspective that the noble Lord rightly described in that broadcast.

As the HEFA comes to consider licence applications, I hope that it will also keep these things in proper perspective and look at the alternatives. Regardless of my previously expressed repugnance at the manufacture of human embryos—my consistent position—there is nothing in this amendment that automatically prevents the creation of so-called human admixed embryos for research, as long as the purpose of the proposed research cannot be achieved by any method not entailing the use of human embryos. The amendment requires that embryos that combine human and animal material should be used only if there is no other means of achieving the same ends. I find it hard to see how anyone could reasonably object to this amendment if they truly believe that a particular project of research is necessary.

The licensing authority and scientists should be duty bound to explore the alternatives, not only due to the ethical concerns but also because of the finite resources. Interspecies cybrid embryos were argued for on the basis that we supposedly need an alternative to using excessive numbers of human eggs for cloning research. These are finite resources that often bring complications for women's health, as we discussed at earlier stages of the Bill, through hyperovulation syndrome.

My amendment also brings the Human Fertilisation and Embryology Act into line with paragraph 8.3 of the International Society for Stem Cell Research guidelines for human embryonic stem cell research, which states:

"The project proposal should include a discussion of alternative methods, and provide a rationale for employing the requested human materials, the proposed methodology and for performing the experiments in a human rather than animal model system."

That is all my amendment seeks to do. I hope the House will consider this amendment carefully and will pause to reflect on what message it wishes to send not only to the British public but to the wider world. Are we to be so ideologically wedded to experimentation with all manner of human interspecies embryos that we blind ourselves to the alternatives, especially when they seem to achieve the same purported ends far more efficiently?

I invite the House to vote in favour of a modest provision that prohibits nothing, but insists with the full force of law that a case must be made that no alternatives are available before permitting the creation and destruction of the human admixed embryos authorised by this Bill. I beg to move.

Photo of Lord Walton of Detchant Lord Walton of Detchant Crossbench

My Lords, I remind my noble friend Lord Alton that issues relating to the use of cells derived from human embryos and the use of adult stem cells were fully and extensively debated in this House many weeks ago. In this group of amendments, we are dealing with human admixed embryos. When the Bill was debated in this House, we made it clear that the purpose behind the development of such admixed embryos was to be able to clone cells derived from the tissues of patients suffering from diseases such as diabetes, Parkinsonism, dementia and many other conditions in order to be able to study in a research method their nature and ways in which they might ultimately be treated or cured.

At that time, the purpose was to have admixed embryos in which the nucleus of a human cell derived from a patient with one of those diseases could be implanted in an animal ovum from which the nucleus had been removed. The only reason this was felt to be a crucial research tool in the study of disease processes was that it would be preferable to implant those cells—say, a skin cell from someone with one of those diseases—into a human ovum from which the nucleus had been removed, but there is, reasonably, a shortage of human eggs. However willing and public-spirited a woman may be, for her to donate eggs may require the insertion of a needle through the vagina in order to remove eggs from the ovary. That is not a trivial procedure. The Bill makes it absolutely clear that once a human admixed embryo is created, it could under no circumstances be implanted into a human being or animal. It can only be used to study the process of the disease from which the individual whose cell was originally taken was suffering.

At the time of our debate in your Lordships' House, the noble and learned Lord, Lord Mackay, was concerned about the definition of human admixed embryos. I understand that he has subsequently had extensive discussions with the Academy of Medical Sciences and others involved in this area. This has led to this series of amendments from the Commons making that definition much clearer. Commons Amendment No. 3, which we have not yet come to, adds a category of human admixed embryos where the animal DNA is not predominant, thus returning, including and embracing within this clause the type of admixed embryo which has been legal for many years under the Animal Procedures Act, and enabling it to be used for research purposes.

I believe that the amendment proposed by the noble Lord, Lord Alton, is unnecessary. Why do I say that? Work involving admixed human embryos is extremely difficult and time-consuming. It occupies a great deal of effort on the part of the scientist. If alternatives to that type of research are available, I have no doubt that scientists will take them and use them wherever possible. This amendment is quite unnecessary. I congratulate the Government on the Commons amendments, which have been so carefully and expertly framed. They will improve the Bill and happen to meet most of the concerns, ambiguities and uncertainties which remained in the Bill when it left your Lordships' House. For that reason, I cannot support the amendment.

Photo of Lord Winston Lord Winston Labour

My Lords, I am grateful to the noble Lord, Lord Alton, for the customary moderation with which he moved his amendment, which is important in this debate. Sadly there has not always been moderation outside the House. Today we heard, unfortunately, of "Nazi experimentation". It is good that we are not indulging in that kind of language, which very unwisely polarises this debate and does not usually lead to much light.

I would like to correct what is, I think, a misapprehension of the noble Lord, Lord Alton. I declare an interest as a member of the UK Stem Cell Foundation, which is the main funding body purely for research into stem cells in this country, and which works in a close relationship with the Medical Research Council. Therefore, it is the leading body funding medical research in this field. The noble Lord's comments about the professor of regenerative medicine are surprising to me. He claims that, in this country, we are not doing anything other than prioritising embryonic stem cells. I have to tell the noble Lord that the UK Stem Cell Foundation has not so far funded a single grant towards embryonic stem cells, nor have we ever had a grant application from this particular professor. I do not think it is unreasonable for me to say that in this Chamber. It is difficult to assess his work, so I do not know why he is leaving this country, but it is certainly not because he has had a grant application turned down because of the prioritisation suggested by the noble Lord, Lord Alton. It is important to put that on the record at the start.

The noble Lord kindly referred to my television programme on the hype surrounding embryonic stem cells, with the extraordinarily sad death of the child of 10 who was hawked around the world. I simplified the story; not only did that child go to Argentina and the Dominican Republic, but also to China and Siberia for treatment. Some people are unfortunately misguided enough to do that because of their desperation. That is another reason why we must be extremely moderate in presenting the work that we do.

It is important, in that context, to make clear that I showed on that television programme that none of the adult stem cell treatments worked either. As far as I am aware, the only adult stem cell treatment that really works and has been shown to work is where we replace bone marrow cells, usually in children with leukaemia. It is a relatively uncommon disease. A few exceptional other diseases can be treated with bone marrow, but we must make it clear that adult stem cell treatments have been equally unsuccessful. The area is still under development. That is the crucial issue for the amendment of the noble Lord, Lord Alton.

The problem is that we can never be certain in any kind of research. The beauty of the Large Hadron Collider is that we do not know whether we will find the Higgs particle, or what other particles we might discover; nor have we any serious idea of what future applications there might be for physics or engineering. To some extent, that is always true in biological experiments. We cannot say absolutely that embryonic stem cells will definitely provide cures for the range of diseases that the noble Lord has listed; it is simply not true. Nor could we say so for adult stem cells.

We must be quite cautious and make judgments about how this research is directed. Therefore, we accept that a regulatory authority has to make the best assessment of that research. We cannot absolutely say that it will definitely work but the current expert opinion, which may change, strongly suggests that it is the case.

Incidentally but remarkably, the professor of regenerative medicine to whom the noble Lord referred has not been working with adult stem cells. According to his publication record, which I checked only this week, virtually all of this work has been on foetal stem cells, mostly in umbilical cord blood. Again, that is a different area of science which is still extremely vague, and has largely been rather unsuccessful in helping treatment of patients so far. Equally, however, it holds hope, as we hope that it will do in the future.

Photo of Lord Patten Lord Patten Conservative

My Lords, I am pleased to follow the noble Lord, Lord Winston. I am particularly interested by his suggestion that things are interesting in science and must therefore always be pursued, looking specifically at the CERN experiment. I wish it well; I hope that it is back on the road—or, rather, underground and rotating—during next year. However, whether it is successful or not, as far as I know it does not raise any great ethical issues. Physics has in the past raised ethical issues, such as nuclear and other related matters, but CERN does not. I do not doubt that, for many scientists, work on embryonic stem cells is extremely interesting, but it comes up quite hard against some difficult ethical questions. I know that the noble Lord recognises that, and I agree with him that we must be moderate in how we discuss these issues.

That is why I strongly support the noble Lord, Lord Alton, in his amendment for two reasons that I shall state briefly, as befits us at this stage of the consideration of the Bill. First, it is reasonable and proper to ask science to demonstrate that there are no alternatives before using admixed cells in this way. To the best of my knowledge, no one has been able to stand up and say that there are no alternatives. That phrase often fell from our lips in another place on economic matters, but I do believe that no alternatives have been demonstrated in this area.

The second reason is that I am told—perhaps the Minister, with his characteristic courtesy, will confirm this point or correct me—that there is nowhere in the world any existing cure, properly approved by the relevant regulatory authorities in that territory, which uses embryonic stem cells, whether admixed or not. There is nothing that is actually working so far.

Photo of Baroness Tonge Baroness Tonge Spokesperson in the Lords, Health

My Lords, I cannot possibly support the amendment of the noble Lord, Lord Alton. That is not because I do not respect the noble Lord—I always have done. He used the word "repugnance" about this sort of research, but he should remember that a lot of us feel repugnance—I certainly do—at not doing research that may help people with terrible chronic illnesses that they have no way of curing. It is repugnant to me that we are denying people the chance of a better life.

The noble Lord referred to the mass manufacture and use of human embryos. I do not really think such a sentence is terribly helpful. By no stretch of the imagination could this research be termed "mass manufacture", and it is not helpful to the general public to use such words.

The noble Lord and I are founder members of the all-party group on cord blood. It is very clearly stated that we want to encourage the collection of cord blood but definitely not for exclusive research on stem cells from cord blood. We believe that all forms of research should be pursued. We cannot possibly know where research will go or whether it will be any good until we have pursued it. That is the major point—we must follow all lines in the interest of ultimately curing human diseases.

Photo of Lord Patel Lord Patel Crossbench

My Lords, I was hoping that we would not have to rehearse all the lengthy discussions we had in Committee and on Report, but it looks as if we might have to. I support all that has been said by my noble friend Lord Walton of Detchant and others who have spoken, although, with all due respect, I do not agree with the amendment.

The noble Lord, Lord Alton, said several things about alternatives. Alternatives for what? Alternatives for research? Alternatives for therapy? In the United States, Professor Yamanaka and James Thomson have done research on induced pluripotent cells, taking an adult somatic cell nucleus and reprogramming it so that it behaves like an embryonic stem cell. The advances in matters of direct reprogramming of human somatic cells, without the use of oocytes or early embryos, is an exciting and welcome development. However, this work is at a very early preliminary stage. The current technology involves engineering the cells in a way that raises a number of safety issues that will need further refinement before these cells can be used in the clinic. It is only by studying the human embryonic stem cells and their behaviour that we know that the induced pluripotent cells behave in exactly the same way. Even Professor Yamanaka, who now does some of his work in California, is continuing to work in embryonic stem cells.

The really important point of any application of these so-called induced pluripotent cells must depend on the understanding of basic human biology, and that demands comparative work with both embryonic stem cells and IPS cells. One can only conclude that we should work with IPS cells only if we are interested in direct application, but if that is pursued without an understanding of the basic biology, it is like, to use the analogy I gave last time, comparing gold with material that looks like gold, but we cannot be sure until we have understood that the properties are exactly the same. Yes, IPS cells may be the future but we cannot work with them until we better understand how human embryonic stem cells behave.

In the debate last time I said it is important at this stage to allow research to continue on all types of stem cells—adult, umbilical cord, cord blood, amniotic and embryonic stem cells, and admixed embryos. Why do we need research with admixed embryos? My noble friend Lord Winston and the noble Lord, Lord Alton, briefly mentioned the availability of human oocytes. Obtaining human oocytes is not without risk and they are also in short supply. To get good stem cell lines you need fresh oocytes, which makes it even more difficult. Just now we are trying to understand the path of physiology and the biology of embryonic stem cells derived from human tissues that carry the genes of a particular disease, so that we are better able to understand how that disease develops from an early stage, are able to modify that and to develop and test drugs in vitro, and so on. Without embryonic stem cells derived through admixed embryos, we will not be able to do this research. It is necessary for research purposes. There are no alternatives but to do research on all types of stem cells.

On therapy, my noble friend Lord Winston mentioned that we have tremendous therapy in bone marrow stem cells for treating leukaemia. I agree with the noble Lord, Lord Alton, that there are other therapies using adult stem cells but they are few and far between. They are mostly autologous therapies—cells taken from one person used for the treatment of that person. Adult stem cells will never be the answer for mass treatment of people with degenerative diseases. Where are we with embryonic stem cells? In research terms we are at a very early stage. In understanding the biology through using embryonic stem cells, the pace has been accelerating quite a bit. We only managed to understand and do induced pluripotent cells because we understood how embryonic cells behave. If we had not, that work would never have come to fruition.

On treatment, there is no treatment today using embryonic stem cells but there are treatments using them at an early stage of trial on animals. There have been some early human trials and it is likely—I hope it will happen—that by the end of next year or early 2010 in the United Kingdom there will be first-phase trials using human embryonic stem cells for age-related macular regeneration. Some 3 million people in this country suffer from, and 30 per cent of people aged over 65 develop, some degree of age-related macular degeneration. I hope that research will come to fruition. None of the stem cell research is likely to have an overnight success. It may not ever happen but we will not know unless we study every type of stem cell.

On funding, I declare an interest. I have declared several interests before, being not only a member of several professional organisations but also a chairman of the United Kingdom National Stem Cell Network. I am also a member of the Medical Research Council. In 2007, 424 grants were awarded—at a rough estimate some £56 billion, excluding charity funding. The majority of grant applications were from the MRC, the Wellcome Foundation and the Biotechnology and Biological Sciences Research Council. The MRC's awards were 50:50 adult stem cell research to embryonic stem cell research. Some 90 per cent of the Wellcome grants were for adult stem cell research. The trend is towards adult stem cell research and towards more research on induced pluripotent stem cells. Grants are awarded to people who submit the best science; that is how it should be. They should not be awarded for poor science that is not judged good by peers. If there is any evidence that grants are awarded for poor embryological science, let us hear about it. In my view, it does not happen.

I hope that I have made the case for why it is necessary to carry out research on all types of stem cells, including admixed embryos. Without it, we will not progress.

Photo of Lord May of Oxford Lord May of Oxford Crossbench 5:30 pm, 29th October 2008

My Lords, I declare an interest as a member of the UK Stem Cell Foundation. Like the noble Lord, Lord Winston, I pay respect to the noble Lord, Lord Alton, for his admirable restraint and honourable declaration of his own interests: abhorrence of stem cell research.

Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench

Embryonic stem cells, my Lords.

Photo of Lord May of Oxford Lord May of Oxford Crossbench

I am sorry, my Lords—embryonic stem cell research. I agree with the noble Lord that, on occasion, the medical benefits and their immediacy are oversold in excesses of enthusiasm. That is nowhere plainer than in some excessively enthusiastic claims made for non-embryonic stem cell research, which, the noble Lord must agree in all fairness, he tends, understandably, to accept more uncritically than he does other things.

I will not go over the ground covered by the noble Lords, Lord Walton and Lord Winston, and the previous speaker, but I re-emphasise that we have legislation; we have a committee on human fertilisation and embryology; we have procedures that look very carefully at these matters; and we have research grants and a process for choosing the best that works well. Ultimately, to put it bluntly, the purpose of this amendment is to impede a certain class of research within that, and that is why I oppose it.

Photo of Lord Turnberg Lord Turnberg Labour

My Lords, the case against the amendment moved by the noble Lord, Lord Alton, has been well discussed. I want to focus on the implications of its wording. It concerns human admixed embryos alone. The purpose of admixed embryos has been driven largely by the difficulty of obtaining human eggs. The implication of the amendment is that there should be no other available method of achieving the same result. It seems possible that human eggs could be used for embryonic research of this type and that, since the use of admixed embryos is the result of our inability to get human eggs, this amendment would drive research towards using human eggs. I cannot think that that is what the noble Lord, Lord Alton, is trying to achieve, therefore this amendment should not be agreed to.

Photo of Lord Bates Lord Bates Deputy Chair, Conservative Party

My Lords, I humbly address the House as a new Member and a non-scientist. I suppose one might ask, then, what I have to add to this debate. It seems to me that, whereas science has a role in saying whether we can, Parliament has a role in determining whether we should. That seems a pretty simple role, and on that basis I rise to support the noble Lord, Lord Alton, in his amendment. Characteristically, he is asking the House and those in the parliamentary process to think again, to pause for thought. That is wise. As I have gone through this Bill, as well as the excellent briefing papers that are available in the Library, I have tried to absorb the material—but the complexity of the issues at stake is bewildering. For that reason, considering matters again more carefully is very important.

As well as giving due consideration, another protection in this process is the use of language. It is critical that we say what we mean. When we use terms that are euphemistic, such as "admixed embryos" when we are talking about human-animal mixes, clearly that can lead people to draw different conclusions to those they would come to if we were more explicit about what they meant.

Having made those two points, I support the noble Lord's amendment.

Photo of Baroness Hollis of Heigham Baroness Hollis of Heigham Labour

My Lords, as one of many non-scientists who have taken part in the extensive debates on this issue, I assure the noble Lord, Lord Bates, that we do not need extra time to think again because we have not thought; I have to say that we spent a lot of time at a detailed Committee stage and on Report in this House discussing this very issue.

Like other noble Lords, I commend the noble Lord, Lord Alton, on the very temperate way in which he introduced his amendment on an issue on which he feels very strongly. It helps the quality of debate if he is able to move amendments as he has today. However, he has not answered the query that some of us addressed to the noble Baroness, Lady Williams, who is unfortunately not here today, when she raised a very similar issue at an earlier stage.

I take it in the noble Lord's amendment—and he will correct me if I have misunderstood it—that when he says,

"or in any circumstances where the purposes of the proposed research", by "purposes" he means outcomes. In that case, my question remains how you know until you have done it. You will know the outcomes of this procedure only when you can compare it with a result by some other means. Unless you follow all avenues, only then do you know which is the more fruitful; what you cannot do is a series of linear experiments, because at that point you cannot know what hurdle you seek to address.

This amendment presents a post hoc ergo propter hoc argument. You already have to know the outcome you would have achieved without doing it so that you therefore know you can get to the same outcome by some other way that you can take. Forgive me, but that is no way in which to conduct research, and certainly not scientific research.

Photo of Lord Tombs Lord Tombs Crossbench

My Lords, I begin by reminding noble Lords that this amendment is about the use of human-animal embryos, and the proposal is that they should not be used if reasonable alternatives are available. The debate has rather turned into a conception of the amendment as an attack on all embryonic research, which plainly it is not. It does not seek to make the world rotate in the reverse direction.

The noble Lords, Lord Walton and Lord Patel, have both described the amendment as unnecessary—the noble Lord, Lord Patel, because scientists are so fixated on purity that they would not do anything other than what the amendment suggests. I have to say that that is not my experience. The noble Lord, Lord May, thinks that acceptance of the amendment would somehow inhibit research, which was a point not agreed on by his colleagues. I want to broaden the debate and talk about what the amendment seeks to do and what effects it might have.

We have been told—and, therefore, most journalists and members of the public believe—that most future cures lie with embryonic stem cell research, that there is a shortage of human eggs necessary for such research and that, therefore, we should use animal eggs to create admixed human embryos. There are still big doubts about whether these cells will yield any treatment at all and it is my contention, which I hope to demonstrate, that the proposals are unproven, unnecessary and unethical.

First, they are unproven. Embryonic stem cells are difficult to obtain, develop and maintain. They are unstable, and mutate in culture. The fact that they produce cancerous tumours when transplanted into animals has led to an understandable reticence in using them in any human therapeutic trials. It is clear that clone cells, used to address the problem of immune rejection, are not normal cells. That is why it took 277 attempts to produce Dolly the sheep and why no one has yet grown a human clone to a stage mature enough to harvest stem cells from it.

Secondly, embryonic stem cells obtained from animals are unnecessary. The ethical alternative of adult stem cells is already used to treat more than 70 diseases and, similarly, umbilical cord stem cells are being used in treatments and are easily and cheaply harvested. The website of the National Institutes of Health this month shows 2,170 clinical trials involving adult stem cells, 125 of which involved cord blood stem cells, but not one clinical trial in humans involving embryonic stem cells. That says volumes and it is not an exceptional month. Adult stem cells require limited, if any, manipulation and are readily available from a number of sources, comparatively at least. They are already providing cures in humans and there are no ethical concerns in their use, making them acceptable to virtually all patients and healthcare providers.

A number of people have referred to the fact—and I return to it now—that the use of embryonic stem cells is believed to be unethical by large sections of the British community, including scientists, who regard human embryos as vulnerable human lives worthy of respect and protection. Many believe that the production of animal-human hybrids crosses a moral Rubicon and, of course, a species barrier, and that the "end" of providing treatments, if it were technically possible, does not justify the "means" of destroying human life even at its earliest stage.

The morning after the other place had voted to allow the creation of animal-human embryos, Mark Henderson, the science correspondent in the Times, who led a vigorous campaign for cloned animal-human embryos, struck a note of sober caution. He wrote that,

"admixed embryos ... are not going to lead to immediate medical breakthroughs ... any insight they might offer into diseases such as Parkinson's and Alzheimer's are probably years away".

But,

"they could be used to investigate how diabetes and motor neurone disease progress and to develop and test new drugs".

Those are valuable things. But if Mark Henderson, the enthusiast, is now so cautious, we may conclude that some of the claims made in this House and in another place have been somewhat overstated. In this connection, I go back to a debate held in this Chamber around 15 years ago, when the promises were extravagant and imminent.

Finally, in these uncertain economic times, but also in any good stewardship, we should be investing most heavily in those research avenues which are most likely to produce cures in the foreseeable future with fair certainty. It is not simply a matter of keeping all avenues open but of putting our money into research that is likely to yield results affecting people and not necessarily extending the boundaries of human knowledge as an end in itself. I strongly urge noble Lords to lend their support to Amendment No. 2A.

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

My Lords, we have spent a significant amount of time in this House debating the use of admixed embryos. The House has voted and has made its position clear, the issue has also been debated and voted on in the other place, and Members of that House agreed to the position in the Bill as it left this House. Therefore let us be clear that the current position in the Bill on this issue reflects the agreed position between the two Houses.

The amendment tabled by the noble Lord, Lord Alton of Liverpool, seeks to restrict the use of human admixed embryos for purposes of research. The effect would be that embryonic stem cell research using human admixed embryos could be carried out only as a last resort. Before any research project involving the creation or use of human admixed embryos could be licensed by the HFEA, it would have to be satisfied that the use of human admixed embryos is necessary. This means that if there were any other way of carrying out the research without using a human admixed embryo, or human embryo, the project could not be licensed.

The amendment tabled by the noble Lord, Lord Alton of Liverpool, would ensure that a human admixed embryo was created or used if the research could not be achieved by any other means. At best, the amendment is unnecessary, because of provisions already in the Bill that ensure that research projects can be licensed only if the creation of the human admixed embryo is necessary. However, at worst, the amendment could force researchers down the route of using human embryos in preference to human admixed embryos. That would also mean that scarce human eggs would be used over animal eggs for some projects, and would be a significant obstacle to research.

A major issue in embryonic stem cell research is the shortage of human eggs to be used in the creation of embryos. Scientists and the Government have listened carefully to arguments from the scientific community about the need to create admixed embryos for research. As I said earlier, the matter has been closely scrutinised by parliamentary Select Committees, and voted on in the other place and in your Lordships' House. An amendment tabled by the noble Lord, Lord Alton of Liverpool, concerning human admixed embryos was debated on the Floor of this House on Report and defeated by 268 votes to 96.

At present, the Human Fertilisation and Embryology Authority must assess whether the use of embryos or human-admixed embryos is necessary to achieve the purposes of research projects. The research must also be necessary or desirable for one of the statutory processes set out in Schedule 2. Amendment No. 2A would mean not only that the use of human-admixed embryos for the purposes of the research should be necessary, but that the research was unable to be achieved by any other method. This would be contrary to the purpose of using human admixed embryos, which is as a means of researching serious diseases while overcoming the problem of the scarcity of human eggs.

The noble Lord, Lord Patten, asked whether we are aware of such research leading to a cure anywhere in the world. We are in early days. As the noble Baroness, Lady Hollis, pointed out, if we do not do the research, we will not be able to find that out. The noble Lord, Lord Patel, eloquently referenced a number of promising early research results. The Government want to see research moving for all sources of stem cells. The country leads research in this field.

The noble Lord, Lord Alton, referred to a scientist who was leaving this country. For every scientist leaving, many have been attracted here to do research in this field, one of whom is Stephen Minger, who has come to the UK because of the legislative framework in place in the UK.

The noble Lord, Lord Alton, asked whether the HFEA has ever refused a licence. It has never done so, because the HFEA executive works with the licence applicant to ensure that the application is satisfactory before it can reach the licensing committee. At the same time, the HFEA requires the applications to be peer-reviewed to ensure that they are necessary and desirable, and meet the criteria.

We have debated this matter in both Houses. I hope that the noble Lord will withdraw his amendment but I invite the House to resist it if he presses it.

Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench 5:45 pm, 29th October 2008

My Lords, I am grateful to the noble Lord, Lord Darzi of Denham, for the way in which he has responded to the debate. Indeed, I am grateful to everyone who has participated in it, especially to my noble friend Lord Tombs, who I am pleased to see back in his customary place. I am grateful also to the noble Lords, Lord Patten and Lord Bates, for their support for my amendment.

The House will be relieved to know that I will not detain noble Lords for long. I will briefly deal with some of the arguments raised. I have not, in this amendment, invited the House to return to the debate mentioned by the noble Lord, Lord Darzi, which we had nearly a year ago. This amendment would not prohibit embryonic stem cell research. It would not prohibit the creation of animal-human hybrids. It invites the House to require the Human Fertilisation and Embryology Authority to seek from every licence applicant, and from the licensing authority, an undertaking that, before using admixed embryos, alternatives had been explored.

I come to the point properly raised in our previous debates by the noble Baroness, Lady Hollis. I agree that this is not about trying to predict outcomes, but about methodology. It is not unreasonable in these changed circumstances—and they have changed even as we have considered this Bill, because we now have induced pluripotent stem cells, which are embryonic in nature, created from our own skin and do not require the creation of human embryos—to say that this is a satisfactory alternative with which all of us can live. We should therefore require the authority simply to consider that question; not the creation and use, as the noble Lord, Lord Turnberg, said, of more eggs; not the creation of human embryos, as the noble Lord, Lord Darzi, said; but the use of adult stem cells, and, through them, the creation of induced pluripotent stem cells as a legitimate alternative to the manufacture of human embryos. I use "manufacture" not in a pejorative or rhetorical way, but I say to the noble Baroness, Lady Tonge, that 2 million human embryos have been destroyed or experimented on, either through IVF or experimentation—these figures were given earlier in the debate—since we authorised the creation of human embryos in 1990. If any Member of the House could say that this has led to cures, it might lend legitimacy to the argument. However, as the noble Lord, Lord Patten, and others have pointed out, it has not. It is not unreasonable, in 2008, to say that if this is still just about hope, it is not something on which we should place too much reliance.

I will be happy to give these papers that have been passed to me to the noble Lord, Lord Winston. I can give him a copy of a briefing produced by Professor David Prentice, in which he lists, as the noble Lord, Lord Tombs, has done, more than 70 different conditions that have been successfully treated using adult stem cells. It is true that some treatments have been by bone marrow, but there have been other examples, too. I chaired a briefing in the Moses Room of your Lordships' House in which Professor Carlos Lima came from Portugal to talk about the use of olfactory cells in spinal cord treatments. A television programme, Miracle Cell, was produced using that material. These are some examples.

The noble Lord, Lord May, agreed with me—there is common ground here—that none of us should overhype the potential of these cells, whether they are from embryos or adult stem cells, because there are many people suffering from debilitating conditions for whom this must seem like a tantalising solution, when it is still probably a long way off. I will be happy to share that information.

The noble Lord, Lord Winston, and others made a point about the comparative amounts of money allocated by the Medical Research Council to these two areas of research. I have the figures here and am happy to share them. In 2005-06, £17.4 million was made available by the Medical Research Council, of which 43.6 per cent was spent on adult stem cells and 56.4 per cent—significantly more—on embryonic stem cells. I say to my noble friend Lord Patel that, instead of the trend being in that direction, the reverse is true. In 2006, the figure was 46 per cent spent on adult stem cells and 54 per cent on embryonic stem cells. There is every indication that the work that Professor Colin McGuckin has undertaken at Newcastle has, as he said, been discriminated against. I think that we should take that seriously, but those are not the arguments that your Lordships are being asked to vote on this evening.

The amendment is very clear. It states:

"in any circumstances where the purposes of the proposed research can be achieved by any method not entailing the use of human admixed embryos".

Therefore, it would be down to the person applying for the licence and for those sitting on the licensing authority to satisfy themselves of those facts before they proceeded to issue such a licence. I think that this is a moderate amendment and I hope that noble Lords will be prepared to support it. I wish to seek the opinion of the House.

On Question, Whether Amendment No. 2A, as an amendment to Commons Amendment No. 2, shall be agreed to?

Their Lordships divided: Contents, 39; Not-Contents, 202.

Division number 1 Private Parking: Ports and Trading Estates — Human Fertilisation and Embryology Bill [HL]

Aye: 37 Members of the House of Lords

No: 200 Members of the House of Lords

Ayes: A-Z by last name

Tellers

Nos: A-Z by last name

Tellers

Resolved in the negative, and amendment disagreed to accordingly.

On Question, Motion agreed to.

Commons Amendment No. 3

Page 4, leave out line 30 and insert-

"(e) any embryo not falling within paragraphs (a) to (d) which contains both nuclear or mitochondrial DNA of a human and nuclear or mitochondrial DNA of an animal ("animal DNA") but in which the animal DNA is not predominant."

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health) 6:08 pm, 29th October 2008

My Lords, I beg to move that the House do agree with the Commons in their Amendment No. 3. I shall also speak to their Amendments Nos. 5 and 30. These amendments follow discussions in this House and relate to human admixed embryos.

The Bill sets out a clear definition of human admixed embryos and ensures that all such embryos are regulated and may not be created without a licence. Government Amendment No. 3 amends the definition of human admixed embryos. The Bill uses the term "human admixed embryo" as an umbrella term for all four embryo types containing human and animal genetic material. These range from those that are, in simple terms, 99 per cent genetically human through to those that are 50 per cent genetically human. The Bill also contains the power to amend these categories of human admixed embryos should new scientific advances be made.

However, by not providing a catch-all definition of "human admixed embryo", the Bill raised concerns as it passed through this House. In particular, the noble and learned Lord, Lord Mackay of Clashfern, tabled an amendment seeking to add to the Bill a fifth, more general definition of "human admixed embryo". This definition, developed in collaboration with the Academy of Medical Sciences, provided a clear statement that a human admixed embryo is any embryo containing human and animal genetic material where the animal material does not predominate. The Government undertook to consider this amendment further in the other place.

Amendment No. 3 captures the essence of the noble and learned Lord's amendment. It adds a general category of admixed embryos, where,

"the animal DNA is not predominant", thereby giving a clearer idea of the range of entities caught by the Bill. This new category will replace the existing regulation-making power to create new categories of human admixed embryos. However, as there is an additional regulation-making power introduced by Amendment No. 2 to amend the existing categories in the light of scientific advances, this will not impede future flexibility. Amendment No. 5 would make consequential amendments to ensure that the power to amend the categories of human admixed embryos applies to the new catch-all provision. Amendment No. 30 is a consequential amendment to the removal of the regulation-making power.

The noble Earl, Lord Howe, has tabled an amendment to Amendment 3, to which I shall respond after he has moved it.

Moved, That the House do agree with the Commons in their Amendment No. 3.—(Lord Darzi of Denham.)

Photo of Earl Howe Earl Howe Shadow Minister, Health

moved, as an amendment to the Motion, Amendment No. 3A:

Line 5, at end insert "including any embryo which has been created in such a way that the animal DNA would not ultimately predominate.

(f) such other embryo not falling within paragraphs (a) to (e) which contains both human and animal nuclear or mitochondrial DNA as may be specified in regulations."

Photo of Earl Howe Earl Howe Shadow Minister, Health

My Lords, I begin by doing something that the Minister may not necessarily expect of me—expressing my appreciation for government Amendment No. 3. At earlier stages of the Bill, my noble and learned friend Lord Mackay, with his characteristic succinctness, expressed considerable misgivings about the wording in Clause 4(5)(e) which was designed as a catch-all provision, but which seemed to him and to many of us unsatisfactorily vague and inappropriate in terms of the language that it employed. Government Amendment No. 3 is a distinct improvement on the original wording and I thank the Minister for having considered the matter so constructively.

My concern is that the government amendment before us, although it is undoubtedly a step forward, may not be quite good enough. Noble Lords may remember that in Committee I pointed out a lack of legal clarity in relation to the interface between this Bill and the Animal (Scientific Procedures) Act 1986. There appeared to be an unsatisfactory grey area in terms of whether human/animal admixed embryos were covered by one piece of legislation or the other. The noble Lord, Lord Darzi, has just put the issue very well, as he did at Third Reading, when he said that the Bill should ensure that the HFEA regulates human-animal embryos at the human end of the spectrum. We should, therefore, try to ensure in the legal definition of a human admixed embryo that any new form of embryo that may be developed containing human and animal DNA, and where the human DNA predominates, is subject to HFEA regulation.

The wording in Amendment No. 3 attempts to encapsulate that idea. However, as my noble friend Lord Jenkin of Roding pointed out in Committee, science is not always as simple as we might sometimes like it to be. The difficulty here relates to the way in which hybrid embryos can develop. My noble friend quoted part of Professor Robin Lovell-Badge's evidence to the Joint Committee. The professor said:

"You may start off with an embryo which is 20 per cent human and end up with something which is 60 per cent human or vice versa".

We need, therefore, to deal satisfactorily with those cases where the human DNA might only comprise a minority proportion of the total DNA at the beginning of the life of the embryo but would end up predominating.

I am not clear that the wording of government Amendment No. 3 would cover an embryo of this type. Such an embryo would evade regulation under the Bill, because it would not have predominantly human DNA within the first 14 days and could, therefore, in theory and perfectly legally under the 1986 Act be implanted into an animal, and perhaps be taken to mid-gestation without even requiring a licence for the research project. The additional words that I propose at the end of new paragraph (e) would bring under the ambit of this Bill all embryos deliberately created whereby it could be reasonably predicted that the animal DNA would not ultimately predominate. However, if such an embryo were implanted and, under the 1986 Act, allowed to develop in an animal, and be found subsequently to be predominantly human, all future such embryos would come under the ambit of the HFEA, because the ultimate outcome would be known.

My second concern is slightly different. We could imagine a situation, as science moves on, whereby an animal embryo is created with a predominantly or entirely human brain. The DNA of the entire embryo could still be predominantly animal. However, Parliament might wish in the future not to permit the creation of a human-animal embryo of this kind. Rather than leave this and other unforeseeable scenarios to the mercies of the Home Office, it would be preferable to leave the opportunity open to Parliament to take a decision in specific cases that are particularly ethically sensitive.

The role of the Home Office would not be interrupted. However, in exceptional cases, should there be objections among the general public or in Parliament to a particularly sensitive type of chimeric creature, such as a non-human primate or large animal with, for example, a largely human brain, the second part of my amendment would provide a regulation-making power to deal with that situation. I am sorry that in the process of improving this part of the Bill the Government decided to jettison the regulation-making power.

I very much hope that my concerns on these issues are misplaced and that the Minister will be able to reassure me on them. I beg to move.

Photo of Lord Mackay of Clashfern Lord Mackay of Clashfern Conservative 6:15 pm, 29th October 2008

My Lords, I should, first, thank the Minister and his colleagues for the further consideration that has been given to this matter since the Bill left this House for a somewhat prolonged sojourn in another place. Here it is back with us with an amendment in almost the same terms as the amendment that I originally proposed.

When the draft Bill was before the committee examining it, it contained a catch-all clause after listing the four examples that remain in the Bill. Unfortunately, none of the experts that gave evidence to our committee could understand the clause. If they could not understand it, we thought that on the whole it was not adequate for the purpose of defining the entity that we had in mind.

When the Bill ultimately came to your Lordships' House, that portion had been deleted altogether, and in its place had been put a regulation-making power of somewhat ambiguous import. In other words, the Government had given up the idea that they could define in a catch-all way what they meant by this type of embryo. I felt, as did other noble Lords, that that was not satisfactory and we should do what we could to agree to a satisfactory catch-all definition that would not interfere with the four examples in the Bill, but demonstrate in essence their characteristics, as an explanation of the concept of an admixed human embryo.

I should perhaps have mentioned that originally a different phrase was used. The phrase "admixed human embryo" was adopted during the passage of the Bill through this House. It is not a self-evident expression. An ordinary person will have some difficulty understanding the phrase. I believe—this may be the general view in the House—that it would be useful to produce what, in effect, is an explanation of the phrase at the same time as a catchall.

There are a number of ways of approaching the matter. One is to say that everything that is not caught by the Home Office would be caught here, but unfortunately the approach of the Home Office in the Animals (Scientific Procedures) Act 1986 is quite different: it concerned pain to animals. If human material is involved, there does not seem to be any particular criterion about the importance that that extra fact confers on the embryo. Therefore, here we have successfully defined the human end of the spectrum of mixture.

It would be highly desirable for the rest of the spectrum to be looked at from the point of view of appropriate regulation. I do not think that the 1986 Act, which, after all, is a little elderly, is adequate to deal with the kind of considerations involved when less than 50 per cent human material is introduced into animals. Many people to whom I have spoken or who have spoken to me about the Bill did not know that such an end of the spectrum existed and has existed in practical terms for some time. The Government would do well to consider whether a different form of control or regulation is required at the other end of the spectrum.

Perhaps because I had some part in framing this definition, I think it is entirely satisfactory. The use of the word "predominant", a word we hit on in the discussions to which the noble Lord, Lord Darzi, has referred with the eminent scientists who were willing to talk to us about it, is a general word which covers the whole period of an embryo's existence. Therefore, you look at whether the animal DNA is to predominate. If it does, it leaves this definition and, if not, it stays within it.

My view is that the amendment proposed by my noble friend Lord Howe is not necessary. However, we discussed it before and it is important to raise it now so that the precise scope of the word "predominate" might be discussed at this stage which might help in any future matter which may arise in court or in some other way. I thank the Minister very much for what he has said. I certainly support government Amendment No. 3 and I say that Amendment No. 3A tabled by my noble friend is not necessary, although I believe this discussion is necessary.

Photo of Lord Walton of Detchant Lord Walton of Detchant Crossbench

My Lords, I, too, congratulate the Government on Amendment No. 3, which is a very worthy attempt to deal with the issues which were so cogently argued by the noble and learned Lord, Lord Mackay, when this matter was last before the House. I am sufficiently attracted by certain features of the amendment now proposed by the noble Earl, Lord Howe, but at the same time I agree very much with the noble and learned Lord, Lord Mackay, that it does not seem to be necessary.

Amendment No. 3 as it stands is the outcome of detailed discussions between the noble and learned Lord, Lord Mackay, the Academy of Medical Sciences and the Government and deals with a fifth category of admixed embryo. It relies on an alternative regulation-making power in new Section 4A to amend the five categories to catch any other entities. The only problem is that it still is not totally and completely inclusive in one respect: the Amendment No. 3 approach is not entirely clear in that it does not specify precisely how an embryo is to be treated where the proportion of animal DNA varies such that it may predominate at some point but not at another. I hope that the noble Lord, Lord Darzi, will deal with that in his reply.

One example of that—I have received a two-page briefing from Professor Robin Lovell-Badge—is the issue of tetraploid complementation and diploid complementation, but I do not understand those sufficiently to be able to impose the details on your Lordships' House. Therefore, I leave that matter in the worthy hands of the noble Lord, Lord Darzi. I hope that he can deal with the issue as to why, in some respects, this amendment, which is very satisfactory in many ways, is not totally complete and must be kept under review by the Government in the future.

Photo of Lord Patel Lord Patel Crossbench

My Lords, I thank the Government for tabling this amendment. I supported the amendment tabled by the noble and learned Lord, Lord Mackay of Clashfern, in Committee and I support this government amendment. I have some sympathy with the amendment tabled by the noble Earl, Lord Howe. We discussed this in Committee and there is an issue to be tackled, as the noble and learned Lord, Lord Mackay of Clashfern, said, at the other end of the spectrum.

To confuse the matter further, all the evidence from animal studies suggests that for tetraploid complementation, mentioned by my noble friend Lord Walton of Detchant, to happen the two species have to be very close. For example, tetraploid complementation will work in sheep and goat embryonic cells, but not in those of mice or rats. For it to work in humans, therefore, it will have to be a closely related species such as a chimpanzee. The transfer of an embryo into an animal will require a Home Office licence and that will not be permitted. If such an entity were created at some point, not too far along in the development of the embryo, it would grow faster than the embryonic tissues, so it is important to know at what point we are talking about. If, for example, it was in a human, I believe—I might be wrong—that could occur at what we call gastrulation. I think the Minister understands what I mean. In humans it would be about 14 days when organs are beginning to be defined. However, for the purposes of this Bill and the research, embryos will not be allowed to be experimented on beyond 14 days and for the purposes of obtaining stem cells, we are talking about four to six days.

The amendment tabled by the noble Earl, Lord Howe, has some issues to be discussed but they may not be directly applicable to this Bill. The fact that the Government in the Commons retained a regulation-making power in new Section 4A(10) which allows existing categories to be amended, may mean that, in future, if necessary, we could discuss this again.

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

My Lords, the amendment tabled by the noble Earl, Lord Howe, would extend the new admixed category where the animal DNA does not predominate to include embryos where the animal DNA would not ultimately predominate. I shall try to explain that. I can appreciate why the noble Earl may think this is necessary, but I can assure him that the provisions in the Bill already address this situation.

If it were considered that an embryo was to be created in which the human DNA would ultimatelypredominate, an application for an admixed research licence would have to be made to the HFEA at the outset. This is because a licence is required to bring about the creation of a human admixed embryo. If a researcher was intending to create an embryo that would at some stage be predominantly human, for however short that time might be, they would need a licence to do so.

The noble Lord, Lord Walton, also referred to tetraploid complementation where the cells of an early animal embryo are altered so that they contain twice the usual complement of DNA. These cells could give rise only to extra-embryonic tissue—for example, a placenta—and any human cells placed within it could give rise to the embryo proper. It would be an admixed embryo for the purposes of the new catch-all category that the Bill is adding to the definition of human admixed embryo at Clause 4.

The amendment tabled by the noble Earl, Lord Howe, adds a regulation-making power to the categories of human admixed embryos to enable the definition to be extended. That was the position the Bill was in when it was last considered by your Lordships' House. We listened to persuasive arguments at that time that such a provision was too open, and we therefore replaced it with a category proposed by the noble and learned Lord, Lord Mackay of Clashfern, of any other embryo containing animal and human DNA where the animal DNA does not predominate. In the case of an embryo in which the brain might be predominantly animal, it is worth reminding ourselves what we mean by "predominant". We refer not only to the percentage of the DNA but also to its location and functionality. If that entity had a human brain, that could clearly have a predominant function so, by definition, it would be at the human end of the spectrum of human admixed embryos and would require an HFEA licence.

The amendments are therefore not necessary and could lead to a lack of clarity in the Bill as they overlap with the current provisions. I invite the noble Earl to withdraw his amendment.

Photo of Earl Howe Earl Howe Shadow Minister, Health 6:30 pm, 29th October 2008

My Lords, that was a very helpful reply, and I am grateful to noble Lords who spoke in this short debate. As the Minister will appreciate, my worry was that it did not seem to me to be totally clear from the wording of the Commons amendment that embryos that would alter their composition to contain predominantly human DNA post-14 days would all be captured. The Minister reassured us that the word "predominate" will cover all scenarios, but my problem is that the word "predominate" relates to an embryo, rather than a foetus, which is the term that would relate to the embryo at a later stage of its development where the proportion of animal and human DNA changes during development. A mid or late gestation foetus would definitely not be classified as an embryo. My amendment, which is inserted at the end of the government amendment, retains all the careful wording that my noble and learned friend helped to develop and clarifies that no matter how late in the potential development of the organism, which could be as late as the point of birth, if the human DNA ultimately predominated, it would be included as a human admixed embryo and thus would not be allowed to develop to that stage. After listening to the Minister's reply, I am not totally secure that he has covered that point because of the use of the word "embryo" rather than "foetus".

I listened with care to his helpful answer on the second part of my amendment. He clarified that the amendment covers not only the percentage of DNA, but also the functionality of the tissue. I had not appreciated that, and I do not think I could have been expected to from a bald reading of the wording of the amendment. It is valuable that that will go down in Hansard to be read. Unless the Minister wants to come back to me on the point I made about "embryo" as opposed to "foetus", which is a significant point, I will bow to his reassurance.

Photo of Lord Mackay of Clashfern Lord Mackay of Clashfern Conservative

My Lords, before my noble friend sits down, it is important to notice that new Section 4A(3) states that:

"A licence cannot authorise the keeping or using of a human admixed embryo after the earliest of the following ... the end of the period of 14 days beginning with the day on which" it is created.

Photo of Lord Elton Lord Elton Conservative

My Lords, before my noble friend sits down, I wonder whether this is an opportunity to enable the Minister to clarify something because what is said from his Dispatch Box

Photo of Baroness Thornton Baroness Thornton Government Whip, Baroness in Waiting (HM Household) (Whip)

My Lords, I do not think this is an appropriate point at which to reopen the debate. The only remark that might be called for is one from my noble friend, if he chooses to speak. We are at the end.

Photo of Lord Elton Lord Elton Conservative

My Lords, I think I am in order in using this opportunity to suggest to my noble friend that he might elicit from the Minister a clarification of a little sentence he put in that could be quite important. He said that predominance would not depend upon percentage only but also on location or function. Could my noble friend ask the Minister whether that means that if the cells concerned relate to the brain, which is the example he gave, although they are less than 50 per cent, they still predominate?

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

My Lords, the answer is yes. If that functionality predominates being human, that embryo will be classified as being at the human end of the spectrum of human admixed embryos.

Photo of Earl Howe Earl Howe Shadow Minister, Health

My Lords, I feel even more reassured and beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

On Question, Motion agreed to.

Commons Amendments Nos. 4 and 5

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

My Lords, I beg to move that the House do agree with the Commons in their Amendments Nos. 4 and 5, to which I have spoken with Amendments Nos. 1 and 3.

Moved accordingly, and, on Question, Motion agreed to.

Commons Amendments Nos. 6 and 7

Page 8, leave out line 31 and insert-

"(1) Section 12 of the 1990 Act (general conditions of licences under that Act) is amended as follows.

(2) In"

Page 8, line 37, at end insert-

"(3) In subsection (2)-

(a) omit the "and" at the end of paragraph (a), and(b) at the end of paragraph (b) insert ", and(c) every licence under paragraph 3 of that Schedule, so far as authorising activities in connection with the derivation from embryos of stem cells that are intended for human application."."

Photo of Baroness Thornton Baroness Thornton Government Whip, Baroness in Waiting (HM Household) (Whip)

My Lords, I beg to move that the House do agree with the Commons in their Amendments Nos. 6 and 7. I shall speak also to Amendments Nos. 10 to 12, 105, 107 and 114 to 116.

During passage of the Bill through this House, debate took place on the use of embryonic stem cells, derived under a research licence, in therapeutic applications. The Government subsequently wrote to all Peers involved in those discussions setting out how, in the Government's view, embryonic stem cells derived under an HFEA research licence could be used in therapeutic applications.

These amendments were made in the light of that debate to ensure that research centres deriving embryonic stem cells, where those stem cells are intended for therapeutic use, are required to abide by the quality and safety standards set out in the European Union tissue and cells directive in relation to the stem cells and the embryos from which they are derived.

The directive lays down standards of quality and safety for human tissues and cells intended for human application, including gametes and embryos. The relevant requirements already apply to embryos used in reproductive treatment as a result of the Human Fertilisation and Embryology (Quality and Safety) Regulations 2007. Stem cells derived from embryos are also regulated under the Human Tissue (Quality and Safety for Human Application) Regulations 2007. It is important that these standards are also applied to the embryos that are used to derive stem cells to be used in human application to ensure the necessary levels of quality and safety of any tissue to be used in treatment.

Moved accordingly, and, on Question, Motion agreed to.

Commons Amendments Nos. 8 and 9

Page 9, line 30, leave out "being treated" and insert "mentioned in subsection (6A)"

Page 9, line 33, leave out "to be treated" and insert "mentioned in subsection (6A)"

Photo of Baroness Thornton Baroness Thornton Government Whip, Baroness in Waiting (HM Household) (Whip)

My Lords, I beg to move that the House do agree with the Commons in their Amendments Nos. 8 and 9. I shall speak also to Amendments Nos. 13, 32, 33, 35, 37, 40, 56 and 95 to 103. These are minor and technical drafting amendments to provide correction, clarity and consistency. Amendments Nos. 8 and 9 are purely technical and ensure consistency with the wording of the new Section 13(6) of the 1990 Act, as inserted by Clause 14 of the Bill. The amendments replace the words "the woman being treated" in the new Section 13(6B)(a) and the words,

"the woman to be treated" in the new Section 13(6B)(b) with the words,

"the woman mentioned in subsection (6A)".

This is to make clear that the reference in new Section 13(6B)(a) and (b) refers back to the woman mentioned in new Section 13(6A).

Amendment No. 13 is simply a minor drafting amendment, removing the superfluous words "any of" in reference to the three paragraphs of new Section 31ZD(3) in connection with the disclosure of information to donors. Amendment No. 32 makes a minor drafting correction to Clause 40. It is purely technical and changes the words in the clause to "the man" instead of "a man", as currently drafted. I turn now to Amendments Nos. 33 and 35. In Clause 43 the woman being treated is referred to as "W". Amendment No. 33 corrects a reference to "she" and replaces it with "W" for consistency. Amendment No. 35 makes a similar correction to Clause 46; the amendment replaces a reference to "the woman" with "W".

Amendment No. 37 relates to Clause 50, which makes clear what a civil partnership is for the purpose of Clauses 35 to 47. This provision is equivalent to the provision in Clause 49 relating to marriage. The clause makes clear that a civil partnership is one which has been subsisting, unless a separation order is in force, and it includes the parties to a void civil partnership if either or both parties reasonably believed it was valid. Currently Clause 50 applies the definition to "the" reference to civil partnerships, but it needs to apply to "any" reference to civil partnerships at any time in Clauses 35 to 47. Amendment No. 37 is therefore a grammatical correction to Clause 50, which ensures that the meaning of civil partnership applies to any reference to civil partnership in Clauses 35 to 47 of the Bill.

Amendment No. 40 makes a minor amendment to Clause 55, which provides for the Secretary of State to be able to make regulations relating to enactments about adoption. Clause 55(3) lists what the enactments about adoption are. Amendment No. 40 makes a technical change to Clause 55(3) to ensure that it reads consistently with Clause 55(1) by changing "enactments relating to adoption" to "enactments about adoption".

Amendment No. 56 is a drafting amendment to ensure consistency in situations where consent is required. This amendment is consequential to the embryo training provisions in the Bill, which allow embryologists to train using donated embryos. Provisions in the Bill ensure that before an embryo is received by any person, effective consent to the use of that embryo must be in place. Under the Bill, this consent could be to treatment, research or both. This amendment adds that consent could have been given for the use of an embryo in training. The person receiving the embryo must ensure that consent to one or more of these purposes is in place.

Amendment No. 95 corrects the amendments in Schedule 6 to the Births and Deaths Registration Act 1953 so that reference to "that person" is replaced with "the woman concerned" to reflect the definition inserted into Section 10(1B)(b)(i) of "a woman concerned" as a parent of a child by virtue of Clause 43 of the Bill. Amendments Nos. 98 and 99 are also technical and correct the amendment to the Registration of Births, Deaths and Marriages (Scotland) Act 1965 so that the references to "other parent of the child" and references to the "person" are replaced by "the woman concerned" to reflect the definition inserted into Section 18B(1) of "a woman concerned" as the parent of a child by virtue of Clause 43 of the Bill.

Amendments Nos. 96, 97, 101 and 102 make technical corrections to ensure that the Bill refers to the formation of a civil partnership and not the time of the civil partnership. This is because Section 1 of the Civil Partnership Act 2004 defines a civil partnership as the relationship, not the ceremony. Therefore, references to entry into marriage cannot be translated to civil partnerships. Amendment No. 100 is a drafting correction to change the reference in Section 18B(3)(b) of the Registration of Births, Deaths and Marriages (Scotland) Act 1965 from "a child" to "the child" as the reference is to the child referred to earlier in subsection (3).

Amendment No. 103 is a technical correction; it corrects the amendment to the Children (Northern Ireland) Order 1995 under paragraph 75 of Schedule 6 to the Bill to make an equivalent provision to the amendment to the Family Law Reform Act 1987 under paragraph 24(3) of Schedule 6 to the Bill, which makes provision for England and Wales. The amendment brings Northern Ireland provision in line with the provision for England and Wales, and ensures that both provisions read "domiciled immediately". I beg to move.

Moved accordingly, and, on Question, Motion agreed to.

Commons Amendments Nos. 10 to 13

Photo of Baroness Thornton Baroness Thornton Government Whip, Baroness in Waiting (HM Household) (Whip)

My Lords, I beg to move that the House do agree with the Commons in their Amendments Nos. 10 to 13, to which I have spoken with Amendments Nos. 6 and 8.

Moved accordingly, and, on Question, Motion agreed to.

Commons Amendments Nos. 14 to 23

Page 26, leave out lines 22 to 41 and insert-

"(g) the disclosure is made so that no individual can be identified from the information,(h) the disclosure is of information other than identifying donor information and is made with the consent required by section 33AB,"

Page 26, line 41, at end insert-

"(ja) the disclosure-(i) is made by a person who is satisfied that it is necessary to make the disclosure to avert an imminent danger to the health of an individual ("P"),(ii) is of information falling within section 31(2)(a) which could be disclosed by virtue of paragraph (h) with P's consent or could be disclosed to P by virtue of subsection (10), and(iii) is made in circumstances where it is not reasonably practicable to obtain P's consent,"

Page 27, leave out lines 38 to 50

Page 28, leave out lines 1 and 2

Page 28, line 7, leave out from "of" to "or" in line 12 and insert "identifying donor information,"

Page 28, leave out lines 18 to 30

Page 28, line 36, leave out "treated together with another" and insert "who is treated together with, or gives a notice under section 37 or 44 of the Human Fertilisation and Embryology Act 2008 in respect of, another"

Page 28, leave out lines 39 and 40

Page 28, line 45, at end insert-

"( ) In this section "identifying donor information" means information enabling a person to be identified as a person whose gametes were used in accordance with consent given under paragraph 5 of Schedule 3 for the purposes of treatment services or non-medical fertility services in consequence of which an identifiable individual was, or may have been, born."

Page 28, line 45, at end insert-

"33AB Consent required to authorise certain disclosures

(1) This section has effect for the purposes of section 33A(2)(h).

(2) Subject to subsection (5), the consent required by this section is the consent of each individual who can be identified from the information.

(3) Consent in respect of a person who has not attained the age of 18 years ("C") may be given-

(a) by C, in a case where C is competent to deal with the issue of consent, or(b) by a person having parental responsibility for C, in any other case.

(4) Consent to disclosure given at the request of another shall be disregarded unless, before it is given, the person requesting it takes reasonable steps to explain to the individual from whom it is requested the implications of compliance with the request.

(5) In the case of information which shows that any identifiable individual ("A") was, or may have been, born in consequence of treatment services, the consent required by this section does not include A's consent if the disclosure is necessarily incidental to the disclosure of information falling within section 31(2)(a).

(6) The reference in subsection (3) to parental responsibility is-

(a) in relation to England and Wales, to be read in accordance with the Children Act 1989;(b) in relation to Northern Ireland, to be read in accordance with the Children (Northern Ireland) Order 1995;(c) in relation to Scotland, to be read as a reference to parental responsibilities and parental rights within the meaning of the Children (Scotland) Act 1995."

Photo of Baroness Thornton Baroness Thornton Government Whip, Baroness in Waiting (HM Household) (Whip)

My Lords, I beg to move that the House do agree with the Commons in their Amendments Nos. 14 to 23.We recognise that it is very important that the 1990 Act and the Bill strike the right balance between, on the one hand, safeguarding the confidential information of patients, their partners, donors and children held by the HFEA and clinics and, on the other hand, allowing information to be disclosed by the HFEA and clinics in circumstances that warrant it. However, at present the 1990 Act is not as conducive to this as it could be. For instance, it prohibits the HFEA from disclosing identity information about patients, even where the patient consents to such disclosure. We regard this as too restrictive. In particular, it is not helpful for follow-up research into the effects of infertility treatment on patients and their children. At present, such research could not draw on information from the HFEA that identified the patient, even if the patient was very keen to see the research take place and had consented to the disclosure of their information.

To help this, Clause 25 introduces a provision that allows the HFEA to disclose information from its register of treatment with the consent of the people identified. Following the debate in this House and amendments tabled by the noble Lord, Lord Patel, we gave further consideration to the detail of the new provision. In particular, we have looked at the relationship between disclosure and consent in certain situations. As a result, we have identified where the Bill could benefit from greater clarification. The amendments that we have tabled address this. The group of amendments provides that disclosure of identifying information about a person aged under 18 must have their consent or, if they are not competent to consent, the consent of someone who has parental responsibility for them. This is important, as researchers may well want information about the child in order to undertake follow-up research into their health. This could be a sensitive issue for the child and it is only right that their consent to the disclosure of information is obtained.

The amendments also ensure that the consent provisions do not allow for the provisions in the 1990 Act and the Bill for the disclosure of identifying information about donors to be inadvertently circumvented. Those specific provisions in Section 31(3) to (7) of the 1990 Act, and carried forward by new Sections 31ZA and 31ZB in Clause 24 of the Bill set out the circumstances in which the HFEA can disclose identifying donor information. They provide, for instance, that identifying information about donors can only be provided to a relevant person aged 18 or over. The amendments ensure that this remains the correct route by which identifying donor information, with all its associated sensitivities, is disclosed by the HFEA to people who may be born as a result of such treatment. The amendments make these circumstances exceptions to the new provisions for the HFEA to release information with the consent of those identified. In doing so, they remove, for example, the risk of parents putting pressure on the HFEA to approach a donor for consent to his identifying information being released to them and their child. I beg to move.

Moved accordingly, and, on Question, Motion agreed to.

Commons Amendments Nos. 24 to 26

Page 32, line 26, at end insert-

"( ) In subsection (7), for "section 10(2)(a)" substitute "section 19B(3)(a) or 20B(3)(e)"."

Page 32, line 31, leave out "(7) or"

Page 33, line 21, leave out ", (6) and (7)" and insert "and (6)"

Photo of Baroness Thornton Baroness Thornton Government Whip, Baroness in Waiting (HM Household) (Whip)

My Lords, I beg to move that the House do agree with the Commons in their Amendments Nos. 24 to 26. I shall speak also to Commons Amendments Nos. 27, 117 and 118.

Amendments Nos. 24, 25, and 26 relate to Clause 29 of the Bill, which amends Section 41 of the 1990 Act that sets out offences under the Act. These amendments are minor and technical and carry forward existing provisions in the 1990 Act.

A licence or appeals committee of the HFEA has the power to require, or summons, oral or written evidence. If the summons is not complied with, it is an offence under the 1990 Act. This is set out in Section 41(7) of the Act, which states that if there is not a reasonable excuse as to why the summons for evidence has not been complied with, a person is guilty of an offence. The Bill has the same power for an appeals or licence committee to require evidence but does not, as currently drafted, make it an offence not to comply with the request. These amendments would ensure that the power under new Sections 19B and 20B could be enforced.

Amendments Nos. 117 and 118 amend Schedule 8 to the Bill, which sets out the sections of the 1990 Act that will be repealed. These amendments ensure that the relevant sections of the Act are not repealed.

Amendment No. 28 relates to the process, set out by the 1990 Act, for appealing against licence decisions. Clause 21 of the Bill replaces these provisions in the 1990 Act with new Sections 20, 20A, 20B and 21. These provisions set out the process for reconsideration and appeals.

Clause 21 introduces two regulation-making powers, at new Sections 20A(3) and 20B(2), to make provision for the proceedings and membership of an appeals committee, and procedure in relation to reconsideration of licence decisions. It was deemed appropriate to make these provisions through regulations rather than in the Bill so that the detail could be consulted upon. Both regulations are subject to negative resolution under the Bill. Amendment No. 28 makes these regulations subject to the affirmative procedure, and follows discussions on this issue during Public Bill Committee in another place. In light of these discussions, and taking into account the likely interest and importance of these regulations, I believe that the affirmative procedure is more appropriate. The Department of Health will consult on the detail of these regulations in due course.

Moved, That the House do agree with the Commons in their Amendments Nos. 24 to 26.—(Baroness Thornton.)

On Question, Motion agreed to.

Commons Amendments Nos. 27 to 30

Photo of Baroness Thornton Baroness Thornton Government Whip, Baroness in Waiting (HM Household) (Whip)

My Lords, I beg to move that the House do agree with the Commons in their Amendments Nos. 27 to 30, to which I have spoken with earlier amendments.

Moved accordingly, and, on Question, Motion agreed to.

Commons Amendment No. 31

Page 37, line 23, at end insert-

"( ) A notice under subsection (1)(a), (b) or (c) by a person ("S") who is unable to sign because of illness, injury or physical disability is to be taken to comply with the requirement of subsection (2) as to signature if it is signed at the direction of S, in the presence of S and in the presence of at least one witness who attests the signature."

Photo of Baroness Thornton Baroness Thornton Government Whip, Baroness in Waiting (HM Household) (Whip)

I beg to move that the House do agree with the Commons in their Amendment No. 31. I shall speak also to Commons Amendments Nos. 34, 53, 62 to 71 and 73 to 88.

The Bill introduces new paragraph 1(2) of Schedule 3 to the 1990 Act, which enables a person who lacks physical capacity to direct another to sign a notice of consent on their behalf. This ensures that where someone is physically incapacitated, they are not prevented from giving consent to the creation, keeping and use of embryos and human admixed embryos and to the storage and use of gametes to create embryos.

Commons Amendments Nos. 31 and 34 ensure that an equivalent provision is made where consent is required to being treated as the father or second female parent of a child born by assisted conception. These amendments enable the person giving consent to direct another person to sign the notice of consent on their behalf. Equally, if the mother of the child is unable to sign the notice she can direct someone to sign on her behalf. These amendments ensure consistency in the Bill.

Amendments Nos. 53, 62 to 71 and 73 to 88 are purely technical in nature and have been raised at this point after further scrutiny of the Bill. Amendment No. 53 replaces the phrase "the incapacitated person" with the phrase a "person unable to sign", to distinguish a person who is incapacitated due to illness, injury or physical disability from people who lack capacity to consent, which is relevant in the context of other amendments later in this Schedule.

During previous consideration of the Bill in this House, the noble Lord, Lord Alton, raised concerns about the words "child donor" in new paragraph 9 of Schedule 3, where these words are referring to a patient who is a child. In order to prevent any confusion with the terminology, minor technical amendments have been made throughout, replacing the words "child donor" with the letter "C". For consistency, further amendments are needed to replace the word "patient" with the letter "P" in new paragraph 10. These are covered by Amendments Nos. 62 to 71 and 73 to 88.

Moved, That the House do agree with the Commons in their Amendment No. 31.—(Baroness Thornton.)

Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench

My Lords, I thank the noble Baroness, Lady Thornton, for the provision that she has just made. As she rightly said, we will come to the substantive question on consent later in our proceedings. However, for the clarification that has been provided in this group of amendments, I am indebted to her.

On Question, Motion agreed to.

Commons Amendments Nos. 32 to 35

Photo of Baroness Thornton Baroness Thornton Government Whip, Baroness in Waiting (HM Household) (Whip)

My Lords, I beg to move that the House do agree with the Commons in their Amendments Nos. 32 to 35, to which I have spoken with earlier amendments.

Moved accordingly, and, on Question, Motion agreed to.

Commons Amendment No. 36

Page 43, line 13, at end insert-

"(5A) In relation to England and Wales and Northern Ireland, a child who-

(a) has a parent by virtue of section 42, or(b) has a parent by virtue of section 43 who is at any time during the period beginning with the time mentioned in section 43(b) and ending with the time of the child's birth a party to a civil partnership with the child's mother,

is the legitimate child of the child's parents."

Photo of Baroness Thornton Baroness Thornton Government Whip, Baroness in Waiting (HM Household) (Whip)

My Lords, I beg to move that the House do agree with the Commons in their Amendment No. 36.

Amendment No. 36 relates to consequential amendments made to other Acts by the Bill. These amendments specifically relate to the Legitimacy Act 1976 and the Family Law Reform Act 1987, in respect of the legitimacy of children born by assisted conception to civil partners, to bring these rules in line with those for married couples.

Since the introduction of the Bill, it has been identified that while a child born to a same-sex couple who later entered into a civil partnership would be treated as legitimate in law for all purposes, a child born to civil partners would not be treated as legitimate in law for all purposes, but only for the purposes set out in statute. For example, many family trusts create classes of beneficiary limited to "lawful issue"; that is, legitimate children. In such cases, the anomaly would operate unless corrected through these amendments. Amendment No. 36 corrects this unintended consequence by making a clear statement that a child born to civil partners will be treated as legitimate in law for all purposes.

The right reverend Prelate the Bishop of Southwell and Nottingham has tabled an amendment to Amendment No. 36. I shall respond to it after he has spoken to his amendment.

Moved, That the House do agree with the Commons in their Amendment No. 36.—(Baroness Thornton.)

Photo of The Bishop of Southwell and Nottingham The Bishop of Southwell and Nottingham Bishop

moved, as an amendment to the Motion, Amendment No. 36A:

at end insert, "but do propose Amendment Nos. 36B and 36C as consequential amendments to the Bill:

Page 52, line 27, at beginning insert "Subject to subsections (3) and (4)"

Page 52, line 28, at end insert-

"(3) No order bringing sections 42 and 43 into force shall be made until after the publication of the results of an 18-month consultation with children and young people on the effects of these sections.

(4) An order under subsection (3) shall not be made unless a draft of the regulations has been laid before, and approved by a resolution of, both Houses of Parliament."

Photo of The Bishop of Southwell and Nottingham The Bishop of Southwell and Nottingham Bishop

My Lords, Clauses 42 and 43 of the Bill were not debated on the Floor of the other place because of the shortage of time. In the final minutes of the remaining stages last Wednesday, it was said by the Member who tabled amendments to Clause 42 and 43:

"I am deeply saddened that we have not had a proper debate, and that there has not been a chance for every Member to go through one or other Division Lobby, on the issue".—[Hansard, Commons, 22/10/08; col. 410.]

On Monday, the following letter appeared in the Daily Telegraph, setting down a challenge to this House:

"Sir—It is a sad reflection on the state of democracy in Britain that last Wednesday, without proper debate, the Government pushed through its highly controversial Human Fertilisation and Embryology Bill (Letters, October 25) ... There was no opportunity to debate the extraordinary proposals for deliberate creation of children with the intention they be denied a father for the duration of their childhood ... we hope the Lords will do all it can to make good these failings".

It is signed by two Members of the other place.

Given the lack of opportunity for scrutiny of Clauses 42 and 43, and attendant concerns that questions will be asked about our parliamentary process, I have been more than happy to table the amendment in my name that seeks to provide opportunity for greater scrutiny of these two clauses. I will first outline some of the problems of these provisions before focusing on the consultation proposed in my amendment.

Currently, at the point of conception, every child has a chance of having a father as a parent during their childhood. I stress the word "chance" because there is no right to have a father than the law can guarantee. In this regard, there are at least two scenarios which we need to keep in view. First, disaster might strike; tragically, some fathers are killed before the birth of their children. Secondly, we must have regard for women who become pregnant either naturally or by IVF, with no immediate prospect of a present father who can input into the child's life. At the point of conception, however, both have the chance of having a father because in the first instance, we do not know that the father will die, and in the second, the fact that a woman is not married or living with a partner when she becomes pregnant does not mean that it is intended that she will remain that way for the duration of the child's childhood. She may marry at a later stage, and then the child would enjoy access to a social father for a period.

While the law cannot guarantee a present father, it would surely be quite wrong, in my view, for the state to put in place a legal framework to allow for the deliberate creation of children with the intention that they should be denied the chance of ever having a father throughout their childhood, yet this is precisely the effect of the clauses before us.

In making this point, I am keenly aware that some will say that with gay adoption legal, the point of principle has been conceded, and Clauses 42 and 43 simply outwork its implications in the context of IVF. This, however, is completely untrue. When a child is conceived who is later adopted by a lesbian couple, they have the chance of being parented by a father and may well have been parented by a father for a period. These children were not deliberately created with official sanction of the intention that they should be denied a father for the duration of childhood. While an argument can be made that despite the evidence suggesting the importance of fathers, it is better for children to be looked after by a loving same-sex family than for them to be in an institution, it is not appropriate—given the balance of research which clearly demonstrates the importance of fathers to the well-being of children as well as the importance of children's rights— deliberately to create children with the intention that they should be denied a father for the duration of their childhood.

When I was at school, we were told how bad things were for children in the 19th century. We were told how the upper classes suffered under a regime in which they were to be seen and not heard and how the lower classes were sent up chimneys and down mines. Since then, our teachers told us, things have improved, and in many ways they clearly have. But this legislation causes me big concerns. It shows a preoccupation with the rights of adults and would-be parents and loses sight of the importance of the rights of the child. In highlighting this point, I am very grateful to the noble Lord, Lord Brennan, who has prepared a legal opinion on the parenthood implications of the Bill. The opinion concludes that the changes proposed in the legislation,

"introduce an imbalance of human rights protections as between same-sex parents and the child. It is often said that in matters such as adoption, the best interests of the child are paramount. I do not see how the best interests of the child are served by the introduction of these changes".

Given the problems with Clauses 42 and 43, not least in relation to human rights, it seems only appropriate that we should pause before implementing these extremely controversial proposals. As well as revisiting the human rights arguments in light of the balance of current research about what is in the child's best interests, I also think it is vital to listen to the views of children and young people specifically. It is interesting that the consultation process that went before the Bill—the 2005 review of the Human Fertilisation and Embryology Act—managed to construe some key questions without even mentioning the child directly. Consider the following:

"The Government seeks views on whether the status and legal parenthood provisions of the Human Fertilisation and Embryology Act should apply to same-sex couples who do not form a civil partnership. If so, how would automatic recognition of parenthood be achieved, given the lack of legal ties between the couple?".

It is almost as if the child were not there.

The provision of an appropriate focused consultation exercise with children and young people would be entirely appropriate given the Government's commitment to consult with children and young people in the Children's Plan. Indeed, it seems to me that if the Government are to consult with children and young people on anything, they must surely talk to them about controversial proposals such as these which seek deliberately to create children with the intention that they be denied a father for the duration of their childhood and are vulnerable to the accusation that they have been developed out of regard for the interests of adults rather than children.

I very much look forward to hearing the views of other Members of your Lordships' House on this important issue. I beg to move.

Photo of Lord Waddington Lord Waddington Conservative 7:00 pm, 29th October 2008

My Lords, the House will be relieved to hear that I do not look upon this as an opportunity to rehash all the arguments about why, when treatment is being considered, regard should be had to the child's need for a father. But in view of the fact that there was no debate in the other place of Clauses 42 and 43, I think some brief comments are appropriate.

We often discuss in this place the rights of children, and I find it absolutely astonishing that we are being asked to sanction the deliberate creation of children with the intent that they be denied a father for the duration of their childhood, completely ignoring those children's rights. That seems so obviously wrong that there is no need for further words of embellishment. But how can it be seriously argued that the right of two women to have a child is so strong that it completely overwhelms and drives out of court other people's rights, in particular the rights of the child they insist on bringing into the world?

One of the purposes of the Bill is to ensure that same-sex couples may produce a child by donor, the arrival of the child being the very object of the exercise. I believe that its human rights are as important, if not more important, than the rights of the same-sex couple. I shall certainly support the right reverend Prelate's amendment, but must say that I find wholly objectionable the idea that by a legal fiction, a child should find itself with two women as its parents instead of a father and a mother. I do not believe that such a child's human rights are being properly protected.

Photo of Lord Maginnis of Drumglass Lord Maginnis of Drumglass Crossbench

My Lords, I very much welcome and support the right reverend Prelate's amendment. It is deeply concerning that Clauses 42 and 43, which raise such profound human rights and welfare questions for children, were never debated on the Floor of the other place. If we vote for this amendment today, that will at least result in the issue being sent back to the other place and then, I hope, in the provision of a proper debate by the elected Chamber on this far-reaching issue. I believe that that is our responsibility, regardless of what we think of the issues.

As previous speakers have pointed out, there is all the difference in the world, from the perspective of the rights of the child, between allowing a child to be adopted by a same-sex couple in preference to their remaining in an institution and for the state to provide for their deliberate creation with the intention they be denied a father for the duration of their childhood. It is not clear to me how we can sanction this without allowing the rights of the would-be parents to trump the rights and best interests of the child. As the right reverend Prelate noted, to this degree Clauses 42 and 43 invoke the failings of previous ages albeit in new contexts.

We need to pause. The Government need to study carefully the legal opinion of the noble Lord, Lord Brennan. We need to at least consider and carefully analyse how children themselves will feel about the future, deliberate creation of children with the intention that they be denied a father. There is an undeniable moral argument that, however powerful a Government may consider themselves to be, they should not embark on such a blatantly unnatural procedure as this Bill proposes. Since moral arguments seem to have less consequence today—not least within the higher echelons of new Labour—let me look briefly at a purely social contradiction.

It is a social requirement—I agree with it—that errant fathers should be pursued and legally obliged to provide for the upbringing of their children. How can that obligation possibly be sustained when the Government are today willing to decree that children can be denied a father? What is the essential difference to a child between its father avoiding the responsibility of fatherhood and the Government nullifying its right to have a father? Both are effectively the same. This Bill will create an absolute paradox as it currently stands. Nor do I hear any cogent case to support this contradiction coming from society in general.

Returning to my original point, it is absolutely clear that we must vote for this Motion and provide the opportunity for a debate on the Floor of the other place on the deliberate creation of children with the intention that they be denied a father. We owe this much to children here in the United Kingdom.

Photo of Lord Patten Lord Patten Conservative

My Lords, it is always a pleasure to listen to and to follow the noble Lord, Lord Maginnis of Drumglass. On this issue I can say to him, "No surrender". I agree with everything he has brought to your Lordships' attention. I will not repeat the views I have expressed earlier in Committee and on Report, although it is a sad reflection on the state of participatory democracy that, as the right reverend Prelate said in his splendid introductory remarks, another place did not find the time to discuss something of rather fundamental importance. History will look back sadly and judge this.

That said, I have two points to make. First, I recall not points that I made earlier but the whole drift of debate here in Committee and on Report from those who supported this approach. They have been highly utilitarian about supporting the needs, desires and wants of parents who choose not to include a father; they should have those desires satisfied now. No consideration at all has been given to possible adverse effects on children years or decades down the line. Those arguments were rather brushed aside as not being worthy of consideration in the times we live in now. I think that is sad. I am sure that if this particular provision passes into law, sociologists and others will quite quickly be starting generational studies to see what happens to children brought up in this way and how they turn out in 10, 12 or 15 years. I cannot predict the results of that but there are serious issues of concern in proceeding in this way.

Secondly, I genuinely support the Government's approach over the past 10 years to wider consultation. It has been good. It is sometimes hard to understand or interpret the results, but that is not the Government's fault. The Government have been exceptionally good at consulting. There is a lesson there for future Governments. Yet I find it extraordinary that this Government, who are so keen on consultation, should choose not to consult children about this key issue. These are their rights. The children we would consult may not be born under these circumstances but when I have consulted those who are called children—albeit statistically a small group—they cannot believe that this sort of thing is happening without their opinion being sought.

It is extraordinary that the Government do not pause and think again on this issue. As the noble Lord, Lord Maginnis of Drumglass, said, we should send this back to another place so that they can look properly at it. They can at least demonstrate that they have given some consideration to something which in future years will be seen to be extraordinarily dismissive of the rights of children in a way that flies in the face of so much else that this Government have done concerning the rights of children.

Photo of Baroness Butler-Sloss Baroness Butler-Sloss Crossbench 7:15 pm, 29th October 2008

My Lords, I apologise to the right reverend Prelate for not being present when he started moving his amendment.

I do not want to repeat what I said earlier in Committee, but I remind the House that Section 1 of the Children Act says that the welfare of children is paramount. I am well aware that we are discussing something rather less than the rights of children. We are talking about the advice given to would-be parents going through the process.

I have experienced in my previous life extremely good care being exhibited by single-sex parents, both male and female. I also care about the situation in which two men who may exclude women from their lives as I do about two women who may exclude men. We need to bear in mind the fact that if we take out the word "father", the message that goes out to the public is that fatherhood—and to some extent perhaps motherhood—matters less than I would have thought this Government thought it did.

Photo of Baroness Barker Baroness Barker Spokesperson in the Lords, Health

My Lords, it has become apparent over the past 10 months or so, as I have closely followed deliberations at every stage of this Bill both here and in another place, that it is the fate of us in this House to be considered heroes when we disagree with the House of Commons and largely ignored when we do not. I say that to make the point that the amendment of the right reverend Prelate is unnecessary for a number of reasons. His amendment to delay the implementation of these two clauses is effectively a wrecking amendment. It takes away the recognition of a woman who is a civil partner of a woman who had received treatment until there has been an 18-month consultation with young people. I will return to the nature of the consultation. To begin, I point out two things.

First, on 19 and 20 May, the whole of the House of Commons, on the Floor of the House of Commons—before the Bill was debated in Committee—discussed the issue we have come to know as the need for a father. They did so and, happily, reached the same conclusion as Members of this House: this legislation should reflect the fact that we now have civil partnerships in this country and that there are families of same-sex couples with children.

The amendment is unnecessary for another reason: this provision was debated extensively in your Lordships' House. Many noble Lords took part in debates at Second Reading, in Committee, on Report and at Third Reading, where some made Second Reading speeches also. The matter was given a great deal of time. I say that to make the following point. Members of this House decided earlier this year that we should have legislation that acknowledges the existence of those families. It did not do so lightly or without consideration of the best interests of children. Members of this House bothered to read research findings that were presented to them. Some of it, such as the dossier provided by Christian Action Research and Education, turned out not to be research at all but merely anecdotal opinion. The sociological studies that the noble Lord, Lord Patten, mentioned have been going on for some considerable time. Professor Susan Golombok and other colleagues at Cambridge, who are the foremost academics on research into families and fatherhood, presented information that was made freely available to all noble Lords. Some of us, who are diligent enough to believe that it is our duty to look after the best interests of children, read that research and arrived at a conclusion.

Some Members of this House do not accept the conclusions that the majority reached and would rather that civil partnerships did not exist. I think that some Members of this House would rather that gay people did not exist, but they do. They do. The whole point of this legislation was to ensure that children born into those families receive the same legal recognition and protection as other children. What will be achieved by doing what the right reverend Prelate asks? It will defer indefinitely protection for a very small group of children who live in families, meaning that they do not have the legal protection of both their parents. They will not be able to inherit property and financial support as other children do.

The right reverend Prelate talks about consultation. Which children and young people would he consult? What would he ask them, and what would he do with the results of the consultation? If we have learned anything over the past 10 months, during which we have looked into all the matters in the Bill, it is that it is very easy for two groups of people to present the same issue completely differently and to elicit from the public diametrically opposite results. I do not believe that that is how we should treat matters of such importance. It is the role of Members of Parliament to consider all the best evidence before them and to come to what they believe is a legislative framework that will look after the rights of children.

We are where we are today in our society. The noble and learned Baroness, Lady Butler-Sloss, was right to remind us of Section 1 of the Children Act. The rights of children are paramount, and some of us who disagree with other noble Lords who have already spoken have kept that to the forefront of our mind throughout debates on this legislation. We have come to the conclusion that it would be right to reflect civil partnership in all its implications and to ensure that children who at the moment do not have the opportunity to grow up in stable and secure families can do so. I hope that noble Lords will recall our earlier discussions and resist the right reverend Prelate's amendment.

Photo of Baroness Knight of Collingtree Baroness Knight of Collingtree Conservative

My Lords, I cannot forbear intervening in this debate, though I will be very brief. I was moved by what the right reverend Prelate said and cannot help thinking that nothing said since has successfully rebutted what he alleged at the very beginning of this debate. I simply cannot understand why it can be right in any circumstances to put the child's interests last; to my mind, they must be put first, as established in previous legislation. In this case, the legislation does not do that; it puts them in a secondary position. We all know how dangerous it is to break with an acknowledged fact—in this case, for instance, that children are very important and should be considered as such because they often have no voice of their own. Once we have agreed that, how can we go back on it? That is what we are doing.

I wish to make one further small point—it seems a big point to me. Surely we are denying children the right to a father not only during their childhood but throughout their life. I have found on many occasions, and many noble Lords will know this from their own family, how a young person over 18 can have as much need and love for his father as a much younger child. I cannot accept this.

Photo of The Earl of Listowel The Earl of Listowel Crossbench

My Lords, I support the amendment moved by the right reverend Prelate. I will not repeat the arguments I rehearsed at Second Reading and will be as brief as I can. A couple of years ago, I attended a course in child development. After one of the lectures I asked the lecturer his view on the very question that we are debating this evening. He said that he had no view but added that he was treating a young man who had been brought up in a same-sex partnership, by lesbian parents. He was treating the young man because those parents did not like men. They found men objectionable and considered them violent so this young man was recovering from an experience where his gender, his identity, was seen as objectionable in his own family.

I hope that that is a one-off situation, but it is an interesting coincidence that the one time I asked the therapist that question, he pointed out that he was treating a young man who grew up in a same-sex partnership and had those issues. I would appreciate reassurance from the Minister. There must be a concern that at least some of those same-sex parents will have antipathy to the other sex. Does it not really reinforce the argument for ensuring as far as possible that there is at least a father figure for a son to turn to if he grows up in such a situation. That causes me concern.

I recognise that this is a very complex matter. The noble Lord, Lord Winston, raised the issue of how you implement legislation in this area. Emphasis should be put on the need to struggle with parents to get them to consider what the needs of the child will be if, for instance, a son is born to two mothers. What additional support will that family need in terms of having a male figure to take an interest in the son?

The noble Baroness, Lady Barker, asked how one would consult children on these matters. I understand that these things are difficult to do well, but the Children's Commissioner for England, Professor Sir Al Aynsley-Green, is well equipped to do that sort of consultation, and Dr Roger Morgan of Ofsted is well used to doing that for young people in care.

I recognise and am grateful for the work of the Cambridge researchers in this area, Professor Susan Golombok foremost. This is clearly important work. However, to the best of my recollection, it was rather a small sample of families and the age range of children examined was only up to the age of 18. I think that it was observed that, within the two groups—the control group with non-same-sex couples and the other group with same-sex couples—incidences of young people having same-sex relations as they were growing up occurred within the group that had same-sex parents, but did not occur in the couples that were a man and a woman together. I remember the noble Lord, Lord Adonis, saying some time ago that we can always find a report to support whatever view we wish to put forward. I am sure that intentions here on all parts are of the best. This is a very emotive issue, but we need to be careful not to take just the evidence that suits us best to achieve our objectives.

The Government have achieved so much for young people, in particular for young people in care. It is a very hard struggle to make a change in this area, as they are starting from such a low base, but the achievements of the Acts on children needing care, and schemes such as Quality Protects and Care Matters, are so important for these young people. I hesitate to criticise the Government in this sort of area because of those achievements. I listened this morning to the noble Baroness, Lady Morgan, giving evidence on the future of children in care and the Government's strategy on that. The key thing is that there will now be children in care councils, and children who are in the care of a public authority will meet regularly with the leaders and other members of local authorities to tell them what their experiences of care have been and what they would like to see change. Her key principle is that the voice of children will be heard in future in this scenario.

The suggestion from the right reverend Prelate that we should take the opportunity to consult children on this matter, which will concern them very much, is a helpful one. This is a vexed and difficult issue, but I hope that the Minister can offer me some reassurance, particularly about the scenario of two women bringing up a son when they do not particularly like men. If the Minister cannot provide me with reassurance on that point, I regret that I shall have to support the right reverend Prelate if he decides to divide on this amendment.

Photo of Lord Mackay of Clashfern Lord Mackay of Clashfern Conservative 7:30 pm, 29th October 2008

My Lords, I associate myself with the remarks of the right reverend Prelate, and particularly the distinction that he makes between the situation on adoption and the situation being created here. It is highly important that the views of children on this matter are taken.

Photo of Lord Bates Lord Bates Deputy Chair, Conservative Party

My Lords, I support the right reverend Prelate in his amendment. The amendment does not seek to wreck the provisions, as some noble Lords suggest; it is calling for further reflection and consideration and seems entirely appropriate. The matters that we are debating today I regard as by far the most serious that we have considered. We have spent a lot of time talking about planning and pensions, which are huge matters—but what is at stake here are pure definitions of life, origin and family.

To follow on from what the noble and learned Lord said, a key issue here will be one of coherence. It is worth reflecting for a second on what Clause 45 as currently worded actually states, which the amendment seeks to change. The clause is entitled, "Further provision relating to sections 42 and 43", and says:

"Where a woman is treated by virtue of section 42 or 43 as a parent of the child, no man is to be treated as the father of the child".

I may not be a scientist, but as a father I am pretty aware that that cannot be true. There is a father to the child; the question is whether that father should be acknowledged or not. The father will be acknowledged over the age of 18, when the child will be entitled to seek out that person—so at that point he will be there. The question is whether the factual existence of the father is acknowledged.

When this legislation was first introduced, it was as a necessary amendment to the 1990 Act in this area, which stated very clearly that various factors had been taken into account, including the need of that child for a father. I am not sure what has changed since 1990 that would make it necessary to delete that sentiment and that fact from the legislation. On the contrary, much of the legislation that has come forward in the Children Act, as well as the Child Support Agency, puts huge pressure on fathers to take on board their financial and moral obligations to children. So we need to be very careful in all legislation that is passed through this House to ensure that we send out the right message. The message that is encapsulated in the amendment as proposed by the right reverend Prelate is that fathers are important—they are a fact and they are essential.

Photo of Baroness Thornton Baroness Thornton Government Whip, Baroness in Waiting (HM Household) (Whip)

My Lords, Amendments Nos. 36A, 36B and 36C have been tabled by the right reverend Prelate the Bishop of Southwell and Nottingham and look to delay significantly the enactment of the clauses of the Bill which enable a child born as a result of assisted reproduction to a same-sex couple to have two legal parents.

The Bill seeks to ensure that civil partners and other same-sex couples are recognised as the legal parents of children conceived through the use of donated sperm, eggs, or embryos, in line with married couples and unmarried heterosexual couples. In addition to this, the Bill amends the Births and Deaths Registration Act 1953 to enable the second female parent to be named on the birth certificate. This is consistent with the wider government policy on promoting equality, as evidenced by the Civil Partnership Act 2004 and the national legislation prohibiting discrimination on the grounds of sexual orientation.

The provisions relating to the recognition of the female second parent are set out in Clauses 42 and 43, which bring the provisions for female civil partners in line with those for married couples, and the provisions for other same-sex couples with those for heterosexual couples who are not married. These provisions enable a child born to a same-sex couple to have two legal parents, which, I am sure your Lordships will agree, must be in the best interests of the child.

Amendments Nos. 36A, 36B and 36C would significantly delay the enactment of these very important provisions. The idea that we have had no time to debate this issue seems to me nonsense; the principle of same-sex parents was debated at length in the context of the need for a father, from the 1990 Act. This specific issue was debated on the Floor of the House in another place for almost three hours; it was also debated at length in this House and many noble Lords took part in those debates during that period. I remind the right reverend Prelate that this is something that has been subject to considerable valuable debate; the House has voted and made its position quite clear. The issue has been debated and voted on in another place and Members of that House agreed to the position in the Bill as it left this House. Therefore, let us be quite clear that the current position in the Bill on this issue reflects an agreed position between the two Houses. As your Lordships are aware, the purpose of today's debate is to consider those changes made to the Bill in another place, not those issues on which the House has already decided.

I shall recap what these changes do. Clause 42 brings the provisions for female civil partners into line with those for married couples. The Archbishop's amendments—sorry, I mean the amendments proposed by the right reverend Prelate. I am giving him a promotion that I am sure he deserves. His amendments would delay, perhaps significantly, the commencement of the Bill's provisions, but would enable both members of the same-sex couple to be recognised as the legal parents of a child born to them following assisted reproduction. To delay this would be unfair to the couple and also deprive the children of having two parents. I shall turn to some of the studies referred to in a moment, but the Bill protects the interests of the child by ensuring that it has two parents named on its birth certificate. A provision that would not give the child a father is simply removing the child's second parent. This would not be in the child's best interest and the Government are content that these provisions are compatible with the convention.

Noble Lords may not approve of same-sex couples being parents but the fact is that they are parents, and they are good parents. The suggestion which has run as an undercurrent through this debate, that same-sex parents are of less value than mixed-sex parents, is quite offensive and incorrect. We have had these discussions many times and we know that opinion on these issues runs high in your Lordships' House, but it is sad to suggest in this day and age that having two women as loving parents is somehow to deny a human right to a child.

Clause 43 makes parenthood provisions for female couples who are not in a civil partnership where one of the women gives birth to a child following assisted conception treatment at a UK-licensed clinic. If valid female parenthood conditions are in place with the partner at the time of the conception of the child, the other woman will be treated as the parent of that child. The provisions in Clause 43 mirror those for unmarried heterosexual couples where the woman has a child as a result of assisted conception with donor sperm in a UK-licensed clinic.

The effect of the amendments proposed by the right reverend Prelate would delay the enactment of these important clauses, which have been debated extensively in this House and at length in another place. I encourage the right reverend Prelate to withdraw the amendment, but if he decides to move it, I invite the House to resist it.

Photo of Baroness O'Cathain Baroness O'Cathain Conservative

My Lords, perhaps I may ask the Minister a simple question. She used the word "offensive" when she was referring to some people who thought it was better for a child to have two parents, a male and a female. What is the Government's definition of a family?

Photo of Baroness Thornton Baroness Thornton Government Whip, Baroness in Waiting (HM Household) (Whip)

My Lords, we have discussed this at great length. Evidence presented to the Joint Committee of both Houses, for example, demonstrated that the emotional well-being and other aspects of development of children growing up in lesbian families are comparable to those in heterosexual families. Many noble Lords, including the noble Earl, Lord Listowel, have suggested that what is important is that children are brought up in loving, supportive families. It is unrealistic to suggest that that is an undesirable situation when that is what happens. We need to make sure that such children are not disadvantaged by the legal process through not having legitimate parents entered on their birth certificates. That is what the amendment is about.

Photo of The Bishop of Southwell and Nottingham The Bishop of Southwell and Nottingham Bishop

My Lords, I want to emulate the noble Lord, Lord Alton, by keeping moderation as the tone of the debate. He set a good example at the beginning of this Session. I am grateful to all noble Lords who have taken part in the debate for the issues they have raised. Now is not the time for an academic seminar. I resist strongly the suggestion that this is intended to be a wrecking amendment. I am conscious that many social lives will be wrecked if we prolong this debate too long, but we are engaging in legitimate due parliamentary process at this time and that is why I am pursuing the matter.

There is a major moral issue here, a major debate. I have heard enough discomfort around the Chamber and I would like to test the opinion of the House.

On Question, Whether the said amendment (No. 36A) shall be agreed to?

Their Lordships divided: Contents, 51; Not-Contents, 121.

Division number 2 Private Parking: Ports and Trading Estates — Human Fertilisation and Embryology Bill [HL]

Aye: 49 Members of the House of Lords

No: 119 Members of the House of Lords

Ayes: A-Z by last name

Tellers

Nos: A-Z by last name

Tellers

Resolved in the negative, and amendment disagreed to accordingly.

On Question, Motion agreed to.

Commons Amendment No. 37

Photo of Baroness Thornton Baroness Thornton Government Whip, Baroness in Waiting (HM Household) (Whip) 7:55 pm, 29th October 2008

My Lords, I beg to move that the House do agree with the Commons in their Amendment No. 37, to which I have spoken with Amendment No. 8.

Moved accordingly, and, on Question, Motion agreed to.

Commons Amendments Nos. 38 and 39

Page 44, line 10, at end insert-

"( ) The reference in section 48(5A)(b) to a civil partnership includes a reference to a void civil partnership if either or both of the parties reasonably believed at the time when they registered as civil partners of each other that the civil partnership was valid; and for this purpose it is to be presumed, unless the contrary is shown, that one of them reasonably believed at that time that the civil partnership was valid."

Page 45, line 16, at end insert-

"( ) the Schedule to the Population (Statistics) Act 1938 (c. 12),"

Photo of Baroness Thornton Baroness Thornton Government Whip, Baroness in Waiting (HM Household) (Whip)

My Lords, I beg to move that the House do agree with the Commons in their Amendments Nos. 38 and 39. The Bill sets out provisions for legal parenthood for same-sex couples. Following assisted conception, provisions in the Bill allow for the female partner of the woman giving birth, whether in a civil partnership or not, to be entered as a parent at birth registration.

Amendment No. 38 relates to Amendment No. 36 as discussed in the previous group. Amendment No. 38, together with Amendment No. 36, ensures that children born to civil partners following assisted conception treatment will be treated as legitimate in the same way as if their parents were married.

Amendments Nos. 39, 47 and 94 relate to the registration of the birth of a child born by assisted reproduction to a same-sex couple. At birth registration, some statistical information is currently collected under statute by the registrar. This relates to the age of the mother and father and, if they are married, the date of marriage, whether the mother has been married previously and the number of children born to the mother. The information that the registrar is required to collect is set out in the Population (Statistics) Act 1938. Following the Bill, the questions that would be asked when registering the birth require amendment. The existing wording would be inappropriate for same-sex couples. Amendments Nos. 39, 47 and 94 make the necessary changes to the Population (Statistics) Act 1938 to allow for the collection of information relating to the age of the same-sex parents and the date of any civil partnership, where applicable, so that same-sex parents are treated equally to other parents.

Moved accordingly, and, on Question, Motion agreed to.

Commons Amendment No. 40

Photo of Baroness Thornton Baroness Thornton Government Whip, Baroness in Waiting (HM Household) (Whip)

My Lords, I beg to move that the House do agree with the Commons in their Amendment No. 40, to which I have spoken with Amendment No. 8.

Moved accordingly, and, on Question, Motion agreed to.

Commons Amendments Nos. 41 to 45

Page 49, line 11, after first "any" insert "reasonable"

Page 49, line 14, after "any" insert "reasonable"

Page 49, line 19, after first "any" insert "reasonable"

Page 49, line 21, after "any" insert "reasonable"

Page 49, line 23, at end insert-

"(2C) Any reference in subsection (2A) or (2B) to a reasonable payment in respect of the doing of an act by a non-profit making body is a reference to a payment not exceeding the body's costs reasonably attributable to the doing of the act."

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

My Lords, I beg to move that the House do agree with the Commons in their Amendments Nos. 41 to 45. Surrogacy is a very sensitive issue on which people hold differing views. We recognise that there are situations where a couple wish to have a child of their own but are not able to and may wish to seek to use a surrogate, such as where a woman in a well established relationship has eggs but no functioning womb. It is important that there are organisations to which they can turn for support and advice if they choose to consider surrogacy.

Amendments Nos. 41 to 45 relate to surrogacy organisations and the aspects of their services for which they may charge. Clause 59 amends the Surrogacy Arrangements Act 1985 to clarify the position in law of non-profit making surrogacy organisations. It makes it clear that they may charge for certain aspects of their services on a non-profit-making basis, and enables them to advertise the services for which they may charge.

These bodies have a useful role to play in initiating negotiations with a view to making surrogacy arrangements and compiling information about surrogacy with a view to its use in making or negotiating a surrogacy arrangement. We recognise, however, that it is difficult for a surrogacy organisation to provide such services for the small number of people who seek advice and help with surrogacy in the UK if they are not able to make a charge to recoup the cost of providing them.

The amendments to Clause 59 state that such organisations may charge for certain activities, but only if they do not make a profit—in essence, if it is not undertaken on a commercial basis. They may charge for initiating negotiations with a view to the making of a surrogacy arrangement such as enabling interested parties to meet each other to discuss a possible surrogacy arrangement, and compiling information about surrogacy with a view to its use in the making or negotiation of a surrogacy arrangement—establishing and keeping lists of people willing to be surrogates, or intended parents, for example.

These provisions would enable not-for-profit organisations to charge for putting couples in touch with each other, but not for any more direct intervention in discussions. The amendments in the Bill to the Surrogacy Arrangements Act 1985 are not seeking to turn surrogacy into a commercial industry. The 1985 Act took firm steps to ban any commercialisation of surrogacy and that principle has not changed.

Amendments Nos. 41 to 45 deal specifically with the issue of cross-subsidisation by surrogacy organisations. There was debate in the other place about the potential for cross subsidisation—surrogacy organisations charging more for the activities for which they are able to charge so that they can undertake those activities for which they are not able to charge. It is our intention that surrogacy agencies should not be permitted to charge more for the activities for which the Bill allows reimbursement in order to subsidise the cost of providing other activities for which charging is prohibited. Amendments Nos. 41 to 45 are necessary to ensure that this position is clarified in the Bill.

Moved accordingly, and, on Question, Motion agreed to.

Commons Amendment No. 46

Page 51, line 13, at end insert-

"( ) An order under this section which modifies an enactment in consequence of any provision of Part 2 may modify subsection (5) of section 53 (interpretation of references to father etc.)."

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

My Lords, I beg to move that the House do agree with the Commons in their Amendment No. 46. This is a technical amendment so that Clause 53(5), which lists enactments where express provision has been made for female second parents, can be modified by an order made under Clause 64, which provides for consequential and transitional provisions. Not to do so would mean that the general rule in Clause 53 (2), enabling references to fathers to be read as references to female second parents, would continue to apply to enactments even where express provision was made in those enactments for female second parents.

Moved accordingly, and, on Question, Motion agreed to.

Commons Amendment No. 47

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

My Lords, I beg to move that the House do agree with the Commons in their Amendment No. 47, to which I have spoken with Amendment No 39.

Moved accordingly, and, on Question, Motion agreed to.

Commons Amendment No. 48

Page 52, line 31, leave out subsection (2)

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

My Lords, I beg to move that the House do agree with the Commons in their Amendment No. 48. This is the privilege amendment.

Photo of Baroness Thornton Baroness Thornton Government Whip, Baroness in Waiting (HM Household) (Whip)

My Lords, I shall speak to this amendment. This amendment will remove the privilege amendment that was made when the Bill moved to another place. As noble Lords will be aware, the financial powers are restricted by the rights and privileges of the other place and by the Parliament Acts. As the Bill originated here and contains financial provisions, a privilege amendment was added to the Bill before its introduction into the other place to ensure that the financial privilege was not infringed.

The amendment is purely technical and is necessary to remove the privilege amendment which provided that nothing in the Bill should impose or vary any charge on the people or public funds.

Moved accordingly, and, on Question, Motion agreed to.

Commons Amendments Nos. 49 to 54

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

My Lords, I beg to move that the House do agree with the Commons in their Amendments Nos. 49 to 54, to which I have spoken with earlier amendments.

Moved accordingly, and, on Question, Motion agreed to.

Commons Amendment No. 55

Page 60, line 1, leave out sub-paragraph (4) and insert-

"(4) For sub-paragraph (2) substitute-

"(2) A consent to the storage of any gametes, any embryo or any human admixed embryo must-

(a) specify the maximum period of storage (if less than the statutory storage period),(b) except in a case falling within paragraph (c), state what is to be done with the gametes, embryo or human admixed embryo if the person who gave the consent dies or is unable, because the person lacks capacity to do so, to vary the terms of the consent or to withdraw it, and(c) where the consent is given by virtue of paragraph 8(2ZA) or 14(2), state what is to be done with the embryo or human admixed embryo if the person to whom the consent relates dies,

and may (in any case) specify conditions subject to which the gametes, embryo or human admixed embryo may remain in storage.

(2A) A consent to the use of a person's human cells to bring about the creation in vitro of an embryo or human admixed embryo is to be taken unless otherwise stated to include consent to the use of the cells after the person's death.

(2B) In relation to Scotland, the reference in sub-paragraph (2)(b) to the person lacking capacity is to be read as a reference to the person-

(a) lacking capacity within the meaning of the Age of Legal Capacity (Scotland) Act 1991, or(b) being incapable within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000.""

Photo of Baroness Thornton Baroness Thornton Government Whip, Baroness in Waiting (HM Household) (Whip)

My Lords, I beg to move that the House do agree with the Commons in their Amendment No. 55. I shall also speak to Amendments Nos. 57 to 61, Amendment No. 72, Amendments Nos. 89 to 93, Amendment No. 106 and Amendment Nos. 108 to 113 in this group.

Consent forms one of the cornerstones of the 1990 Act. A person's gametes cannot be used to create embryos without their express consent. Schedule 3 to the Bill amends the consent provisions in the 1990 Act bringing them up to date with new techniques for creating embryos, for example, by requiring consent for the use of cells to create embryos.

The Government listened very carefully to concerns raised in this House about this framework for consent in relation to the use of stored cells and cells from children with serious diseases, but also made it clear that any exceptions to the requirement for consent needed to be compatible with convention rights. The government amendments in this group provide for certain exceptions while also providing safeguards in recognition of those rights.

With regard to stored cells, the government amendments apply only to cells taken and stored before commencement of the Bill's provisions and the exception applies only if the HFEA is satisfied that the cells are anonymous and thus the donor cannot be identified, or that the licence holder cannot reasonably trace the donor. If the researcher can identify and trace the donor, then unless the donor consents themselves their cells cannot be used. If the person identifies the donor, and they are found to be deceased, consent would be required from a person, for example a close relative, as set out in a hierarchy modelled on that found in the Human Tissue Act 2004. Before the cells can be used, the HFEA must be satisfied that scientific research would be adversely affected to a significant extent, if the only cells that can be used are cells that consent has been obtained for.

The amendments reflect the fact that rare or well researched samples are a valuable asset better to understand and treat serious disease. We have weighed the burden of being unable to use those cells against the rights of the person who originally donated them, and believe we have struck the right balance in the terms of the suggested amendments.

Further amendments tabled on Report in the other place rectified concerns about the interaction of clauses relating to the use of cells from deceased donors, and untraceable donors. The amendments enable a researcher to use the cells of untraceable donors where there is reason to believe they are dead, where no relatives can be traced to consent to use of the cells. The amendments also allow cells to be used if a donor's family can be traced but it is not known, only reasonably believed, that the donor is dead. In these cases, a person in a qualifying relationship can now consent to use of the cells in the same way that they can when it is known the person is dead. In these cases, the HFEA must still be satisfied that the other safeguards are fulfilled before the cells can be used, including the significant adverse impact upon science test.

Regarding consent to the use of cells from children, these amendments apply where those children would never be able to give their consent because of age or a lack of capacity. This is the case with children affected by certain aggressive forms of diseases such as muscular dystrophy, Batten disease and spinal muscular atrophy. To this end these amendments propose that children with such conditions who are too young to consent or lack capacity should be excluded from the requirement for effective consent, if a person with parental responsibility gives consent. This exception is subject to strict safeguards which ensure that a child's cells cannot be used unless the HFEA is satisfied that the child suffers from a serious medical condition; that the research is intended to increase knowledge about that condition or about its treatment; and that there are reasonable grounds for believing that research of comparable effectiveness cannot be carried out using the cells of a person who could give their own consent.

On further consideration of the exception for cells from children, it became clear that it was also desirable to make provision to enable the use of cells from an adult who lacked capacity in very limited circumstances. This would be to address situations where, for example, rare genetic conditions lead to the sudden onset of lifelong incapacity. Following the precedent of the Mental Capacity Act, the Government's amendments propose that in such cases the researcher would need to approach an individual's carer and consult them on their views about the wishes of the person.

The Government felt, for several reasons, that it was appropriate to extend the provisions to adults who lack capacity: first, for the sake of consistency. Without the provisions, cells could be taken from a "child" of 17 if they were unable to consent, perhaps because of illness rather than a lack of understanding, whereas tissue could not be taken from someone who was a year older in the same situation. In addition, if this provision was not made, researchers might favour using tissue or cells from children rather than adults when researching these serious medical conditions, because exceptions were made only for these circumstances. It is my view that this would not be appropriate.

Again, the exception relating to cells from adults who lack capacity is subject to a number of stringent safeguards. The HFEA must be satisfied that, at the time, the adult lacks capacity and is unlikely to have capacity again; that the adult suffers from a serious medical condition; that the proposed research is intended to increase knowledge about that condition or about its treatment; that there is no evidence that the adult would have refused to participate; and, most importantly, that there are reasonable grounds for believing that research of comparable effectiveness cannot be carried out using the cells of a person who could give consent themselves.

In all cases, it will be for the researcher to provide evidence that satisfies the HFEA that all the conditions have been met before a licence to undertake the research may be given. The safeguards set out in the Bill are modelled on the protection provided under the Mental Capacity Act 2005. Research involving people who lack capacity, and the use of their tissue to create embryos, are excluded from the Mental Capacity Act by provisions in the Bill. This prevents any overlap between the two pieces of legislation.

These amendments follow the precedent of the Mental Capacity Act and set out stringent safeguards that must be adhered to before the research can take place. Specifically, there is a requirement for the researcher to approach a carer of the person who lacks capacity to consult them on their views about the wishes of the person.

Moved, accordingly, and, on Question, Motion agreed to.

Commons Amendments Nos. 56 to 91

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

My Lords, I beg to move that the House do agree with the Commons in their Amendments Nos. 56 to 91, to which I have spoken with earlier amendments.

Moved accordingly, and, on Question, Motion agreed to.

Commons Amendment No. 92

Page 66, line 5, at end insert-

"Cases where human cells etc. can be used without consent of person providing them

After paragraph 15 (as inserted by paragraph 13 above) insert-

"Parental consent conditions

15A(1) In relation to a person who has not attained the age of 18 years ("C"), the parental consent conditions referred to in paragraphs 6(3ZA) and 13(4) are as follows.

(2) Condition A is that C suffers from, or is likely to develop, a serious disease, a serious physical or mental disability or any other serious medical condition.

(3) Condition B is that either-

(a) C is not competent to deal with the issue of consent to the use of C's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research, or(b) C has attained the age of 16 years but lacks capacity to consent to such use of C's human cells.

(4) Condition C is that any embryo or human admixed embryo to be created in vitro is to be used for the purposes of a project of research which is intended to increase knowledge about-

(a) the disease, disability or medical condition mentioned in sub-paragraph (2) or any similar disease, disability or medical condition, or(b) the treatment of, or care of persons affected by, that disease, disability or medical condition or any similar disease, disability or medical condition.

(5) Condition D is that there are reasonable grounds for believing that research of comparable effectiveness cannot be carried out if the only human cells that can be used to bring about the creation in vitro of embryos or human admixed embryos for use for the purposes of the project are the human cells of persons who-

(a) have attained the age of 18 years and have capacity to consent to the use of their human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project, or(b) have not attained that age but are competent to deal with the issue of consent to such use of their human cells.

(6) In relation to Scotland, sub-paragraphs (1) to (5) are to be read with the following modifications-

(a) for sub-paragraph (3) substitute-

"(3) Condition B is that C does not have capacity (within the meaning of section 2(4ZB) of the Age of Legal Capacity (Scotland) Act 1991) to consent to the use of C's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research.",

(b) in sub-paragraph (5)(a), for "have capacity to consent" substitute "are not incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving consent", and(c) in sub-paragraph (5)(b), for "are competent to deal with the issue of" substitute "have capacity (within the meaning of section 2(4ZB) of the Age of Legal Capacity (Scotland) Act 1991) to".Adults lacking capacity: exemption relating to use of human cells etc.

15B(1) If, in relation to the proposed use under a licence of the human cells of a person who has attained the age of 18 years ("P"), the Authority is satisfied-

(a) that the conditions in paragraph 15C are met,(b) that paragraphs (1) to (4) of paragraph 15D have been complied with, and(c) that the condition in paragraph 15D(5) is met,

the Authority may in the licence authorise the application of this paragraph in relation to P.

(2) Where a licence authorises the application of this paragraph, this Schedule does not require the consent of P-

(a) to the use (whether during P's life or after P's death) of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research, (b) to the storage or the use for those purposes (whether during P's life or after P's death) of an embryo or human admixed embryo in relation to which P is a relevant person by reason only of the use of P's human cells.

(3) This paragraph has effect subject to paragraph 15E.

Consent to use of human cells etc. not required: adult lacking capacity

15C(1) The conditions referred to in paragraph 15B(1)(a) are as follows.

(2) Condition A is that P suffers from, or is likely to develop, a serious disease, a serious physical or mental disability or any other serious medical condition.

(3) Condition B is that P lacks capacity to consent to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research.

(4) Condition C is that the person responsible under the licence has no reason to believe that P had refused such consent at a time when P had that capacity.

(5) Condition D is that it appears unlikely that P will at some time have that capacity.

(6) Condition E is that any embryo or human admixed embryo to be created in vitro is to be used for the purposes of a project of research which is intended to increase knowledge about-

(a) the disease, disability or medical condition mentioned in sub-paragraph (2) or any similar disease, disability or medical condition, or(b) the treatment of, or care of persons affected by, that disease, disability or medical condition or any similar disease, disability or medical condition.

(7) Condition F is that there are reasonable grounds for believing that research of comparable effectiveness cannot be carried out if the only human cells that can be used to bring about the creation in vitro of embryos or human admixed embryos for use for the purposes of the project are the human cells of persons who-

(a) have attained the age of 18 years and have capacity to consent to the use of their human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project, or(b) have not attained that age but are competent to deal with the issue of consent to such use of their human cells.

(8) In this paragraph and paragraph 15D references to the person responsible under the licence are to be read, in a case where an application for a licence is being made, as references to the person who is to be the person responsible.

(9) In relation to Scotland-

(a) references in sub-paragraphs (3) to (5) to P lacking, or having, capacity to consent are to be read respectively as references to P being, or not being, incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving such consent, and(b) sub-paragraph (7) is to be read with the following modifications-(i) in paragraph (a), for "have capacity to consent" substitute "are not incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving consent", and(ii) in paragraph (b), for "are competent to deal with the issue of" substitute "have capacity (within the meaning of section 2(4ZB) of the Age of Legal Capacity (Scotland) Act 1991) to".Consulting carers etc. in case of adult lacking capacity

15D(1) This paragraph applies in relation to a person who has attained the age of 18 years ("P") where the person responsible under the licence ("R") wishes to use P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research, in a case where P lacks capacity to consent to their use.

(2) R must take reasonable steps to identify a person who-

(a) otherwise than in a professional capacity or for remuneration, is engaged in caring for P or is interested in P's welfare, and(b) is prepared to be consulted by R under this paragraph of this Schedule.

(3) If R is unable to identify such a person R must nominate a person who-

(a) is prepared to be consulted by R under this paragraph of this Schedule, but(b) has no connection with the project.

(4) R must provide the person identified under sub-paragraph (2) or nominated under sub-paragraph (3) ("F") with information about the proposed use of human cells to bring about the creation in vitro of embryos or human admixed embryos for use for the purposes of the project and ask F what, in F's opinion, P's wishes and feelings about the use of P's human cells for that purpose would be likely to be if P had capacity in relation to the matter.

(5) The condition referred to in paragraph 15B(1)(c) is that, on being consulted, F has not advised R that in F's opinion P's wishes and feelings would be likely to lead P to decline to consent to the use of P's human cells for that purpose.

(6) In relation to Scotland, the references in sub-paragraphs (1) and (4) to P lacking, or having, capacity to consent are to be read respectively as references to P being, or not being, incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving such consent.

Effect of acquiring capacity

15E(1) Paragraph 15B does not apply to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo if, at a time before the human cells are used for that purpose, P-

(a) has capacity to consent to their use, and(b) gives written notice to the person keeping the human cells that P does not wish them to be used for that purpose.

(2) Paragraph 15B does not apply to the storage or use of an embryo or human admixed embryo whose creation in vitro was brought about with the use of P's human cells if, at a time before the embryo or human admixed embryo is used for the purposes of the project of research, P-

(a) has capacity to consent to the storage or use, and(b) gives written notice to the person keeping the human cells that P does not wish them to be used for that purpose.

(3) In relation to Scotland, the references in sub-paragraphs (1)(a) and (2)(a) to P having capacity to consent are to be read as references to P not being incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving such consent.

Use of cell lines in existence before relevant commencement date

15F(1) Where a licence authorises the application of this paragraph in relation to qualifying cells, this Schedule does not require the consent of a person ("P")-

(a) to the use of qualifying cells of P to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research, or(b) to the storage or the use for those purposes of an embryo or human admixed embryo in relation to which P is a relevant person by reason only of the use of qualifying cells of P.

(2) "Qualifying cells" are human cells which-

(a) were lawfully stored for research purposes immediately before the commencement date, or(b) are derived from human cells which were lawfully stored for those purposes at that time.

(3) The "commencement date" is the date on which paragraph 9(2)(a) of Schedule 3 to the Human Fertilisation and Embryology Act 2008 (requirement for consent to use of human cells to create an embryo) comes into force.

Conditions for grant of exemption in paragraph 15F

15G(1) A licence may not authorise the application of paragraph 15F unless the Authority is satisfied-

(a) that there are reasonable grounds for believing that scientific research will be adversely affected to a significant extent if the only human cells that can be used to bring about the creation in vitro of embryos or human admixed embryos for use for the purposes of the project of research are- (i) human cells in respect of which there is an effective consent to their use to bring about the creation in vitro of embryos or human admixed embryos for use for those purposes, or(ii) human cells which by virtue of paragraph 15B can be used without such consent, and(b) that any of the following conditions is met in relation to each of the persons whose human cells are qualifying cells which are to be used for the purposes of the project of research.

(2) Condition A is that-

(a) it is not reasonably possible for the person responsible under the licence ("R") to identify the person falling within sub-paragraph (1)(b) ("P"), and(b) where any information that relates to P (without identifying P or enabling P to be identified) is available to R, that information does not suggest that P would have objected to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project.

(3) Condition B is that-

(a) the person falling within sub-paragraph (1)(b) ("P") is dead or the person responsible under the licence ("R") believes on reasonable grounds that P is dead,(b) the information relating to P that is available to R does not suggest that P would have objected to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project, and(c) a person who stood in a qualifying relationship to P immediately before P died (or is believed to have died) has given consent in writing to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project.

(4) Condition C is that-

(a) the person responsible under the licence ("R") has taken all reasonable steps to contact-(i) the person falling within sub-paragraph (1)(b) ("P"), or(ii) in a case where P is dead or R believes on reasonable grounds that P is dead, persons who could give consent for the purposes of sub-paragraph (3)(c),but has been unable to do so, and(b) the information relating to P that is available to R does not suggest that P would have objected to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project.

(5) The HTA consent provisions apply in relation to consent for the purposes of sub-paragraph (3)(c) as they apply in relation to consent for the purposes of section 3(6)(c) of the Human Tissue Act 2004; and for the purposes of this sub-paragraph the HTA consent provisions are to be treated as if they extended to Scotland.

(6) In sub-paragraph (5) "the HTA consent provisions" means subsections (4), (5), (6), (7) and (8)(a) and (b) of section 27 of the Human Tissue Act 2004.

(7) In this paragraph references to the person responsible under the licence are to be read, in a case where an application for a licence is being made, as references to the person who is to be the person responsible.

(8) Paragraphs 1 to 4 of this Schedule do not apply in relation to a consent given for the purposes of sub-paragraph (3)(c).""

My Lords, I beg to move that the House do agree with the Commons in their Amendment No. 92.

Moved, That the House do agree with the Commons in their Amendment No. 92.—(Baroness Thornton.)

Photo of Baroness Knight of Collingtree Baroness Knight of Collingtree Conservative 8:15 pm, 29th October 2008

moved, as an amendment to the Motion, Amendment No. 92A, leave out "agree" and insert "disagree".

Photo of Baroness Knight of Collingtree Baroness Knight of Collingtree Conservative

My Lords, there can surely be no dispute that the subject we are debating, touching as it does on life and death, conscience and ethics, with the losing of freedoms and rights that we once thought were ours without question thrown in, is one of monumental importance. I am not alone in the view that, in a matter of such gravity—and there can be few subjects of greater gravity—this House and the other place should have been granted more time to debate and consider exactly what we are being asked to sanction in what is before us.

Amendment No. 92 is very long indeed. It stretches over six and a half pages and its very first words have a shadow of menace when they refer to:

"Cases where human cells ... can be used without consent of person providing them".

This amendment is the main amendment allowing researchers to create cloned human or animal-human embryos from a person's cells without their consent. In its new and extended guise, it has never been debated on the Floor of either House until now. Until now, it has been the common view that one's body is one's own and others have no right to take it over against one's will. I am prepared to believe that, buried in various places in this lengthy amendment, there might be some good and just measures. However, because of the extremely limited time allowed to us for investigating and debating this possibility, I felt that there was nothing for it but to seek to delete the whole amendment; not only to preserve the rights that should be ours, but to bring more clarity and purpose to the Bill. That is why I challenge the whole of this sinister and unwieldy provision. More time might have permitted some parts of it to be agreed, but we shall never know.

Sub-paragraph (2) of new paragraph 15A states that permission to use a person's cells can be granted because the patient was,

"likely to develop, a serious disease".

Well, any one of us might become seriously ill at any time. None of us can bet that we will not. Surely, only a medically qualified person in full possession of our physical record and details of our parentage can say with any authority that anyone is likely to become ill. As I understand it, the decision on whether that person is likely to become ill will not be made by a doctor or a nurse or anyone medically qualified, but by a researcher. However, a researcher is surely anxious to go ahead with his or her research. I can envisage the temptation to get the raw materials by the simple means of expressing the view that the patient might get ill.

Why is there no sanction of a doctor's opinion? All that seems to be necessary in the case of an under-18 year-old is parental agreement that the patient might get ill. That is not enough. If the young person in the frame were not competent to deal with the issue of consent for the use of his body, no one should believe for one moment, or act on the premise, that that person does agree; he has never been asked the question. People who are mentally or physically incompetent should be protected, not used against their will.

I have spoken previously in this House about the use of the word "reasonable". I have vivid memories of my time in another place, where Ministers refused to have that word in legislation because it meant all things to all men. What is reasonable to one person may be totally unreasonable to others. The word is sloppy and unclear and should be avoided. However, it comes up eight times in this amendment alone. This brings me to another point. In sub-paragraph (2) of new paragraph 15D, it says that the researcher must take "reasonable steps" to identify a person who is engaged in caring for a patient, or who is interested in the patient's welfare. The patient in this case is an adult who is said to be lacking capacity. Well, anyone can say that they are interested in a person's welfare. I am interested in the welfare of all noble Lords: I can sincerely say that. Anyone can allege that they are caring for somebody else. A researcher anxious to begin his research may take the easy option by accepting statements to this effect, which this amendment permits him to do.

Why is this so casual? Why is the researcher not required to check or to get proof of what is being said? If there is no adult at all whom the researcher can claim to be responsible for the incapacitated person, then, according to the amendment, the researcher must take reasonable—there is that word again—steps to find someone or other who will take responsibility. If such a personage does not come easily to mind, the researcher can choose someone else. He is allowed to choose someone who will allege that he is interested in the patient, but surely he can shoo in anyone at all to say that. It is not enough to state that the person must have no connection with the project. He or she, chosen by the researcher, could very easily be the researcher's husband, wife, friend or aunt or someone working in the same laboratory on another subject. There is no problem there. That colleague would not need to be told the rhyme or reason for the use of the cells, as he would know that already; nor surely would he be likely to stand in his colleague's way. There is no requirement whatever for him to know anything at all about the patient or the views of the patient; he would just need to say something in front of his fellow researcher.

Sub-paragraph (3) of new paragraph 15G makes it possible, just because there is a supposition that an individual is dead, to permit the use of that person's cells for what he or she may have regarded as a repugnant purpose. Surely that is also wrong. If we accept that, surely we are saying that a person's body may be used in any way once he is dead. That has always been opposed. So far as I know, no one has ever said that it would be right to use a cadaver in any way that a person wished, and the thought that we are now asking to do so concerns me greatly. Again, surely it would be wrong to claim that, just because a person who may or may not be dead never said that he did not want his body to be used to create half animal/half human embryos, he would not mind if such a thing were done. Even if that person had agreed that his body parts could be used after death for transplants to help sick people, that is a very long way from agreeing that those parts should be utilised to make animal/human embryos. This is a matter on which many people have strong views, and I claim that they have every right to them. In fact, sub-paragraph (1) of new paragraph 15G does not require that the research be medical but simply scientific, and scientific research goes much wider than medical research—far beyond the straightforward pursuit of curing disease.

If I read new paragraph 15G carefully, it suggests that "any" of the conditions listed will be sufficient for the authorisation of research, and I ask the Minister whether that is correct. Will just one of them be sufficient or is it necessary to accept that they are all relevant and applicable?

As I understand it, the whole of Amendment No. 92 has been acknowledged by the Government as interfering with Article 8 of the European Convention on Human Rights. In fact, the present Leader of the House, in an earlier incarnation as a Whip with responsibilities towards this Bill, said:

"If a child is incapable of giving consent to the creation of a human or human-admixed embryo themselves, because they are too young to do so, it would be wrong for any person, including the parents, to make that decision for them, given the significance of creating an embryo using their genetic material".—[Hansard, 21/1/08; col. 52.]

The noble Baroness the Leader of the House also said that,

"even though the original cells may have been taken from the donor with their consent to research in general, the use of their genetic material to create cloned embryos or human admixed embryos is exceptional, and requires its own express consent. To provide otherwise would be incompatible with the convention rights ... It would also be incompatible with the Human Rights Act".—[Hansard, 21/1/08; cols. 46-7.]

I have the greatest respect for the integrity and sincerity of the noble Baroness, Lady Royall, and I have absolutely no doubt that she meant every word that she said. However, since then, the Government's position has changed. They now claim that, after all, this is justified. But is it? Queen's Counsel Mr Aidan O'Neill, who has been asked to provide a legal opinion on the matter, agrees with the Government that the use of human cells for the creation of human embryos and/or human admixed embryos does indeed engage the Article 8 rights of the donor. He also agrees with the Government that removing the requirement for consent would interfere with this right. However, his legal opinion is that the provisions before us today in this amendment are not compatible with the convention because they do not give proper weighting to the interests of those whose genetic material is now being used.

The scientific need for these provisions on consent has, so far as I know, never been demonstrated. So far as I am aware, there is not a shred of evidence that creating animal/human creatures will bring about cures or even palliatives to assist sufferers from recognised diseases. If Ministers are serious about adhering to the important human rights convention, they simply cannot pass this part of the Bill. I listened with great care to what was said earlier in the debate on that very matter, but the question which has not been addressed until now is that it may well be in direct contravention of human rights.

Every human being has a right to decide whether he or she supports creating cloned human or animal/human embryos from their cells for research, and he or she permits his or her own body to be used in that way. Unless we are ready to deny this right, we cannot allow Amendment No. 92 to pass into law. Removing these consent provisions will return the Bill to the state that it was in when it previously left the House.

It is a serious misuse of Parliament to curtail debate and proper investigation into this vital matter, but that is what is happening at the moment. I was shocked to hear that so strict was the curtailment that MPs in another place were given no time at all to debate on the Floor of the House the amendments dealing with consent. I earnestly hope that the Government have put no Whip on their Members and that they do not troop into the Lobby to vote against this amendment without having listened to the arguments, but I fear that such a Whip is in existence. If human rights mean anything to the Government, they must not allow them to be trampled on to please one section of scientists, however well intentioned.

Finally, so little time has been available for public knowledge to be disseminated about this debate that so far very few comments have had time to surface. However, I want to quote Professor David Jones, who is the director of the Centre for Bioethics and Emerging Technologies—which are very important in this context—St Mary's University College. He says that this is retrospective legislation, allowing the use of tissues that were not donated for that purpose. I do not think that we have touched on his concern. He says that it would be very counterproductive to allow the most controversial kind of research without the safeguards of effective consent. How can people trust scientists, if their cells can be used without their consent for research to which they are strongly opposed?

If effective consent is not restored to the Bill, there is a real danger that public confidence in tissue banking will be undermined, to the great detriment of scientific research. I have no wish whatever to halt or harm scientific research. I do, however, deeply care about the rights of human beings. I beg to move.

Photo of Lord Neill of Bladen Lord Neill of Bladen Crossbench 8:30 pm, 29th October 2008

My Lords, I support the amendment put forward by the noble Baroness, Lady Knight. I want to concentrate on one single point: the human rights convention and Article 8 thereof. We are looking at three categories of cases; parents giving consent on behalf of children, consent where an adult lacks capacity and the use of existing cell lines. A Minister told us on 21 January that it was not possible to allow consent in all those cases as that would all be contrary to Article 8 of the human rights convention.

The noble Baroness, Lady Knight, has referred to what the noble Baroness, Lady Royall of Blaisdon, said then. When the Minister dealt with existing cells—stuff that is already in the archive—she said:

"In essence, the Bill sets out a framework which ensures that, if a person's gametes or cells are used to create an embryo, effective consent is in place beforehand. In the case of cell lines, even though the original cells may have been taken from the donor with their consent to research in general, the use of their genetic material to create cloned embryos or human admixed embryos is exceptional, and requires its own express consent. To provide otherwise would be incompatible with the convention rights. We have done a lot of work on this issue. It would also be incompatible with the Human Rights Act".—[Hansard, 21/1/08; cols. 46-47.]

Later—and the noble Baroness, Lady Knight, has also referred to this—the Minister dealt with the other two cases, of children and adults, saying:

"No one can give consent on behalf of an adult who lacks capacity, and, for the same reasons, I do not believe that a child's cells should be used to create embryos or human-admixed embryos without that child's own consent.

If a child is incapable of giving consent to the creation of a human or human-admixed embryo themselves, because they are too young to do so, it would be wrong for any person, including the parents, to make that decision for them, given the significance of creating an embryo using their genetic material".

The noble Baroness, Lady Royall, then referred to the powerful arguments put forward by the noble Lord, Lord Patel, and by my noble friend Lord Walton of Detchant, but she concluded that,

"the Government take the view that we should not, in any circumstances, presume that a person's cells can be used in the creation of embryos without their consent or knowledge".—[Hansard, 21/1/08; col. 52.]

That position came on 21 January this year from a Minister speaking on behalf of the Government. Ten days later came the first sign of the U-turn, in a letter from the noble Lord, Lord Darzi. Making no reference whatever to the passages that I have just read, he sent a letter to all those, including myself, who spoke in the debate on the earlier stage of the Bill. The letter dealt entirely with the use of existing cells. The hour is late, but the noble Lord, Lord Darzi, made it clear that, since the debate on 21 January, the science community had been arguing why that valuable archive was a tool that they really wanted to use. From their point of view, I entirely understand what they were seeking to achieve.

In his letter, the noble Lord began by saying that,

"further discussions with scientific researchers have more clearly identified the scientific need to use existing cell lines"— so, there was more factual evidence. He continued:

"A compelling case has been made that the requirement for express consent could, in certain circumstances, impose a significant burden on research in this field. On this basis the Government takes the view that it would be possible to make an exception to the requirement for express consent, provided that stringent safeguards are in place. We would expect that such an exception would focus on situations where the inability to continue using existing cells would have significant adverse effects on research, where such research would be in the public interest. The detail of such safeguards to ensure compliance with Article 8 requires further consideration".

That was the first hint we got that there was going to be a change. It was followed up in paragraph 16 of his letter, which dealt specifically with the human rights situation. The noble Lord wrote:

"In considering whether the interference can be justified and proportionate to a legitimate aim the Government considered the concerns of the scientific community. Specifically the issue is whether the issue can be justified on the basis of 'the protection of health' under Article 8(2)".

We can see what has happened: the evidence from the scientists has come in, showing a "scientific need"—a term the noble Lord used in the early part of his letter—and that is transmogrified and put forward here in altered garb as the protection of health under Article 8(2).

That is how matters stood. Then we had the amendments in the other place, on which the noble Baroness, Lady Knight, has commented at length. I shall not go into the detail of that. The noble Lord, Lord Darzi, then wrote another undated latter, which we received just before today's hearing. That letter does not mention Article 8 at all, but the Minister referred to the Explanatory Notes to the Commons Amendments—and if we look at them, "scientific need" comes back into the picture in paragraph 57. It states:

"Although removing the requirement for consent would interfere with this right"— the Article 8 right—

"the Government is satisfied that, in the limited cases provided for by the amendments, such interference can be justified on the basis of scientific need. The amendments include significant safeguards".

The term "public health", which is used in paragraph 2 of Article 8, is not used at all but "scientific need" is. No argument is advanced at any point as to why all the hard work done before 21 January, which put the Minister in a position to say, "This is not possible under the convention", has been turned around to become very possible; an escape route has been found through the reference to health.

If matters stood there one would be complaining about why we have had no straightforward explanation from the Government as to why they held the original opinion, and why they have now changed it. Are we to understand that they did not originally consider the possible exceptions to the basic provision of Article 8.2? Anyone advising on whether or not the article applies will look at the exceptions. However, the matter does not stop there. We have received an opinion, to which the noble Baroness, Lady Knight, referred, although I do not know how widely it has been circulated because I received it only yesterday. The opinion is that of a well known Queen's Counsel, a Scottish silk who works in Edinburgh, whose work I have come across in other contexts, but I have never met him. He is a highly professional and skilled lawyer. He concludes, at paragraph 3.9 of his opinion:

"In sum it seems to me that the provisions dispensing with or substituting consent if passed could well be the subject to successful challenge for their incompatibility with the requirements of the European Convention on Human Rights".

In particular, he focuses on the charter of rights, which your Lordships will recall from the many days that we spent discussing the treaty of Lisbon and its adjunct, the charter of rights. It is a familiar text to us all. Article 1 of the Charter of Fundamental Rights states:

"Human dignity is inviolable. It must be respected and protected".

Article 3 on the,

"Right to the integrity of the person", states:

"Everyone has the right to respect for his or her physical and mental integrity ... In the fields of medicine and biology, the following must be respected in particular ... the free and informed consent of the person concerned, according to the procedures laid down by law".

In addition, there is another convention, which the UK attended but did not sign, although 34 member states of the Council of Europe did, called the Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine—also known as the Oviedo convention. It opened for signatures in 1997 and has now come into force as between the signatories. Some 23 nations have ratified the convention among the 34 which signed. The UK has not signed, as well as other countries, including Germany, Russia and one or two others. Most countries have signed. The provisions that matter are Articles 1, 2, 5 and 6. Article 1 states:

"Parties to this Convention shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine".

Article 2, "Primacy of the human being", is important. It states:

"The interests and welfare of the human being shall prevail over the sole interest of society or science".

The human being, the individual, prevails over the interests of science.

Article 5, the "General rule", states:

"An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it. This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks. The person concerned may freely withdraw consent at any time", which is contrary to the Government's proposals. Article 6 on,

"Protection of persons not able to consent", states:

"Subject to Articles 17 and 20 below, an intervention may only be carried out on a person who does not have the capacity to consent, for his or her direct benefit".

In other words, all of those provisions are aimed at protecting the rights of the individual and are a direct objection to the proposal now being made. They add weight to my first contention that we do not know why the Government have changed their mind on the scope of Article 8. We have now received the opinion and provisions that I referred to, which we need to consider calmly, and send the matter back to the other place.

Photo of Lord Walton of Detchant Lord Walton of Detchant Crossbench

My Lords, in speaking to this amendment, so skilfully moved by the noble Baroness, Lady Knight of Collingtree, I must declare two interests: first, many years ago, I was president of the General Medical Council; secondly, I am now an honorary life president of the Muscular Dystrophy Campaign. When I was president of the GMC, we struggled for years with the problem of informed consent. However, there is no question but that the medical profession accepts that the principle of informed consent lies at the core of medical practice. It is absolutely right that a doctor may recommend to a patient the appropriate treatment for his condition but it is up to the patient, having fully appreciated the circumstances relating to the treatment recommended, whether he should accept such treatment. Therefore, he must give his informed consent. Within the law and within medical practice, he is fully entitled, if he so wishes, to refuse that consent, even if it results in death.

The same principles were adumbrated in the General Medical Council's advice about medical research. It was made absolutely clear that an individual patient could be involved in medical research only with his fully informed consent. However, the issue arose of whether a child who was below the age of valid consent, in other words a child who was not Gillick-competent in terms of law, could give consent. If the child was not, the issue arose as to what would be the proper course of action in relation to such research. Although I wholly appreciate the valid points made by my noble friend Lord Neill, the GMC recommended, and that recommendation still holds, that it would be proper for a parent to give consent on behalf of a child to participate in research if it could be shown that the research in question could lead to developments that would be to the benefit of that child as an individual. I think that that remains at the core of this problem.

In terms of the amendment tabled by the Government, that would only be possible if the child suffers from a serious medical condition or illness and if the research is linked to that condition—such as muscular dystrophy, spinal muscular atrophy, and so many more conditions which are progressive and potentially fatal. An additional safeguard, which is essential in such cases, is that there must be reasonable grounds for believing that research of comparable effectiveness could not take place with cells from a person who could consent. That is the important issue in relation to research involving children.

Amendments tabled in the Commons addressed the issue of cells from an adult who does not have capacity to give consent. They drew particularly on the Mental Capacity Act 2005 to frame appropriate safeguards, including a requirement to consult carers and a requirement that the adult is suffering from or is likely to develop a serious disease or serious disability about which the proposed research is intended to increase knowledge. Again, the important issue is that the research in question would be likely, ultimately, to be to the benefit of that individual.

The issue of cells or cell lines stored before the legislation is brought into force is one that has been raised for many years. I was much involved in the discussions in your Lordships' House on the Human Tissue Act 2004. It was clearly stated then that archival material stored over some time and derived from an individual for whom it is no longer possible to give or withhold consent, can be used for research purposes. It is now quite clear that where a cell donor cannot be identified or traced or has died since the cells were stored, the requirement for effective consent can reasonably be waived subject to the criterion that, in the view of the Human Fertilisation and Embryology Authority, research would be adversely affected to a significant degree if the cells or cell lines cannot be used. Where the cell donor has died and can be traced, consent would be required from a person such as a close relative as set out in the clear hierarchy modelled on that found in the Human Tissue Act.

I do not believe that the amendment so carefully and explicitly moved by the noble Baroness would be to the benefit of patients at all. I therefore strongly support the amendments tabled by the Government.

Photo of Lord Waddington Lord Waddington Conservative 8:45 pm, 29th October 2008

My Lords, your Lordships will appreciate that there is a very important point to be made before we even get to the merits of this matter. It was made to some extent when we discussed the amendment moved by the right reverend Prelate, but this is an even more glaring example of how routine and draconian timetabling of Bills prevents proper discussion by the elected representatives of the people of important measures. That is a shocking state of affairs.

These major changes were discussed for just two hours in the Public Bill Committee and were never discussed at all on the Floor of the House of Commons. An amendment to remove them was never reached; and it was without debate and with the use of a three-line Whip that these new proposals were added to the Bill. If we reject these changes we will be doing a service to the House of Commons, because for the first time there will be an opportunity for the other place to discuss these matters properly. I have heard from far more erudite and informed people than myself on the merits of the proposal, so I shall spare the House my views; but I hope that noble Lords take the point that I have made. It is surely our duty to see that the House of Commons considers these matters properly, which it has not done so far.

Photo of Lord Mackay of Clashfern Lord Mackay of Clashfern Conservative

My Lords, this is a remarkable amendment to have been proposed in the House of Commons in view of the statement that the noble Baroness, Lady Royall, made in this House in January. I have listened carefully to the noble Lord, Lord Walton of Detchant, and I think that he has possibly overlooked the point that, in relation to the children and adults who lack capacity, the amendment does not require that the research should be for their benefit. It is possibly for the benefit of those suffering from the same or a similar condition. That is what the amendment says, not the terms that the GMC thought were appropriate.

I want to concentrate on the use of existing cell lines which we are told were lawfully stored for research purposes immediately before the commencement date, or which are derived from human cells which were lawfully stored for those purposes at that time. They were given for those purposes, so why are they not used for such purposes? The force of the amendment shows that the Government consider that the consent given for research purposes is not adequate to cover research using human admixed embryos. I do not understand how those cell lines could be useful in connection with human admixed embryos. Whatever may happen in the future, I understand that the present position is that human and mixed embryos are used in the process of research because of the scarcity of human eggs. To get over that difficulty admixed human embryos are used, using cattle—cows or some other animal.

That has nothing to do with stored cell lines as I understand it, so this is a different situation which should be covered from the consent that was given. It is extremely difficult to say that this is in any way consistent with Article 8 of the European Convention on Human Rights. It is difficult to connect the scientific purpose that has been the foundation of this amendment with the use that is to be made in connection with human admixed embryos. The purpose is to supplement the difficulty arising from the scarcity of these eggs. The Human Tissue Act contains requirements for consent, which are reflected in proposed paragraph 15G(5). However, the ultimate purpose of the amendment is to deal with a case where there is no possibility of consent under these provisions. The ultimate test of this amendment is a case in which there is no consent to allow the person using the material to go beyond the research purposes for which it was originally given. I originally took the view that if it was given for research purposes, then it is being used for research purposes after the commencement of the Act, but the Government's approach shows that they consider that the consent given for research before the commencement of the Act is not sufficient to cover the research to which they now wish to put this tissue. Therefore, I regard it as extremely doubtful whether this could be regarded as coming within the proper confines of the Human Rights Act and the convention.

Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench

My Lords, I support the noble Baroness, Lady Knight, because her Amendment No. 92A should command widespread support throughout your Lordships' House. The arguments have already been put extremely well, not least by my noble friend Lord Neill. Noble Lords have emphasised the importance of looking again at the implications of Article 8 of the European Convention on Human Rights.

I follow the noble Lord, Lord Waddington, in emphasising the importance of parliamentary scrutiny. Your Lordships' House is regarded as the guardian of our legitimate rights and as probably the only place—it is certainly the case in this instance—where issues of this sort can be properly and thoroughly scrutinised. Some 260 new lines have been added to the Bill. They were not part of the Bill when it left your Lordships' House, and they were added after the assurances we were quite sincerely given by the noble Baroness the Leader of the House, who we all respect. She told us emphatically that:

"The Bill sets out to ensure that human and human-admixed embryos may only be created for research purposes, and only where the person to whom the cells belong gives their explicit consent".—[Official Report, 21/1/08/; col. 52.]

There is no doubt that that was said with sincerity on the Floor of the House, and it was repeated, in effect, in the letter that the noble Lord, Lord Darzi, sent to us in January. He wrote:

"This is likely to include a person's right to determine under what circumstances their genetic material is used to create a human embryo or human admixed embryo".

Referring to Article 8, he wrote:

"The use of a person's genetic material, without their express consent, to create embryos and their subsequent use and storage would interfere with a person's rights under Article 8 of the convention".

Nothing has changed since we were given those assurances in January, except for what is now in the Bill. It was guillotined in the other place. Only 14 Members were present at the debate that took place in the Standing Committee, which means, in effect, that 632 Members were prevented from having any say on these provisions because when the Member of Parliament for Stone, Mr Bill Cash, moved an amendment to do what the noble Baroness, Lady Knight, is seeking to do this evening, it was not reached. The Bill was guillotined and a three-line Whip was used to see it through. That is no way to make legislation of this kind where these hugely important questions are involved.

We have been told about the legal opinion given by Aidan O'Neill QC. A further opinion has been given today by Mr James Bogle of 10 Kings Bench Walk, Temple, who reaches the same conclusion. He wrote:

"For all the reasons that I have canvassed above, I consider that there is good reason to consider that a successful challenge could be mounted against the presumed and substituted consent to research provisions of the Bill and I am not satisfied that the government's claims, upon advice, that these provisions, without the inclusion of any further and/or better safeguards, are all Convention-compliant is sufficiently well-founded".

This level of advice and the conflicting views we have heard about the compatibility of Article 8 make it doubtful whether the words on the very face of the Bill stating that it is compliant with the European Convention on Human Rights are accurate. That should surely make us want to consider this further. We would not be doing our job properly if we did not now take the opportunity to send this part of the Bill back to another place so that they have the chance to debate these provisions, to look at their compatibility and decide how best to proceed.

I conclude simply by reminding the Minister of what happened in my own city of Liverpool at Alder Hey children's hospital when science went too far. Presumed consent was believed to be in the interests of patients and organs were taken from children. It brought a wonderful children's hospital into total disrepute. The National Health Service had to think again, very thoroughly, about these questions. This could jeopardise the whole altruistic and well-founded movement of people providing organs and tissue for medical purposes, if they believe that the state is taking on the vestiges of an authoritarian entity that decides it knows best. The noble Baroness, Lady Knight, is right to remind us of the importance of these questions. I hope noble Lords will support her amendment.

Photo of Baroness O'Cathain Baroness O'Cathain Conservative 9:00 pm, 29th October 2008

My Lords, I want to make two quick points. Of course I support the noble Baroness, Lady Knight; what she said was brilliantly described. First, there has been no public consultation whatever on this. Is that a democratic process? Secondly, there are those, and I am one of them, who have decided in their wills to leave their bodies for medical purposes. If I knew, as I now do, what might happen, I am afraid that will be stopped. I have always been a supporter of donor cards, but the whole thing would be such a disaster that we really have to think again.

Photo of Baroness Barker Baroness Barker Spokesperson in the Lords, Health

My Lords, I wonder if I might delay the House slightly to make two points in particular. I am moved to speak by the use of the word "sinister" by the noble Baroness, Lady Knight of Collingtree. I repeat something that I have said many times: I thank the noble Baroness for raising these issues, as she has consistently over the years, in order to bring them to the attention of your Lordships' House and the public. However, there is a difference this evening. Listening to the contributions, one would be forgiven for forming the view that there has been some kind of conspiracy between the scientific community and the Government. That is not so. Noble Lords should remember that the noble Lord, Lord Patel raised these matters in your Lordships' House in Committee and on Report. Fourteen Members of your Lordships' House, including the noble Baroness, Lady O'Cathain, the noble Lord, Lord Alton, and the right reverend Prelate the Bishop of St Albans, took part in that discussion.

We are suffering to an extent from a very partial portrayal of the events that have led up to this moment. There is partiality in that people have forgotten that this House and another place spent a considerable time—not only in their Chambers but in a Joint Committee—looking at the issue of consent when the Mental Capacity Act was going through. There was detailed consultation on that matter with a wide range of bodies, ranging from the Catholic Church to disability organisations. They were specifically asked about that issue. It was the considered opinion of another place and your Lordships' House that, with very strong and explicit caveats and safeguards, people who lack capacity should, in certain circumstances, be able to take part in research. I well remember Members of your Lordships' House who have a disability talking movingly about the need to make sure that people who lack the capacity to make some decisions should still be allowed to decide to take part in medical research.

The other partiality this evening is the proposal that the Government said emphatically on 21 January that they would consider this no further. That is not true. The noble Lord, Lord Neill of Bladen, read out an extensive excerpt of what the noble Baroness, Lady Royall, said that night. She also said that she heard the sentiments in this House and would take these matters away for further consideration. It is for the noble Baroness, Lady Thornton, to explain the Government's thinking to us. I happen to agree with Members of this House who think that the processes in another place are deficient. I agree that there has been a lack of scrutiny by elected Members, but I do not believe that it has been to the degree that has been indicated this evening or that there has been some kind of conspiracy.

I return to my original point: it is not a matter of being sinister. In fact, the scientific community raised these issues. They raised the issue of the existing stem cell bank. They raised the issues of children who lack capacity and have life-limiting diseases to the extent that they will not reach adulthood. They raised the question of adults with mental capacity issues. Why? Because they wanted those issues to be brought before Parliament and for legislation to be properly formed. When we come to make our decision on this, we should do so in a way that sets out the proper background to the point we are at.

Photo of Lord Elton Lord Elton Conservative

My Lords, they may not be sinister, but they are startling. That is what gives point to our deliberation this evening. It has been and is being a fascinating debate because it has a sort of hybrid character, with little Second Reading paragraphs coming in and Committee points being raised. Then we have the whole question of the constitutional procedure, on which I shall add a word to what my noble friend Lord Waddington said.

As a second Chamber with a watching brief on constitution and procedure, we must be aware of what is happening in the other place, even if we are not entitled to express our opinion to it. What has happened in the other place colours our reception of what arrives here from there. A large and, for laymen—such as most of us on this matter—complex series of paragraphs has been introduced which has elicited speeches, such as that of my noble and learned friend Lord Mackay of Clashfern, crying out for a discussion in Committee. I would like to ask questions about our friends "C" and "P" in particular, who have very chequered histories through the paragraphs in Amendment No. 92; they are ill in all sorts of ways, incapacitated in others and finally dead, but still contributing to the human species. All of them give their human, although not their other, selves, I see.

One could make those points in Committee, but not in a debate like this. I regret that we are being asked to deal with these fundamental, important and complex matters through a procedure that does not allow one, as I have been reminded this evening, to speak after the Minister as one can in Committee. Most of one's real questions bubble up following what the Minister has said in reply. If the reply is inadequate, one cannot say so. One cannot test it. It is there, then followed by a whipped vote and the matter is closed. I ask your Lordships to support my noble friend not only for the merits of the amendments under consideration, but for the important procedural points that accompany them.

Photo of Lord Patel Lord Patel Crossbench

My Lords, my name has been mentioned in relation to these amendments. The previous amendment I had tabled in Committee was directly related to the archival material that could be used for research. I do not want to re-rehearse the whole argument, because it took hours then and the time is late now.

Why do researchers want the ability to use this archival material obtained from children and adults with serious diseases? In the case of children, I have used the examples of diseases such as Batten disease, lissencephaly and nonsyndromic renal hypodysplasia. These diseases and others cause abnormalities in children's brains and kidneys. The majority of those children die in the first two years of life. We do not understand why brain cell development in these children is abnormal from the very beginning. What genetic and biological mutations occur so early on in the development of an embryo, maybe, to cause these defects? The only way to study these is to take the archival material from these children and, now that we have the ability, put it through to create pluripotent stems cells using these tissues, and begin to understand the fault that lies in the early development of these neuronal cells.

The other example I used was in adults, with material collected, over many years, of conditions such as muscular dystrophy, some of which is genetically related. After many years, we have collected only 50 such samples; they are in a tissue library in the United States. All this material was given with consent for medical research, lawfully obtained. The ability to take these tissues from people who suffer from this particular type of muscular atrophy and to learn what goes wrong at an early phase of development is very important. It is not that research is not being done on these tissues; it is that research is not allowed to be done by first converting the tissues into early-phase stem cells. That is the difference. That is why we require the government amendment to be passed. Whether this comes under human rights legislation or not, I will leave noble and learned Lords to advise us. All I can tell you is why research in this area is so vital.

Photo of Baroness Thornton Baroness Thornton Government Whip, Baroness in Waiting (HM Household) (Whip)

My Lords, the amendment tabled by the noble Baroness, Lady Knight, would remove all those important exceptions that were so passionately argued for by the noble Lord, Lord Patel, and many others during previous debates.

I will attempt to address all the issues raised by noble Lords. I must first address the question of whether the Government's position has changed on this issue. As the noble Baroness, Lady Barker, said, my noble friend had said that she would take this away and consider it. Very often in your Lordships' House, noble Lords are pleased when the Government do that and then decide on a different course of action. We regard that as one of the things we are very good at. I will go through the reasons why we did that; we have, of course, taken advice.

Throughout the progress of the Bill, we listened carefully to the debate and considered our position accordingly. We reviewed our position on using cells in exceptional circumstances to create embryos for research without specific consent. The issue of interference with Article 8 of the European Convention on Human Rights was the position we revised on further information we received and which concluded that interference in this case was justified and proportionate.

We identified that the use of cells to create embryos raised human rights issues under the article, and our view is that the principle of that has not changed. However, under the convention, interference with Article 8 can be lawful if justification can be shown for such interference which is necessary and proportionate. When this issue was first debated, the Government were not aware of sufficient evidence that would justify the removal of consent. However, following the evidence that emerged as a consequence of the debates in your Lordships' House and consultations with the Academy of Medical Sciences, the MRC, the Wellcome Trust and medical research charities, it became clear that the justification for an interference could be made provided that this was subject to stringent safeguards and limitations and that the exceptions to consent would be carefully drafted to reflect this. In short, the Government's analysis of the convention has not changed but the evidence and the guidance available have.

The Government wrote to the Joint Committee on Human Rights about this. I have a letter to the chair from my right honourable friend in the other place, Dawn Primarolo, in which she specifically raises the issues I outlined in my opening remarks on why Article 8 was compatible. I could read these out but they are quite lengthy. Yet they clearly draw the attention of the Joint Committee on Human Rights to this issue in full and the discussions that have taken place in this House. The Joint Committee raised no concerns as result of that communication. I hope that goes some way to explain what happened and what the Government then did about it.

The noble Baroness, Lady Knight, was concerned that the researcher has to be satisfied that the person has a serious medical condition. The researcher would have to satisfy the HFEA that all the conditions were met before a licence would be granted. It is not that some researcher dreams something up and then goes ahead with it. A large number of conditions have to be fulfilled, which are outlined in the Bill. That is why it is quite a lengthy amendment. On the issue raised by the noble Baroness of requirements having to be met, all the circumstances have been set out and they would have to be met.

The noble Baroness raised the issue that a child's tissue should not be used without consent. A child's tissue can be used to create an embryo only in limited circumstances, as I have previously set out. In other circumstances the use of tissue from children can also be used with the parents' consent under the Human Tissue Act. That is not unique to this legislation. The noble Baroness drew attention to the fact that the word "reasonable" was used eight times. It will be for the HFEA to determine what is reasonable; for example, the reasonable grounds for believing that research of comparable effectiveness could not take place. I repeat again: this will not be for the researcher to determine but for the HFEA.

The noble and learned Lord, Lord Mackay, raised the issue that the amendment does not require that this will be of help to the person from whom the tissue has been taken. The person from whom the cells are derived may be seriously ill and may die before they could benefit from any treatment. Yet the Bill requires that it must be used to develop treatment for someone with a similar condition. This provision mirrors that in the Mental Capacity Act. The noble and learned Lord also raised the issue of stored cells and human admixed embryos. Cells that are stored from someone with a particular condition could be used with an animal cell. This could enable stem cells to be derived which could be studied to learn more about the process and mechanism of the disease.

The noble Baroness, Lady O'Cathain, raised the issue of the donation of her body to science. I hope it will help to allay her fears that an objection can be registered to ensure that tissue is never used to create embryos for research. One of the conditions under paragraph 15G is that cells cannot be used to create embryos if the researcher has any information at all which suggests that the donor would have objected.

These amendments are important for those rare exceptions where it may be appropriate for research to be carried out on tissue from someone who is not able to consent. To prevent this research would place unnecessary limits on finding potential cures. The stringent safeguards are appropriate and will ensure that this research will take place only where absolutely necessary. The provisions were debated previously in this House and also during debates in Committee in another place.

These amendments were tabled in response to the compelling arguments put forward by the noble Lord, Lord Patel, and others in this House. They are also supported by the Academy of Medical Sciences, the Association of Medical Research Charities, the Medical Research Council and the Wellcome Trust, which provided briefing for today's debate.

These exemptions are rooted in exceptional circumstances. The potential for benefits to sufferers of serious conditions is too great to overlook, and any research that can be undertaken in the hope of better treating or curing these conditions must be allowed to continue.

On that basis, I invite the noble Baroness to withdraw her amendment, and, if she presses it, I invite the House to resist it.

Photo of Earl Ferrers Earl Ferrers Conservative 9:15 pm, 29th October 2008

My Lords, before the noble Baroness sits down, could she answer the very telling question put by my noble friend Lord Waddington and the noble Lord, Lord Alton? There are 211 new lines in the Bill that have not been discussed by another place. It is groundbreaking stuff, which many of us do not understand and on which many in the House of Commons ought to be able to give a view. Would it not be good if, irrespective of its content, my noble friend's amendment were accepted to give the other place the opportunity to discuss these matters?

Photo of Baroness Thornton Baroness Thornton Government Whip, Baroness in Waiting (HM Household) (Whip)

My Lords, I thought that I had said that this amendment and these issues have been discussed at length in this House and in another place. The reason that the amendment is so long is that it covers in detail the stringent requirements that we are introducing. Research will take place only when absolutely necessary.

Photo of Baroness Knight of Collingtree Baroness Knight of Collingtree Conservative

My Lords, at this time of night I will be very brief, but I must use my right of rebuttal to reply to some very serious points. I thank those who have supported me in this debate. I share the respect held for the noble Lord, Lord Walton, in all parts of this House. He said, perfectly correctly, that the medical ethics committee of the BMA had debated the consent exemptions for children and for tissue already in storage and considered them to be reasonable. But I am told in a letter, which arrived only today, that the BMA does not have a policy on the use of tissue.

Photo of Lord Walton of Detchant Lord Walton of Detchant Crossbench

My Lords, I talked about the GMC, not the BMA.

Photo of Baroness Knight of Collingtree Baroness Knight of Collingtree Conservative

My Lords, if that is the case, I should like to place on record that the view of the BMA has not been established or spoken of. On incapacitated adults, the BMA spokesman said:

"This is a contentious issue on which the BMA has not developed policy".

We have not heard from the BMA on either of those issues.

I must say to the noble Baroness, Lady Barker, that I find most extraordinary the argument that one should take over the right to do what one wishes with the body of a person said to be incapacitated, otherwise you will be disadvantaging them. You are disadvantaging someone if you allow them to choose what should be done with their body? I cannot follow that.

It is perfectly true that the very long amendment that I seek to delete has not been debated in its entirety. Whatever side issues may have arisen from it, it was not debated and there was no time in the other place to do so. That is a serious matter.

If all the decisions on whether tissue can be used must go before the body to which the noble Baroness referred, I would point out that in my experience such bodies take a long time to decide on cases. I imagine that there must be some urgency before the use of the tissue passes over. That may negate any point in passing it to another body first and saying, "Can we do this?"

There are very sincere and big worries about this legislation and I beg the Government to receive what I have said in the sense in which it is offered to them and recognise that we face here a most serious matter, which could well lead the Government into trouble later if it is decided to challenge the Article 8 position. I wish to test the opinion of the House.

On Question, Whether the said amendment (No. 92A) shall be agreed to?

Their Lordships divided: Contents, 34; Not-Contents, 105.

Division number 3 Private Parking: Ports and Trading Estates — Human Fertilisation and Embryology Bill [HL]

Aye: 32 Members of the House of Lords

No: 103 Members of the House of Lords

Ayes: A-Z by last name

Tellers

Nos: A-Z by last name

Tellers

Resolved in the negative, and amendment disagreed to accordingly.

On Question, Motion agreed to.

Commons Amendments Nos. 93 to 103

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health) 9:36 pm, 29th October 2008

My Lords, I beg to move that the House do agree with the Commons in their Amendments Nos. 93 to 103, to which I have spoken with earlier amendments.

Moved accordingly, and, on Question, Motion agreed to.

Commons Amendment No. 104

Page 99, line 24, at end insert-

"2A In section 7 of the 1990 Act (reports to Secretary of State) for subsection (1) substitute-

"(1) The Authority shall prepare-

(a) a report for the period beginning with the 1 August preceding the relevant commencement date (or if that date is a 1 August, beginning with that date) and ending with the next 31 March, and(b) a report for each succeeding period of 12 months ending with 31 March.

(1A) In subsection (1)(a) "the relevant commencement date" means the day on which paragraph 2A of Schedule 7 to the Human Fertilisation and Embryology Act 2008 comes into force.

(1B) The Authority shall send each report to the Secretary of State as soon as practicable after the end of the period for which it is prepared.""

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

My Lords, I beg to move that the House do agree with the Commons in their Amendment No. 104, which refers to the requirement on the Human Fertilisation and Embryology Authority, the HFEA, to produce an annual report. Section 7 of the 1990 Act requires the HFEA to produce an annual report. Section 7(1) requires a report covering a year that runs from August to July, reflecting the fact that the HFEA came into operation on 1 August 1991.

The Treasury's Financial Reporting Manual requires non-departmental public bodies such as the HFEA to produce an annual report to accompany their annual accounts. It is therefore practical that we amend the reporting period in the 1990 Act to cover the financial year April to March in line with the requirements of the Financial Reporting Manual.

Amendment No. 104 is purely a minor administrative amendment to bring the statutory reporting requirements into line with Treasury guidance. There is no change to the requirement for the Secretary of State to lay the annual report, or any other reports produced under this section, before Parliament.

Moved, That the House do agree with the Commons in their Amendment No. 104.—(Lord Darzi of Denham.)

Photo of Baroness Barker Baroness Barker Spokesperson in the Lords, Health

My Lords, it will come as a relief to noble Lords to know that I have absolutely no feelings on the HFEA's annual report that I wish to share with them. However, I should like to thank the Government for the assistance that they have given to those of us in the Opposition parties during the passage of the Bill. I thank also the Bill team, which has been outstanding. I thank the scientific noble Lords for the medical education that some of us have received. I thank also those Peers with whom I did not always agree but who were always assiduous in putting forward some very difficult and technical views. The Bill that we have before us is a great deal better than the Bill which first appeared in this House. I offer thanks from these Benches.

On Question, Motion agreed to.

Commons Amendments Nos. 105 to 118

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

My Lords, I beg to move that the House do agree with the Commons in their Amendments Nos. 105 to 118, to which I have spoken with earlier amendments.

Moved accordingly, and, on Question, Motion agreed to.