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The Bill will help maintain the UK’s position as a world leader in ground-breaking research for the treatment of serious diseases, including through embryonic stem cell research. Its provisions are an overhaul of the existing law and will promote public confidence together with best regulatory practice. We have not, however, proposed to abandon the basic foundations on which the existing law is based. We have not tried to fix what is not broken, nor have we thrown the baby out with the bathwater. Rather, we have kept to the fundamental underpinnings of the regulatory scheme based on the report of the committee of inquiry chaired by the noble Baroness, Lady Warnock, on which the original legislation was based. Nevertheless, technology has moved on and so have attitudes. There are, for example, novel ways of creating embryos for research, a much increased capacity to screen embryos for serious genetic diseases, and at the same time legal recognition for different family forms. These developments demand a rigorous examination in Parliament of the regulatory framework, and a resetting of the controls and boundaries for the future.

The Bill was introduced on 8 November, a month after our response to the pre-legislative scrutiny report. It comprises 69 clauses and eight schedules, arranged in three parts. The first part consists of amendments to the 1990 Act, amending, for example, the definitions used. Part 2 consists of provisions relating to legal parenthood in certain circumstances, for future cases involving assisted reproduction. Part 3 contains miscellaneous and general provisions, including amendment of the Surrogacy Arrangements Act 1985. As well as the Explanatory Notes relating to the Bill, the department has also prepared an illustrative text of the 1990 Act, showing how it would look if the amendments proposed in the Bill were made. This text also incorporates changes to the 1990 Act made by various other instruments, including the regulations made earlier this year to implement the requirements of the European directive on tissues and cells.

The Bill’s main provisions will ensure that all human embryos outside the body, whatever the process used in their creation, are subject to regulation. The existing law refers to the process of fertilisation, which has cast doubt on whether embryos produced by more novel processes are within the regulator’s remit. It is important for the future of embryo research that there should be clarity about what is regulated, and moreover to ensure that human embryos cannot be created and used lightly.

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The Bill will clarify the regulation of interspecies embryos for research. The original legislation was concerned almost entirely with human embryos. It banned the mixing of human and animal gametes, other than for the limited purposes of testing the fertility of human sperm. Beyond this, the 1990 Act does not mention embryos combining human and animal material.

Technology has moved on and promising avenues of research have expanded. For example, scientists now wish to use animal eggs in place of human eggs for the purpose of creating embryos for stem cell research, in part to overcome the shortage of human eggs available for research. The aims of such research would be, for example, to explore the potential for treatment of degenerative conditions such as Parkinson’s disease. Again, it is essential that the law and regulations are clear about what falls within the Human Fertilisation and Embryology Authority’s remit. We are proposing that interspecies embryos can be created for research, subject to the HFEA’s decisions to license individual research projects as being necessary or desirable. These are exactly the same controls as apply for embryo research projects using human embryos, and subject to the same safeguards. The embryos cannot be kept beyond 14 days’ development, nor can they be placed in a woman or an animal.

Besides interspecies embryos, the Bill will also increase the scope of legitimate research activities, while retaining strong regulatory controls and oversight. The existing legislation is not, for example, as clear as it could be that basic research using embryos—the type of research that underpins more advanced applied research into serious diseases—is permitted. Similarly, the restrictions on the use of data collected by the HFEA are overly restrictive and make it difficult for the success of treatments to be followed up through good research. The Bill contains enabling powers to make access to those data easier, while allowing full attention to be given to proper confidentiality controls.

The Bill will impose a statutory ban on the sex selection of offspring for non-medical reasons. This will put on the face of the legislation something which is at present a matter of HFEA policy, giving Parliament the opportunity to fully debate the provisions. The Bill will also make explicit the basic parameters for screening and selecting embryos. Again, the intention is that this should be undertaken only on the grounds of avoiding serious disease, and the Bill preserves some flexibility for how that is to be determined. The current situation, which has been the subject of legal challenge, is not sufficiently clear, and again the opportunity is presented for Parliament to give a clear steer for the future.

The Bill includes clear recognition of same-sex couples as legal parents of children conceived through the use of donated sperm, eggs or embryos. This will mean, for example, that the woman who gives birth and her civil partner will both be recognised as the parents of a child conceived via assisted reproduction. At present, the partner would have to apply to adopt the child. Similarly, two men will be able to apply for a parental order to become parents of a child conceived through a surrogacy arrangement. At present, parental

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orders are open only to married couples. In considering these matters we must ensure that we do not overstress concerns and anxieties, or depart into the realms of science fiction. Similarly, we must be careful not to overhype promising areas for future exploration.

The Bill contains a number of secondary legislative powers, as well as areas of discretion for the regulator, that are intended to allow scope for flexibility where appropriate. This is to enable a rapid response to new developments as well as attention to detail in different cases. There is also in the Bill the capacity to recognise in practice when developments have become commonplace. We are, for example, imposing on the regulator an explicit duty to act always in accordance with the principles of better regulation. The Bill also provides for a more streamlined approach to administration by the regulator. For example, it removes the current requirement that the membership of HFEA licence committees must be limited only to members of the authority.

I must also briefly mention two things that the Bill does not do, and that the Government have no intention of doing. It does not—as has been claimed by some observers—deviate from the Government’s position that human reproductive cloning is illegal. The Bill’s provisions replace the Human Reproductive Cloning Act 2001 by putting new controls directly into the 1990 Act. I am sure that we will have extensive discussions in Committee about precisely which activities are permitted in relation to eggs and embryos, but let me be quite clear from the outset that the Government’s policy remains not to allow reproductive cloning.

Another issue on which we have been quite clear from the inception of the review of the law on assisted reproduction is donor anonymity. Under the 1990 Act as originally passed, donors are anonymous. A change was made by regulations in 2004 so that where donors of gametes or embryos were registered from 1 April 2005, the donor-conceived person will have the right of access to information, including the name of the donor, from the age of 18. The Government have made clear that we have no intention of altering this position, arrived at as a matter of principle, and put successfully into practice. In fact, the Bill will enable greater access to information by donors and donor-conceived people, recognising the importance placed on genetic origins and relationships.

I look forward to an interesting debate on the extremely important issues raised by the Bill. Once more the eyes of the world are upon us. In this and subsequent stages of the Bill I believe that this House will provide, as it has in the past, the considered and expert scrutiny that is vital.

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

3.26 pm

Lord Mackay of Clashfern: My Lords, I declare an interest as an honorary fellow of the Royal College of Obstetricians and Gynaecologists, of the Royal College of Surgeons of Edinburgh and of the Royal College of Physicians of Edinburgh. I am also patron of the Lawyers’ Christian Fellowship and a member of a number of other Christian bodies.

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I had the great honour of presenting to this House the 1990 Bill, which became the 1990 Act, and I retain a feeling of fatherhood towards it. I also had the honour of serving on the Select Committee of both Houses that scrutinised the draft Bill under the very distinguished chairmanship of Mr Philip Willis, an honourable Member of another place.

I thank the noble Lord, Lord Darzi of Denham, for his clear exposition of the Bill and its principal features. At the outset I should say how pleased I am that the Government have decided to abandon the suggestion of amalgamating the Human Fertilisation and Embryology Authority with the Human Tissue Authority. I believe that to be a thoroughly wise decision and, as the noble Lord said, it is warmly supported by the Joint Committee.

It was said that the 1990 Act required fertilisation to be part of the definition of an embryo. I think that it is right to say that that was argued, but the court decided that the wording of the 1990 Act was sufficiently broad to capture an embryo however it was created.

I wish to deal with certain points in the time allotted to me as a Back-Bench speaker because, as the noble Lord indicated, many issues of great concern and importance are dealt with in the Bill. When an activity is to be licensed, it is necessary to define the activity in question. In the draft Bill, the Government expressed a desire to license the creation and use of interspecies hybrids. They did this in a list corresponding generally to paragraphs (a) to (d) of new Section 4A(5), which they propose to insert into the 1990 Act. However—this is crucial—they added what was described as a catch-all provision, which they modified in manuscript in a letter to the Select Committee. They were attempting an exhaustive definition of interspecies embryos.

Unfortunately, the scientific experts who came before the Select Committee found the catch-all provision to be incomprehensible. Because of that difficulty, the Select Committee hoped to afford the Government some help by suggesting lines that they could take. We therefore proposed a draft definition of interspecies embryos, which we recognised required work before being finalised. When the Government came to work on it, they dropped it altogether and replaced it with a power on the part of the Minister to make regulations. The difficulty with that is that if an activity is not restricted by the licensing conditions that are already in place, it will not be restricted at all. A ministerial regulation that comes thereafter will be rather late and rather retrospective, which is highly undesirable.

It would be much better to have a working definition of interspecies embryos as a whole—one that was not only a list of particular cases but a description of what is meant by the phrase in the Bill. We managed to do that in 1990 for embryos in a way that has lasted and I am sure that the present Government have at least as good resources and qualified Ministers to do that as we had. Ours has lasted for 17 years; I hope that theirs will last somewhat longer. The Minister is of course an expert in the science associated with medicine and surgery. I therefore look forward to hearing him explain

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in his response what he understands by the words “interspecies embryo”. I shall then be very happy to pick that up and table it as an amendment to the Bill when it reaches Committee.

Although this is Second Reading and I should not be getting too deeply into Committee points, I should point out that one sees the force of this in two provisions in the Bill. The first is in new Section 4A, which it is proposed should be added to the 1990 Act. It says:

However, there is already a provision in Clause 3 that says:

As I understand the definitions—I hope that I have understood them correctly—every permitted embryo is a human embryo, but every human embryo, since “human embryo” is not defined, is not a permitted embryo. Therefore these two provisions do not stand together. Some misunderstanding underlies them, and I suggest that reconsideration of the definition provisions would not be out of place.

The Select Committee also suggested that the Human Fertilisation and Embryology Authority should be given the power to grant an exemption if a given application before it did not really include the need for embryonic consideration—or the consideration of the embryo—because the definitions are very wide. Just as a planning authority may find with regard to certain applications for planning permission, it may find that no permission is necessary. We suggested that. I think that the Government thought that we were trying to provide for the authority to exempt IVF treatment altogether. Certainly from my point of view—and I think that I represent the committee’s views—that was not the point at all. The evidence shows that this could catch basic science that does not involve consideration of matters particularly related to an embryo. We therefore thought that this was a good power and I have the impression that much of the respected scientific community thought the same.

I shall now pass, in the last two minutes available to me, from these rather technical matters to the point about removing from the 1990 Act the provision that required, in considering the welfare of a child in IVF treatment, consideration of the child’s need for a father. That provision in the 1990 Act was negotiated here in this House with considerable care and it was accepted unanimously here and I think also in the House of Commons. As I understand the process, male material is still necessary for the procreation of human life—I hope that I am right in that; I think that I am. If it is necessary, it seems extraordinarily undesirable, the very moment when the child comes into existence, to leave that out of account altogether.

The provision in the 1990 Act is a very general one and does not prescribe anything. It just says that the need for a father has to be kept in view. However, so urgent is the desire to change this that the Government want to miss out entirely that very innocuous provision. I did not understand why that was so during the

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previous Committee stage and I do not understand it now. From my point of view, it would be much better left in place. We should recognise that nature requires male material in a living human being as well as female. That should be recognised in considering the welfare of a human being about to be brought into the world regardless of whether that human being will ultimately have a father in any ordinary sense of the word, though a male who is within the framework of his society and friendship may well be the one who would be sufficient to satisfy the condition, as the evidence before us showed.

3.37 pm

Baroness Tonge: My Lords, it gives me great pleasure to speak in this debate. I suspect that none of us will be able to do justice to it on Second Reading but I should like to highlight a few issues on which I feel strongly and on which my party has a position.

Before I do so, however, I want to pay tribute to the work done by the noble Baroness, Lady Warnock, and her committee which led up to the 1990 Act. Every time I pass the noble Baroness's office, which is next to mine in 2 Millbank, it reminds me what a privilege it is to be in this place rubbing shoulders with people such as Mary Warnock. The 1990 Act was a masterpiece of legislation and has made this country the envy of medical scientists all over the world. Our regulatory system and liberal approach to embryology research have put the UK in a lead position in this field.

However, advances in the field make it imperative for the 1990 Act to be reviewed. Here I also congratulate the researchers in the field in the UK on their restraint, especially, recently, the team lead by Professor Stephen Minger at King's College and the team at Newcastle led by Dr Lyle Armstrong. They both wish to use stem cells to grow cell lines in an attempt to treat conditions such as Parkinson's disease, Alzheimer's disease, diabetes and spinal injury—very common conditions that will affect many noble Lords. They are waiting for the passage of this Bill and I commend them on their patience.

This research could transform the lives of huge numbers of people if successful. All of this research is so exciting. Reading up over the weekend on the latest discoveries on mitochondria—those little specks in the cytoplasm of human cells—I realised that we were very close to finding out how life emerged from the chemical soup that was on this planet millions of years ago. It is the biological equivalent of looking up at the night sky, as one does, and thinking about what lies beyond the Milky Way, and beyond that, and beyond that, until the mind boggles. This is on the same level and it is thrilling. The Government must also be congratulated on the wide consultation on the Bill and on the fine work of the committee that scrutinised the draft Bill. My noble friend Lady Neuberger was a member of that committee. I wish all legislation could be dealt with in this way in this House.

The main field under consideration in the Bill that interests me is the creation of cytoplasmic hybrid embryos or cell lines—I wish we could call them cell lines, not embryos. It is done by using the nucleus of a

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human somatic cell and implanting it into an animal cell from which the nucleus has been removed, so using the energy from those magical bodies called mitochondria to do the work. Precious human eggs have been used for this. They have to be harvested from women's ovaries in an invasive and occasionally dangerous procedure, so using animal cells would be much better.

Other interspecies embryos, or cell lines, covered by the Bill are true hybrids. I have to commend to noble Lords the Enchanted Forest at Groombridge, to which I am dragged by my family every Halloween. There is a Zeedonk there, which is a hybrid of a donkey and a zebra. It is worth going just to see the expression on the animal’s face. He stands there looking as if he is thinking, “I feel a little silly”. He is worth seeing, and it is worth being reminded of what can happen with true hybrids. The Bill also considers chimera and human transgenic embryos.

I understand the horror that some people feel when talking about these things, bombarded as we are through our televisions and cinema screens with monsters of all shapes and sizes. Probably the most important provisions of the Bill, which cannot be emphasised enough, are that any embryo must not be kept or used after 14 days or when the primitive streak first appears, which is at around 14 days, and that no interspecies embryo—human embryo or interspecies embryo; the noble and learned Lord, Lord Mackay, made a very fine point—must be implanted in a woman's uterus. It must not happen.

That is one line of research, but there are others. At the weekend, Professor Wilmut, who created Dolly the sheep, was said to be working on turning somatic cells directly into stem cells. That is another very interesting line of research, but we need all avenues of research if we are going to conquer the diseases that persecute the human race. We must encourage, and we must regulate while we encourage.

The objectors will say human life is sacred, full stop. The difficulty is to define exactly what is human life. The sufferers of the diseases I mentioned are certainly human, and their lives could be transformed if this work is successful. Do we want to deny them that? What about all the eggs from my ovaries and the embryos of less than 14 days that I might have lost in the course of over 40 years of happy marriage? Was that human life? We get into very difficult areas when talking in these terms. People worry about the transmission of infection via mitochondria but, if that is a possibility, the only way we can develop ways to combat it is to allow the research to go ahead to find out what happens. What of rogue scientists acting outside the law and creating monsters? There have always been rogue scientists, which is why the law and regulations must be in place to ensure that they are caught and stopped. I shall not get carried away at this stage. Suffice it to say that my party supports this research, but we will have a free vote when the time comes.

I shall touch on other issues very briefly. Clause 14(2)(b) removes the reference in the 1990 Act to the child's need for a father. I say to the noble and learned Lord, Lord Mackay, that of course every child needs a biological father—thank goodness—but children

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can be brought up well without either parent in some circumstances. Two of my grandchildren have been brought up without a mother for the past three and a half years, but they have been surrounded by a loving family and a social network, the requirement for which is also mentioned in the 1990 Act and remains in the Bill. That network of support for any future child is more important than either parent; there must be a social network and an extended family. Our party has never discriminated against gay people, which is what this debate is really about, and we will therefore support the removal of those words. There will also be a prolonged debate on the child’s right to information about parentage and the effect that this may have on the availability of donors. I have a lot to say on that subject, but I will leave those arguments for the Committee stage.

I confess to sometimes feeling a little anxious about the treatment of infertility, having spent the past 10 years studying the effects on world resources, food supply and climate change of the population explosion all over the planet. At the same time, we are helping desperate, childless people to have babies. We must spend much more on making contraception available to those people who cannot stop having babies. That is not the last that I shall say on this subject.

Finally, we do not think it appropriate for us in this House to put forward amendments to the Abortion Act. That must be the prerogative of the House of Commons, Members of which are the elected representatives of the people of this country. However, if there are noble Lords here who are distressed at the number of abortions in this country—who is not?—I hope that they will support my party in our call for good statutory sex and relationship education in all of our schools and for a halt to the closure of family planning clinics nationwide, as the primary care trusts balance their books and use what they see as the easy option for cuts.

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