Read a third time.
Clause 3 [Prohibitions in connection with embryos]:
1: Clause 3, page 3, line 21, leave out “Regulations” and insert “A licence”
The noble Lord said: My Lords, within the past few weeks there has been a major development in the field of human neuromuscular disease in that the Medical Research Council has established a major research centre for the study of such diseases jointly between University College London and Newcastle University. An inaugural symposium was held last Friday at which I was privileged to be present and to hear an outstanding lecture by one of the world’s experts on mitochondrial disease, Professor Salvatore DiMauro from New York.
I am not going to be repetitive as I heard what the noble Baroness said about arguments previously set out at Second Reading and in Committee. Mitochondrial disorders are a cruel class of inherited disease that are life-threatening conditions and are coupled with great unpredictability about how future children will be affected. They can include blindness, fatal liver failure, stroke-like episodes, mental retardation with intractable epilepsy, profound muscular weakness, diabetes and deafness. There are 29 mitochondrial genes, but in them there are 200 mutations, all of them harmful, as Professor DiMauro said last week.
The subject of this amendment is a process whereby it is theoretically possible to remove from a woman with the mitochondrial abnormalities in the cytoplasm of her ovum the nucleus containing 99.95 per cent of her DNA and transplant into a cell from which the nucleus has been removed a donor ovum with normal cytoplasm and normal mitochondria. Recently, Professor Douglass Turnbull from Newcastle University has taken matters further. Through a simple process of in vitro fertilisation an ovum from a woman with mitochondrial disease has been fertilised by her partner or husband’s sperm, and as soon as the first cell is formed it contains two pronuclei, one from the woman and one from the partner or husband containing 100 per cent of the partner’s DNA and 99.95 per cent of her DNA. That process has been successfully carried out under licence from the HFEA. The licence, however, does not allow that fertilised ovum to be transplanted into the uterus of the female from whom the original ovum was derived.
Professor Turnbull has completed excellent research in animals since he received a licence in 2005. The embryos created by this IVF technique have proved to be perfectly normal and viable. The purpose of this amendment, crucial to the future of huge numbers of individuals with this group of mitochondrial diseases, is not to require that the issue has to be further reconsidered by introducing regulations to be debated by both Houses of Parliament, but to enable the HFEA, after careful consideration of all the ethical and scientific consequences, to award a licence for treatment by the implantation of fertilised ova, with the consequence that the women in question will be able to have normal children with no risk of mitochondrial disease. I beg to move.
My Lords, the difficulty with this amendment is that it was introduced at Committee stage but was not reintroduced at Report stage. The noble Baroness, Lady Royall, was right to remind us at the outset of proceedings this afternoon about the guidance of both the Procedure Committee report of 2006 and of the Companion to the Standing Orders. This issue ought to have been concluded at Report stage, rather than here at Third Reading. I have no doubt that there is a lot in what the noble Lord said. He is one of the great authorities on mitochondria. But there are differences between Members of your Lordships’ House over the way in which we should proceed—whether we should create embryonic stem cells to deal with this disease or whether we can use reprogrammed adult cells.
In many ways, this amendment is linked to the next one, tabled by the noble Baroness, Lady Barker, and the noble Lord, Lord Walton, which is about purposes of infertility. These two amendments could include the making of embryos with altered nuclear and mitochondrial DNA cells added to the embryo other than their own cells. An embryo would not need to be made by fertilisation. This amendment cannot be considered in isolation. It would be better considered when this Bill goes to another place and is considered in Committee there. It is best left to the proceedings that will ensue there rather than being resolved today. It was not considered in the scrutiny committee, it was not considered at Report stage in our proceedings and, as we do not have the chance to reflect properly on the implications of what my noble friend has said to the House today, it would be better resolved at a later stage of the Bill.
My Lords, the Government have made clear on a number of occasions our recognition of the serious and debilitating medical problems that can result from mitochondrial diseases and our support for research into understanding and developing treatments for those diseases. The noble Lord, Lord Walton, may recall that the Government accepted the recommendation made in June 2000 by the Chief Medical Officer’s expert group on stem cell research that this type of research should be permitted subject to the controls of the 1990 Act and that we subsequently brought forward regulations to achieve that. The Government are aware that promising research is under way that could lead to the development of methods for avoiding serious mitochondrial diseases. We are grateful to the noble Lord for his update following Friday’s symposium. We took full account of this research in drawing up our proposals in the draft Bill and subsequently in the Bill presented to this House.
The Bill provides, in new Section 3ZA in Clause 3, a power to make regulations covering eggs or embryos that have had applied to them, in prescribed circumstances, a process designed to prevent the transmission of serious mitochondrial disease. There is always a powerful case to be made for anticipating future developments in the Bill so that no time is lost if research bears fruit quickly. However, in this case there are a number of reasons why the Government have opted to come back to Parliament with future regulations to be decided by affirmative resolution, and we believe that this remains the most appropriate route. I assure noble Lords that we keep developments closely under review, as does the HFEA with its horizon scanning panel.
The safety aspects of implanting an embryo that has undergone a process of mitochondrial repair would need to be assessed carefully before this could be deployed as an option for patients. Moreover, the status of the egg donor in these circumstances—the person providing the healthy mitochondria only—would need to be considered, and we feel that further consultation is needed on this. This may be rather a different case from the current situation of egg donors. These are issues that we believe Parliament should be asked to take a view on when more facts are available about what the therapy involves, and what implications follow. We have ensured that the Bill contains the flexibility to return to this issue, in recognition of the progress being made. I hope that noble Lords will not feel it necessary to press this amendment before Parliament and the public are fully able to assess the implications of that progress. I hope that the noble Lord will withdraw his amendment.
My Lords, I listened carefully to what the Minister said and I appreciate entirely the Government’s stance on this issue. Perhaps I should say to my noble friend Lord Alton, who spoke on the amendment, that this has nothing to do with stem cells; it is, in fact, simply in vitro fertilisation involving a subsequent pro-nuclear transfer. It is therefore a very new technique, which is why I worded the amendment slightly differently from the one that I tabled in Committee. This is new and exciting. It will be the first time in the world that this type of therapy or prevention of mitochondrial disease will be achieved. If I can get an assurance from the Minister that regulations will be introduced as soon as possible in relation to this issue, I shall be happy to withdraw the amendment.
My Lords, the noble Lord can certainly have that assurance. In the mean time, we have to ensure that proper debate takes place among the public on these very important issues, and we will come back to Parliament in due course when they have all been considered. However, I assure the noble Lord that we shall not wish to lag behind in any way.
2: Clause 3, page 3, line 26, at end insert—
“(5A) Regulations may provide that—
(a) an egg can be a permitted egg, or(b) a sperm can be a permitted sperm, even though the egg or sperm has been developed from one or more human cells in a prescribed process designed to treat infertility.(5B) Regulations under subsection (5A) may
(a) provide that any sperm be developed from one or more cells of a genetic male and any egg be derived from one or more cells of a genetic female.(b) specify, or otherwise restrict, the nature of the infertility which the prescribed process is intended to treat.”
The noble Baroness said: My Lords, I am mindful of the noble Baroness’s reminder to us all of the procedure at this stage of the Bill and therefore I intend to speak only briefly to the amendment, which noble Lords will acknowledge I move in the absence of the noble Lord, Lord Patel.
On Report, we had a debate about this issue in which it was clear to all noble Lords that the potential to create artificial gametes offers an unprecedented opportunity in the treatment of infertility. Nevertheless, it is a scientific development that carries potential ethical questions, and it is important that Parliament debates the matter fully in order that scientists are given a clear indication of what the ethical limits to such scientific developments should be.
There are two main reasons for raising the amendment today in this form. The first is to stress, in a way that the noble Lord, Lord Patel, did not during our earlier debates, that we are talking here only about the treatment of infertility. This is not about the production of artificial gametes for any other purpose.
The second reason is perhaps more substantial. Noble Lords will remember that during our debates on the previous occasion, in replying to the noble Lord, Lord Patel, the noble Baroness said that the Government had some concerns that there may be issues of human rights compliance under Article 14. Therefore, the noble Lord, Lord Darzi, helpfully wrote to all Peers who had taken part in our debate on 31 January setting out the Government’s response to a number of different issues. However, he did not mention what those concerns were in relation to this matter. Therefore, to enable Members of this House and of another place to understand the Government’s concerns fully, can the noble Baroness tell the House what they are in relation to Article 14? I realise that we are not in a position to resolve this issue today but I think that that would be helpful in enabling Parliament as a whole to take this matter to the point where it should be, which is as a potentially very exciting treatment for infertility and power to do good. Can the noble Baroness also tell us whether this matter will be discussed when the Bill goes to another place? I beg to move.
My Lords, I hope that paramount in the Minister’s answer will be the question of the safety of these techniques. It is very important to understand that the maturation of a gamete which has been artificially derived is a very complex procedure. It requires careful maturing of different events within the egg cell or the sperm cell. It has to ensure that the chromosomes are correct. It has to ensure that all the genes are expressing in a normal way. None of us wants to assume that this technique is going to be rapidly here. It is excellent that it is on the statute book but I hope that the Government will recognise that this has potential risks for the unborn child which need to be taken into consideration at whatever stage this technology is finally introduced. In my view, a huge amount of animal work will be needed before one can contemplate this procedure going to the human embryo.
My Lords, I strongly support the comments just made by the noble Lord, Lord Winston. I remind the House that the Minister herself said:
“There is no way in which the Government could consider this issue in depth, as we would have to, before Third Reading. Therefore, I ask the noble Lord”—
it was my noble friend Lord Patel—
“to withdraw his amendment, on the understanding that we will look at it further in the other place”.—[Official Report, 15/1/08; col. 1202.]
I am sure that is the right way to proceed rather than asking the House to come to a conclusion on this issue today.
It was also suggested that Comment on Reproductive Ethics, an organisation known as CORE, was in support of this amendment. I have taken advice from CORE and it says that in fact it is very strongly opposed for reasons that I set out to the noble Baroness, Lady Royall, last Friday in a letter. I do not intend to labour those points today but it is important for the House to understand that if this amendment were accepted in its present form, it would allow genetically engineered embryos, embryos created by cell nuclear replacement techniques, embryos produced by artificial gametes in numerous ways, a combination of those things, and something that I alerted the House to on Report—a technique developed by Professor Shinya Yamanaka at Kyoto associated with adult stem cells where it would be possible to create gametes from adult cells and for one person, therefore, to be both father and mother to a child. Before we agree to anything quite so profound, surely the House and society at large would want to consider that matter much more carefully.
My Lords, the Bill seeks to prohibit placing in a woman any embryo, sperm or egg other than a permitted embryo, sperm or egg. New Section 3ZA defines permitted embryos and gametes. With respect to gametes, this means that only an egg produced or extracted from a woman’s ovary or sperm produced or extracted from a man’s testes can be used in treatment. The Bill does nothing to prevent the creation or use of other types of gamete, including so-called artificial gametes for the purpose of research. The use of artificial gametes, or in vitro-derived gametes as they may also be called, refers to the creation outside the body of eggs and sperm from stem cells. If this technology were to be used in treatment, it would enable, for example, an infertile man who does not produce sperm to have a genetically related child. At Report stage we heard some persuasive arguments on the use of in vitro-derived gametes and we acknowledge that there is a lot of support for a regulation-making power that would allow at some point in the future gametes derived in such a way to be considered to be permitted gametes and therefore to be used in assisted reproductive treatment.
This amendment is different from the one discussed on Report. It therefore requires different consideration and raises new concerns. Following the debates in Committee and on Report, we have had discussions with scientists about the derivation of sperm and eggs from stem cells. We are also gathering information about progress in this area and the feasibility of this technology for use in treatment. This advice is in part being obtained from the HFEA’s Scientific and Clinical Advances Group and its international horizon scanning expert panel and from discussions with other scientists and stakeholders.
The amendment tabled by the noble Lord, Lord Patel, introduces a regulation-making power that would allow regulations to be made specifying a process to create eggs or sperm from one or more human cells. That is a relatively broad power as it does not limit the way in which these gametes can be created. However, it provides for the possibility of limiting who could use this technology—for example, limiting its use according to types of infertility or to same-sex couples wishing to have a child related to both partners. Developments in the field of assisted reproduction and embryo research can be fast moving, and the area of artificial gametes is no exception.
As recently as 2 February the journal New Scientist reported views from some research scientists that it may, in principle, be possible in the future for eggs to be created from the stem cells of men and sperm from the stem cells of women. That possibility, distinct though it may be, means that the Government must give serious consideration to what other technologies may realistically become available to determine the scope of any regulation-making power. Although the amendment would allow for the power to be limited, it would not necessarily be. Careful consideration would need to be given to such limitation to ensure that it is not discriminatory. Of course, such technologies may be too far off to make any predictions about their use, but the Government are committed to exploring possibilities with the scientific community.
The noble Baroness, Lady Barker, asked about human rights and Article 14. The Government’s concern relates to Article 14 of the ECHR in conjunction with Article 8 on the right to privacy. The Government are concerned about whether the technique is available for same-sex couples or whether they will be treated differently. If they are treated differently, the Government’s view is that this must be justified to comply with Article 14 of the ECHR. Techniques for same-sex couples may be a lot further off or unsafe at this moment, and different treatment may be justified, but we are exploring these issues and will consider them further in the Commons.
The issue of safety was raised by my noble friend Lord Winston. The safe use of any gametes derived in vitro is of prime importance, which is one of the issues that we are currently considering with scientists and the wider world. Noble Lords have debated extensively issues around fathers and mothers. The use of in vitro-derived gametes could mean children being born without a genetic father in some circumstances or a genetic mother in others. That also raises the question of whether this issue is for secondary legislation, or more appropriate for revisiting as primary legislation when more facts are available about what is envisaged in practice.
I trust that our commitment to look at this further in the other place and the progress made to date in initiating this process will reassure noble Lords of our intention to consider this issue fully. With that assurance I hope that the noble Baroness will withdraw the amendment.
My Lords, will the noble Baroness undertake to set out in a letter to noble Lords the restrictions currently in place to prevent a scientist bypassing the Human Fertilisation and Embryology Authority to create a child using the gametes from just one person?
My Lords, I thank all noble Lords who took part in the short debate. I particularly welcome the intervention of the noble Lord, Lord Winston, for bringing us back to present reality. Nevertheless, it was extremely helpful for the House to hear the noble Baroness set out precisely the concerns under Article 14 of the ECHR. I very much welcome her undertaking that this matter will be looked at again in more detail in the Commons. I take the point made by the noble Lord, Lord Alton, that it is a difficult issue that needs detailed scrutiny by Parliament—perhaps on several occasions. I thank the noble Baroness for her answer and beg leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Clause 4 [Prohibitions in connection with genetic material not of human origin]:
3: Clause 4, page 4, leave out line 32 and insert—
“(e) such other embryo, not falling within paragraphs (a) to (d), which contains the DNA of a human and the DNA of an animal, in which the DNA of an animal does not predominate throughout the period of its keeping or use”
The noble and learned Lord said: My Lords, this amendment attempts to provide in the Bill an explanatory definition of the principal term used. Since the Bill commenced its proceedings in this House, considerable progress has been made in achieving a satisfactory definition. I am grateful to the Bill team, who have given me a lot of time in discussing this, and to distinguished scientists Professor Martin Bobrow and Robin Lovell-Badge, who helped in the formulation of the amendment. I understand from the letter the Minister kindly sent me at the end of last week—copied to others who took part in the debate—that the Government are moving in a direction which may not be far from this amendment, and that they would like to continue consideration of it in the Commons. I beg to move.
My Lords, the issue of defining human admixed embryos has long vexed all those who have tried to tackle it. It was probably the topic that the Joint Committee of both Houses that scrutinised the draft Bill spent most time considering. That was followed by a specific inquiry on the issue by the Science and Technology Committee of the other place. Noble Lords will agree that it has been the subject of most interesting and helpful debate while the Bill has been in this House. That the terms used during this process have ranged from “hybrids” and “cybrids” to “interspecies embryos” and “human admixed embryos” is indicative of how thinking on this has been modelled and shaped as views and debate have developed. I recall comments being made that the scientists who are expert in this field themselves struggled to reach a consensus on how to define an embryo. That indicates the difficulty that the Government and noble Lords have faced in trying to define the appropriate way through this complex and important area.
Throughout this period, we have been highly fortunate to have the input of the noble and learned Lord, Lord Mackay. His views and amendments have been most welcome, and have given us a great deal of cause for thought. The definition of human admixed embryos in Clause 4 is accepted as hitting the mark by stakeholders, such as scientists working in this field, the Home Office and the HFEA, and this reflects the pressing of the Government by the noble and learned Lord to get this right. We should all thank him for that.
We are now facing what we hope will be the final steps in this journey. At the moment, Clause 4 includes a regulation-making power to extend the definition of human admixed embryos if necessary. It has been included to ensure that if someone comes up with the type of human-animal embryo at the human end of the spectrum that is not captured by the definition, there is a power to extend the definition to catch it. This is a future-proofing mechanism. The noble and learned Lord is concerned that such a future-proofing provision is too broad and does not have relatively easy-to-understand phrases to indicate what it covers. His amendment seeks to make the provision more specific by applying it only to cases where the human DNA, not the animal DNA, predominates. His aim is to reflect the Government’s intention that the Bill ensures that the HFEA regulates human-animal embryos at the human end of the spectrum.
Yet, much as we are grateful for the hard work which the noble and learned Lord has put into this, we have concerns that phrases such as,
“throughout the period of its keeping or use”,
are ambiguous. For example, it could be read to mean that an embryo must predominantly be human for the entire period it is kept in order to be regulated by the HFEA. Clearly we want to ensure that any embryo that is predominantly human in its genetic make-up is regulated, however short the period that human DNA predominates.
We believe that the principle behind the amendment is correct, but we cannot accept the wording as it stands. We also want to maintain the regulation-making power to extend the list of entities, which the amendment to Clause 4 removes. It is important to ensure that we can bring within the HFEA remit anything that we should need to. As we all know, this is a fast-moving field and we should be secure in the knowledge that we can amend the list should the need arise. We also believe that it would be best to give more time to the scientific community for it to reassure us that this approach does not give rise to any practical difficulties.
In conclusion, we are grateful to the noble and learned Lord, Lord Mackay, and are content with the principles of predominant DNA that his amendment is intended to achieve, although we cannot accept it in quite the way it is drafted. We will give very serious consideration to bringing forward a government amendment in the other place. I invite the noble and learned Lord to withdraw the amendment.
My Lords, I am extremely willing to withdraw the amendment on the understanding that the Minister has expressed, and I am very grateful to him for what he said. It is in all our interest that the definition should be as self-explanatory and otherwise satisfactory as possible. I am sure that the Government will ultimately achieve that. I beg leave to withdraw the amendment.
Amendment, by leave, withdrawn.
[Amendment No. 4 not moved.]