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Research into deriving embryonic stem cell lines for treatment purposes is proceeding, and UK-based researchers are widely regarded as among the leaders in the field. There have been recent reports, for instance, of embryonic stem cells having a great potential to treat acute macular degeneration, and researchers from Moorfields hospital in London and Sheffield University are now developing embryonic stem cells in a GMP-compliant facility—meaning good manufacturing practice—to take that work to the next stage of clinical testing. The Medical Research Council, with the Department of Health, has invested £1.2 million to create laboratory facilities in which embryonic stem cells can be developed to appropriate standards for clinical application in humans. The MRC plans further investment in the development of tissue-typed embryonic stem cell lines.
When we debated in this House in 2001 the regulations amending the Human Fertilisation and Embryology Act 1990, many of us, including myself, took the view that the purpose of those regulations was to amend the Act in order to allow stem cells to be used for the treatment of serious human disease. We were therefore surprised when, either in Committee or on Report, the noble Baroness, Lady Royall, suggested that the use of such cells in treatment was not allowed under the Act and that it might even require new primary legislation. However, I am grateful to the noble Lord, Lord Darzi,
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Neither I, nor the scientists, nor the Government are arguing that the HFEA will be involved in regulation beyond the use of the embryo to derive the cell lines. For those of us who wish to see the therapeutic use of this technology without the need for further legislation—that now appears to be the Government’s view—the question is whether the terms of the original licence to create or use embryos, which can only be a research licence as the Bill stands, are adequate to enable us to say, with the certainty required by research scientists, their funders and investors, that therapeutic use will be permitted. That assurance requires more than an assertion of ministerial hope or parliamentary belief—it requires legal certainty.
I therefore ask the Minister to give a clear assurance that stem cell lines derived from embryos under a research licence can ultimately be used for treatment purposes once all stages of clinical research are completed. I ask also for a commitment that the translation of research into treatment will not be delayed by the need for further legislation and that a pathway for any such legislation has been agreed. I beg to move.
Baroness Tonge: My Lords, I support the noble Lord, Lord Walton. The idea that stem cells should eventually be used for treating diseases is a major selling point of this Bill for the general public. We must have some clarification on that. In Committee, I understood that primary legislation was needed to achieve that purpose. In the letter from the Department of Health I think we are now being told something different, but I confess to not really understanding the letter. Therefore, I hope the Minister will now clarify the position for the benefit of all of us.
Lord Alton of Liverpool: My Lords, who would determine whether embryos would be used in therapies rather than just in research, as currently? What expertise exists within the Human Fertilisation and Embryology Authority to determine issues surrounding the kinds of diseases that the noble Lord, Lord Walton of Detchant, has mentioned? Furthermore, what assessment has been made of safety hazards and risks that there might be because, where foetal cells have been used in the United States for the treatment of sufferers of Parkinson’s, those treatments had to be withdrawn owing to the irremediable damage that they did?
Baroness Royall of Blaisdon: My Lords, I am grateful to the noble Lord, Lord Walton, and the noble Lord, Lord Patel—who is not in his place, and I
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The noble Lord referred to the letter from my noble friend Lord Darzi, which covered a number of the issues raised during the passage of the Bill, including a considerable contribution on this subject, and copies have been placed in the Library. I am happy to repeat the salient points for all noble Lords present.
The Government have consistently supported the use of cells derived from embryos for the treatment of human disease and medical conditions, and have therefore given the issue very serious consideration. On the basis of advice and discussions we have had following Report, the Government are of the view that the licensing framework which would be in place following the introduction of the Bill would allow the derivation of embryonic stem cells. Furthermore, it would allow the development of those cells into a therapeutic product without the need for further amendment. Any embryonic stem cell line intended for therapeutic use will need to be subjected to considerable research activity, including rigorous safety assessment, before entering into preclinical and clinical studies. As each cell used would be different, significant investigation would be required in each case prior to, and during, preclinical and clinical study.
Regulatory oversight by the HFEA finishes once a stem cell line is derived. This means that once embryonic stem cell lines have been developed, the HFEA regulatory framework under which the embryo was produced is not relevant to any further use of that cell line, whether for further research or for therapy.
There are a number of ethical and safety issues regarding the use of stem cells in patients that go wider than the regulatory remit of the HFEA. They include the regulation of clinical trials using stem cells, of the widespread therapeutic use of stem cells and of the standards against which the use of such stem cells would be regulated.
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These are questions which a working group of regulators comprising the HFEA, the Human Tissue Authority and the Medicines and Healthcare Products Regulatory Agency are considering. This work will inform the research community about the steps to be taken to enable cell-based therapies to be introduced into clinical practice. The issue will be informed by the work of the stem cell bank steering committee, chaired by the noble Lord, Lord Patel, and the Medical Research Council.
The Government remain committed to developing an enabling regulatory system as part of the 10-year UK stem cell initiative. We look forward to engaging with all relevant stakeholders to ensure that the overall regulatory framework is effective and proportionate at all stages of the research pathway from laboratory to clinic. We are of the firm belief that there is no legal impediment to current research being developed into clinical application. As such, I hope that the noble Lord will feel able to withdraw his amendment.
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Lord Walton of Detchant: My Lords, I was greatly reassured by the Minister’s statement, because it covered the main points with which the scientists involved in this research are concerned. In consequence, I am happy to beg leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Clause 14 [Conditions of licences for treatment]:
Baroness Royall of Blaisdon moved Amendment No. 7:
“(6BA) In the case of treatment services falling within paragraph 1 of Schedule 3ZA (use of gametes of a person not receiving those services) or paragraph 3 of that Schedule (use of embryo taken from a woman not receiving those services), the information provided by virtue of subsection (6) or (6A) must include such information as is proper about—
The noble Baroness said: My Lords, much of our discussion about the Bill has related to the importance of donor-conceived people being made aware of that fact. It has been expressed by, among others, the noble Baronesses, Lady Warnock and Lady Finlay, that this should at least be provided for in the code of practice, but, more ideally, also in the Bill.
The Government recognise the importance of ensuring that prospective parents understand the importance of telling a child at an early age that they were donor-conceived. A child who grows up with this knowledge will be better informed and is likely to have a better family relationship. They would receive the information from their parents in the most sensitive, constructive and least distressing way.
It is the Government’s view that this is best achieved by education rather than enforcement. The Donor Conception Network has a planned programme of work, supported by the Department of Health, to promote the importance of letting donor-conceived children know at an early age that they are donor-conceived. The work will include providing, for patients who are to have treatment with donated sperm, eggs or embryos, guidance on the process of donor conception, its implications and its particular responsibilities. The aim is to prepare them for being the parents of a donor-conceived child. The work will also involve a “telling and talking” project that aims to encourage parents who have donor-conceived children to tell them, from a young age, about their origins. The work will be piloted and evaluated to assess the best way of communicating with parents and prospective parents, and to give them an opportunity to feed back information.
Encouraging openness in this way is the best way forward. The 1990 Act requires counselling to be available, and for such relevant information as is proper to be provided by all licensed treatment clinics. It is a condition of all licences that a woman shall not be provided with treatment services unless she and any person who is to be treated together with her have been given a suitable opportunity to receive proper counselling and relevant information. We introduced
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Amendment No. 7 addresses concerns expressed in relation to the importance of parents discussing with their donor-conceived children, from an early age, details of their conception. Amendments Nos. 8 and 16 have two effects. The first strengthens the Bill with respect to the provision of counselling and information, in addition to requiring that all patients be offered counselling and provided with information. It also requires that the HFEA produces, in its code of practice, guidance for the clinics about doing so. In addition, Amendment No. 16 introduces a provision which ensures that it is a condition of all licences that people being treated using donor gametes, or embryos taken from a woman who is not being treated, must be provided with information about the importance of telling their child that they were donor conceived, as well as information about the best way to do this. The combined effect of these amendments will mean that clinics are obliged to provide patients with information about the importance of talking to children about their donor conception, and that the code of practice should provide details of what information should be provided, as well as how the offer of counselling should be made. I beg to move.
Earl Howe: My Lords, I thank the Minister for listening so carefully to the concerns expressed at earlier stages of this Bill and for these amendments, which go a long way towards meeting those concerns. I am sure I speak for the noble Baroness, Lady Finlay of Llandaff, who is, unfortunately, unable to be present today, in expressing that gratitude.
Lord Jenkin of Roding: My Lords, as the mover, at Report stage, of amendments both to make it a condition of the licence, and to see that it went into the guidance, I also express my gratitude to the Minister for having met us so fully on this. This is a valuable addition. To have this in the Bill as a licence condition is a very important step forward. Can we assume that there will be a comparable paragraph in the guidance?
Baroness Warnock: My Lords, I add my thanks to the Minister and associate my noble friend Lady Finlay of Llandaff with these thanks. We really are extremely grateful.
The Lord Bishop of Chester: My Lords, I support the amendment, but would like to ask one question of the Minister. The amendment speaks of an early age, and the Minister used the expression “a young age.” That could mean a range of ages. While I am entirely supportive of the amendment, I am one of those who share the anxiety that children are denied their childhood these days by sometimes being treated as adults when they are too young. There is a very delicate balance here in all sorts of areas of life. This
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Baroness Royall of Blaisdon: My Lords, I entirely agree that children must be allowed to have their childhood. That is where the important work of the Donor Conception Network must be taken into consideration. It is working with families now, undertaking a pilot. I do not want to specify an age today at the Dispatch Box but we will be informed by the important work that the Donor Conception Network is carrying out. I can assure the right reverend Prelate that we would not want to do anything that would adversely affect a child’s childhood. In answer to the noble Lord, Lord Jenkin, yes, it will be included in the guidance.
Baroness Howarth of Breckland: My Lords, the noble Baroness stood up so quickly that I did not have a chance to stand up. I should like to make two brief points. First, I say to the right reverend Prelate that I hope that children are brought up in an atmosphere where they know from a very early age. We know from all the work in adoption that children fare much better when they know about their situation when they are very young indeed. It does not then come as a shock later on. Children who suddenly discover, at quite a young age, that they are adopted, find that extremely difficult to deal with. I remember talking to a child of four, when I was on Childline, about what “adopted” meant because she had just found out and was in a slight state of shock. She was being helped by an older child to call Childline to talk about this.
I did not have the opportunity to make my second point, but having spoken to a number of donor families, the thing that really concerns them is not being ordinary families. I understand that and we want them to be ordinary families as much as they can in bringing up their children. We want to get to the most resistant families who do not want to engage in telling the children at all about their backgrounds. That is why I shall support the later amendment of the noble Lord, Lord Jenkin, on research into how this process has worked through.
In the guidance, has the noble Baroness thought about the kind of materials that might be available to help the various authorities in knowing how to tell children, because that can be quite daunting? We have learnt from adoption that materials alongside counselling can be helpful because you have something in your hand that you can take away.
Lord Mackay of Clashfern: My Lords, I should like the Minister to comment on the difference between ordinary cases of donor conception covered by the amendment and the placing on the register at birth of facts that inevitably point to donor conception, thus distinguishing children affected, for example, by what is now Clause 46 from all other children who are donor conceived.
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Lord Alton of Liverpool: My Lords, perhaps I may welcome these amendments and ask two questions. First, can she respond to a point raised at an earlier stage by the noble Earl, Lord Howe, about how our guidance and laws relate to those in other European Union countries? I am thinking especially of Spain where a number of people now go to receive fertility treatment. Are we thinking of ways of dovetailing our laws with theirs, because in Spain, for instance, anonymity pertains for donors, unlike in the United Kingdom?
As well as looking at overall compliance within the European Union, can the noble Baroness say a word about the long-term effects on donor-conceived children? That issue was raised by the noble Baroness, Lady Howarth of Breckland, a few moments ago and in our earlier debates. Do the Government intend to keep it under review as the years proceed? On Report, the noble Lord, Lord Jenkin of Roding, made an attempt for us regularly to return to this question. If that cannot be done in statute, can the Government at least provide an assurance that we will keep this under review?
Baroness Royall of Blaisdon: My Lords, the notion of the noble Baroness, Lady Howarth, on making materials available for families is very good. Of course adoption and donor conception are very different, but we can learn from what we have done in the sphere of adoption. We will certainly take that on board. I note the point made by the noble and learned Lord, Lord Mackay, but our intention is that all children have a right to know whether they were donor conceived. The difference between us is on the way that this is done, but it is our intention to ensure that all children are availed of that right.
On the question on other EU countries, it is important that we work to ensure that our systems in this country are as like those of other European Countries as is possible, so that people can travel freely and widely, and because there are so many couples. One partner may come from France and another from Greece; another partner might come from the UK and another from Denmark. So we have to take into consideration what is happening in other European Countries.
The long-term effects on donor-conceived children are of course of the utmost importance and we will certainly keep this issue under review.
On Question, amendment agreed to.
Baroness Royall of Blaisdon moved Amendment No. 8:
(a) the giving of a suitable opportunity to receive proper counselling, and(b) the provision of such relevant information as is proper,in accordance with any condition that is by virtue of section 13(6) or (6A) a condition of a licence under paragraph 1 of Schedule 2.””On Question, amendment agreed to.
Clause 24 [Register of information]:
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Baroness Royall of Blaisdon moved Amendment No. 9:
The noble Baroness said: My Lords, I shall speak also to the other government amendments grouped with it. These amendments have become apparent only since Report stage and correct minor drafting points.
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