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Lord Greaves: My Lords, I, too, thank the Minister for introducing the regulations. Like the noble Baroness, Lady Byford, I believe that it is reasonable that we widen the discussion slightly from the rather modest regulations that are before us.

The regulations are modest. The Explanatory Memorandum states that the objectives are,

It also states that the regulations are,

    "not expected to have any financial implications, either to the public, to industry, to local authorities or to central Government".

I believe that the Minister quoted the exact wording, which suggested that,

    "virtually the whole of England will achieve the new objectives on the basis of existing policies".

Therefore, in a sense, these new regulations, and the targets within them, follow existing trends rather than set new ones. On that basis, I consider them to be modest.

However, we meet today in your Lordships' House on the 50th anniversary of the infamous great smog of London in which it is estimated that between 4,000 and 12,000 people died. I am pleased to say that I did not live in London in those days, but I did live in the Yorkshire coalfield, where smog was as prevalent as it was in London—perhaps for different, or partly the same, reasons. Those of us who remember the smogs of those days find it difficult to explain to people who are too young to remember them just how awful they were. They were dreadful, and it is one of the great triumphs of legislation, through the Clean Air Acts and so on, that we no longer have to suffer them.

However, it has now emerged that when, in 1952, the government of the day—a Conservative government but that does not matter; any government would have done the same—had to deal with the problem, they pretended that the cause of the large number of deaths and of the large number of people suffering serious illness without dying was an influenza epidemic. In today's Evening Standard, Professor Devra Davis, a

5 Dec 2002 : Column 1309

visiting professor at the London School of Hygiene and Tropical Medicine, claims that it was a cover-up. She said:

    "By the end of February"—

that is, in 1952—

    "around 12,000 people had died unexpectedly, yet there was no evidence that one-third of people in London at that time had influenza".

I suppose that that is the way that governments behave. But, fairly soon after that outbreak, it was realised that the whole country—the government and society—had been in denial about what was happening to people's health as a result of what, at the time, was blamed on the weather but what was, in fact, atmospheric pollution.

In a report called The Clean Air Revolution: 1952–2052, which is being published today and is available in this building, the National Society for Clean Air suggests that this country is in denial yet again. It suggests that deaths from lung cancer, for example, caused by air pollution number approximately 4,000 a year. That is more than the average number of 3,500 deaths which occur through road accidents. Official estimates suggest that 24,000 people a year die due to peak air pollution episodes.

According to that report, there is new evidence that long-term exposure to everyday levels of pollution may increase heart disease. Those of us with family members who suffer from asthma, as does my daughter, know how difficult that condition is. Again, the increase in the prevalence of asthma is being widely related to increased atmospheric pollution, particularly from road transport.

I mention those matters because, although the provision before us today is modest, increasingly it appears to be the case that the Environment Act 1995 and the air pollution strategy which the Government published two years ago are proving, and will prove, to be inadequate. We shall have to face such issues in a far more fundamental way than has been the case so far. Having said that, we on these Benches are content with the modest measure which the noble Baroness has put before the House.

Baroness Farrington of Ribbleton: My Lords, I thank both the noble Baroness, Lady Byford, and the noble Lord, Lord Greaves. I shall begin with the final points raised by the noble Lord. Estimating the number of deaths caused by air pollution is a very complex and difficult task. However, we understand the problem better today than we did 50 years ago. We agree that further work is needed to quantify the precise number of deaths caused by air pollution and the key factors which contribute to it.

In this response to both the noble Baroness and the noble Lord, we recognise that targets reflect what we know can be achieved. The point that is being made is that they are not sufficiently ambitious. However, we have to strike a balance between environmental, economic and social objectives. Tightening the regulations will help but the targets must also be achievable.

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The noble Baroness also raised the issue of research into the effects of traffic-calming measures. The Department for Transport has a major research programme, known as TRAMAQ, which concerns traffic management and air quality. It is examining the effects on air quality of all traffic-calming measures. I am sure that the noble Baroness will be pleased to hear that. We are adopting the new measuring method because benzene has long-term health effects and it is sensible to measure its levels over a complete year. That is directly in line with the European directive. I shall return to that point in a moment.

The noble Lord, Lord Greaves, raised the question of the impact on local authorities. We support running costs in the calculation for RSG, and additional borrowing powers towards capital costs are available through the supplementary credit approval programme. Since 1997, 21 million has been awarded.

The noble Baroness, Lady Byford, explained that under the Conservatives the targets were tighter. We examined that issue and the targets that had been set. Our modelling shows that it would be impossible to meet the original target set by the Conservative government in relation to particles even if all the cars in London were switched off and not running. Therefore, we have had to balance the knowledge available. That is not a criticism of the noble Baroness's government. The benefit of the new modelling and targeting proposals is that they show that it is difficult to set targets unless one considers whether it is possible to achieve them.

The noble Lord, Lord Greaves, made the allegation that air pollution is worsening. In fact, it is improving. We accept that there has been a substantial fall in the level of bad air quality. We want to continue to tackle that issue. For example, ozone levels are strongly affected by pollutants blown over from mainland Europe, and we are working at a European level to tackle that problem.

The new objectives do not include polycyclic aromatic hydrocarbons. In answer to the noble Baroness, monitoring data are strictly limited. We have added a further 15 monitoring sites to the national network. We now have 25 and hope to develop more. We need to make separate regulations to transpose the EU directive. That will require the Secretary of State to meet the limit values. The Air Quality Limit Values Amendment Regulations are expected to be laid for negative resolution later this month. We cannot use the draft regulations before us today to transpose EU limit values. Local authorities do not possess all the powers that are needed to meet that. We believe that our targets are challenging. Aviation is included. Central government and local authorities both consider emissions from airports and aircraft, and many airports are developing air control strategies.

I hope that I have covered all the points raised by noble Lords. If I have missed any, I shall write to them.

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In conclusion, I am conscious that today is Plain English Campaign Day, but I defy even that organisation to deal with this subject without straying from what most people view as plain English. I thank the noble Baroness and the noble Lord.

On Question, Motion agreed to.

Stem Cell Research: Select Committee Report

4.50 p.m.

The Lord Bishop of Oxford rose to move, That this House takes note of the report of the Select Committee on Stem Cell Research (HL Paper 83, Session 2001–02).

The right reverend Prelate said: My Lords, it has been an immense privilege and responsibility to chair the Select Committee set up by your Lordships. The issues, at once scientific, legal, ethical, philosophical and theological, have been testing .

I want to thank members of the committee for the seriousness with which they approached the task and the variety of experience, gifts, and perspectives that they brought to it. In particular, I thank our clerk, Tony Rawsthorne and his team and our scientific and legal advisers, Professor Chris Higgins and Professor Roger Brownsword.

Above all, we were conscious of two overriding issues: first, the relative potential of stem cells derived from adults compared with those taken from the early embryo; and, secondly, the moral status of the early embryo—that is the multiplying cells of the fertilised egg to the first signs of a nervous system or primitive streak at about 14 days.

In relation to the first question, your Lordships will appreciate that this is a very fast-moving field. A great deal of research was reported from the time that we were set up in March 2001 until the time that we reported in February 2002. Since then, further interesting and important papers have been published. Some of that research has suggested that adult stem cells hold out the best promise for therapy. Others have pointed out the questions and difficulties that still remain with work done on adult stem cells and argue that for certain forms of therapy embryonic stem cells are likely to prove necessary. Those are highly technical, complex matters in, as I say, a fast-moving field.

However, even as non-specialists, albeit ones who tried hard to get on top of the basic scientific principles involved, we were able to make the following judgments. First, at this stage it is not possible to predict whether therapies using adult stem cells or embryonic stem cells will prove more effective. Any form of therapy using stem cells is still many years away—estimates vary as to how many years. It could be that adult stem cells will prove more effective for some conditions, and embryonic cells for others. At this stage it is simply not possible for anyone to know,

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not even those at the forefront of research. Given that, it would certainly be wrong, on scientific grounds, to close off one or other of those promising lines of research.

That is the judgment of highly distinguished scientists whose work is exclusively with adult stem cells; for example, Professor Helen Blau, the director of the Baxter Laboratory for Genetic Pharmacology at Stanford University in the United States, wrote to the committee to say,

    "The work in my laboratory is entirely focused on adult stem cells".

She went on to indicate some of the successes that she has had, stating:

    "At this point in time it is impossible to say which type of cell, ES or adult stem cell, will prove more useful in treating a given disease. One may be preferable in some cases whereas the other may be preferable in other cases. Time will tell. Thus, research on both should be encouraged and facilitated".

I emphasise that that comes from a director of a laboratory that is focused entirely on adult stem cells.

We certainly believed, and therefore recommended, that both funding bodies and the Government should support work on adult stem cells. Paragraph 3.22(c) says:

    "recent research on adult stem cells, including stem cells from the placenta and umbilical cord, also holds promise of therapies; and research on them should be strongly encouraged by funding bodies and the Government".

In the light of that recommendation, it is difficult to see what force there is in the criticism that we may have ignored this promising area.

Secondly, in order that such therapies may be developed a great deal of fundamental research still remains to be done. Here we became convinced that such research needs to be done on embryonic stem cells as well as adult ones. That is because embryonic stem cells—those taken from the blastocyst after four or five days—are pluripotent; that is, they are capable of developing or differentiating into any one of the specialised cells that make up the human body. As such they provide a benchmark with which to measure what adult stem cells are or are not capable of.

For a similar reason we concluded that some research on cell nuclear replacement—misleadingly called therapeutic cloning—is likely to prove necessary, as in this scientific procedure a specialist cell from an adult is, as it were, fused with an egg and in the process becomes de-differentiated; that is, it ceases to be a specialist cell and becomes a stem cell. As therapies in the future, or at least some of them, could be based on the ability of cells not only to regenerate but to de-differentiate and then differentiate into other kinds of specialist cell, research in this area, simply trying to find out what is happening and why, certainly looks necessary.

I say "looks necessary" because as your Lordships know we have the Human Fertilisation and Embryology Authority (HFEA) which will license work on embryos only if it is convinced that such research is strictly necessary and that the desired research results cannot be obtained in other ways. It was clear to the committee that the HFEA has a very

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high reputation internationally and we are certainly fortunate in this country in having such a regulatory body. It ensures that where embryos are concerned, only research that is necessary is carried out.

However, the considered judgment of your Lordships' Select Committee is that if the benefit of therapy is to be realised, whether using embryonic stem cells or adult stem cells, much fundamental research remains to be done and research on embryonic stem cells will play a key role in that, not least in realising the potential of adult stem cells. That is the judgment of those whose work is exclusively with adult stem cells, who have, we might say, a vested interest in such work, but who recognise that research work on both kinds of stem cell is absolutely essential.

Since we produced our report there has been a much publicised paper from Professor Verfaillie's laboratory in Minnesota. That laboratory identified a class of adult stem cell which can differentiate into a variety of adult cell types when transplanted into a host mouse. That is clearly a promising line of research, although there are many unanswered questions as well as different ways of interpreting the evidence, as spelt out by Professor Verfaillie herself. Furthermore, in her televised interview at a science museum debate, Professor Verfaillie said that, following her findings, the first thing she needed to do was to hire an expert in embryonic stem cells if the potential of those particular adult cells was ever going to be understood and realised. The next stage was further research using ES cells.

The second overriding question that we considered is that of the moral status of the early embryo. The committee fully respects the position of those who believe that from the moment of conception the dividing, multiplying cells of the early embryos should be accorded the rights of a human person. We state the arguments against that position and the moral case for research in the following words: first, in Chapter 4.10,

    "the fact that a person has the potential to qualify as a member of some class in the future, if certain conditions are met, does not confer the rights that belong to members of that class of being until those conditions are met. A medical student is a potential physician, and if he or she qualifies may practise as such; but the potentiality alone does not confer a right to practise".

Secondly, in Chapter 4.16 and 4.17, we state:

    "Burden of proof arguments are notoriously hard to resolve. If there were no morally serious issues for undertaking research on human embryos, then the mere possibility that the early embryo is a person would be sufficient reason not to do such research. However, if there are morally weighty reasons for doing such research a decision must be reached on the basis of arguments that fall short of proof.

    There are morally weighty reasons for doing research that may lead to therapies for many serious and common diseases, and the concept of respect for persons can also be invoked on this side of the argument".

Recognising that people give different weight to those ethical arguments in their personal lives, we concluded nevertheless that it would be wrong for us, as legislators, to put a stop to all research on embryos at this stage. Ever since the report of the noble Baroness, Lady Warnock, and the 1990 legislation,

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this issue has been extensively discussed, legislated for, and voted on, so we concluded that section in these words:

    "Whilst respecting the deeply held views of those who regard any research involving the destruction of a human embryo as wrong and having weighed the ethical arguments carefully, the Committee is not persuaded, especially in the context of the current law and social attitudes, that all research on early human embryos should be prohibited".

There is an appendix in the report which shows why it is possible for there to be two readings of the long Christian tradition on the status of the embryo. I shall not repeat what is said there, but I believe that what it sets out is fair to both sides of the argument.

There are of course a number of other important considerations and recommendations in our report, such as the international dimension of what is happening in other countries, as well as reflections on our own law. Then there is the commercial element. I hope that others of your Lordships, including members of the Select Committee, will comment on some of these. We also make a number of specific resolutions on which your Lordships may wish to comment. The Government have of course made their own response and I was glad to read that it was so positive, but I think it might be more appropriate if I comment on particular points, fairly briefly, at the end of the debate when I have had an opportunity to hear what the Minister might have to say.

Finally, I remind your Lordships that you set up this committee to reflect in greater detail and depth on the regulations that were passed by this House on 22nd January 2001. For the reasons we have set out in our report, we believe that your Lordships were right to pass those regulations. This is an important area of research that holds out real promise, in the long run, for people suffering from a whole range of serious diseases. While people are right to raise ethical questions, we believe that the law as we have it, together with the regulatory framework that we have in place, provides the necessary safeguards. I beg to move.

Moved, That this House takes note of the report of the Select Committee on Stem Cell Research (HL Paper 83, Session 2001–02).—(The Lord Bishop of Oxford.)

5.2 p.m.

Lord Turnberg: My Lords, the House owes a great debt of gratitude to the right reverend Prelate the Bishop of Oxford and his colleagues on an extremely impressive and important report. They have painstakingly sifted through the scientific evidence about embryonic stem cell research, of which there is a great deal, and have weighed the ethical and legal arguments with great wisdom. I do not believe that there could be a more authoritative report on such a difficult issue than this one. The Government have wisely recognised that in their response.

I took the opportunity of re-reading our debate of almost two years ago, as I am sure many noble Lords did. It is difficult to imagine what new points there can be to make after the eight or more hours of debate that

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we had on the subject. It is difficult to imagine a better informed body of men and women than your Lordships on this complex subject, in light of that debate and now this report. I shall limit my remarks to one or two points.

On that occasion I spoke in favour of the changes in the regulations that would allow this type of research to be pursued, so I am naturally very pleased with the conclusions of the committee's report. I have to express an interest as scientific adviser to the Association of Medical Research Charities, whose member charities were eagerly awaiting this report and who now feel overjoyed. It is no exaggeration to say that they are extremely pleased that this potentially valuable avenue of research has not been closed off.

Of course, they and the patients and carers who support them know as much as anyone that cures for the diseases that they are concerned about are not just around the corner. They know from bitter experience that miracle cures, promised regularly in the press, are all too often empty promises. However, stem cell research has exciting potential and offers them hope—not for today or even perhaps for tomorrow, but for some time in the future. It is hope not necessarily for them, but for future sufferers. Hope sustains many of them.

It is worth looking at what has happened in the past couple of years, since our debate. It is clear that, while there are many welcome advances in the adult stem cell field, these have not yet obviated the need for embryonic stem cell research, despite efforts to say otherwise. As Professor Verfaillie herself has said, we still need both types of research. They are complementary.

There has been some hopeful research in the background sciences. For example, a recent report in June in Nature from the National Institutes of Health in Bethesda said that animal experiments reported of a cure of an animal model of Parkinson's disease in rats, using rat embryonic stem cells. Of course, much more research is needed in animals and in man, but that is a small step in a very encouraging direction. The field is moving forward on several fronts, as it should be.

The right reverend Prelate has outlined well many aspects of the report and I am sure that other noble Lords will discuss them. I finish by reiterating my welcome for the committee's confirmation that reproductive cloning is to be banned—no one would deny that—but that embryonic stem cell research should be allowed to continue under the strict regulations laid out in the report and under the control of the Human Fertilisation and Embryology Authority, which has served us so well. I am gratified by the Government's ready acceptance of it.

5.6 p.m.

Baroness Platt of Writtle: My Lords, this was one of the most challenging subjects placed before a committee of the House. It is a complex subject in terms of scientific background. Stem cell research has the potential in the long term to relieve the most

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painful and distressing symptoms suffered by many victims of Parkinson's disease, other neural diseases, spinal cord injury and liver and pancreatic diseases.

At the same time, the research necessitates the need for the use of embryonic stem cells as well as adult stem cells—as the first two speakers have mentioned—and those produced also by the placenta and the umbilical cord. That raises difficult ethical questions with which we literally struggled during the year that we were given to produce our report.

After all our hard work, it is encouraging that the Government's reaction is generally favourable to our recommendations. During the year, we had representations from many people with differing views, including those of differing faiths, which was of great assistance. The passing of the Act prohibiting human reproductive cloning and making it a criminal offence in 2001 was a very important safeguard against any slippery slope argument.

There was no doubt in our minds that human cloning is a very dangerous scientific experiment that could result in unacceptable human abnormalities. It should not be allowed to happen. We hope the Government will be successful in supporting a United Nations international ban on human reproductive cloning as soon as possible.

The inquiry did not come in at the start of embryonic research. The legislation permitting abortion has been in place for over 30 years. As we say, it would be difficult to justify an absolute prohibition on the destruction of early embryos while permitting abortion in a wide range of circumstances post-implantation and well after the emergence of the primitive streak.

Later, the 1990 Act was enacted after the Warnock committee inquiries in the 1980s and subsequent lengthy public and parliamentary debate. That allowed research on early embryos up to 14 days after fertilisation to promote not only treatment of infertility and to increase knowledge of congenital disease and the causes of miscarriages, but also to develop more effective techniques for contraception. Its very strict rules are published at the beginning of the book of evidence. I hold up the book of evidence so that noble Lords can see what we had to listen to and read. The Human Fertilisation (Research Purposes) Regulations 2001 added to them, increasing knowledge about the development of embryos and increasing knowledge about serious disease and enabling any such knowledge to be applied in developing treatments for serious disease—the reason for the committee's report.

We considered in depth, taking into account the evidence we had received from many witnesses, the respect to be given to the human embryo from the beginning, including the experience built up from the passing of the above two provisions. We took evidence from the Human Fertilisation and Embryology Authority under the excellent chairmanship of Ruth Deech, and learned of its strictness in the application of the 1990 regulations, of which we wholly approved, and which we believe

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should continue in the future in applying the new regulations. In that light we have adhered to the original 14-day limit for research on an earlier embryo when it is still in fact smaller than a pinhead and before the development of a nervous system.

In carrying out the enforcement of the 1990 Act, the HFEA in applying the regulations strictly has allowed the creation only of 118 embryos for research during the ensuing decade. We believe the strict regulations should continue, particularly as we were advised of the existence of 53,497 spare embryos in March 1999. We made a very strict recommendation, perhaps the most important recommendation in our report:

    "That embryos should not be created specifically for research purposes unless there is a demonstrable and exceptional need which cannot be met by the use of surplus embryos".

We are glad that the Government in their response have underlined the need for that strictness.

If these surplus embryos are not implanted, they will eventually be destroyed. However, even so they must not be used without the informed consent of those donating the embryos, having been given relevant information on the possible research and time to consider it. Once again, that process has been strictly regulated by HFEA for over 10 years. It has also made clear that no payment can be made for donation and that the clinical and research roles are separated.

Clearly, the coming years will show successful development in the treatment of disease using both embryo and adult stem cells. However, evidence was given to us that the pluripotence of embryo stem cells will contribute through careful research to the successful treatment of disease by both types of cell. We also hope that more research will continue into the application of stem cells from the placenta and umbilical cord. At present they are discarded, but they contain the relevant cells for the baby, and may perhaps in the future be preserved for use in their future lives.

We recommend that the Government should, towards the end of the decade, undertake a review of scientific developments and particularly of the progress of adult stem cell research to see if research on human embryos is still necessary, with which the Government have agreed. That is another important safeguard. We are pleased too that the Government have agreed to ensure that the HFEA has sufficient resources to carry out its important work.

Clearly, the results of this research need to be available in the future for therapy of serious diseases, such as Parkinson's disease, with their distressing symptoms. However, it will be necessary for the proper and strict control of the purity, provenance and monitoring of their use. We recommended that a condition of granting a licence that the HFEA should require that any ES cell line generated in the UK in the course of the research should be deposited in a national stem cell bank overseen by a steering committee.

It is good that the research councils have indicated their intention to make the banking of cells a requirement in any award for research. The

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Government in their response added that in pursuance of their statutory duty to satisfy themselves of the necessity for research the HFEA should also take into account the suitability of existing ES cell lines already banked before granting a licence.

The UK has established an international reputation for the strictness of the HFEA over the past decade, which also includes ethical approval by local research ethics committees. We all hope and pray that over the years stem cells will enable therapies to be developed for serious and distressing diseases.

However, HFEA strictness is essential. The Government's response underlines the necessity for stringency in the HFEA when carrying out its statutory duties. As we say on page 36 of our report,

    "a number of scientific witnesses argued strongly that reputable scientists do not look for a research environment with minimum regulation, but want an effective regulatory regime which sets out clearly what is and what is not permitted, so that they know where they stand both scientifically and ethically; and that is why the regulatory environment in the United Kingdom is attractive to researchers".

It is on that reputation that our report is built, and it must continue; on that basis our time and effort, we hope, will not have been wasted.

5.17 p.m.

Lord Dahrendorf: My Lords, I rise with great diffidence and after agonising whether I should speak at all. I am, in a sense, the first victim of the Statement on the Local Government Financial Settlement, having to make an inevitable trip and having delayed it so that I can take part in the entire debate today. If the House is prepared to listen to me despite the fact that I cannot stay for the Minister's response, I should like to begin by associating myself with the noble Baroness, Lady Platt of Writtle. She, if I may remind the House, was one of seven noble Baronesses on the committee. If it is not improper to say so, the remaining men were put to shame by the style in which the majority of the committee conducted our debates.

I mention the remaining men because while we were sitting Lord Carnarvon met an untimely death. I am sure that many noble Lords remember him with great affection. He would have made further contributions to the work of the committee.

The commitment, the deep understanding of issues, the fairness and the openness of discussion which we experienced were the result of the membership of the committee and of its eminent chairman, the right reverend Prelate.

In the debate preceding the setting up of the committee, I was one of those sitting on the fence. I was genuinely not clear which way I would come down on this question of embryo stem cell research. Indeed, I am often trying to work out moral issues; I do not have the certainties that enable some to be clear about answers even before they undertake further inquiry. However, at the end of our work, I firmly support the report.

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There are four reasons why I changed my mind to move to one side of the fence. The first is, in a sense, scientific. It has to do with the status of the "early embryo", as we called it.

In passing, I may say that one problem in this whole area is that even the terminology is in some ways polemical. The right reverend Prelate mentioned the expression "therapeutic cloning", which is really cell nuclear replacement, but which, by including the word "cloning" suggests that something is happening that bears a distinct similarity to the cloning of human beings, which we all want banned.

The term "early embryo" is also in some ways misleading, because the cells that define the early embryo before implantation cannot by themselves develop into a human being. Implantation in the womb is essential for the development of those cells into a human being. To me, as an amateur in the matter, that is an important scientific fact—even apart from the moral and, indeed, anthropological facts that the noble Baroness, Lady O'Neill, adduced in our discussions, and to which she may return today.

The second reason why I changed my mind was practical. I was struck by the fact that the scientists whom we met were not excessively enthusiastic about research on embryos. Indeed, they were all looking for other ways to conduct the fundamental research that needs to be done and extremely interested and intrigued by the possibilities of adult stem cell research. I support that, and so did the committee, but adult stem cell research, which is so strongly praised by those who are highly sceptical about early embryo research, is a peculiar process. It involves the dedifferentiation of adult stem cells to a point at which they have many of the qualities of embryonic stem cells.

As an amateur, and without wanting to take the point too far, at times I wondered whether, at the end of that road, we may not reach a point at which dedifferentiated adult stem cells have precisely the qualities of pluripotent and, ultimately, totipotent embryos. That would raise a peculiar issue about artificially producing human beings. In other words, I felt that the scientists' attitude was welcome, but raised and left open questions that some opponents of such research must answer if they really want to use adult stem cells as a substitute.

However, let me not stray too far from areas in which I can claim some competence and come to my third point. Obviously, we were all impressed by the moral dilemma between research on early embryos and the possibility of finding cures for terrible, disabling diseases. It is regrettable that some scientists these days have adopted the celebrity culture and announce prospects of success long before they are real—a harmful habit that, I hope, will be countered by others who see the difficulties. There is a moral dilemma and, at the end of the day, my decision was in favour of the potential for cure.

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There is fourthly the need to control research projects and what research is allowed. The noble Baroness, Lady Platt, has said everything that I would want to say on the subject. I wholly support her view that that must be done in a competent, impartial, thorough and, above all, stringent manner. I hope that recent doubts cast on some actions of the HFEA can be either dispelled or corrected, so that we end up with an agency that we can trust.

That leads me to a final point, which concerns cloning and the international scene. In many continental countries, British practice in the area is regarded as especially liberal—indeed, more. One German newspaper recently described the United Kingdom as a "clone Eldorado" and lumped it together with Singapore and China. That is simply incorrect. The argument rests on a total misunderstanding of the practice of licensing research that we advocate and is in force in this country. On the contrary, we avoid the German hypocrisy of allowing research on imported stem cell lines but banning those produced at home. We also avoid the American hypocrisy of demanding a total worldwide ban while not legislating at all on what happens in United States laboratories.

Admittedly, the international scene is confusing. At one end are the cloners. Severino Antinori in Italy does not declare where he is undertaking his work, and the Canadian, Brigitte Boisselier, works in Las Vegas in the United States. Both claim that the first human clones will be born within weeks. I am not sure that those claims are well founded, but I fear that, one day, something of that kind will happen. I hope that your Lordships will not regard it as cynical when I say that it is probably only when it happens—it is bound to go wrong in significant ways—that many will wake up to the need to find international ways to ban the cloning of human beings.

However, Britain is far from that end of the spectrum, and from the position of countries that promote controlled but unrestricted research on embryos as a matter of public policy. China is one example of that; another is Singapore, which has gone out of its way to create something called Biopolis, a huge research centre, which, I understand, has now attracted one of the "inventors" of Dolly the sheep, Professor Alan Coleman. It has gone out of its way to try to attract scientists from all over the place.

There are those who offer the opportunity of unrestricted research. There are those who want to ban all research. The report steers a kind of middle course for Britain. Although I do not normally advocate a third way, in this case the middle course is appropriate, and I therefore support the Motion.

5.30 p.m.

Lord Alton of Liverpool: My Lords, my concerns about the Select Committee's report fall broadly into four categories: procedural, ethical, scientific and regulatory. I understand the points that the noble Lord, Lord Dahrendorf, just made, and I know that he has agonised about the issues. However, the dilemma

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that he faced, when we debated the questions in 2001, was the dilemma of the whole House. The noble Lord had to vote in favour—as he did—of therapeutic cloning at the end of that debate because the Select Committee that we established was a retrospective Select Committee. Even if he had wanted to continue agonising, he was required to cast his vote before your Lordships were able even to consider the matters.

Your Lordships may recall that, during our debate, I moved an amendment asking for a Select Committee to consider the questions before we proceeded. I said that our situation was like that of a court being asked to give out,

    "the verdict and sentence, before hearing the defence, the prosecution and the witnesses".—[Official Report, 22/1/01; col. 23.]

During the debate, my noble friend Lady Warnock said:

    "We have been bullied and pushed to do things more quickly than we should".

She also said that people who feared the developments in embryology should be,

    "given some hope that their fears may be listened to".—[Official Report, 22/1/01; col. 45.]

The failure to appoint to the Select Committee anyone who spoke in the debate against reproductive and therapeutic human cloning was unlikely to strengthen the impression that anyone was listening. All 26 witnesses who were called to appear before the committee to give evidence from a scientific or medical perspective were from the pro-embryo research lobby. Notwithstanding what the right reverend Prelate the Bishop of Oxford said today, no scientists were specifically called to submit oral evidence from an exclusively adult stem cell perspective. The importance of evidence on adult stem cells from, for instance, Professor David Prentice, whom I asked to travel here from the United States, where he is a senior scientific adviser to Congress, is not even referred to in the report. The right reverend Prelate asked for force to be given to that criticism.

The cursory way in which adult stem cell technology was investigated was brought home to me by a question put by a member of the Select Committee at the final public hearing:

    "Are you saying that it is possible, certainly as you understand it, to understand the process whereby an adult stem cell, which, as I understand, it is not yet possible to isolate, can be used but not in isolation?"

Not only can adult stem cells be isolated, but they can offer greater potential than embryonic stem cells. During the same hearing, Professor Prentice warned of the dangers to public health of using embryonic stem cells.

I remain profoundly concerned about the effect on society when we treat nascent human life as a natural resource to be mined, exploited and commodified. The Department of Heath recently confirmed to me—I am grateful to the Minister—that, since the passage of the Human Fertilisation and Embryology Act 1990, over 900,000 human embryos had been created through in vitro fertilisation. Almost 300,000 embryos remained unused and were therefore destroyed. A mere 4 per

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cent of nearly a million human embryos have seen the light of day. I repeat: a mere 4 per cent of nearly a million human embryos created since 1990 have seen the light of day. Where is the special status that my noble friend Lady Warnock talked about in her report and which Parliament is supposed to have accorded the human embryo? We trade in human embryos, we manipulate them, we experiment upon them and we destroy them. They have no special status worth talking about.

An article in Nature magazine on 4th July 2002 underlined how much we knew about our earliest moments of life. I support the remarks that have already been made in your Lordships' House about how fast-moving the science is. We now know much more than we knew then. The article, entitled "Your Destiny from Day One"—not from day 14—states:

    "Your world was shaped in the first 24 hours after conception. Where your head and feet would sprout, and which side would form your back and which your belly, were being defined in the minutes and hours after sperm and egg united".

The embryologist Alan Handyside also warns that meddling with early human embryos might carry serious adverse consequences:

    "It's possible you could be removing a cell with a predictable fate and causing damage".

Even if we do not accept the inviolability and sacredness of human life from conception—I am disappointed that the report fails to mention the unanimous submission of a group of eminent theologians from all Christian traditions—the precautionary principle surely requires us to err on the side of caution wherever there may be any doubt. We are not potential human beings; we are human beings with potential. The right reverend Prelate gave the example of the medical student who could fulfil his or her potential by one day becoming a doctor. If we terminate that life, he or she will never fulfil that potential. We are always on a gradient, from the moment of conception until our natural death.

In our debate in January 2001, the right reverend Prelate said (at col. 37) that embryo

    "research should only be done . . . if it is truly necessary and that research cannot be done any other way".

There is now no doubt that the research can be done in another way, either using adult stem cells or embryonic stem cells from non-human primates. Everyone in Parliament wants therapies that alleviate illness. There is no disagreement between us about that. However, it is dishonest to suggest that the only way to make progress is by the creation and destruction of countless human embryos. Should we not, at least, ask what progress has thus far been achieved at the expense of one million human embryos, before we permit the destruction of more?

An editorial in New Scientist—not a religious voice—had this to say just a few months ago:

    "Like stuck records, Ministers and policy makers continue to enthuse about therapeutic cloning even though the majority of bench scientists no longer think it's possible or practicable to treat patients with cells derived from cloned embryos. They have already moved on to investigating the alternatives".

In its editorial, Nature said:

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    "The idea of 'therapeutic cloning' seems to be on the wane...most now believe that it will be too expensive and cumbersome for regular clinical use".

The conclusions in the Select Committee's report are based upon outdated research that has been superseded by research conducted since 1999 and demonstrates profound levels of healing using adult stem cells.

I must also refer to the regulatory issues that were touched on by the right reverend Prelate and others in the debate and are raised in the report. The committee and, today, the right reverend Prelate expressed confidence in the work of the Human Fertilisation and Embryology Authority. He said that it is held in high international esteem. However, the regulation of embryonic stem cell research has been entrusted to an organisation in disarray. In July, the House of Commons Science and Technology Committee was highly critical of the HFEA:

    "The Lords Stem Cell Research Committee reported that the HFEA is 'highly regarded, both at home and abroad . . . [and] has the full confidence of the scientific and medical research community'"—

the very things that we have been told in our House today. It said:

    "We are unclear on what evidence it based this assertion".

And so am I. The recent mix-up scandals at IVF clinics; the contemptuous issuing of a licence authorising embryonic stem cell research in 1997, four years in advance of parliamentary approval; this week's revelations regarding Professor Ian Craft's egg trading arrangements, in flagrant disregard of Section 12 of the 1990 Act; the suffering that that has caused women; and the shocking disclosures from the embryologist, Dr Sammy Lee, in the Sunday Telegraph on 10th November, demonstrate that the criticisms of the Science and Technology Committee are not unfounded. Indeed, they reflect a general concern that is widespread in the country today. I am surprised that that is not reflected in the report before us.

Dr Lee wrote that he knew of at least six cases where the wrong embryos were put into women. He maintains that it is,

    "galling that the HFEA has sought to brush aside any meaningful discussion of why mistakes occur in IVF clinics, and how frequently".

Yet the Government continue to insist that the HFEA has their full confidence and that they have no plans to conduct an inquiry into its work. In a reply to me earlier today, they say that they are simply going to double the money they give to the HFEA to 5.5 million. Surely, that is something that the Public Accounts Committee should examine.

Also consider for a moment our international isolation on these matters. The noble Lord, Lord Dahrendorf, talked about a "cloning Eldorado". The noble Baroness, Lady Platt of Writtle, mentioned her hope that there would be international action to end reproductive cloning. On that issue we would be in total agreement.

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It is all very well asking other countries to support us, but we have obligations too. Article 18 of the European Convention on Human Rights and Biomedicine, which the Government have still not signed, prohibits the creation of embryos for research purposes. At the end of last month, the European Parliament voted for a total ban on reproductive and embryonic cloning. In the US, there is a four-year moratorium on cloning for biomedical research. I agree with the noble Lord, Lord Dahrendorf, that that is insufficient and proper regulations should be passed by Congress as well. In Germany, destructive embryo research is prohibited. In France, President Chirac is opposed.

In other words, it is perfectly possible and reasonable to reach conclusions different from those of the Select Committee, and many of our international partners have done so. Here, at the behest of the pharmaceutical and bio-tec industry, the United Kingdom has compromised its high standing in the international community.

To conclude, I have outlined my disquiet about the genesis of the Select Committee and its attitude towards the ethical, scientific and regulatory issues that are at stake. Adult stem cell research is a viable scientific alternative and has clearly overtaken research using human embryos. It is simply not true to say that we need to do both. While I admire many of the individual noble Lords and Baronesses who have served on the committee, I do not believe that this is a good report. I believe that it is deeply flawed and I fear that it will not stand the test of time.

5.41 p.m.

Lord Tombs: My Lords, the debate which led to the setting up of the Select Committee lasted for almost seven hours and attracted a large number of speakers. Those speakers can be divided into three groups—those supporting the government Motion without reservation, those supporting it with reservations, and those opposing it.

In the first group—those supporting the Motion without reservation—there were 14 speakers, two of whom were later appointed members of the Select Committee. In the second group—those supporting the Motion with reservations—there were 11 speakers, two of whom were later appointed members of the Select Committee, and one of them chairman. In the third group—those opposing the Motion—there were 13 speakers, none of whom was appointed to the Select Committee.

Therefore, of the eventual membership of the Select Committee—11 in all—four were appointed from those supporting the Motion, and none from those opposing it. I believe that the Committee of Selection, perhaps unknowingly, served the House badly in that regard. The respect which Select Committees of this House enjoy widely is based on the belief that they are fully independent of the issues being considered. That is a valuable asset which must be jealously and conscientiously guarded.

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However, when we turn to the declaration of interests by committee members, the situation worsens. Of the 11 members, nine declared interests—past or present—in academic fields, medical charities or the pharmaceutical industry, which could lead them to favour unfettered medical research. Of course, such a background does not preclude examination of the ethical dimension, but it suggests sympathies and peer pressures that make an independent appraisal more difficult.

In those circumstances, I have sympathy with the members of the committee. They were placed in a situation where their natural sympathies lay with unfettered medical research and were not exposed to the challenging discussions which would normally take place in a Select Committee.

So it was no surprise, to me at least, that the conclusions of the Select Committee supported the policy of the Government. It was no surprise, but it was a great disappointment because it meant that an historic opportunity to introduce an ethical dimension into this medical research policy was missed. Instead, on this subject at least, the unenviable position of the United Kingdom as one of the most ethically indifferent of western nations was confirmed.

The Select Committee concluded that the embryo enjoyed special but not absolute rights—a view, incidentally, not shared by many church leaders and theologians. But it also concluded that research on human embryos could be ethically justified only if there was no alternative. Here the alternative route of adult stem research is crucial. We owe a great debt to my noble friend Lord Alton for using his appearance before the Select Committee to introduce scientific evidence on the immense developments in that field. I am sorry to say that the Select Committee failed to recognise the importance of that evidence.

But, perhaps because of that, Recommendation (xix) of the report suggests that,

    "At an appropriate time, perhaps towards the end of the decade, the Government should undertake a further review of scientific developments, particularly of the progress of adult stem cell research and therapies, and of the development of stem cell banks, with a view to determining whether research on human embryos is still necessary".

The Government have accepted that recommendation.

Welcome though such a recommendation is, it raises the question of why the benefit of the doubt is not given to the embryo rather than to the research scientist. A carefully argued written submission by the Roman Catholic Bishop of Plymouth, the right reverend Christopher Budd, put the case for a five-year moratorium on embryo stem cell research, and recent developments in the field certainly support that advice.

The view of the Standing Committee that embryo research is necessary for the present rests on the fact that the UK research establishment remains fixated on embryo research and its seemingly great potential. The astonishing advances in adult stem cell research and therapy over the past two years have taken place in other countries, notably the USA, and it is unfortunate that the Select Committee failed to invite evidence on the current situation from those countries. Instead, it

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relied heavily on advice from British scientists, influenced by their attachment to embryo research and unfamiliar in many cases with the rapid advances in adult stem cell work internationally.

I digress to say that it is not in the least surprising to me that scientists in one field do not seek to criticise the need for work in other fields—dog does not eat dog—and that researchers are content to work in their own fields and to observe with interest the work of others. It would be naive and unfair to expect them to decide the issues which the Select Committee was set up to examine.

The same mistake must not be made in any future review of the need for research on embryo stem cells, and the speed of developments in adult stem cell research and therapy make the suggestion of a review towards the end of the decade an unsatisfactory one. Instead, the pace of development requires, in my view, that there should be an annual review by a standing committee, independent of government and including international scientists familiar with developments in the adult stem cell field. I hope that the Government will seriously consider that option.

5.47 p.m.

Baroness Warnock: My Lords, I add my congratulations and expressions of gratitude to the right reverend Prelate the Bishop of Oxford and his committee on their report. I declare an interest having been involved in the 1990 legislation, within the framework of which the debate is now taking place.

The report has been criticised on the ground that its conclusions were wholly predictable, but that does not entail that they are wrong. I find it difficult to understand the suggestion that the report is in favour of unfettered medical research because it is clear that the framework of regulation within which research using human embryos is carried out is rigorous and quite specific. I also find it difficult to understand how it can be said of the report that it has missed an opportunity to revisit the ethical and moral considerations that lie behind the 1990 legislation.

I shall confine my few remarks to Chapter 4 of the report, where the central moral issue of the status to be accorded to the early human embryo is discussed. As the report notes, this moral question has not changed since the 1980s and the lead-up to the legislation of 1990.

In paragraphs 4.6 to 4.17 (pages 21 to 22) of the report, under the heading "Should the early embryo be treated as a person?", I thought that the report, for once, failed in clarity. It failed to make clear the confusion generated by introducing the concept of personhood into the debate. The question of whether the embryo is a person is not a different question from that of the status we should accord to the embryo; it is exactly the same question.

People sometimes speak as though asking whether an embryo is a person is like asking whether an animal is a horse—a member of the genus equus—to be settled by observation, scientifically. But, of course, that is not the case. The question of whether someone or

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something is a person is a legal—or, at least, quasi-legal—question, a matter of deeming someone to be a person. There is no sense in saying such things as, "The embryo may possibly be a person", or, "The embryo is probably, or probably not, a person". Neither probability nor discovery comes into the question at all. It is a matter of decision—and Parliament did decide in 1990 that the early embryo did not have the right to the protection that presumably belongs to persons.

I regret that in the original report that led up to the 1990 legislation we used words such as "respect for the embryo". That seems to me to lead to certain absurdities. You cannot respectfully pour something down the sink—which is the fate of the embryo after it has been used for research, or if it is not going to be used for research or for anything else.

I think that what we meant by the rather foolish expression "respect" was that the early embryo should never be used frivolously for research purposes. That is perfectly exemplified by the regulations that are brought in and the licensing provisions that are looked after by the HFEA. It is the non-frivolity of the research which is conveyed by such expressions as "respect for" or "protection for" the embryo.

Finally, one question that must be addressed is whether embryos should be created specially for research purposes. Personally, I have never been able to see any moral objection to creating embryos for research purposes once the central moral decision about the status of the early embryo has been taken. Of course, those who believe that the embryo must be given the full protection of the law from the moment, or the process, of fertilisation believe that it would be utterly wrong to create human embryos for research. But if you have taken the decision that the early embryo is to be used, where necessary, for research, my own view is that there is no difference between an embryo that is surplus to IVF requirements and an embryo that is specially created.

The enormous value, as I see it, of the new knowledge, the new science, the new understanding to be gained from embryonic stem cell research suggests that embryos should, if necessary, be specially created—so that this knowledge can be acquired and can ultimately be used for therapeutic purposes. I do not believe in a sharp distinction between fundamental research and practical and useful research. You cannot have therapeutic research unless you understand the science. That is brought out clearly in the report.

I am in favour, therefore, of using embryos created by cell nuclear replacement as research tools. But one point worries me. It was mentioned by my noble friend Lord Alton, and I believe it to be serious. There is the possibility that women may be exploited into giving away whole cycles of eggs. This was the most shocking story—I entirely agree with my noble friend. The HFEA or another body must address it immediately, perhaps by introducing new regulations to prevent the exploitation of women who, because they are

5 Dec 2002 : Column 1328

desperate to have children, agree to give away a whole cycle of eggs in exchange for free IVF treatment. That is a shocking thing to do.

We need new regulations to cover egg donation. The possibility of donors being exploited is another reason to carry out research using adult stem cells rather than embryonic ones. However, both areas of research must be explored, and I accept fully the probable limitation of the use of adult stem cells.

5.55 p.m.

Lord Brennan: My Lords, stem cell research is a matter of profound medical, legal and social significance. I must, therefore, begin with two very important cautions. First, the topic deserves to be debated with intellectual discipline and reliable reasoning; therefore, the message should not go out from this House today that stem cell research will produce cures for serious disease. It might. It is a speculative aspiration. It is unproven whether it will cure and, if it does cure, it is unknown when.

The second caution is that we must not proceed in the expectation that the legislative framework embodied in the regulations of 2001 represents valid law. Next February, the Judicial Committee of this House will hear the final appeal on the question of whether the regulations are valid. Its decision will involve a major question of constitutional importance: whether the courts of our country have any role in plugging legislative gaps created by the legislature or whether those matters should be remedied by the organ of democracy that created them.

Central to the report is the assumption that the regulatory framework of the Human Fertilisation and Embryology Authority—I shall hereafter refer to it as "the authority"—works effectively in the public interest and can be seen to do so. Secondly, it assumes that there is a reliable legislative framework overall. Thirdly, the committee readily accepted the limited nature of its inquiry into the field. It did not, and could not, come to any conclusions about the degree of control society should exercise over the use of the products of stem cell research for the benefit of the community. I will deal with each point in turn.

First, does the authority have an adequate system of regulatory control in practice? Let us test the proposition. One, licence applications are never published before they are considered by the authority. It is, therefore, impossible for the public to know to what the licence application is directed. As a result, it is impossible for them to know whether the Government's undertakings and the authority's declared policy are being met, namely that stem cell research will be permitted only where it is necessary, desirable and there is no alternative. How are the public to know?

Secondly, after licensing decisions are made they are not referred to in public for up to two years after they have been made. The report of the authority for the year November 1999 to November 2000 was only published in the late summer of the year 2002. When I say "published" as regards what happens with these

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licences, I am being generous. By way of example, in the 1997 report there is one page that embraces 19 licence decisions, the longest of which stretches to just over 40 words in its description. That cannot plausibly be said to represent informing the public about a licensing decision. In any event, it is too late for anyone to do anything about it because the licence has been given and acted on.

Finally, the right reverend Prelate quite rightly emphasised that at the heart of this question is the integrity and value of the research that is accomplished. Outside the world of this authority, science seeks to achieve those standards by peer review. I shall test with noble Lords the proposition of whether the peer review system under the authority is established as being reliable to our satisfaction: we do not know the system of selection; we never know the expertise of the peer reviewer; and we do not know whether there is any conflict of interest. If your Lordships think that I am being overly strict, I have with me a real-life example from a licensed applicant. In evidence given to the Science and Technology Select Committee of the other place, Dr Austin Smith—who is a holder of a licence and a declared peer reviewer—said:

    "Unfortunately the [Authority's] . . . committees seem insufficiently familiar with the science also. In responding to my queries it seems that the [Authority] . . . looks to the Medical Research Council for specialist input, who in turn ask my view, with the result that I am asked my view of a ruling which I am seeking. Research regulation seems to be at the margin of their activities".

He measured his words carefully, but it is almost risible to suggest that that is a proper system of peer review. It may not be representative; indeed, he may be wrong. However, we do not know.

From all of those propositions I invite noble Lords to consider with me the following suggestion. In scientific issues of this importance, should we not endorse the views of the Science and Technology Select Committee of the other place, which observed in 1999 that there was a crisis of confidence by the public in the regulation of science and technology and called for greater openness and dialogue. Do any of us disagree? If that is a proper objective, I invite my Government to consider the following proposals with the authority. First, adequate details of licence applications should be published. This should not be brushed aside with reference to the nonsense of commercial confidentiality. We are talking about the investigation of humankind for the benefit of humankind.

Secondly, adequate details of decisions should be published. Thirdly, the people who are peer reviewing should be identified, as should their expertise and terms of reference, and a declaration should be required of no conflict of interest. Fourthly, let the authority explain why this research was the only alternative. And, fifthly, let the licence holder who sought leave to investigate report its conclusions, successful or otherwise, back to the authority so that it can summarise the conclusions in its annual report.

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None of that presently happens. Therefore I question the conclusions in paragraphs 8.1 and 8.2 that the public can be satisfied that the authority works in a way that we know and can understand.

The second question is whether there is an adequate legislative framework. The authority is reported as declaring in the report at paragraph 8.22 that it does not have regulatory control over stem cells once extracted from the embryo. I understand that it repeated the same declaration in a court case about tissue typing the other day: embryo control, yes; extracted material, no control by us.

Unless I have misunderstood the science, it is the extracted material that founds much of the research intended to be carried out. If the authority declares that it has no regulatory control over it and no competence in that regard, how can it be said that the present legislative framework is there?

I give two illustrative examples. Extracted material can be used for either research or treatment, but in both instances without regulatory control. It can be so used without any criterion applied as to whether it is necessary and desirable and whether there is an alternative. What we legally require in respect of embryos, we do not legislatively require in respect of material extracted from them.

I turn to the question of commercial control. I do not want to give my own views, to which I spoke in January 2001, about where all this was going and who was going to own these wonderful benefits to society: the Geron corporation which has just bought up the Dolly company in the North of England and now has most of the patents in the world in this field; or should it be us, the people who want the benefit from it?

In the evidence to the committee at page 448, Professor Wyatt, a sceptic on stem cell research, concluded:

    "The extent of funding of all research involving embryos should be transparent and open to public scrutiny . . . The commercial ownership of cell-lines and research data needs careful regulatory and public scrutiny. There should be legal protection of 'whistle-blowing' by scientists in commercial organisations if ethical concerns are raised".

Who is to disagree? I turn to a stem-cell research enthusiast, the noble Lord, Lord Walton of Detchant, at page 156, who put the matter crisply in a way that cannot be improved on:

    "My own personal belief is that the results of such research should be universally available without significant commercial considerations".

Who would disagree?

Whichever line one takes, there is no government policy of which I am aware, nor any external policy of NGOs in the medical world, as to how society will obtain the benefits of this research, if they ever occur, in a way that serves the community and not the profit-maker. I recall for your Lordships the phrase "intellectual discipline and reliable reasoning". Where are we going?

My conclusion is short and, I hope, simple. The authority should grant no licences until steps regarding the system I have recommended are, at the

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very least, considered; until the legislative framework covers the concerns I have expressed; and until society can be satisfied that what is sought to be done will serve society. This debate is not the end; it is merely an episode in a long-running debate on a legal and social concern for us all. The need for legislative oversight cannot be deferred until the end of the decade; it is a constant requirement. I for one intend to pursue that oversight.

I have not troubled your Lordships with my disagreement with the committee's conclusion. I adopt the reasoned arguments of the noble Lords, Lord Alton and Lord Tombs. I thank noble Lords for their patience.

6.11 p.m.

Baroness Cox: My Lords, I speak with trepidation because this subject has such profound ethical, theological, scientific and clinical implications and because of my respect for members of the committee, for the enormous amount of work they have devoted to the preparation of this report, and to their personal commitment to ethical and scientific integrity. I therefore express my concerns with profound humility. However, I have voiced them previously, and subsequent developments have not allayed them. These include the apparent arrogance of the United Kingdom in going it alone while other European countries and the United States have been constrained by scientific and ethical arguments from going down the path recommended in this report. That point has been very fully made by the noble Lord, Lord Alton.

Furthermore, while great emphasis is laid on the therapeutic potential of embryonic stem cells, it is acknowledged that these cannot have any effective clinical application for many years. However, the progress being made with adult stem cell research suggests that they may have more to offer without the immense ethical or safety problems associated with embryonic stem cells. Everyone wishes to hasten therapeutic developments to alleviate the anguish of illnesses such as Parkinson's disease. As a nurse, I cannot feel anything other than passionately committed to measures to relieve suffering in a whole range of diseases which may be treated by stem cell therapies. However, the question must be asked whether it is prudent to proceed now with a more ethically and clinically problematic route of embryonic stem cells when the option of adult stem cells is generating very positive results and is being used successfully in many parts of the world. Indeed, the United Kingdom is being left behind in this field of research.

The right reverend Prelate the Bishop of Oxford referred to the report's encouragement for adult stem cell research. Encouragement is one thing, funding is another. In the United States, 75 per cent of private funding is going to adult stem cell research organisations, whereas embryonic stem cell research organisations are receiving a very small amount and are struggling to survive. I should therefore like to ask either the Minister or the right reverend Prelate how

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much funding is currently underpinning the encouragement for adult stem cell research. I should also like to concur with the noble Lord, Lord Tombs, when he expressed his grave concern about the suggestion that the situation should be reviewed towards the end of the decade. The issue is much more urgent than the end of the decade. However, I shall focus on the risks of embryonic stem cells as they seem to receive such inadequate consideration in the report, perhaps because the relevant experts who could present the alternative arguments were under-represented in the witnesses giving evidence.

The report claims that there is no reason to suppose that the risk of tumour formation is higher in embryonic stem cells than in adult stem cells and that cultured embryonic stem cells are unaltered and can be grown and manipulated safely in culture. But these claims are contrary to all the available peer reviewed evidence. I therefore offer some counter arguments which are grounded in reputable scientific research. Time will not permit me to cite the sources but I shall make those available in a fuller paper which I shall place in the Library for anyone to check my claims and arguments.

First, the report does not address the very serious risk of teratoma or teratocarcinoma formation with embryonic stem cells. These are tumours composed of a mixture of various inappropriate tissue types such as bone, cartilage, hair or teeth, which can develop anywhere in the body, for example, in the heart or in the brain.

Tumour formation is not a hypothetical risk but is, or can be described as, an intrinsic property of embryonic stem cells. Indeed, the presence of only a minute number of embryonic stem cells (relative to the numbers implanted in stem cell therapies) is sufficient to generate these tumours. The report also clearly implies that adult stem cells are just as likely to form teratomas, stating that there is

    "no reason to believe that (there) is a significantly greater risk for embryonic stem cells than for (adult) stem cells".

But, so far, adult stem cells have not been found to produce these tumours.

Secondly, there are a number of ways that embryonic stem cells and their differentiated progeny could generate cancer, when they are cultured as would occur in the process of multiplying embryonic stem cells for therapies and to an even greater extent in the case of the proposed stem cell bank. The risk is greater still if the embryonic stem cells are obtained from "therapeutic" cloning.

Recently, a form of mutation in embryonic stem cells in culture has been identified which could result in cancer. In this case the cells appear to have the correct number of chromosomes, but they are the wrong chromosomes. There are no copies of a chromosome from one parent but two from the other parent. It is a particularly dangerous form of mutation. The study, which investigated mutations in embryonic stem cells, was reported in the proceedings of the National Academy of Sciences in the United States of America earlier this year. The authors state that the increased

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risk of tumour formation after (embryonic) stem cell therapy should be viewed with concern. By contrast, they state that this mutation

    "is not commonly observed in other normal somatic cells"—

this includes adult cells.

Thirdly, the report also claims that cultured embryonic stem cells are unaltered and safe because these cells, at least in the case of mice, can form normal offspring. But the report does not reveal the vast numbers of embryos produced from cultured embryonic stem cells that fail before one succeeds, and the very high percentage that have foetal abnormalities or are born with gross abnormalities or that die at or around the time of birth or shortly after.

The reality is that the experiments described so positively in the report demonstrate clearly that cultured embryonic cells are altered and unsafe, not unaltered and safe. It thus appears to give them a clean bill of health whereas there are numerous ways in which they could cause tumours, including cancers. If this issue is not addressed thoroughly, and if in future years people develop such tumours from embryonic stem cell therapies, they and their relatives will not look kindly on the committee which claimed that embryonic stem cells were unaltered and could be safely cultured despite the fact that there is much evidence to the contrary.

With respect to "therapeutic" cloning, the risks would be even higher because of the very high incidence of severe abnormalities in cloned embryos. If these defective embryonic stem cells were used for "therapeutic" cloning, they would produce defective cells. Unfortunately, in the majority of cases, the abnormalities would not be detectable, as at present in many cases there is no way to tell which are the defective cloned embryos. If such defective cells were used for therapies, they would be likely to cause cancer.

Finally, through ignoring the dangers of embryonic stem cells, and attributing the unique advantages of adult stem cells also to embryonic stem cells, the report commends a procedure that would instantly result in tumour formation if embryonic stem cells were used, despite having received clear warning of those dangers.

Numerous studies with animals with serious diseases such as heart attack, liver failure, stroke and traumatic brain injury have shown that adult stem cells can be injected intravenously or transplanted some distance from the site of injury, since they migrate to the site of injury, differentiate into the appropriate cell type and begin to repair the damage. There have been astonishing levels of success with disorders such as heart attack and liver failure, and dramatic reductions in mortality.

Those studies show that adult stem cells have the ability to migrate to the site of injury and repair the damage. In some cases, differentiation of the stem cells at the site of injury was also clearly demonstrated. That is extremely advantageous, since it means that adult stem cells in many cases could be injected or even mobilised from internal stores rather than surgically transplanted. That is particularly helpful in cases like

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stroke, heart attack and spinal cord injuries, where surgery could be dangerous. It also means that the adult stem cells do not need to be either dedifferentiated or differentiated before transplant, since local signals in the body direct events appropriately. It therefore provides a very elegant, quick, simple and safe procedure. However, that procedure cannot be carried out using embryonic stem cells, because of the severe risk of tumour formation when injecting or transplanting undifferentiated embryonic stem cells into the body.

I conclude by arguing that there seem to be strong grounds for concern about the conclusions of the report. I hope that they will be taken into account before it leads to potentially irreversible developments that could harm those whom it is intended to help.

6.21 p.m.

Baroness O'Neill of Bengarve: My Lords, I do not believe that any of us can do anything but accept the seriousness of these issues, and the tone in which we are discussing them is entirely appropriate.

I was a member of the Select Committee and learned a great deal while serving on it. I remind noble Lords that the Select Committee was established to consider issues arising from stem cell research. One thing that we learned was that these are early days, and we are not talking about therapies as yet. Enthusiastic mention has been made of developments that may be adult stem cell therapies, or may not. We are in such early days that it is rash to go beyond the evidence with claims about the relative merits of different sorts of therapies.

In general, I do not believe that opponents of the regulations that this House passed in 2001 or the critics of the Select Committee report have disagreed with the report on the thought that these are serious purposes. They disputed two points: in some cases, they have argued that the regulations are unnecessary and in others that they are unacceptable. Those who believe that embryonic stem cell research is unnecessary will believe that the regulations are unnecessary and that there should have been no extension of the purposes of the schedule to the 1990 Act, which sets out the original purposes for which early embryo research was permitted. They claimed that it was unnecessary because adult stem cell research alone would provide what we all hope for.

The Select Committee spent a great deal of its time on that point. Some claimed that scientific and medical witnesses invited to appear before the Select Committee were selected from a supposed pro-embryonic stem cell lobby, but that was not the case. The committee did not choose its witnesses but invited a wide range of bodies to respond. Many chose to do so while some did not choose to do so. It invited many representatives of faith communities. Many distinguished experts appearing on behalf of those bodies had experience of research into adult stem cells. As far as we know, none was working on or had worked on human embryonic stem cells.

Contrary to some publicity, subsequent work on adult stem cells has raised new difficulties as well as new hopes. I believe that that is inevitable at this stage

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of the research. In particular, the right reverend Prelate referred to the much-cited work of Professor Verfaillie of the University of Minnesota, who, as she herself said, raised problems that can be resolved only by further work on embryonic stem cells.

In short, we found no evidence of a division among scientists into distinct adult and embryonic stem cell research communities. Experts who gave both oral and written evidence did not support the view that adult stem cell work alone would be sufficient. Any of us might have hoped that they would support the view, but they did not. Many of them considered that work on embryonic stem cells was the only way to provide a bench-mark against which adult stem cell research could be calibrated.

Since publication of the report, I believe that there has been an additional reason for thinking very carefully about adult stem cell research—that is, like all adult cells, adult stem cells have been through the process of imprinting during the period of embryonic and foetal life. That means that they have been differentiated or marked in certain ways that we do not yet well understand and their reversal is a difficult matter.

At a later date, when the most basic scientific questions about stem cells of all sorts have been answered, it might prove possible to advance the purposes of the 2001 regulations without further research on embryonic stem cells. In that case, the 1990 Act would not permit the Human Fertilisation and Embryology Authority to license further embryonic stem cell research. Licences for work using early embryos may be issued only where,

    "the research cannot be achieved by other means . . . and is necessary or desirable for a permitted purpose".

The drafting of the 1990 legislation makes the refusal of a licence for research on embryos the default position, and licences to do such work require explicit justification. I have a great deal of sympathy with the point made by the noble Lord, Lord Brennan, about the way in which the process of accountability for the issue of such licences could be improved. I myself am sceptical that publishing them is as effective a remedy as he would hope, but I am sure that there is room for improvement.

Other witnesses who opposed the 2001 regulations and the 1990 Act did not venture into predictions. They did not claim that adult stem cell research alone would prove sufficient. I believe that they were prudent in that respect. They argued against embryonic stem cell research as a matter of principle. That is a position for which I have a great deal of respect. But I have most respect when those who advance it openly state that they wish to abolish all IVF treatment in this country. They are the only consistent opponents of embryonic stem cell research. They acknowledge that IVF treatment, too, involves the destruction of early embryos and that it could not have been introduced without embryo research. However, I cannot see that anyone who considers IVF treatment to be acceptable can consistently object to

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tightly regulated research on embryonic stem cells for purposes that are every bit as important as the treatment of infertility. The two stand or fall together.

While the committee came to the view that there were morally serious reasons for undertaking stem cell research, including embryonic stem cell research, we also made recommendations, which the Government have accepted, that will, we believe, put downward pressure on embryonic stem cell research.

The most significant proposal was to encourage the formation of a stem cell bank, to require that any cell line developed in the UK be deposited in that bank and to require that cells from the lineages in that bank be made available for research. That was not because we did not think that the cell lines that are the products of stem cell research needed regulation, but because we did not think that they needed regulation by the HFEA. The regulation that they would require is rather different and is more comparable to the regulation for the use of all cell-based therapies.

Matters have moved fast. Since the committee reported, the Medical Research Council, with support from the Biotechnology and Biological Sciences Research Council, has established the UK stem cell bank at the National Institute for Biological Standards and Control. That initiative will allow important research to go ahead with minimal use of early embryos. The bank will hold existing and new adult, foetal and embryonic stem cell lines and will give researchers access to ethically approved, well characterised, well documented and quality-controlled stem cell lines. Those lines will continue to multiply and reproduce themselves and they can survive indefinitely. The Human Fertilisation and Embryology Authority would not then be permitted to grant licences for any early embryo research for work that could be carried out by the alternative method of using cell lines held by the bank.

I want to make a small additional point about the international team. To characterise it as a team which the UK lies outside seems to me entirely mistaken. Anyone who followed the debates in European parliaments last year will know that there was a great deal of movement and a great deal of shifting of ground so that by the end of the year the position of the United Kingdom was much less exceptional than it had appeared at the beginning. We should also recognise that many of those jurisdictions may have committed themselves to fine words, but they are not enforcing the standard to which they claim to commit themselves.

If I wanted somewhere to carry out irresponsible research on embryonic stem cells, this is the last country that I would choose for rather obvious reasons. The climate of strong condemnation, coupled with permissiveness, that we see, for example, in the United States and Italy, is something that one may hope international regulation could bring under some control, but as the Select Committee realised, that will be a difficult matter.

All noble Lords can see that the point of embryonic stem cell research is that it holds promise. At this stage we do not know whether it is high promise, middling

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promise or low promise. That is the nature of research. However, it holds promise of enabling something to be done to alleviate terrible diseases. It is early days and we cannot foresee the sequence or the pace of fundamental scientific and medical advance. But I believe that the creation of the MRC stem cell bank will be a good way to support regulated and effective research and to minimise the use of early embryos.

6.32 p.m.

Lord Chan: My Lords, I thank the right reverend prelate the Bishop of Oxford for drawing our attention to the Select Committee report on stem cell research. I have listened carefully to the speeches of noble Lords and my contribution to the debate arises from my professional experience as a neonatal paediatrician caring for new-born babies for nearly 30 years here and in South-East Asia. Therefore, I shall concentrate on the treatment uses of stem cell research.

I wish to remind your Lordships of the history of stem cell research. It is not a new phenomenon. It has been taking place, using animal cells and human cells, particularly bone marrow, for more than 40 years. The first bone marrow transplant took place in 1969 in a patient with leukaemia. Adult, foetal and umbilical cord blood cells have been available to researchers for the same period. I have used bone marrow transplants and, therefore, it is not true to say that stem cell therapy has not been available. We are using it and it is available. The harvesting of a large number of cells to repair deficient or damaged tissues and their lack of immunological rejection by the host have been features looked for by researchers to satisfy the treatment needs of patients.

Stem cell research from embryos is new and was launched in 1996, only six years ago, by James Thomson of the University of Wisconsin working on non-human primates. His group successfully cultured human embryonic stem cells from five-day embryos in 1998. Embryonic stem cell research has become fashionable since then.There is a close relationship between research and treatment using stem cells because many, if not all, serious diseases in human beings have the potential to be treated by regenerating new tissue from stem cells. However, tragic results have occurred from experimental treatment, for example using foetal tissue implants to treat Parkinson's disease, which is a degenerative disease of the brain. Patients' symptoms and signs of disease disappeared initially after foetal tissue transplants, but the disease returned with a vengeance later and the latter condition of patients was worse than before treatment with foetal implants.

This failure of treatment was thought to be due to immunological rejection of the foetal implants, hence the quest for stem cells without the capacity of being rejected by the diseased host—in other words, looking for cells that had not already had imprints. In this regard, the best tissue to use for treatment would have to come from the patient's bone marrow.

Reports of the use of adult stem cells have been more positive now than when the Select Committee wrote its report and are certainly further along than when it sat

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to hear evidence. For example, the American Heart Association's journal, Circulation, published two papers on 3rd September this year on the repair of heart muscles damaged by heart attack. The first paper, by Strauer et al, from Germany, reported the successful use of the patient's own bone marrow stem cells in 10 people with heart attacks. Three months after they received their own bone marrow stem cells infused into their heart, significant decreases in the areas of heart damage were found. These areas were significantly smaller than in patients who did not receive stem cells. This is permissible and legitimate experimentation and is quite difficult.

Another paper in the same journal reported research in mice. Heart cells derived from embryonic stem cells had a tendency to develop irregular beating rhythms. The US scientists found that heart cells derived from mouse embryonic stem cells had abnormal beating rhythms. The transplant of such cells into an already damaged heart could promote abnormal heartbeat. The scientists concluded that adult stem cells—in this case in the mouse—had more restricted developmental potential and are more suitable for treating damaged hearts. Embryonic stem cells have great potential for development, as noble Lords have described. That potential makes them more dangerous to use than adult stem cells with restricted developmental potential.

Furthermore, umbilical cord stem cells and bone marrow stem cells can be injected into the body by catheters—I have done that myself—and directed to specific damaged tissues. In contrast, embryonic stem cells would require to be implanted by surgery, because they can form tumours, as the noble Baroness, Lady Cox, has described, when injected into the blood stream.

Clearly, the evidence being accumulated today favours research in the use of adult stem cells in the bone marrow or from umbilical cord blood, particularly of a close relative. The rapid advance in stem cell research in the United States and continental Europe makes some of the conclusions of the report out of date and inappropriate, particularly the encouragement of embryonic stem cell research to the same degree—that is how I understand it—as adult stem cell research.

Embryonic stem cells cannot possibly be the treatment of first choice in serious diseases, and not even for a limited number of disorders where damage is due to severe trauma to the brain or spinal cord, because of all the advances in adult stem cell research with therapeutic use in these areas. Therefore, much more encouragement and funding should be given to adult stem cell research if we are concerned with treatment. Another problem with embryonic stem cell research is the need to use donated embryos produced by various methods of fertilisation, including in vitro fertilisation. Problems about that have already been discussed by noble Lords.

I believe that the Select Committee's report is over-optimistic in its confidence on the HFEA's ability to regulate IVF clinics. Recent reports of the white

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mother who delivered black babies after IVF treatment because of a laboratory error is, I suggest, only the tip of the iceberg of such errors. How many more mistakes have taken place and been undetected because all the babies were white?

Finally, I was looking for recommendations for the improved monitoring and audit of IVF clinics and of embryonic stem cell research by the HFEA. That is more necessary now than when the Select Committee was sitting.

In conclusion, the future of stem cell research should logically promote the use of adult stem cells, particularly in the bone marrow. The Select Committee's report may have been overtaken by new reports of the use of adult stem cells. More stringent regulations must, therefore, govern embryonic stem cell research in Britain if we do not wish to be lumped with Singapore and China as the El Dorado of embryonic stem cell research. In May when I was in Singapore, the Singapore Government publicly declared that because Britain had encouraged embryonic stem cell research, they would go even further: they wanted to be the first in the world to use, what I would consider as, unfettered embryonic stem cell research.

6.41 p.m.

Baroness Northover: My Lords, this has been an excellent debate. I welcome the fact that we are at last debating the report. It is impossible to predict precisely how medicine will develop far into the future, but we have a responsibility to try to see where promise seems to lie. In fact, we mostly seem to agree that the promise of stem cell research is one of the most exciting prospects for treating disease in the future. But, as so many noble Lords have said, we do not know whether, when, or how this could be applied. What we do know is that such research helps our fundamental understanding of human biology. It has always been on that that advances in medicine have been made; and yet research on stem cells has been surrounded by controversy.

Those of us who were members of the Select Committee came to it with a range of different opinions—from those who had supported the noble Lord, Lord Alton, in the original vote, to those who supported the proposal that research should take place. We came from a wide range of political positions and a wide range of backgrounds, with some having a deep knowledge of the area, and others of us very little or none.

The chairman, the right reverend Prelate the Bishop of Oxford, could not have been more even-handed, patient and thoughtful, as we sought to find our way through the issues. We listened; we disagreed with each other; we debated; and we came to a unanimous agreement; and that is the report in front of your Lordships.

We had sterling support from our expert advisers. We certainly needed the scientific advice from Professor Chris Higgins from the Hammersmith

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Hospital. He was very careful to answer our questions factually. We were also anxious to have advice from a legal and ethical expert. That role was admirably carried out by Professor Roger Brownsword. It was important that we had the balance of the two advisers, even though we were so fortunate to have among our number such an outstanding expert on ethics and philosophy as the noble Baroness, Lady O'Neill.

We were able to call for evidence from experts of the highest calibre. We were especially determined that those who opposed research in this area should make their case. They did; both on paper and to the committee. Although no date seemed possible for the noble Lord, Lord Alton, to make his presentation, he needs to know that we concluded that we should simply continue our work until we found a mutually agreeable date, which I am very glad to say was the case. We contacted a wide range of people and organisations and received a mass of material. The quality of what we received was mostly of a high standard, as your Lordships can tell from the supporting papers. Some of the material that we received had not been accepted by peer-reviewed journals. As your Lordships would expect, we took that fact into account when assessing the feasibility of what they claimed to have been able to achieve.

We considered the issues long and hard and, while respecting those who hold the view that no research should be carried out on embryonic stem cells, we concluded that we should not shut the door on that promising line of research. The majority of people in Britain feel that the 1990 Act has in most instances worked well to control the matter, and we were not persuaded to overturn that status quo. We recognised that there is a deeply held view that any research on human embryos is wrong. That is a straightforward difference of opinion and should be recognised as such.

However, society as a whole accepts that work on embryonic cells up to 14 days is acceptable in research on fertility. We felt that to extend the benefits of such research to cast light on normal development as a key to understanding serious disease was, if anything, even more justifiable. We endorsed the position laid down in the 1990 Act that no such research should take place after 14 days. The stage at which ES cells would be extracted would be well within that time, as that must be done before they start to differentiate. We reiterated that there were strong ethical and other objections to the idea of reproductive cloning—which is of course illegal; and we did not propose to challenge that in any way.

As the noble Baroness, Lady Cox, and the noble Lord, Lord Alton, pointed out, there is a lively debate about which have more potential: adult or embyronic stem cells. While we sat that debate raged, and it rages still. We considered that question long and hard. However, we were persuaded that whereas the long-term potential of adult stem cells to produce tissues compatible with a donor may have particular promise, first, more needs to be known about how cells develop—which, we concluded, may at present best be learnt from embryonic stem cells.

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We were frequently presented with the argument that adult stem cells offered greater possibilities. A distinction must be drawn. One may oppose research on embryonic stem cells for moral reasons. That is fair enough. But the argument that science finds that one field shows more promise than another must be assessed separately and dispassionately. I assure your Lordships that we considered that question longer and harder than almost anything else. We concluded that, at present, both sides of that research show promise and that adult stem cell research alone simply does not eclipse the potential of embryonic stem cell research—if anything, the reverse is the case.

We therefore conclude that, at present, research should continue in parallel. Work is being undertaken on both embryonic and adult stem cells around the world, and only time will tell how each informs the other. It is self-evident that if scientists and clinicians find greater illumination from their study of adult stem cells, that is where the scientific community will focus.

As the noble Baroness, Lady Platt of Writtle, and my noble friend Lord Dahrendorf explained, we laid down a series of checks and regulations on the research. We therefore felt that it was appropriate that control of this area should be held by the HFEA. Our main concern, as a result of doing that, was that it should have the resources to handle all its new responsibilities. I seek strong assurances from the Minister on that point.

Stem cell research undoubtedly has the potential to benefit vast numbers of people who suffer from all kinds of diseases and disabilities. Our task was to review the field and thus, implicitly, see whether the decision that your Lordships made to allow research to proceed was the right one. I assure your Lordships that the committee, which came from a spectrum of views on the matter, took evidence widely, considered carefully and concluded unanimously. We recognise that some people feel very strongly on the issue. For them, in all honesty, no protections, promises or possibilities will ever be enough. However, we feel not only that our conclusions are fully justifiable, but also that they are widely shared in Britain today.

6.51 p.m.

Earl Howe: My Lords, it is a pleasure for me to congratulate the right reverend Prelate the Bishop of Oxford on a compelling speech at the start of the debate and on the equally compelling and succinct report of the Select Committee that he chaired. I was among noble Lords who firmly supported the establishment of that committee, even though at the time of our debate—22nd January last year—I was persuaded that the regulations then before us were worthy of approval.

In taking that apparently—or ostensibly—equivocal position, I was mindful of one issue above all others: the need for Parliament to secure public trust. Despite all the consultation, there was at the time a distinct feeling that, in their enthusiasm to promote stem cell research, scientists and politicians had, in an important sense, left the public behind. I think back, in

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particular, to the speech made by the noble Baroness, Lady Warnock, in our earlier debate. She made that very point, and it was a wise one.

It is not just in this area of medical research but in many others also that we must remember an important principle. The fact that something can be done is no reason for us to refrain from asking, on behalf of the public, whether it should be done. In the present context, Parliament was satisfied as to the "should", but there were perhaps three central issues that gave rise to hesitations: the possibility that soon there might be an ethically uncontroversial alternative to research on early embryos involving adult stem cells; the ethical acceptability of creating an embryo for the sole purpose of conducting research into stem cells; and, thirdly, the question that perhaps overarches all the others—the ethical status of the early human embryo.

At the same time our debate gave rise to related and parallel concerns. One such concern, well expressed, as I remember, by the noble and right reverend Lord, Lord Habgood, was that, if Parliament were to consent to stem cell research involving human embryos—as it went on to do—that consent should not be open-ended, either as to time or to substance. Many of us felt that we needed further and better particulars about the boundaries of the proposed research and that Parliament should retain proper oversight over the consent that it had granted. To do that, it needed to be sure that those charged with day-to-day responsibility for implementing its wishes were capable, in the fullest sense, of doing so and, equally, that the Government were sympathetic to the notion of de-limiting the timespan of the order.

Those were the main considerations underlying the decision of the House to establish a Select Committee, and they must, therefore, be seen as the benchmarks of the committee's success. Having read the committee's report and the Government's response to it, I am in no doubt that the right reverend Prelate and his colleagues have fulfilled their remit in a most creditable fashion. That said, the noble Lord, Lord Alton, has voiced a number of criticisms of the report, which I know are deeply held, and I have listened to him with particular seriousness, as I always do. Other noble Lords have supported him.

Perhaps I may be allowed to focus on a few of the main issues that have been highlighted. The first, where all debate has to start, is the overarching ethical issue of the status of the embryo. The report covers that in Chapter 4 and in an interesting short appendix about the Christian tradition. On the theological position I take my cue, as I always have done, from the right reverend Prelate. The report acknowledges that there are differing traditions and beliefs among different Christian denominations and groups. However, it is significant that the Jewish belief accords with that which the right reverend Prelate enunciated in our last debate—that is to say, the gradualist view of an embryo acquiring increasing moral status as it develops. In essence, that is the position adopted in the Warnock report and which was accepted by Parliament in the 1990 Act.

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Of course, there are many, including the noble Lord, Lord Alton, to whom that view will never be acceptable. Those who believe that a person is created at the moment of conception will take issue with the notion of an early embryo being used instrumentally as research material.

The report points out—and I agree—that the consequences of trying to ascribe to a very early embryo the full moral status of a person are, in current societal terms, untenable. The corpus of existing law and public attitudes are relevant here. Public attitudes are, of course, not the same as right and wrong, nor do they determine what is right or wrong. But the law on stem cell research cannot operate in a vacuum. In vitro fertilisation is a widely accepted procedure, yet it cannot be conducted without wastage of a large number of spare embryos.

The abortion laws have been in place for many years. While it is possible to have an ethical debate—and many do—about the detail of those laws, there are no serious moves to challenge the laws in principle, whether on a human rights basis or any other. Nearer to home, the HFEA has been in operation for over 10 years now, but its decisions have never been the subject of a legal challenge, nor, so far as I am aware, of concerted criticism. It would be anomalous to ban embryonic stem cell research while allowing those other activities to remain legal.

One of the reasons why it is important to revisit and confirm the decisions of the Warnock report as to the ethical status of the human embryo is that, if in due course stem cell research is successful in pointing the way to therapeutic treatment of disease, there will be inevitable commercial consequences. Parliament has always recoiled from condoning the commodification of human beings in any form. If we accept that the early embryo lacks the status of a person but is, nevertheless, to be accorded respect, we need to decide how far such respect should extend when it comes to commercial patents. The ability to patent an invention is generally seen as a spur for conducting research. The downside of patenting, however, is that it tends to raise the cost of research and thus impede access to healthcare.

The Select Committee's report touches briefly on those issues but comes to no firm conclusions. My own view is that it should not be legal to buy, sell or patent human embryos, however defined. However, there is a case for allowing the purchase and sale of embryonic stem cell lines and for the patenting of the products and technologies arising from them. As the noble Lord, Lord Brennan, indicated, the purposes for which patents may be granted and the scope of such patents should be the subject of ethical scrutiny. For example, I believe that the law should not allow a company to patent a technology relating to embryonic stem cells merely with a view to blocking its competitors. Nor should it be possible to register a patent that is unduly broad in its scope, as that would give the patentee an excessive degree of control. There is a balance to be struck between the interests of inventors and the interests of society. I share the view

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of the Select Committee that this whole issue needs to be kept under review, but that ought to mean some solid work being commissioned sooner rather than later.

Some witnesses who gave evidence expressed the view, as have a number of noble Lords today, that the ethical difficulties inherent in embryonic stem cell research could be avoided altogether if the research were exclusively conducted on adult stem cells. I believe this either/or view to be profoundly mistaken. The weight of evidence presented to the Select Committee arguing for embryonic stem cell research, and for such research to run in parallel with work on adult stem cells, was considerable.

I have seen recent evidence emanating from the University of Edinburgh which seriously questions the possibility of adult stem cells being able to differentiate and proliferate into various cell types. It is thought that such cells might simply fuse with existing cells so as to create genetically mixed cells of questionable medical value. The Bio Industry Association has pointed out that it is difficult to isolate adult cells that are free of contamination from other cell types.

The point, however, is that solid evidence about which cells are likely to be useful for which therapeutic purposes, and to what extent, is at present lacking. As the report points out, both routes appear to have potential, but as for the notion of favouring adult stem cells exclusively, we are simply not in a position to say that they offer the route to salvation or the answer to every question. Nor are we likely to have those answers for some time. We first need to understand how all stem cells behave, and in that context it is accepted that embryonic stem cells, at least for now, have an important role to play.

This is where the technique of cell nuclear replacement, or CNR, is particularly relevant. There are those who argue, as did the noble Lord, Lord Alton, that CNR should be prohibited on the grounds that it is unlikely to provide a general basis for disease therapies for the foreseeable future. But the Select Committee was, I believe, right to downplay this argument. CNR and the related procedure known as oocyte nuclear transfer have considerable potential for identifying the process of de-differentiation in cells and for preventing the transmission of mitochondrial disease.

It is something of a relief that in the Government's view basic research of the kind that is needed initially before any applied research is possible will fall within the scope of the current regulations. There was a fear that it might not. However, there is a point that arises from this. The Select Committee's insistence that no embryo should be created specifically for research purposes without prior proof of demonstrable and exceptional need is surely right, but, where basic research is concerned, demonstrable and exceptional need is not a straightforward matter to prove, especially given the standard requirement that licence applications presented to the HFEA should be as tightly drawn as possible. It would be helpful if the Minister could comment on this.

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Perhaps I may say at this point how much I welcome the establishment of the UK stem cell bank which in time should considerably reduce the need for research using early human embryos. Meanwhile it is absolutely essential that the HFEA should keep itself abreast of scientific developments which, as has already been said, are very fast moving.

The HFEA has two principal roles—as an adjudicator and as a policeman. In its capacity as an adjudicator it has, I believe, a good track record. Perhaps the one area where I have cause to question my previous views has been in relation to the HFEA as a policeman. The recent press stories of serious and basic administrative errors in IVF clinics may or may not point to a wider problem. Either way the public need to have confidence that they are being well served by such clinics.

The recent article in the Sunday Telegraph by Dr Sammy Lee pointed to a less than satisfactory culture operating in certain IVF clinics, where only a minority of embryologists are registered with the HPC or have any real experience of the tight working disciplines that are needed. There are allegations, too, that some clinics are abusing the trust of patients.

We need to be sure that the HFEA is equipped to regulate all the clinics and research establishments that fall under its jurisdiction. With that in view, I welcome the recent announcement of increased base-line funding for the HFEA. That funding should, I hope, enable it to focus on two additional issues highlighted both by the Select Committee and by the Science and Technology Committee in another place: the need to monitor research data and research outcomes, and the need to communicate more openly with the public, and in so doing to promote public confidence. That point was well made by the noble Lord, Lord Brennan.

It is open and public debate about policy which so often acts as a lubricant for good science. In a field such as this, neither the science nor the debate will remain stationary. Because of that, all policy decisions should be regarded as having a limited life and should be regularly revisited to ensure that they remain valid in the prevailing circumstances.

I believe that the Select Committee's report will serve us very well as a base-line for that continuing debate. For that reason as much as any other it should be warmly welcomed.

7.6 p.m.

The Parliamentary Under-Secretary of State, Department of Health (Lord Hunt of Kings Heath): My Lords, for the third time in the past two years we have had a debate of high quality on the question of stem cell research.

I want to begin by praising the work of the committee, so admirably chaired by the right reverend Prelate the Bishop of Oxford. Despite the daunting scale of the task, as the right reverend Prelate suggested, the Select Committee has produced a report which has been widely praised as comprehensive and authoritative in a remarkably short time.

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Perhaps I may echo the remarks of the noble Lord, Lord Dahrendorf, and pay tribute to Lord Carnarvon for his contribution to the Select Committee.

I know that the noble Lord, Lord Alton, would have preferred the Select Committee to report before the House debated the order that was passed in 2001. All I would say is that this House, when it debated the order, had a very clear choice. Following the most intense and robust debate that I have experienced in this place, the House came to a clear view.

In response to the question raised by the noble Lord, Lord Tombs, about the committee members, this is not a matter for the Government but for the House and the Committee of Selection. Looking through the list of members of the Select Committee, it would be very hard to believe that they were not as robust as they possibly could be in dealing with the very difficult matters before them.

On the conduct of the Select Committee, I have no doubt that the right reverend Prelate the Bishop of Oxford will wish to respond. I know that there will never be unanimity of view on the matters debated by the Select Committee. However, I have been struck by the very positive comments that I have received from the many people who have read the report.

Stem cell research is important because of the potential ability to differentiate into so many different cells and tissues. The research does hold prospects for the development of new treatments. The hope is that tissues derived from stem cells will be used to develop treatments for diseases and injuries which are currently incurable.

We have heard from many noble Lords about that potential. My noble friend Lord Brennan is cautious about the expectations, and my noble friend Lord Turnberg said that such outcomes may not be round the corner. But be that as it may, I believe that stem cell research offers hope for the future.

I also recognise that there is a considerable amount of debate to be had about whether research into the potential of adult stem cells is in the end likely to prove more fruitful than research into embryonic stem cells. The noble Baronesses, Lady O'Neill and Lady Northover, were particularly persuasive of the need for work to continue in parallel. The Select Committee concluded that both human embryonic and adult stem cells hold the promise of new therapies and that funders should encourage research on both.

There is always a risk that we will quote from our most favoured scientists. I do not intend to indulge in that. However, it is significant that many of the most eminent researchers in the field of adult stem cell research believe that, given the current state of science, it is important to understand how cells behave, because solid evidence is lacking—the noble Earl, Lord Howe, made that point. That is why, given the current lack of knowledge, it is surely important for research on adult and embryonic stem cells to continue.

I also accept the need for research into cords. I agree with the noble Baroness, Lady Platt. We are considering proposals to double the size of the

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National Blood Service cord blood bank over the next three years. Its aim, along with the banking of adult stem cells in the MRC national stem cell bank, is to ensure that we have the capability to research using all known avenues.

That also applies to the question by the noble Baroness, Lady Platt, about funding. I confirm that funding is available for all types of research. That must be right at the moment. The Select Committee called for continued funding of stem cell research. We are working with partners in the research councils and have prioritised stem cell research. We have also asked the Medical Research Council to take the lead with other funders and the regulatory agencies in developing a national stem cell initiative.

The Government were able to accept or endorse 24 of the report's 28 recommendations. Of the remaining four recommendations, two dealt with the test that should be applied before embryos are created for research purposes. The recommendation was:

    "Embryos should not be created specifically for research purposes unless there is a demonstrable and exceptional need which cannot be met by the use of surplus embryos".

There are certain reasons why scientists would wish for the creation of embryos for research. Noble Lords referred to the statistic that 118 have so far been created for research.

The 1990 Act sets out stringent tests that the HFEA must apply when deciding whether to approve such use of embryos. Schedule 2, paragraph 3(1) of the Act permits the HFEA to authorise research that involves the creation, keeping or use of embryos. Schedule 2, paragraph 3(6) states:

    "No licence . . . shall be granted unless the Authority is satisfied that any proposed use of embryos is necessary for the purposes of the research".

The noble Baroness, Lady Warnock, can see no difference, once that position is reached, between embryos created for research and those created for other circumstances. The existing law in this area is robust. In combination with a case-by-case review of research applications by the HFEA, it ought to achieve the Select Committee's objective.

I turn to the two remaining recommendations in the report. In paragraph 8.8 the department is asked to examine with the HFEA the possibility of drawing up indicative guidance as to what constitutes "serious disease". During the passage of the 2001 regulations, I indicated that we were not convinced that a list of what constitutes "serious" would be helpful. Noble Lords will know that I am not very keen on lists. I believe that they build unnecessary inflexibility into legislation. It is much better for the HFEA to operate on a case-by-case basis. It should also carefully consider the disease or diseases to be studied to ensure that the requirements of the 2001 regulations are met. Noble Lords have referred to the fast pace of science. Having a list in the regulations would not be consistent with the situation.

Paragraph 8.23 calls for a new committee to oversee the use of embryonic stem cells in clinical trials as treatments. The Government are not convinced of the

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value of establishing another committee. At present, the main thrust of embryonic stem cell research is to improve our scientific understanding of cell development. We cannot know when, or whether, ES cells will be used as therapies. The use of cell-based treatments, with which I shall deal later, is already subject to existing controls operated under the medicines legislation and will be reinforced by developing EU legislation currently in draft. Therefore, in these circumstances, we do not believe that additional controls are needed. However, I undertake to look at developments in the use of ES cells and to consult with key stakeholders if we believe that further action is needed.

I listened with great care to the noble Baroness, Lady Warnock, and the noble Lord, Lord Alton, who referred to what they described as the "exploitation of women" in the practice of offering free IVF treatment to women if they agree, first, to donate some of their eggs. I agree that this raises some serious ethical issues. I understand that the HFEA has referred the matter to its ethics committee. I shall undertake to ensure that the conclusions of that committee, together with those of the HFEA, are communicated to noble Lords. I shall also arrange for a copy of those conclusions to be placed in the Library of the House.

I turn to the question of the HFEA and its performance as regulator. I have no quarrel with any noble Lords in their determination to ensure that the authority is robust in the operation of its duties. On the passing of the 2001 order, I said that the robustness of the authority was critical to public confidence; and I say so again this evening. I also respond to the comments made by the noble Earl, Lord Howe, who asked me whether I thought the HFEA was proving to be robust as a policeman.

Clearly, all of us have been concerned about a number of recent cases. I am glad to report to the House that the HFEA is to introduce a range of measures to help meet the challenges that it faces as a regulator. That includes an increase in the number of inspectors and other regulatory staff, more training for inspectors, more unannounced inspections, a new code of practice for clinics with clear standards that clinics will be required to meet, more account to be taken of patients' views in the inspection process, and a faster processing of licensing applications, renewals and variations. I believe that the latter represent very welcome action. I can assure noble Lords that the Government will be keeping a very close eye on the performance of the HFEA.

In a number of recent cases I have been most anxious to ensure that the HFEA was as thorough as it could be. I do not believe that that detracts from the overall performance of the HFEA over what is now a decade. I pay tribute to the work of the authority, especially to its past chair and to the current new chair who is doing sterling work in ironing out some of the issues that have been raised.

I turn to funding. We expect funding for the HFEA to increase in the next year from just over 2 million to 5.5 million. The Government's contribution to the

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new figure will be 1.5 million. That should ensure sufficient funding for processing applications for embryonic research to produce stem cells lines and to ensure the authority can establish the robust policing role I have described. We will keep funding closely under review.

Like the noble Baroness, Lady O'Neill, and the noble Earl, Lord Howe, I thought that my noble friend Lord Brennan raised some important matters about the licensing processes. I have some sympathy with a number of the points he raised although I am not sure that I agree with some of his solutions. The HFEA is reviewing its procedures for processing research licence applications. I will ensure that my noble friend's points will be referred to the HFEA. I regret that the HFEA's last annual report was late, but I am glad to say that the next one is due out on time and will be published shortly.

My noble friend Lord Brennan asked about the regulation of the use of the embryonic stem cell once extracted. A research licence would not be granted by the HFEA in the first place if the stem cell line was not intended to be used for one of the purposes in the regulations. Once extracted, the stem cells are not within the scope of the Act. The reason for that is that, unlike the embryo, embryonic stem cells are unable to become a pregnancy; if planted into a woman they cannot develop. For that reason, those cells are treated as any other human cell lines, but at that stage research governance requires ethical approval to be obtained for any research involving human tissues and cells. The recent consultation document Human Bodies, Human Choices proposes new controls to cover all human tissues and cell lines.

The noble Baroness, Lady O'Neill, referred to the establishment of a national stem cell bank, the first of its kind. This is very important. It will curate ethically-sourced quality controlled stem cell lines for research leading to the development of new therapies. It will provide access to standardised reagents, reduce the need for individual groups to generate their own cell lines and will reduce the numbers of embryos used for embryonic stem cell research.

A stem cell bank steering committee has been established under the chairmanship of the noble Lord, Lord Patel. It will meet for the first time shortly. Its work plan will include development of a code of practice for the stem cell bank and reviewing, on a case by case basis, all applications to deposit and access embryonic stem cell lines.

I say to the noble Baroness, Lady Platt, that the Government would welcome world-wide action to ban human reproductive cloning and will undoubtedly support action within the United Nations. On the question of international action I must reject the image of the UK as the El Dorado of stem cell research as a realistic picture. The reason scientists are attracted to this country to work is because they believe that we have achieved the right balance between allowing legitimate scientific research within a strict legislative and regulatory framework. Long will that balance continue in this country.

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This has been a splendid debate. I am not sure that any of us has brought any new insights to it, but none the less the arguments have been well put. The Select Committee has done an excellent job and its report is remarkably well written. I pay tribute to all Members for their work.

I reiterate that these are very difficult and sensitive issues. The Government have a responsibility for ensuring that the regulations, the legislation and the work of the HFEA are as effective as possible. I assure the House that the Government will keep all these matters under very close review, which is as it should be. I am sure that, as we come to debate these matters on further occasions, we will be able once again to address some of the issues which undoubtedly will develop in the years ahead.

7.25 p.m.

The Lord Bishop of Oxford: My Lords, I thank everyone who has taken part in the debate. I believe—and I hope that the noble Lord, Lord Brennan, will agree—that it has been not only a very serious and thoughtful debate but a rational debate. It has been greatly encouraging to have such a high level of discussion. I hope that noble Lords will excuse me if I deal only very briefly with the points made and take up perhaps just one point from each speech.

I am very glad that the noble Lord, Lord Turnberg, reminded us that at the heart of this debate is the prospect of hope for people who are suffering. It was good to have that brought before us again right at the beginning. We are talking about people suffering from a range of terrible diseases. Whatever research risk route we may think is or is not right to go down, we believe that there is hope for such people in the long run.

The noble Baroness, Lady Platt, emphasised the strict nature of our regulatory authority, the HFEA. This has been questioned by a number of noble Lords on all sides of the House. I wonder whether it is not right to draw a distinction between problems which might have emerged at the moment and for which the HFEA has been highly criticised and the fact that we have in existence a regulatory body with clearly defined powers. What we do know is that many other countries look to that regulatory body as a model for what they would like to have in their own country. I think that that is what we primarily have in mind in supporting the HFEA in our report. It is not for me to respond to the criticisms, but I think that the Minister has responded very strongly to that issue. We know that those concerns will be taken into account.

It was very good to hear the noble Lord, Lord Dahrendorf, sharing with us how he had become a member of the committee with a very open mind and how he had gradually been persuaded by the arguments which the committee eventually accepted.

In a powerful speech, the noble Lord, Lord Alton, made a number of points which need to be taken very seriously. The first was a point that he has made before and that was made by various other noble Lords—that only 26 scientific or medical witnesses invited to

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appear before the committee were from the pro-embryonic stem cell lobby and that no scientists were called to submit oral evidence from an exclusively adult stem cell perspective. Although the noble Baroness, Lady O'Neill, has already mentioned this, I feel that I ought to emphasise that the committee issued its call for evidence to a very wide range of representative organisations. These naturally included the major scientific and research organisations such as the Royal Society and the Medical Research Council. How could we not ask those representative bodies to come before us? Inviting organisations to give oral evidence, the committee did not specify who should represent them. In the event, however, those who appeared on behalf of those bodies included some distinguished experts with experience of research in adult stem cells and, as far as we know, no one working on human embryonic stem cells.

The committee also asked a number of international experts working on adult stem cells for their views on the way forward, and they were unanimous that research needs to continue on both ES and adult stem cells.

The noble Lord, Lord Alton, also drew attention to the very important report by a number of theologians which was submitted as part of the evidence from the Linacre Centre and to which reference has been made. I assure your Lordships that I read that report very carefully a good number of times and I believe that the position—that is, the two readings of the Christian tradition—is fairly represented in the appendix at the back of the report.

The noble Lord, Lord Alton, pointed out that since our report was published an article had appeared in Nature magazine that cast doubt upon the utility of cell nuclear replacement. However, our report also indicated a certain scepticism on the part of the scientific community at present with regard to that matter. We had already taken that on board. I refer the noble Lord to paragraph 5.9. We did not need the article in Nature to remind us that the original high hopes in regard to that matter are not at the moment shared by the scientific community.

The noble Lord, Lord Alton, suggested—as he has suggested before—that this country is isolated internationally as regards the matter that we are discussing. But, as the noble Lord, Lord Dahrendorf, pointed out—this was reiterated by the Minister—it is much fairer to say that we are in the middle of a spectrum. If one looks at what is happening in the United States, in Germany and in Europe, we are not nearly as isolated as some people suggest. For example, as regards EU funding for research under framework six, until the end of 2003 the Commission will not fund research projects involving the use of human embryonic stem cells with the exception of stem cells already banked or isolated in culture. That agreement means that research projects that used banked embryonic stem cells, such as those going into the new Medical Research Council bank, will qualify for EU funding until January 2003. Other research, such as that involving the extraction of embryonic

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stem cells from embryos, will be subject to a temporary suspension until the end of 2003. The UK is not isolated in this regard. Other countries, including the European Union, are to some extent following the lead that we in this country have taken.

The noble Lord, Lord Tombs, took up some of the other points that the noble Lord, Lord Alton, made in relation to what is perceived as our lack of proper attention to adult stem cells. I do not want to repeat what I said when I opened the debate. However, we need to draw a distinction between a person's basic ethical position and other matters. I deeply respect the position of those who think that no research on embryonic stem cells should take place. I respect that basic ethical position. However, we should not confuse that with an objective assessment of the pros and cons of research on the different kinds of stem cell. I find it very difficult to believe, and rather disappointing, that people cannot appreciate how strongly our report supports work on adult stem cells, that we believe that it needs financial encouragement and that there is clearly real hope there. I cannot go on repeating that point but if people look at our report they will certainly find that that is the case.

The noble Baroness, Lady Warnock, mentioned the status of the embryo and questioned the use of the words "person" and "respect". I shall certainly read her comments carefully as she made some important points that I should like to ponder further.

I believe that we all agree that the noble Lord, Lord Brennan, made an extremely weighty speech with regard to informing the public about licensing decisions, questions raised in regard to peer review and the commercial aspect of the matter, which the Minister has already indicated he will take seriously. I hope that I may stress a fairly obvious point; that is, that the stem cell bank is owned by the Medical Research Council and therefore stem cells will not be available on a profit basis.

The noble Baroness, Lady Cox, pointed to the real possibility of tumours developing as a result of using therapies based upon embryonic stem cells. We were aware of that. I refer noble Lords to paragraph 3.6 of our report, in which we say that that is a possibility and add that it is essential to guard against those risks. In our scientific chapters, we try to set out the advantages and limitations of both kinds of research as objectively as possible. There are grave questions about some forms of adult stem cell research. The main weight of the scientific community could not agree with the view that adult stem cell research alone is likely to produce all of the results.

The noble Lord, Lord Chan, wanted more encouragement to be given to adult stem cell research. It was good to have an informed medical opinion. As the noble Earl, Lord Howe, said, recent studies suggest that there are major questions about what is really happening with regard to some forms of adult stem cell research. Is it truly transdifferentiation or is it cell fusion? I am not a scientist and I do not know the answer. I merely suggest that there are still many questions to be answered by further research on adult stem cells and embryonic stem cells.

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I thank the noble Baroness, Lady Northover, for indicating to the House the way in which the committee worked and for saying that we worked harder on the issue of adult stem cells than on any other. We tried to look as objectively as possible at all of the issues.

I thank the noble Earl, Lord Howe, for his thoughtful speech and the important points that he made about patents. The Minister has already suggested that he will address that issue. Finally, I thank the Minister for the positive response to our report and the fact that the Government have accepted 24 of our recommendations. I am not sure whether he mentioned that we made 27 or 28 recommendations; there were three recommendations that he could not accept. I hope that it is fair to the committee to say that those recommendations were fairly finely judged anyway, particularly with regard to the question whether there should be an indicative list of serious diseases. We were uncertain at the last moment about whether to advance that.

I thank all those who have taken part in this debate and I am grateful for the tributes to the committee's work. We have had a serious, thoughtful and rational debate. I commend the report to the House.

On Question, Motion agreed to.

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