Human Fertilisation and Embryology (Research Purposes) Regulations 2000

Part of the debate – in the House of Lords at 3:15 pm on 22nd January 2001.

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Photo of Lord Hunt of Kings Heath Lord Hunt of Kings Heath Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health) 3:15 pm, 22nd January 2001

My Lords, I am glad of the opportunity which allows us to debate today an issue of considerable importance. It is of importance to hundreds of thousands of people in this country who suffer from distressing and long-term illnesses, to those whose diseases and conditions often deny them a basic quality of life, and to those whose only hope for a cure lies in medical research and science.

However, our debate this afternoon goes further. Inevitably, it will touch on matters which go to the very core of our individual beliefs, principles and values. We shall hear from noble Lords who believe that research on embryos should not take place under any circumstances; from those who believe that research on embryos is ethically justified in the fight against serious diseases; from noble Lords who worry about the end point of so many scientific advances; and from those who rejoice at the opportunities which new medical discoveries bring to humankind.

I believe that it is to our country's credit that over the years we have been able to strike a balance between those different viewpoints and arrive at sensible conclusions. In respect of that sensible balance, I inform the House at the beginning of our debate that it is the Government's intention to support the amendment in the name of the noble Lord, Lord Walton of Detchant, which proposes that the order be approved with government support for the appointment of a Select Committee and for the Government to review the regulations following the report of that Select Committee.

I spoke about a sensible balance. Nowhere is that more apparent than in the Human Fertilisation and Embryology Act 1990 and the forerunner to that Act--the committee of inquiry set up under the noble Baroness, Lady Warnock, to consider and make recommendations on recent and potential developments in science and medicine in relation to human fertilisation and embryology.

The noble Baroness's committee reviewed those areas comprehensively. That was followed by the enactment of the Human Fertilisation and Embryology Act 1990. The 1990 Act was and is a model in its regulation of certain infertility treatments and embryo research. It reflected the need to provide a strict framework within which regulation could be conducted and to take account of the advances in medicine anticipated both by the Warnock committee and Parliament in 1990. It is surely a tribute to the noble Baroness and her committee, to the 1990 Parliament and to the Human Fertilisation and Embryology Authority, the HFEA, which conducts its work in such an effective way, that the Act continues to provide such a framework.

In 1990 Parliament debated at length whether to allow embryo research and, should it be permitted, what safeguards would be required. Parliament agreed then that embryos may be used in this way and also agreed the strict safeguards that are now found in the Act. Those include that research on embryos may be conducted only until the first signs of neural development--that is, at the very latest after 14 days. The penalty for using an embryo after that time is severe: the 1990 Act makes it an offence, punishable by imprisonment for up to 10 years, or an unlimited fine or both.

The 1990 Act provides other safeguards. Most importantly--this is crucial to our later debate--the authority must be satisfied that the use of embryos is necessary for research and that research can be conducted only for specific purposes.

The authority takes its role seriously. Over the past 10 years, it received 130 applications to conduct research, and it rejected 17 of those--more than 10 per cent. The authority is not a rubber stamp. We should be proud of its work in putting into effect Parliament's intention to safeguard the use of embryos and in protecting the interests of patients.

Those safeguards in the 1990 Act mean that the regulations would not allow embryos to develop into foetuses from which organs may be harvested, and they do not allow reproductive cloning. I must emphasise that to the House. We are emphatically against those developments and will ensure that they continue to be banned in the UK. At the moment, reproductive cloning is banned because the authority said that it will not licence such research or treatment. Anyone who undertook that work without a licence would commit an offence under the Act and would be liable to imprisonment or a fine, or both.

Your Lordships will be aware that in their response to the Donaldson report, the Government gave a commitment to bring in, when the parliamentary timetable allows, a Bill explicitly to ban reproductive cloning. I am happy to repeat that commitment today. We will not permit reproductive cloning to take place in the UK, and a Bill will be introduced to that effect as soon as possible to put the matter absolutely beyond doubt.

The principles and law that were established in the 1990 Act are clear. Embryo research may be allowed now, but only for conditions such as infertility, contraception and congenital disease, including cystic fibrosis and haemophilia. The question before the House today is whether those purposes should be extended to include serious diseases such as Parkinson's disease, Alzheimer's disease, cancer and diabetes--a provision anticipated and included as a regulating-making power in the 1990 Act.

That question arises because the late 1990s saw developments in cell nuclear replacement technology in animals and because of the announcement in the US of the extraction of stem cells from a human embryo. That was of huge potential. It suggested that it might be possible to apply the understanding gained from embryonic stem cell research to patients' own cells, so that they could be made to generate new cells and tissues. The embryonic stem cell, uniquely, has the potential to develop into almost any tissue in the body. The majority of the research work is likely to centre on the extraction of stem cells from embryos created from eggs and sperm, using spare embryos that are no longer required for infertility treatment. Such research will help techniques for extracting stem cells from embryos, growing them on in the laboratory, and learning how to make them differentiate into various types of tissue. That offers the potential to understand the way in which to treat a whole range of degenerative diseases, strokes, Parkinson's disease, diabetes, cancer, and so on.

Although much attention has focused on cell nuclear replacement, that will not necessarily be the main focus of the initial research effort. That, of course, is what research is about: to try to find out what is the best way forward, and which techniques show the greatest promise. Cell nuclear replacement is essentially the technique in which an adult cell nucleus is injected into an unfertilised egg that has had its nucleus removed. That induces the adult nucleus to act as if it had just been created, following the fertilisation of an egg. The adult nucleus retains the potential to go back to its original undifferentiated state, and the act of transferring it into the egg switches that back on.

The main aim of cell nuclear replacement research is to study the chemical process that controls that mechanism, and to learn how to turn the clock with regard to adult tissue cells. If we succeed in doing that, and learn how to make adult cells revert to the undifferentiated state, we could grow them into new forms of tissue to repair damaged organs, and so on, without having to use cell nuclear replacement. The tissue would not be rejected and would have the advantage of not involving the use of embryos at all.

The House of Commons Science and Technology Committee recognised in 1997 what it called the "profound implications" of the research conducted at the Roslin Institute into cell nuclear replacement. Those issues were taken up early in 1998 by a joint committee comprising the Human Genetics Advisory Commission and the Human Fertilisation and Embryology Authority, which conducted a public consultation on them. In their response to that joint committee's report, the Government announced in June 1999 that they were setting up an expert advisory group under the chairmanship of the Chief Medical Officer to consider the potential benefits for human health of such research.

The expert group included representatives from a range of interests, including ethicists, scientists, doctors and geneticists. They sought evidence both nationally and internationally on all of those matters.

So, the regulations that we are debating today are the result of a considerable amount of work, which was conducted for more than a year by the Chief Medical Officer's expert group. The group concluded by recommending that a further purpose should be added to the five currently allowed by the 1990 Act. That would allow research into serious disease and disorders and their cell-based treatments, but under the same strict conditions and time limits that I have already mentioned, and which apply to all embryo research under the 1990 Act.

After very careful deliberation, the group concluded that research on stem cells provides the possibility of exciting prospects for future therapies for a range of debilitating diseases. However, the group recognised that a great deal of research will be needed to realise such potential and that the answers are not going to be provided quickly. That point underlines the importance of our not delaying a decision today.

The regulations put into effect the recommendations in Professor Donaldson's report. What the regulations do not do is permit human embryos to be used in the treatment of such diseases; they do not permit the use of embryos to create stem cells to be used in treatment; and they do not permit human reproductive cloning.

I emphasise again that the regulations will not, and cannot, permit human reproductive cloning. We are talking in this context only about the basic research that is needed to find out how cells are involved in the disease and injury processes and their potential for use in treatment.

The regulations are divided into three parts, the first of which is to increase knowledge about the development of embryos. That is of critical importance. That research will tell us how embryos develop normally, and why they frequently do not. It will also tell us how stem cells may be developed and extracted, and whether embryos developed through the process of cell nuclear replacement will be able to produce viable stem cells.

The second part of the regulations provides for research to increase knowledge about serious disease. It will, of course, be a matter of judgment for the Human Fertilisation and Embryology Authority to decide what is meant by a "serious disease" when any particular application is made for a research licence under the new provisions. It is certainly likely to include as "serious" conditions such as juvenile and type-2 diabetes, paralysis from spinal cord injury, Parkinson's disease and Alzheimer's disease. There are many others--the list is clearly not exclusive.

The third part of the regulations would allow the research that has been conducted under the previous two headings to be used in research to develop treatments for disease. It is, once again, important to note that that provision will not allow embryos to be used in treatments; it will only allow the research to take place.

Given the stringent controls in the 1990 Act and the overwhelming potential for life-saving and life-changing treatments for people who suffer from chronic diseases, there is a strong ethical case for supporting the recommendations in the Donaldson report. The law as it stands permits research on embryos, subject to the safeguards in the 1990 Act. I have already mentioned some of the purposes for which embryos may be used in research. The principles underpinning the use of embryos in research, on which the 1990 Act is based, are that the embryo of human species has a special status, but not the same status as a living child or adult; that the human embryo is entitled to a measure of respect beyond that accorded to an embryo of other species; and that such respect is not absolute and may be weighed against the benefits arising from proposed research.

It is a matter of the balance that I talked about at the beginning of my speech. The question is whether the benefits to be gained by the research might outweigh the objections to using embryos in that way.

The Donaldson committee took the view that the reason which led in 1990 to embryos being permitted to be used in research, subject to strict conditions and only for particular purposes, must apply equally to research for the potential treatment of serious diseases being proposed now. The expert group concluded that the embryos should be recognised as having a special status as a potential human being but that it may be justified to use early embryos for serious research purposes which may benefit others.

The ethical issues raised by creating embryos by cell nuclear replacement was also considered. Again the group considered that that research is justified in the light of the likely transitional nature of the research, the considerable potential benefits it could bring and the range of safeguards in the 1990 Act. That, of course, is very much a matter of judgment for each and every Member of your Lordships' House.

An issue which has been touched upon in debates on this matter over the past few years is the view that we do not need to use stem cells derived from embryos at all because it is said that the same research can take place by using adult stem cells. I cannot emphasise enough that all the evidence points to that being an unsubstantiated claim. That is the continuing view of members of the Donaldson expert group who considered those matters very carefully; it is also the view of the overwhelming majority of members of the research community.

The Donaldson report recognised that other sources of stem cells were important to research. Those included some adult tissues, some fetal tissue and umbilical cord blood. It discussed that at length and concluded that embryonic stem cells have the potential to develop into a greater range of tissues than adult-derived stem cells.

As I mentioned, the Donaldson committee has continued to monitor the evidence about that. Its conclusion is firmly that while research involving adult-derived stem cells shows much potential, research involving embryo-derived stem cells remains by far the most promising if significant advances and greater benefits are to be made. That view is supported by the Association of Medical Research Charities, the Wellcome Trust and the Royal Society, following a comprehensive review of the papers and by many researchers and scientists around the world.

Part of the problem of using adult-derived stem cells is that they are few in number and hard to find. We are not even sure whether there are specific stem cells for every type of cell in the body. The main difference is that embryonic stem cells are able to renew themselves and form many different cell types whereas the potential of adult stem cells is uncertain with research suggesting that they may be much more limited in the ability to form other cell types.

Those issues underline the importance of taking forward work on both embryo-derived and adult stem cells in order to provide the maximum benefit of this research. Without that knowledge, we are unlikely ever to be able to learn how to reprogramme our own cells, with the potential for treatments with compatible tissue for a wide range of diseases and injuries.

I turn to the process by which these regulations have reached this House. I shall pick up some of the issues implicit in the three amendments tabled on the Order Paper. There can be no question that the matters before us have not had extensive debate in the public domain. The House of Commons Select Committee examined cloning in 1997. It considered that discussions of the science today have been overly concerned with potential risks and have not considered properly the potential benefits. It recognised the potential uses of cell nuclear replacement in research into human diseases.

The Human Genetics Advisory Commission and the Human Fertilisation and Embryology Authority undertook extensive public consultation before reporting in December 1998 on cloning issues in reproduction, science and medicine. They concluded that the safeguards in relation to human productive cloning in the UK were wholly adequate. The report also drew specific attention to the potential beneficial therapeutic consequences from research using cell nuclear replacement. Indeed, they recommended the regulations with purposes we are currently debating.

The Donaldson expert committee discussed those issues, as I said, extensively over a year and sought views from experts worldwide. That report--it is on its recommendations that these regulations are based--is well-focused and authoritative.

The Royal Society, in its submission to Donaldson in February 2000, stressed the wide range of diseases and injuries which may be treatable through stem cell therapies. It stressed that research on human embryonic stem cells will be required because other cell types, such as adult stem cells, may not have the same breadth of application.

The Nuffield Council on Bioethics spent months weighing the ethical implications. It concluded, as did Donaldson, that this research raised no new fundamental ethical issues.

As well as those reports, the Wellcome Trust, the British Heart Foundation, the Juvenile Diabetes Foundation and the Parkinson's Disease Society have all stressed the potential of that research. Certainly, the other place was impressed by that and on a free vote, by a very large majority, agreed to the regulations.

This, then, has not been a rushed process. It has been a long and thorough process. It is difficult to see on what basis it may be felt that there is insufficient evidence for your Lordships to make a judgment today on the regulations. It is certainly difficult to see a justification for rejecting the regulations and delaying a decision for many months while a Select Committee sits to consider the matter, thereby delaying for many months any possibility that applications to start research programmes in relation to serious diseases could be put forward.

Of course, Select Committees of the House undertake immensely valuable work and are listened to very carefully by the Government. It is in that regard that I suggest that the amendment tabled by the noble Lord, Lord Walton of Detchant, provides us with an appropriate way forward. It allows for the regulations to be passed this evening but it also establishes a Select Committee. I assure the House that the Government will listen to the Select Committee's views and review the regulations in the light of its report.

In any case, any research proposal put to the authority would take some months to complete the process--perhaps nine months. But by agreeing the regulations today, your Lordships can ensure that the process of making research applications is not delayed.

The longer-term aim of the proposed research is to be able to apply the understanding gained to patients' own cells so that they can be made to generate new cells and tissues. It is hoped that we shall learn how adult cells may be reprogrammed. That is the really exciting potential of that research. If, by using embryos, we can learn how cells develop and work, we can look forward to a time when embryos are not needed at all for that research. We shall learn how to manipulate the cells from our own bodies to produce the tissues that we need, whether for our heart should we develop heart failure, or brain tissue for Parkinson's, or nervous tissue for our spines should we become paralysed in an accident. That is the ultimate aim for which the proposed embryo research is one temporary step along the journey.

I hope that your Lordships will agree with the report that the proposed extension to the current five purposes for which embryos may be used in research is justified, given the potential benefits in terms of alleviating and curing serious illnesses in so many people.

I doubt that there is a single person or family who has not been touched at some time by the distress that some of those diseases bring. It is said that more than half of the world's diseases have no effective treatment and that we are unable to develop drugs or other treatments to cure or alleviate many of those conditions. In any case, drugs are not always the answer, and never will be. In these cases, the only treatment that is likely to offer chance of a real cure is one based on the person's own body, a treatment which is cell-based and individual.

In reaching conclusions on the Donaldson report, we must consider the importance to those people who shoulder the burden of these terrible diseases, their families and friends as well as the wider community. In addition to research into effective contraception and in addition to research into congenital diseases, your Lordships are asked to agree that embryos may be used in order to find treatments for serious and debilitating illnesses that affect literally millions of people.

We must decide on such a balance. It is clear that this research has the potential to provide the answers to these diseases. The human embryo has a special status and we owe a measure of respect to the embryo. We also owe a measure of respect to the millions of people living with such devastating illnesses and the millions who have yet to show signs of them. This matter is not taken lightly but such research provides the one real hope for those who wait on our decision today. I beg to move.

Moved, That the draft regulations laid before the House on 12th December be approved [33rd Report from the Joint Committee, Session 1999-2000].--(Lord Hunt of Kings Heath.)