May I first of all take this opportunity of thanking the Committee members for allowing my colleagues and I to present our evidence to the Select Committee today.
I am joined by Professor David Prentice, Professor Neil Scolding, Mr. Gareth Williams, and Dr. Michael Antoniou.
Before we respond to your questions, I would like to summarise the position which we hold in relation to the Human Fertilisation and Embryology (Research Purposes) Regulations 2001. In the light of the decision of the High Court last Thursday and the decision of the European Parliament on Wednesday last, in relation to the use of EU funding for experiments using human embryos for cloning, this is a timely moment to revisit these issues.
On April 28th, 1999, in a debate which I initiated on the floor of the House, and subsequently during a debate with Lord Winston organised by the Parliamentary and Scientific Committee, on December 13th 1999, and then, in opposition to the Orders, on January 22nd last I set out my principled reasons for opposition. I argued that the Orders were unethical, of dubious legality, and unnecessary and that, at an international level, they placed us at variance with most civilised opinion .
In January I moved an amendment calling for the creation of a Select Committee to meet prior to primary legislation and I questioned both the pell mell rush – which Lady Warnock described as the “bullying of parliament” -and the use of unamendable Orders piggy-backed onto inappropriate legislation as a means of achieving the Government’s objective.
A former Law Officer, Lord Rawlinson, warned the Government that their approach was open to contest in the Courts and the outcome in the High Court last week more than vindicates that opinion.
Although grateful for this opportunity to submit oral evidence, I stand by my criticisms of the process that has been used. While admiring many of the members of Your Lordships Committee personally, I cannot believe that you are easy with the principle of creating retrospective Select Committees. As I said in the House of Lords in January:
“Imagine a court of law where the judge gave out the verdict and sentence before hearing the defence, the prosecution and the witnesses. Such a process would be held up to ridicule.” (Hansard, House of Lords, 22.01.01., Col. 23)
In addition, the objectivity of the whole embryo research and human cloning debate has to be called into question. When the HFEA and the HGAC asked a Committee of four people to act as an advisory body it appointed them knowing that all four were from scientific backgrounds, that all four had previously expressed support for cloning, and that two had links with the pharmaceutical industry. The Prime Minister recently put the value of the European bio-tech industry at £70 billion; others have put it at £100 billion. It therefore wields incredible and disproportionate influence and power.
By contrast, the Chief Medical Officer’s 14 strong Expert Working Group on Therapeutic Cloning did not contain any dissenting voices. It has always troubled me that anyone who upholds the sanctity of human life from fertilisation is automatically excluded from the debate, and especially from key committees.
A further illustration of this problem has been highlighted by Dr Elizabeth Allan, who has submitted written evidence to you, that the first license application for work with human embryonic stem cells has been sent by the HFEA for peer review to scientists already working with animal embryonic stem cells. Such scientists have a clear interest in approving the application and may be in ignorance of the advances made using adult stem cells.
The legitimacy of the consultation process has therefore been seriously undermined and does nothing to assuage the concerns raised by the House of Lords Science and Technology Select Committee that the ethical debate and scientific debate are out of sequence and that public opinion is therefore being alienated. They said “Science’s relationship with United Kingdom society is under strain.”
Today you will hear oral evidence from those who are opposed to the Regulations. You will today hear from Professors Scolding and Prentice, and Dr. Antoniou. But there are others who would have been happy to submit oral, as well as written, testimony. These include Dr. Elizabeth Allan, who has submitted highly detailed and impressive written evidence, Dr. Phil Jones of Oxford University, Dr Michelene M Roth of Harvard Medical School, and members of the Campaign Opposing Exploitation of the Disabled, whose patron is Baroness Masham. This organisation wrote to Peers in January expressing its concerns over the manner in which disabled people were being exploited. Lord Darendorf rightly said in the debate in January that it is wrong to caricature people who oppose the use of human embryos in destructive experiments as being in favour of human suffering.
One does not have to believe in the sanctity of human life, or that life begins at fertilisation, to be concerned about the general commodification of human life. Every generation is tempted by the seductive and tantalising prospect of universal happiness as a trump over all other values and principles, but human dignity must always be defended against the abuse of scientific techniques. These Regulations, in allowing embryos, new human beings, to be created, manipulated, impregnated, disembowelled and destroyed, remove from them the last vestiges of respect that the Warnock recommendations were supposed to have left them. Exactly how can the “special status” of the embryo be reconciled with these Regulations? .
Lest anyone believe that there is any theological justification for the way we treat embryos in the UK, I refer the Committee to the written submission by an ad hoc group of Christian theologians from the Anglican, Catholic, Orthodox and Reformed tradition. They conclude:
“In asserting that life must be defended from conception, twentieth century Christians were in continuity with the belief of the early Church that all human life is sacred from conception. This view has been constant in the Christian tradition, despite disagreements over the origin of the soul and the legal penalties thought appropriate for early or late abortion. The only exceptions to this constant view have been the Roman Catholic laxists of the seventeenth century and some Protestant and Roman Catholic writers of the late twentieth century. The great weight of the tradition, East and West, Orthodox, Catholic and Reformed, from the apostolic age until the twentieth century, is firmly against any sacrifice or destructive use of the early human embryo, save in the context of seeking to save the mother’s life.” (See attached list of those who endorse this statement – Appendix A)
Furthermore, the extent of religious, not just Christian, concern over these Regulations was graphically illustrated by an unprecedented joint letter that Lordships received in January. The signatories were 11 of our religious leaders, headed by the most reverend Primate the Archbishop of Canterbury. They included the Chief Rabbi, the Cardinal Archbishop of Glasgow, the President of the Muslim College, the Director of the Sikh Network, His Holiness the Dalai Lama, and other leaders of the Christian denominations.
As I said in my address to the Parliamentary and Scientific Committee in December 1999, to treat the “human embryo as just another accessory, to be created, bartered, frozen or destroyed – has taken us a long way from the traditional belief that life is a gift from God, and to be treated with reverence and accorded profound and deep respect.”
Yet not only are the regulations unethical, they are also illegal in so far as the attempt to authorise experimental or as the Government likes to call it, ‘therapeutic’ cloning.
In our Response to the HGAC/HFEA consultation paper, Cloning Issues in Reproduction. Science and Medicine’, in April 1998, the Parliamentary All-Party Pro-life Group stated that:
“The HFE Act defines an embryo as ‘a live human embryo where fertilisation is complete’ and ‘references to an embryo include an egg in the process of fertilisation’. (section 1(1)(a) & (b)) Since a cloned embryo has not undergone fertilisation, it might be argued that a cloned embryo is not an embryo for the purposes of the Act. If the courts were to adopt this interpretation, it would follow that the HFEA has no power to regulate the creation or keeping of cloned embryos.” (APG)
– a view endorsed in the High court last week.
Professor Ian Wilmut of ‘Dolly’ fame supports this view. In his book, ‘Second Creation’ at p.299 he comments on cloning;
“..the essential part of the creation process – the fusion of eggs and sperm – is missing. Fertilisation is replaced by another process: that of nuclear transfer.”
Section 3 of the 1990 Act imposes restrictions on what may be done with ’embryos’. Having said that an embryo cannot be kept after the appearance of the primitive streak, section 3(4) defines the primitive streak as appearing 14 days after “the gametes are mixed”. However, CNR does not involve the mixing of gametes. It involves (and as the female egg is evacuated this itself is arguable) only one gamete. Therefore, if section one is interpreted in the light of section 3(4), cloned embryos cannot be subject to the 1990 Act.
The HFE Act specifically prohibits cloning by the nuclear substitution of a cell that forms part of an embryo. (section 3(3)(d)). In 1990 it was assumed that cloning would involve the nuclear substitution of a fertilised egg. The ‘Dolly’ technique was then unknown. Parliament intended to cover all forms of cloning, whether live birth cloning, or, as the Government has rebranded it,’reproductive’cloning or experimental cloning. (from APG submission to Select Committee para 2.7.)
The Minister, Yvette Cooper, acknowledged;
“It is true that Parliament in 1990 did not envisage the possibility of cell nuclear replacement.” (Hansard, House of Commons, 19.12.00 Col. 215)
Yet this is what the Government wanted to authorise through the Regulations. Furthermore, even though the House was debating something which Parliament had not envisaged in 1990 we were told by Miss Cooper that “I do not believe that there are fundamentally new moral issues at stake that were not raised in the debate on the 1990 Act.” (Col. 215) Many of your lordships House and the High Court were of a different opinion.
I submit that the law, as represented by the HFE Act, has fallen way behind the science, and is in urgent need of repeal, or at the very least, comprehensive review. The possibility of human embryos being produced without eggs is a real one (see Dr.Allan’s submission, pp. 63-65), reiterating the need for a new and comprehensive definition of the word, “embryo”. Legislation is also required to prohibit all possible combinations of human and animal genetic material in embryos and I am concerned that the British Government, unlike its US counterpart, have no plans at present to collect centrally information on the importation and use of stem cells. (Written answer from Lord Hunt, 12.11.01 PQ 1949/2001/2002 – to be circulated as Appendix C)
On 27th of July, 2000, Lord Hunt in an earlier written answer (PQ4105/99/2000 to be circulated as Appendix C) said that “the importation of embryonic stem cell tissue is not regulated by the HFEA 1990.” It should be.
Finally, from the legal perspective, the regulations approved by Parliament earlier this year authorise licences to be issued for new purposes. Therefore, they raise new principles, a point which the Committee may wish to pursue with us.
Amongst other things, we must consider:
increasing knowledge about the development of embryos;
The basis of the ‘safeguards’ provided by the 1990 Act is that research on human embryos would be allowed only if directed towards clinical goals deemed sufficiently worthy, a utilitarian calculation with which I disagree. But the new regulations allow pure research for “increasing knowledge about the development of embryos” and undermine the need for justification to be given for certain research projects, despite what Ministers in both Houses may have said. ( see Y Cooper, House of Commons, Hansard, 19.12.00, Col. 214-215, Col. 219, Cols. 260-261 & Lord Hunt, House of Lords, Hansard, 22.01.01, Cols. 18-19)
Once again, I draw members’ attention to the written submission of the All Party Parliamentary Pro-life group;
“Any well designed experiment that a scientist might want to conduct on a human embryo would be licensed under the new regulations. Despite the fact that we have always maintained that the principles of the 1990 Act were incoherent, and that the “safeguards” provided were illusory, we find it most significant that those principles are now being quietly abandoned.” (APG Submission, para 3.9)
To summarise so far, the 2001 Regulations are both unethical and of dubious legality. Thirdly, however, they are unnecessary. There is no need to conduct embryonic stem cell research.
During the earlier debates I was pleased, Lord chairman, by your own remark that if alternatives existed then they should be pursued. My scientific colleagues will expand on the detail but it is now abundantly clear that adult stem cell research shows more clinical promise than embryonic stem cell research.
I will circulate some graphic examples of the ethical alternatives which offer common ground to all who wish to see scientific progress without the destruction of human life.
Clearly, the scientists will go into greater detail, but I would like to stress that we are not trying to ‘hype’ adult stem cells as Anne McLaren accuses us in a recent issue of ‘Nature’ magazine. (1.11.01, p.131) but it is not unreasonable to question the over exaggerated emphasis placed on the use of human embryos. For example, Yvette Cooper spoke of the 2001 Regulations as giving a chance to the paralysed child (Hansard, House of Commons, 19.12.00, Col. 221) and helping the Parkinson’s disease sufferer (Col. 222), as though those of us who opposed the Regulations were impervious to their suffering.
“For many diseases and conditions, it holds out the only hope anywhere on the horizon.”(Hansard, 19.12.00, Col. 260)
As my colleagues will testify, astonishing progress is being made in treating diseases and conditions using adult stem cells. Yet where are the advances with embryonic stem cells? Impatience with the inflated claims of some scientists seems to be building. For example, the Geron Corporation’s failure to make sufficient progress in developing medical treatments using embryonic stem cells has led the University of Wisconsin’s patent licensing foundation to threaten to revoke at least part of Geron’s exclusive commercial rights related to embryonic stem cells. (New York Times 02.11.01)
Furthermore, the use of embryonic stem cells carries serious and unpredictable medical risks. They include teratoma and teratocarcinoma formation (including hidden abnormalities), and the tendency towards unregulated growth. I am sure members of the Committee will have read of the disastrous side effects in patients with Parkinson’s disease following their treatment with foetal cells. Well, the medical risks attached to the use of embryonic stem cells are even higher. These risks can be avoided through the use of adult stem cells. Such cells are readily available, in contrast to the difficulties in obtaining a sufficient supply of eggs for experimental cloning, they are not liable to immune rejection, unlike foetal cells, and have demonstrated a far greater range of differentiation than previously anticipated.
May I conclude by referring to international opinion.
By passing regulations authorising unlimited embryonic stem cell research, Britain is dangerously out of line with most civilised opinion. By our pre-emptive actions and by failing to create international consensus we are endangering the opportunity to create a world-wide framework of law and regulation.
The current US administration have stated their opposition to destructive embryonic stem cell research,
President Chirac has said , “I do not favour the authorisation of therapeutic cloning….It leads to the creation of embryos for the purposes of research and the production of cells and, in spite of the ban, makes reproductive cloning practically possible and leads to the risk of trafficking in eggs….The ever-present search for the right ethical balance should not be balkanised at the national or European level, or it will be bound to fail.”
In Germany a member of their Parliament’s Ethics Committee likened experimental cloning to “cannibalism” and another warned, “We don’t want to repeat the dreadful genetic experiments made by the Nazi Regime.”
Dr Volker Herzog, director of the German Institute for Cell Biology has described work on embryo cells as a “fall from grace” (Frankfurter Allgemeine Zeitung, 08.07.01) On the 13th November the German federal parliamentary inquiry commission, ‘Law and Ethics of Modern Medicine’, resolved by 17 votes to 26 to prohibit the import of human embryonic stem cells. With this the commission rejected research on embryonic stem cells in Germany as this could proceed legally only with imported stem cells.
European Parliament Resolutions of 14th April 1997 and 15th January 1998 are unambiguous in their opposition to cloning.
I will now circulate an extract from Resolution, B5-0710, 0751, 0753 and 0764/2000, (which states that”..’therapeutic cloning’, which involves the creation of human embryos solely for research purposes, poses a profound ethical dilemma, irreversibly crosses a boundary in research norms and is contrary to public policy as adopted by the European Union”) and the text of the Resolution passed last week (which banned EU funding for experiments using cloned human embryos)..
I will also circulate an extract from the European Convention on Human Rights and Biomedicine which prohibits human cloning. Under Article 18 (2) of this Convention the creation of human embryos for research purposes is prohibited. Furthermore, the Additional Protocol to the Convention For The Protection Of Human Rights And Dignity Of The Human Being With Regard To The Application Of Biology And Medicine, on the Prohibition of Cloning Human Beings is categorical in its prohibition on cloning;
“Article 1 (1): Any intervention seeking to create a human being genetically identical to another human being, whether living or dead, is prohibited.
Article 1 (2): For the purpose of this article, the term human being “genetically identical” to another human being means a human being sharing with another the same nuclear gene set.”
I hope that your Select Committee will be calling Government Ministers in order to establish how they intend to reconcile their publicly declared intention to sign this Protocol and Convention while promoting the 2001 Regulations. They are clearly incompatible.
Members of the Committee should be in no doubt as to the extent of British isolation from the International community. Why else would a maverick like Severino Antinori, who has only last week declared his intention to attempt the first production of cloned human embryos within the next few months (Reuters, 05.10.01), be seeking to work here?
The Government has expressed its opposition to live birth, or ‘reproductive’, cloning but the knowledge of early embryonic development acquired through experimental cloning inexorably paves the way for full live birth cloning.
The French and German governments have recently petitioned the UN General Assembly to place the cloning issue on its agenda so that negotiations to prohibit human cloning could begin as soon as possible.
I will now circulate some further corroborative evidence:
Dr Alan Trouson, animal cloner and human IVF specialist has said; “The Creator’s (a pseudonym for a pro-cloning scientist) spirit has been awakened by the historic moment we’re in right now; a convergence of under-the-radar pro-cloning agitation, falling taboos, and the inexorable march of science. These fears are overlapping so neatly that human cloning could be done tomorrow”.
In addition, Dr Michael Bishop, President of Infigen, a company specialising in animal cloning has claimed: “Last spring, I attended a secretive summit which attracted every known human cloner. One evening after dinner, some of us were talking, and there was not one of us who believed it (human cloning) had not already happened.” (both quotes from Garrett’s book, ‘Human Cloning and the Abuse of Power’.) Lest these two scientists be dismissed as reckless mavericks, a recent Sunday Times report (Oct. 28, 2001) – ‘Monkey test breakthrough brings human clones closer’ – revealed that Scientists have created the first embryonic clones of an adult primate and are preparing to implant them into surrogate mothers.
As the All-Party Parliamentary Pro-life group said in our written submission to this Committee, the licensing of CNR projects works directly against the Government’s. stated objective to stop ‘reproductive’ cloning; “..it is not unlikely that the main technical hurdles to reproductive cloning would be overcome by British researchers working under licenses granted by the HFEA.” (APG Submission para. 4.4)
To conclude, the Human Fertilisation and Embryology (Research Purposes) Regulations 2001 are unethical, of dubious legality, unnecessary and out of line with civilised international opinion. As I am sure that your lordships will recognise, the mass destruction and trivialisation of human life – and its corrupting effect on society as a whole – is the supreme challenge of our times.