RESPONSE TO THE PUBLIC CONSULTATION ON THE
REVIEW OF THE HUMAN FERTILISATION & EMBRYOLOGY ACT
FROM THE CHURCH AND SOCIETY COUNCIL OF THE CHURCH OF SCOTLAND and its SOCIETY RELIGION AND TECHNOLOGY PROJECT
This is a submission from the Church of Scotland through its Church and Society Council and its Society, Religion and Technology Project (SRT).
The General Assembly of the Church of Scotland has considered in detail many matters to do with reproduction, stem cells, the embryo and research as well as a range of wider issues of the family. Study groups of the Board of Social Responsibility reported on human genetics and genetic selection in 1995, on embryology and IVF in 1996. In 1997 the SRT Project reported on animal and human cloning. Both groups reported on stem cells and ‘therapeutic’ cloning in 2001, and further stem cell reports were made from 2002-4. Sex selection issues were considered in 2002 and 2003. Our responses draw on this body of work and also on a multi-disciplinary expert working group on stem cell issues which is currently in progress and which will report to the May 2006 Assembly.
This submission also draws on the ongoing work of the SRT Project, in its pioneering role in the ethical debates on cloning, stem cells and related areas of research, and in its considerable involvement in the evolving understanding of public engagement on biosciences and its role vis a vis the regulatory process.
SRT has also been involved with wider international discussion of research legislation in these fields through the Bioethics Working Group of the Conference of European Churches. It has made invited presentations on stem cell and cloning issues to the European Commission’s Ethical Group on Technology and the New Sciences, to the Human Genetics group of the European Parliament, and to members of the European Parliament. It has several times been an official observer to meetings of the Bioethics Committee of the Council of Europe (CDBI) and the International Bioethics Committee of UNESCO.
We welcome the Government’s intention to re-examine legislation in this field. The Act is much respected and was ground-breaking legislation, but has remained controversial on issues such as embryo research, sex selection and stem cells. We have been concerned that the time was ripe to consider whether the 1990 HFE Act reflected public opinion and the considerable recent developments of thinking on ethical and societal issues on biotechnology.
Concerns about the Role of the Commons Select Committee report
The SRT Project engaged with the previous consultation process of the House of Commons Select Committee on Science and Technology on Reproductive Technologies. It expressed concern at the manner in which this parliamentary committee reported on these questions. We would be much concerned if the Government were now to set too much weight to the views expressed in that report. On relevant matters, more notice ought to be given to the much more studied and authoritative analysis in the House of Lords Select Committee on stem cell research.
We would especially note that the philosophical focus of the Commons Select Committee to proceed unless there was demonstrable ‘harm’ is seriously inadequate as an ethical basis on such matters of moral concern and public sensitivity. We would be most concerned if matters of ethical principle were reduced ones of comparative risk assessment. This point is important to many of the questions. Family, consent and welfare issues all demand a broader base than a technical focus on ‘harm’. ‘Harm’ is also difficult to specify and is too limited a concept. The embryo has a special place in the concept of human being, which requires an ethical as well as a technical regulatory framework. The example should not be followed of the Clothier Committee of 1992 in which a judgement on germline gene therapy was made purely on risk grounds without assessing the ethical concerns.
We start from the premise that all humans are equally creations of the triune God, uniquely made in God’s image, regardless of gender, age, race, health, wealth, rationality, genetic ‘impairments’ or any other functional framing of the human condition. Human beings are not ‘no more than’ products of time and chance in a random evolutionary process. The various levels of scientific description, valuable as they may be, are inadequate to be seen as the sole account of human being and its origins. Each individual is loved by God and is of inestimable value exactly as each is. Humans are also made relational and communal. We value uniquely the union between man and woman and have regarded with concern developments in reproductive technologies that loosen the ties of that bond. For believers, the ultimate fulfilment of human life lies in the life beyond death in resurrection in union with Jesus Christ.
In the footsteps of Jesus Christ many Christians are deeply committed to works of healing, medical care and research, and have been pioneers in many areas of medicine. We welcome many of the scientific developments which have enabled diseases to be understood and treated and suffering greatly reduced. We also recognise the finitude and fallenness of all human life before God and the inherent limits of medicine and medical research. The powerful mandate to heal the sick does not of itself override other moral considerations, but needs to be taken in balance with them in ways that are often complex and sometimes involve heart-searching dilemmas.
In approaching these issues we are acutely aware both of the magnitude of their theological import, their social implications and the difficult human situations of human suffering to which many of them relate, in childlessness, chronic or terminal disease and many other conditions. We acknowledge the dilemma of the individual and social dimensions of ethics in these fields. It is not easy faced with individual cases of pain and disease sometimes to stand back and take a wider perspective. Our Christian tradition calls us to do this with compassion and an appreciation of humanity on a broader scale as well as the individual.
The particular Presbyterian tradition of the Church of Scotland means that we approach ethics with the understanding that differences of judgement are to be expected among God’s people, as we seek together to understand the mind of God on novel and often highly technical challenges to moral reasoning. On matters to do with the embryo especially we are aware of deeply held and sincere differences of view within our membership, spanning the range from ‘absolute’ to ‘gradual’ positions of the developing embryo, but few, if any, would regard embryonic human life as possessing no moral status.
Q.1-12 The model and scope of regulation
Q.1 The Government believes that both the development and use of human
reproductive technologies, and their regulation in response to public concerns,
should continue to be subject to legislation. (Paragraph 2.7).
Q.2 On balance, the Government believes that the current model of regulation,
whereby Parliament sets the prohibitions and parameters within which an
independent statutory authority licenses activities, has worked well and should
continue. (Paragraph 2.14).
We strongly agree that human reproductive technologies should remain within a firm and all-encompassing regulatory regime, which should be no less tight in both force and scope than has been the case since 1990. It should remain under the licensing authority of a strong independent regulatory authority, embracing both clinical and research practice, as is at present performed by the HFEA. We are aware that pressures are being brought to bear on the Government by some figures in the scientific community and elsewhere to reduce the licensing powers, to deregulate research in these fields, or to liberalise the range of allowed practices. We note that this is to some extent reflected in what the dissenting members of the Commons select committee report referred to as its ‘libertarian’ aspects. Our experience of debating this issue suggests that there is not a widespread public sympathy for a relaxation of the HFEAct and its regulations.
We also note that at an equivalent stage in development in the mid-1990’s, a House of Lords Select Committee heard strong calls to limit the regulation applied to GM crops and their risks, which led to a reduced consideration for public concerns and eventually to the unfortunate backlash against the technology as a whole. Public support for reproductive, genetic and stem cell research is considerable, but it will only be sustained if people continue to feel confident that there is a tight system operated by an independent regulator answerable to Parliament. This is not a time to slacken the regulations.
We have also long been concerned at the situation in the USA where private sector embryo research and IVF clinics are essentially unregulated, and where individual states may adopt markedly different practices. Through our work in the international arena we have also had opportunity to see the high regard in which the HFE Act and its regulatory body are held internationally. While other countries may not agree with certain aspects that are allowed by the Act, many see the model itself as an excellent one and some have adapted it as a basis for their own legislations.
Q.3 However, the Government also accepts that legislation should be more explicit and provide Parliament with greater powers to debate and amend the law. In particular, the Government accepts the need to clarify the extent of any policy-making role of the regulator. (Paragraph 2.15).
We consider that the current functional model adopted by the HFEA generally works well, but that there are also notable failures in the current system especially as it relates to the handling of new scientific developments outwith the immediate scope in which the Act was framed. These would need to be addressed in any new legislation. We illustrate some of these in relation to the handling of various aspects of the stem cells issue.
i). On any substantial new research area there should be a statutory requirement on the licensing authority to undertake a wide-ranging public consultation, using appropriate methods of engagement. It should also be stipulated that such consultation needs to go beyond simply inviting written comments to a consultation document, which is generally recognised as insufficient to be the primary measurement of public concerns.
The public consultation undertaken by the HFEA on novel and controversial issues has been inconsistent and insufficient in respect of the stipulated purpose in Q.1 of the regulation of reproductive technologies in response to public concerns. Considerable effort was made by the HFEA to consult over foetal ovarian tissue in the mid-1990’s and on sex selection in 2003, but it did no consultation on stem cells, arguably the most important scientific breakthrough in its field of responsibility since the HFEA was set up. This was surprising because the Office of Science and Technology had just completed its major survey of the need for public consultation in the biosciences process, in which SRT took part, which has led to the extensive use of focus groups, citizens’ juries, consensus conferences, card games and other methods to gauge in depth public attitudes towards new technologies.
At the time of the Donaldson Report in August 2000, the public at large had just started to become aware of the issues, but the only opportunity to engage had been to make written responses to the consultation earlier that year. It is well established within the field of social research that the primary opinions gleaned from this process are those of the major stakeholder groups like ourselves, but that very few of the general public are in a position to take part. The Government, however, went straight from this expert committee report to a vote in Parliament within three months. This was premature in the view of many observers at the time. MPs told us that before the key Commons debate in December 2000, many still did not know how they were going to vote that evening. The fact that immediately after the two Parliamentary votes, the House of Lords called for a further wide-ranging ethical assessment is indicative of the failure to have consulted adequately.
ii). Closely related to this is that there should be a requirement on the regulatory authority to consult Parliament on important novel areas of science which occur from time to time.
We are aware of the limitations of public consultation and that the authority to decide ultimately rests with elected representatives in Parliament. This has not worked well enough in practice. For example, recently controversial licenses were granted by the HFEA which allowed for the creation of parthenogenetic embryos and for mitochondrial nuclear transfer without any public discussion and no apparent oversight from Parliament or any other body. It was of some surprise that the Commons Select Committee report commended the HFEA for having acted in this way, when elsewhere it calls for more Parliamentary oversight.
We agree with the present concept of a broadly based statute with powers for Parliament to amend in response to new scientific or clinical developments. A balance needs to be struck which allows the regulator something like HFEA’s present powers to interpret the meaning of the Act in more routine areas, but to enable powers to amend the regulations to be in the hands of Parliament for more major issues of principle or radical new areas of science.
It may be that a body needs to be set up to advise the Regulator on when Parliament should be consulted on a specific issue, but in any case a better regular reporting mechanism is required. It was not felt adequate that the only reporting mechanism should simply be an annual report to the Minister. This report might be taken to a relevant Parliamentary Committee and would subsequently be the subject of a Commons debate each year.
iii). Where Parliamentary powers are used to amend regulations in the light of new scientific advances, this needs to be undertaken in a way that is more independent of Government, especially if this is to be the matter of a free vote.
The Government’s power to determine the parameters of a proposed change of the regulations was too strong in the case of the stem cells debate in December 2000. MPs were given the option only to vote for all research with embryos into serious diseases (primarily for stem cell research) or none. This ignored the widely recognised ethical distinctions (as noted in the Donaldson report and by such leading authorities as the EC’s ethical advisory group) between spare IVF, created IVF and created cloned embryos. The Government overrode the protests of some MPs on this matter so that the ‘free vote’ was not as free as it should properly have been. The complaints which followed the unfortunate way the vote was framed led to the setting up of a House of Lords Select Committee in 2001.
iv). There is also a need to make clear the extent to which the Regulator should be obliged to take into account the views of Select Committee reports such as the Lords’ 2001 stem cells report, or other views of competent authorities. There was a concern that over recent issues such as cloned embryo research, the HFEA under legal advice stuck only to the letter of the law, to avoid the risk of judicial review, which had the effect of limiting the HFEA’s role of ethical review of new issues. The new authority’s mandate ought to allow it on suitable occasions to make ethical judgements over new technologies that are more restrictive than the law may formally require.
v). The documentation and decision making processes of regulator on embryo research licenses should be in the public domain.
It has been a matter of concern that the workings of the committees of HFEA are too opaque. In an era of transparency this is no longer acceptable. Over such sensitive matters of public concern, commercial confidentiality or patent concerns should not be allowed to override proper public scrutiny. It should be at the regulator’s discretion to decide which aspects, if any, should be withheld from the public for commercial purposes and with the principle that these should be the minimum.
The present system that requires a license applicant to give a lay summary of proposed research is laudable but it is not working. Not enough information is provided for the public to understand the import of what is being proposed. In the first Newcastle cloned embryo application the lay summary provided by the licensee was especially misleading and had no link to any other information. The Regulator should have power to require a more detailed description, with suitable explanatory links, and should advertise that access can be obtained on demand to the relevant primary documents of the application.
Q.4 The Government believes that legislation should make clear that all human
embryos outside the body are within the scope of regulation and subject to the
control of the statutory licensing authority regardless of the manner of their
creation. (Paragraph 2.20).
We agree. All embryos used ex vivo should be subject to regulation and control.
Q.5 The Government considers that the best approach is to define the forms of embryo which may be placed in a woman and in what circumstances,
… and to regulate other forms of embryo insofar as these are created and used for research. (Paragraph 2.22).
We strongly urge that where the use of embryos for research is allowed, it should only be done under very closely defined circumstances and subject to strict control of the regulatory authority. Many in the churches who might accept the use of spare embryos would object to their creation for research. This should remain regarded as something allowed only under exceptional circumstances.
Defining the embryo became problematical when legal doubts arose whether cloned embryos created by nuclear transfer would be covered by the definition in the HFE Act. The lesson from this is perhaps that the precise definition of the embryo (on which there will be many differing views) is less important then to ensure that the categories of embryonic entities and materials used in research should be broad enough not to leave any out of the scope of the legislation and of regulatory control. Please see our comments in response to Q.6.
Q.6 The Government proposes that eggs undergoing processes intended to result in the creation of embryos – whether fertilisation or other non-fertilisation processes – should continue to be subject to regulation. (Paragraph 2.27).
We agree. All eggs undergoing processes or made subject to processes which could result in the creation of an embryo should be subject to regulation regardless of whether that embryo is capable of progressing to a viable pregnancy. The current definition of the embryo and the handling of entities outside the definition is one of the less satisfactory aspects of the current legislation. It does not allow a proper account of parthenogenetic, artificial, hybrid or other usual embryonic structures to be defined and legislated. For example, this has led to the anomaly that while hybrids are absolutely prohibited by law, parthenogenetic embryos were a matter for the HFEA to decide. Both may be argued to be, in effect, embryos whose manner of creation make them too severely damaged to be viable, which raises serious ethical objections. It is of much concern that the HFEA has recently granted several licenses for research using parthenogenetic embryos without any form of consultation.
Q.7 The Government believes that the potential use of artificial gametes raises safety issues and that some uses may also raise ethical concerns. …
Ethical issues undoubtedly arise. It is worrying that the phrasing of this question is uncertain on this point. The ambiguous expression ‘artificial’ itself already connotes a sense of something technical and perhaps inappropriate about something deeply rooted in human meaning. Various routes already suggested to create gametes outside the normal human organs - such as using mice to create human sperm or the derivation of sperm and egg from embryo stem cells - would undoubtedly raise ethical issues. For example, profound questions of identity and belonging arise from gametes so produced.
Major risk questions have also been raised. In the present state of knowledge of artificial gametes it is highly unlikely that a clinical trial would be countenanced by a UK ethical committee. Artificial could be thought to include genetically engineering gametes.
… therefore the Government proposes that the use of artificial gametes in assisted reproduction treatment should not be permitted …
… but that the HFE Act should contain a regulation-making power giving Parliament more flexibility to allow the use of artificial gametes in future should it wish to do so. (Paragraph 2.31).
Giving flexibility to Parliament effectively implied that feasibility and safety were assumed to be the primary considerations rather than ethical concerns. Parliament’s powers must be such that ethical issues must be examined alongside safety. We would be concerned if this presumes that the primary consideration is not ethical but merely one of safety and clinical efficacy, which could be debated by Parliament if these were once assured. We criticised the Select Committee’s report for an inadequate ethical methodology on novel scientific developments in this respect. We would agree that Parliament should have the capacity to examine new scientific developments without having to address the entire Act, but that this should be framed in such a way as to consider whether the procedure was ethical as a pre-condition, before considering safety or clinical aspects. We make a similar point in connection with several other novel scientific procedures within this consultation.
Q.8 The Government seeks views on the extent to which regulation should apply to
the use of a couple’s “fresh” gametes. Should this be limited to technical and safety issues only or should treatment involving a couple’s fresh gametes be subject to the full requirements of the HFE Act where these are relevant? (Paragraph 2.37).
Gametes should be subject to the full regulation by HFEA where relevant. As soon as a third party is involved in medically assisted procedure, this third party has responsibility towards the creation of a child. Thus, fresh gametes in assisted fertilisation procedures should come under the HFE Act.
Q.9 The Government intends to make the operation of internet services which involve the supply of gametes subject to regulation. Should the law (a) prohibit the operation of such services, 9b) regulate the safety and quality aspects of such services, (c) regulate safety and quality and remove any anomalies with other methods of gamete donation?
(a) would be the preferred option but it would clearly be impossible to impose a ban on service providers outwith the UK. Prohibition would nevertheless be desirable. Note that the Church of Scotland is opposed to gamete donation on the basis that it involves the intrusion of a third party into the marriage relationship (General Assembly 1996).
Q.10 The Government seeks views on whether moving toward the transfer of a single embryo during a treatment cycle should be (a) a matter for legislation; (b) be a matter for the regulator; (c) be a matter for the professional bodies only.
The professional bodies would be the best agencies to regulate this area. It would seem wrong to introduce legislation which would prevent twin pregnancies. The risk to the mother increases considerably in multiple pregnancies. This was taken into consideration by NICE in their recommendation to transfer no more than two embryos in one cycle. Obviously parents require open and honest advice on the risks involved in multiple pregnancies. The overwhelming desire of parents to achieve a pregnancy, however, tends to influence them to accept risks. Hopefully improving techniques will make single embryo transfer more successful in future.
Q.13-17 : Welfare of the child
In the context of medically assisted procreation, the 1996 Deliverances of the General Assembly of the Church of Scotland, which represent the latest statements on the subject of the welfare of the child (understood in the broad sense of rights, interests and well-being ), indicate that the Assembly will:
- Recognise that the IVF treatment may be right for married couples and, while not equating cohabitation with marriage, for unmarried couples in faithful, stable, lasting relationships, where the gametes used are those of the partners;
- Oppose donor insemination and IVF treatment where either the sperm or the egg are donated;
- Oppose the offer of infertility treatment to those in same sex relationships;
- Oppose surrogacy;
Whilst formulating these Deliverances, the Assembly also took into account the 1996 report of the Board of Social Responsibility of the Church of Scotland which indicated that:
“The question of who should receive infertility treatment arises because the traditional understanding of the family (a husband, a wife, and one or more children) has been challenged by social developments, especially the growing incidence of divorce, and the increasing number of children born to single women. Assisted reproductive technology has also made the notion of parenthood more complex. The debate about the meaning of the family is carried over into the field of reproductive medicine as unmarried heterosexual couples, same sex couples, and single women, request technical assistance in reproduction. ”
In this context, the report indicated that while not denying the “capacity of people of homosexual orientation or single parents to rear children with loving concern” it emphasised the importance for “children to have role models of both genders” and that “assisted reproduction should only be used to overcome obstacles to pregnancy in a relationship where child-bearing is the natural outcome. ”
In other words, since the General Assembly of Church of Scotland took the view that some aspects of the social context in which a child should be created as a result of treatment are to be addressed, legislation should include provisions relating to the welfare of the child. In addition, the welfare of the child requirements in a new HFE Act should be subject to HFEA guidance and regulation which should address the need for a father and a mother as well as the medical, social and psychological risks which may endanger a child.
The Church would also like to strongly support the principle that the best interests of children created through infertility treatment should be paramount. Because of this, it would question whether any modification to the present HFEA Code of Practice should take place which supports the ability for prospective parents to provide a stable and supportive environment for a child. Accordingly, it is surprised that an HFEA decision was announced on the 2nd of November 2005 to delete any mention of the supportive environment for a child in a new Code of Practice to come into affect in January 2006 when the Department of Health was consulting on this very topic between the months of September and November 2005!
Q.18-30 : Use and Storage of Gametes and Embryos
Q.18 The Government believes that on balance, the HFE Act’s existing requirements for written consent remain proportionate and appropriate, and prove a valuable protection of the wishes of patients and donors. Do you agree?
Agree to consideration. These requirements should also apply to assisted conception treatments in all licensed clinics.
Q.19 Should the requirement for written consent be extended to apply to all assisted conception treatments provided in licensed clinics, including treatment using a couple’s own ‘fresh’ gametes such as IUI and GIFT?
Yes. Obtaining informed consent should be a sine qua non in all medical procedures and in the unique and complex field of fertility treatment this requirement should be clear in legislation.
It is difficult to see why obtaining written consent should be considered a burden on licensed services. Surely this is no more than good clinical practice and demonstrates that appropriate counselling and information have been given.
Q.20 The Government proposes that the laws should allow the storage of gametes without the consent of a person lacking capacity where the gametes were lawfully removed. Do you agree?
At present legislation does not cover the contingency of a situation whereby the removal and storage of gametes from a person rendered incapable of consent by accident or illness might be desirable to allow them to reproduce at a future date.
A similar scenario might arise with a young person below the age of informed consent. It would seem sensible to legislate for this contingency while retaining the need for that person’s consent to usage of stared gametes at a later date. Nonetheless storage should not take place without the appropriate lawful consent.
Q.21 The Government proposes that a person’s gametes stored in these circumstances may only be used with the consent of that person. Do you agree?
Yes. (See Q.20)
Q.22 The Government invites views on whether the law should be changed to require the withdrawal of the consent of both parties whose gametes were used to create an embryo in order to allow a stored embryo to perish, and that such an embryo should otherwise continue in storage until the statutory maximum storage period is reached.
Yes. This change would appear to be acceptable and sensible. The Government’s position is clearly that it would not give one partner priority over the other. Dual consent is necessary. It should also be clarified whether the stored embryo should be allowed to perish or to be used for donation.
Q.23 Do you think that the law should continue to set statutory maximum storage periods for gametes and embryos and if so how should these be determined?
Storage limits are currently set both for reasons of safety (the effects on gametes or embryos of extended storage) and to avoid problems arising from disputes between the original donors. Maximum storage periods therefore should not exceed the natural reproductive life of the woman.
Q.24 If you think that the law should continue to set statutory maximum storage limits, should the storage limits for donation be brought into line with the storage periods for treatment.
It would seem logical to bring maximum storage limits for donation into line with
this. We recommend that couples should be counselled on the repercussions of creating excessive numbers of embryos given that there are currently more than 100,000 embryos in storage nationwide.
Q.25 The Government invites views on whether the requirement on licensed centres to provide “such relevant information as is proper” should remain a legal requirement.
This should remain mandatory. Standard setting requires a firm evidence base. This is simply good clinical practice.
Q.26 If so, should that requirement be extended to require clinics to be specific about which treatments they provide are outside the National Institute for Clinical Excellence’s clinical guideline on infertility treatment?
Yes. This should be a requirement. All centres offering treatment, as already stated, should meet quality and safety standards. NICE guidelines are designed to indicate best practice. Deviation from those guidelines should be clearly identified.
Q.27 The Government invites views on whether the requirement on licensed centres to offer a suitable opportunity to receive counselling should remain a legal obligation.
Yes. Counselling cannot really be separated from the giving of information in the consent process. Failure of communication is at the root of most problems in every area of medical care. Communication is a two way process. There are, of course, added complexities which would make counselling mandatory in a donor situation (although General Assembly of course is opposed to D.I.) The BMA has had concerns in the past that people who had no realistic chance of conceiving had been accepted for private fertility treatment. Good pre-treatment counselling should include not only risks but chances of success. (note 24)
Q.28 Alternatively, should the legal requirement to offer a suitable opportunity to receive counselling apply only in the case of treatment involving donated gametes and embryos?
See under Q.27 above.
Q.29 The Government invites views on whether the appropriate level of compensation for donors should be set by the regulator or by Parliament by means of regulations, rather than by the HFEA as now.
Remuneration for donors raises many issues where the sum involved exceeds simple payment of expenses. Setting an arbitrary figure such as £15 would not appear to be very logical as anything other than a very token payment.
If a donation is made for altruistic reasons the remuneration would obviously only be for reimbursement of expenses.
Perhaps a useful parallel might be drawn with Blood Transfusion Services which operates very successfully on a ‘no fee’ basis. The Church of Scotland view is that human body parts should not be traded. Parliamentary control seems most apt.
Q.30 The Government invites views on whether payments for the supply of gametes (other than compensation for expenses or inconvenience) should be prohibited in all circumstances, including research that is currently outside the scope of the HFE Act. (Paragraph 4.47).
Payment for gametes should be prohibited, beyond the normal levels of compensation for inconvenience and necessary expenses. The widely accepted international standard is laid down in the European Convention on Human Rights and Biomedicine is quite clear that the human body and its parts should not be the subject of financial gain. From a Christian perspective the human body is a gift of God and should not in any of its parts or in any sense be commodified into an item of trade. It has a dignity which cannot be reduced to an object of the kind that can be bought, sold or bequeathed. Grave international concerns have been expressed about the illegal practice of trafficking in human organs. In this context, significant social harm would also result in setting up a market in the sale of gametes. The profit motive must not drive reproductive decision making. Whilst it may be argued that individuals have a right of disposal of gametes in altruistic donation, this does not equate to having property rights of exchange for money.
Q.31-38: Reproductive choices: screening and selection
Q.31 The Government invites views on whether legislation should set out the general criteria under which embryo screening and selection can be undertaken. If so, what should those general criteria be? (Paragraph 5.19).
Many in the Church of Scotland would be absolutely opposed to Pre-implantation Genetic Diagnosis and selection because it knowingly sets out to destroy embryos that do not meet the selection criteria. The likelihood that they may carry a predisposition to a serious condition is not sufficient warrant for other humans to deny them the chance of living.
There is a further potential objection with procedure, if the totipotent cell(s) removed to perform the test could be considered as equivalent an embryo (as in German legislation). If
subsequent research demonstrates that this cell could become a viable embryo in its own right, then its destruction through the testing procedure would be seen as unacceptable by those, in the church, who consider that an embryo has the same moral status as an adult human person.
Others might accept PGD only under very limited circumstances. In response to the list of conditions in section 5.9 of the main report for which the screening or selecting of embryos or gametes are allowed by the HFEA we would make the following comments.
1. so that the child bears similar physical characteristics to the infertile partner or couple where donor gametes are used
2. to avoid inherited genetic disorders and diseases
3. to avoid sex-linked diseases (such as Duchenne muscular dystrophy)
4. to screen out chromosomal abnormalities to reduce the risk of miscarriage
5. so that the child is able to be a tissue donor for a seriously ill sibling (this involves a process known as ‘tissue-typing’).
Sex selection in the case of gender-linked serious genetic disease was accepted by the 1996 and 2002 General Assemblies (condition 3). The general use of embryo screening inherited genetic disorders and diseases (condition 2) has not been debated by the Assembly, and PGD is one of the issues which the stem cells and embryology group will examine in due course. For the present consultation, we would judge that only to be acceptable in cases of exceptional severity. It should not be treated as a general option for all genetic disorders and diseases.
We would oppose the inclusion of condition 1 above because this is not a medical issue but one of personal preference. It is not justified reason to sanction the destruction of the embryos just because they expected appearance of the child would be judged unacceptable. Condition 5 is discussed under Q.35 below.
On the assumption that embryo screening would continue to be allowed in law, we advocate that it should be permitted only under a clear legislative framework set by Parliament. We note in passing the difficulty which the House of Lords’ select committee on stem cells had in identifying what is meant by ‘serious disease’ with regard to embryo research in the present Act. Nevertheless, we suggest that a list should be drawn up of the conditions for which PGD may be permitted, with the presumption that all others are excluded. We also suggest that power be given to the regulatory authority to add conditions others to this list, should clear cases emerge in future.
We share the concern of the bioethics working group of the Conference of European Churches about ‘liberal eugenics’, described by Habermas as being ‘carried out by the agglomerated preferences of consumers in the genetic supermarket’. We consider that such cases remain exceptional and should not be left to the choices of patients and clinicians. The avoidance of significant harm is the key ethical criterion, over and above reproductive autonomy. It is not for government to support any particular world view, but to put in place measures likely to protect individuals and society from significant harm.
Diminished tolerance of the ‘imperfect’ or disabled are also deemed to have such serious consequences for social attitudes and family relationships that a stance must be taken against moves in the direction of eugenic selection, either positive or negative. We are greatly concerned at the shift in attitude from welcoming acceptance to a critical scrutiny of whether an embryo is ‘fit’ to be brought to term.
Clear criteria are also required in terms of clinical risk, validity, utility and specificity. Strict controls must be applied to address questions of poor reproducibility, false readings, and the degree of association between the identified gene and the condition.
There is merit in the use of screening with a view, not to selecting out embryos, but for enabling cases where certain early remedial measures could be taken for a pregnancy which would be continued.
Q.32 Do you think that there should be a prohibition on deliberately screening in, or
selecting for impairments and disabilities – as opposed to screening out, or selecting against? (Paragraph 5.20).
Screening in disability is severely problematic ethically because it pre-determines a disability which the child might have wished not to have had, and such a far-reaching decision cannot be meaningfully taken on that child’s behalf. This would be an inappropriate and irreversible degree of control over one’s children’s phenotypic traits. Screening out disability runs the risks of stigmatisation of those deemed to be disabled. We do not subscribe to the notion that certain members of the human race are less ‘fit’ to exist than others because they have particular disabilities.
Q.33 Should the particular uses of embryo screening and selection remain a matter for decision and licensing by a statutory regulator in accordance with the general criteria set by Parliament? (Paragraph 5.21).
Q.34 Alternatively, should the particular uses of embryo screening and selection be a matter for patients and clinicians, within the legal limits set by Parliament? (Paragraph 5.22).
As already indicated under Q.31 above this should be a matter for decision and licensing by a statutory regulator in accordance with the general criteria set by Parliament.
Q.35 What are your views on the regulation of PGD with tissue typing? Should the
legislation set out criteria under which this should be allowed? If so what should
they be? Beyond that should particular uses need to be approved by the regulator – or should patients with their clinicians be free to make their own decisions? (Paragraph 5.23).
On balance, we would be opposed to this use of PGD.
Many were concerned when the HFEA changed its stance and allowed this practice in 2004. According to our correspondence with the HFEA on this matter, the change was made primarily on the basis of a favourable risk assessment. Ethical concerns evidently played a minor part. The use of PGD for tissue typing raises serious ethical concerns because it involves choosing the child to be born because of its potential value for the life of its sick brother or sister. Instead of the Christian view of a child as a gift, the child to be is being seen in terms of its usefulness against certain criteria. This is an essentially instrumental view of a future child. This is having a child not because of what any child could give but only what a certain type of child could give.
In the process the couple would also be discarding many otherwise perfectly good embryos. They are discarded not because they were simply non-viable, as may happen in normal IVF treatments, and not because they carried a severe genetic disorder. They are discarded because they did not come up to a certain standard, that of their functional ability for someone else. The selection of a future child because of its function or quality is a route we should not begin to go down.
While the focus is understandably on the deep concern for the existing, suffering child, there is an the ethical obligation not to do harm as well as to do good. There are concerns about the new child. Statistically, in a certain proportion of cases the procedure will work, but in some it will fail. The sick child will die despite the donation of cells from the new sibling. Will the donor child go through later life with a sense of failure or guilt, because the reason he or she was chosen, as against all the other discarded embryos, did not work? The very reason why the child was ‘chosen’ is undermined. This may not be an entirely rational reason, but it could be very real, as in the case for example of the guilt often felt by sole survivors of disasters in which everyone else was killed.
One ethical solution to the case might be if the couple, having chosen the best match embryo, were prepared to freeze the other embryos for later implantation, or perhaps donation to an infertile couple, rather than just to discard them. The choice would then be the timing not the child.
The case history of this area also raises concerns. We also note that one family has gone through 6 cycles of IVF and still failed to find one viable embryo which would be a tissue match. The Nash family are said to have gone through 30 embryos to produce the one which was selected. Although this did succeed in saving the sibling, it underlines the sense of instrumentality which some feel about tissue-typing PGD. Even for those who do not see a less than 14 day embryo as a full person, there is a certain distaste in going for 30 embryos in order to produce just 1 to fulfil the intended purpose. If there is any meaning to the special status of the embryo as the basis for the current Act, then a limit to the number of cycles allowed to obtain an embryo. This would also be necessary to protect the mother.
Q.36 The Government invites views on what statutory controls, if any, should apply to the screening and selection of gametes. (Paragraph 5.27).
The Church of Scotland objects to the use of donor gametes, this would apply only to selection of one’s own gametes. We would wish them controlled by statute as with embryos. We are aware that considerable professional concerns have been raised about commercial organisations seeking to offer sex selection without the stringency that is required of IVF clinics.
Q.37 The Government seeks views on sex selection for non-medical reasons. In
particular, should this be banned? Or should people be allowed to use sex selection techniques for family balancing purposes as the Science and Technology Committee suggest? If so, how many children of one gender should a couple already have before being allowed to use sex selection techniques to try for a child of the other gender? (Paragraph 5.32).
From its 1996 and 2003 General Assemblies the Church of Scotland is clearly opposed to the notion of sex selection for any purpose other than the avoidance of a serious gender-linked genetic disease. The relevant deliverance is as follows :
5. Urge HM Government that sex selection by sperm-sorting:
(a) be brought under the regulatory control of the Human Fertilisation and Embryology Authority, and
(b) be made illegal except where serious hereditary gender-related disease is to be avoided, in accordance with the European Convention on Human Rights and Biomedicine, article 14
We also note that the public consultation process undertaken by the HFEA clearly indicated that there is widespread public opposition to sex selection for so-called family balancing. We are concerned at the manner in which the Commons Select Committee report (para 142 especially) sought to undermine this. It considered that ‘we do not see this [majority public opposition] as adequate grounds for prohibition’ it in favour of a view solely based on the risk of harm. ‘The onus should be on those who oppose sex selection for social reasons using PGD to show harm from its use.’
We disagree with the Select Committee’s view of the criteria to be applied. This is not primarily a matter of risk but of ethics. The key principle is the maintenance of the crucial ethical distinction between medical and non-medical reasons, which is the root of the European Convention on Human Rights and Biomedicine and also UNESCO Human Genome Declaration on this subject. If social reasons were once accepted as a legitimate reason for selecting embryos, the principle is established that would allow selection or human genetic engineering for other medical interventions.
There is extensive ethical and social discussion on the abuses of sex selection in cultures and ethnic groups which favour male children over female. Whereas we do not expect a serious imbalance of the population to occur were this practice to be legalised, the issue is once again the notion implicit in family balancing that a child of the wrong sex is unwelcome in one’s family. A law should not be passed that enshrines the unethical concept that children are accepted not for what they are in themselves but for what they are to us.
Q.38 The Government proposes that the prohibition in the HFE Act on genetic
modification of embryos for reproductive purposes should continue and be
extended to gametes used in treatment. We invite views as to whether the
legislation should include a power for Parliament to relax this ban through
regulations (rather than primary legislation) if assured of safety and efficacy.
Q.38 Reproductive Intervention in the human germline
Germline genetic intervention is extremely controversial. While the Church of Scotland has no formal view on germline intervention, because the human genetics study group of 1995 saw it as unlikely to be developed for therapy, it noted some serious ethical problems. These lead us to agree that the prohibition of the genetic modification of embryos for reproductive purposes should continue that it should be extended to gametes used in treatment. The implications are so far reaching that any change to this should only be contemplated through primary legislation and with extensive public consultation.
The primary objections to germline intervention are expressed both on the grounds of unforeseeable risk to future generations and the ethical objection of irrevocably and irreversibly altering the genome of the child to be born and all his or her future offspring. Informed consent has no meaning in this case.
It is a matter of great concern to us that this question frames the issue as though it were primarily a matter of safety and efficacy without any reference to ethical concerns. We draw to the Government’s attention that such intervention is seen as unacceptable in all the major ethical bodies who have considered it, including the EC ethical advisory group, the Convention on Human Rights and Biomedicine of the Council of Europe, and the United Nations Universal Declaration on the Human Genome. We also point out the remarks of the leading ethicist Professor Michael Banner, Director of the ESRC Genomics Forum, that the 1992 Clothier Committee was seriously amiss in failing to address ethical aspects of germline intervention in recommending a prohibition merely on the basis of risk.
We would be greatly concerned if the Government were to adopt the approach of the Commons Select Committee report about which we have observed in our introductory remarks, that novel technologies are primarily a matter of harm and not of ethics. We were concerned at how lightly germline issues were treated in that report, and especially in citing the article in the New Scientist attributed to Ian Wilmut which has been widely critised for its failure to address the ethical aspects, and which the author himself has told to us does not correctly represent his views.
In our response to Q.60 below we note that in practice the risks as to safety and efficacy are unresolvable because any experiment would entail imposing not only on human subjects but also all their offspring precisely the risks entailed, which would be fundamentally unethical. It would be quite wrong to allow capacity in the new Act for a regulatory relaxation for which the research to obtain the necessary data would itself be unethical.
Some argue that for the an extreme case of a single gene dominant disease like Huntington’s chorea, it is possible to argue that a future child may have wished the genetic defect removed at the embryonic stage, if we had had the means to do so, and that the risks involved would not be worse than the inevitable disease itself. It is held by many that this would be an unlikely intervention because other simpler means exist, for example using PGD. The 1995 study group noted that no alternative method in this area is ethically uncontroversial.
Other concerns that once begun this would inevitably lead to pressures to modify the human germline for non-medical purposes of human ‘enhancement’ and to eugenic concerns.
Q.39-45 : Information relating to donors and donation
In this complex area of rights, we suggest there are important parallels between adoption and donation records, and the data access rights of both children and their natural parents. It is sensible to ensure that children’s rights to know about their origins are similar, whether they are adopted or donor-conceived. In the same way rights of parents who have donated gametes and embryos should be similar to those whose offspring have been adopted.
It is also important to keep records about how often the various categories of information are accessed, and the results of doing so, as judged by those exercising their rights. By reviewing such access data from time to time, it will become clearer which rights are the most valued. Also data about the benefits, and disbenefits, of exercising these rights should be used within the information and counselling processes covered in Section 4.
Notes: The Church of Scotland is currently opposed to gamete donation, though the issue has not been discussed by General Assembly since 1996, when it was recognised as an area where the attitude of society is changing from disapproval to acceptance. Reasons for CofS view in 1996 and previously in 1985 and 1982 were a mix of ethical and practical considerations:
o Gamete donation involves the intrusion of a third party into the marriage relationship. But in Christian marriage husband and wife accept each other now and in the future in the totality of their being, fertile or infertile;
o Issues about how and what to tell donor-conceived children, other family members, etc. – especially when donors were anonymous, a situation which will not apply from 2006, so that children will be able to seek information about donor parent(s) in due course, just as adoptees can do already;
o CofS has not formally discussed the issue of embryo donation, it was not raised in 1996. A preliminary view is that it could be likened to ‘very early adoption’, and so would be ethically acceptable.
CofS strongly supports good adoption and fostering practices, including increasing the number of potential adopters, and has recently responded to a Scottish Executive Consultation on Adoption and Fostering. We believe there would be advantages in making some of the information and counselling stages for both IVF and adoption common. However we recognise that, currently, the overwhelming majority of children available for adoption in UK are not babies.
Q.39 The Government believes that it is essential to maintain a central register of donor treatment to which donor-conceived people can have access for information about their donor, and to find out if they are related to someone they intend to marry.
Q.40 The Government invites views on whether people should be able to obtain information about whether they were donor-conceived and about their donor (including identifying information where lawful) from the age of 16 rather than, as now, from the age of 18.
We agree. Ideally, a donor-conceived person would not begin any form of sexual relationship with someone to whom they are related – rather than developing a loving relationship and then learning that they are biologically related, so it must cease. To that end, we prefer age 16 to 18.
Q.41 The Government proposes to enable donor-conceived people to access information to discover whether they are related to someone with whom they intend to form a civil partnership, and would welcome comments.
We agree, see also Q40 comments.
Q.42 The Government invited views on whether the law should specify what non-identifying information about offspring can be released to gamete and embryo donors.
We suggest only the place and date of birth and sex – i.e. what a natural parent would typically have for an adopted child. However we also suggest that donors should be able to register for further information, as for an adopted child – see below.
Q.43 The Government seeks views on whether donor-conceived people should be able to access information about their donor-conceived siblings (where applicable). If so should this be limited to non-identifying information?
Q.44 Should the natural children of donors be able to access information about their donor-conceived siblings (where applicable) and vice-versa? If so should this be limited to non-identifying information?
Q.43-44 Rights should be similar to those for adopted children, i.e. both parties have to be willing to be located, but onus is on the donor-conceived person to make the initial contact. Details of the Adoptions Contact Register available at http://www.gro.gov.uk/gro/content/adoptions/adoptioncontactregister/index.asp
Q.45 The Government seeks views on what measures would be appropriate, if any, to ensure that parents tell children conceived through gamete or embryo donation that they are donor-conceived?
There are many similarities with adoption. The best practice in a telling child should be included in the information given, and counselling services (see responses to Q.25, 27, 28). We are aware of data indicating that donor-conceived children are much less likely to be told they are donor-conceived when young than adopted children and believe that withholding such information is not in the best interests of the child. Thus we regard open, early, informal communication of suitable information within the family setting as much more important than the formal legal age at which access to specific details is permitted, as per Q40.
Q.46 The Government invites views on whether, in future, the HFEA’s data register should continue to record and publish information on all licensed treatments including outcome data (where it is satisfied that they are not misleading).
Yes. There is a clear need for good reliable data to measure the effectiveness and outcomes. As this information is also vital in maintaining the licensing process the register should continue. The data must of course be validated by a rigid inspection process.
Q.50 The Government invites views on what, if any, changes are needed to the law and regulation as it relates to surrogacy.
Q.51 If changes to the law and regulation on surrogacy are necessary, do the recommendation of the ‘Brazier Report’ represent the best way forward?
Q.52 If changes to the law and regulation on surrogacy are necessary, should they be taken forward as part of the review of the HFE Act, or in separate legislation?
We support the proposals of the Brazier Report and also of the House of Commons Science and Technology Committee that there should be separate legislation on surrogacy, though recognising that licensing of treatment centres will also be required via HFEA/RATE.
We welcome holistic research studies such as that referenced in para 7.15, which can inform debate on the practical and ethical issues involved.
Q.53-56 Status and legal parenthood
Q53. The Government invites views as to whether the HFE Act should treat an
unmarried man as the father of a child resulting from treatment in the same way it
treats a married man. If so, how would this be achieved given that there is no legal definition of an unmarried couple? (Paragraph 8.16).
Q54. Should a court be able to make a parental order in favour of unmarried as well as married couples in surrogacy cases? (Paragraph 8.18).
Q55. The Government seeks views on whether:
• a court should be able to make a parental order (following surrogacy) in favour
of civil partners, subject to the same rules and requirements that apply to
• where one of the civil partners carries a child as the result of assisted
reproduction treatment, the other civil partner should be treated in law as the
parent of the child in line with married couples. (Paragraph 8.22).
Q56. The Government seeks views on whether the status and legal parenthood
provisions in the HFE Act should apply to same-sex couples who do not form a
civil partnership. If so, how would any automatic recognition of parenthood be
achieved given the lack of legal ties between the couple? (Paragraph 8.24).
Q.57-65 Embryo Research
We note with surprise and concern that in Q.57-65 the Government has not sought public views on whether embryo research remains acceptable to the population at large. Ethical opinions often change with time. Twenty years on from the Warnock report, a serious opportunity has been missed for gauging levels of public support or concern on this central issue to the whole area of legislation. The unfortunate impression is given that the Government is not open to listening to what people think on this point. Its consultation process is thereby diminished.
For many in the Church of Scotland, the human embryo already has the equivalent moral status of a new born baby, no research is permissible and they object strongly to the provisions of the existing Act which allows such research. For some, the use and subsequent destruction of embryos to extract stem cells is tantamount to sanctioning the murder of one human person in the hopes of saving the life of another, and therefore ought to be absolutely impermissible.
Others in the Church of Scotland take one or other of a variety of views of the embryo which would allow for limited research under particular, specified circumstances and controlled by a license issued by the Regulator. Such views include a gradual increase in moral significance as the embryo develops. Others would not privilege fertilisation as the moment of greatest significance in the beginning of a human life, but would cite implantation or the formation of the primitive streak, or various other measures of the beginning of a human life. Some cite the enormous natural wasteage that occurs in the very early stages of pregnancy as incompatible with regarding all such embryos as human persons and ascribe significance from fertilisation only for embryos which go to produce a successful pregnancy.
Those among us who accept research on embryos see it as something only to be allowed under specific, limited and peer-reviewed purposes in terms of:
o that the desired research outcome is of great medical importance and is realistic in its aims
o that there are clear potential benefits in terms of relief of human suffering within a realistic timescale
o that the potential benefits would be widely available, not just for wealthy individuals or societies
o that no realistic or practical near-term alternative exists to using human embryos and that the potential for such alternatives have in every case been explored by the license applicant
o that the primary source of embryos are those which are ‘spare’ from IVF and other reproductive treatments
o that consent procedures should be extremely carefully followed, with appropriate counselling, especially where, for example in some stem cell research, truly informed consent is difficult to give because the outcomes are inherently uncertain.
Some who accept research with spare embryos consider that embryos should not be created specifically for research under any circumstances, others would allow their creation but only except under very exceptional circumstances. A failing with the present operation of HFEA is that t
Q.58. The Government believes that research undertaken on embryos using the cell nuclear replacement technique for the purpose of studying mitochondrial diseases should be permissible in law, subject to licensing. (Paragraph 9.22).
Although the HFEA recently granted a license for research involving cytoplasmic transfer, it poses a remarkable combination of ethical problems. It involves embryo research, mixed genetic parentage, nuclear transfer, human germline genetic modification and some formidable potential risks. At first sight, each of these might on its own render the practice of mitochondrial nuclear transfer impermissible, but in each case it is not so simple.
For those opposed on principle to research or therapy which will knowingly lead to destroying an embryo, mitochondrial transfer using newly fertilised embryos would be unacceptable.
For those who accept some measure of embryo research, the deliberate sacrifice of one of two early embryos so that one will be free of a particular defect in mitochondrial DNA would be a difficult moral decision. Some would consider it too instrumental for this to be an acceptable potential therapy.
Nuclear transfer also runs a series of serious potential risks for which there would need to be a strong evidence that major harm from the process was very unlikely.
Whilst the Church of Scotland objects to the use of donor gametes in IVF, it is not self-evident that exchanging cytoplasm ranks as intervention in the genetic bond between man and woman in the way that donor egg or sperm (50% each of nuclear DNA) would be. It involves only 37 genes out of some 25,000. It is also a discrete set of genes not normally associated with unique individual characteristics and within which there is only comparatively little variation among a given ethnic population. One of the main functions of mitochondria is as the energy source of cells. It seems a reductionist oversimplification to say, as some have, that mitochondrial transfer is just changing a faulty battery for a good one. This makes light of other functions of mitochondrial DNA. But the confusion of genetic identity by having mixing maternal mitochondrial DNA does not seem to be a decisive issue. In so far as this is a donation involving the non-nuclear part of the genome which is not associated with specific identity, it need not be seen as necessarily violating the marriage bond.
A serious objection to mitochondrial nuclear transfer is that involves germline genetic modification. The question is whether mitochondrial DNA is subject to the same ethical and risk-related objections as we have noted above about germline modification involving nuclear DNA. The ethical objection to changing irrevocably the DNA of future generations is less of an issue if mitochondrial DNA is less associated with individual characteristics, but the question of the right to impose on the child’s future offspring a permanent inherited genetic change remains. On balance, we are inclined to argue the same objection to risk on human subjects, which would mean that the research would not be justified unless it were to a different therapeutic aim.
Q.59. Further, the Government invites views on removing the current prohibition on
“replacing a nucleus of a cell of an embryo with a nucleus taken from the cell of
any person, another embryo or a subsequent development of an embryo” for
research purposes, subject to licensing. (Paragraph 9.23).
Q.60. The Government invites views on whether the law should permit altering the
genetic structure of an embryo for research purposes, subject to licensing.
Q.60 Research involving intervention in the human germline
Research on all interventions in the human germline should be expressly banned in law. There is no justification for doing germline embryo research if we have no reason to believe that germline therapy could ever be safe.
Please see our critical comments on germline intervention in the human embryo under Q.38 above in relation to ethical objections and risks. The risks are serious and far reaching and it seems clear that it is impossible to resolve them without recourse to running those risks on unborn human subjects and all their descendants. We and many others would consider this completely unacceptable. Given this and the unlikelihood of germline therapy being practicable, it is quite clear that there is no justification for research on human embryos which performs, or whose aim is, germline modification of nuclear DNA. The law on human embryo research should be governed by the principle that there has to be a realistic therapeutic goal. Merely doing embryo research is not a good enough reason.
We note that in some areas of stem cell research, genetic modification of the eventual cells intended for transplanting into the patient may be envisaged, for example to assist the performance of the cell or to reduce the risk of its rejection by the patient’s immune system. In this case we urge that such modifications are performed only on the stem cell line or the cells derived from it and not from the embryo from which the cells are taken.
Q.61 The Government invites views on whether the law should permit the creation of human-animal hybrid or chimera embryos for research purposes only (subject to the limit of 14 days culture in vitro, after which the embryos would have to be
destroyed). (Paragraph 9.35).
The Church of Scotland General Assembly is expressly opposed to the creation of human-animal hybrid or chimeric embryos. We note that the 2000 Donaldson Committee also came to a similar conclusion. We were most concerned at the naïve assertion in the Commons Select Committee report that because less human material would be involved there would be less ethical concerns than using human embryos.
We reject the suggestion made by various researchers that hybrid embryos, parthenotes and embryos that have been modified to make then non-viable would be an ethical solution to deriving stem cells from embryos. Whatever the status of such creations, it is would be at least as unethical to use methods that would create an ‘embryo’ so deformed that it could not be viable and which therefore inherently denies its potential to develop.
In the course of its research the Society Religion and Technology Project has given much consideration to human-animal issues in the context of xenotransplantation, cloning and other issues. We hold to the view that humans and animals, though holding many deep similarities, are nonetheless different in more than just the biological differences among species. We have found that the issues of the admixture of the human and the animal at a fundamental cellular level are complex. They are more than just a matter of unfamiliarity or the so-called ‘yuk reaction’ and are underlain but profound ethical issues.
In the historic Christian tradition (drawing on Hebrew scriptures) humans are believed uniquely created in God’s image and set apart from all other creatures spiritually and have a unique moral responsibility which animals do not have. While humans are given the task of caring for the animal kingdom as fellow creatures of God, they are not seen as of equal status to humans. Intercourse between animals and humans is also expressly condemned.
The admixture of the human and the animal at a fundamental cellular and developmental level would breach this distinction in a much more problematic way that xenotransplants, and should not be allowed.
Q.62 The Government invites views on whether the current list of legitimate purposes for licensed research involving embryos remains appropriate. (Paragraph 9.38).
Q.63 The Government believes that the purposes for which research using embryos may legitimately be undertaken should, as now, be defined in law and research projects should continue to be approved by a national body in order to ensure compliance with the law, national consistency and appropriate ethical oversight. (Paragraph 9.41).
Q.62-63 We agree strongly with the Government’s belief expressed in Q.63. The General Assembly has in the past allowed some limited research on embryos, but has given no formal opinion on the current list of legitimate purposes. This is one of the matters currently under review by a working group which will report to the May 2006 Assembly. In the meantime we can make the following observations.
A Case-by-Case, No-Unless Approach
The justification for embryo research should remain within a restricted list and should be on a ‘No research unless …’ basis, not ‘Yes, provided …’ That is to say, say licenses for embryo research should be allowed,
• only on a case-by-case basis, and
• only when the realistic benefit is of such significance that the destruction of embryos for the purpose might be considered a justified moral cost, and
• only if the license applicant has demonstrated to the regulatory body’s satisfaction that no other realistic option exists without using embryos.
Maintaining the Special Status of the Embryo
We are especially concerned that the Warnock Committee’s concept of the ‘special status’ of the embryo is not lost with the growing pressure to increase embryo use from communities engaged in stem cell, nuclear transfer and related areas of research. We believe this concept remains as valid today as it was in the 1980’s, an expression of the moral dilemma felt by many that, while some research using embryos for certain crucial medical reasons, we are still dealing with an entity which either is already, or under the right circumstances could become, a human person. We note that a Medical Research Council study revealed a greater reluctance to submit embryos for research among some people who have gone through IVF treatment. This is a valid indicator, from a group of people in a special position to be aware of the issues, that we are not just dealing with a mere ‘ball of cells’.
We fear that particularly with stem cell research, human embryos will become regarded as mere research objects in a catalogue on which it is open season for scientists to research, provided that their objective falls within one of the allowed categories. We would stress that the fact that a license application is for a listed purpose is not itself an automatic justification. Each application should be justified that that particular experiment needs to be done.
In a submission made in October 1999 by the SRT Project and the Human Genetics working group of the Board of Social Responsibility to the Donaldson Committee, we drew a distinction between types of research uses of embryos. One type includes research on the embryo itself and research geared towards understanding and treatment of the causes of infertility, in which the embryo remains regarded as a reproductive entity. Stem cell research for serious diseases marked a new type, in which de facto the embryo is regarded simply as a cellular resource from which to extract particular cells. The 1999 submission argued that, while a measure of instrumentality was already admitted in embryo research, the proposed new use was significantly more instrumental. It called into question the special status of the embryo if it became a mere resource for cells. The suggestion in the Donaldson report that ‘specialness’ could be seen in the uses to which the embryo was being put in stem cell research has not satisfied the concerns expressed. For this reason some in the church argue that embryos should never be created for stem cell research.
In 2001 a House of Lords Select Committee explored the broad range of stem cell research which was potentially allowed under the term ‘serious disease’. It noted the problem of determining what counts as a ‘serious disease’ which would justify embryo stem cell research. We refer you to our general discussion of the purposes for which PGD might be allowed under Q31. The uncertainties inherent in research would make a complete list difficult to define and would call for greater flexibiliy to allow extension. Some guidelines for what does not constitute a serious disease might be helpful. We would expect that the primary regulatory ‘filter’ to be whether the particular research objective justified using embryos, rather than merely whether the research involved a listed disease.
The Lords’ committee concluded that it should only be an exceptional reason that justified the use of cloned embryos for stem cell research. In making several of its recent licensing approvals for cloned embryo research, the HFEA has not treated this recommendation sufficiently seriously in exercising its statutory role of ethical oversight. The continuing objections by the European Parliament are one of many examples which indicate how controversial within the European context is the UK’s policy to allow cloned embryo research.
Research using cloned embryos should not be justified on the current premise of the claims for ‘therapeutic cloning’ (genetically-matched cell replacement using cloned embryos as the source of the stem cell line). A number of leading experts in the field have expressed the opinion that it would never be practicable to apply therapeutic cloning to the wide range of diseases which it is claimed it could treat. This is because the number of potential UK patients alone runs into hundreds of thousands, each of whom would require several donated human eggs in an individual procedure geared to their own genetic type. This not realistic because it would depend on obtaining extremely large numbers (perhaps millions) of human eggs. It uses an invasive and sometimes painful procedure which is not free of risk. Altruistic donation of intimate tissues on this scale would be unprecedented. This and the large financial cost point to the likelihood that any such therapy would be available, at most, to a few fortunate patients suffering from a particular disease who can afford to pay. Yet the rhetoric used to justify this aspect of cloned embryo research has been on the basis that it would enable widespread therapies.
This is an example where a speculative area of embryo research is not justified if the claimed therapeutic intention is unrealistic. We would also caution against making judgements in this area at this point in time which are predicated on the future availability of alternative methods for obtaining human eggs from stem cells. These are speculative, of uncertain feasibility and would themselves also raise significant risks and some ethical concerns (see Q.8).
The extent of the list
Since the consultation document has not offered examples where the list might be considered for extension, we urge that no extensions should be allowed, since we would not have had opportunity to consider them and to offer comment to Government.
We were concerned that in 2000 opportunity was not given to Parliament to vote separately on the three categories of stem cell research widely identified (for example by the EC Expert Group on Ethics in Science and the New Technologies) of spare IVF embryos, IVF embryos created explicitly for stem cell research, and cloned embryos created explicitly for stem cell research. We note from Hansard that a number of MPs expressed this concern on various occasions, given that it was to be a free vote.
We therefore urge that any new UK legislation should split these three stem cell sources into separate categories and allow a vote on each one. We also urge as a general principle that the list should remain variable only following specific public consultation and by the vote of Parliament, and that the procedure should be flexible enough to allow voting on different aspects of research uses.
Q.64 The Government invites views on what, if any, additional regulatory requirements should apply to the procurement and use of gametes for purposes of research. (Paragraph 9.45).
Gametes should not be procured for payment beyond normal small remuneration for inconvenience, travel, etc.
Q.65 The Government invites comments on the desirability of allowing the creation of embryos for the treatment of serious diseases (as distinct from research into
developing treatments for serious diseases which is already allowed). (Paragraph
Hitherto the arguments have concerned only performing research with embryos. While some might argue that the point of allowing embryo stem cell research is frustrated if the final realisation in stem cell based therapies were not to be allowed, others contend that this would instrumentalise embryos too far if we were now to allow them to be created routinely for treatment. This would have lost the sense of Warnock’s ‘special status’ and agreed that embryos are just balls of cells of no more moral worth than research mice in a catalogue.
The 2003 General Assembly said that a principal aim of both embryo and adult stem cell research should be to enable therapeutic routes which do not require embryos to be used.
While it did not expressly decide against any therapeutic routes using embryos, it indicated that we should not prematurely embark on that route until it has been established that no route is reasonably likely using adult or placental stem cells or some other therapeutic method.
At this time it would therefore be quite premature to include in any new Act an article which expressly allowed for embryos to be created for the treatment of serious diseases. We suggest instead that a provision should be made for this possibility to be addressed by a regulatory change, after extensive public consultation, to be decided one way or the other by a free Parliamentary vote.
Q.66-73 The Regulatory Authority for Tissues and Embryos
Q.66 The Government proposes that RATE, in common with the HFEA and HTA, will be headed by a lay chairperson, and have substantial lay representation among its membership. The membership will also need to have, or have access to, sufficient medical and scientific expertise in relation to the activities that come within its remit. (Paragraph 10.4).
We agree, but having substantial lay membership is itself not enough to encompass public values in these sensitive areas. There should be an express requirement placed on RATE to consult widely with a broad spectrum of both stakeholders and general public, using appropriate interactive means of consultation. It is now well established among those involved in the public engagement of science and in relevant parts of the social science community that the present type of written consultation exercise is inadequate. It typically gauges the opinion only of committed stakeholders with the time, resources and expertise to address a very large number of technical or ethically demanding questions. Lay publics are often unaware that such a consultation is happening and in any case usually lack the means to respond. For major new areas such as stem cell research a large scale consensus conference would have been expected, following well established practice in Europe. On more specific issues, public meetings, focus groups, citizens’ juries, card games and other means should be used.
Q.67 The Government proposes that:
• RATE will be an executive non-departmental public body. Its primary
function will be to consider applications for licences to undertake those
activities which Parliament decides should be subject to licensing. It will be
funded principally from fees levied on licence-holders
• RATE will be responsible for regular inspections of premises where licensable
activities are carried on.
• RATE will issue codes of practice giving guidance to persons undertaking
those activities within its remit
• RATE will maintain a central database of, at least, information relating to the
use of donated gametes and embryos, and children born as a result.
This is not a full set of the requirements on embryo research, and needs considerable amplification.
Q.68 Both the HFEA and the HTA currently have statutory functions including to
monitor or review developments relating to the activities within their remits, and
to provide advice to the Secretary of State where appropriate or where asked to do so. The Government believes that a similar ‘advisory’ function would be
appropriate for RATE as this body will be well placed to observe and monitor
developments through its licensing and inspection procedures and its information gathering function. (Paragraph 10.6).
Q.69 The Government proposes that:
• the chairperson and members of RATE will be appointed by the NHS
• RATE will publish an annual report, which must be laid before Parliament
• legislation will set out requirements for consultation and approval of codes of
• RATE will publish summaries of embryo research licence applications
received. (Paragraph 10.7).
The fourth bullet point is not enough. The full detail of the application needs to be available also, for proper transparency, since this is a public issue. The welcome change in the HFEA’s practice since May 2004, when it began to publish licenses applied for, not merely ones that had been granted, has not been well executed in practice. The information provided by the license applicant may be exaggerated, insufficient or misleading. The first such example (the Newcastle group’s cloned embryo licence) was misleading in that it did not encompass the researcher’s full intentions revealed later in a Financial Times interview. We complained that the key information about the proposal was omitted and was not accessible to the public. Eventually, information was provided to one of the NGOs who complained, which has still not been made public on the HFEA website.
We recommend that Regulator vets the summary of the research proposal for accuracy, comprehensibility and comprehensiveness, and that it advertise that fuller details are available and from where they may be obtained.
We also urge that the minutes of the relevant meeting at which the licensing decisions are made are immediately made public, and that they include a full discussion of the pros and cons and on what basis the final decision was made.
In today’s climate of transparency in regulatory affairs, anything less is no longer acceptable on both these points. In order for public confidence in the Regulator to be maintained it needs to see how it is going about its duties in licensing.
Q.74 : Any other issues
Current Public Views on Embryo Research
As observed under the embryo research section, the scope of questions of this consultation has been too limited by not asking whether, twenty years after the Warnock Committee published its seminal report, the provisions of the current Act and regulations in relation to the status of the embryo remain acceptable to the public. A significant opportunity has been missed.
At present, the HFE Act only applies to activities which take place within the United Kingdom. It does not apply to the provision of treatment or to research involving embryos by UK citizens or UK-based organisations in other countries where there may be very little or no regulations at all. This means that it is possible for UK citizens to undertake fertility procedures abroad which may be considered dangerous and are prohibited in the UK. This is sometimes referred to as reproductive tourism. There are precedents for laws which apply to activities taking place outside the UK. For example, criminal penalties exist in connection with underage sex tourism abroad. Accordingly, it may be appropriate for extra-territorial provisions to be drafted in any new legislation in order to prohibit UK citizens going abroad in order to bypass UK legislation to obtain treatments or other activities involving embryos which are prohibited under UK law.