We believe that Assisted Reproductive Therapy (ART) should be regulated by law, in order to protect both the right to life of the unborn and the unique status of the family founded on marriage. We welcome this opportunity to make some recommendations to the Commission.

For general background, we refer the Commission to the recent publication Assisted Human Reproduction, Facts and Ethical Issues, which has already been sent to you for your consideration.

We wish to make the following specific observations and recommendations:

i. Ethical background (general)

A human embryo is the new organism which comes into existence at fertilisation. This organism is not simply a collection of cells, but a genetically distinct human individual, "which is oriented towards further development." Research on human embryos is frequently motivated by the desire to understand and to be able to respond to the problem of infertility, or to the causes of genetic abnormality. It is felt that this possible benefit to humanity provides a justification for the destructive consequences for the embryo itself, of research. The human embryo must, however, be regarded as a subject and not an object. It is an end in itself, and not a means to an end. The fundamental issue at stake is that of respect for human life.

In the normal course of events, research involving human subjects is classified under two headings, therapeutic (i.e., that which offers the prospect of benefit to the subject) and non-therapeutic (i.e., that which holds no prospect of benefit to the subject). In cases where research is therapeutic, and the patient is unable to give consent, this consent may be given by his / her legal guardian. In the case of non-therapeutic research, however, the person who is the subject of the research must be a volunteer. A human embryo, by definition, is incapable of giving consent.

ii. Research and the Cloning of Human Embryos

Cloning is frequently associated with stem-cell research. Human Cloning is the production of a genetic copy of another human being. Stem-cells are versatile cells in the body which are able both to reproduce themselves and to produce more specialized cells. One possible motivation for human cloning is the possibility of using the new embryos to obtain human stem-cells, for the treatment of people suffering from a range of conditions such as Alzheimer’s or Parkinson’s Disease. In this context, cloning is generally referred to as therapeutic cloning. It is clearly not therapeutic in the sense understood by the Declaration of Helsinki, because any therapeutic outcome is for the benefit of the other person involved; the embryo is inevitably destroyed in the process. The possibility of achieving a good outcome for another person does not justify treating the embryo a means to an end, rather than as a human subject.

We are concerned that discussion surrounding the issue of human cloning has not kept up with developments in medical research. Stem cells reside in human bone marrow, which has a long history in the successful treatment of leukaemia. It is now widely recognised that these stem cells have an advantage over embryonic stem cells in the healing process since they are destined to this purpose, while embryonic stem cells are destined to divide until a whole new organism is created. This may explain why a high incidence of tumours has been noted when embryonic stem cells have been used. By contrast, the use of human bone marrow is tried and tested; it is known to be safe. In addition, the taking of a bone marrow sample is much easier than extracting stem cells from embryonic tissue. The procedure involving bone marrow can be taken out of the laboratory and into clinical trials immediately, which is not the case for embryonic stem cells. For example, in the last few months, bone marrow cells have been re-injected into people who have suffered damage to heart muscle, and have been shown to bring about a significant improvement. A further advantage in using a person’s own bone marrow stem cells is that there is no risk of rejection.

Research and subsequent treatment involving stem-cells from bone marrow can be carried out without the destructive consequences entailed by embryo research and the extraction of stem cells from embryos.

iii. Recommendations

B. Donation of Human Reproductive Material / Embryos

The donation of human reproductive material generally takes place in the context of the treatment of infertility, e.g., where the husband’s sperm is deficient, or where there are difficulties relating to ovulation on the part of the wife. Depending on the circumstances, sperm cells, ova, or indeed complete human embryos are donated. These donations may, at times, be associated with the payment of money.

i. Ethical background

A donor of human reproductive material or of an embryo, while remaining in a very real sense the parent of any child who is born as a result of this donation, no longer has any possibility of exercising parental responsibility.

Every child has a right to an identity of origin, i.e., to know who are his / her parents. This is increasingly recognised in the management of adoption. This right of children would necessarily conflict with any attempt to guarantee the confidentiality of donors of reproductive material.

The donation of human reproductive material or embryos introduces an additional relationship into the social structure of the family. When biological parenthood is separated from social parenthood, this has the capacity to introduce a lack of clarity into the identity of the child. It may well be argued that this is substantially what happens in the case of adoption, or remarriage after the death of a spouse. The fundamental difference, however, is that in these circumstances people are responding to a situation which has already arisen. By contrast, the donation of reproductive material sets out to create that situation.

ii. Recommendations

i. Ethical background

The nature of human sexuality is such that it is the norm for a child to be born into a family where he / she has a mother and father who are in stable relationship with one another, and who are in a position to offer a stable environment in which the child can grow and mature. This is why marriage is so fundamental to the well-being of children and of society. It is not possible to guarantee absolutely the stability or permanence of any human relationship. In so far as it relates to the transmission of human life, however, we would have a serious moral concern that this stability should not, by default, come to be regarded as being in any sense optional.

We have already referred to the ethical issues associated with the cloning of human embryos for research or "therapeutic" purposes. We would also have many serious moral concerns about the prospect of using cloning as a means to transmit human life. We believe that, quite apart from any concern about the reliability or safety of such a procedure, the cloning of human beings would reduce human procreation to the level of a manufacturing process. It would conflict with the dignity of the person, and would fundamentally alter the meaning of parenthood.

ii. Recommendation

Any legislation to provide for Assisted Reproductive Therapy (ART) should recognise and protect the right of every child to be born to a mother and father who are permanently committed to one another.

The cloning of human embryos for the purposes of reproduction should be prohibited by law.

i. Ethical Background

The storage of human reproductive material / embryos most commonly arises, either with reference to donation or with reference to research. As there is no ethical difficulty per se with research involving sperm or ova, so there is no ethical difficulty with the storage of same, for research purposes, provided the appropriate consent has been obtained.

The storage of sperm and / or ova, for the future reproductive use of those from whom they have been obtained may be seen as desirable in certain medical circumstances, as for example prior to radium treatment or chemotherapy. This possibility, however, raises important ethical issues, to which reference has been made in the booklet Assisted Human Reproduction: Facts and Ethical Issues.

The ethical discussion of the storage of embryos should be guided by the fundamental principle that the relationship between parents and their embryo is one of guardianship rather than one of ownership. The storage of embryos is most frequently proposed because of the fact that, in the course of fertility treatment, more embryos are produced than can be used safely in one treatment-cycle. The hope is that these embryos can be used in the future if the first treatment is unsuccessful, or if the couple wish to have another child at a later stage.

It seems to us, however, that there is no practical way to protect the right to life of these embryos other than by ensuring that they are replaced in the mother’s body in a location where they are likely to survive. Any other course of action leads to a very real ethical dilemma. Once embryos are placed in storage, the possibility must be taken into account that they will remain in storage because of a change of circumstances or a change of mind on the part of the couple. Because of such a possibility, legislation in other jurisdictions tends to make provision for the disposal of these embryos, or for their donation to other couples, or for their use in research. We have already addressed the issues of research, and of donation. The perceived need to provide for the disposal of human embryos after a set period of time has elapsed highlights our conviction that the production and storage of surplus embryos raises insuperable ethical problems.

ii. Recommendations

E. The Allocation of Resources

The regulation of assisted reproductive therapy gives rise to the question of whether ART should be regarded as healthcare in the ordinary sense of the word, and therefore as something to which citizens have a right, just as they have a right to other forms of healthcare, according to the general principles of distributive justice.

The crux of the matter is that, while infertility is often a grave disappointment and even a source of stress for couples who wish to have a child, it is not a life-threatening illness. In the context of limited healthcare funding, and in particular when there are lengthy waiting lists for life-saving treatment, it is hard to see how the state could justify diverting limited resources to the provision of assisted reproductive therapy. The alternative scenario is not ideal either, because if ART is not publicly funded, then it becomes a privilege of the wealthy.

We would strongly recommend that, in so far as the state sees fit to make resources available to this area of healthcare, serious attention needs to be given to identifying the causes (including social or life-style causes) of infertility; and to treating infertility itself, rather than simply to the facilitation of circumventive procedures.

ENDS