Guidelines for Preimplantation Genetic Diagnosis in New Zealand
Nathaniel Centre Staff
Issue 15, April 2005
In November 2004 The Nathaniel Centre responded to an invitation from the National Ethics Committee on Assisted Human Reproduction (NECAHR) to comment on proposed guidelines relating to the practice of Preimplantation Genetic Diagnosis (PGD) in New Zealand. PGD is defined in the NECAHR consultation document as "a procedure devised to test early human embryos for serious inherited genetic conditions... PGD involves several steps: the creation of an embryo via IVF; the removal of one or two cells from the embryo; the genetic testing of these cells for specific genetic conditions; and a subsequent transfer of unaffected embryos to a woman's uterus." [i]
General Remarks
Ethical reflection on PGD, whether from a faith perspective or other perspectives, raises profound questions regarding the direction in which the use of this technology could take us as a society. This insight is succinctly expressed by Hilde Lindemann Nelson when she writes:
... technology multiplies choices. This is hardly a novel observation, but its consequences have not always been well understood. An accumulation of choices can be a burden as well as a blessing ... Medical technologies exert power over persons ... Technologies create their own culture of practices, institutions, and discourses, and these become a powerful force that inscribes individual bodies to its own specifications. [ii]
The Catholic Church welcomes medical and technological advances that promote health and alleviate suffering. However, such advances must not be at the expense of fundamental moral values. We are concerned that the decision in principle by the Minister of Health to allow New Zealand couples to access PGD has occurred without sufficient or robust debate. We are concerned that there is insufficient recognition of the nature of human reproductive technologies as "a powerful force" that will create its own "culture of practices". To the extent that this is so, we are in real danger of allowing the validity of morality to be debated with regard to science and technology, rather than allowing ethics to underpin and to set the agenda for technology.
The implementation of PGD in New Zealand has the potential to result in deleterious social consequences for our society. The NECAHR document on PGD openly acknowledges this possibility. It states (para 34) that the purpose of the proposed guidelines is to "provide protection against potential misuse of the technology by prohibiting the use of PGD for non-medical reasons. In addition, the guidelines will only allow PGD to be carried out when there is a high risk of serious abnormality."
Looked at in isolation the individual case for PGD can be compelling. The field of bioethics, however, challenges us to consider the broader personal, legal, spiritual, cultural and social implications of PGD. The right of adult persons to make their own reproductive choices is an important aspect of the debate concerning reproductive procedures, but is only one aspect to be considered as we look to the future and, in particular, as we contemplate the sort of society that we might become and how that correlates with what we would wish to be.
Lindemann Nelson highlights the need for New Zealanders to use their moral imaginations and consider the implications of PGD beyond the obvious and immediate consequences of its use or non-use. In particular we believe that the manner in which the decision was made to approve in principle the use of PGD in New Zealand, and the justification presented for it, fails to show proper cognisance of the broader societal effects of PGD for New Zealand. Consideration of the broader effects must include, but also go beyond, the need to deal with the pragmatic issues of genetic disability/illness and infertility faced by particular couples contemplating having children. It will also draw upon and reflect the various cultural perspectives about human life and in particular Māori culture.
We acknowledge that the proposed guidelines by NECAHR are a genuine attempt to limit the use of PGD and consequently to minimise its potential harm. One of our particular concerns is that the document lacks clear evidence of an ethical framework for determining the nature of the limits. The limits proposed appear somewhat arbitrary and vague. In the absence of such a framework it is not clear how particular decisions about the limits have been reached. Neither is it clear how changes to these limits may be decided upon in future. There can be no real transparency or clarity with respect to the way decisions are made without a clear framework for addressing the ethical dilemmas posed by PGD. Some decisions may in fact be made without people realising it or without understanding the full implications and consequences of these decisions for our society.
We need to consider the future dilemmas that might be raised by ongoing advances in technology. Decisions made in the current context might impact on other uses not currently possible or even anticipated, and may impact in ways that are not immediately obvious. The use of moral imagination will involve us facing with openness, courage and honesty, questions relating to such things as the acceptance of disability, attitudes towards diversity, understandings of parenthood, attitudes towards those who choose not to be tested, and attitudes towards selecting embryos for enhancement of desirable features, to name but a few.
PGD presumes the use of IVF for the creation of embryos. Catholic teaching insists that IVF is not, of itself, a morally neutral activity. Of all its objections to IVF, the most serious is that it almost inevitably involves the deliberate creation of extra embryos that will never be implanted. On this matter, Catholic teaching states that the fruit of human generation from the first moment of existence, that is to say, from the moment the zygote has formed, demands the unconditional respect that is morally due to the human being in his or her bodily and spiritual totality. It is this belief that lies at the heart of a Catholic-Christian response to the use of PGD. Therefore, the discarding of embryos for any reason is unacceptable.
PGD is often portrayed as an ethically preferable alternative to prenatal diagnosis followed by abortion. From a Catholic perspective there is essentially no moral difference between the death of an embryo and the death of a fetus. We strongly reject the idea (paragraph 26) that "a healthy pregnancy balances out the negative act of discarding affected embryos."
All embryos have equal moral status and human dignity. While this is rightly regarded as an extension of Catholic beliefs regarding the status of the embryo, we argue that many other people would concur with this belief, including those who might not recognise that the moral status of an embryo was equivalent to that of a person. This stance rules out discriminating against embryos on the basis of health or disability. Embryo selection implicitly and explicitly devalues life that is already weak and marginalised. Allowing embryo selection for any reasons, including those related to the health of the child to be born, may actually open the way to significant pressure for eugenic or discriminatory activity.
PGD draws on social judgements about the worth of a child, the meaning of disability and the significance of life. We note the efforts made in our society to outlaw and eliminate discrimination among children and adults on the basis of disability. As a society we rightly reject the notion that disability or serious illness somehow compromises the dignity of such persons. Given the continuity to human existence, and the fact that there is no threshold that embryos cross to become human, the question arises: "at what point does it become acceptable to discriminate on the basis of disability?" To permit discrimination against embryos on the basis of disability and illness is logically inconsistent with our efforts to outlaw it for adults and children.
The length of a person's life and/or the absence of suffering are inadequate measures of a meaningful life. We are concerned that the willingness to accept PGD signals a societal move towards judging the quality of life by the length of a life and the absence of illness. Therefore, we concur strongly with those who argue that using technology to 'screen out' people with disabilities has the real potential to create a more intolerant and prejudiced society. It is at best naïve to think that there is no connection between these states of affairs. The argument that couples already have recourse to prenatal diagnosis to test for the same kinds of abnormalities (paragraph 31) is irrelevant in terms of judging the ethical acceptability of PGD. The voices of self-advocates representing disability groups are the most significant in terms of deciding what selecting against embryos with disabilities implies about attitudes towards people with disabilities. To fail to listen to and heed these voices on this question would amount to a form of "ethical colonialism" in which numbers and influence would become the deciding factors rather than openness, inclusiveness and respect for diversity.
The Catholic-Christian tradition in which we stand relies on a version of moral accountability which acknowledges, for the sake of a caring society, that we cannot behave as if we are accountable only to ourselves. We accept and work from the principle that the good of our fellow human beings will at times pose limits to the exercising of personal autonomy. PGD requires us to face the question: "What limits will we put on individuals choices?" Breakthroughs in technology have removed many physical constraints on our actions. Therefore we have an even greater need for ethical constraints. A key concern is whether the direction of a particular technological breakthrough is moving our relationships further towards respect for that which is 'other', or further reducing the world to something we can control, manipulate and use as a means to an end. This concern is shared by many New Zealanders and does not rely on espousing a particular religious viewpoint.
We regard all life as being a 'gift' from God. The practice of PGD would seem to imply that the lives of some may be regarded as 'gift' while the lives of others are to be regarded as 'burden'. Given the Catholic position on IVF, discriminatory selection and the destruction of embryos, we do not support PGD being used for the sake of selecting some embryos and discarding others.
Mindful of the fact that ministerial approval in principle was given in June 2003 for PGD to proceed in New Zealand, and while not condoning either IVF, embryo selection or the destruction of embryos, we take our place alongside other citizens in the task of regulating these activities, with a view to minimising the extent and incidence of them. Our specific comments on the proposed guidelines now follow:
Guidelines 1, 2, 3.
The document employs the term "high risk of serious abnormality" as a means of describing which disorders might qualify for carrying out PGD in New Zealand. We note that the Systematic Review of the Quantifiable Harms and Benefits of Preimplantation Genetic Diagnosis prepared by the Cochrane Menstrual Disorders and Subfertility Group for the New Zealand Guidelines Group talks about "familial disease of a severe nature". (emphasis added) and recommends a "cautious" approach. The reason given for this is the limited and inconclusive evidence on the effectiveness and long-term safety of PGD. The word 'severe' sets a higher threshold of safety, one that is more consistent with the lack of evidence regarding the safety of PGD and the implementation of a "cautious" approach. It also takes better account of the unknown and potentially negative broader societal effects of PGD. We wish to see the word "serious" replaced by the word "severe" throughout the document.
Guidelines 1, 2, 3.
The use of PGD should be limited to disorders "that are lethal in childhood". In particular we note very recent moves in Britain (October 2004) that allow for the screening and destruction of embryos that might be genetically predisposed to develop a type of cancer that may or may not develop 20, 30 or 40 years onward. This represents a disturbing broadening of the use of PGD. It is a use that we strongly believe many New Zealanders – some of whom might be in favour of PGD in certain circumstances - would want to rule out. Yet, it is a use which, while not necessarily anticipated by the NECAHR guidelines, is not ruled out either.
Aneuploidy screening: Guideline 4
We support the move that applications for aneuploidy screening need to be considered on a case-by-case basis by an approved ethics committee. However the actions of this committee need to be fully transparent. Transparency is not achieved simply by reporting back on decisions previously taken. The criteria to be used by NECAHR when considering whether or not to give ethical approval to such applications are not provided. Without this transparency there can be no proper accountability. Without specific criteria the current guidelines effectively remove these decisions from public scrutiny and accountability.
Aneuploidy screening: Guideline 4
If applications for aneuploidy do not fall within the category of "high risk of a severe abnormality" they will presumably be turned down. Will "advanced maternal age" be considered as being "high risk"? In our minds the medically established "higher risk" of abnormal births for women of "advanced maternal age" should not be considered sufficient cause for such screening unless there is also evidence of high risk of severe familial chromosomal disorder. Otherwise we see that there exists the temptation for certain couples with the financial resources to choose elective IVF as a means of gaining access to PGD for reasons outside those envisaged in the guidelines themselves.
Serious genetic disorders: Guideline 5
From an ethical viewpoint it is totally unacceptable that the providers of PGD should be responsible for ascertaining whether a familial disorder is severe. Providers have a vested interest which generates a serious conflict of interest based on the potential for commercial reward. Failure to prevent provider capture of the decision making process breaches a fundamental principle of ethical review. Genetic counsellors must be completely independent of the providers of PGD. This excludes them being employed by the providers of PGD.
Human leukocyte antigen (HLA) tissue typing: Guideline 6
We believe that this guideline needs to be complemented with some general principles and concerns which will make clearer and more transparent the standards to be used by NECAHR in making their decisions. We endorse the move that these decisions need to be submitted to an ethics committee such as NECAHR for approval on a case-by-case basis. One of the particular dangers inherent in allowing the selection of embryos for the sake of another is that it seems to be endorsing the idea that it is acceptable to use a person simply as a "means" for another.
Human leukocyte antigen (HLA) tissue typing: Guideline 6.5
We suggest rewording this phrase: "Only cord blood for the purposes of the treatment - ensuring that an adequate amount of cord blood remains available for future use by the donor - and not other tissues or organs until the donor is in a position to legally give informed consent".
Other conditions: Guideline 8
See our comments in paragraph 18 above on Guideline 4
Patient information: Guideline 9
Those who are seeking to use PGD are not patients in the normal sense of the term. Therefore, we do not believe that the term "patient" is an appropriate term to use in these circumstances. We suggest removing it and replacing it with the phrase: "those seeking PGD".
Patient information: Guideline 9
We would like to see it specified that general information on PGD be prepared by the Ministry of Health after appropriate consultation. This task should not be left to the providers of PGD.
Patient information: Guideline 9
We believe that those seeking PGD should also be informed of the broad ethical issues posed by the use of PGD and that this should be carried out by a suitably qualified and independent party. Conflict of interest precludes this being done by the providers of PGD.
Patient information: Guideline 10.1
Genetic and clinical information about the specific condition should include information on the severity of the condition and the likely degree of its impact.
Patient information: Guideline 10.1 and 10.2
This information should be provided by a qualified genetic counsellor who is independent of the providers of PGD.
Patient information: Guideline 10.4
We wholeheartedly support the idea of families and individuals giving testimony to the full range of experiences of living with the condition in question. This needs to be facilitated by a neutral party, and should include the perspective of disability self-advocates as well as families and professionals.
Genetic counselling: Guideline 11
We wholeheartedly support the commitment to genetic counselling from a qualified counsellor with specific training in genetic counselling. Our concern is that there currently exists in New Zealand a very real shortage of genetic counsellors. In addition we believe that the "training" required needs to be specified in terms of its duration and its nature.
Genetic counselling: Guideline 12.3
Discussion of "the likely impact on the offspring and their family" should be done in conjunction with the degree of support available for the family.
Genetic counselling: Guideline 12.10
Discussion of the family circumstances of the people seeking PGD should include reference to the resources available.
Genetic counselling: Guideline 12.12
The wording of this guideline could easily imply that the difference in moral status afforded to an embryo compared with a fetus is a "given". As well as this, the way it is currently worded could easily give the impression that there are only two alternatives; PGD or "termination of a pregnancy following prenatal diagnosis". Continuation of the pregnancy - with or without prenatal testing - is also a real option that needs to be presented to people if they are to make properly informed decisions. Consequently, we would like to see this statement recast in a more neutral way. Our suggestion is that it be reworded in the following or very similar manner: "ensuring those seeking PGD are made aware of the various positions and understandings regarding the status of the embryo, as well as the implications of all the positions that exist."
Genetic counselling: Guideline 12.13
We would like to see added to this guideline the phrase: "and the option of continuing pregnancy."
Prohibited applications of PGD: Guidelines 13.1 & 13.2
We strongly support the prohibition of PGD for social reasons, including sex selection, as well as for the purpose of altering the genetic constitution of an embryo.
Prohibited applications of PGD: Guideline 13.3
From a Catholic perspective all embryos are equal and deserve unconditional respect. Therefore, embryos with genetic abnormalities have as much right to exist and be selected as those who are supposedly free of genetic abnormalities. To hold to the view that embryos without abnormalities are somehow superior in status is, by extrapolation, to also hold the view that people with disabilities are inferior to those without. We are concerned that this guideline could potentially prevent some parents from having children for whom the only option might involve choosing an embryo with an "abnormality". This guideline also effectively denies the right to life of specific groups of persons based on their genetic makeup. There is no precedent for this in New Zealand. We would regard any attempt to enforce this guideline as nothing other than eugenics by stealth.
Conclusion
The fact that something is possible does not make it ethically acceptable. Breakthroughs in technology have removed many physical constraints on our actions. Therefore we have a greater need for ethical constraints. From a Catholic perspective, there are many reasons to reject PGD. Those who find PGD unacceptable and those who would tolerate it in certain specified and limited circumstances find common ground in their understanding that PGD constitutes an action with potentially serious consequences requiring rigorous societal oversight and regulation. The guidelines represent a real attempt to take into account the societal risks posed by the availability and use of PGD in New Zealand. Nevertheless, we remain particularly concerned about:
- provider involvement in the decision making process
- the lack of a clear ethical framework against which decisions will be made
- the need for NECAHR to articulate the guidelines that will be used in approving case by case applications
- the provision of adequate numbers of adequately trained independent genetic counsellors
We all need to take proper cognisance of the broader effects of PGD for New Zealand society. This will involve taking real account of, and giving priority to, the testimony of self-advocates representing disability groups. At risk is the welfare of some of the most vulnerable and marginalised human subjects.
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Editors Note
NECAHR received a total of 70 written submissions on the proposed guidelines from various groups. These resulted in a number of changes being made to what was originally proposed. In January 2005 NECAHR sent the revised guidelines to the Minister of Health. The Minister approved the guidelines for implementation in March.
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[i] National Ethics Committee on Assisted Reproduction. (2004). Guidelines for Preimplantation Genetic Diagnosis in New Zealand. Wellington: Ministry of Health, p.2.
[ii] Lindemann Nelson, Hilde. (1995). Dethroning Choice: Analogy, Personhood, and the New Reproductive Technologies. Journal of Law, Medicine & Ethics, 23, 2: 129-35.
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2005