The Nathaniel Centre

Submission on Human Tissue (Organ Donation) Amendment Bill (2006)

A Submission from The Nathaniel Centre – The New Zealand Catholic Bioethics Centre
Issue 19, August 2006

General Comments

We are called to show the utmost respect to a person's body at all times, including after death. This respect is an ongoing expression of the dignity owed to each person on the basis of our shared humanity. To desecrate or in some way to violate someone's body is simultaneously to desecrate and violate the person. A person's body is integral to, rather than incidental to, their personal identity. In New Zealand this responsibility is reflected in the longstanding current law which holds that no one can ever "own" the body of another.

In the Catholic tradition we believe that all human beings are created in the image of God. We speak of human nature as being corporeal and spiritual. Yet, while accepting such a distinction (sometimes expressed in terms of "body" and "soul") we reject any dualistic understanding of the human person. The body is not merely a vehicle or container for the person. Spirit and matter are not two natures united, but rather their union forms a single nature. We understand all life to be a gift that is entrusted to us from the Creator. The dignity accorded to human life can be understood as a direct response to the belief that life is a gift to be held in trust.

The donation of one's organs and tissue after death is a response that is consistent with the respect we are called to show towards our own life. Catholic statements and teaching on organ and tissue transplantation speak of it as a form of "self-giving", a selfless act of love modelled on, and motivated by, Jesus Christ's unselfish offering of his own life. For this reason, the donation of human tissue and organs is often referred to as an "enduring gift". No one should ever presume such a gift. Provoked by love, and freely offered, an act of tissue or organ donation can be seen as an expression of human solidarity that serves the common good.

Organ Donation and Consent

1. Nobody should be able to lay a claim to the body of another except on the basis that it has been "gifted". The gifting of human tissues or organs, either before or after death, is not something that anyone should feel obliged to do, or be pressured into in any way.

2. For this reason, the use of all or parts of a person's body should only ever be done with their explicit consent, or, where such consent has not been recorded, with the consent of next of kin or close family recognised as knowing the mind and intent of the person. We recognise and uphold the intent of the proposed Human Tissue (Organ Donation) Amendment Bill legislation to ensure that all consent is informed and free of duress.

3. From a moral standpoint we regard the donation of one's body as a "heroic action" and a rich gesture of generosity to fellow humans. The Catholic theological analysis of organ donation as an "enduring gift" highlights the respect given to informed individual choice. Those who are ultimately responsible for shaping legislation around tissue and organ donation must seek to preserve and promote such actions for what they truly are - rich gestures of generosity. For this reason we would be opposed to an "opt out" register based on "presumed consent". The onus is on our society to properly educate and inform persons and obtain their informed consent. We support the proposed Amendment Bill which emphasises the need for persons to "opt in".

Consent – Binding or Non-Binding:

4. In New Zealand, respect for the autonomy of the patient is a fundamental principle that informs the provision of healthcare in New Zealand. This principle is upheld in "The Code of Health and Disability Services Consumers' Rights". Right 7 spells out the "Right to Make an Informed Choice and Give Informed Consent". Right 2 upholds the "Right to Dignity and Independence". While recognising that the principle of autonomy exists alongside - and may at times be in tension with - other key ethical principles, we hold the view that proper respect for the dignity of a person normally implies that their expressed wishes as to what happens with their body after death would be upheld.

5. In reshaping the legislation relating to organ donation after death, we wish to highlight the importance of giving proper consideration to the cultural and religious diversity of New Zealanders. The dominant model of informed consent upon which health-care decisions in New Zealand are made is largely premised upon particular cultural assumptions about personal identity and well being in which the person is defined first and foremost as an 'individual'. These assumptions are somewhat inconsistent with other cultural understandings in which an individual's personal identity is more strongly tied to the family or whanau group to which they belong. The differences in assumptions provide for different approaches to personal decision making, which at times can set up a tension. While the strong presumption should always be to act in favour of an individual's expressed wishes, we would be uncomfortable with a legal framework that ruled out absolutely a family's rights to veto their loved one's wishes. A system that seeks to resolve this tension by creating an automatic legislative preference for one set of cultural or religious assumptions over another is arguably unfair. We see that the application of the principle of informed consent within different cultural and religious frameworks provides one of the greatest challenges in shaping the new legislation.

6. The existence of an individual's clearly stated wish to be an organ donor creates a strong moral claim in favour of carrying out those wishes. At the same time, the medical process of obtaining the organs necessarily changes the natural dynamics that surround the death of a loved one. As a result, the actualising of a person's decision to be a donor makes significant additional demands on a person's family / next of kin, especially when it is filtered through the lens of anticipatory grief. The needs of family and loved ones also matter. The benefit of not departing from current best practices around organ donation (whereby health professionals will only proceed if there is family or next-of-kin approval) is that there is a guaranteed incentive to work closely with, and be sensitive to the multiple needs of the family of the deceased person.

7. One of our concerns is that there may not be the same incentive for health professionals to work alongside the grieving family if future legislation was to insist on an absolute presumption in favour of acting on the dead person's wishes regardless of her/his family's approval.

8. We wish to see the appointment of independent personnel, specially trained in grief and trauma and with specialised knowledge about the process of organ donation, to manage the process around organ donation. Such people are already working successfully in many hospital environments world-wide. The advantage of such personnel, apart from being specially trained, is that they are not involved in decisions around care and treatment options, and nor are they involved in the actual transplantation process. Thus there exists a clear separation between those assessing the likelihood of death and those involved in any subsequent harvesting of organs. They can address the particular grief needs of the deceased person's family/next-of-kin without having any perceived agenda. This system would also assuage the identified – and understandable - hesitation of some ICU doctors to approach families for consent.

9. The wishes of the deceased are paramount, and an individual's wishes should be upheld in all but exceptional circumstances. In cases where the family of a would-be donor object on cultural or religious grounds, it would be part of the role of the trained and independent personnel to work with the family. It should be their starting presumption that the issue would be resolved in favour of the individual's wishes. We believe such a process would in most cases resolve family/next-of-kin concerns while upholding the express wishes of the deceased, bringing about a win-win situation.

10. Nevertheless, in the face of continued cultural and/or religious objections we believe that the legislation should provide a degree of ethical and legal space for the wishes of the family to prevail. Respect for cultural and spiritual values is a strong aspect of New Zealand culture and is enshrined in many important pieces of legislation relating to health and welfare. Furthermore, to insist otherwise, that is, to provide for absolutely no circumstances in which the family could over-ride the deceased wishes, could, in the long-term, have a negative effect on the overall willingness of some individuals belonging to certain groups to become donors.

11. While much has been made of the fact that the current legislation allows family members to over-ride the expressed wishes of family members, it is our understanding that it has not been established that this is necessarily a significant factor in New Zealand's low rate of organ donation. In our opinion, making all New Zealander's more aware of, and educating and informing them about, the issues surrounding organ donation are the key factors in positively influencing the rate of donation in New Zealand.

12. The importance of keeping family closely involved in the decision making at all points becomes all the more evident when one considers that a sustained campaign to increase donor rates has the potential – even if unwittingly – to change the dynamic around end of life decision making. With a more focused drive to source organs comes an increased risk of abuse; that is, decisions being made that may not, in the first instance, be in the best interests of the critically ill/dying person. It is never permissible to bring about or hasten the death of a person for the purposes of retrieving organs, even when this is done to prevent the death of other persons. The input of the family remains an integral part of the care of the person and a key to ensuring that good decisions are made, and the risks of abuse minimised.

13. Furthermore, the necessary participation of family and loved ones in the decision whether or not to withhold or withdraw treatment or life-sustaining equipment is part of the process of organ donation. This means that the family are already intimately involved in the process of organ donation. Good legislation will take this reality into account as opposed to presenting the decision about organ donation as a 'stand alone situation' that should be managed quite apart from what precedes and follows it.

Systemic Issues:

14. Mindful of the relatively low rates of organ donation in New Zealand, we recognise the need for individual New Zealander's to be encouraged to think more seriously about their own willingness to act as donors. Education programmes integrated into the health curriculum could provide an important means for achieving this. Effective marketing strategies such as have already been undertaken by the Ministry of Health on various issues may also be an effective strategy. The proper resourcing of these campaigns requires a certain amount of political will. A higher level of awareness among New Zealander's will hopefully mean that more and more people will have discussed their decision to be a donor with family and next-of-kin at the time when they make their informed choice and well before the actual circumstances in which their decision needs to be effected.

15. We agree strongly that the current process, whereby individuals record their consent to be an organ donor at the time they renew their driving certificate, is inadequate and ineffective. This is the case not least because the option of becoming a donor is presented in a way, at a time, and in a place where there is insufficient time and information for people to make a properly considered choice. The setting up of the Organ Donation Register as specified in section 4B seems a suitable and robust means for people to have their wishes recorded.

16. We also believe that the relatively low rates of organ donation in New Zealand may reflect inadequacies within the current health system such as a shortage of available ICU beds. Issues such as these are of a more systemic nature. Once identified, they are also best dealt with through political means.

Conclusion

A comparison of New Zealand organ and tissue donation rates with other countries shows that we have one of the lowest donation rates in the world. We support efforts to increase the rates of organ donation in New Zealand. The nature of organ and tissue donation is that it is a "gift" and the processes around organ and tissue donation must respect this absolutely. Respect for a person's autonomy suggests a strong presumption to act in accordance with an individual's expressed wishes. The dynamics around end of life decisions, not to mention the needs and grief of family and next-of-kin, require that they remain closely involved in the process and that all attempts be made to ensure their support for a person's wishes to be a donor.

Submission from The New Zealand Catholic Bishops’ Conference and The Nathaniel Centre on The Use of Gametes and Embryos in Human Reproductive Research: Determining Policy for New Zealand (2007)

The Use of Gametes and Embryos in Human Reproductive Research: Determining Policy for New Zealand

Submission from The New Zealand Catholic Bishops' Conference and The Nathaniel Centre

Introduction

Life and physical health are precious gifts that have been entrusted to us. We have a responsibility to take care of them while taking into account the needs of others and the common good. Concern for the health of its citizens requires that society work assiduously to support all persons to live fulfilled lives. To this end the Catholic Church recognises the importance of, and is committed to, ongoing research into human health and well-being.

All research on human beings must be subject to respect for the dignity of human life. Science and technology must be ordered to the well-being of human kind from which they take their origin and development. The purpose of human research and an awareness of the ethical limits of research are grounded in, and remain at the service of, the integral good of human beings. Actions that are of themselves contrary to the dignity of persons cannot be legitimated in the name of research or experimentation. "The Church respects and supports scientific research when it has a genuinely human orientation avoiding any form of instrumentalization or destruction of the human being." (Pope John Paul II, Address to the Pontifical Academy for Life, February 24, 2003)

The question is whether our technical progress will be guided by an equally advanced sense of the dignity of each and every human life. Human society only benefits from research that reflects good science and good ethics. The debate over the use of embryos for research highlights a paradox: Whether or not we should destroy human life in its earliest and most vulnerable form in the cause of following our deeply humanitarian impulses to reduce suffering and find cures to human diseases.

This introduction outlines the context in which we offer the following comments on the proposed guidelines for the use of gametes and embryos in reproductive research within New Zealand.

Executive Summary

The question that stands at the heart of the debate about embryo-destructive research is whether or not it is ethical to achieve a good outcome using bad means – in this case the destruction of pre-nascent human life. Catholic teaching provides clear guidance on this question and the stance taken by the Catholic Bishops of New Zealand in their submission is summarised below. The position is essentially a positive one that argues an alternative way forward based on sound principles that reflect a rich understanding of the human person, a desire to protect and promote human dignity and a deep commitment to research and healing.

Only interventions which respect the life and integrity of the embryo and are directed towards its well-being are morally licit. All other research or interventions on embryos should be prohibited. We oppose the deliberate creation of embryos for embryo-destructive research. We also oppose the use of so-called "surplus" IVF embryos for embryo-destructive research.

In the case of embryo-destructive research carried out in the name of finding cures, the means actually contradicts and undermines the end or outcome being sought – human life is destroyed in the name of preserving human life.

Other alternatives to embryo-destructive research exist. Real progress that is genuinely "therapeutic" has been, and continues to be, made with 'adult' stem cells. Progress is also being made in sourcing pluripotent cells that exhibit the same behaviours as ESC's but which can be obtained without the need to destroy human embryos.

We consider that the inviolable dignity of the human embryo is sufficient reason for us as a society to step back from embryo-destructive research. However, even leaving aside the controversial question of the moral status of the embryo, it is our considered view that taking proper account of all other relevant moral factors, it is not possible to create a sufficiently persuasive - let alone substantially persuasive - moral account necessary to justify allowing the practice of embryo-destructive research in New Zealand.

The divide in the debate surrounding the use of embryos in research is sometimes falsely presented in terms of those in favour of progress and those against. This is a misrepresentation. Our stance against embryo-destructive research reflects a positive commitment to uphold the inviolable dignity of human life. Research that does not uphold human dignity will not ultimately advance human well-being.

A recommendation by ACART in favour of embryo-destructive research would be a recommendation for New Zealanders to cross a fundamental moral line never before crossed: permitting the direct killing of human life in its earliest and most vulnerable stages in the name of medical 'progress'.

New Zealand is currently in a unique position of being able to exercise moral leadership by rejecting embryo-destructive research and supporting stem cell research.

Research using gametes should be regulated through guidelines and then allowed to proceed on a case-by-case basis with appropriate ethical scrutiny. Particular regard needs to paid to informing women of the risks associated with egg donation and to protecting them from exploitation. The commodification of human life is also of concern.

1. What are your views on research, or aspects of research, using gametes?

Research using gametes should be regulated through the development of guidelines and then allowed to proceed on a case-by-case basis having undergone appropriate ethical scrutiny and having received appropriate ethical approval. We would expect that such research would be governed by the same or very similar ethical provisions as applies to research on other types of human tissue.

We uphold the principle enshrined in New Zealand legislation that transactions involving body tissue not be commercialised. We are concerned about the very real potential for the exploitation of women that would result from an increased demand for human eggs for purposes unrelated to fertility treatment. The potential for exploitation is there whether or not women are remunerated for their tissue. Egg donation carries very high risks and there needs to be very specific protocols developed to protect women donors. In particular, consent must be sought in a non suggestive and non coercive way that ensures women are fully informed of all the consequences and risks. Even benign appeals to a woman's altruistic nature can be coercive, especially when the health of other family members is involved and egg donation is presented as a necessary step towards therapies.

We are also concerned that an increased demand for human gametes, and eggs in particular, might contribute – even unintentionally – to furthering the commodification of human life.

We are opposed to any research with gametes that results in the creation of an embryo that would then be destroyed for the reasons we outline in answer to question 2 (see below).

We are also opposed to all research involving the fusion of human gametes with gametes of other species so as to create human-animal hybrid embryos. Such research raises profound questions regarding the identity and moral status of the new life forms.

2. What are your views on research, or aspects of research, using embryos?

It is our strongly held view that all research, or aspects of research, using embryos should be prohibited. The reasons for our view are as follows:

i. Human embryos are a part of the human family and deserve the same level of respect that is due to all human beings.

The desire to carry out research on human stem cells originates from a concern to better understand the human body, alleviate disease and improve people's quality of life. Without doubt, this desire is grounded in the integral good and well-being of human beings. The debate about the use of embryos in human reproductive research is not a debate about the merits of stem cell research. There are ethical and unethical ways to conduct stem cell research and the question is to which category a particular technique – the destruction of living embryos for their cells – belongs.

Neither is the debate about when human life begins. It is an accepted biological fact that a human life begins when a human embryo is created, irrespective of the means by which it was created. We were all once embryos! Proponents and opponents of embryo-destructive research agree that the dilemma associated with research on human embryos is the destruction of developing human life. The ethical questions centre on the sort of respect we should accord human life; in particular whether it is ethically consistent to accord a different level of respect to humans in the earliest stages of life, as well as whether there are ever factors that mitigate the respect due to human life at any stage of development.

The belief held by some that the life of a human embryo matters less than other human life at a more developed stage may reflect the fact that it is largely invisible – it isn't missed as other human beings can be missed. Yet even at the four cell stage, an embryo is not simply a collection of cells that happen to be contiguous. These cells are a human embryo, a new human individual and part of the human family. Embryos become children in the same sense in which children become adults, not by some addition to what they are, but simply by developing further as the kind of beings they already are.

To claim that a four-celled embryo is a human being clearly takes us beyond the level of empirical observation. However, to judge something solely at the 'material' level ("it is only a clump of cells") is to ignore the fact of what something is – in this case it omits an important truth about embryos in the same way that the statement 'I am sitting on a collection of timber and steel' omits the crucial truth that I am sitting on a chair. In other words, that a particular statement is strictly speaking accurate may not reflect its adequacy in describing the full reality of the situation.

The common understanding of person in our culture has been shaped by modern philosophies' emphasis on self-consciousness as the mark of personhood. A much older understanding of person, however, locates personhood in the dignity of a being's rational nature, irrespective of whether that being is conscious at a particular phase in his or her life. According to this traditional view there is nothing problematic about saying that an unborn child or a persistently unconscious patient is a person, for they are truly our fellow human beings. The key to understanding what a human embryo is lies in the connection that exists between a human embryo and an adult member of the human species.

The Catholic position accords unconditional respect for human life at all stages of its development. In calling for unconditional respect Catholic teaching is being absolutely consistent. It holds that without exception the living embryo has, from the moment of fertilisation, an absolute right to life. A life is begun which is neither that of the father nor the mother. It is already the human being it will always be and will only grow in size and complexity. On that basis all embryos are entitled to be granted a place in the human family and treated with the same respect as persons.

ii. Support for embryo-destructive research is based on a flawed understanding of human dignity as externally conferred rather than being an intrinsic characteristic of human life.

Arguments in favour of embryo-destructive research are premised on the belief that embryos possess varying degrees of moral status depending on the circumstances. The highest status is reserved for the 'wanted embryo in the womb'. Equally a very high value is attached to the 'wanted unfrozen embryo outside of the womb' because the parents have done so much in order to have it. The 'wanted frozen embryo' enjoys a mixed status – it is wanted but not wanted just yet.

The 'unwanted frozen embryo' has a certain status as a potential object for donation or research, and if the parents agree then its status can change from being unwanted (by them) to being wanted by others. In fact its status is reduced to that of 'experimental laboratory material'. If not wanted by others for research then it appears to have even less status or no status at all.

However, there is something inherently illogical about this rationale - the varying degrees of status belie the scientific fact that all embryos are biologically and ontologically the same kind of being, all members of the human species. Our common biological origins and shared ontological nature highlight the moral inconsistency of according embryos varying degrees of status and rights based on human subjective preference.

We can only justify such a range of 'status' if we are prepared to accept that human dignity and moral principles can be reduced to matters of preference, subjective opinion and even convenience. To take such a stance is to countenance an approach to bioethics that elevates personal choice and personal preference over a principled and objective approach to decision making.

From a Catholic perspective it is not so much a question of a different calculation of the amount of respect due to embryos as it is a question of the type of respect that is due. Catholic teaching believes that human dignity must be based on an 'intrinsic' respect; that is a respect which is independent of all factors or conditions that are extrinsic or external to the embryo including what ever subjective value might be attached to it by the couple whose gametes have contributed to the creation of the embryo.

Ultimately, to abandon an intrinsic understanding of human dignity and make it contingent on subjective preference is to destroy the foundation upon which universal human rights are based.

iii. There is no precedent for the introduction of embryo-destructive research in New Zealand, despite claims that the availability of abortion provides a precedent.

It has been argued that if we do not allow destructive embryonic research then, logically, we also have to repeal the abortion laws. In other words, the availability of abortion is seen as setting a moral precedent for embryo-destructive research; as an indication that our society already accepts that pre-nascent human life may be terminated for good reason.

At first glance we might be inclined to agree with the sentiments of the argument on the basis that there is a direct link between the two issues – the direct killing of unborn human life. That said, the question invites a deeper consideration.

The way in which the abortion laws in New Zealand work is to recognise certain situations in which the mother's rights have precedence over the rights of the embryo/fetus. In other words, current laws governing abortion in New Zealand do not extinguish the rights of the embryo / fetus. Rather, they confirm the existence of embryonic / fetal rights. That is, when considering legislation and/or regulations involving embryo-destructive research, the current legal situation reinforces the existence of such rights as the starting point for any debate. What is at stake is the moral significance of those rights in the face of society's desire to develop new cures – a very different moral dilemma from the typical abortion scenario.

A critical difference is the status of the 'second party'. Abortion is a procedure which is reluctantly allowed to proceed in very limited circumstances on examination of the particular situation by a competent authority. In a paradoxical way the application of abortion law in New Zealand actually confirms that the norm is for human life, once conceived, to be born, not destroyed. Abortion is an exception to the norm in cases where it is deemed that there is a proven disadvantage to the mother and it is tolerated as a way of preventing specific harm to a specific person in a specific situation – essentially the mother. It is quite another thing to allow the destruction of pre-nascent human life for a cause that is only potentially related to the generic good of society sometime in the future.

Consequently, it does not immediately and automatically follow that we should equate the rights of a woman wanting an abortion with the needs of society to carry out stem cell research. That conclusion remains to be debated. Embryo-destructive research is not a logical consequence of the current abortion laws in New Zealand.

iv. Embryo-destructive research is unethical because the means employed is in conflict with the end that is sought.

The dilemma posed by embryo-destructive research comes about because of an apparent conflict between two key values; the desire - indeed responsibility - we have of curing terrible illnesses and diseases versus the need to show respect to human life in all its stages.

Moral theories offer various ways of resolving such conflicts. One approach that is favoured in our society today is to evaluate the competing values in terms of 'cost' and 'benefit'. For many people, the payoff of developing cures that could benefit millions is seen as being worth the cost – in this case the lives of a few (perhaps unwanted) human embryos. The ethical dilemma is presented in fundamentally numerical terms. This cost-benefit analysis reflects a desire to produce the best outcome and to maximise benefits – commonly referred to as the utilitarian principle. In simple terms 'the end justifies the means'.

It is over-simplistic to say that we are concerned about saving human lives and that this is sufficient justification for destroying human embryos. This is not an adequate ethical description of what is actually happening. It is inadequate because it ignores the deeper meaning of the action. Actions chosen as the means to an end have a meaning and moral quality of their own, independent of the circumstances or outcome, and not reducible to the outcome. The deeper meaning of what is happening is revealed by a closer analysis of the 'intent' and 'content' of the actions of those involved in embryo-destructive research.

In embryo-destructive research there is a lack of congruence between the means employed and the outcome or end that is sought? The 'intent' of the action and the 'content' of the action are at odds with one another. In fact there is a contradiction – human life is destroyed in the name of saving human life.

For any action to be ethically acceptable there has to be consistency between what is done – the means – and the reason it is done - the end.

v. To the extent that we are prepared to look at early human life in a more utilitarian and commodified way we are more likely to view and treat other human life in such a way.

"But they are going to be destroyed anyway!" This line of reasoning is used to justify research on embryos that are 'left over' from fertility treatments. Those who argue this way sometimes draw a parallel with the practice of organ donation; in giving its life for the sake of others an embryo's existence is given meaning and value. Its proponents argue that such an outcome appeals as a moral choice because it confers a reason for existence on the embryo, casting its death as an altruistic and salvific act and giving some value to its (otherwise meaningless) life.

This argument ignores any difference between what philosophers refer to as 'evil done' vs. 'evil suffered'; a distinction that rests on the moral importance of intention. If a person is run over and accidentally killed by a vehicle and another person is deliberately killed by another vehicle, it is not untrue to say that the outcome is exactly the same – in each case a dead person. However, at the moral and legal level we do not regard the two incidents in the same way because intention matters. It is always bad when a human being is killed, but it is worse when their death results from the deliberate and evil will of another. In other words, the moral evil of murdering someone is a greater threat to human dignity and society than is the physical 'evil' of death alone. In the same way, just as it is ethically inadequate to judge these two incidents simply from the perspective of what is lost, so too it is inadequate to count and compare the lives of embryos lost while assuming that how they are lost somehow does not matter.

While embryos created for IVF and held in storage are eventually going to perish this is not the same as intentionally destroying them. (The same logic applies to those who argue that the high natural attrition rate of embryos in utero somehow makes it acceptable to intentionally kill embryos.) To consider that there is no ethical distinction between allowing embryos to die and intentionally destroying them is to fail to take proper account of the moral harm associated with the deliberate destruction of human life; in particular its wider repercussions and consequences for the way we look at all human life.

What might be the wider repercussions? Firstly, it is a fundamental axiom of morality that all our actions are self-reflexive; that is to say, what we do reflects back on ourselves; we become what we do. Our actions have either a positive or a negative effect on our moral sensibilities, both individually and collectively. Once we recognise that all our actions shape our characters - either positively or negatively - we can also recognise that there are some things we should never do simply because they will damage our moral character and the moral underpinnings of our society.

To the extent that we are prepared to adopt a utilitarian approach to the status of human life in embryonic form, we are more at risk of perceiving and treating other human life in a utilitarian manner.

vi. Because the proposed benefits of embryonic stem cell research are at best hypothetical and indeterminate, there is no basis for even a utilitarian rationale in favour of embryo-destructive research.

Even a cursory analysis of the New Zealand discussion about the use of human embryos as a source of stem cells shows that the promise of beneficial treatments remains uppermost in people's minds. A recent Sunday Star Times article is typical of the way the debate has been carried out in New Zealand: "Embryonic stem cells have the potential to turn into any other cell in the human body ... and hold the promise of astonishing new disease therapies" (Sunday 18 Feb 2007). In that same article the chair of ACART suggests that the dilemmas posed by the use of human embryos can be resolved by a process of weighing up and comparing the benefits versus the harms.

Our own position (as already noted) is that utilitarianism cannot offer an adequate framework for resolving the ethical dilemmas associated with the deliberate destruction of human life. We recognise that not everyone is prepared to accept that this is the case. Nevertheless, without yielding our own moral ground, we fail to see that any real or meaningful comparison of "benefits" and "risks" is able to be made at this point in time given that there is no tangible evidence of outcomes, and given the general consensus that the clinical benefits could be a decade or more away.

To this end, we were somewhat surprised (and concerned) that the ACART discussion document continues to refer to SCNT as "therapeutic cloning". In overseas literature there has been a deliberate move to re-label such cloning, many preferring to use the term SCNT. Using the term "therapeutic" provides an inaccurate description of what is actually happening and reinforces the mistaken impression that such experiments are therapeutic in nature. In short the term conceals rather than reveals what is really happening.

If alternatives exist that will enable stem cell research to continue without the need for further destruction of embryos – and they do – then, from a purely utilitarian perspective, it would seem imperative that there be specific evidence of additional benefits to justify the immense additional "harm" associated with the destruction of human life. Lack of such evidence renders the utilitarian calculation impotent. From a strictly rational point of view it is irresponsible, and therefore unethical, to follow a path that results in extra harm in the absence of any tangible evidence of additional benefits.

We make this point not to imply that evidence of such benefits would legitimise embryo-destructive research, but simply to emphasise that, for those who subscribe to utilitarianism, an honest utilitarian calculation cannot currently be made in support of such research.

Recent comments made by eminent stem cell researchers not averse to embryo-destructive research highlight the uncertainty surrounding the prospects of therapies. Alan Trounson, an eminent Australian scientist involved in stem cell research, has been quoted in a Nature Medicine article as saying: "The so-called therapeutic cloning to my mind is a non event." In terms of developing therapies or cures he has said that "it's just not realistic." ("Scientists seek simple remedies to cloning conundrums". Nature Medicine. May 2005, p. 459.) In the same article a prominent US cloning researcher, Jose Cibelli, professor of animal biotechnology at Michigan State University concurs: "I can predict that therapeutic cloning is going to be obsolete." In a similar vein Lord Winston, a pioneer of fertility research in the UK who has pushed for embryo-destructive research, has admitted that in the 2001 debate in the UK the immediate potential of embryonic stem cells was exaggerated. He has described the debate surrounding embryo stem cells as a case study in scientific arrogance and the dangers of 'spinning' a good story and has commented: "I view the current wave of optimism about embryonic stem cells with growing suspicion" (The Guardian, September 5, 2005).

The disconnect that exists between the picture of individualised cures painted by those pushing for embryo-destructive research, and the lack of evidence that sick people will ever benefit from stem-cell research, remains of very real concern to us, as does the lack of awareness of that disconnection in the general media and public perception. The net effect of this is to exploit the emotions of many patients and their families. The existence of the disconnect threatens to undermine the integrity and value of the public consultation process currently being undertaken in New Zealand. While the ACART discussion document warns that "[an] appropriate degree of caution is therefore necessary in discussing the potential benefits of this research" (n. 88) it appears that it is the prospect of therapies that continues to be used to drive public opinion about the merits of embryo-destructive research.

If contemplating relaxing a legislative ban on SCNT, or the creation of embryos specifically for embryo-destructive research, it would at this point in time be grossly misleading – if not unethical – if ACART's advice to the Minister was argued on the basis of unproven potential for therapeutic outcomes.

vii. Other ethical alternatives to embryo-destructive research exist and New Zealand has a unique opportunity to exercise leadership by taking a principled stand in favour of stem cell research AND the dignity of human life.

In recent years there has there has emerged a growing body of research that is focused on developing cells with the abilities of those derived from embryos, but without the need to harm human embryos. The new avenues include the reprogramming of adult cells to function like embryonic stem cells, deriving pluripotent cells from testes and the discovery of cells with seemingly pluripotent abilities in the placenta, human cord blood and amniotic fluid. On top of that, progress continues in the field of adult stem cell research, including promising studies that are challenging the long held paradigm that adult stem cells have undergone an irreversible process of terminal differentiation. In other promising research carried out in 2006 Japanese scientists Kazutoshi Takahashi and Shinya Yamanaka have produced pluripotent stem cells by introducing four key factors into mouse cells under specific culture conditions; a process that totally bypasses the use of eggs and the creation of embryos.

When other alternatives exist we have an ethical obligation to follow those alternatives.

New Zealand has, over the years, consistently shown moral courage and leadership by taking principled stands on a host of issues related to upholding human dignity and advancing human well-being. Research that does not uphold human dignity will not ultimately advance human well-being. We need to foster and support stem cell research in New Zealand that is ethical and that promotes human dignity even while it seeks to serve the greater common good. Ample opportunity exists for us to do. We have the opportunity to make a significant contribution to advancing the causes of human health and well-being without resorting to the deliberate and intentional destruction of human life in embryonic form.

3 . The discussion paper outlines a number of possible sources of gametes and embryos for use in research. What are your views on the use of these sources?

All sources of embryos should be prohibited. We oppose all forms of embryo-destructive research as noted above.

The donation of gametes would need to be governed by strict procedures that uphold the key principles that form the basis of all health research ethics review in New Zealand. As noted in our response to Question 1 we are particularly concerned about the potential exploitation of women as a source of eggs, as well as the risks to women inherent in obtaining the eggs.

The HART Act requires ACART to give advice specifically on the genetic modification of gametes and embryos and the import and export of gametes and embryos.

4. What are your views on genetic modification of gametes?

We believe that the genetic modification of gametes should be subject to a lengthy moratorium.

We believe that this question has huge implications for society. It is too important and too complex to be dealt with in such a cursory fashion in a document that is arguably focussed on a range of other ethical dilemmas. The ethical issues associated with this question warrant a discussion document and full and substantial public consultation in their own right.

It is questionable whether at this time we possess the wisdom and maturity to handle such technology wisely and safely.

5. What are your views on genetic modification of embryos?

Genetic modification of embryos should likewise be subject to a lengthy moratorium.

The only basis on which we would ever consider that it might acceptable to genetically modify a human embryo would be in circumstances where it was done as a therapeutic intervention that was aimed at the prevention of serious hereditary diseases and specifically carried out in the interests of the embryo in question and prior to it being implanted. In other words such interventions would need to uphold the inviolable dignity of all human life as expressed in our response to Question 2 above.

6. What are your views on the import and export of gametes?

We think it is acceptable that the import and export of gametes should be regulated through the development of guidelines and then assessed on a case-by-case basis.

That said, New Zealand must not compromise its stance against the commercialisation of body tissue including gametes. A fundamental premise of research in New Zealand is that the tissue is donated by people who were fully informed, and who gave their full consent as part of a process that was free from any sort of coercion. This should remain a condition of using gametes in research, whether that research is based in New Zealand or overseas and whether the gametes were sourced in New Zealand or overseas. Our commitment to the non-commercialisation of tissue should mean we reject the importation of all tissue obtained in a commercialised manner.

One of the challenges facing researchers who import gametes is the difficulty in verifying the manner in which tissue was obtained overseas. Given the potential for exploitation of women in order to gain eggs, we are particularly concerned about the importation of eggs from other countries where ethical oversight may be less robust than it is in New Zealand.

Similarly the export of gametes raises ethical as well as cultural and spiritual issues. It is questionable whether the provisions upon which tissue is donated will always be upheld by researchers in other countries.

7. What are your views on the import and export of embryos?

The import and export of embryos should be prohibited. We are opposed to all embryo-destructive research and therefore oppose the import and export of embryos for research purposes.

8. Principle (g) of the HART Act states that the different ethical, spiritual, and cultural perspectives in society should be considered and treated with respect.

We are interested in your views on how this principle could be incorporated into New Zealand's policy position on gamete and embryo research.

What are your views on how this principle could inform ACART's advice to the Minister, and, if research does proceed in some form, how it could be reflected in guidelines?

New Zealanders hold various ethical, spiritual and cultural beliefs which influence their views regarding the use of human embryos in research. Nevertheless, we believe that there is a clearly identifiable common core of values that form part of most people's world view. We identify the values relevant to this discussion as: a concern to find cures and advance medical research; a commitment to uphold human dignity and promote respect towards human life; a commitment to show appropriate respect to human life in its earliest forms; and a strong sense of stewardship of, and respect for, all life forms and the environment.

These core values which characterise the various ethical, spiritual and cultural perspectives of New Zealanders can best be respected by a policy position that promotes only stem cell research using pluripotent cells obtained by means that do not require the destruction of human life in its most basic form.

It is possible to foster and support stem cell research in New Zealand that is ethical and that promotes human dignity even while it seeks to serve the greater common good. As noted above, research that does not uphold human dignity will not ultimately advance human well-being. New Zealand researchers are already renowned for their groundbreaking work with adult stem cells.

New Zealand has the opportunity to continue making a significant contribution to advancing the causes of human health and well-being in the field of stem cell research without resorting to the intentional destruction of human life in embryonic form.

Submission on Aspects of Assisted Reproductive Technology (August 2007)

Question 1:
Do you agree that the following procedures should remain subject to guidelines developed by ACART, and review by ECART?

· clinic-assisted surrogacy
· embryo donation for reproductive purposes
· donation of gametes between certain family members
· certain uses of PGD?

Yes, we believe that the procedures listed should remain subject to guidelines developed by ACART, and review by ECART.

Explanation:

The use of the procedures listed above raises significant psycho-social issues. Technology, often unawares, introduces into the act of human life-giving various elements which do not sit well with the dignity of the human person. It is vital that as a society we take into account the effect of reproductive technologies on core societal values and the common good, including their potential to redefine certain fundamental under-standings around parenting and children. Meeting the needs of couples who are infertile is, by itself, not sufficient as a criterion for evaluating the use of particular technologies.

Given that the broader view of the ethical issues associated with assisted human reproduction is too often eschewed in favour of a narrow focus on the reproductive rights of adults, ethical oversight by ECART based on approved guidelines provides some assurance that the broader issues will be taken into account.

Question 2:
What are your views on the proposed guidelines for clinic-assisted surrogacy?

It is our firm view that the proposed guidelines for clinic-assisted surrogacy significantly widen the parameters within which surrogacy is considered acceptable. This causes us great concern.

Explanation:

We remain opposed to all forms of surrogacy because we believe that the overall well-being of children is compromised by arrangements under which a woman agrees to become pregnant for the purpose of surrendering custody of a child to be born. We also believe that the practice of surrogacy can place the health and welfare of women at risk.

While not condoning surrogacy we propose – in line with the current guidelines – that the following prerequisites be added to the first guideline as a way of limiting the harm associated with this procedure:

• That at least one of the intended parents should be the potential child's genetic parent.
• That the intended mother should have a medical condition (or medical diagnosis of unexplained infertility that has not responded to other treatments) that prevents her from becoming pregnant or makes pregnancy potentially damaging to her or the child. (We see nothing in the proposed guidelines that will prevent the possibility of surrogacy being employed for social reasons.)
• That the intended parents be permanent residents in New Zealand (so as to prevent "reproductive tourism").
• That a determination has been made that the would-be surrogate mother has completed her family.
• We also believe that the guidelines need to emphasise:
• That there is to be no payment for surrogacy other than reasonable costs related to pregnancy and childbirth.

Question 3:
What are your views on the proposed guidelines for embryo donation?

We believe that the proposed guidelines on embryo adoption ignore some key issues and need to be added to.

Explanation:

We are supportive of embryo adoption on the basis that unconditional respect for embryos created by IVF rules out all activities other than for the purpose of implantation and bringing to birth the human life that has already begun.

The health and well-being of children who are born as a result of the performance of an assisted reproductive procedure must be paramount in all decisions regarding embryo adoption.

We do not believe that embryo adoption should be limited to infertile couples with medical conditions precluding normal reproduction. All couples who otherwise meet the conditions for adoption should be considered as potential recipients. While the definition in the discussion document defines embryo adoption as the donation of 'surplus' embryos "to an infertile couple or person" (p. 10) we note with approval that the proposed guidelines do not seek to limit donation only to infertile couples.

More specifically, we argue that the proposed guidelines need to be added to or amended as follows:

• We are concerned that the process around the "selection" of an embryo for adoption has the potential to encourage a "consumer" approach to the birth of children. Therefore, in line with principles (b) and (g) of the Hart Act, we think it is critical that it is donor couples who choose the potential recipients. This should be specified within the guidelines.
• In line with all other adoption procedures, the ethics committee involved needs to receive confirmation that prospective parents have been thoroughly screened by the appropriate authorities.
• In cases where one partner of a potential donor couple is deceased we believe that donation of that couple's embryos should be able to proceed without the prior written consent of the deceased person. To dictate otherwise would be out of step with what currently occurs as a matter of course; after a person's death the partner takes on all the legal responsibilities of the couple and makes decisions on the basis of what they believe to be in the best interests of their family. We regard this scenario as morally distinct from wanting to use the gametes of a deceased person to create embryos without their prior written consent.

Question 4:
What are your views on the proposed guidelines for donation of gametes between certain family members?

We are opposed to the donation of gametes between family members. Being aware that this procedure is already allowed in particular circumstances, it is our firm view that the revised guidelines should reflect the current guidelines. In their current form we fear that the proposed guidelines widen the circumstances in which gametes are able to be donated within families. Therefore, we argue that the proposed guidelines need to be added to.

Explanation:

We are opposed to the donation of gametes between family members because of the way it redefines traditional genetic relationships and because of the potential for identity confusion that too easily results. Relationships within families also complicate the processes for obtaining informed consent without coercion.

That said, we are aware that the present laws allow for this procedure in particular circumstances. Given this situation, the best way in which to protect the health and well-being of the children to be born, as well as donors and recipients, is for all such decisions to be subject to very specific guidelines and to be carefully scrutinised by an objective and independent ethics committee.

In their current form we fear that the proposed guidelines widen the circumstances in which gametes are able to be donated within families. Therefore, in line with the current guidelines we propose that the following prerequisites be added to the proposed guidelines:

• That at least one of the intended recipients should be the potential child's genetic parent.
• That "within-family gamete donation may only occur when there are medical conditions precluding normal reproduction in respect of the recipient couple or unexplained infertility that has not responded to other treatments" ("Guidelines on Within-family Gamete Donation, April 2005).

Question 5:
What are your views on the proposed guidelines for uses of PGD that are reviewed by ECART?

The proposed guidelines are seriously lacking because they fail to limit the situations in which PGD may be used. More specifically, they fail to uphold two key notions that were identified when PGD was first approved in New Zealand. The effect of this would be to send out the (erroneous) message that the use of PGD poses few if any ethical issues, taking us a step closer to regarding this type of diagnosis as a 'normal' - and even desirable - part of IVF treatment.

Explanation:

Regarding our stance towards PGD, we reiterate what we have stated in earlier submissions:

(i) Embryo selection is unacceptable because it implicitly and explicitly devalues human life.
(ii) Allowing embryo selection for any reasons, including those related to the health of the child to be born, opens the way to significant pressure for eugenic or discriminatory activity.

While not condoning IVF, embryo selection, or embryo destruction, our comments on the proposed guidelines are made with the intention of limiting the harm. We are particularly anxious that current restrictions on the use of PGD not be relaxed in any way.

The use of PGD has social consequences resulting from the cumulative effects of people's individual decisions to use PGD. The social consequences of PGD impact on society in a way that goes beyond the intentions of individuals using the technology.

That the use of PGD in New Zealand has the potential to result in deleterious social consequences for our society was openly acknowledged by NECAHR in an earlier stage of public consultation when it noted that the purpose of 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."

The notions that the use of PGD be limited to situations where there is a high risk of serious abnormality and that it be prohibited for non-medical reasons must be upheld in the revised guidelines. Therefore we wish to see the proposed guidelines supplemented by adding in the following prerequisites:

• PGD may only be used in situations where there is a high risk of serious abnormality
• PGD may not be carried out for social reasons, including sex selection
• PGD may not be carried out to alter the genetic constitution of an embryo

We would also stress that recent research into the nature of early embryonic development up to the eight cell stage has raised significant concerns about the risks associated with embryo biopsy. In light of this we believe that PGD as a procedure needs to be reviewed on the basis of principle (a) of the HART Act; the health and well-being of children born as a result of an assisted reproductive procedure.

Question 6:
What are your views on the proposed guideline for PGD using HLA tissue typing?

Notwithstanding our opposition to the use of PGD, it is our firm belief that PGD using HLA tissue typing should continue to be restricted to those situations when PGD is needed to test the embryo for a familial single-gene disease or a familial sex-linked disease.

Explanation:

It is vital that as a society we take into account the effect of reproductive technologies on core societal values and the common good, including their potential to redefine certain fundamental understandings around parenting and children.

Using PGD in order to benefit solely the existing sibling of the potential child crosses a definite ethical boundary. The potential child is used as means to an end. Even when it is argued that the potential child is wanted for its own sake, the procedure introduces a "conditional" element into the existence of the child which sets up its own unique relational dynamics within the family; dynamics that could be to the detriment of the child already in existence and/or the child yet-to-be conceived.

There is a liberating truth in knowing the unconditional nature of our origins. We believe that the idea of a family as a place of unconditional love and acceptance needs to be protected by an understanding of belonging that is rooted in the notions of life as an unconditional gift. Seeing our children as "gift" defines our relationship with them in a very different way from seeing our children as products of conception created by adults and subject to the wilful manipulation of adults. PGD that uses HLA tissue typing involves a degree of instrumentalising of human reproduction that compromises the dignity of children and therefore the proper respect due to them. The liberating truth associated with the unconditional nature of our origins is threatened by the use of PGD with HLA typing.

The use of PGD is arguably pushing us further along that continuum which makes it easier to see our children more and more as artefacts and more difficult to dismiss the notion of children as "commodities".

Question 7:
What are your views on whether the use of PGD should be extended to allow the testing of embryos solely for tissue typing for an existing child with a disease?

As noted above we do not believe that the use of PGD should be extended.

Question 8:
Do the guidelines proposed in chapter 3 adequately address the needs, values and beliefs of Māori?

We defer to the views of Māori on this question while noting that within the Māori tradition there is a strong emphasis on the link between self identity, family and community conveyed by the notion of whakapapa.

Question 9:
What are your views on whether an embryo for reproductive purposes should be allowed to be created using a donated egg and donated sperm?

We are opposed to the creation of embryos for reproductive purposes using a donated egg and donated sperm.

Explanation:

We are first and foremost relational beings. The Catholic moral tradition regards the human body as a personal reality; as the sign and place of our relations and connection with others. It is not something that can be reduced to pure materiality. In other words, it is part of the wonderful mystery of being human that our self identity is intrinsically linked with our bodies and their genetic origins. It is for this reason that Catholic teaching on the transmission of human life centres on a commitment to holding together the genetic, gestational and social dimensions of family and parenting.

A very similar understanding of the importance of self identity through family and community is found in the Māori concept of whakapapa, a concept readily understood and embraced by most New Zealanders. "It is the genesis – the core, the nature, the history and the origins of a people. For none can move forward not knowing where they come from. Without a starting point there is no direction. Whakapapa is not only our past. It is the preciousness of who we are today and the promise of who we can become" (source: www.maori.co.nz/related_topics/whakapapa.html).

What is at stake in this question is the importance of genetic origins and affective relations in establishing enduring human relationships and in securing a healthy self identity. To approve of embryos being created from donated eggs and donated sperm is to disregard the critical importance of affective relations with the biological parents and extended family, and to act as if it is the nurturing role of parenthood that is most determinative.

Whatever people believe about the acceptability of IVF, a clear moral distinction exists between homologous IVF (where the gametes are sourced from both partners within the relationship) and heterologous IVF (where one or both gametes are sourced outside of the commissioning couple). This distinction rests on the fact that homologous IVF conserves the link between parenthood, family and genetic origins. We acknowledge that heterologous IVF is currently approved in New Zealand. However, we think it should remain limited to situations where one of the parents is genetically related.

There are occasions when, for the good of a child's welfare, the decision is made that they not be brought up within their family of origin or by one of their biological parents. Even then, the difficulties for adopted children and their parents are significant. To reluctantly accept that there are circumstances when we need to separate a child from their genetic family of origin is one thing. To set out to deliberately deprive children of this link for the sake of the needs of the adults involved is quite another. It is inconsistent with respect for the family and for the child. It is this distinction that makes the adoption of an already existing embryo morally distinct from the deliberate creation of an embryo from donor eggs and sperm.

Using donated sperm and a donated egg for reproductive purposes undermines the first principle of the HART Act; the protection of the health and wellbeing of children born as a result of assisted reproductive procedures. It also ignores the deeper cultural and spiritual reality of our human nature and thereby undermines principle (g) of the HART Act. Our commitment to upholding the Treaty of Waitangi demands that we give proper consideration to the concept of 'whakapapa'.

We recognise that the burden of infertility can be overwhelming for couples. They can be encouraged to look at the other options available, including adoption of children and embryo adoption.

Question 10:
Do you agree that embryo splitting requires no specific recommendation to the Minister of Health (which will mean that it is unable to proceed, although it will not be prohibited)?

We are strongly opposed to embryo splitting.

Explanation:

Embryo splitting is in essence nothing other than a form of human cloning.

The very act of cloning treats the procreation of a human being as an act of production, and reduces human life to the status of a 'thing'. We are opposed to all forms of cloning on the grounds that it is an affront to the intrinsic dignity of human life. There are also unknown and potentially serious risks associated with such procedures.

Human cloning would create a human being who deserves to be treated as our equal but in a way that undermines this equal dignity.

Question 11:
Do you agree that the import and export of donated in vitro embryos and gametes should be allowed, provided that the prohibitions and principles of the HART Act are met?

We believe that where there is sufficient proof of an existing and established relationship between the applicants and donated in vitro embryos and gametes, the importation or exportation of such could be approved in limited circumstances where the applicants, having already undergone IVF treatment in one country and having taken up residence in another country, wish to use the embryos or gametes for the purposes of having another child that is genetically related.

Explanation:

We do not approve of the use of IVF. It raises a number of significant ethical and moral issues related to the well-being of children – including the commodification of human life – and, in cases when couples are seeking to use donated eggs, issues related to the exploitation of women.

In general we think that the importation and exportation of in vitro donated gametes or embryos is open to significant abuse and may be difficult to regulate. In many countries, human eggs are readily able to be purchased. Given the well documented stories of exploitation of vulnerable women in order to gain eggs, we are particularly concerned about the importation of donated embryos from those countries where ethical oversight is less robust than it is in New Zealand.

We believe that it will be very difficult in some cases to verify that imported gametes or embryos meet the requirements that are part of the HART Act; for example verifying that the embryos or gametes concerned were truly "donated" and not provided under duress or purchased, and verifying information about donors. Without stringent regulations and adequate 'policing' of regulations we could inadvertently bring about the commercialisation of human reproduction in New Zealand in what would be a flagrant breach of the HART Act. We also believe that the importation of gametes and embryos could raise significant bio-security issues.

The comments that follow are made on the assumption that all bio-security needs can be met. They are also made with a view to restricting the importation and exportation of embryos and gametes to a very limited set of circumstances.

(1) In regard to the importation and exportation of donated embryos: We believe that this should be limited to cases where there is sufficient proof of an existing and established relationship between the applicants and the donated in vitro embryos. More specifically, the importation or exportation of such embryos could be approved in cases where the applicants, having already undergone IVF treatment in one country and having taken up residence in another country, wish to use donated embryos (i) for the purposes of having another child that is genetically related to any existing children, or(ii) for the purposes of having their first child in situations where previous attempts to implant embryos have failed and a number of embryos remain in storage. To allow the importing or exporting of existing embryos that are in storage for the purposes of having another child allows parents to exercise the moral responsibility they have towards the embryos that exist; the option that is most consistent with the unconditional respect due to the embryo.

(2) In regard to the importation and exportation of donated gametes:

We believe that this should be limited to cases where there is sufficient proof of an existing and established relationship between the applicants and the donated gametes. More specifically, the importation or exportation of gametes could be approved in cases where the applicants, having already received IVF treatment in one country and having taken up residence in another country, wish to use gametes for the purposes of having another child that is genetically related to any existing children. Alternatively, it should be possible for persons who for medical reasons have had their own gametes placed in storage to reclaim these gametes in cases where they now reside in another country.

To broaden the parameters within which donated in vitro gametes and embryos might be imported and exported would take us a step closer towards the commodification of human life and could potentially undermine principles (b), (c), (d), (e) and (g) of the HART Act.

Question 12:
Do you agree that requirements for the import and export of donated in vitro embryos or gametes should be set out in guidelines developed by ACART, rather than regulations?

We believe that requirements for the import and export of in vitro embryos and gametes should be set out in regulations.

Explanation:

As explained above, there is a significant potential for people to abuse the right to import and export embryos and gametes. Associated with that, there are difficulties in verifying that imported embryos/gametes meet the requirements that are part of the HART Act. This is especially so in cases where they are sourced from countries where ethical oversight is less robust than it is in New Zealand.

We believe that the seriousness of inherent risks associated with the practice of importation and exportation of embryos and gametes, including the bio-security risks, make it more appropriate for the requirements to be set out in specific regulations rather than guidelines.

Question 13:
Do you agree that it is necessary to prescribe requirements for informed consent in regulations?

We agree that it is most desirable to prescribe requirements for informed consent in regulations under the HART Act.

Explanation:

The HART Act upholds the importance of informed consent. Arguments in favour of the use of assisted reproductive technologies often reflect the assumption that affective relationships with ones genetic family are less determinative for the well-being of the child than the nurturing parent relationship. In New Zealand the risks associated with severing the ties between children and their genetic origins (the donors of gametes) have been recognised in the HART Act by an absolute insistence that children born by way of assisted technologies have a "right" to knowledge about, and access to, their genetic origins.

This right can, in turn, only be upheld by an absolute insistence on the consent of all parties involved. We believe that this is best done by way of prescribing the requirements in regulations under the HART Act.

Question 14:
What specific requirements for informed consent would you like to see

The regulations must protect and enhance the rights of children to access information about their genetic origins.

We do not believe that donors of gametes should be able to withdraw their consent after embryos have been created on the basis that the embryo has a right to life.

Question 15:
Do you agree that, where written consent is not given prior to death, the use of gametes from deceased persons for reproductive purposes should be prohibited?

We concur with ACART's reasoning that the principle of informed consent prohibits the use of gametes from deceased persons where no written consent exists.

Explanation:

We agree that ACARTS proposed advice to the Minister is in accordance with principle (d) of the HART Act. To make allowance for a situation in which gametes might be used without specific consent undermines one of the critical foundational principles of the HART Act. It would also set a precedent which might be used to erode the application of the principle in other situations.

In addition we believe that consideration of the emotional and social health and well-being of any child or children born from such a procedure (principle (a) of the HART Act) also mitigates against the assisted conception of children in such circumstances.

Question 16:
Does the advice proposed in chapter 4 adequately address the needs, values and beliefs of Māori?

We defer to the views of Māori on this question. The only comment we wish to make is that, in our view, the principle of individual choice is sometimes used as an excuse not to take full account of Māori concerns, and as a reason for ignoring culturally different processes for obtaining consent.

Our obligations to the Treaty of Waitangi dictate that we look at the way in which the application of processes and guidelines surrounding the use of reproductive technologies may exclude a characteristically Māori approach to obtaining consent and/or undermine other key cultural values.

Question 17:
What are your views on the Tikanga outlined in Appendix 2?

We defer to the views of Māori on this question.

Question 18:
Are there any other Tikanga that ACART should take into consideration?

We defer to the views of Māori on this question.

Question 19:
Do you have any further comments to make that have not been covered in the questions set out above?

There have been many remarkable advances in science and technology that contribute to improving the welfare of humanity and the world in which we live. At the same time, many of the developments have the potential for adverse effects - for society as a whole, as well as for individuals and certain groups of individuals.

Developments in science and medical technologies have provided us with new means of having children. Many couples who were previously infertile are now able to have children. However, the use of assisted reproductive technologies has significant ethical implications. Firstly, use of the technologies has an effect on family dynamics, particularly the relationships between children and their parents. Secondly, the possibilities and choices generated by the technologies is redefining our understandings of pregnancy, parental responsibility, attitudes to children and understanding of families at a societal level.

Therefore, a proper assessment of the uses of reproductive technology includes a consideration of the ethical, cultural, social and spiritual dimensions of our human nature. It is for this reason too that certain decisions about the use of these technologies go beyond the rights of individuals to exercise their reproductive choices.

In light of that we wish to re-emphasise the importance of ongoing third-party oversight in the use of human assisted reproductive technologies. Greater availability and/or use and/or acceptance of particular technologies associated with human reproduction does not lessen the need for ethical oversight and scrutiny – greater use of these technologies demands more oversight as increased use has the potential to bring about a greater complacency about the social consequences of the various practices.

We endorse the need for robust guidelines and regulations and reiterate the importance of the role of, and work being done by, ACART and ECART.

Consultation on the Use of Frozen Eggs in Fertility Treatment: Discussion Document (2008)

The Nathaniel Centre welcomes the opportunity to comment on the use of frozen human eggs in fertility treatment.

Introductory Comments

A Catholic approach to the transmission of human life is characterised by two key beliefs: the dignity of the human person and, flowing from that, a belief that the context in which humans are conceived, and the means that are used, reflect this dignity. The conjugal act is seen as the only means that is wholly consistent with the dignity of the human child. The use of technology in human reproduction is assessed as upholding the dignity of the human person to the extent that it assists the conjugal act but does not replace it. Children must always be conceived in a way which shows that they are respected and recognised as equal in personal dignity to those who give life. This rules out all actions which in any way instrumentalise or treat the child as an object, whether intentionally or otherwise.

One of the implications of this is the need we have, emotionally, psychologically and spiritually to experience ourselves from our very origins as contingent beings; beings who came about in a fortuitous way conceived for no other reason than love, beings conceived in a way that is free from the manipulation of other persons. Technological interventions that allow parents to exercise ever greater control and dominance over the sorts of children that are born can put this very human quality of our existence at risk. A selfless love calls for parents to accept children as gifts without introducing a conditional element into their acceptance into a family.

The freezing of human embryos is always to be regarded as an affront to their innate dignity in so far as it suspends, and puts at risk, the inviolable right to life that is theirs simply by virtue of the fact that they are fully human. While not condoning IVF, we recognise that the technology which allows eggs to be frozen and stored might, in the foreseeable future, mean that there are fewer embryos that are stored in this way and also, ultimately, discarded.

A Catholic approach to marriage and procreation precludes the donation of gametes from a third party outside of the marriage relationship. The mutual and exclusive self-giving of the spouses that characterises the permanent and loving commitment at the heart of marriage calls forth a reciprocal respect that means couples recognise the right to become parents only through each other.

Question 1:
Given these risks and benefits, what is your opinion on ACART's proposed advice to the Minister of Health? Please give reasons for your views.

(See chapter 3 for a discussion of risks and benefits, and chapter 6 for the proposed advice.)

Any assessment of risks to the health and well-being of children must first take into account the physical risks associated with the use of a particular intervention. While it is stated that "the risks to a resulting child associated with the use of frozen eggs are no greater than the risks associated with the use of frozen embryos or [IVF] generally" (p. vi) we also note that there have only been a relatively low number of children born from frozen eggs and that "it is still a relatively new technique" (p. 13). Therefore, while the available evidence may point to its safety (p. 13), it has to be accepted that because there is "a lack of data on outcomes for children born from eggs that have previously been frozen" (p. 8), this technology remains largely experimental.

In other words, given the overall depth of the data available, it seems that at best ACART's view on the acceptability of the risks can only be provisional. On that basis it seems somewhat premature to be declaring this an established procedure.

It is our considered view, therefore, that at this time the use of eggs that have been frozen should reflect the way that we approach the use of other novel or innovative clinical practices; it needs to occur against a background of the sort of ethical and medical oversight that is provided by a specialist Health Research Ethics Committee. In the event that the relevant committee in question may not have the necessary expertise amongst its current members, there should be provision for its makeup to be complemented by persons with the appropriate scientific and medical background.

Question 2:
What is your view on the information that ACART suggests should be collected to monitor the use of frozen eggs in fertility treatment?

(See chapter 3)

In line with what we have said above, we agree that there needs to be ongoing and extensive collection of data so as to better assess the outcomes, and especially the risks, associated with the use of eggs that have previously been frozen. It is beyond the scope of our expertise to comment more specifically on either the nature or the manner of collection of this information.

Question 3:
Has ACART identified all the ethical issues relevant to the use of frozen eggs in fertility treatment? Do any of these issues affect ACART's proposed advice that the use of frozen eggs should be allowed in fertility treatment? If so, how?

(See chapter 5 for a discussion of the ethical issues, and chapter 6 for the proposed advice.)

The posthumous use of frozen eggs raises similar ethical issues to the posthumous use of frozen sperm. We regard the use of assisted human reproductive technologies in such circumstances as inconsistent with the dignity of the child because it intentionally deprives them of a relationship with a mother and a father for reasons that ultimately amount to the satisfaction of adult needs.

As noted above, a Catholic approach to marriage, emphasising as it does the connection between the conjugal act and the transmission of human life, rules out for moral reasons the reception of gametes from a third party.

While not condoning IVF, we can see that the use of egg freezing might lead to fewer embryos being stored. We are not opposed to it on the basis that it will limit the harm that is associated with the storage and subsequent discarding of human embryos that is a characteristic of IVF infertility programmes.

At the same time we remain particularly concerned that this technology might lead to a significant increase in women postponing pregnancy for "social reasons". We note that ACART considers the freezing of eggs as "at best a backstop measure for those who are at risk of losing their fertility altogether, and that it would be unwise for women to rely on egg freezing for social reasons" (p. 12). On the basis of a Catholic approach to the transmission of human life (briefly outlined above) we agree with this assessment for reasons that include, but go beyond, the obvious clinical contraindications of egg freezing.

Question 4:
Should the use of frozen eggs in fertility treatment become an established procedure? If not, why, and how should the use of frozen eggs be regulated?

We do not believe that the use of frozen eggs should become an established procedure at this particular point in time because we regard the use of this technology as still largely experimental. (See our answer given in Question 1 above.) For reasons related to a Catholic understanding of the transmission of life we also believe that this procedure should be limited to those requiring it for "medical" reasons as opposed to "social" reasons.

Question 5:
Should the use of frozen eggs in fertility treatment be limited to the individuals the eggs came from, or should frozen eggs be able to be donated to others for use in fertility treatment?

While out of step with a Catholic understanding of marriage, we recognise that current procedures allow for couples to receive gametes donated by third parties. Our reasons for arguing that the use of frozen eggs should be limited to the individuals they come from are the same reasons we use to argue against the donation of any gametes by a third party; the mutual and exclusive self-giving of the spouses that characterises the permanent and loving commitment at the heart of marriage calls forth a reciprocal respect that means couples recognise the right to become parents only through each other.

Question 6:
Should frozen eggs be able to be donated for research purposes?

We uphold the principle enshrined in New Zealand legislation and culture, that transactions involving body tissue not be commercialised. On that basis we see no reason to oppose the donation of eggs for ethical research projects.

As we have stated on other occasions, research using gametes should be regulated through the development of guidelines and then allowed to proceed on a case-by-case basis having undergone appropriate ethical scrutiny and having received appropriate ethical approval. We would expect that such research would be governed by the same or very similar ethical provisions as applies to research on other types of human tissue.

We remain concerned about the very real potential for the exploitation of women that would result from an increased demand for human eggs for purposes unrelated to fertility treatment. Because the donation of frozen eggs presumably means that such eggs are no longer required for fertility reasons, this practice could, in theory, lessen the need to procure eggs in other ways.

We oppose all research using frozen eggs to create a human embryo.

We are also opposed to all research involving the fusion of human gametes with gametes of other species so as to create human-animal hybrid embryos.

Submission to ACART on the Use of Donated Eggs in Conjunction with Donated Sperm (March 2009)

Introductory Comments

We have laid out our opposition to the creation of embryos using donated eggs and donated sperm in an earlier submission to ACART and we summarise below what we have previously stated with a view to reiterating our absolute opposition to this procedure.

We are opposed to the practice of using donated eggs and donated sperm to create embryos on essentially two grounds; (i) it contravenes the right that married couples have to become parents only through each other, and (ii) intentionally depriving children of the close connection between genetic parenthood and the responsibility of care constitutes a serious offence against the dignity of the child.

Catholic teaching on the transmission of human life reflects a commitment to holding together the genetic, gestational and social dimensions of family and parenting. Our sense of personal well-being is linked with a healthy self-identity, something that is intimately tied in with a lived knowledge of our biological ties. This knowledge is put seriously at risk by arrangements that exclude children from growing up with the families of their biological origins. On this basis we believe that children have the right to grow up within the family networks that are generated by our biological ties. This right should only ever be compromised in situations where it is clearly in the interests of the child involved.

What is at stake in the debate about using donated eggs and sperm is nothing less than the importance of genetic origins and affective relations in establishing enduring human relationships and in securing a healthy self identity. T he Discussion document itself makes it abundantly clear that this particular procedure raises complex issues that impact directly on the identity and well-being of the children that result. To approve of embryos being created from donated eggs and donated sperm is to disregard the critical importance of affective relations with the biological parents and extended family. It remains our firmly held view that an honest appraisal of this procedure from the perspective of the child, one that keeps the interests and well-being of the child to the fore (as required by the HART Act), would rule out the use of donated eggs and sperm as a means of conceiving a child.

Whatever people believe about the acceptability of IVF, a clear moral distinction exists between homologous IVF (where the gametes are sourced from both partners within the relationship) and heterologous IVF (where one or both gametes are sourced outside of the commissioning couple). This distinction rests on the fact that homologous IVF conserves the link between parenthood, family and genetic origins. We acknowledge that heterologous IVF is currently approved in New Zealand. However, we think it should always remain limited to situations where one of the parents is genetically related.

We note that the New Zealand Guidelines on Surrogacy Arrangements (2007) require at least one of the intending parents to be the genetic parent of any resulting child. The reasons for this, which reflected the clear views of submitters, relate to the well-being of the child; above all they give concrete recognition to the absolute importance of the connection between self-identity, personal well-being and biological origins.

A decision to approve the intentional creation of embryos from donated eggs and donated sperm cuts right across this reasoning, and effectively severs the genetic dimension of parenting from the gestational and social dimensions. No other approved assisted reproductive technologies have previously gone this far. In this way, the approval to create embryos from donated eggs and sperm takes the use of assisted reproductive technology in New Zealand to a new place, one which places the well-being of children at greater risk than ever before.

Inevitably, the question will also then be asked as to why surrogacy arrangements should remain subject to the restriction that one of the intending parents must be the genetic parent.

To those who argue that "a genetic or gestational link is not necessary for a strong parent-child attachment" (see p. 10 of Discussion document) we would respond by saying that there is much more at stake in this matter than parent-child attachment. The key issue, we would argue, is the child's own sense of identity and well-being. Even in situations where adopted children and adoptive parents form close and strong attachments the personal emotional difficulties are often still significant. If the experiences of adoption have taught us anything then it is surely the fact that strong attachments between adopted children and their adoptive parents do nothing to displace the sense of loss of, and yearning for, connection with their families of biological origin.

The need to foster or adopt children highlights that there are occasions when, for the good of a child's welfare, the decision is made that they not be brought up within their family of origin or by one of their biological parents. In these situations the decision to adopt represents an act of outstanding generosity. To accept that there are circumstances when we need to separate a child from their genetic family of origin is one thing. To set out to deliberately deprive children of this link for the sake of the needs of the adults involved is quite another. It is inconsistent with respect for the child and it undermines the ideal of the family. It is this distinction that makes the adoption of an already existing embryo morally distinct from, and morally more acceptable than, the deliberate creation of an embryo from donor eggs and sperm.

The burden of infertility can indeed be overwhelming for couples. In situations where neither of the partners can provide the gametes for IVF, other options exist including adoption of children and the adoption of 'surplus' embryos. While the context within which they were created means that the adoption of spare embryos is morally distinguishable from the use of donated sperms and eggs, they are in all other respects virtually indistinguishable since in each case the intending parents are not the genetic parents of a resulting child.

We recognise that in formulating this Discussion document ACART have made a significant attempt to consider the issue from the perspective of the child that is to be conceived. We note that in formulating its preliminary position that the procedure of using donated eggs and sperm not extend to surrogacy arrangements, ACART have concluded that "the complexity of the arrangement does not provide sufficient safeguards for the wellbeing of the potential child" (p. 11). We agree with this position, but fail to see how giving proper consideration to the child's wellbeing does not bring ACART to make the same determination in all cases of using donated eggs and sperm. This seems totally inconsistent. Nowhere is it spelled out in the document how, ethically speaking, ACART have arrived at the determination that the safeguards are sufficient in one set of circumstances but not in the other.

In conclusion, then, we respectfully submit that in its consideration of the well-being of the child (as demanded by the HART Act) ACART has, by its decision to recommend the use of donated eggs and sperm, failed to give it the ethical weight demanded by an authentic concern for the dignity and well-being of the children who will potentially be born by way of this procedure. We believe, therefore, that any advice given by ACART to the Minister approving in principle the use of donated eggs and sperm should be urgently reviewed in line with the first purpose of the HART Act which is to "[take] appropriate measures to protect and promote the health, safety, dignity, and rights of all individuals, but particularly those of women and children in the use of [assisted reproductive procedures]" (Part I: Preliminary provisions (a) )

Questions on the draft guidelines

Question 1 (Whether the procedure could involve a surrogacy arrangement):

The paper presents ACART's proposal and another point of view about whether the use of donated eggs with donated sperm could involve a surrogacy arrangement (page 10).

(i) ACART is proposing that the use of donated eggs with donated sperm in conjunction with a surrogacy arrangement should not be permitted.
(ii) However, ACART has noted a view that the guidelines should enable, in exceptional circumstances, the use of donated eggs with donated sperm in conjunction with surrogacy.

Do you agree with (i)?
Or do you agree with (ii)? If you agree with (ii), what content would need to be in the guidelines?
Or do you have a view that is different to either (i) or (ii)?

In line with the arguments made in our Introductory comments (above), we agree whole-heartedly with the reasoning given by ACART that the use of donated eggs with donated sperm in conjunction with a surrogacy arrangement should not be permitted. The additional complexity of the arrangement constitutes an even greater increase in the likelihood of adverse risks to the well-being of the child.

To think that the use of donated eggs with donated sperm in conjunction with surrogacy might be allowed in "exceptional circumstances" would be to allow the notion of reproductive autonomy to completely over-ride concerns for the wellbeing of any child that might be born. Yet, the adverse risks are the same for any potential child irrespective of the circumstances of the commissioning couple. Therefore, the circumstances of the couple are, from an ethical perspective, irrelevant in terms of protecting the rights and promoting the well-being of children. It is logically inconsistent to argue otherwise, because then there no longer exists any reasonable basis upon which to argue that the practice in question could not be allowed in any circumstances!

Question 2 (Whether there should be a limit to the number of siblings):

ACART is proposing (page 13) that the use of donated eggs with donated sperm should be limited to producing full genetic siblings in no more than two families. Do you agree with this position?

The existence of full genetic siblings in more than two families would be highly undesirable for the reasons given. At the same time, if it is the case that healthy embryos that have been created will not be available for adoption because of the two family rule, this creates a new situation of injustice. The right to life of the human embryo then becomes subject to what is in many ways an arbitrary decision, even though it appears as a response to genuine concerns regarding the medical, psycho-social and genetic risks associated with relationships between adults with genetic parents in common.

These additional dilemmas only serve to show that, while the decision to allow the use of donated eggs and sperm may arise from a genuine and simple concern to alleviate infertility problems for couples, the practice inevitably leads us into, and opens up, a 'moral maze'. This, in itself, highlights yet another significant reason why we should not approve of this procedure in the first instance.

Question 3 (Informed consent and decision making):
ACART's thinking to date on consent and decision making is set out from page 15.

Do you have any comments about the issues raised in this section?
Do you have any comments about how consent and decision making in relation to the use of donated eggs and donated sperm should be managed?
Should the guidelines on donated eggs with donated sperm include specific provisions about informed consent, withdrawal of consent and decision making?

We believe that egg or sperm donors should not be allowed to withdraw their consent once an embryo has been created. Catholic teaching holds that human life begins at the point of fertilisation. From that point on the embryo needs to be afforded the same dignity and right to survive as a person. We believe this on the basis of the continuity of human existence – an embryo is already the human being that it will always be. To allow donors to withdraw their consent after the embryo has been created would be to tolerate a situation where the inviolable right to life was made subject to the preferences of other persons.

To focus on the limits for withdrawing consent essentially frames the responsibilities associated with the transmission of human life in a negative way. It is a disturbing feature of the use of assisted reproductive technologies that we find ourselves increasingly defining human relationships of care in such a minimalistic and legalistic way. Rather than stipulating the limits of 'withdrawal of consent', the guidelines should somehow stipulate and promote the positive duties of care that are a consequence of the generation of any new human life.

In most situations associated with assisted human reproduction, the providers of the gametes assume responsibility for the care of embryos that are created on the basis of their biological connection to the embryo. However, the use of donated eggs in conjunction with created sperm makes it quite unclear who has ultimate responsibility of care for the embryos created. On the one hand, the context of decision making surrounding the donation of gametes works against donors recognising and acting on the moral commitment that is a consequence of their biological link to the embryo.

On the other hand, the lack of any biological connection between commissioning parents and embryos produced using donated eggs and sperm means that the basis (and therefore motivation) for their duty of care to the embryos created for them can be reduced to something quite 'tentative'; tentative because it is essentially founded on, and therefore dependant on, nothing more than an ongoing desire for a child. The more tentative nature of this relationship, and the different ways in which we are coming to regard the relationships between embryos of differing origins and couples, are already evident in current ACART Guidelines: The "Guidelines on Embryo Donation for Reproductive Purposes" (17th November 2008), for example, specifically exclude couples from donating embryos not created from their own gametes, and thereby make a clear differentiation between the moral authority of the two sets of parents. The effect of this, overall, is to make certain embryos more vulnerable than others even though, ontologically speaking, they all share the same moral status and the same right to life.

This, in turn, is likely to lead to the unacceptable situation whereby many more embryos will be simply 'abandoned' and fertility clinics find themselves having to assume 'guardianship' because of their custodial role in storing the embryos; yet another example of the 'moral maze' that will result if approval is given for embryos to be created using donated eggs and donated sperm.

Question 4 (Issues of particular interest to Māori):

ACART has noted on (page 17) some issues that may be of particular interest to Māori. Are there other Māori issues and perspectives that should inform the guidelines?

We defer to the views of Māori on this question while noting that within the Māori tradition there is a strong emphasis on the link between self identity, family and community.

Question 5 (The draft guidelines):

The draft guidelines are set out from page 20. Are these draft guidelines appropriate for managing the use, for reproductive purposes, of embryos created from donated eggs with donated sperm?

We have no specific comments to make on the proposed guidelines.

Question 6 (The discussion paper, including the draft guidelines):

Do you have any other comments or suggestions about either the draft guidelines themselves or the associated discussion?

We note that there have been a number of studies carried out recently which highlight that the practice of donating eggs to help infertile couples comes with both psychological and physical risks. Counselling for the women involved in egg donation should cover these potentialities.

Submission to ACART on the Use of In Vitro Maturation (March 2009)

Question 1:
Given the identified risks and benefits, what is your opinion on ACART's proposed advice to the Minister of Health?

(See chapter 3 for a discussion of risks and benefits, and chapter 6 for the proposed advice.)

It is our considered view that IVM remains a novel procedure. We note, in particular, that "IVM compromises subsequent embryo development rates [and that] the reasons for this are complex and not yet fully understood" (p. 5 of Discussion document). While current indications are that "the rate of congenital abnormalities appears consistent with that of IVF generally [and while] physical and neurological development appears consistent with that of IVF generally" (page 6, emphasis added) we note the tentative nature of these conclusions. The relatively small number of births worldwide (300 to 400 babies), and the fact that IVM is "rarely practised" in most countries (p. 3), surely mean that conclusions about the safety of the procedure safety can be nothing other than tentative at this stage.

We conclude, therefore, that it is premature to declare that the risks associated with IVM "fall within a level of risk that is acceptable in New Zealand" as stated by the HART Act. On that basis we think it is still premature to classify the practice as an "established procedure". The use of IVM requires more intense monitoring than is demanded by the classification of a practice as an established procedure. It is our view that IVM should be treated as innovative practice and subjected to a level of ethical review and ongoing oversight that is consistent with the introduction of other innovative health procedures in New Zealand.

We note that ACART is currently seeking further clarification as to whether or not it is an option to treat such a procedure as an innovative Act.

Question 2:
Has ACART identified all the ethical issues relevant to the use of IVM in fertility treatment? Do any of the identified, or any other ethical issues, affect ACART's proposed advice that the use of IVM should be allowed in fertility treatment? If so, how?

(See chapter 5 for a discussion of the ethical issues, and chapter 6 for the proposed advice.)

Aside from issues relating to the safety of the procedure, we do not see that IVM creates any other significant ethical questions not already raised by the use of IVF.

Question 3:
Should the use of IVM in fertility treatment become an established procedure? If not, why, and how should the use of IVM be regulated?

As outlined in Question 1 (above) we think it is premature to classify IVM as an "established procedure".

Question 4:
Should the use of in vitro matured eggs in fertility treatment be limited to the individuals the eggs came from, or should the eggs be able to be donated to others for use in fertility treatment?

We note that a precedent already exists for women to donate their eggs to other women for the purposes of fertility treatment. Our reasons for opposing the donation of eggs by one woman to another are the same as for all other instances of egg donation: the nature of marriage means couples recognise the right to become parents only through each other. We believe strongly that it is also in the interests of a child to be born into a family where its parents are the biological parents.

We understand that egg donation is already allowed in New Zealand under certain circumstances. On the basis that the live birth rate with IVM is significantly less than with conventional eggs, it strikes us that couples would be ill-advised to undertake IVF procedures using donated eggs matured in vitro.

Proposed Amendments to Guidelines on Surrogacy Arrangements Involving Providers of Fertility Services and Guidelines on Donation of Eggs or Sperm between Certain Family Members

A Submission to the Advisory Committee on Assisted Reproductive Technology

Preamble:

While assisted reproduction has traditionally been seen as a way to help people who are infertile, it is increasingly being seen as a means of providing people outside those categories with the opportunity to build a family; for instance, same-sex couples who wish to become parents through a surrogacy arrangement. The current review of the Guidelines on Surrogacy Arrangements was occasioned by a complaint, received through the Human Rights Commission, that they discriminate on the basis of sex and sexual orientation. The complaint was specifically about two linked provisions in the guidelines requiring that there be an “intending mother” who has a “medical” condition or diagnosis that justifies the use of a surrogacy arrangement.

On reflection the ACART Committee agreed that there was prima facie discrimination in the guidelines not justified by the principles of the Human Assisted Reproductive Technology Act 2004. For consistency, ACART also needed to review the medical criteria in the guidelines concerned with donation of eggs or sperm between family members. (In some surrogacy arrangements, people wish to use eggs or sperm donated by a family member.)

The following article is based on the submission developed by staff members of The Nathaniel Centre in response to the amendments proposed by the ACART Committee.

Introduction

The broadening of the eligibility criteria for intending parents who wish to enter a surrogacy arrangement using a fertility services provider and/or use eggs or sperm donated by a family member poses critical ethical questions regarding the welfare of any children born as a result of these procedures.

As noted in previous submissions, we are opposed to all forms of surrogacy because we believe that the overall well-being of children is compromised by arrangements under which a woman agrees to become pregnant with the explicit intention of surrendering custody of the child to be born. We also believe that the practice of surrogacy can place the health and welfare of women at risk.

We have also laid out our concerns about the creation of embryos using donated eggs and donated sperm in earlier submissions to ACART and we reiterate the view we have previously stated which sets out our opposition to this procedure. Catholic teaching on the transmission of human life reflects a commitment to holding together the genetic, gestational and social dimensions of family and parenting. We would argue that one’s sense of personal well-being is fundamentally linked with a healthy self-identity, which in turn is intimately and inextricably tied in with a lived knowledge of our biological ties - whakapapa. This knowledge is put seriously at risk by arrangements that exclude children from growing up within the families of their biological origins or, worse, deny them knowledge of their biological origins.^[1] It is for this reason we believe that children have the right to grow up within the family networks that are generated by their biological ties. This right should only ever be compromised in situations where it is clearly in the interests of the child involved.

Key Issues

What is at stake in the debate about using surrogacy in conjunction with donated eggs and sperm is the recognition of the significance of being raised by those to whom we are immediately biologically related. The importance of genetic origins in securing a healthy self-identity and the role biological relations play in establishing enduring human relationships cannot be ignored. To approve of embryos being created from donated eggs and/or donated sperm is to set aside the critical importance of affective relations with one’s genetic parents and extended family and to create what one author has referred to as “existential challenges of novel dimensions.” This is no less the case when the donation comes from a family member of one of the partners.

We note, approvingly, in the proposed amendments to the Surrogacy guidelines, that where there are two intending parents, at least one must be a genetic parent. We also note the stipulation that where there is one intending parent he or she must be a genetic parent of any resulting child. We see these requirements as a clear affirmation of the importance of holding the genetic, gestational and social dimensions of family and parenting together – a position that we believe reflects the principle, upheld in the HART Act, to promote the health and well-being of the children who are born. Our own considered view is that when this principle is given the concrete recognition it deserves, it would rule out the use of donated gametes (and multiple parents) in any and all circumstances.

The critical importance of the relationship between parents and their biological family is well documented. Even in situations where adopted children and adoptive parents form close and strong attachments, the personal emotional difficulties for both are often still significant. The experiences of adoption have taught us that strong attachments between adopted children and their adoptive parents do nothing to displace their sense of loss of, and yearning for, meaningful and close connection with their families of biological origin.

The fostering or adoption of children reflects the fact that there are sometimes occasions when, for the good of a child’s welfare, it is judged best that they not be brought up within their family of origin or by one of their biological parents. In these situations the decision to adopt represents an act of outstanding generosity premised on the well-being of the child. To accept that there are circumstances when we need to remove a child from their genetic family of origin is one thing. To set out to deliberately deprive children of this link for reasons related primarily to the needs of the adults involved is quite another. It is inconsistent with the guidelines outlined in the International Convention on the Rights of the Child where the rights of the child to be raised in their birth families is clearly spelled out.^[2] We would also argue that it undermines the ideal of the family which, we would contend, is based on what is optimal for children.

Similarly, there are many situations where, for often tragic reasons, a parent finds him or herself as a sole care-giver. While, in such circumstances, parents cope admirably and children may not appear to have been harmed to any great extent, there are few people who regard this as an ‘ideal’ situation. Once again, it is one thing to accept that some children are, out of necessity, brought up in single-parent families but quite another to set out to deliberately create situations that would deprive children of one or both genetic parents and be cared for by a single parent as will be the case when there is only one intending parent.  

We also believe that any moves to broaden the eligibility criteria for surrogacy and/or the donation of gametes will, even if unwittingly, contribute to people regarding children as a ‘positive’ right for adults who so choose. This would represent a significant change. It could all too easily generate an expectation that the state has an absolute obligation to provide for all and any adults the necessary means to procreate. This would have significant resource implications in the future. It would also, potentially, have implications for the way in which we come to view the parent-child relationship, including a greater propensity to see children as commodities rather than gifts to be received. We would argue that there is no ‘positive’ right to a child. Rather, we regard procreation as a ‘negative’ right by which we mean that the State has an obligation not to interfere in the choice of couples to have a child.

Assessing the Health and Well-being of Children

We note the extensive review of information about outcomes for children raised by single people and same-sex couples that forms part of the consultation document. We also note the considered conclusion “that there is no large body of robust evidence that children are harmed if raised by male couples or by single men” (page 10) as well as female couples or single women. In response we offer the following brief comments.

In the first instance, the comment that there is “no large body of robust evidence” ignores the fact that there is some evidence which suggests otherwise. Secondly, we would suggest that the studies referred to do not adequately account for the fact that there may well be a difference in outcomes between children born to parents in heterosexual relationships, one of whom then ‘migrates’ into a gay partnership, and children born to same-sex couples by way of assisted reproductive technologies involving third-parties. Thirdly, we would make the point that when advocating policy changes that affect the make-up of a long-standing social institution such as the family, the burden of proof is surely on those advocating for such changes to prove beyond reasonable doubt that children will not be harmed.

Furthermore, with respect to the idea that it is “family functioning, rather than family structure, [which] is crucial for children” (p. 10, emphasis added) we would stress that the notions of “family functioning” and “family structure” are very closely related. In support of this we note research which shows men and women parent differently and a growing body of contemporary research which has established that certain genes in young mammals have been shown to be activated by parental behaviour.^[3] The exploration of the complex relationships between paternal, maternal and offspring phenotypes and the effect of the environment on this dynamic, represent a new and challenging field of research that is still very much in its infancy. We should, therefore, be wary of concluding that the question of likely harm to children conceived and reared outside of the traditional heterosexual family structures is a closed one. That being so, we should be wary of writing what some have referred to as “a blank cheque in the name of non-discrimination” that will allow for more children to be routinely created outside of the two-parent heterosexual family structure.

Lastly we would make the point that the project of parenting is about the flourishing of children rather than simply securing for them an absence of harm or an ‘acceptable’ degree of risk of harm. In which case, what is surely required is that research show that single parent and same sex parent families are capable of providing the same optimal conditions for flourishing as heterosexual couples, rather than simply avoiding harm; the former test calls for a much higher threshold than the latter. We note with interest that ACART believes that “surrogacy arrangements carry substantial risks for the adults involved and potential children” (p. 9). This assessment, which we agree with, would seem to support the argument that such procedures are, at best, less than optimal and, at worst, introduce very real risks likely to lead to harm to women and children. Yet, there is absolutely no evidence in the consultation document of the grounds used for establishing how such “substantial risks” could be judged to be outweighed by the inequity involved in restricting access to surrogacy to (some) same-sex couples or to (some) single intending parents.

Granting single-intending parents or same-sex couples access to fertility services for the purposes of having a child will, through biological necessity, inevitably require the use of third-party gametes. In the case of a single intending male parent, male couples and some female couples, it will also require a surrogacy arrangement. We anticipate that the proposed changes will lead to a greater demand for gametes from family members (and others) as well as a greater demand for the provision of surrogacy with all the “substantial risks” that this will involve.

Conclusions

Our opposition to granting single intending parents and same-sex couples access to fertility services for the purposes of having a child follows from, and is consistent with, our overall and long-standing opposition to the introduction of third parties as part of human reproduction. It is also consistent with our belief that a family made up of two parents of opposite gender represents the optimal context for human flourishing. More specifically, because the proposed changes involve the intentional separation of the genetic, gestational and social dimensions of parenting, our concern is that they thereby frustrate the sense of identity and kinship that we maintain is a crucial dimension of human well-being. Put another way, no matter how we look at the practices of surrogacy and the donation of gametes, it cannot be denied that they knowingly and intentionally involve adults and society in the deliberate creation of fragmented families, complicating the most fundamental and vulnerable of human relationships – that of a child with its parents.

We wish to emphasise that, for us, it is not a matter of concluding that surrogacy and the use of third parties in human procreation “is not in the best interests of children because it is unnatural and/or immoral” (page 12). Rather, it is a case of arguing that it is ‘immoral’ because it is not in the best interests of children and because of the risks it introduces. Ultimately, the position we are taking flows out of, and reflects an absolute commitment to, the well-being and dignity of the children involved. Conversely, we cannot help but conclude that the changes being proposed in this consultation document are being driven first and foremost by the needs and desires of adults. 

In summary, it is our contention that the move to give single intending parents and same-sex couples access to surrogacy, relying as it does on the deliberate unlinking of parenthood from biology, undermines the fundamental right of a child to have both a mother and a father (as opposed to multiple parents or only one parent). We understand that in light of current practices (that we already consider problematical) our position may appear to some as discriminatory towards single intending parents and/or same-sex couples, in particular male couples. To those who might level this criticism against us we would reply that to argue otherwise is to let the general nature of human rights act as a barrier to the proper recognition of children’s human rights. To reiterate, our considered position represents a positive commitment to the health and well-being of children born as a result of the performance of an assisted reproductive procedure; the sort of commitment that we believe is called for by the HART Act. In light of this we think it is inaccurate to frame the argument in favour of maintaining the status quo as an act of unjustifiable discrimination.

It is a general principle of social justice that one does not address the discrimination of one group by way of acts which have the real potential to cause harm to others, in this case women and children. Because the proposed changes pose real risks for women and children, and because they will lead to a greater demand for surrogacy and third party gametes, something that has significant resource implications, we urge ACART to revisit its conclusion that there is not a justifiable basis for at least maintaining the status quo.

We also urge that, in its analysis of the effects of broadening the eligibility criteria for surrogacy to include single parents and same-sex couples, the threshold used needs to be based on the ‘flourishing’ of children rather than the much lower, and to our minds inadequate, test of ‘no evidence of harm’. Only the former test, we believe, will satisfactorily meet the criteria set out in the HART Bill – in particular the requirement to uphold the health and well-being of any children born.

Submission on PHARMAC Decision Making Criteria

Submission by Dr. Greg Coyle and Dr. John Kleinsman (The Nathaniel Centre) on PHARMAC Decision Making Criteria. 

Background of Submitters

Greg Coyle

Greg completed a doctoral thesis in 2011 examining how government funded public health agencies distribute or ration health resources to citizens. PHARMAC’s Community Exceptional Circumstances was used as an exemplar to test the principles of distributive justice in the operation of the rationing policy. He is employed by The New Zealand Salvation Army as Principal Advisor to the Social Programme.

John Kleinsman

John is the Director of the Nathaniel Centre – The New Zealand Catholic Bioethics Centre, an agency of the New Zealand Catholic Bishops’ Conference established in 1999. Its role is to address bioethical and biotechnology issues on behalf of the Catholic Church in New Zealand. Key functions include:

• carrying out research into bioethical issues and promoting the study and practical resolution of ethical, social, cultural and legal challenges arising out of clinical practice and scientific research.
• carrying out research and action to support the Church’s pastoral response to bioethical issues taking into account the needs of different cultures and groups in society.

Introduction

The review of PHARMAC’s decision-making criteria is timely. We believe that PHARMAC is a very effective operational subsidising arm of the New Zealand health service which rations pharmaceuticals on behalf of District Health Boards (DHBs).

The NZ Health and Disability Act 2000 charges PHARMAC with two primary statutory purposes[i].  The first purpose is to ration, at the national agency level, the supply of pharmaceuticals to the general community by managing Pharmaceutical Schedules. PHARMAC must do this consistently, as well as determine the rules for eligibility for subsidies applied to the medicines. The second statutory purpose is to ration subsidies through claims made by individuals, or very small groups of people, for the supply of pharmaceuticals which are not listed on the Pharmaceutical Schedule. Sufferers of rare and orphan diseases commonly fall into this category, presenting in circumstances described as exceptional.

PHARMAC’s First Statutory Purpose

PHARMAC does an excellent job of consistently providing subsidy for an adequate range of quality pharmaceuticals. Cumming[ii] has estimated that PHARMAC has saved approximately $1.17 billion over 14 years by utilising internationally recognised rationing tools. PHARMAC takes excellent advantage of its market dominance, provided through an exemption from PART II of the NZ Commerce Act (1986). The agency employs aggressive monopsonistic purchasing practices in negotiating contracts with international pharmaceutical companies.

PHARMAC celebrates its use of utilitarian decision making, providing the greatest value for the greatest number of people through a robust system of cost utility analysis (CUA) of new drug listings onto the Pharmaceutical Schedule. Studiously avoiding consideration of personal circumstance, CUA provides assessment of the relative value being purchased for the size of the therapeutic group.

Examination of the relative clinical effectiveness of medicines has led PHARMAC to take money-saving advantage of the availability of generic drug purchases.  PHARMAC’s Board and staff are well served by committees of health economists, clinical experts and medical academics who give advice on the economic performance and clinical effectiveness of medicines. 

These rationing decisions are considered under the framework of nine decision-making criteria[iii]. However we believe that economic performance, clinical effectiveness and affordability are the three primary criteria upholding PHARMAC’s decisions.

No weighting is ever given to the use of the nine criteria and any examination of decisions made by PHARMAC cannot determine the extent to which one criteria has dominated or been undermined by other criteria. As already stated, we believe that economic performance, clinical effectiveness and affordability are the dominant criteria PHARMAC considers.

PHARMAC’s public consultation processes are considerable, and as a public health agency PHARMAC enjoys good support from Ministers, parliament, the DHB’s and the general public for its work in managing the Pharmaceutical Schedule.

In short PHARMAC is appreciated in New Zealand as a world leader in meso-level rationing of subsidies on pharmaceuticals. It provides for a good range of effective medicines to the community. It has done this consistently over 15 years and thereby saved considerable amounts of taxpayer’s money.

PHARMAC’s second statutory purpose

Research[iv] into PHARMAC’s second purpose of providing access to medicines for people whose needs are described as exceptional, demonstrated that  PHARMAC’s decision-making process does not closely align with high levels of fairness to individual claimants, particularly sufferers of rare and orphan diseases. Using a formatted view of distributive justice described by Rawls[v] and Sen[vi], it appears that PHARMAC does not provide subsidy equitably for people whose circumstances are considered exceptional and who suffer diseases often requiring high cost medicines.

The research also showed that PHARMAC’s decision-making operates in a somewhat speculative fashion. In the past, committees deciding claims of individuals have not recorded the reasons for decisions nor advised claimants under which criteria their applications have failed. Underlying this PHARMAC practice is a deep anxiety that if claimants were provided with the reasons why their claims were denied, some decisions would most certainly be challenged. This would require the decision-makers to defend the material they considered and defend the attitudes and values which have gone into making the final decision. PHARMAC has not demonstrated an appetite for such openness and prefers to tell claimants simply that their applications have been considered and denied.

PHARMAC has evaluated the equity issue in the Review of High Cost Medicines and the Review of Exceptional Circumstances. Both reviews have supported the position that high cost and low cost medicines should be examined by the same decision-making criteria. The Named Patient Pharmaceutical Assessment (NPPA) scheme, which replaced the Community Exceptional Circumstances scheme, was recently adjudged by Ombudsman[vii] McGee, to be lawful but not clearly reasonable. He noted there was no differentiation between the criteria used to decide on the Pharmaceutical Schedule drugs and the NPPA claims.  He stated that “…to attempt a specific recognition for rare diseases in the NPPA policy would significantly undermine the Pharmaceutical Schedule”.

Our views on the value of the current nine decision criteria

Criterion 1: The health needs of all eligible people within New Zealand;

We believe that the pharmaceutical needs of eligible people among the wider population are in large part being met, but the needs of people suffering rare diseases are not being fairly considered.

These barriers play a much larger part in sustaining health inequalities than the supply of treatments and services. In a study conducted by the Commonwealth Fund in 2010[viii], New Zealand’s public health system was compared to Australian, Dutch, USA, Canadian, German and British health systems for equity, access, quality, efficiency and life expectancy.  The Dutch health services scored the highest in all categories.  The Commonwealth Fund found that New Zealand has the highest ranking among countries in the study for quality of care.  However, New Zealand ranked sixth of seven (next to the USA) in the equity category.  In relation to these comparator countries in the study, New Zealand provides very cost-effective care of high quality, but fails to provide health care in the public sector to all citizens equitably.

We agree with Blakely and Summers[ix] who describe the fundamental drivers of health inequalities as the unequal distribution of social determinants (e.g. income, housing conditions and employment). The NZ Medical Association’s[x] statement of health inequalities suggests that the task of addressing the social determinants of health lie beyond the mandate of health services. Therefore, we do not see how PHARMAC can demonstrate the influence their decision-making is having on these social determinants.   

Significant government funding has been provided to primary and secondary health services in New Zealand to reduce these access barriers since 2001. Despite this, they still exist, particularly in poor urban and deprived rural areas. In essence, the more money that is spent on health care the worse this inequity problem becomes, because the services go to the better well-off.

PHARMAC has no metric for assessing decision-making against this criterion and consequently, we believe it to be meaningless and should be dropped. The specific health needs of Māori and Pacific people, along with all other citizens, should be considered under Criteria 1. Instead, we propose that the government urgently examine the very high levels of social and economic inequality in New Zealand and the considerable barriers to equitable access to publicly funded healthcare, which confront poor and marginalised communities.

We are also aware that representative groups of sufferers of orphan and rare diseases have raised concerns about the clinical experts PHARMAC relies on when it considers subsidising high-cost medicines for the treatment of rare diseases. For example, on several occasions the New Zealand Organisation for Rare Diseases (NZORD), has complained that the PHARMAC decision-making experts adjudicating on the effectiveness of highly specialised drugs do not have the knowledge or experience to properly decide, and have given PHARMAC poor quality advice leading to wrong and unfair decisions.

We believe that PHARMAC should listen to the recommendations of groups such as NZORD recommendations regarding clinical experts and consider a wider suite of advice than is currently being considered.

We believe that this calculation falsely assumes that the health values can be compared between one treatment and anther. For example, the additional adjusted quality of life year (or part of a year) gained by treating an ingrown toenail is compared in dollar value the cost of treatment of coronary artery disease. The QALY for each condition is assumed to be equal in every way, although the dollar value per QALY is vastly different. The personal suffering and disruption to life of the sufferer and his/her family cannot in any way be compared. We do not believe that economists are able to make such determinations, which claim to capture the essential comparison, with any accuracy or validity. Inevitably they muddle through, making decisions which they believe to be reasonable, and this emasculates the CUA process. Whilst the decisions may be reasonable, the process leads to claims about performance of medicines, which are based on little more than spurious assumptions reduced to what are seen to be reasonable determinations, but promoted by PHARMAC as indefeasible economic analysis.

In the CUA utilised by PHARMAC, only costs and benefits against the public health service are measured. QALY’s cannot measure need, nor consider the relative benefit of that which an individual has good reason to value in their lives. For example if a medicine was provided that would get a person back to work, the benefits to that person and his/her family and community in becoming a tax payer rather than a tax taker, have significant human and financial value. The CUA excludes important factors which should be included in the analysis and gives undue weight to a very narrow set of economic measures. We strongly suggest that these factors need to be considered by PHARMAC.

Another problem, pointed out by Gillon[xi], is that such a calculation has no way of measuring what harm will be done without the provision of the treatment. We accept that such personal opportunity cost and potential individual and community benefit factors may be difficult to measure, but this does not mean they do not exist and are not vitally important. No amount of CUA can replace the absence of such considerations.

We contend, therefore, that PHARMAC’s general use of CUA and QALY’s is appropriate for considering the relative costs and benefits in the supply of pharmaceuticals to large populations. However, the use of CUA, as is presently undertaken by PHARMAC, is too narrow when assessing individual claims for medicines and does not consider relevant factors which should be taken into account.

However, the bigger question raised by the use of this criterion, is how fair the outcome of the analysis is for an individual and how fair is the outcome for the wider society? Herein lies the nub of the problem for PHARMAC. Whose needs should take precedence; those of the individual or those of the wider society? Our position is that there needs to be community input and debate on the moral position and ethical values which inform answers to such a question. Medical experts analysing clinical effectiveness of treatments, and economists analysing economic performance of medicines, cannot and should not be a proxy for this debate.

Amartya Sen argues that fairness must take regard of substantive economic opportunities and a CUA, utilising a price per QALY, is one such measure which does this. However he also proposes that an equally important element of fairness is the outcome for citizens. Fair outcomes   include both the procedural fairness of the process PHARMAC is following as well as the advancement of the capability of citizens to enjoy the things they have good reason to value[xii]. Otherwise we have public policy which suits the needs of decision-making actors and institutions and not the people they are set up to serve. In this vision the rules which PHARMAC follow would be assessed in the broader more inclusive perspective which is inescapably linked to the world which emerges for the individual claimant.

We believe this tension between PHARMAC’s decision-making rules and just outcomes for individuals has its roots in NZPHD Act (2000) and has never been adequately explained or managed by PHARMAC. Indeed it cannot possibly be managed if PHARMAC is to successfully achieve its statutory (first) purpose provided for by the legislation. The Ombudsman confirmed this point in his recent decision when commenting that, to meet the needs of individuals fairly, PHARMAC must significantly undermine the Pharmaceutical Schedule.

The NZPHD Act (2000) assumes that both competing interests (individual versus community) can be managed, and leaves the decisions about both types of assessments for PHARMAC to make.  Therefore, while it is entirely appropriate for PHARMAC to manage the provision of subsidy medicines for wider society using criteria based on the utilitarian principle of providing the greatest good for the greatest number, we believe that another agency should manage individual claims, utilising a set of decision-making criteria based on the principles of justice as fairness to individuals, within a separate budget provided for this purpose.

PHARMAC’s explicit rationing priorities do not consider community values. We know that PHARMAC does consult the public, but it does not have a framework for including community values in its decision-making. While PHARMAC might argue that its Board provides this function, we would argue that a more adequate mechanism is needed. The primary role of the Board is to ensure PHARMAC remains solvent and carries out its statutory duties, which makes it extremely difficult to give adequate weighting to community values. We believe that budgetary control and solvency are paramount considerations in the minds of PHARMAC directors and, because of that, fairness and equity considerations are secondary.

In relation to individual claims for medicine subsidies, PHARMAC has no way of knowing about an individual’s ability to pay direct costs for medicines. With regard to the wider community meeting direct costs for medical prescriptions, we submit that apart from the small part-charge on pharmaceutical dispensing, medicines on the Pharmaceutical Schedule should be provided without direct costs to citizens. If PHARMAC cannot afford to place medicines on this basis it should say so. Part-charges for medicines are perceived, particularly by the poor, as a barrier to them up lifting medicines prescribed by their doctors.

If people choose to pay for medicines which are not on the Pharmaceutical Schedule (either self-fund or recover costs through insurance arrangements) that is their prerogative. If medicines are provided without direct costs to citizens, we believe criterion seven is unnecessary and should be dropped.

This criterion hands PHARMAC a carte blanche to make funding decisions for either communities or individuals in any way it likes. PHARMAC is under no obligation to justify publicly why it would utilise this decision-making criterion. We are not aware of this criterion being abused but neither are we aware of it being used effectively. Such decisions should always be subject to under the principles of openness and accountability. We believe this criterion is unnecessary and should be dropped.

Another Matter

We are concerned that the funding of prenatal-testing for pregnant mothers, and the consequent actions which flow from such testing, have physical, social, cultural and ethical impacts on the unborn, families and the wider community. We believe that there is a wider moral issue here and we wish to signal our intention to discuss this with PHARMAC in the future.

We Need a Fairer System for Individual Claimants

We believe that New Zealand needs a fairer system for analysing individual claims, which is both legal and reasonable and based on the principles of distributive justice.

It is very unfair to expect PHARMAC to achieve its statutory first purpose of managing the Pharmaceutical Schedule within a capped budget and have what are essentially unaffordable claims for high cost medicines made against it. It is also unfair to accuse PHARMAC of being prejudicial to people by not meeting these claims.  This situation has created animosity and on-going frustration for significant numbers of people suffering rare and orphan diseases. The media have taken advantage of this situation also, in promoting the interests of selected mediagenic sufferers  above those of other equally worthy and deserving claimants.

It is equally unfair for sufferers of rare or orphan diseases to be denied medicines which will improve their life expectancy because they are being assessed against an economic metric which applies to a model based on 4 million people. We believe this approach to provision of health care punishes people because they have a rare disease. The fact that PHARMAC can achieve success only by acting against the interests of these high cost claimants has created a patently unjust situation in New Zealand which must be addressed.

We need to ensure that PHARMAC is unencumbered in its statutory first purpose of managing the subsidisation of an adequate range of pharmaceuticals for New Zealand. PHARMAC does this well and should be enabled to continue in this role. But, we need a fairer system that utilises a different set of rationing criteria more suited to the task in order to achieve the statutory second purpose of rationing the needs of individuals.

A New ‘Rare Diseases Funding Agency’

We believe decision-making regarding individual and small group claims should be taken away from PHARMAC, the NPPA scheme scrapped and a new fund should be established called the ‘Rare Diseases Funding Agency’ (RDFA). It would be administered by a Board appointed by the Minister of Health and facilitated by the Ministry of Health. The fund should be capped off at approximately $25m annually and the adequacy of the fund should be regularly reviewed and reported to the Minister.

The RDFA will need to live within the budget set for it and continually review with PHARMAC medicines for those diseases at the boundary of the definition of rare, and medicines that should be listed on the Pharmaceutical Schedule. 

The RDFA will need to carefully consider both relative economic efficiency and the best clinical advice available. It would be appropriate for PHARMAC to undertake the CUA’s when required, on behalf of the new agency. The decision-making criteria will also need to include a method of understanding the quotient of fairness and to be aligned with community values in its micro-rationing decisions. As a first priority, the Agency should examine methods of engaging with community values to guide decisions.

We understand that the National Institute of Clinical Excellence in the UK has a model for making equity judgements which includes community input, not simply consultation but for decision-making. Another framework for organisations to use entitled ‘Accountability for Reasonableness’, presented by Daniels and Sabin,[xiii] contributes to the debate between those calling for explicit and implicit rationing. This decision-making framework calls for transparent and informed debate, including agreement between all those involved in a case as to which choices are relevant for that particular case. This framework occupies a middle ground somewhere between the explicit and implicit approaches, which allows the construction of principles that will produce fair decisions about real cases.  We believe that the social inclusion in such an approach provides the best prospect of achieving agreement over sharing medical resources fairly. The new RDFA Board should investigate these two suggested frameworks, and other decision-making frameworks, which allow for the inclusion of community values into its rationing decisions.

In assessing individual claims, we believe that the needs of the poor should be prioritised over the needs of those who have greater ability to pay. Such a system will reduce health inequity and direct government funding to those whose need for government support is greater. This is the same principle behind taxation scales where more tax is taken from those who earn more than from those who earn less.  The RDFA should adopt a criterion which captures this principle.

Adequate appeal processes need to be in place for claimants who are dissatisfied with the RDFA decisions to have their cases reviewed. An External Review Panel (akin to the National Institute for Clinical Excellence Citizen’s Council in the UK), independent of RDFA Board and staff, should be instituted. It would be made up of non-medically qualified citizens appointed by the Minister of Health and would be required to review cases and make recommendations to the Board. In such cases the External Review Panel would review all the information provided in the claim, including the RDFA’s ability to provide a subsidy. The RDFA Board would be required to make a final decision.

Conclusion

In this submission we have discussed the nine decision making criteria and we have argued that criteria 2,7,8, and 9 should be dropped.

We believe the government should urgently examine the very high levels of social and economic inequality in New Zealand and the considerable barriers to publicly funded healthcare experienced by poor and marginalised communities.

We have promoted the separation of the management of the Pharmaceutical Schedules by PHARMAC from the claims for subsidy made by individuals (and small groups). We suggest this be done by a new agency named the Rare Diseases Funding Agency. This agency should be facilitated by the Ministry of Health, have its Board appointed by the Minister of Health and be provided with a fund of around $25m.

Thank you for considering our suggestions.

Greg Coyle
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027-5110-353

This email address is being protected from spambots. You need JavaScript enabled to view it.">John Kleinsman
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