The Nathaniel Centre

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

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Maintaining a principled ethical approach in the face of a global fertility market

A submission to the Advisory Committee on Assisted Reproductive Technology

Earlier this year the Advisory Committee on Assisted Reproductive Technology (ACART) released a background discussion paper on the “Import and Export of Gametes and Embryos.” The paper was in response to growing numbers of New Zealanders looking overseas for fertility treatment. New Zealand requirements surrounding the sourcing and use of gametes and embryos are often very different from, and in many cases more ‘restrictive’ than, other countries. In the face of differing standards, there is increasing pressure from some to loosen the restrictions on what is allowable in New Zealand. Staff of the Nathaniel Centre offered the following reflection on the current situation as part of their contribution to this debate.

Introduction
Robust ethical review requires critiquing the underlying and often unexamined assumptions and convictions that shape individual and societal thinking about a particular issue. We are particularly concerned that in a society such as ours, questions relating to the common good are too easily subsumed by a distorted focus on individual autonomy. When this occurs, we can too easily fail to take full account of the fact that medical technologies, such as human assisted reproductive technologies “create their own culture of practices, institutions and discourses, and these become a powerful force that inscribes individual bodies to its own specifications.”[1]

While we have commented on this issue on a previous occasion, it strikes us that the realities of the global fertility market have introduced a new dynamic into the debate.

A shift in ethical frameworks
A particular feature of contemporary ethical discussions on the use of assisted human reproductive technologies is the way in which the language and thinking of ‘supply and demand’ (the market) is increasingly coming to the fore. This language indicates a shift, in at least some quarters, towards viewing the creation of human life more and more as part of a framework of thinking that is typically characteristic of economic transactions. At the same time the use of such language confirms and further perpetuates such a shift in other people’s minds.  

We accept that, to some degree, the use of ‘market’ language is understandable (and even unavoidable) in the context of exploring genuine questions relating to the regulation of reproductive technologies in a commercial environment. Nevertheless, we find the uncritical use of such language of great concern. Importantly, it betrays a tendency to think more and more about new human life as a ‘commodity’ that is subject above all to the desires, demands and expectations of those paying for the service – the consumers, prospective parents.

This has considerable implications for ethical reflection because the frameworks of thinking we adopt shape the way we look at and think about an issue. In particular, the influence of a market-based paradigm reinforces a particular and impoverished understanding of human freedom. In the words of the philosopher Michael Sandel, human freedom is reduced to mean “the freedom of the consumer.”[2] Consequently, parenting is at risk of becoming reduced to little more than another extension of the consumer mentality that permeates our society.

At the same time, as human procreation becomes increasingly subject to commodification, there arises an increased sense of ‘entitlement’ to a child. From this flows a lower tolerance for regulatory interference of any kind, especially from the State. Thus, when the question of access to assisted human reproductive technologies arises there are many who ask: “What possible business is it of any ethics committee? Why should they have to apply to a bunch of interfering medicos for permission?”[3]

The increased sense of entitlement is typically verbalised as a ‘right’ to access whatever ‘means’ are available for bringing about a child. In addition, and perhaps more worryingly, it is also increasingly framed as the right to exert a kind of consumer freedom over our children. What we mean by this is that the so-called right to a child leads people to believe they have a right to a certain type of child and therefore the right to exert ever greater degrees of control over the ‘products’ of conception.

There exists an urgent need to draw on other frameworks in order to challenge the shift in ethical discourse that is happening in our society. At the same time we need to remain clear about, and committed to, the principles that have given shape to the current New Zealand regulatory framework governing the use of assisted human reproductive technologies. To the extent that we allow a market mentality to shape our thinking it is to be expected that the principles underpinning the HART Act will start to make less sense to some people.  

The threats to a principled approach to decision making
In the wake of an increased sense of entitlement, the need to protect the very narrow meaning of ‘consumer freedom’ that Sandel (and others) speak of emerges for many as the primary ethical issue. This shift in ethical focus has been further exacerbated, we believe, by the increased opportunities that now exist for prospective parents to access assisted human reproductive technologies overseas. Compared with other jurisdictions which lack the robustness of New Zealand’s regulatory system, many people are judging the HART regulatory framework to be unnecessarily and unfairly restrictive. At the same time, others who might be less inclined to see it as ‘restrictive’ are perhaps increasingly inclined to see it as espousing a once workable, but now unworkable, ideal.

Therefore, even while many of the ethical dilemmas surrounding the import and export of embryos and gametes remain largely the same as in the past, it is our view that the realities of the global fertility market pose a new and heightened challenge to responsible human procreation. Indeed, we would go so far as to suggest that what is at stake in the present debate about greater (overseas) access to human assisted reproductive technologies is ultimately nothing less than the continued viability of the current principled approach to decision making that defines the HART Act.

We understand that, already, increased numbers of New Zealanders want to travel overseas to source eggs and embryos, a situation exacerbated by the shortage of donated eggs in New Zealand. While the motivation for this may well be largely pragmatic, rather than because of a desire to circumvent the law in New Zealand, the reality is that the eggs or embryos will be, in many if not most cases, commercially sourced. Because this is in breach of what is allowed in New Zealand, we anticipate this will eventually result in increased pressure to allow commercially sourced gametes and embryos to be directly sourced from within our own country.

We have, in the past, indicated that we are sympathetic to the idea of allowing couples who have previously conceived embryos overseas to bring them into the country for the purposes of having another child that is genetically related. While our position on this remains the same, we recognise that this also has the potential to lead to increased pressure to loosen the restrictions on what is allowable in New Zealand, particularly if some of the imported embryos have been created under standards and principles that fall short of our own.

Furthermore, while there are no legal barriers to couples travelling to countries that allow for embryos to be created in ways that, for good reason, are unacceptable in New Zealand, those without the financial resources will have a case that the ethical standards in New Zealand exist only for those who lack the resources to go overseas.

On all these counts an argument can be made that the status quo, even if unwittingly, fosters a significant degree of ethical inconsistency and unfairness. Why, it will be asked, should other couples not be allowed to have the children they want when precedents exist and all that is required is a simple law change? There is, in other words, a certain inexorable logic that points towards the further liberalisation of HART law in New Zealand, including the current constraints on using imported material that does not meet current New Zealand standards.

This is why we believe that more and more people will, in the future, come to question the viability of the current New Zealand framework including the principles that underpin it.

Managing ethical inconsistency and unfairness
Those, like us, who are hesitant about further ‘opening up the market’ for embryos and gametes because of their commitment to the ethical principles upon which the current New Zealand laws are based, find themselves needing to justify a regulatory approach which allows for ever increasing degrees of ‘inconsistency’ and ‘unfairness’. We readily admit that maintenance of the status quo will involve living with a degree of ‘inconsistency’ and ‘unfairness’ for individuals/couples. How might this be justified?

The arguments in favour of greater liberalisation, as described above, ignore a vital tension. We would describe the source of this tension as originating in the ethical space that exists between the desires and rights of individuals and the welfare or ‘common good’ of the society in which we live. As noted above, one of the (often unnoticed) fundamental issues at stake is the robustness of the (economic) paradigm that is increasingly being used by many to make sense of the world in which we live. More specifically we would argue that the language and thinking associated with ‘transactions’ and ‘entitlement’ is at odds with, and has the potential to undermine, the traditional way in which peoples across many cultures and ages have thought of new human life – what we, as well as many secular philosophers and anthropologists, would describe as an approach centred on ‘gift’ and ‘givenness’.[4] Of great concern for us is the fact that the shift to view human procreation more and more in terms of the market represents a significant departure from the way in which society has long thought about parenting and the role of children.

The very fact that granting individuals increasingly unfettered reproductive freedom will impact on societal understandings surely demands that any changes to the current regulatory system be subject to a ‘societal impact risk assessment’. This is what we find lacking in many of the arguments being put forward in favour of leaving assisted reproductive choices more and more in the hands of individuals or couples. Not unsurprisingly, the shift to consider questions about the transmission of human life within a more ‘market-based’ paradigm makes ethical questions about the societal impact (or common good) seem more and more irrelevant.

Concluding comments
For us, the key ethical issue is not about protecting an increasingly impoverished notion of freedom centred on choice. It is more about protecting a notion of human flourishing that takes into account the effects of the accumulation of individual choices on the society in which we live, including the likely impact on the welfare of the children who are conceived and the institution of parenting. We must be wary of making changes to the current regulatory framework that are premised largely on the value and importance of individual choice. This is especially important when it can be established that such changes are being influenced by the incremental progression of a market-based paradigm into the domain of parenting and families.

We should, of course, limit individual choice only for good reason. One of the challenges we face as a society is that these reasons do not always come to the fore in contemporary debates, not because they are not important but because the particular framework we employ renders them invisible. Such reasons become apparent when we recognise the inadequacy of giving exaggerated emphasis to individual choice and embrace other frameworks of thinking.

Our position is well described by Michael Sandel when he notes:

When science moves faster than moral understanding as it does today, men and women struggle to articulate their unease. In liberal societies, they reach first for the language of autonomy, fairness, and individual rights. But this part of our moral vocabulary does not equip us to address the hardest questions posed by cloning, designer children, and genetic engineering. That is why the genomic revolution has induced a kind of moral vertigo.[5]

And as the New Zealand Bishops have previously stated in an early Submission on the HART Act:

An over emphasis on the sufficiency of individual informed consent, as has been exemplified by a number of commentators with respect to recent debates in the bioethical area, reflects a failure to acknowledge the wider impact of technological interventions.

Finally, we appeal to ACART, in its reflections on this issue, to continue to take full account of the fact that the questions raised by human assisted reproduction are complex and have the potential for transforming the most basic of human relationships. The context which has given rise to the current debate places in jeopardy key principles at the heart of the HART Act. In particular we see that two principles are at risk; (i) the rights of children who are born to access knowledge of their origins and have a relationship with gamete donors, and (ii) a longstanding commitment to the principle that transactions involving body parts not be commercialised.

The current debate calls for a strong stand in favour of upholding the principles that underpin the HART Act. These principles have been debated at length and represent long-held cultural, social, ethical and religious values that promote human flourishing. They are also consistent with general public policy in New Zealand.

This will, in turn, mean saying ‘no’ to certain demands being made by couples or individuals, demands that may well increase as New Zealanders take advantage of the opportunities for having children, not always ethical by our standards, that exist overseas. However, we argue that the current principled approach, along with its growing perception of inconsistencies, can be seen as justified by an ongoing commitment to the common good and, above all, to the dignity and well-being of children. In which case, we will need to accept that it will become increasingly difficult to align New Zealand ethical standards with those of other countries.

In the face of globally varying ethical standards and competing principles, we would argue that the cause of ethical consistency and the well-being of children, parents and society, is best served by New Zealand working with other countries to uphold and promote the key principles that define our current regulatory framework around the use of reproductive technologies. To quote from the Consultation document: “New Zealand should not support or be seen to support, policies and practices in other countries that would be regarded as unethical in this country.”

Staff of The Nathaniel Centre

Submission to ACART on extending the storage period of gametes and embryos

Preamble:

The Human Assisted Reproductive Technology Act 2004 (the HART Act) sets a maximum storage period of 10 years for sperm, eggs and embryos unless the Ethics Committee on Assisted Reproductive Technology (ECART) approves extending the storage period. Parliament recently amended the HART Act to clarify that the 10-year period begins from 2004 or later, depending on when the gametes or embryos were first stored. This applies even where gametes and embryos were stored before 2004.

The amendment also clarifies the powers of ECART and the Advisory Committee on Assisted Reproductive Technology (ACART). When deciding applications for extending the storage period of gametes and embryos beyond 10 years, or beyond an approved extended storage period, ECART must use guidelines issued by ACART.

In February 2010 ACART released its proposed guidelines on extending the storage period of gametes and embryos and invited interested parties to respond.

Introductory comments:

In order to avoid a statement of an explicitly philosophical nature, Catholic teaching refrains from defining the embryo as a person. However, as science demonstrates, there is undoubtedly a personal presence at the moment of the first appearance of a human life and a continuity in development from that point on. We hold that such continuity does not allow for positing either a change in nature or a gradation in moral value for the entire span of that individual human life. On this basis the question arises: "How can a human individual not be a human person?" It would never be made human if it were not human already.

Therefore, we reason that the embryo is to be respected and treated as a person from the moment of conception. It follows from this that the rights accorded to a person must be recognised from that same moment. Chief among those rights is the inviolable right of every human being to life, that is, the right not to be killed.

Because it interrupts the natural continuity in development, the cryopreservation of embryos represents an affront to their innate human dignity. Furthermore, it also exposes them to serious risks of physical harm and even loss of life given that a high percentage do not survive the process of freezing and thawing.

In addition, the storing of embryos means that their future (their right to life) becomes subject to decisions made by others; firstly those responsible for bringing about the human life, the commissioning parents in conjunction with the fertility clinics; secondly the state, when regulations (such as those governing the length of time embryos may be stored) mean that an embryo's right to life can also become dependant on various forms of legal concession. It is ethically inconsistent that a fundamental right becomes contingent on concessions, legal or otherwise, conferred by others.

Such regulations, even when they are well intentioned, can easily add to the injustice associated with storing embryos because they may well constitute a further obstacle to the embryo being able to continue on its rightful path of human development. The shape of the regulations may also present a direct obstacle to parents who are genuinely committed to implanting their stored embryos, as well as confusing the question of who is ultimately responsible for their welfare.

Taking into account all of the above, the question of further extending the storage period of embryos poses a unique moral dilemma from our perspective. On the one hand it can only be interpreted as the continuation of a serious injustice because it involves an ongoing risk to their viability and obstructs their right to develop. On the other hand, we recognise that in certain circumstances extending the storage period may be what is required to ensure that particular embryos are given a chance to live the life that is already rightfully theirs.

We accept that by seeking to extend the period that embryos may be stored, the proposed guidelines are, at least in part, designed to make additional provision for embryos to be implanted and to continue the path of their development. To this extent, and while it is regrettable that there are so many embryos in storage, we appreciate that robust guidelines have the potential to impact positively on what will still remain, at best, an unjust situation.

Obviously, the moral issues that characterise the storage of gametes differ because of the differing moral status of gametes when compared to embryos.

Responsibility for making applications to ECART for extending the storage of gametes and embryos:

In light of their moral status, we are concerned about the question of who is morally responsible for particular embryos. In the first instance we believe that it is the commissioning parents who are responsible. It is therefore most appropriate that they should be able to initiate and empower the application process and be perceived as doing such.

We believe that the current wording of the guidelines, insofar as it focuses largely on the role of fertility clinics and researchers, fails to adequately highlight the primary moral responsibility of the commissioning parents. In line with this we believe that all applications relating to the storage of embryos and gametes for fertility reasons need to be in the name of the commissioning party rather than the clinic.

That said, we understand that from a pragmatic point of view it is best that the application process be managed by a clinic because of their access to key information as well as in the interests of consistency. In other words, our criticism is not so much about the process being suggested as it is about the presentation of the process and its implications for people's understanding of what is at stake.

In the case of gametes being held for research purposes, we are happy that researchers take responsibility for any application for extending the storage of gametes knowing that the consent of the donors is integral to this process. Our stance on this reflects the fact that the reasons for such an application are ultimately for the benefit of the researcher rather than the donor. This makes such an application different in essence from any application to extend the storage of embryos as well as different from applications to continue storing gametes for fertility reasons.

Reasons ECART may approve extending the storage of gametes and embryos:

We note positively that the guidelines anticipate couples with 'surplus' embryos created from their own gametes seeking an extension period for the purposes of finding and donating their embryos to a suitable couple.

In line with our introductory comments we agree that the reasons for extending the storage of gametes and embryos must be limited to those individuals seeking fertility preservation in cases where the initial reasons for storage relate to an underlying medical need. We understand, and approve of the fact, that this will rule out those seeking fertility preservation for 'insurance' or 'lifestyle banking' reasons. To act otherwise would only lead to the untenable situation where we would have even more embryos being created and stored for reasons of personal convenience, exacerbating further what is already a problematical state of affairs.

We also approve of the fact that the guidelines rule out extending storage in cases where treatment is prohibited or precluded at the time of an application for extending storage. Again, to act otherwise would only lead to greater numbers of stored embryos unlikely to be implanted.

Informed Consent Requirements:

We wish to make the observation that the provisions around gaining consent from gamete donors for extending the storage of embryos unintentionally create a situation where commissioning couples (whom we argued earlier should have primary moral responsibility for embryos in storage) may be prevented from exercising their rightful parental responsibility.

We foresee situations where couples desiring a child, perhaps wanting a full sibling for other children, and with a keen sense of accountability for the embryos in their care, find themselves unable to carry through their parental commitment because of an inability to make contact with, or otherwise gain consent from, those who originally provided the gametes. Even while we uphold the importance of consent as a key principle in ethical decision making, such a situation strikes us as patently unjust, both from the perspective of the embryo and the commissioning parents. It creates an impossible hurdle to life for the embryo while also creating (abandoning) a particular class of embryo for whom no-one is able to be responsible. It also frustrates the would-be parents whose desire to have a child, which was the source of the original consent sought, has remained singularly constant.

On the other hand, we recognise that giving birth to children who may not be able to ever contact their biological parent or parents (or whose biological parents may not want contact) is also patently unjust and something that would impose a burden on any child that came to be born.

This is a good illustration of the way reproductive technologies have the ability to fracture the inherent relational integrity that should exist between parents and children. It also illustrates some of the unintended and undesirable consequences associated with separating the genetic, gestational and social dimensions of parenting, something that characterises many assisted reproductive procedures. More particularly, it highlights for us the contradictions and inconsistencies inherent in allowing heterologous IVF (i.e. relying on sperm and/or ova donation), something that we have previously stated we are strongly opposed to.

While hoping that honest reflection on the consequences of using heterologous IVF may discourage its use, we acknowledge that the practice has already been embraced by some in our society. Without wanting to further encourage its use in any way, and mindful of the situation we have described above, we suggest that ACART advocate that provision for extended storage of embryos be included as a standard part of the original consent sought from gamete donors.

HDC Consultation on research involving adult participants who are unable to give informed consent (2017)

 General Discussion:

We note and endorse the idea that “The right to make an informed choice and give informed consent before receiving health or disability services, including participating in research, is the cornerstone of New Zealand’s Code of Health and Disability Services Consumers’ Rights”, (HDC Consultation Document, p. 1). In a similar vein, we have previously written about the critical importance of informed consent, advocating that all people have a right not to be experimented on without their knowledge or consent, whatever the nature of the research.¹

It is broadly accepted that the history of ‘informed consent’ in human research goes back to the Nuremberg Code of 1947. This Code was developed after the Nuremberg trials at the end of the Second World War which exposed the unethical nature of research carried out by many Nazi researchers. The lesson learnt from this and other well-known instances of unethical research, such as Tuskegee and Willowbrook, is that justifying research on the basis of its potential benefits or outcomes alone, and without reference to the inalienable rights and dignity of human participants, all too easily leads to human exploitation and harm. Upholding informed consent is one of the key ways in which the rights and dignity of research participants can be protected.

In New Zealand, current thinking and practices around ethical review and the centrality of informed consent have been informed by our own instances of unethical research, including the removal and retention of organs from deceased babies without parental consent and the ‘unfortunate experiment’ on patients with cervical cancer carried out at National Women’s Hospital.

The current Code of Health and Disability Services Consumers’ Rights allows research on a person who is unable to give consent to take place only if participation in the research is in the person’s best interests. It thus reflects a strong commitment to the principle of informed consent. It also reflects a commitment to ensuring that the interests of the person must not be subsumed to those of society. In other words, it embodies a rejection of the main premise underpinning utilitarianism, the idea that ‘the greatest good for the greatest number’ is a sufficient measure of what is ethically acceptable.

If there are to be changes to the parameters which currently proscribe non-consensual research on adults, it is critical that our society’s commitment to the notion that the best interests of the person must ultimately always outweigh those of society (Consultation Document, p. 44, n.3) be upheld and not eroded in any way.

We have previously argued that there can be legitimate exceptions to the requirement that informed consent be obtained from research participants, in certain exceptional circumstances. Thus, in 2015 we wrote that the “only exceptions to this are in circumstances where (i) the research is strictly observational or (ii) participants are, for various reasons, unable to give consent, in which case consent must be sought from someone legally entitled to provide consent for them.” In the same article we also stated: “In exceptional circumstances, limited disclosure may be justified or consent might be obtained retrospectively, for example because of the need to avoid a biased response. It is also possible to seek a waiver of consent where the risk is low and where there are strong reasons why it would not be practical or possible to obtain consent.” We then added: “… in these situations, the ethical rider is that such research must always be held up to close scrutiny by an appropriately accredited and independent review body.”²

We note that current practice in New Zealand, by allowing consent to be waived in circumstances when it is deemed to be in the person’s best interests, already constitutes an exception to the principle of informed consent, albeit a very narrow one. This debate, therefore, is about the scope of such exceptions in New Zealand and, more specifically, whether they might now be broadened to include some situations where research on a person unable to give consent is justified on grounds other than being in their personal best interests.

Our overall position is that we are not in principle opposed to broadening the parameters which regulate non-consensual research on adult participants.

Ethical Discussion:

Our response to the two fundamental questions posed in the Consultation document (“Are New Zealand’s current laws regarding non-consensual research [involving adult participants] appropriate and, if not, how should they be amended?” (Consultation document, p.2)) reflects our belief that it is, in theory, both possible and ethical, in certain prescribed circumstances with adequate scrutiny and safeguards, to broaden the parameters that apply to non-consenting- adult participants in research.

We add the qualifier “in theory” because we believe that any moves to broaden the parameters around non-consensual research would be acceptable only within a system of robust, accredited and independent ethical overview. Given the experience of two of the writers of this submission who have previously served as members of an HDEC Ethics Committee for a combined period of 11 years, our concern is that some of the more recent restructures of New Zealand’s HDEC ethical review system have contributed to a less comprehensive and less robust system than was previously the case – fewer committees and fewer members as well as a significantly narrower set of criteria for determining when research requires HDEC review.

Any moves, therefore, to change the current law must, in our mind, first be considered against the current effectiveness of ethical review committees in New Zealand. In which case, a decision in principle to broaden the criteria for non-consensual research (which, as already noted above, we would support) might be considered unworkable or unsafe in the current context of ethical review. The decision might, therefore, be made not to proceed with any changes for pragmatic reasons even while it was otherwise considered ethically acceptable in theory.

In the event it was deemed practically acceptable to broaden the parameters, it is our firm belief that, because of the inherent risks in non-consensual research, such applications should require an additional layer of scrutiny to what is already currently available by a group under the auspices of the Health and Disability Commissioner’s Office that includes representatives of, or people able to speak on behalf of or advocate for, the group of persons on whom the research will be carried out. 

When reflecting on why it might be ethically acceptable to allow non-consensual research on a person when it is not in their best interests and when it will introduce an element of risk, the obvious answer is that there will be benefits for others, whether persons in similar circumstances or, perhaps, society in general. Herein lies the greatest danger in broadening the parameters of non-consensual research because any such move inevitably opens the door to the sorts of utilitarian arguments and premises that have characterised unethical trials such as Tuskegee and Willowbrook.

This danger reinforces for us the need to de-lineate three other parameters when evaluating non-consensual protocols: (i) ‘the interests of the person must always be assumed to outweigh those of society’; (ii) in situations where this is not clear for a specific person, the ‘precautionary principle’ must be automatically invoked which dictates that the person not be included and (iii) any expression of dissent (“whether by showing signs of resistance or otherwise” – Mental Capacity Act 2005 (England and Wales) as quoted in Consultation Document, p. 43) from a potential participant incapable of giving consent should be regarded as sufficient reason for them not to be included (see also Declaration of Helsinki, as quoted in Consultation Document, p. 58).

In addition, as we highlighted in our submission to the National Ethics Advisory Committee (NEAC) on Cross-sectoral Ethics Arrangements for Health and Disability Research (February 2015), we see that it is a significant weakness of the current system of ethical review in New Zealand that there is no mechanism for checking that a particular study is carried out according to the agreed protocol. We believe that such follow up should be mandatory for all non-consensual research projects, something that will require a specific mechanism to be created and funded. This requirement, we note, is stipulated in Paragraph 24 of the Declaration of Helsinki under the heading of Research Ethics Committees: “The committee must have the right to monitor ongoing studies.”

Whereas some might see such requirements as creating unnecessary barriers for researchers, we see that they will ensure that non-consensual research proceeds only when it is absolutely required, and that non-consensual research is undertaken with a strong focus on ethical practice.

An Adjusted Framework for Non-consensual Research on Adult Participants:

Our suggestion is that an adjusted New Zealand Code follow and reflect the relevant sections of the Declaration of Helsinki which address the question of non-consensual research:³

28. For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorised representative. These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden.

29. When a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorised representative. The potential subject’s dissent should be respected.

30. Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research group. In such circumstances the physician must seek informed consent from the legally authorised representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent to remain in the research must be obtained as soon as possible from the subject or a legally authorised representative.

 In summary, we argue that the key points of an adjusted Code which would broaden the parameters within which non-consensual research could be carried out in New Zealand are:

•  The research cannot otherwise be carried out using participants capable of providing informed consent and …

•  The research will directly promote the health of the group represented by the potential subject and …

•  The research entails only minimal risk and minimal burden and …

•  The potential subjects dissent, however it is expressed, is respected absolutely and …

•  The research may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research group and …

•  Informed consent is sought from a legally authorised representative and …

•  The research is given a full review by the appropriate accredited HDEC Committee and …

•  The research is subject to an additional layer of scrutiny by a group that is overseen by the Office of the Health and Disability Commissioner, a group which includes representatives of, or people able to speak on behalf of or advocate for, the group of persons on whom the research will be carried out and …

•  There is ongoing, independent, effective and active monitoring of the research project while it is being carried out and …

•  The participants’ confidentiality is absolutely respected and …

•  In cases where a participant regains consciousness after having been included in a trial, they are given the option of having their data withdrawn where that is possible and …

•  Any data that is retained after a study is only be able to be used for further research in an aggregated or totally anonymous form unless separate independent ethical consent is sought.

Conclusion:

We are in principle open to the parameters of non-consensual research being broadened within New Zealand in line with the World Medical Association Declaration of Helsinki that we have outlined above. What we are proposing would involve moving from the “best interests framework” that characterises current practice in New Zealand to one that takes account of and permits a degree of minimal risk and minimal burden to participants.

The key questions in moving to an approach that tolerates a degree of risk are ‘Who decides?’ and ‘How will assessments about “minimal risk” and “minimal burden” be made?’ For this reason we have argued that there must first be a degree of confidence in the current system of ethical review in New Zealand. That is, a determination must be made that the HDEC review committees are adequately resourced and adequately trained to foresee and prevent the sort of excesses that have characterised research on vulnerable persons throughout the 20th Century in numerous places around the world including New Zealand.

While broadening the parameters of non-consensual carries inherent attitudinal risks because it can dispose society to the dangerous excesses of utilitarian thinking and make certain actions which undermine the inherent dignity of persons seem morally acceptable, we think this risk can be safely managed by the introduction of an additional layer of ethical scrutiny that is carried out under the auspices of the Office of the Health and Disability Commissioner.

John Kleinsman (PhD) is director of The Nathaniel Centre and a former member and Deputy Chair of the Central Region Health and Disability Ethics Committee. He is a current member of two Institutional Research Ethics Committees.

Sue Buckley (MA(Applied)Soc.Sc.Res) has been involved in social and health research over the last 16 years in both government and university contexts. 

Associate Professor John France (PhD, DSc, FAACB) is a reproductive scientist (now retired). He is a former member of the Auckland Health and Disability Ethics Committee and former member and Deputy Chair of the Northern Regional Health and Disability Ethics Committee. 

1.Kleinsman, J, and S. Buckley. "Facebook Study: A Little Bit Unethical but Worth It?" Bioethical Inquiry 12, no. 2 (2015): 179 - 82.

2. Ibid.

3. Declaration of Helsinki. 64th WMA General Assembly, Fortaleza, Brazil, October 2013. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ (emphasis added)

“A Strategy to Prevent Suicide in New Zealand. 2017. A Draft for Consultation”

A Submission to the Ministry of Health by Staff of The Nathaniel Centre

General Discussion

We note and endorse the ambition of the Strategy that ‘everyone is able to have a healthy future and see their life as worth living’. Promoting the concept that every life is worth living is critical, we believe, in addressing the high suicide rates in New Zealand. Exploration of this concept, which raises important philosophical and ethical questions concerning societal views about what a ‘successful life’ looks like, may generate important insights as to why suicide rates for certain groups, such as youth, Māori, elders, and disabled people, are higher than for other groups.

A cornerstone of Catholic teaching is the belief that every human life has “intrinsic value” and is to be protected and nurtured at every stage of its development. Those who do not conform to the increasingly dominant ableist idea of what a successful life looks like (e.g. those who suffer deprivation, disability, mental illness, or the limitations of ageing), are particularly vulnerable to the suggestion that their lives are not worth living. These are the people who are most in need of protection and support. We see that there is an urgent need to focus on reducing the stigma associated with ‘difference’ and to foster the view that every human life has unconditional dignity and worth. Among other things, this will require our society to counter the increasingly accepted and relationally impoverished societal narrative which equates the value of a person’s life with their subjective perceptions about the quality of their life, all too often based on factors that reflect an ableist or functionalist worldview.

Feedback

1. The Strategy provides little specific or material direction for how suicide rates might be reduced:

• No organisations, agencies or individual roles are identified as taking a lead in developing the activities listed (except the very general – ‘employers’, ‘communities’, ‘whanau’).
• The ‘Activities’ are very general. Statements like ‘communities working together to establish age-friendly communities’ express admirable aspirations, but are not helpful in providing direction to ‘communities’ or to an agency that might take a lead. There are many such statements in the Strategy.

2. The Strategy does not appear to build on suicide prevention work that is already taking place or on earlier work in this area. It does not explicitly refer to the Action Plan 2013-2016, nor draw on other strategies, for example, the Youth Suicide Prevention Strategy In Our Hands and Kia Piki te Ora o te Taitamariki, and the two evaluations of that Strategy.

3. For these reasons, we have found it difficult to provide specific feedback on much of the Strategy as the pathways and actions are so general they can be interpreted to cover almost all possible interventions.

4. We are concerned at the way that ‘Maori’, ‘Pacific’, ‘Maori communities’ and ‘whanau, hapu and iwi’ are tasked with many Activities while there is no suggestion that any agency has been tasked with funding or providing resources to these groups and individuals. While it is essential that Maori and Pasifika are involved in the development of suicide prevention initiatives for their own communities, it appears from the Strategy that they are expected to already know what is needed to prevent suicide while being left to take full responsibility to undertake the various Activities suggested.

Suicides Amongst our Elders

5. We note that the Strategy focuses largely on young people aged 15 – 24 years, something that is understandable given their markedly higher rates of suicidal behaviour. However, we consider that there needs to be a complementary focus on older age groups as well, particularly for those over 75 years of age.

6. While the rate of suicide tends to decrease over the older age groups, there is an increase in numbers committing suicide in the age groups over 70, and for males over 85 years the suicide rate of 40.9 per 100,000 is the highest for any age group (males 45-49 is 32.6 and males 20-24 is 28.8 per 100,000). The 85+ age group is a particularly vulnerable group, and evidence of increasing loneliness amongst elders and of increasing elder abuse in New Zealand suggests that rates could worsen.  See graph below for 2013 figures:

Figure 1: Age-specific suicide rates, by five-year age group and sex, 2013

                Notes:

                Rates are expressed per 100,000 population.                Error bars represent 95% confidence intervals. If two confidence intervals do not overlap, there is considered to be a statistically significant difference between the two groups being compared.               Source: New Zealand Mortality Collection.¹

7. In a presentation to the Suicide Prevention Conference 2013, Prof Yeates Conwell² made several points concerning older adults:

• Older adults are the most rapidly growing segment of the population
• 'Baby boomers' have tended to have higher suicide rates than earlier or later cohorts at all points in the life course. The fact that 'baby boomers' are now coming into the older age groups, a time of increased risk and increased lethality, means that we are therefore likely to see more suicides amongst this cohort.
• There is one completed suicide for every 30 attempts in the general population, but for older adults there is one completed suicide for every 4 attempts. This is because older people are more frail (more likely to die), are more isolated (less likely to be rescued), and older people use more immediately lethal means and use them in ways more likely to result in death.

8. It well accepted that even mild depression – the kind that would not render a person legally incompetent – can have a marked effect on one's predisposition to life, including a person's willingness to consider ending their life prematurely. The Mental Health Foundation of New Zealand identifies depression in the elderly as often linked to health problems. It also notes that "The risk of suicide in people with depression is significant."³

9. Dysthymia, a chronic form of depression that is typically described as a "mild depression" (also referred to as "subthreshold depression") has been shown, because of its ongoing nature, to have a devastating impact on people's lives. Persons with this type of "minor depression" are at increased risk of developing a major depression⁴ and exhibit very similar statistics relating to suicide mortality and number of repeated suicide attempts as persons with major depressive disorders.⁵

10. While the New Zealand Mental Health Survey indicates that those over 65 years have proportionately lower rates of depression than other age groups, there is evidence that some groups of the elderly suffer high rates of depression. In the New Zealand LiLACS longitudinal study, which recruited 421 Maori aged 80-90 years and 516 non-Maori aged 85 years living in the Bay of Plenty and Rotorua districts, the prevalence of depression (measured by the Geriatric Depression Scale) was reported as ranging from 22 percent for Maori men and 23 percent for non-Maori men to 26 percent for non-Maori women and 30 percent for Maori women.⁶ In addition, physical health generally declines with age which has consequences for social functioning and emotional role functioning.⁷

11. Detection and treatment of depression has been found to be an effective strategy to prevent late-life suicide.⁸

12. Conwell reported that 'indicated' (e.g. screen, detect and treat depression at primary care level) and 'selective' (e.g. a depression care manager in primary care) interventions are successful, particularly for older women.

13. The 2015 Office for Senior Citizens (Ministry of Social Development) report on Elder Abuse notes a number of studies which have demonstrated links between elder abuse and depression.⁹  The recent Australian Report on Elder Abuse notes that risk factors for the person experiencing abuse include depression, as well as social isolation and physical disability.¹⁰  

14. The Office for Senior Citizens report also notes that "around one in ten older people ... report some form of abuse (closely linked to vulnerability and coercion)". While there are no population-based studies of elder abuse in New Zealand, most research estimates that between 2 to 5 percent of the older population may be victims of elder abuse.¹¹ The proportion increases dramatically when the person is dependent on carers, where studies estimate almost a quarter of older people who are dependent on careers have reported suffering "significant psychological abuse".¹² Similarly, Age Concern in New Zealand reports that it receives more than 1,500 confirmed referrals each year of older people facing abuse or neglect.¹³

15. Reports from the 2001 Census show that there were 450,426 people aged 65 and over living in New Zealand, which means there could be between 9008 (2 percent) and 22,520 (5 percent) older New Zealanders suffering some form of abuse and neglect.  It is estimated that only 16 percent of the actual number of abuse incidents reach service agencies.¹⁴

16. Any strategy to prevent suicides amongst our elders must be closely linked to the prevention of abuse experienced by this group.

17. Research has established that those making serious suicide attempts are likely to be characterised by high rates of social isolation, feelings of loneliness, poor social support and lack of a close, confiding relationship.¹⁵ Several studies have established that loneliness is a significant problem for elders in New Zealand: an Auckland Council commissioned study found that 9 percent of Auckland residents aged over 50 were severely lonely, and 44.5 percent moderately lonely;¹⁶ a study investigating the rate, degree and impact of loneliness in a sample of 332 older community-dwelling New Zealanders found more than half of the sample (52 percent) was found to be lonely to some extent with 44 percent being moderately lonely and 8 percent severely lonely;¹⁷ the New Zealand Longitudinal Study of Aging described a minority of participants as 'not lonely' (48.8 percent); the rest were considered 'moderately lonely' (41.2 percent); 'severely lonely' (7 percent); and 'very severely lonely' (3 percent).¹⁸

18. While there are many precipitating factors involved in elder suicide, we believe that much more attention needs to be given to critiquing the ageist and ableist societal narrative that is increasingly inclined to equate value of life and personal dignity with health and independence ('not being a burden').

19. A focus on the suicide of elders, while 'targeting' a particular group and raising awareness of the 'value' and dignity of this group, may also work at a universal level by challenging societal attitudes about 'useful' or 'successful' lives that will assist in suicide prevention for all age groups.

  Suicides within Corrections Facilities

20. We note also that there is no mention of prisoners in the Strategy and yet the suicide rate for prisoners is higher than that of the general population. In addition, the rate of suicide amongst Māori men is higher than that for all men (25.6 Māori men compared with 18.8 men per 100,000 in 2012), which the Department of Corrections reports as significant for them, since around 90% of offenders in prison are male and just over half identify as Māori.¹⁹

21. The Department of Corrections also reports an increase in 'self-harm threat to life incidents' from six for the year 2011/2012 to 26 for the year 2015/2016. ('Unnatural deaths', with suicide being the most common cause of these, increased from five to 11 over the same period).20

22. Given these figures, and given the high rates of mental health or substance use disorder amongst prisoners,21 we would like to see more emphasis in the Strategy on suicide prevention for the prison population.

Disabled People and Suicide

23. While New Zealand data concerning disabled people and suicide are not readily available, there are a number of reasons why this group should be considered vulnerable to higher suicide rates.

24. It has been found that disability status is a strong predictor of suicide ideation risk.[i] Disabled people are among the most disadvantaged in terms of employment, interpersonal acceptance, economic stability, freedom of mobility and community access, all variables thought to have a significant bearing on suicide potential.²³ 

25. The New Zealand Disability Survey reports that for 12 percent of adults and 21 percent of children, psychological or psychiatric difficulties were the main impairments.²⁴ It suggests that an estimated 242,000 people (adults and children) were living with long-term limitations in their daily activities as a result of the effects of psychological and/or psychiatric impairments.

26. It is disappointing and concerning that disabled people are not mentioned at all in the Strategy.

Deprivation

27. It is also the case that deprivation and suicide are correlated. The Ministry of Health Report on suicide for 2013 found that rates of suicide increased consistently with the level of deprivation. The highest rate was among those residing in quintile 5 areas (the most deprived areas), with a rate of 15.4 per 100,000 population, followed by quintile 4 (12.1 per 100,000). The lowest suicide rate was seen among those who resided in the least deprived areas, quintile 1 (7.3 per 100,000). For both males and females, the suicide rate was twice as high amongst those residing in the most deprived areas compared with those living in the least deprived areas.²⁵ 

28. The association between deprivation level and suicide is most apparent in the youth population (15–24 years) where there were at least four times the number of suicides for this population in deprivation quintiles 3–5 compared with quintiles 1 and 2. For those aged 25–44 years, there were 2.5 times the number of suicides in deprivation quintiles 3–5 compared with quintiles 1 and 2.²⁶ 

29. Other studies have found an association between deprivation and suicide rates for young and middle-aged males in England²⁷ and young adults in Scotland.²⁸ 

30. The association of deprivation with suicide is not addressed in the Strategy but we suggest this is a potentially a risk factor for suicide, particularly amongst young people, and as such definitely needs consideration. 

State of Mental Health Services in New Zealand:

31. In New Zealand currently, there are clearly pressures on mental health provision, and funding over recent years has not been able to meet increased need. In view of this, we consider that the Strategy should also advocate for increased provision of mental health support at both primary and secondary health care levels as part of its approach in addressing suicide rates amongst all age groups.

32. The Ministry of Health's Director of Mental Health reported²⁹ that specialist mental health and addiction services are experiencing increasing pressure. The number of people engaging with specialist services increased from 143,060 people in 2011 to 162,222 people in 2015. It noted that despite increases in funding, the sector faces 'new and shifting challenges' and that 'services are experiencing increasing pressure'.

33. In a report on discharge planning for mental health patients from hospital, the Auditor-General has recently found that 'the timeliness, quality, and effectiveness of discharge planning (and the associated follow-up work) are impaired by pressures on inpatient and community services and other factors' and that some inpatient units have high occupancy rates – sometimes beyond their capacity – and in some places there is limited availability of community services to discharge people to.³⁰ 

34. We note also that those who suffer from mental illness would be particularly susceptible to a premature death under the proposed End of Life Choices Bill being sponsored by David Seymour in which a person is eligible for assisted dying if they suffer from 'a grievous and irremediable medical condition', which can include mental illness.

Links between suicide in the general population and legalised euthanasia and assisted suicide:

35. There is also the potential additional risk of an increase in suicide rates in response to moves to legalise/decriminalise assisted suicide/euthanasia, which needs to be considered and addressed. The strategy document does not address the issue of physician-assisted suicide or euthanasia. While the issues may appear at first glance to be separate, there is sufficient evidence to suggest that they may well be directly linked to the wider issue of suicide in society.

36. Legalising assisted suicide is a particular risk for our elders in a context in which older people are experiencing greater rates of social isolation and depression as noted above. Were euthanasia or assisted suicide to be legalised, many such 'legal' requests could potentially hide what would otherwise have been regarded as tragic suicides linked to a reactive depression that is directly related to abuse or neglect or to the limitations of ageing – a depression that can and should be treated.³¹

37. The contagion effects of suicide are well known, both the links between media coverage of suicide and youth suicide,³² as well as that between parental and offspring suicidal ideation and suicide attempts.³³ It has been found that the relative risk of suicide following exposure to another's suicide is two to four times higher among 15-19 year olds than among other age groups.³⁴

38. Exposure to the suicidal behaviour of family members has been well-established as a risk factor for youth suicidal behaviour.³⁵

39. While it is still premature to make definitive comparisons of suicide rates in jurisdictions that have or have not legalised euthanasia, it is worth noting that in the Netherlands the number of completed suicides (excluding premature death by euthanasia) has risen from 1,500 in 2003 to 1,871 in 2015, that is from 9.6 to 11.1 per 100,000 population (euthanasia was legalised there in 2002).³⁶

40. If assisted suicide/euthanasia were to be legalised, young people and others at risk of suicide would be faced with two competing paradigms - 'acceptable suicide' and 'unacceptable suicide'. The concept of 'rational' suicide, for those who find their lives intolerable and not worthwhile, will be in direct conflict with the fundamental goal and message of suicide prevention programmes.

41. In view of recent attempts to change the law regarding assisted suicide/euthanasia, the Strategy needs to address and challenge this potential development, which would impact significantly on the approach and messages of suicide prevention initiatives.

Conclusion:

While the "Strategy to Prevent Suicide in New Zealand" is wonderfully aspirational, we believe it needs to be more specific in terms of articulating specific interventions and in identifying, and advocating for, the resources and support required to ensure that the expressed aspirations lead to effective action.

While we understand and agree with the need to focus on the groups identified - Māori, mental health service users, Pacific peoples, and young people – we believe that the Strategy has failed to identify other demographic groups at risk of suicide, that is, our elders, persons being detained in correctional facilities and disabled people, as well as those living in the most highly deprived areas. We consider these groups should also be included for targeted activities.

We suggest that those who do not conform to the increasingly dominant ableist and ageist idea of what a successful life looks like, for example, those who suffer deprivation, disability, mental illness, or the limitations of ageing, are particularly vulnerable to the suggestion that their lives are not worth living. We suggest that a strategy to prevent suicide might need to address this underlying social narrative.

Finally, we have highlighted the need to be aware of the competing paradigms that would be created were New Zealand to legalise euthanasia or assisted suicide. Such a move that would effectively amount to acknowledging the notion of 'rational suicide', something which we believe would impact negatively on suicide prevention in the general population.

Endnotes

1. (Ministry of Health, 2016b, p. 8)
2. (Professor Yeates Conwell, 2013)
3. See https://www.mentalhealth.org.nz/get-help/a-z/resource/13/depression
4. (Cuijpers, 2004).
5. (Holmstrand, Engstrom, & Traskman-Bendz, 2008)
6. (Teh et al., 2014)
7. (Budge, Claire, Stephens, Christine, & Stichbury, Christopher, 2014)
8. (Turvey et al., 2002)
9. (Office for Senior Citizens, 2015)
10. (The Australian Law Reform Commission, 2017)
11. (Glasgow, K & Fanslow, J.L., 2006)
12. (Cooper, Selwood, & Livingston, 2008) (2008) 37 Age and Ageing 151 at 158
13. http://www.ageconcern.org.nz/ACNZPublic/Services/EANP/ACNZ_Public/Elder_Abuse_and_Neglect.aspx
14. See https://www.ageconcern.org.nz/ACNZPublic/Services/EANP/ACNZ_Public/Elder_Abuse_and_Neglect.aspx#howmuch
15. (Beautrais, A.L., Collings, S.C.D., Ehrhardt, P., & et al., 2005)
16. (Waldegrave, Charles, King, Peter, & Rowe, Elizabeth, 2012)
17. (La Grow, Neville, Alpass, & Rodgers, 2012)
18. (Noone, Jack & Stephens, Christine, 2014)
19. (Department of Corrections, n.d., p. 63)
20. (ibid n.d., p. 63)
21. A 2015 study found ‘62% of prisoners had experienced a mental health or substance use disorder, while 20%  had experienced both in the 12 months before the study’ (ibid n.d., p. 62)
22. (Russell, Turner, & Joiner, 2009)
23. (Gill, 1992)
24. (Statistics New Zealand, 2013)
25. (Ministry of Health, 2016b, p. 19)
26. (Ministry of Health, 2016b, p. 20)
27. (Rezaeian, Dunn, St Leger, & Appleby, 2005)
28. (Exeter & Boyle, 2007)
29. (Ministry of Health, 2016a)
30. (Office of the Auditor-General, 2017, pp. 3–4)
31. (O’Connell, Chin, Cunningham, & Lawlor, 2004)
32. (Crepeau-Hobson & Leech, 2014). (Sisask & Varnik, 2012)
33. (Goodwin, Beautrais, & Fergusson, 2004)
34. (Haw, Hawton, Niedzwiedz, & Platt, 2013)
35. (Crepeau-Hobson & Leech, 2014, p. 59)
36. https://www.cbs.nl/en-gb/news/2016/26/more-suicides