Submission to ACART on the Use of Donated Eggs in Conjunction with Donated Sperm (March 2009)
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)
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.
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.
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".
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
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.
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. 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.
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. 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. 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.
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.
 While New Zealand law prohibits anonymous donation of gametes, we note that, in practice, many children may not gain access to identifying information about their biological origins until they are 18 years of age or older. They are, in other words, effectively denied knowledge of their connections during their formative years.
 See, for example, the findings of Weaver et al in Nature Neuroscience which provide the first evidence that maternal behavior produces stable alterations of DNA methylation and chromatin structure in rat offspring: http://academic.reed.edu/biology/courses/BIO342/2010_syllabus/2010_readings/Weaver_etal_2004.pdf
A summary of the key points made in this submission
- It is our view that personal well-being is linked with healthy self-identity which is, in turn, inextricably linked to a lived knowledge of our whakapapa or biological ties. This knowledge is put at risk by arrangements that exclude children from growing up within the families of their biological origins or, worse, deny them knowledge of these origins. We believe children have a right to grow up within the family networks that are generated by biological ties.
- When all is said and done, the practices of surrogacy and the donation of gametes result in the deliberate creation of fragmented families as well as complicating the most fundamental and vulnerable of human relationships – the parent-child relationship. We note ACART’s own expressed view that these practices carry “considerable risks”.
- We do not believe that the question of ‘outcomes’ for children in single parent or same-sex parent families has been settled despite the evidence provided to date. We think the research is incomplete, particularly given the new insights being generated by the emerging discipline of epigenetics.
- When advocating policy changes that affect the make-up of a long standing social institution such as the family, it should be noted that the HART Act identifies the health and well-being of children as the first principle. In our minds the test that should be used needs to be based on the ‘flourishing’ of children rather than simply an ‘absence of harm’. The key question from the perspective of a child is whether or not single parent and same sex parent families are capable of providing the same optimal conditions for flourishing as heterosexual couples.
- In our considered opinion the suggested changes to the Guidelines are being driven first and foremost by the needs and desires of adults rather than what is best for children.
- 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.
- The proposed changes to broaden the eligibility criteria for surrogacy and/or the donation of gametes will contribute to people regarding human procreation as a ‘positive’ right. This 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 as well as implications for the way in which we come to view the parent-child relationship.
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 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 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.
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.
PHARMAC has never stated what pharmaceutical provisions for Māori or Pacific people are being provided which are not being provided to non-Māori or non-Pacific people. We do not see that PHARMAC has contributed in any way to the lowering of health inequality between Māori and Pacific people and the rest of the New Zealand population. For example, the prevalence of cardiovascular disease in the Māori population has reduced at a very similar rate to the general population. The reduction in smoking rates and the provision of medicines to achieve this result has not changed the health inequality gap between the two populations. We believe that barriers to accessing treatment for Māori and Pacific peoples are the problem, not the supply of pharmaceuticals. We believe this is a serious issue for New Zealand.
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.
This criterion is sound.
We believe that analysis of the clinical effectiveness and risks of pharmaceuticals, before subsidising decisions are made, is essential. It is attractive for the public to believe that a determination of clinical effectiveness, dosages, indications and contraindications are cut and dried matters. PHARMAC certainly presents their decisions to the public under this criterion in such terms. However, researcher-authors in respectable peer reviewed international medical and pharmaceutical journals do not always agree on how well medicines work in particular cases. Consequently, as a matter of necessity, PHARMAC has to decide which advice it prefers and which experts it agrees with. This underlies the contestable nature of determinations about clinical effectiveness and risk. PHARMAC should be much more open with the public about such contention and spell out more clearly the reasons why it prefers the advice selected.
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.
PHARMAC has made extensive use of CUA and Quality Adjusted Life Years (QALY) metrics as a rational basis for a utilitarian calculation about relative value. The QALY measure assumes a calculation of the cost of an added year of capacity and quality to a person’s life. Each QALY is regarded as equal in every way to every other QALY for all medical conditions and equal between one person and another. Such a singular quantitative approach militates against providing treatment for people who are unlucky enough to suffer a rare disease because of the high cost per QALY. Conversely, it provides treatment for people who are ‘lucky’ enough to suffer common diseases which are treated at a lower cost per QALY, because the pharmaceutical treatment satisfies a stronger CUA calculation.
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.
When medicines cannot be afforded because of budgetary impact, PHARMAC should say so. We believe that in the past PHARMAC has asked for more information to support funding applications as a proxy for simply saying the drug cannot be afforded.
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.
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.
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.