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University of Otago Law Theses and Dissertations |
Last Updated: 25 September 2023
Tailor Made for You?
Challenging the validity and ethics of the law in regulating the use of genetic engineering in reproductive technology
Grace Baird
A dissertation submitted in partial fulfilment of the degree of Bachelor of Laws (with Honours) at the University of Otago - Te Whare Wānanga o Otāgo.
7 October 2022
For Dr Colin Gavaghan – thank you for your insight, patience, and shared passion for this topic that has fascinated me for years. For Dr Jeanne Snelling – thank you for your guidance and for unknowingly inspiring me from day one.
For my parents – your unwavering support has helped me become who I am today and I am eternally grateful for you. For my four siblings who never cared for biology and will never read this – thanks for keeping me grounded, entertained, and loved.
For Jess – thank you for your countless hours spent listening, theorising, reassuring, distracting, proofreading, motivating, and continuing to believe in me.
For my flatmates and friends who have made my time in Dunedin unforgettable, kept my sanity intact, and were always there for me – thanks for putting up with me.
And for Emma – there are still no words except I miss you.
“Every man's island, Jean Louise, every man's watchman, is his conscience. There is no
such thing as a collective conscious.” – Go Set A Watchman, Harper Lee.
"For thus hath the Lord said unto me, go set a watchman, let him declare what he seeth.” Isaiah 21:6.
Introduction
Our lives are a summation of millions of choices made each day. Some carefully considered and others made on a whim. Some of those choices are made before we are born, and others will be made after we have gone. Some we will live to regret and others will become pivotal in our lives. Some of those choices will be right and many will be wrong, but the important thing is that while we are here, we get to make them.
Genetic technology is rapidly evolving: our capacity to genetically modify the next generation is greater than ever before. In 2018, scientist Jian-kui He made a choice that irrevocably changed the world and impacted the future of genetics and reproduction. He announced via YouTube that he had created the world’s first genetically modified human babies.1 He claimed that the twins, known as Lulu and Nana, had their DNA edited using CRISPR-Cas9 technology to make them immune to the HIV virus.2 Jian-kui He was jailed in 2019 for breaching Chinese regulations banning the genetic editing of human embryos.3 Following widespread international legal, ethical and social condemnation, the complementary fields of gene editing and reproductive technology have had to complete substantial introspection. Global calls to collectively continue the ban on germline gene editing have largely been achieved.4 However, Jian-kui He has completed his sentence and the twins turn four this year with uncertain futures ahead of them.5 The precipice of genetic engineering at the embryo stage is upon us, and New Zealand’s regulation must adapt to keep up.
1 The He Lab “About Lulu and Nana: Twin Girls Born Healthy After Gene Surgery As Single-Cell
Embryos” (26 Nov 2018) YouTube <https://www.youtube.com/watch?v=th0vnOmFltc>.
2 Jing-ru Li and others “Experiments that led to the first gene-edited babies: the ethical failings and the urgent need for better governance” (2019) 20(1) J Zhejiang Univ-Sci B (Biomed & Biotechnol) 32 at 33. 3 Marcos Alonso and Julian Savulescu “He Jiankui’s gene-editing experiment and the non-identity problem” (2021) 35 Bioethics 563 at 564.
4 UNESCO Report of the International Bioethics Committee (IBC) on Updating its reflection on the Human
Genome and Human Rights (Document SHS/YES/IBC-22/15/2 REV 2, Paris, 2 Oct 2015).
5 Antonio Regalado “The creator of the CRISPR babies has been released from a Chinese prison” MIT Technology Review (online ed, 4 April 2022).
Genetic editing at the embryo state implicates reproductive choice. Society has had a harrowing history of state intervention in reproductive decisions, most notably the eugenics movement of the 1920s–1940s. This has been reflected by numerous campaigns for reproductive justice and autonomy worldwide.6 At the time of researching this dissertation the US Supreme Court overturned the infamous Roe v Wade decision, which interferes dramatically in the reproductive lives of many women in the USA.7 The fight for freedom of choice continues.
This dissertation is divided into four chapters. Chapter One will outline the necessary concepts in genetics and reproductive technology and define key terminology used in this dissertation. Chapter Two will explain how reproductive technology and genetic engineering is currently regulated in New Zealand, including outlining and critiquing the current regulators that get to guide reproductive choices on our behalf. It compares this to the regulatory framework in the United Kingdom. Chapter Three will discuss a selection of ethical perspectives held on the topic of engineering that are premised on the ethical acceptance of PGD. Chapter Four will attempt to answer the question how the law should respond to changes in genetic engineering and reproductive technology by putting forward a model founded in reproductive choice. Chapter Five will discuss the implications of this model.
My hope is that this dissertation urges those who read it to think about what choices they might make and whether they should be allowed to make them. Ultimately, the law should be tailor made for the society in which it serves – is it tailored to you?
6 See generally Loretta Ross Reproductive Justice (University of California Press, California, 2017).
7 Lisa H Harris (2022) "Navigating loss of abortion services—a large academic medical center prepares for
the overturn of Roe v. Wade" 386 N Engl J Med (2022) 2061 at 2061.
CHAPTER ONE – Genetic Engineering and Reproductive Technology
This dissertation examines the role of the law in regulating genetic engineering and puts forward an argument predominantly in favour of it. Consequently, it is necessary to understand the key technical terminology upon which the argument is founded to avoid dystopian notions of what genetic engineering might look like. This chapter establishes this core knowledge base. Notably it will provide a basic introduction to genetics and establish a shared and realistic understanding of the complexities involved in genetic engineering. Lastly, it will explain the current reproductive technology involved in editing embryos that contextualises how genetic engineering could be accessed in the future.
I Concepts in Genetics
A Genetic Variation
DNA contains the fundamental biological code required to create life. The double stranded molecule is composed of four different nucleotide bases that undergo complementary base- pairing and twist to create the infamous double-helix structure.8 The sequence of bases in various combinations can influence eye colour to timing of cell differentiation.9 A genome refers to the entire set of DNA contained in an organism – for humans this is about 3 billion base pairs.10
DNA is present in every human cell and is stored in the cell nucleus.11 A gene is a specific
sequence or segment of DNA that codes for a functional protein.12 That protein is involved
8 Manju Bansal “DNA structure: Revisiting the Watson–Crick double helix" (2003) 85 Current Science
1556 at 1556.
9 Ohad Nachtomy, Ayelet Shavit, and Zohar Yakhini "Gene expression and the concept of the phenotype." (2007) 38(1) Studies in History and Philosophy of Science Part C: Studies in History and Philosophy of Biological and Biomedical Sciences 238 at 239.
10 Mark P Sawicki and others “Human Genome Project” (1993) 165 The American Journal of Surgery 258
at 259.
11 Tom Misteli "Concepts in nuclear architecture” (2005) 27(5) Bioessays 477 at 479.
12 Graziano Pesole “What is a gene? An updated operational definition” (2008) 417 Gene 1 at 1. Note this is the commonly accepted definition of a gene but the topic has recently been up for significant debate.
Compare Manolis Kellis and others "Defining functional DNA elements in the human genome." (2014)
– often combined with others – in structural, regulatory or functional roles in the cell. Genes grouped together on the same strand form chromosomes. Each autosomal human cell contains 23 pairs of chromosomes, with one of each type of chromosome being inherited from the mother and father.13
Genes are inherited from the parents in a process called meiosis which occurs in the reproductive organs (ovaries and testes). The process takes a diploid cell with 23 pairs of chromosomes and creates a haploid cell called a gamete (sperm and ova).14 The process ‘mixes up’ the alleles in an individual to create new combinations that can be passed down to the future generations. This process, broadly known as recombination, is the reason that we are not clones of our parents and their parents and so on. It allows for increased genetic variation each generation. A gamete formed still contains DNA from the parent but in a shuffled form. There are over eight million possible recombination possibilities that can occur to form a gamete.15
This pairing of chromosomes means that each human cell contains two copies of the same gene. Those copies (known as alleles) might vary slightly but perform the same function. Combinations of different alleles vary gene expression.16 Differences which occur at a single nucleotide are called single nucleotide polymorphism (SNPs).17 The laws of gene expression dictate how different combinations of alleles will be expressed in an individual. Some alleles are dominant over others and only require one copy to be expressed (observed in the final phenotype) while others will require two copies to be expressed.18 The pattern of inheritance can often be given as a percentage. For example, a person with Huntington’s
111(17) Proceedings of the National Academy of Sciences 6131 and W Ford Doolittle and Tyler DP Brunet
"On causal roles and selected effects: our genome is mostly junk." (2017) 15(1) 1.
13 Anthony Griffiths and others Introduction to Genetic Analysis (9th ed, WH Freeman and Company,
New York, 2008) at 37.
14 Above n 9 at 240.
15 Nicholas Barton and Brian Charlesworth "Why sex and recombination?" (1998) 281(5385) Science 1986 at 1988.
16 Above n 13 at 34.
17 Anthony J Brookes “The essence of SNPs” (1999) 234 Gene 177 at 179.
18 Above n 13 at 38.
Disease has a 50 per cent chance of passing it to offspring.19 Genetic variation promotes species survival and is the reason why everyone possesses different traits. Other variation comes from larger structural alterations in genes including inserted, deleted, or substituted base pairs creating new alleles.20
Very rare variants are known as mutations.21 These might occur due to errors in DNA replication when the cell divides, or in response to other chemicals such as mutagens that can induce mutations.22 Mutations can be silent, beneficial, or deleterious.23 Those deleterious changes to the sequence of DNA can create genetic disorders.
B Genetic Disorders
Genetic disorders are caused by variants that adversely affect an individual. They vary significantly in severity and the nature in which they arise.24 Their strong genetic component means they have a high chance of affecting future generations if inherited. Avoiding them is a key goal in genetic engineering. Genetic disorders can be loosely grouped into three classes:25
only a single base-pair changes but other times longer sequences are
19 Raymund AC Roos "Huntington's disease: a clinical review" (2010) 5(11) Orphanet Journal of Rare
Diseases 1 at 4.
20 Stephen Scherer and others “Challenges and standards in integrating surveys of structural variation” (2007) 39 Nat Genet 57 at 58.
21 Note that all forms of variation technically started first as a mutation, but contemporary genetics now uses the term mutation to refer to an allele (or SNP/structural variant) that has a frequency of less than 0.01 in the population versus another form of SNP that has a frequency of more than 0.01. Roshan Karki and others “Defining "mutation" and "polymorphism" in the era of personal genomics” (2015) 8(37) BMC Med Genomics 1 at 2.
22 As above n 13 at 518.
23 Laurence Loewe and William G Hill “The population genetics of mutations: good, bad and indifferent” (2010) 365 Philosophical Transactions of the Royal Society 1153 at 1513.
24 Above at n 23 at 1156.
25 Theodore Roth and Alexander Marson “Genetic Disease and Therapy” (2021) 24(16) Annu Rev Pathol 145 at 153.
interrupted. Common examples include hemophilia, Huntington’s Disease, and cystic fibrosis.26
II Defining Genetic Engineering
There is disagreement surrounding the definition of genetic engineering. Engineering commonly means to design or build something, but also describes the act of tailoring circumstances to achieve a desired result. This makes it difficult to define exactly what genetic engineering is. Some broadly use the term to mean the purposeful tailoring or selecting of certain genetic traits to develop some qualities or avoid others.30 Others define genetic engineering as designing or creating people using a certain combination of genes:
26 Nicholas Lench and others “The clinical implementation of non-invasive prenatal diagnosis for single-
gene disorders: challenges and progress made” (2013) 33 Prenat Diagn 555 at 556.
27 Tomas Olsson, Lisa F Barcellos, and Lars Alfredsson "Interactions between genetic, lifestyle and
environmental risk factors for multiple sclerosis." (2017) 13(1) Nature Reviews Neurology 25 at 25.
28 Yonghong Li and Ann B. Begovich "Unraveling the genetics of complex diseases: susceptibility genes for rheumatoid arthritis and psoriasis" (2009) 21(6) Seminars in Immunology 318 at 318.
29 Turner’s Syndrome is where a female only has one X chromosome instead of two. Caroline Mansfield, Suellen Hopfer and Theresa M Marteau "Termination rates after prenatal diagnosis of Down syndrome, spina bifida, anencephaly, and Turner and Klinefelter syndromes: a systematic literature review" (1999) 19(9) Prenat Diagn 808 at 808.
30 Julian J Koplin, Christopher Gyngell and Julian Savulescu “Germline gene editing and the precautionary principle” (2020) 34 Bioethics 49 at 50.
producing what is popularly termed designer babies.31 This is sometimes referred to as ‘enhancement.’ Opponents to genetic engineering are often against the design aspect of it, but accept its use at the other end of the spectrum – to avoid genetic disorders.
A A sliding scale
This dissertation uses a sliding scale to refer to different aspects of genetic engineering and will focus the bulk of regulatory discussion around genetic enhancement. It illustrates that there is significant debate about creating distinct definitions of terms involved in genetic engineering, at some point terms will slide into the next one along the scale.
The sliding scale can be split into three different categories illustrated in Figure 1: (1) selective breeding; (2) gene therapy; and (3) genetic enhancement.
Selective Breeding
Gene Therapy
Genetic Enhancement
Figure 1. The sliding scale of genetic engineering.
31 Bonnie Steinbock “Designer babies: choosing our children’s genes” (2008) 372 The Lancet 1294 at
1294.
32 Jinxue Ruan and others "Genome editing in livestock: Are we ready for a revolution in animal breeding
industry?" (2017) 26(6) Transgenic research 715 at 715.
selection technique that achieves the purpose of avoiding harmful traits. It is currently used in this way in NZ but has the capacity to be used for positive selection as will be discussed further below.33
B Why the sliding scale?
Some opponents of genetic engineering object only to enhancement, rather than all forms of genetic engineering.37 I contend that establishing discrete boundaries between different forms of genetic engineering is actually very difficult as they all exist along the continuum. Importantly, all forms of engineering on the sliding scale affect the ‘natural order’ of the genes that might occur in any given individual. They also all make a subjective judgment on what is correct or harmful (a key criticism of enhancement), which will be further analysed in Chapter Three. Drawing regulatory lines between these technologies is a formidable task given the current framework we have. Current issues surrounding regulation will be further illustrated in Chapter Two and my recommendations for change will be put forward in Chapter Four. I accept that many would disagree with my definition
33 Jeanne Snelling "Implications For Providers And Patients: A Comment On The Regulatory Framework
For Preimplantation Genetic Diagnosis In New Zealand" (2006) 8(1) Medical Law International 23 at 23.
34 David B Resnik Bioethics of Gene Therapy (John Wiley & Sons Ltd, Chichester, UK, 2012).
35 Faith Lagay “Gene therapy or genetic enhancement: does it make a difference?” (2001) 3(2) Virtual Mentor 37 at 37.
36 Above n 35 at 38.
37 Christopher Gyngell, Thomas Douglas and Julian Savulescu “The ethics of germline gene editing” (2017) 34 Journal of Applied Philosophy 498 at 501.
of genetic engineering but reiterate that throughout this dissertation the term ‘genetic engineering’ encompasses the entire sliding scale. The terms selective breeding, gene therapy, and genetic enhancement will have the meanings given to them in the above paragraph.
III Genome Editing
A Genetic Limitations - Determinism and Environmental Factors
Genetic engineering clearly poses significant potential, but it is crucial to not overstate the influence of our genes in determining traits and disease. The concept of genetic determinism refers to “the impulse to treat DNA as destiny” by “discounting the interaction of other genes, the environment, and ‘free will’”.38 It is often incorrectly utilised by opponents of genetic engineering to argue that it is morally wrong to dictate the destiny of an unborn child.39 The notion that our genes wholly dictate our future is a misassumption.
The environment plays a significant role in limiting gene expression. External factors influencing trait expression include diet, nutrition, childhood, and internal factors known as epigenetics.40 The combination of your genes and the environment make up your phenotype – the observed characteristic or trait. Genetics is complex and predicting the influence of genes on traits is difficult. This serves as a reminder that the effect that genetic engineering could have on changing the genetic makeup of society under a reproductive choice model is (at least for now) limited.
The prevalence of genetic determinism and the exaggerated influence of genetic engineering are emphasised because they remain a paramount barrier to embryo modification in society.41 This dissertation and the arguments presented for regulatory reform are premised in the future when safety concerns can be overcome to allow for
38 Karen Rothenberg and Alice Wang "The Scarlet Gene: Behavioral Genetics, Criminal law, and Racial
and Ethnic Stigma" (2006) 69 Law and Contemporary Problems 343 at 356-357.
39 See generally Nathaniel Comfort “Genetic determinism rides again” (2018) 561 Nature 461.
40 Muin J Khoury “Genetics and genomics in practice: The continuum from genetic disease to genetic information in health and disease” (2003) 5 Genetics in Medicine 261 at 266.
engineering technology at the embryo level that is safe enough for mainstream use. Research must continue but calls for complete bans on embryo modification and research will not help us reduce the risks and uncertainties surrounding this technology. Refusing to engage in the discussion is no longer an acceptable option and once safety concerns can be overcome, NZ needs to be ready with a legitimate regulatory framework in place to accommodate the technology.
B CRISPR-CAS9
Rapid development of gene editing technology in the last decade has revolutionised gene editing. CRISPR-Cas9 is a technology which allows geneticists to be more accurate than ever before. The technology is modelled on the naturally occurring immune response system found in some bacteria.42 The technique has been hailed as “biological scissors” which can snip the DNA at a particular base to delete, insert, or replace the sequence in DNA.43 An RNA sequence complementary to the sequence where the cut will take place (for example, the beginning and end of a deleterious mutation) can attach to the Cas9 protein and help guide it to the correct place in the genome where the protein can make the cut in the DNA strand.44 The method, while not yet fool proof, is cheaper, faster, and more accurate than it has ever been before.45 It was also the system used to edit the genomes of Lulu and Nana (the first genetically modified human babies).46 The accuracy of CRISPR- Cas9 is what provides so much promise for the future of genetic engineering.
C What traits could we actually engineer?
Given that there are significant limitations with the extent that genes can wholly influence traits, it is difficult to know what we could potentially change even if we had the accurate
42 ML Maeder and CA Gersbach “Genome-editing Technologies for Gene and Cell Therapy” (2016) 24
Mol Ther 430 at 433.
43 Swati Tyagi and others “CRISPR-Cas9 system: A genome-editing tool with endless possibilities” (2020) 319 Journal of Biotechnology 36 at 36.
44 P Liang and others “CRISPR/Cas9-mediated gene editing in human tripronuclear zygotes” (2015) 6 Protein & cell 363 at 364.
45 Paul Knoepfler GMO Sapiens: The Life-Changing Science of Designer Babies (World Scientific Publishing Co Pte Ltd, Singapore, 2016) at 11.
46 Above n 2.
technology and knowledge of genes to do so. Current research in genetics shows a significant genetic component to the following traits:47
Sex; height; improved memory; lower mortality; increased happiness, higher
metabolism; less addictive personalities; disease resistance; and eyesight.
These traits have great enhancement potential, which along with the use of gene therapy to avoid genetic disorders makes genetic engineering so alluring. Current clinical gene therapy trials for somatic cells in the USA and the UK show promising signs to correct the genetic cause of disorders such as muscular dystrophy,48 cystic fibrosis, and many more.49 The use of mitochondrial replacement therapy is now available in the UK which allows for DNA from three people to be used to create offspring that do not contain harmful mitochondrial diseases caused by the small amount of maternally inherited DNA that the mitochondria carry.50 Once more becomes known about the genetic contribution to traits and disorders, more can be done to correct them and the capacity for enhancement will increase. These traits serve as a speculative but pragmatic way to imagine how genetic engineering might look if people were given the choice to use it.
IV Assisted Reproductive Technology
This dissertation is concerned with genetic engineering at the embryo stage. This is because it dominates genetic engineering discourse and yields greater potential.51 Many of the gene therapy trials discussed above occur in the somatic cells of fully consenting adults. Changes made through that form of gene therapy will not be passed to future generations, unlike
47 Jonathan Anomaly, Christopher Gyngell and Julian Savulescu “Great minds think different: Preserving
cognitive diversity in an age of gene editing” (2020) 34 Bioethics 81 at 82; and Colin Farrelly Genetic Ethics: An Introduction (Polity Press, UK, 2018) at 45, 58, 117 and 167.
48 Niclas E Bengtsson and others "Progress and prospects of gene therapy clinical trials for the muscular
dystrophies" (2016) 25(1) Human molecular genetics 9 at 9.
49 Uta Griesenbach, Kamila M Pytel and Eric WFW Alton "Cystic fibrosis gene therapy in the UK and elsewhere." (2015) 26(5) Human gene therapy 266 at 266.
50 Rosa J Castro "Mitochondrial replacement therapy: the UK and US regulatory landscapes" (2016)
Journal of Law and the Biosciences 3(3) 726 at 728.
51 Colin Farrelly Genetic Ethics: An Introduction (Polity Press, UK, 2018) at 2.
embryo gene-editing.52 I will discuss two assisted reproductive technologies (ARTs) which are currently in mainstream use in NZ: in vitro fertilisation (IVF) and preimplantation genetic diagnosis (PGD). The use of IVF would be necessary to create a genetically engineered child. The explanation illustrates the onerous process that prospective parents
A Reproduction
Fundamentally, an embryo is formed when an egg and sperm cell fuse to form a zygote.53 Naturally (in vivo), this process takes place in a female’s fallopian tubes and when formed the embryo will insert itself into the uterine wall.54 The zygote is a two-celled organism that contains 23 chromosomes from each parent.55 The zygote divides exponentially to grow the embryo, forming the fetus and subsequent child. Editing that zygote when it is only two cells, or additionally the sperm or ova before they fuse is the simplest and likely most effective way of genetically engineering a whole organism: all subsequent cells will contain exact copies of the edited DNA.56
B In Vitro Fertilisation
First taking place in 1978, IVF is where the sperm and egg are fertilised outside of the body
5252 Above n 51 at 45.
53 Henry T Greely The end of Sex and the Future of Human Reproduction (Harvard University Press, Massachusetts, 2016) at 39.
54 Above n 53 at 40.
55 Above n 53 at 40.
56 Mosaicism is a large issue facing genetic engineering so the less cells that need to be edited the less risk there is of mosaicism. Kelly E Ormond “The clinical application of gene editing: ethical and social issues” (2019) 16(4) Per Med 337 at 338.
57 Remah M Kamel “Assisted reproductive technology after the birth of louise brown” (2013) 14(3) J Reprod Infertil 96 at 96.
each year to achieve pregnancies.58 It requires egg collection which necessitates hormone medication to stimulate egg production, and then a surgical procedure under sedation or general anaesthetic to remove the eggs from the female’s ovaries.59 Sperm collection is straightforward and imaginably less invasive. An embryologist or other clinician will then artificially fuse the two in the lab to create the embryo.60 Once formed, this embryo is cultured to promote cell division. After three to five days the embryo will then be transferred into the uterus of the carrier for implantation.61 Once implanted, most pregnancies can continue normally with routine monitoring. Often multiple embryos are created during any one cycle of IVF: viable embryos may then be cryopreserved for implantation in the future.62 In NZ, embryos may be stored for 10 years.63 When selecting which embryo to implant, multiple screening processes are used to test the viability and other characteristics of each embryo.
C Preimplantation Genetic Diagnosis
PGD is a screening technique which is an extra step during IVF and is performed on embryos prior to their implantation into the uterus. The exact tests performed depend on the reason for embryo screening. A couple of cells are taken from each embryo formed and tested to check their genetic profile.64 The nature of the genetic testing depends on the reason for the procedure. Often tests are done to screen for known genetic disorders that are carried within a family so that selected embryos are those that do not contain the genes causing the disorder.65 The selection based on these genetic tests is highly regulated in NZ and there are very specific requirements about what the embryos can be tested for, this will be further discussed in Chapter Two. Common tests performed are for cystic fibrosis, Huntington’s disease, Fragile X Syndrome and Haemophilia.66 This procedure is a form of
58 George Anifandis and others "Bioethics in human embryology: the double-edged sword of embryo research" (2022) 68(3) Systems Biology in Reproductive Medicine 169 at 171.
59 Fertility Associates “Pathway To A Child Booklet” (August 2017) at 22.
60 As above n 59.
61 Above n 59 at 64.
62 Above n 59 at 64.
63 Human Assisted Reproductive Technology Act 2004, s 10.
64 Frances A Flinter “Preimplantation genetic diagnosis” (2001) 322(7293) BMJ 1008 at 1008.
65 Above n 33 at 30.
66 Above n 64 at 1008.
selective breeding which in this dissertation, per Figure 1, is encompassed by genetic engineering. The procedure can realistically screen for anything there is a genetic test for67 so the capacity for expansion of its future use in genetic engineering is substantial.
V Summary
This chapter has described some fundamental principles of genetics to present a pragmatic understanding of the genetic basis of traits. It has defined key terms such as genetic engineering, selective breeding, gene therapy, and genetic enhancement. It has also explored the limits of genetics in determining traits and environmental influence on genes. It has outlined some possible genetic traits capable of enhancing and the CRISPR-Cas9 editing system to illustrate how gene engineering could occur. Lastly it has discussed IVF and PGD as two key ARTs that are already in mainstream use in NZ and their potential for use in engineering. This illustrates the complex and onerous process involved in genetic engineering that would be undertaken by prospective parents if they were given the choice to do so.
67 Best Practice Advocacy Centre New Zealand The New Zealand Laboratory Schedule Test Guidelines:
genetic tests (Best Tests, November 2014) at 3.
CHAPTER TWO – Current Regulatory Frameworks
This chapter will outline the status of genetic engineering regulation in New Zealand and the wider framework of ARTs. It will critically assess select shortcomings of the current system. It will also describe the ART regulatory framework in the UK to provide an alternative model that counters some issues with the New Zealand system.
I NZ’s Regulatory Framework
A HART Act 2004
The principal legislation regarding reproductive technology is the Human Assisted Reproductive Technology Act 2004 (HART Act). Gaining royal assent on 21st November 2004 and commencing in parts thereafter,68 the Act creates a framework designed to regulate all aspects of reproductive technology and any dealings with human embryos. The Act’s central purposes include securing the benefits of reproductive technologies that maintains the health, safety, dignity and rights of persons involved,69 as well as providing a “robust and flexible framework” for regulation.70 The Act also outlines seven key principles designed to guide all decision-making under the Act. Notably these include: the health and wellbeing of children born; an emphasis on women who are more greatly affected by the Act; the values of Māori; and the “different ethical, spiritual, and cultural perspectives of society” that should be considered and treated with respect.71
B Categories of Regulation
The Act operates by assigning all procedures into three mains categories with varying degrees of regulation: (1) prohibited; (2) established; and (3) assisted reproductive procedures.
Prohibited procedures are those expressly forbidden by the HART Act. These include: PGD for non-medical sex selection; artificially forming a hybrid embryo for reproductive purposes; and human reproductive research on embryos past 14 days old.72 Pertinently, it is expressly forbidden to implant a genetically modified gamete or human embryo.73 The HART Act also expressly forbids commercialisation of human gametes and embryos indicating an aversion to commodification of embryos. 74 This could create tension with proponents of enhancement in human embryos. Most importantly for our purposes, there is an unequivocal ban on genetic modification at the embryo level and clear parameters around reasons for selection. This means that Parliament would have to remove this prohibition to allow genetic engineering. The rest of the framework is described to allow for discussion about options for reform within the current system.
Procedures declared to be established procedures can take place routinely without prior written approval under the Act.75 These are listed in the Human Assisted Reproductive Technology Order 2005 which can be updated upon a recommendation by ACART.76 The HART Order has the status of secondary legislation and can be scrutinised by the House of Representatives.77 Established procedures relevant to genetic enhancement at the embryo level are IVF, egg and sperm collection, and PGD selection to avoid known genetic disorders.78
An assisted reproductive procedure is defined as one involving the creation of an embryo; the use of human gametes; the use of cells derived from embryos; and the implantation into
76 Human Assisted Reproductive Technology Order 2005; HART Act s 6.
78 Human Assisted Technology Order 2005, Sch 1.
humans of gametes of embryos – but does not include an established procedure.79 All procedures that are not established or prohibited fall into this category. These procedures require case by case written approval from ECART before they can take place.80 Examples of procedures in this category include PGD for HLA tissue typing, surrogacy, gamete donation within families, research on gametes or non-viable embryos (up to 14 days old).81
C ACART and ECART
The HART Act also delegates decision making powers and functions to two committees: the Advisory Committee on Assisted Reproductive Technology (ACART) and the Ethics Committee on Assisted Reproductive Technology (ECART).82
ACART formulates policy on assisted reproductive procedures which ECART follows, and provides advice to the Minister of Health (the Minister) about changes to the HART Act.83 Guidelines published by ACART are secondary legislation and could be subject to the scrutiny of the House of Representatives.84 ACART also has a role in monitoring outcomes of assisted reproductive procedures as well as keeping up with advances in technology and research on embryos.85 They are under a statutory obligation to consult with relevant members of the public, relevant government agencies, and other relevant committees before publishing guidelines.86
81 As inferred from: ECART Minutes for 11th February 2021 (ECART, Feb 2021); ECART Minutes for 8th April 2021 (ECART, April 2021); ECART Minutes for 3rd June 2021 (ECART, June 2021); ECART Minutes for 5th August 2021 (ECART, Aug 2021); ECART Minutes for 30th September 2021 (ECART, Sept 2021); ECART Minutes for 29th October 2021 (ECART, Oct 2021); ECART Minutes for 9th December 2021 (ECART, Dec 2021).
84 HART Act s 35(4). Note that this has only recently been clarified by the Secondary Legislation Act 2021. Guidelines before that had an uncertain regulatory role and therefore have not been subject to Parliamentary scrutiny before. For more see Jeanne Snelling “Obstruction and obfuscation: Regulatory barriers to human embryo research in New Zealand” (2020) 20(4) MLI 339.
ECART replaced the previous committee known as the National Ethics Committee on Assisted Human Reproduction.87 ECART can only act on the advice of ACART’s published guidelines, and the principles guiding all decision-making under the HART Act.88 Their main role is to respond to applications for approval under the category of Assisted Reproductive Procedure.89 The committee meets six times each year to consider applications.90
Committee members are appointed by the Minister or in accordance with ministerial guidance.91 They include both laypersons and experts.92 Thus, it is the role of ACART to keep up to date with changes to the technology, set and revise guidelines based on advances in technology, and consult with the Minister of Health and public on those guidelines. It is the role of ECART to interpret and apply those guidelines to individual applications for the use of ART.
D The regulation of PGD
The use of PGD is limited under the HART Act. It is allowed if it is used to avoid genetic disorders if there is a known family member with a genetic disorder, a 25 per cent or more chance of having an affected embryo and that the embryos would likely be seriously impaired because of the disorder.93 These requirements apply for monogenic disorders, sex-linked disorders, and chromosomal disorders.94 PGD can also be used if it is done for selecting an embryo with an HLA tissue match with another sibling in order to utilise stem cells for that sibling.95 This requires case-by-case ECART approval. Using PGD for the deliberate sex selection of embryos is prohibited and can lead to up to one year
87 Jeanne Snelling “Embryonic HLA Tissue-Typing and Made-to-match Siblings: The NZ Position” (2008)
9 Med.L.Int.13, at 15.
90 ECART “2021 Minutes” (26 April 2022) <https://ecart.health.govt.nz/meetings/2021-minutes/>.
92 ACART expressly requires at least half of the committee to be laypersons: HART Act s 34(6).
93 Human Assisted Reproductive Technology Order 2005, Sch 1 Part 1; Sch 1 Part 2 s 6.
94 As above n 93.
95 Jeanne Snelling “Embryonic HLA Tissue-Typing and Made-to-match Siblings: The NZ Position” (2008) 9 Med.L.Int.13, at 15.
imprisonment and or a $100,000 fine.96 Thus, whilst I have categorised PGD as a form of
genetic engineering its current use in NZ is strictly controlled.
II Issues with the Framework
This dissertation aims to question what the role of the law should be in regulating reproductive technology with the advent of genetic engineering. This necessarily involves addressing some of the current system’s issues and the reasons why it might be in need of review. These issues could also impede the success of the reproductive autonomy model proposed in this dissertation. I have identified three main issues with the current regulatory framework: (A) the framework is too slow to keep up with rapid changes in technology;(B) Committees are time-poor and lack full independence to make decisions; and (C) there
is no real appetite for change.
A Framework is too slow to keep up with rapid changes in technology
The combination of primary and secondary legislation and guidelines issued by ACART are designed to achieve a “robust and flexible” framework, however, it is too slow to keep up with rapidly changing technology. Since commencement 18 years ago, the HART Act has only undergone minor tweaks to sections in isolation as well as some small updates to guidelines. There is no built-in mechanism for review of the Act and no review has been conducted as was done in the UK.97 An example of the slow progress speed would be the revision of guidelines around posthumous reproduction which first appeared for review on ACART’s work schedule in 201498 and whilst are supposedly finished have not yet been published.99 This would lead one to presume that the current guidelines for posthumous reproduction are those currently published on ACART’s website which were formed in 2000 and predate the HART Act itself.100 Even if ACART were to recommend that the
97 Their Act saw substantial review and amendment in 2008. Michael Legge and Ruth Fitzgerald “Does the
Human Assisted Reproductive Technology Act 2004 need a review?” (2021) 17 PQ 79 at 80.
98 ACART Minutes for 13th June 2014 (ACART, June 2014) at cl 7.
99 Their minutes state that the guidelines are complete but not yet published. It is unclear whether ECART
is currently using them: ACART Minutes for 30th June 2022 (ACART, June 2022) at cl 13.
100 See National Ethics Committee on Assisted Human Reproduction Guidelines for the Storage, Use, and Disposal of Sperm from a Deceased Man (February 2000). Website last checked 6th Oct 2022.
law allow for genetic enhancement, it is still just a recommendation. Under the current framework implementing genetic engineering would firstly require Parliament to remove the ban and then ACART would need to arduously formulate guidelines on genetic engineering. This process would likely be lengthy and inefficient.
The HART Act itself took a long time to come into force. Commencing eight years after Diane Yates introduced a private member’s bill in 1996.101 The bill was based almost entirely on the UK’s licensing system of reproductive technology.102 This system will be described below. When Parliament finally enacted the HART Act in 2004, it looked nothing like Yates’s original bill.103 Yates’ system was rejected in 1998 by Attorney- General Doug Graham who believed the system was inappropriate for NZ.104 He thought licences would be too costly on taxpayers given that NZ has far fewer fertility providers than the UK.105 A review of NZ’s system could, amongst other things, assess how the UK system might better serve the HART Act’s original purpose of a “robust and flexible” framework to secure the benefits of reproductive technologies.
B Committees are time-poor and lack full independence to make decisions
Unfortunately, ACART’s mandate is too vast for the time they are given. ACART’s lack of time means they are ill-equipped to enact major reform. ACART must research new technology, update reform guidelines, and advise both the Minister and ECART. In 2021, ACART met a total of six times with meetings taking up about five hours a day.106 Ordinary
101 Michael Legge and Ruth Fitzgerald “Does the Human Assisted Reproductive Technology Act 2004
need a review?” (2021) 17 PQ 79 at 79.
102 Diane Yates “Dialogue: Proposed changes to the Human Assisted Reproductive Technology Act (2004)” (2015) 29 WSJ 34 at 34.
103 Jeanne Snelling “Cartwright calamities, Frankenstein monsters and the regulation of PGD in NZ” in Sheila A.M. McLean, Sarah Elliston (ed) Regulating Pre-implantation Genetic Diagnosis: A Comparative and Theoretical Analysis (Routledge, London and New York, 2013) 171 at 171.
104 Doug Graham, Attorney General of NZ “Current Medico-legal Issues” (Address To 7th Annual NZ MedicoLegal Conference, Wellington, 23 February 1999).
105 As above n 104.
106 Averaged over 2021: ACART Minutes for 19th Feb 2021 (ACART, Feb 2021); ACART Minutes for 15th April 2021 (ACART, April 2021); ACART Minutes for 24th June 2021 (ACART, June 2021); ACART Minutes for 13th August 2021 (ACART, Aug 2021); ACART Minutes for 21st October 2021 (ACART, Oct 2021); ACART Minutes for 10th December 2021 (ACART, Dec 2021).
members are entitled to one day’s pay per meeting and one half day to prepare.107 Both committees are serviced by fulltime workers within the Ministry of Health to achieve standard regulatory functions but apart from that ACART members are dedicated for roughly nine days a year with the Chair and Deputy-Chair having slightly more resource allocation.108 In order to achieve their workload, members will likely have to dedicate significant personal time. Even if members were willing, this is unsatisfactory for a Committee tasked with such a significant regulatory role. This situation does not put ACART in a position to be able to handle further oversight of genetic engineering – as they would need to both formulate guidelines and continually monitor its use if Parliament were to lift the ban on genetic engineering.
Whilst technically ACART has full independence to make decisions and advise on any area they think fit; this has unfortunately not been the reality.109 ACART’s work schedule is agreed upon with the Minister of Health.110 This is evident through the cumbersome battle to see vital areas such as the embryo research guidelines reformed.111 This process is still a work in progress and has seen numerous Minister’s decline to engage the issue.112 ACART members are appointed by the Minister.113 This, compounded by ACART’s lack of time, means they are unlikely to pursue areas of reform that are of no interest to Ministers.114 This puts ACART in danger of not being fully independent as their work schedule by default becomes dependent on political interest. Although ACART can advise the Minister on law changes there is no accountability for the Minister having to respond to those changes.115 Similarly, ECART also spends the majority of their time considering
107 ACART “Terms of Reference” (12 May 2022) < https://acart.health.govt.nz/about-us/terms-of-
reference/>; ECART “Terms of Reference” (24 March 2021) < https://ecart.health.govt.nz/about-us/terms- of-reference/>.
108 As above n 107.
109 Jeanne Snelling “Obstruction and obfuscation: Regulatory barriers to human embryo research in New Zealand” (2020) 20(4) MLI 339 at 354.
110 As above n 109.
111 National Ethics Committee on Assisted Human Reproduction Guidelines for Research on Gametes and Non-viable Embryos (1 January 2005).
112 Above n 109 at 354.
114 Above n 109 at 354.
applications for surrogacy arrangements.116 If genetic engineering where to be introduced on a case-by-case basis for ECART approval, it is doubtful that their time constraints would allow proper adequate consideration of all the applications they receive. Nor would it be fair to expect this of them. Thus, the committees tasked with updating NZ’s reproductive legislation do not have the time resourcing or political independence to adequately and objectively assess new reproductive technology for regulation in NZ.
C No appetite for change
The last and perhaps most important problem with the status quo is that there is no real appetite for change. Reproductive technology falling outside the established procedures is seen to affect only a small number of people and many do not see the problem with the current framework unless working in those specific areas. Ministers have no real reason to make changes to the system because of the lack of public demand on them. ECART received just 182 new applications in 2021, the majority of these being for surrogacy arrangements.117 The Law Commission presented a report to Parliament in May 2022 proposing significant amendments to how ECART approves these arrangements which, if implemented, would see a significant decrease in ECART’s workload.118 A bill is currently at select committee stage that would implement some of these changes.119 ACART is currently dissatisfied with this bill and the effect that it might have on their operation.120 These instances show an increased focus on surrogacy being the key issue at the forefront of the ART debate currently and present a real challenge to change in other areas. Parliament’s reluctance to address mounting and pressing reproductive issues puts further strain on ACART’s resources.
116 Above n 81.
117 ECART Minutes for 9th December 2021 (ECART, Dec 2021). 118 Law Commission Review of Surrogacy (NZLC R146, 2022). 119 Improving Arrangements for Surrogacy 2021 Bill (72-1).
120 ACART Minutes for 30th June 2022 (ACART, June 2022) at cl 10.
Additionally, NZ currently takes a very conservative approach to genetically modified organisms.121 This is largely due to the heavy reliance on the agricultural sector for exporting and the limited ability to contain the spread of GMOs for use in agriculture. Other examples of general conservatism are shown in NZ’s continued ban of nuclear energy that has been in place since the 1980s.122 Whilst not determinative, these instances might show a lack of demand in the public to change laws that would allow access to reproductive technology or to encourage review of the current system. The diversion of resources by the Ministry of Health (responsible for ACART and ECART) during the last three years due to the COVID-19 pandemic has also slowed down other items on ACART’s agenda such as the new guidelines for post-humous reproduction123 which have been in progress since they were first noted on ACART’s work schedule in 2014.124 This was an area where there was significant appetite for change125 and yet progress was still slow. Progress is likely to be even slower under the current system if no appetite exists.
D Summary
In sum, New Zealand’s current regulatory scheme is unlikely to yield the full potential of rapid advances in genetic technology advances. First, I established that the framework is too slow to keep up with fast-changing technology. Second, I established that ACART is time-poor and inadvertently subject to political scrutiny, which significantly affects their capacity to complete their workload. Third, I established that there is a lack of political and public appetite for change. These factors mean the system would likely be unable to keep up with the constant monitoring that genetic engineering would demand of it. Reform to allow genetic engineering might require more than a simple Parliamentary amendment removing the current prohibition.
121 Philipp Aerni "Exploring the Roots of the Old GMO Narrative and Why Young People Have Started to
Ask Critical Questions" (2021) 30(7) Plant Biotechnology 277 at 277.
122 New Zealand Nuclear Free Zone, Disarmament, and Arms Control Act 1987.
123 ACART Minutes for 24th June 2021 (ACART, June 2021) at 13.
124 ACART Minutes for 14th August 2015 (ACART, Aug 2015) at 7.
125 See Nicola Peart “Life Beyond Death: Regulating Posthumous Reproduction in New Zealand” (2015) 46 VUWLR 725.
III United Kingdom’s Regulatory Framework
The regulation of reproductive technologies in the UK is somewhat different to NZ. Their regulations are world-leading, and their main regulatory authority has the independence, resources, and track record that NZ lacks when it comes to ART regulation.
A World Leading Reproductive Policy
UK legislation on reproductive technology first arose in 1990 upon recommendation by a national Committee of Inquiry after they produced the infamous Warnock Report.126 The report is well-regarded around the world and the UK has become a leader in reproductive technology policy. Their system is well-resourced, independent, and engages numerous actors to formulate policy including the UK Parliament, the Human Fertilisation and Embryology Authority (HFEA), and the Nuffield Council on Bioethics.127 These institutes set a high bar for public consultation, debate, and sound scientific research informing all policies in the UK.
B Human Fertilisation and Embryology Act
The principal statute regulating reproductive technologies in the UK is the Human Fertilisation and Embryology Act 1990 (HFE Act). It underwent considerable reform in 2008. 128 The HFE Act sets up a licencing framework for all reproductive technologies. All uses of gametes and embryos outside the body are prima facie prohibited by the Act unless they are taken place pursuant to a licence.129 Licences are given out by the HFEA and fit broadly into five different categories: storing and using gametes, and creating, storing, and using embryos.130 The Act lists certain activities that cannot be licenced, these include
126 Known colloquially as the “Warnock Report”. Report of the Committee of Inquiry into Human
Reproduction & Embryology 1984 (Cmnd 9314) (London: HMSO).
127 Above 109 at 347.
128 Human Fertilisation and Embryology Act 1990 and as amended by the Human Fertilisation and Embryology Act 2008.
130 Nuffield Council on Bioethics Genome editing and human reproduction (Nuffield Council on Bioethics, London, 2018) at 102.
those which involve embryos that are not classed as “permitted embryos” as defined in the Act.131 Genetically edited embryos are excluded from this definition meaning no licence can currently be given to allow genetic engineering.132
C The HFEA
The HFEA has substantial discretion to impose other conditions activities that they licence.133 They can licence any activity that is not expressly prohibited by the HFE Act but is pursuant to the specified purposes of the Act.134 The HFEA is an “arm’s length independent body” that works for the UK Government but its members are not appointed by them.135 Its significant resource allocation allows its scientific research institute to remain ahead of the world in researching advancing technology, publishing timely advice, and formulating policy on reproductive technology.136 The HFEA’s ability to remain at the forefront of reproductive technology since its inception in 1990 is worthy of significant praise. The combination of independence, resources, and rapid appetite for change achieve what the NZ system cannot and offer a model for what ACART could become if not encumbered by NZ’s current framework.137
D Mitochondrial Replacement Therapy
The implementation of mitochondrial replacement therapy (MRT) is a recent example in which the UK has achieved leading reproductive policy. In October 2015, the UK became the first country in the world to implement policy allowing MRT.138 This procedure allows people to have children that are biologically related to them that do not carry genetic diseases caused by maternally inherited mitochondrial DNA. The egg of a mitochondrial donator is genetically edited to remove the nucleus to allow the nuclear DNA of the
135 HFEA “About Us” (Oct 2022) <https://www.hfea.gov.uk/about-us/how-we-regulate/>.
136 Above n 130 at 101.
137 Above n 109 at 364.
138 Above n 50 at 726.
biological mother to be inserted and fused with sperm to form an embryo.139 The UK have implemented this therapy through Regulations made by Parliament that update the definition of “permitted embryo”.140
Despite allowing this form of gene therapy the UK House of Parliament took great care to emphasise that MRT does not amount to genetic modification due to the small amount of DNA involved.141 However, this clarification has been met with significant criticism142 and would constitute gene therapy on the sliding scale outlined in Chapter One. The regulation of MRT in the UK illustrates how the UK’s regulatory framework has adapted well to recent advancements in gene therapy and likely will continue to do so in the future. The UK system contrasts NZ’s regulatory framework allowing for faster regulatory changes and provides great promise for NZ – this will be discussed further in Chapter Four.
IV Summary
NZ’s regulatory framework for reproductive technologies consists primarily of the HART Act and its ancillary documents. Gene therapy, enhancement, and most forms of directional selection are expressly prohibited. ACART has oversight of regulations regarding reproductive technologies alongside ECART who can respond to applications under the HART Act. The system has numerous issues including its inability to keep up with rapid changes in technology, the lack of time and independence allocated to ACART, and the lack of appetite for change. Comparatively, the UK system operates under a licencing system that is robust yet flexible and allows for greater adaptability to new technologies. It has not encountered the same issues as the NZ framework. Their system already allows MRT which is a form of gene therapy. Having established that the current regulation prohibits genetic enhancement and therapy it is important to look at the ethical reasons for why such changes should be made.
139 G Hudson, Y Takeda, and M Herbert M “Reversion after replacement of mitochondrial DN” (2019) 574
Nature 8 at 9.
140 Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015.
141 Above n 130 at 103.
142 Above n 130 at 104.
CHAPTER THREE – The Ethics of Genetic Engineering for Future Generations
The debate about genetic engineering is not a new ethical concern, but it is a live issue as technology advances and society becomes more familiar with it. This chapter describes some of the key ethical arguments both for and against the use of genetic engineering in reproductive technology.
I Premise
Firstly, the ethical arguments presented in this chapter take place on the premise that PGD is already in use in NZ albeit in limited circumstances – its use in those circumstances is widely accepted. Secondly, all technology proposed for regulation is premised on it eventually meeting an accepted safety threshold. At present this cannot be said for genetic engineering, but in the future these concerns will likely be overcome.143 For this reason ethical arguments relating to safety concerns will not form the basis for discussion. Third, as outlined in Figure 1, engineering is a sliding scale and the line between selective breeding and gene therapy is blurry. The same is true for differentiating between gene therapy and genetic enhancement.144 Whilst many disagree about the inability to draw discrete lines, some draw that line readily.145 An ethical objection that allows one but not the other fails to properly attack the core issues involved with the act of selecting the next generation – an aspect that is at the heart of genetic engineering. For the sake of clarity, this dissertation conceives of the entire sliding scale as genetic engineering. The ethical arguments explored in this chapter relate to the entire sliding scale and target the act of directional improvement (applicable to each aspect of the sliding scale) rather than persuade about where to draw lines or what traits are ethically permissible to engineer. From each of these premises all other ethical arguments will proceed.
143 As affirmed by the Nuffield Council on Bioethics. See Nuffield Council on Bioethics Genome editing
and human reproduction (Nuffield Council on Bioethics, London, 2018) at 155.
144 Above n 37 at 509.
145 W French and MD Anderson “Human Gene Therapy: Why Draw a Line?” (1989) 14(6) The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine 681 at 681.
A Ethical arguments not discussed
There are several important and widespread arguments that this dissertation does not discuss. The ethical perspectives discussed all target genetic enhancement – which sits at the furthest end of the sliding scale. Ethical perspectives not discussed either do not address this aspect of the sliding scale or they openly reject the premise that PGD is ethically permissible. Without prejudice to the plausibility or merit of these arguments they are listed to show the sheer breadth of ethical perspectives. These include: the moral status of the embryo;146 playing God;147 disability rights concerns (regarding the act of positively selecting individuals without disabilities);148 a child’s right to an open future;149 a child’s right to be born;150 the non-identity problem;151 Kant’s categorical imperative to not treat people as mere means;152 and the slippery slope objection (in that by allowing PGD we have already begun the slippery slope).
B Addressing historical concerns
One of the most emotive ethical objections to genetic engineering is that it is analogous to the repugnant eugenics movement of the 1920s to late 1940s. This comparison is understandable, especially with the advent of genetic enhancement – the word eugenic translates to “good birth”.153 This has often meant that proponents of genetic engineering have been compared to Nazi supremacists.154 Those attempting to navigate debate on genetic enhancement must defend against such moral repugnance in order to avoid the emotive term and the connotations it implies.
146 See R Pardo and F Calvo “Attitudes Toward Embryo Research, Worldviews, and the Moral Status of the
Embryo Frame” (2008) 30(1) Science Communication 8.
147 See F Coyle and J Fairweather “Space, time and nature: exploring the public reception of biotechnology in New Zealand” (2005) 14(2) Public Understanding of Science 143.
148 See Jackie L Scully “Disability and genetics in the era of genomic medicine” (2008) 9 Nature Reviews 797 at 797.
149 Joel Feinberg "The child's right to an open future" (2015) 1 Justice, politics, and the family 145.
150 Above n 147.
151 Derek Parfit Reasons and persons (Clarendon Press, Oxford, 1987).
152 Martin Gunderson “Seeking perfection: a Kantian look at human genetic engineering” (2007) 28 Theoretical medicine and bioethics 87.
153 Walter Veit and others “Can ‘eugenics’ be defended?” (2021) 39 Monash Bioethics Review 60 at 61.
154 Above n 153 at 62.
The movement at its peak saw widespread compulsory sterilisation for “feebleminded” individuals particularly in the USA and Europe.155 This policy was adopted and extended by the Nazi party and used to justify mass extermination of Jews, homosexuals, disabled individuals and others across Germany in World War II.156 NZ had its own experience with the movement, famously heralded by one of the founders of the NZ Plunket Society, Dr Truby King.157 As a nation NZ almost passed its own compulsory sterilisation laws in 1928 as a part of the movement.158 At the time it did not elicit the emotive response seen today and was seen as a progressive movement.159 This further illustrates the often dramatic change in attitudes over time – movements once seen as progressive or legitimate become archaic and absurd.
Discourse in recent years has attempted to steer discussion to address what was truly so outrageous about eugenics. One influential view is that the dominant quality that made eugenics so wrongful was the fact that policies were state mandated and ignored human autonomy and rights.160 It also formed a monistic and illegitimate point of view about what qualities or traits constituted being of ‘good birth’.161 The decision about who could have children – today regarded as an innately private and personal choice – was removed and reinforced by a dictatorial state. There are other scholars who would disagree with this dismissal and urge that eugenics is also evident even without state coercion, often called
155 J Glover Eugenics: Some Lessons from the Nazi Experience (Clarendon Press, Oxford, 1998) at 7.
156 Above n 155.
157 Plunket as of 2020 have distanced themselves from the views of Truby King. But until this still held him out to be a “visionary” and “idealist”. Emily Writes “Plunket’s founder was an awful person obsessed with eugenics” The Spinoff (online ed, 7 May 2019).
158 Hamish Spencer "Eugenic Sterilization in New Zealand: The Story of the Mental Defectives Amendment Act of 1928” (2018) Eugenics at the Edges of Empire, Palgrave Macmillan 85 at 85. 159 Above n 158 at 85.
160 Diane Paul "What was wrong with eugenics? Conflicting narratives and disputed interpretations" (2014)
23(2) Science & Education 23 259 at 264.
161 Allen Buchanan "Institutions, beliefs and ethics: Eugenics as a case study" (2007) 15(1) Journal of Political Philosophy 22 at 22.
“liberal eugenics”.162 They argue that what is truly wrong and at the core of eugenics is the ambition to design.163
There are numerous different interpretations of the term eugenics and the historical connotations it carries. The debate on this topic could be endless, with the term sometimes generating more heat than light, to the extent that some bioethics experts have suggested that perhaps it might be best to retire the term altogether.164 Whether or not we use this term, though, understanding the core objections to the various movements of the past allows us to be wary of repeating the same mistakes in the future. For many people, the coercive aspect of the eugenics movement – and how it elevated the concerns of the state over and above those of individuals – was integral to what made the movement so objectionable. For others, it was the idea that there are certain traits collectively worthy of pursuit. If these are right, then it would be a mistake to conflate eugenics with the sort of genetic engineering considered here, which would rely on consent and free choice. A movement that prioritises reproductive autonomy lacks many of the characteristics that were common to the eugenics movements of the past and thus lacks many of the negative connotations attached to it.
II Reproductive Autonomy
One of the strongest ethical views in favour of genetic engineering is reproductiveautonomy.
A What does reproductive autonomy look like?
The well-known ethical principle of autonomy necessitates letting people be authors of their own lives.165 It involves letting people who have the requisite capacity and information make decisions that are free from limitations.166 When placed in the context
162 Stephen Wilkinson “Eugenics talk” and the language of bioethics” (2008) 34 Journal of Medical
Ethics 467 at 467.
163 Michael J Sandel “The case against perfection” (2004) 293(3) The Atlantic Monthly 50.
164 Above n 162 at 471.
165 Above n 51 at 95.
166 Above n 51at 96.
of reproduction it dictates that decisions relating to all aspects of reproduction are made free from limitation and with respect to the right of an individual to exercise the decision. This includes decisions about: deciding to become a parent; who (among those willing) to have a child with; when to have a child; how many children to have; and how to raise that child.167 It can also be extended to cover how a person is to have a child, for example through IVF, adoption, or surrogacy. Often used interchangeably with other terms such as reproductive liberty, reproductive justice, and procreative choice – each with their own slight differences and overlap – the term has an important historical background that previously saw significant female oppression with respect to reproductive decisions.168 Historical rights movements as well as anti-patriarchy protests have brought reproductive autonomy to the forefront of many political, economic, and social debates.169 When the State exercises their own judgment that fails to recognise the rights of autonomous females with respect to their own body then there has been a significant breach of reproductive autonomy.170 That is not to say that men do not have their own reproductive rights but simply acknowledges that females are often more affected by reproductive decisions and their limitations due to the situational nature of reproduction and IVF. This view of autonomy can be labelled in negative terms – there is a presumptive right not to have laws against choosing (or choosing not to) to have a child and other aspects related to it.171
Reproductive autonomy can also be termed positively – that there should be a presumption in favour of access to technologies that allow us to expand our choices such as access to IVF.172 Some would consider that the principle should not extend from the negative right
- not having your choice to have a child interfered with – to the positive right – allowing access to technology that could help choose what that child might look like.173 Why should the onus be framed in this way? There are numerous other aspects of life where access to
167 Above n 51 at 96.
168 See above n 6.
169 See above n 6.
170 See above n 6 at 17.
171 Catherine Mills “Reproductive Autonomy as Self-Making: Procreative Liberty and the Practice of Ethical Subjectivity” (2013) 38(6) The Journal of Medicine and Philosophy 639 at 639.
172 Above n 171 at 639.
173 See above n 6 at 149.
choices and options is the presumption, picking a partner or a career. The onus should be on those wishing to limit reproductive autonomy in this way to justify why the principle – that historically has been framed in negative terms – should not be extended or framed positively in this way to cover the right of parents to make decisions about what their children might look like.
B What are the limits of autonomy?
John Stuart Mill devised a principle that would deal with the extent that the exercise of any power could interfere with the actions and choices of human beings – the harm principle.174 He recognised that the right to autonomy was not absolutely without limit but ended where the choices of others began to harm others. In these instances, where others are harmed, power or limits can be exercised over somebody to prevent the exercise of their free choice.175 This principle is often termed in the simpler phrase: my right to swing my fists ends where your nose begins. When put in the context of reproductive autonomy it generally means that parents should be free to make decisions about reproduction up until that decision starts to cause harm to others. In the first instance this means harm to the child, but in the wider instance it means harm to others in society.
Defining when decisions harm others is challenging in the context of genetic engineering. Direct harm is easy to identify but identifying indirect harm, and the extent to which parent’s decisions in relation to their own children begin to harm other children, is harder to discern. Does having a child with greater athletic ability harm another child who is not as athletic? Do the opportunities provided to that child come at the expense of another who lacks those opportunities? Does choosing a child without a disability harm other people living with disabilities? These are the difficult questions that must be explored when looking at the limits of autonomy. The limits and scope of autonomy is especially important from a regulatory perspective and will be further addressed in Chapter Four.
174 John Stuart Mill On Liberty (Longman, Roberts & Green, London, 1859).
175 Above n 174 at 8-9.
III Life as an unbidden gift
Michael Sandel – an American philosopher – has contested genetic engineering by emphasising a case against life as an unbidden gift.176 To live a full life undeterred by things outside our control is one of life’s true meanings. He presents the case of naturally gifted athletes contrasted with those who have reached success through training and hard work. The belief that success is only ever earned through merit and effort rather than natural inheritance clouds the view that life is full of beautiful and natural gifts.177 Mastery over humankind is a fruitless mission – the one proposed by genetic engineering. He calls parenthood itself a “school for humility” that allows parents to recognise their limitations and learn to love their children unconditionally.178 Parents who seek to control or influence their children’s future through genetic engineering are seen as “hyper-parents” that share no “openness to the unbidden”.179 Such actions could also result in the burden of responsibility for the failings of your children if their choices made at birth turned out to be incorrect.180 Sandel’s argument will likely resonate with those of religious faith who believe in a higher power: being open to the unbidden is consistent with faith in a higher power’s plan.
IV Injustice, Inequality, and Discrimination
Another highly persuasive ethical perspective is that genetic engineering will create widespread injustice, inequality, and discrimination.181 Injustice refers to unfairness in society. It can lead to inequality which is imbalance or the uneven state of being. Unfairness in access to genetic engineering technology – issues that arise with all technology – could lead to “two-tiers” of society and significant inequality amongst genetic traits shared by people. Additionally, this can lead to further unfairness due to discrimination against
176 Michael J Sandel “The case against perfection” (2004) 293(3) The Atlantic Monthly 50 at 70.
177 Above n 176 at 55.
178 Above n 176 at 60.
179 Above n 176 at 56.
180 Above n 176 at 60.
181 Above n Tom Shakespeare “Choices and Rights: eugenics, genetics and disability equality” (1998) 13(5) Disability & Society 665 at 665.
people based on their genetic traits which in turn could be based on social, economic and
physical grounds.
The “genetic arms race” might become too much to overcome and contribute further to intergenerational poverty and inequality.182 The harm caused by genetic engineering could be a gap in access to the technology. Similarly, there might be a pressure to conform in an effort to ‘keep up’ with the decisions that other parents are making. This is an inevitable side effect of genetic engineering.
It is also thought that genetic engineering will increases discrimination against those that do not have ‘desirable traits’ or whom still suffer from a disability.183 There is a real fear that by choosing not to have a child with Down Syndrome (or other genetic disorder) then it is implied that children with Down Syndrome are less valued which might also lead to a lack of community support and advocacy due to less people living with the condition.184 The question is not likely to be a huge problem with the reproductive choice model proposed in this dissertation, as many people would still choose to have children with disabilities through ‘natural’ reproduction. However, it has formed a real concern and is heavily premised in discrimination that occurred on this basis during the eugenics movement. This perspective assumes is that injustice is caused by the technology itself – rather than the current state of society. Society is already inherently unequal – so is the genetic lottery. The question of how this injustice can be addressed will be discussed more in Chapter Four.
V Tikanga and Mātauranga Māori
Another pertinent perspective in Aotearoa New Zealand is that held by Māori. This isparticularly so with the HART Act’s express purpose to “protect and promote the dignity
182 Above n 176 at 68.
183 Above n 148.
184 Above n 148 at 179.
and rights of all individuals,”185 the need to uphold partnership as a Treaty of Waitangi principle,186 and the HART Act principle implores that “the needs, values, and beliefs of Māori should be considered and treated with respect.”187 I am not Māori and do not attempt to speak for Māori, nor to perpetuate that there is one singular view deemed that held by Māori. This perspective is included to provide a starting point for consultation and research to incorporate and recognise various tikanga and mātauranga Māori views on genetic engineering as those perspectives evolve. DNA, both the physical samples and the data generated from and collected from it hold valuable information about an individual and their whānau ties.188 This link is to both past and future generations making it part of whakapapa information and makes DNA considered taonga.189 The role of reproduction in creating life itself is tapu and needs to be treated with utmost respect.190 This means that genetic engineering is a difficult sphere to navigate. Doing so will require developing and furthering understanding of Mātauranga Māori led perspectives in science.191 Additionally, regulatory discussion naturally implicates Tikanga Māori and the place that Māori systems of governance have in regulating reproduction.192 The reproductive choice model that I have proposed derives from western views of autonomy and might not fit Māori systems of governance. Consultation and partnership must continue in this area to elaborate how Māori views in particular – as required by the HART Act – can be implemented under the reproductive choice model.
185 This would naturally include Māori. HART Act s 3.
186 See Waitangi Tribunal The Radio Spectrum Management and Development Final Report (Wai 776,
1999) for discussion of partnership.
188 Hirini Moko Mead Tikanga Māori: Living By Māori Values (Huia Publishers, New Zealand, 2016).
190 Ani Mikaere "Cultural invasion continued: The ongoing colonisation of Tikanga Maori" (2005) 8(2) Yearbook of New Zealand Jurisprudence 134 at 134.
191 M Kovach "Doing Indigenous Research in a Good Way – ethics and reciprocity” in Indigenous methodologies: characteristics, conversations and contexts (University of Toronto Press, Toronto, 2009) at 141.
192 Above n 188.
VI Procreative Beneficence
A contrasting ethical perspective is that championed by Julian Savulescu, an Australian bioethicist, called procreative beneficence.193 The principle creates a positive moral obligation on parents to select the child (who in their view) that will have the best possible life having considered all the relevant and available information.194 Originally referring only to selection of embryos195 – for example to use in PGD – the principle can be extended to allow for a moral obligation to select or choose offspring that will have the best life possible based on information and technology at the time. The principle does not operate singularly but in collaboration with other ethical principles: notably procreative autonomy, non-maleficence, non-directive counselling (whereby clinicians should remain neutral when suggested or providing options), and the best interests of the child principle.196 The principle is not coercive in the same manner as state-imposed submission seen in sterilisation movements of the past, but rather relies on persuasion, with regard to the highly individualised circumstances of those seeking out the technology. The obligation is framed in a way that you should create the child that will have the best possible life in the same way that you should give up smoking – it is something that you have good reason to do.197 When applied to genetic engineering, a couple deciding to undergo IVF would evaluate the results of genetic testing prior to implantation and select or edit an embryo that would go on to live a flourishing life. Determining what makes a flourishing life would be the subjective interpretation of the parents – this is likely to create natural diversity and variety of views that reflect differing opinions on what constitutes the best life. Choices are made on best information available at the time so, as more information about the genetic influence becomes known, choices can change.
193 Julian Savulescu “Procreative Beneficence: Why we should select the best children” (2001) 15 Bioethics
413.
194 Above n 193 at 415.
195 Julian Savulescu “In defence of procreative beneficence” (2007) 33 J Med Ethics 284 at 285.
196 Above n 193 at 418-419.
197 Above n 193 at 415.
VII Summary
These are only a small portion of contrasting ethical views and perspectives around genetic engineering. There are countless others that could contribute and inevitably will lead to more discussion. However, there are convincing ethical reasons both for and against genetic engineering. It is only apposite that reasonable people will passionately disagree about their own perspective. This is the nature of bioethical debate. There is no unitary ethical answer that dictates how one should act when faced with a choice about genetic engineering. The same can be said for the various ways in which people might choose to genetically engineer their child, or even if they would choose to go through with it in the first place. The genetic lottery of life is unfair. People will disagree on what the right thing to do to address the problem is. The question remains about who the law is currently tailored to and who it should be serving given the substantial dissent among ethical perspectives.
CHAPTER FOUR – Tailor Made for You: A Reproductive Autonomy Model
A successful policy model that permits genetic engineering will need to cater for contrasting ethical perspectives as well as address the issues with NZ’ current regulatory framework. Despite NZ’s conservative tendencies, the advancement of genetic engineering is not a policy issue that NZ can afford to maintain its staunchly prohibitive stance. There is a real possibility that reproductive tourism could mean advancements in other countries
regulatory model needs to one that is tailored to the contrasting views held by society. This will ensure that the “tyranny of the majority”,199 one that has been historically oppressive and patriarchal, does not continue to reign over the innately private and personal decision on how to reproduce. This chapter proposes and defends a reproductive choice model that addresses all these aspects and provides a future-proof framework that can change over time as the technology and societal views inevitably will.
I A Reproductive Autonomy Model
I propose a model based on reproductive autonomy. This dissertation has addressed the ambit of the technology, the current regulatory frameworks in NZ and the UK, as well as a myriad of ethical views on genetic engineering. A model grounded in reproductive autonomy would allow for flux in technology, decrease regulatory burden, ensure NZ is ready for changes in genetic engineering availability, and allow freedom of choice for more people.
This reproductive model would uphold the right for prospective parents to make autonomous reproductive decisions based on their own values, beliefs, and needs. The policy model will have limited regulation that mitigates harm to others and is predicated
198 Above n 130 at 114.
199 Above n 174 at 8.
on safety concerns being sufficiently overcome in the future. The more limitations placed on parental choice, the harder it becomes to justify as a legitimate regulatory framework as the entire system is based on respect of capable humans in exercising their own reproductive judgment. When the state begins to intervene about acceptable choices parents can make, or comment on the acceptability of certain traits over others then autonomous foundations of the model will begin to crumble. When parental choices become unjustifiably limited then the mandatory state commentary on ‘acceptable’ traits begins to look more like a eugenics revival in sheep clothing. This model is not perfect and certainly not without controversy. As discussed in Chapter Three there are many people who object to genetic engineering and numerous pre-existing regulatory issues that this model does not address as outlined in Chapter Two. However, it provides a blue-skies, principled-based approach for the law to begin responding to those contrasting ethical perspectives. Those subscribing to a particular view along the spectrum need not engage the technology if that is what they choose. It allows both followers of Sandel, in his acceptance of life’s unbidden gifts, and Savulescu, in his ambition to provide the best life for future children, to exercise their beliefs alongside each other in a liberal democracy.
The remainder of this chapter will provide justification for the autonomy-led model underpinning regulation of genetic engineering in reproductive technology in five key areas: (II) by justifying using reproductive autonomy as the key foundational principle by responding to contrasting perspectives; (III) by emphasising the need to maintain regulatory legitimacy and limit state intervention; (IV) by acknowledging the fallacy of collective consciousness; (V) by reflecting shifting international attitudes to genetic engineering regulation (the Nuffield Council); (VI) by learning from the UK’s regulatory framework.
A Responding to the openness to the unbidden argument
In responding to Sandel’s argument that parents should be open to the unbidden, reproductive autonomy recognises that people will hold different views as to what makes a good life and what is required for human flourishing. Sandel himself would be allowed to practice parenting as a “school of humility” and accept the unbidden gifts of his children.200 Choosing not to have a disabled child does not have to comment on the lives of other children born with disabilities who have their own unique personalities and gifts. Society currently already has prenatal screening for those wishing to undertake it, as well as numerous health advice encouraging pregnant women to take folic acid and other supplements to prevent major birth defects.201 Loving a child and their disability can coexist with also not wishing to inflict that same disability on another child, or at least recognising that other parents ought to be afforded that choice. The reproductive choice model would allow parents to continue exercising their choices in this manner.
B Responding to injustice and inequality
A reproductive autonomy model would not exacerbate issues of injustice and inequality beyond what currently prevails. Injustice and inequality are inherently social issues with social solutions. I concede that under the reproductive autonomy model there will be some parents able to utilise the technology to their own advantage and in a way that might elevate their children above those that do not have access. However, people are already born into considerable intergenerational inequality. A society without genetic engineering, where everyone suffers at the mercy of the genetic lottery, is not one free from discrimination and
200 Above n 176 at 12.
201 Rhodi E Bulloch and others "Plasma folate and its association with folic acid supplementation, socio- demographic and lifestyle factors among New Zealand pregnant women" (2019) 122(8) British Journal of Nutrition 910 at 910.
inequality. Which can arise from wealth, race, religion, education, fundamental resources, and family support. Every day, wealthy people pour money into their children through private education, healthy homes, networking opportunities, and financial freedom – why do we prevent them from doing so in relation to reproduction? Savulescu writes that “reproduction should not become an instrument of social change”.202 Limiting reproductive autonomy because it would be introduced into a society with pre-existing social problems fails to address genetic engineering in itself. The view becomes the forest and not the trees. To make reproduction the issue when societal injustice is responsible and will continue to be so with or without this technology, is to avoid the true issue at hand. The genetic lottery already contributes to inequality, as does other areas of society. Remedying other societal issues rather than limiting reproduction is where better progress on inequality can be made.
C Responding to Mātauranga Māori perspectives
A system based on reproductive choice can allow for those following tikanga to make decisions that align with those values. For Māori, the decision of how to reproduce will almost always implicate wider whānau and it might be that the limits of reproductive autonomy end where they harm others – others might be viewed as wider whānau, hapū, or even iwi. Mātauranga Māori can continue to add to the discourse on genetic engineering as the technology develops to add to the knowledge and inform Māori communities on how to act if they choose to abide by tikanga. Public consultation should take into account and emphasise these views.
D Responding to procreative beneficence
The principle of reproductive autonomy forms the basis for procreative beneficence.203 The reproductive choice model would allow for parents to keep making decisions that should give their children the best life. However, the policy would not go as far as encouraging or criticising parents for choosing not to genetically alter the traits of their children. This allows it to coexist with followers of Sandel as well as the principle of procreative
202 Above n 195 at 6.
beneficence. The model would also allow for those with other perspectives not discussed to act in a way consistent with their views – such as those guided by religion. This is one of the key merits of the reproductive autonomy model and why the principle is so important.
III The Need to Maintain Regulatory Legitimacy
Genetic engineering regulation must be legitimate. Regulatory legitimacy is the concept that regulators must be able to justify that their laws have a legitimate regulatory purpose, are achieved through legitimate means, and are effective.204 Genetic engineering poses significant challenges to this concept because new technology evolves at a rapid pace, prompting regulators to adjust, re-examine, and constantly defend their positions amidst new waves of information.
A State intervention and representation
The issues of regulatory legitimacy and state intervention are linked. This dissertation has already outlined the important and egregious history of state intervention in reproductive decisions as well as limitations on reproductive rights in accessing contraception and abortion. The current starting point is prohibition, and it has been this way since the HART Act was enacted in 2004. At this time, Parliament consisted of just 31 females – around 25 per cent of Parliament.205 Female voices were largely lacking in input to the system – whilst accepting that females can still be represented by male politicians – this is not a good omen for legitimate regulatory decision making. Today’s Parliament consists of 59 females, falling one short of attaining a 50 per cent gender split.206 This further proves the need to revisit the current default position to maintain regulatory legitimacy that represents societal views.
204 Roger Brownsword Rights, Regulation, and the Technological Revolution (Oxford University Press,
2008) at 10.
205 Parliamentary Library, Research and Information Report on the 2002 General Election (NZ Parliament, 27 October 2002).
206 NZ Parliament “Members of Parliament” (Oct 2022) < https://www.parliament.nz/en/mps-and- electorates/members-of-parliament/>.
B The private nature of parenting
The private nature of reproduction and decisions regarding child rearing have traditionally been that of the parents to decide. The right to act autonomously in parenting decisions often goes unchallenged. Parents have almost unfettered rights – at least when their child is still young – about what school to send their child to, what religion to bring them up in, what they will eat, who their friends will be. Later in life they can decide whether to pay for their university education or allow them to live at home. These choices, whilst often heavily criticised, are almost never taken away from a parent. The culmination of these micro-decisions has a massive impact on a child’s life, but it is only retrospectively that one sees the true impact of each decision. How then, can Parliament justify that their regulatory purpose is legitimate? Under the reproductive choice model, Parliament would not get a large say in these matters. Prospective parents would be able to decide based on their own beliefs, values, finances, and upbringing to determine what they think would constitute the best possible life for their child.
C Shifting the onus in favour of autonomy
The onus should be on those trying to prove that interference with parents’ reproductive autonomy is justified rather that the current prohibition. The HART Act itself states that one of its guiding principles is to consider and respect the differing ethical, spiritual, and cultural perspectives in society.207 There is no mention in the Act of the word autonomy. Some would argue that a system favouring reproductive choice would allow immoral behaviour. However, the relationship between morality and the law is complex.208 Regulators face additional challenges to those moral challenges faced by individuals when making decisions – a key one being the need to justify their purpose, means, and effectiveness.209 The reproductive choice model allows people to make their own moral decisions without the law having to step in. There is currently very limited justification for state intervention in this area of parental decision-making. Whilst the regulator might have a well-founded purpose, the means in which that purpose is enacted (a complete ban)
208 See Oliver Wendell Holmes Jr "The Path of the Law" (1897) 1(10) Harvard Law Review 457.
209 Above n 204 at ch 2.
undermines autonomy in an overly paternalistic way that cannot be viewed as legitimate. Therefore, it should be the job of the regulator in maintaining legal legitimacy to justify why they should get to intervene in this way, rather than the other way around.
IV The Fallacy of Collective Consciousness
There is no single view of what is collectively good.210 This is true even if the law and morality could produce congruent outcomes. The current prohibitive approach to advances in genetic engineering fails to satiate the tension between what is good for the individual versus society. Whilst this position is understandable, there is no justification that the status quo is better than what might occur given greater parental choice. It is well-known that careful and considered decisions that are good for individuals can be disastrous for society as a whole.211 The reproductive choice model would not encounter these same problems as parental decisions already make the crucial difference in children’s lives. Parents make decisions all the time that positively reinforce privilege and wealth. Access issues, discrimination and inequality already exist regarding technology and human flourishing. This was evident by the unequal access to ICT during lockdowns, and further prevalent in that the right to be a parent is already limited to those that can afford expensive IVF when ART is there only hope of raising a family.212
Furthermore, even if society were to allow genetic engineering under very specific circumstances, this would lead to divergence in opinion about what traits are worthy of pursuit. The attempts to draw lines in the sand become arbitrary when individual conscience redraws those lines at will. This indecision does not justify universal prohibition on the technology’s use but simply reinforces the high value placed on individual autonomy rather than paternalistic regulation. The task of philosophy is not only to figure out what is right but to encourage others to think for themselves.213 Lots of harm can be done in the world where people rely on others to be their moral watchman. While we cannot all be
210 Above n 174 at 6.
211 See generally the tragedy of the commons.
212 The average cost for one cycle of IVF in NZ is between $11,500 and $17,000: Above n 59.
213 Julian Savulescu "Bioethics: why philosophy is essential for progress" (2015) 41(1) Journal of Medical Ethics 28 at 28.
Descartes, Aristotle, or Kant we can – and should – allow people to think for themselves and make decisions based on those views. Especially in the field of reproductive technology when diversity in opinions and views contributes positively to society as a whole – that can only be part of a common good. Thus, the reproductive choice model tailors the law to all different ethical viewpoints instead of imposing one conservative view on an entire population under the guise of the common good.
V Shifting International Attitudes on Genetic Engineering
The reproductive autonomy model reflects the international shift towards a morepermissive approach to genetic engineering.
A The Nuffield Council on Bioethics
The Nuffield Council released an extensive report in 2018 considering all aspects of regulation of heritable genome editing. 214 The Nuffield Council on Bioethics was founded in 1991 and is an independent charitable body based in the UK.215 It examines and reports on the range of bioethical and medical issues faced by advancements in technology. The Council has significant global influence and will likely instil significant change, especially in the UK.216 This is a sign that NZ needs to update their position to make it consistent with imminent overseas regulation.
B Findings from the report
In short, the extensive 205-page report concluded that it can be ethically justifiable to allow genetic engineering for use in reproduction in qualified circumstances:217
We can, indeed, envisage circumstances in which heritable genome editing interventions should be permitted ... Although our report identifies circumstances in which genome interventions of this sort should not be permitted, we do not believe
214 Nuffield Council on Bioethics (2018) Genome editing and human reproduction: social and reproductive
issues (Nuffield Council on Bioethics, London).
215 Above n 214 at 4.
216 Above n 135.
217 Above n 214 at 154 cl 5.2-5.3.
that there are absolute ethical objections that would rule them out in all circumstances,
for all time.
The report covered a wide variety of viewpoints and discussed the ethical arguments outlined in Chapter Three of this dissertation as well as many other perspectives. It also provided commentary on the specific governance challenges related to reproduction. It made specific recommendations to the UK that will be discussed next. The report discussed the ethical permissibility of genetic engineering with reference to the interests of individuals, others living in society who might be affected, and the human population at large. The interdisciplinary working party contained members with relevant expertise in human reproduction, biology, genome editing, law, and ethics as well as extensive consultation from different societal groups.218 The principal author of the report, Karen Yeung, writes from a legal background making the report more attuned to the specific challenges posed to regulators and the role that they should have in genetic engineering. 219
C Regulatory shift
The report also calls for international dialogue and increased public debate:220
We endorse the desirability of monitoring and dialogue among nations, which recognises and attends to the diversity of voices within each nation and which may be furthered by support for ... the work of international institutions.
The report is highly persuasive as the widespread consultation is on a scale that ACART could not achieve due to their time limitations. It does not propose a model free from regulation as that posed by the reproductive choice model. However, the report is a huge step forward from previous international papers such as those provided by the UN calling for continued moratoriums on heritable genome editing.221 The report’s underlying justifications remain rooted in reproductive autonomy and the need for prohibitive
218 Above n 214 at 12.
219 Above n 214 at 10.
220 Above n 214 at 160 cl 5.22.
221 Above n 4.
regulators to have sufficient justification for their intervention.222 This shift in attitude is reflected in the reproductive autonomy model. The spearheading report paves a way for gene editing technologies to exist, albeit limited, and refuses to follow the same consignment to moratoriums that has plagued the international community and formed the basis of NZ’s current regulatory stance. The WHO has responded with their own report in 2021 echoing the calls of the Nuffield Council.223 This signifies that changes are afoot and suggests that regulators who refuse to engage with discussions about reform risk being unable to justify their completely prohibitive stance.
VI Learning from the UK’s regulatory framework
The UK’s regulatory framework contrasts NZ’s system. Both systems were discussed extensively in Chapter Two. There are some aspects of the UK system that could provide lessons to NZ regulators when implementing the reproductive choice model. I qualify that these remain limited observations worthy of further consideration – the precise question of whether the UK framework might better serve NZ than the current one is not the subject of this dissertation.
Firstly, the HFEA has a considerable level of authority and the independence to exercise it. It has authority to issue licences to ART providers pursuant to the purposes of the underlying HFE Act, rather than in accordance with specific guidelines based around the technique used as ECART must do.224 It also has the authority to penalise practices taking place without licences. It is not subject to the same Ministerial “impasse” that has plagued ACART’s past attempts to issues guidelines.225
Secondly, the UK has the full-time resources dedicated to researching, consulting, updating, and advising on reproductive technology. This capacity is unrivalled in NZ. If more resources or time were allocated to ACART to fulfil their role, then they might be
222 See generally above n 214.
223 World Health Organisation Human genome editing: position paper (WHO, Geneva, 12 July 2021).
224 HFE Act Sch 2 cl 3A(2); HART Act s 29.
225 Above n 109 at 164.
able to achieve their entire workload. NZ suffers from multiple areas of reproductive technology regulation that is outdated. This is not ACART’s fault but is an area that needs to be addressed if NZ is to achieve similar standards of regulation as the UK.
Lastly, it is important to note that the UK’s system is not perfect. The Nuffield Council concluded that an amendment allowing genetic engineering “should be broached in the context of a thoroughgoing review of the appropriateness of the present regulatory approach”.226 Even a system with many benefits and allowing far more ART procedures than NZ’s, such as the UK’s, would likely need significant amendment to accommodate reform for genetic engineering in reproductive technology. This implies that implementing the reproductive choice model in NZ should occur on the background of wider regulatory reform to address some of the issues that I have also outlined with the HART Act.
VII Summary
This chapter has outlined a model that should guide the regulation of genetic engineering in reproductive technology moving forward. This model is founded upon the principle of reproductive autonomy. It provides that parents or prospective parents prima facie get to make decisions in relation to their children. This principle prevails against other ethical principles because it allows for all people to make decisions that align with their own values and perspectives. Ultimately, this chapter argues strongly in favour of a reproductive autonomy model but not infinitely so. Parental autonomy ends where others are harmed. The exact nature of that harm will require further clarification and debate in the future. The model avoids the mistakes of the past regarding unnecessary state intervention an upholds the concept of regulatory legitimacy by shifting the onus onto regulators to justify why they are intervening. It reinforces that there will never be one unified view on right and wrong and that the individual conscience of each person will differ – the model calls each person to think for themselves about how they ought to act. The model fits with the international trend towards a more permissive approach to genetic engineering as evidenced by the Nuffield Council’s recent report. It has hinted that there might be some factors from the
226 Above n 214 at 160 cl 5.22.
UK framework that could be worthy of considering in NZ as part of this wider reform.
These factors justify why the reproductive autonomy model should be implemented in NZ.
CHAPTER FIVE – Implications of a Reproductive Autonomy Model
This chapter discusses some the implications of implementing a reproductive autonomy model. If we were to allow such a model to form the basis of policy reform in NZ what will this mean for society? Additionally, can we trust people to exercise their reproductive autonomy in a way that does result in substantial harm to others or other morally reprehensible behaviour?
I Ethical Pluralism
One of the largest implications of the reproductive choice model is that there will be significant disagreement amongst society as to how one should exercise their autonomy. Mill himself acknowledged this radical consequence of personal liberty by stating that it would lead to ethical pluralism.227 From Mill’s point of view this arises because every moral agent has the right to choose their own values and lifestyle. Thus, there is an open possibility of dialogue and disagreement between people of different traditions, cultures, beliefs, and attitudes.228 This in turn can encourage others to review their own position and exercise their own judgment. Traditionally in society bioethics has sought a singular consensus about how one ought to live.229 The reproductive choice model ceases to achieve this but rather accepts that such consensus is fruitless. Abortion, and euthanasia are current examples of this acceptance.
The model determines that no singular point of view or belief should be imposed on the majority where those people reasonably disagree (given that their decision does not affect others). Such a model is likely to have significant ramifications for religious groups and other campaigners of mass social behaviour.230 Their views are not eliminated by the reproductive choice model and followers can continue to live according to their views. The key difference is that groups can no longer expect their point of view to be the one imposed
227 Max Charlesworth “Don't Blame the 'Bio'- Blame the 'Ethics': Varieties of (bio)ethics and the challenge
of pluralism” (2005) 2(1) Journal of Bioethical Inquiry 10 at 15.
228 Above n 174 at 79.
229 Above n 174 p 18.
230 Above n 227 at 16-17.
on others. This approach is consistent with the general trend towards freedom of choice in other areas of bioethics in NZ.
It is important to remember that genetic engineering will be implemented through IVF. As outlined in Chapter One this process is taxing on those involved. At least until ART becomes more accessible, the sheer number of people utilising the technology is likely to be minimal.231 Essentially, we do not have to like other people’s choices to accept that they have the right to make them. Learning to exist in such a society might pose a challenge for many people but there is no reason that it cannot occur given the current value pluralism we live with. Each person utilising genetic engineering cannot be ‘tried in the court of public opinion’ but must look internally and exercise their own individual conscience – as all others will also have the right to do.
II Further Questions
First, how is society going to deal with the probability that some parents could create very specific children? Specificities, such as extreme athleticism, that do not necessarily harm the child but could impact them in other ways. Additionally, how is society going to deal with the fact that, at least initially, there are going to be access issues with the new technology? The problem with this question is that there is an almost infinite number of ways that parents could do this. The exact likelihood and impact of these choices are not yet fully realised and likely will not be until such choices are allowed to be made.
231 See the prohibitive cost of IVF. Above n 212.
Second, the model leaves open the right for parents to create children who might be deaf or have other disabilities if it is accepted that these cause no harm to the child. This is where further clarification of harm is required.
Third, will there come a time when choosing not to have a child that is genetically engineered for certain traits harms them? Will not conferring genetic disease resistance on your child be the new choice not to get your child vaccinated? Will this create a positive obligation on parents to choose in a particular way?
The starting point for answering these questions should be with the principle of reproductive autonomy and the associated harm principle. I have taken a wide, optimistic, and trusting view of the reasonable choices that individuals will make given the autonomy to do so. This has formed the basis of the answer to the question about what the law should be. However, even the most liberal philosophers would allow that harm to others is a reasonable basis for constraining individual liberty.232 If it can be shown that a particular intervention is likely to be harmful to a child or to others – such as those instances I have posed here - then interference would be possible, but it must start with the underlying principles of the reproductive autonomy model.
III Legal Reform
Implementation of the reproductive choice model will involve a few fundamental steps, couched here in general terms. Noting that these steps would take place once acceptable safety concerns around gene editing technology have been overcome.
232 As above n 174.
with regards to genetic engineering – as implicated by the sliding scale defined in Chapter One.
IV Summary
This chapter has outlined the implications of the reproductive choice model. It has conceded that this model is not without its limitations and there will surely be significant disagreement in values and views in society just as there currently is. It has acknowledged that this model will lead to further questions but that these can – and should – be developed overtime. Lastly, it has proposed some next steps for legal reform required to implement the reproductive autonomy model. It has acknowledged that this might lead to a wider
review of the HART Act itself. This will ensure that regulation of reproduction in New
Zealand remains relevant, legitimate, and tailor made for the society it serves.
Conclusion
“Every man's island, Jean Louise, every man's watchman, is his conscience. There is no
such thing as a collective conscious.” – Go Set A Watchman, Harper Lee.
"For thus hath the Lord said unto me, go set a watchman, let him declare what he seeth.” Isaiah 21:6.
Reproductive autonomy empowers people make choices that fit with their own values, beliefs, and morals. This dissertation aimed to question what the role of the law should be in regulating genetic engineering for use in reproductive technology. In doing so it has proposed and justified a model based on the principle of reproductive autonomy. This model is aspirational and idealistic. It is set in the future when safety concerns about gene- editing technology can be overcome.
This dissertation has grounded its discussion in a realistic appreciation of the complexity of genetic concepts and reproductive technology. It has defined genetic engineering on a sliding scale to encompass selection, therapy, and enhancement. It has outlined the current scope of NZ’s regulatory framework and compared this to the UK’s framework. It has explored a selection of ethical perspectives held on the topic of genetic engineering at the embryo level. It has argued for a model founded in reproductive autonomy and choice, albeit limited to prevent harm to others. It has examined the implications of such a model on society.
This dissertation does not present a view on what traits are worthy of enhancement. It merely challenges the validity of state intervention in reproductive choices. The law should be tailor made for the society in which we live. Our lives are a summation of millions of choices made each day – the important thing is that we are the ones that get to make them.
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