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Page, Stephen --- "Two worlds colliding: The science and regulation of assisted reproductive treatment" [2020] PrecedentAULA 8; (2020) 156 Precedent 32

TWO WORLDS COLLIDING

THE SCIENCE AND REGULATION OF ASSISTED REPRODUCTIVE TREATMENT

By Stephen Page

It is estimated that infertility affects one in six couples in Australia,^[1] making it the third most common chronic disease after cancer and heart disease. According to the American Bar Association’s Guide to Assisted Reproduction: Techniques, Legal Issues and Pathways to Success,^[2] assisted reproductive treatment (ART), including IVF, is considered to be one of the top medical advancements in more than six decades, as it enables people to become parents who would otherwise have remained childless.

Since the birth of the first IVF baby, Louise Brown, in 1978, ART has continued to remain at the cutting edge of medicine, science and society. The law has often fallen behind. The response by legislators at times has been highly proscriptive, in a bid to rein in what is perceived to be unethical behaviour. These legislative changes have in turn brought their own challenges.

A BRIEF OVERVIEW OF THE SCIENCE

‘Trophectoderm’ is a word that I first heard some years ago at an IVF clinic’s conference I attended. I had never heard of it before and wondered what it was. I also wondered if it were in the Scrabble dictionary, because I figured that if it were, and in the odd event that I was playing a game of Scrabble, I might win! Sadly, trophectoderm is not in the Scrabble dictionary, but it is very real. It is in essence the skin of a human egg (hence ‘derm’). Once the egg is fertilised, ultimately the trophectoderm becomes the placenta.

I mention trophectoderm because ART seemingly has more jargon than a lawyer can ‘poke a stick at’. Understanding the jargon makes ART easier to understand.

Table 1: Understanding the jargon

The magic of fertilisation

There are different ways to achieve fertilisation in the laboratory. The traditional way is standard IVF where a straw of sperm (up to 200,000 sperm) is placed in a petri dish with one human egg. A human egg is a human’s largest cell. By contrast, a sperm is a human’s smallest cell. Ordinarily, one of the sperm will pierce the trophectoderm of the egg, resulting in fertilisation (which is the cell division).

In cases involving men with a low sperm count (low motility) or in cases involving surrogacy, it is the typical practice of an IVF clinic to use ICSI instead.

ICSI involves holding the unfertilised egg with a glass catheter. The best sperm candidate is then chosen and its tail is chopped off. The head is placed in an even finer glass catheter which has a pointed end. That catheter is then used to pierce the trophectoderm, squirting the individual sperm into the egg. The fine catheter is then pulled out of the egg, resulting in the trophectoderm resealing. Fertilisation then occurs.

In the almost 40,000 cycles that were undertaken in 2017, fertilisation was attempted 67 per cent of the time using ICSI and 33 per cent using IVF.^[3]

REGULATION OF ART IN AUSTRALIA

Australians should be very proud of our IVF clinics, which are among the best in the world. A database is maintained in Australia and New Zealand to collect information, including information about pregnancy and birth rates, from all IVF clinics.^[4] Australia and New Zealand have the lowest twinning rate in the world,^[5] which is an excellent indicator of process quality. The usual practice in Australia is to implant only one embryo.^[6] If one embryo is implanted, there is a risk that the embryo will split, resulting in identical twins being conceived and born. Any pregnancy involving twins is considered by doctors to be a high-risk pregnancy, both for the woman giving birth and for the twins. Twins typically are developmentally delayed, at least in their primary school years, and they also have a higher risk of medical complications when compared to singleton children.

There are both Commonwealth and state and territory laws affecting ART. The rules are incredibly complex and at times seemingly contradictory.

Every IVF clinic in Australia must have a licence from the Reproductive Technology Accreditation Committee of the Fertility Society of Australia (RTAC). This in turn requires compliance with ethical guidelines issued by the National Health and Medical Research Council (NHMRC) (the Guidelines).^[7] Any research concerning embryos requires a licence from the NHMRC. All states and territories (the NT excepted) have passed similar licensing legislation.^[8] The Guidelines are not statutory instruments,^[9] but a clinic’s licence depends on compliance with them.

Licensed clinics:

• must comply with the audit and accreditation requirements of the Fertility Society of Australia through RTAC. RTAC undertakes mandatory auditing of clinics. Clinics typically also need to comply with NATA^[10] and ISO^[11] requirements. Where there is a conflict between the Guidelines and Commonwealth, state or territory legislation, the Guidelines give way.

• are prohibited from certain conduct, or are permitted certain other conduct with a licence under the Prohibition of Human Cloning for Reproduction Act 2002 (Cth) and corresponding state and ACT legislation.^[12] An example of prohibited conduct is the offence of commercial trading in human eggs, human sperm or human embryos under s21, a breach of which has a maximum penalty of 15 years’ imprisonment.

The regulation of the IVF industry varies across Australia. While the ACT, NT, Queensland and

Tasmania rely primarily on the Guidelines, NSW, SA, Victoria and WA each have legislation which regulates part of the process of ART, or in effect contains a code of regulation.

All states and territories have enacted human tissue legislation, dealing with transplant conditions, the use of eggs, sperm and embryos, advertising for donors (which varies), and payments that can be made to donors (which varies, although all payments must be altruistic). Confusingly, the name of the legislation varies from jurisdiction to jurisdiction.^[13]

Egg, sperm and embryo donations are therefore regulated under the Guidelines, the human cloning laws and the relevant human tissue legislation. At times, there is uncertainty about payments to donors. In addition, the RTAC has issued information bulletins to clinics which although not binding, give a clear warning to clinics about expectations, particularly of auditors. Remembering that clinics do not want to lose their most valuable asset – their licence – the tendency of clinics is to act conservatively.

The most regulated IVF industries are in WA and Victoria; they (and Israel) are unique worldwide because they are the only jurisdictions in which intended parents must obtain approval from a state regulator to proceed with their surrogacy journey. Recent reviews of ART in these two states were highly critical of each regulator.

Western Australia

In WA, the regulator is called the Reproductive Technology Council. Its role is to:

• regulate IVF clinics;

• approve surrogacy arrangements; and

• approve import/export of donor gametes.

The 2019 Allen review^[14] recommended that the Reproductive Technology Council be abolished. The numbers are compelling. Since the enactment of the Surrogacy Act 2008 (WA), one child a year has been born through the WA process of surrogacy. Many more (I estimate up to 17 a year) have been born overseas.

Victoria

In Victoria, the regulator is called the Patient Review Panel. The recent Gorton review^[15] into ART/ surrogacy in Victoria did not include a review of the Patient Review Panel in its terms of reference. Nevertheless, there was much anecdotal criticism of the Patient Review Panel for, among other things, causing a waiver of legal professional privilege on any surrogacy application so that before intended parents can obtain approval and therefore become parents, they must provide a copy of their legal advice. The anecdotal reports also indicate that Patient Review Panel members engaged in interrogation of those who appeared before it. It was perceived as providing barriers that were discriminatory towards LGBTI people – who instead access surrogacy overseas.

Victoria probably has a world record for the number of regulators of its IVF industry. These regulators include:

• NHMRC;

• RTAC;

• Victorian Department of Health and Human Services, which takes a very keen interest in ART;

• Victorian Assisted Reproductive Treatment Authority; and

• Patient Review Panel.

Victoria, which is alone in the world on this, requires both police and child protection screening by any intended parent undertaking ART. Victoria is now considering abolishing these checks, which are perceived to be onerous and ineffective.^[16]

Those who undertake egg donation overseas might also be committing offences at home, due to long-arm laws.^[1] Those who advise the donors (for example, doctors), may be charged with aiding a person to commit an offence and be held liable as a principal offender.^[1]

Surrogacy

Surrogacy is largely regulated under state and territory legislation. Currently there is no legislation in the NT governing surrogacy, although there have been moves in this direction.^[1] In broad terms, all surrogacy in Australia must be altruistic (that is, non-commercial).^[1] There are two broad models of surrogacy regulation:

• models based solely on arrangements entered into between the parties (ACT, NSW, Queensland, SA and Tasmania); and

• models which require pre-approval from a state regulatory authority (Victoria and WA).

Most Australian surrogacy involves IVF clinics (although this is not necessary),^[1] and egg or sperm (and occasionally embryo) donation.

Many Australian intended parents undertake surrogacy overseas due to a perceived or actual shortage of surrogates in Australia. Many undertake egg donation overseas for the same reasons.

Australia is almost unique in the world for criminalising overseas commercial surrogacy. Other than the ACT, NSW and Queensland, the only other jurisdiction in the world that makes it a criminal offence to engage in commercial surrogacy overseas is Hong Kong.

Despite these laws and reports of the prevalence of overseas commercial surrogacy, over the last ten years there has been no reported prosecution in Australia under these offence provisions.

In SA and WA, a person undertaking surrogacy overseas might be exposed to criminal liability under the long-arm laws in those jurisdictions.^[1] However, such arrangements will not give rise to criminal offences in the NT, Tasmania and Victoria, although in the NT an offence may be committed in Australia if an overseas egg donation is part of the process of surrogacy. Extreme care must therefore be taken by those contemplating overseas surrogacy or egg donation journeys.

There is a lack of conformity in the regulation of surrogacy by states and territories. Where intended parents and a surrogate live in different states, they may incur substantial costs in order to comply with the laws in both jurisdictions.

Similarly, there is no consistent definition of commercial (that is, prohibited) surrogacy and what is sometimes thought to be commercial surrogacy may not be.^[1]

Table 2: Australian international surrogacy rules and offences^[1]

RIGHT TO DONOR INFORMATION

Since 2004, a child born as a result of a donation of genetic material is, on turning 18, entitled to information from the IVF clinic about the donor. This will involve counselling either facilitated by the clinics themselves, or by counsellors appointed by the NSW or Victorian governments.

Victoria was the first jurisdiction in the world to legislate to remove donor anonymity. The Victorian parliament took the view that a donor-conceived adult has the right to know where they have come from, and that this right supersedes any agreement as to confidentiality between the donor and the IVF clinic. There have been moves to adopt similar legislation elsewhere in Australia, although as yet no other state has done so. It is likely that the legislation will be adopted not only interstate but also overseas.

Nevertheless, Australians still undergo egg donation in places where the legislation requires donor anonymity (for example, Spain).

However, due to the popularity of vast international databases, such as ancestry.com and 23me.com, true anonymity in donation is over. These databases can be used to track down a donor for many donor-conceived adults. For example, Dr Fiona Darroch discovered through use of multiple databases that her deceased father was not her biological father, that she had been conceived using sperm supplied through an IVF clinic, and that the now deceased IVF doctor had been the sperm donor. She also discovered genetic relatives throughout the world, some of whom like her are very keen to know and find their relations.^[1]

Anecdotally, I have heard reports of intended parents who have undergone surrogacy in developing countries and who despite selecting a specific egg donor, were supplied with eggs of a different donor whose information was not adequately recorded, if at all, by the overseas clinic. This means that there will be adults in Australia who will never be able to find out information about parentage.

Anonymity was originally favoured in order to ensure a supply of donors and also because it was feared that some donors may seek to interfere in the life of the recipient family.^[1]

A recent case before a rabbinical court in Israel provides an example of the conflict that is apparent in the process. In this case, the anonymous egg donor was listed as Jewish. The court refused to accept that a boy born from that donor egg was Jewish, because the Jewishness of the donor was unable to be verified.^[1] The Attorney-General, who was joined in the proceedings, refused to disclose the donor’s identity because of the fear that it would deter future donors.

Recent efforts towards donor transparency must be applauded. However, transparency comes at a cost: those who are potential donors are much less likely to want to donate because of the fear that their offspring may track them down. As a result there are severe shortages of sperm and egg donors in Australia, with the inevitable consequences that sperm particularly, and to a lesser extent eggs, are imported into Australia, and Australians are going overseas in large numbers for egg donation. For example, in March 2016, I visited an IVF clinic in South Africa where the medical director advised me that the clinic was treating three to five Australian heterosexual couples every business day using South African egg donors.

POSTHUMOUS USE

There have been a number of cases in Australia over the years where women have sought posthumous use of sperm, either by way of retrieval of sperm from the deceased or by use of stored donor sperm. Retrieval of the sperm typically must occur within 24 hours of death. In the past this has meant an urgent application to the Supreme Court, although it would appear that the better course is to follow the procedures of the local Human Tissue Act, as it is doubtful that the Supreme Court has jurisdiction to hear these matters. For example, in Re Cresswell^[1] it was held that the Queensland Supreme Court did not have the power to make the urgent retrieval order and that the process under the legislation must be followed. Similar approaches have been taken in NSW^[1] and WA.^[1] Although there have been differences of opinion, it would appear that sperm belonging to a deceased when he was a live donor will be owned by him and therefore will form part of his estate,^[1] whereas the sperm retrieved from a deceased is not part of the deceased’s estate, but is in the possession of the doctors who retrieved the sperm and therefore ultimately the principal for whom they acted (typically the widow or de facto partner).^[1]

In several parts of Australia, posthumous use is highly problematic or prohibited, with the result that, following retrieval, the sperm might be exported interstate (typically to Queensland or the ACT) to facilitate treatment.^[1]

In WA for example, retrieval of sperm is lawful, but use of it is not. In GLS v Russell-Weisz,^[1] the Supreme Court determined that Reproductive Technology Council approval was not required for the export interstate of a deceased’s sperm for use by his former de facto partner because approval was required for a donor – but he was not a donor.

Table 3: Barriers to posthumous use

POST-SEPARATION USE

There have now been two reported cases in Australia (both from WA) in which separated couples have disputed the ownership of embryos. In one case,^[1] the parties had consented to the embryos succumbing in the event that they separated. The court ordered that the embryos be allowed to succumb. In the other,^[1] the parties had undertaken surrogacy with donor eggs in Canada. The husband wanted to reproduce again but the wife did not. Under Canadian law, the husband was the only donor and genetic provider, and was therefore allowed to use the embryos.

CAN SPERM BE OWNED?

Yes! If there was ever any doubt about it, the dispute between the two warring IVF doctors in Clark v Macourt^[1] makes this plain. Dr Clark agreed to buy an IVF clinic from Dr Macourt for approximately $400,000, and part of the purchase included the stock of sperm. Dr Clark paid one-third of the purchase price, but then discovered that most of the sperm was non-compliant with statutory requirements. The High Court held that Dr Clark was entitled to claim damages relating to the loss of the bargain from the non-compliant sperm (a Hadley v Baxendale type case). She estimated that her damages were in excess of $1 million.

STRUGGLING TO KEEP UP?

The law has struggled to keep up with this cutting edge of both society and medicine. The High Court has recently stated that a parent under the Family Law Act is someone who would be considered in the wider view of society to be a parent, and this may not be limited to two people.^[1] It is likely that this decision will lead to the widespread use of sperm donor agreements, because intention is now relevant as to who is a parent.

CONCLUSION

Assisted Reproductive Technology is an area that is constantly changing and evolving. The pace of change (scientific, digital disruption and societal) has, if anything, increased. Legislators and courts (and by implication, lawyers) have struggled to keep up. The pace of change is likely to accelerate in the future, not slow down, making the challenges of keeping up even harder.

Stephen Page is a father through surrogacy. He is a legal practitioner director of Page Provan, Brisbane and has been a Queensland Law Society Accredited Family Law Specialist since 1996. He is a Fellow of the International Academy of Family Lawyers and a Fellow of the Academy of Adoption and Assisted Reproduction Attorneys, and an international representative on the ART Committee of the American Bar Association. Stephen lectures in ethics and law in reproductive medicine at UNSW. EMAIL stephen@pageprovan.com.au.

^[1] <https://www.healthdirect.gov.au/infertility>, viewed on 17 December 2019.

^[2] JA Kasky, M Neufeld, Guide to Assisted Reproduction: Techniques, Legal Issues and Pathways to Success, American Bar Association, Chicago, 2006.

^[3] Assisted reproductive technology in Australia and New Zealand 2017, National Perinatal Epidemiology and Statistics Unit, University of New South Wales, 2019, 8.

^[4] ANZARD: Australian and New Zealand Assisted Reproduction Database.

^[5] Assisted reproductive technology in Australia and New Zealand 2017, above note 3.

^[6] Ibid.

^[7] The current version is called Ethical Guidelines on the Use of Assisted Reproductive Technology and Clinical Practice and Research (2017).

^[8] Cth: Prohibition of Human Cloning by Reproduction Act 2002 and Research Involving Human Embryos Act 2002; ACT: Human Cloning and Embryo Research Act 2004; NSW: Human Cloning for Reproduction and Other Prohibited Practices Act 2003; Qld: Research Involving Human Embryos and Prohibition of Human Cloning for Reproduction Act 2003; SA: Prohibition of Human Cloning for Reproduction Act 2003 and Research Involving Human Embryos Act 2003; Tas: Human Cloning for Reproduction and Other Prohibited Practices Act 2003; Vic: Prohibition of Human Cloning for Reproduction Act 2008 and Research Involving Human Embryos Act 2008; WA: Human Reproductive Technology Act 1991; and there is no separate legislation in the NT.

^[9] National Health and Medical Research Act 1992 (Cth), s7.

^[10] National Association of Testing Authorities.

^[11] International Standards Organisation 9001-2000 quality management systems.

^[12] The one clinic in the NT is bound by Commonwealth legislation. In addition, the clinic operates under an agreement with the NT government with doctors registered in SA – who may therefore be subject to SA law concerning their practices while operating in the NT.

^[13] Transplantation and Anatomy Act 1978 (ACT); Human Tissue Act 1983 (NSW); Transplantation and Anatomy Act 1979 (NT); Transplantation and Anatomy Act 1979 (Qld); Transplantation and Anatomy Act 1983 (SA); Human Tissue Act 1985 (Tas); Human Tissue Act 1982 (Vic); Human Tissue and Transplant Act 1982 (WA).

^[14] S Allen, The Review of the Western Australian Human Reproductive Technology Act 1991 and the Surrogacy Act 2008, WA Government, 2019.

^[15] M Gorton, Helping Victorians create families with assisted reproductive treatment: Final Report of the Independent Review of Assisted Reproductive Treatment, Victorian Government, 2019.

^[16] By comparison, through its Surrogacy Act 2019, SA now requires police checks to be undertaken of any intended parent undertaking surrogacy in SA.