1. Introduction

Recent legislative reforms to abortion law in New South Wales gave rise to vigorous public and media discourse. As is not uncommon for sensitive and complex topics, the debate saw various issues in healthcare regulation become intertwined, which tended to conflate distinct ethical and regulatory domains. My engagement in the discussion underscored a need for careful delineation of different regulatory regimes across the country.

This post seeks to provide some of those delineations. It first examines the recent NSW abortion reforms before addressing the regulatory frameworks for research involving human embryos, the intricacies of Assisted Reproductive Technology (ART) in Australia and, finally, the guidelines relevant to research involving fetal tissue derived from abortion procedures. The intention is to untangle these regimes and provide a general reference for (my own and others’) future research.

2. Recent Abortion Law Reform in NSW: A Summary

More than a month has now passed since parliamentary votes were cast on the Abortion Law Reform Amendment (Health Care Access) Bill 2025 (NSW). The Bill was assented to on 11 June 2025. This was a Bill to amend the Abortion Law Reform Act 2019 (NSW) (ALR Act). Some months ago, I discussed some aspects of that Bill here. When those votes were cast, they were for a much shorter and somewhat reformulated version of the Bill originally presented. The Bill’s metamorphosis stemmed from an animated debate in both houses of the NSW Parliament. Those changes can be sketched as follows.

• The passed Bill dropped the proposed duty to ensure abortion services are provided within a reasonable distance of residents’ homes and related information is publicly available

The proposed s 4A (discussed here), which would have imposed a duty on the NSW Minister for Health to ensure that abortion services would be provided throughout the State of New South Wales within a reasonable distance of residents’ homes, and to ensure information about access to abortion services was publicly available, was jettisoned. That section would have empowered the Minister to give compulsory (binding) directions to the secretary of the NSW Ministry of Health or a public health organisation (ie, any organisation that was part of the public health system) relating to this duty. Related amendments, such as the commencement provisions, were also dropped.

• The passed Bill dropped the ‘transfer of care’ mandate for conscientious objectors

The proposed changes to s 9(3)(a) of the ALR Act regarding conscientious objection were jettisoned. These change would have required health practitioners to immediately (without delay) tell a person seeking an abortion that they held a conscientious objection to abortion, and required them to transfer the person’s care (ie, transfer their clinical responsibilities to this prospective patient in the public health system) to another registered health practitioner or health service provider who the objector reasonably believed could provide the service and does not hold a conscientious objection. The passed Bill omits this stronger ‘transfer of care’ requirement, reverting to the existing framework. The existing framework is similar, but it only requires a public health practitioner to give information to the person seeking an abortion about how to locate or contact a medical practitioner who, in the objector’s reasonable belief, does not hold a conscientious objection to the performance of an abortion. In essence, health practitioners remain subject to an information provision requirement rather than a transfer requirement.

• The passed Bill dropped the proposed removal of abortion data collection requirements; instead, it enhances those requirements and adds a government reporting requirement

The Bill originally proposed the repeal of s 15 of the ALR Act. That section currently requires medical practitioners who performs abortions to provide certain information to the Secretary of the Ministry of health. The repeal proposal, which would have removed requirements for information provision and collection, was abandoned. In its place, an amendment was proposed through the course of the Bill’s debate that a new s 15A be added to the ALR Act, requiring the Secretary of the NSW Ministry of Health to prepare and table an annual report regarding abortion services, including their availability, accessibility and waiting times, clinical performance, adverse events or clinical incidents, and comparative information about NSW and other states. The requirement on medical practitioners to provide information was also expanded to include other registered health practitioners.

• The passed Bill expands the range of registered health practitioners permitted to perform abortions (as originally proposed)

A proposed amendment that actually was passed provides for the expansion the kinds of registered health practitioners who are entitled to perform abortions for pregnancies not more than 22 weeks. This amendment was passed largely unchanged. The new section 5(4) of the ALR Act will define a ‘prescribed health practitioner’ as a medical practitioner, an endorsed midwife and a nurse practitioner. This will enable each of these registered practitioners to perform abortions. However, the new section 5(5) also provides that nothing in section 5 will: permit any of these health practitioners to act outside their scope of practice; affect their obligations to practise in accordance with their professional standards; or affect the operation of the relevant therapeutic goods legislation (ie, the Poisons Standard). As this provision is virtually the only provision of the original Bill that was passed, it is probably appropriate to comment on its operation.

Abortion by nurse practitioners and endorsed midwives: the guardrails

The guardrails in s 5(5) are perhaps stricter than they first appear. Read in the wider context of health practitioner regulation, they ensure nurse practitioners (NPs) and endorsed midwives (EMs) cannot perform surgical — as opposed to medical or chemical — abortions. This becomes evident when one considers the relevant professional standards and codes applicable to NPs and EMs, including the respective international codes endorsed by the National Board.¹

A key principle in all these standards and codes is that of competence: acting only within one’s knowledge or skills.² Performing surgical abortions are not part of the standard training for NPs, and the relevant NSW public health policy directive does not facilitate surgical abortions by NPs. For comparison, it is helpful to note that recently updated guidelines for non-surgical cosmetic procedures make the administration of cosmetic injectables outside the scope of registered nurses in their first year of their training; those guidelines also make clear that EMs will not be permitted to administer injectables. Of course, surgical procedures are several magnitudes of skill and competence more advanced than injections. Several professional practice frameworks (PPFs) — one developed for enrolled and registered nurses by the Nursing and Midwifery Board of Australia (NMBA); another developed by the Australian College of Nurse Practitioners (ACNP) for nurse practitioners — set out performance standards for those nursing professionals.

For this reason, surgical abortions will remain outside the scope of practice for NPs. Similarly, EMs’ scope of practice is not aligned with surgical abortion skills, and surgery would fall well outside of their scope of practice. Any NP or EM who attempted to perform a surgical abortion would: be subject to immediate action under s 150 of Health Practitioner Regulation National Law (NSW); almost certainly be prosecuted for professional misconduct as defined in s 139E of the National Law; and likely be found guilty and deregistered.

The reference in the new s 5(5)(c) of the ALR Act to the relevant NSW therapeutic goods law is a savings provision. It provides that nothing in s 5 affects the operation of that law, but it adds no new limit of its own. For medical abortion, the relevant product is MS-2-Step, a composite pack of mifepristone and misoprostol. Its product information and its entry in the Australian Register of Therapeutic Goods (ARTG) state that it is indicated for the medical termination of an intrauterine pregnancy of up to 63 days of gestation. That figure is the product’s registered indication. It defines what the sponsor may supply and promote the product for, and it does not set a legal ceiling on a practitioner’s clinical use. (Mifepristone is also registered separately, as a stand-alone 200 mg tablet, for use beyond the first trimester.) The mechanics by which Commonwealth therapeutic goods law, and more specifically the so-called Poisons Standard,³ are incorporated into NSW (and other state and territory) law are somewhat complex, although I have explained those operations in other writing.⁴

In essence, the Poisons and Therapeutic Goods Act 1966 (NSW) (NSW Poisons Act) adopts the Poisons Standard, the Commonwealth instrument that classifies substances into schedules according to their risk of harm. As mifepristone and misoprostol are listed in Schedule 4 (prescription only) of that Standard, and as the Standard is adopted by s 8(7) of the NSW Poisons Act, these drugs may be prescribed and supplied only by authorised practitioners. That scheduling controls who may prescribe the drugs. It does not convert the registered indication into a condition on clinical use. Nor do the TGA’s conditions of registration bind prescribers. The offence for breaching such a condition applies to the person in relation to whom the goods are registered, that is, the sponsor (see, eg, Therapeutic Goods Act 1989 (Cth) s 21A(5)(a)). MS-2-Step’s own history illustrates the point. Until the TGA removed them with effect from 1 August 2023, its conditions of registration required prescribers to be certified and dispensing pharmacists to be registered. Those obligations fell on the sponsor, MS Health, which met them by running a certification program for prescribers and pharmacists. Prescribing MS-2-Step beyond 63 days is therefore off-label use rather than unlawful use. The TGA’s position is that off-label prescribing is a matter of clinical judgment that the Therapeutic Goods Act does not regulate, although one analysis argues that the Act’s text may technically reach it.⁵ For NPs and EMs, the practical limits after 63 days lie in scope of practice, professional standards and NSW Health policy, which s 5(5)(a) and (b) preserve.

It may be worth briefly describing what MS-2-Step is. This medicine is made up of a Mifepristone Linepharma 200 mg tablet and a GyMiso misoprostol 200 microgram tablet. The two tablets are administered in combination, and taken within 24–48 hours of each other. Mifepristone is a synthetic steroid with antiprogestogenic activity. In other words, it is a progesterone receptor antagonist, meaning that it binds to the progesterone receptor but does not activate it, but instead prevents progesterone from binding to the receptor and exerting its effects.

Progesterone is essential for establishing and maintaining pregnancy, because it prepares the uterine lining for the implantation of the embryo, keeps the uterus quiescent (ie, preventing contractions) and maintains cervical closure (essential for retaining the pregnancy within the uterus and protecting against fetal infection). When the effects of progesterone are inhibited, this contributes to the termination of the pregnancy, specifically by causing the breakdown of the uterine lining (decidua),which leads to detachment of the pregnancy, and increasing uterine sensitivity to prostaglandins, which induces contractions.

Beyond medical abortion, another reason therapeutic goods law would generally prohibit NPs and EMs from independently performing surgical abortions relates to a common need for general anaesthesia. As noted by health services like The Royal Women’s Hospital, many surgical abortions are performed under general anaesthesia or IV sedation (known as twilight sleep).⁶ The complex drugs involved in anesthesia, including Schedule 8 opioids and other potent anaesthetics, and the advanced skills required for general anaesthesia administration, are firmly within the domain of specialist anaesthetists (doctors) or GP anaesthetists.

Generally, neither NPs nor EMs have undergone the training or have received the medication authorities to administer general anaesthesia (even in team settings). Similarly, procedural sedation is regulated by comprehensive standards.⁷ While some NPs may achieve competency in administering IV sedation for certain procedures, independently managing the anaesthetic component of a surgical abortion will exceed their established scope of practice.

For the above reasons, neither NPs nor EMs could lawfully perform surgical abortions under the soon-to-be amended ALR Act. However, it is perhaps notable that the Act does not itself classify which different types of abortion procedures (eg, medical or surgical) different registered practitioners are able to perform at which gestational periods. Instead, the ALR Act sets a general 22-week limit for abortions performed by ‘prescribed health practitioners’ under section 5, and then imposes stricter requirements for abortions performed after that general limit under section 6 (those abortion procedures being confined to specialist medical practitioners).

The public debate

The potential impacts of the Bill drew considerable public attention and precipitated some public disquiet. A media request from the Australian Associated Press’s AAP FactCheck organisation marked my foray into the debate. I was asked to respond to certain claims being made about the Bill’s provisions. That engagement — combined with my academic publication history — would lead to several interesting questions, as I will detail below.

By the time I was contacted by AAP FactCheck in March, several claims had been made about the Bill. It had been said that proposed section 4A would herald the imminent or potential ‘shut down’ of faith-based public hospitals in NSW. Whether that claim was correct was one of the questions I was tasked with fact-checking. As is often my practice with media commentary, I reproduced the questions I was asked and my answers — sent by email — in full, here. But I did also expand on these answers in a later phone call with AAP FactCheck. The result of those inputs was the publication of this article, which contains several quotations from me about the proposed reforms.

Soon after the Fact Check article was published, a video on YouTube appeared. It responded to the AAP FactCheck piece and advanced several criticisms of the piece. It also offered some curious commentary about my perspective and the perspectives of two other academics in health law and policy. Perhaps the less said about that the better. But the video did bring to light some issues with my analysis.

Firstly, I had said that the Minister would have little more power than to write a ‘letter’ to public hospitals, including faith-based hospitals. That proposition was said to downplay the power the Minister would have, making it seem ‘innocuous.’ It was said that I had dismissed out of hand the potential for those directions to directly or indirectly lead to the shut-down of faith-based public hospitals in NSW.

Secondly, it was said that, as I had engaged in research about embryonic stem cells (and their regulation), I was not objective — not well placed to discuss the regulation of abortion, presumably because both were considered unethical or because there was a connection between the two.⁸ As is often the case in research, criticisms from all corners can inspire new thinking and new ideas.

Directions, letters, orders: Putting Ministerial powers in perspective

I will first explore what I called the Minister’s power to write a ‘letter’ in reference to the ministerial directions. To reiterate, the Bill originally proposed (in a new section 4A) that the Health Minister would be subject to a duty to ‘give directions’ to public health organisations in certain circumstances. To be clear, my description of the Minister’s power to ‘write a letter’ was a reference to the Minister’s power to issue this statutory direction. I was not referring to any additional form of communication that the Minister might send before issuing the direction (as appears to have been understood by the video’s creator). The other point to note is that I did call the proposed section ‘weak.’ Although this was also criticised, there are good reasons, I think, to stick by that claim.

Orders and directions compared

This first order was made by the Health Minister under s 126G(1) of the Health Services Act 1997 (NSW) (HS Act) in 2008. Relevantly, s 126G(1) of the HS Act provides as follows:

126G Directions by Minister in relation to acquisition of services

(1) The Minister may, by order in writing, from time to time —

(a) require a public health organisation to acquire specified services from the Health Secretary or some other specified person if and when such services are required, and

(b) give a public health organisation any necessary directions for the purposes.

As can be seen in this example of an order made under this section, the relevant order is titled ‘Order pursuant to s126G of the Health Services Act 1997’ and then, under the word ‘Order,’ the document states as follows:

I, John Della Bosca, Minister for Health, in pursuance of section 126G( 1) of the Health
Services Act 1997, by order require each public health organisation to acquire all health
support services (including those specified below) from the Health Administration
Corporation …

Clearly, the purpose of this instrument is to ‘order’ public health organisations in NSW (ie, public hospitals) to acquire certain support services. Although s 126G’s heading refers to these as ‘directions,’ the instrument appears in the Gazette as an ‘order,’ a form enabled by the statutory phrase ‘by order

The second example is an order made under s 62B of the HS Act. That section permits the Minister for Health to recognise certain organisations as ‘affiliated health organisations’ for the purpose of the PS Act (ie, to being them within the public health system). The specific provision authorising the making of these orders states as follows:

62B Recognition of networked affiliated health organisations

(1) The Minister may, by order published in the Gazette, declare that one or more affiliated health organisations are to be treated as a network for the purposes of the National Health Reform Agreement in respect of some or all of their recognised establishments or recognised services.

(2) Such an order may be made—

(a) on the application of one or more affiliated health organisations, or

(b) on the Minister’s own initiative. …

The language of this provision is similar to s 126G(1) in that it speaks of the minister declaring a matter ‘by order.’ However, the section is also stricter than s 126G(1) because it expressly requires that the order be published in the Gazette.

A third example comes from an order served on an individual by a delegate of the New South Wales Secretary of Health under s 175(1) of the Poisons And Therapeutic Goods Regulation 2008 (NSW). That section provides as follows:

75 Secretary may restrict authorisations conferred by this Regulation

(1) The Secretary may, by order in writing served on any person, prohibit or restrict the person from doing anything authorised by this Regulation.

(2) Such an order may be made on any one or more of the following grounds–

(a) the person requests or agrees in writing to the making of the order

(…)

Interestingly, this example, which is gazetted as an ‘order,’ reports that a direction has been served as follows:

… a direction has been issued that the Order that took effect on and from 24 September 2018, on Dr [Withheld], prohibiting him as a medical practitioner, from supplying, having possession of or issuing a prescription for a drug of addiction as authorised by clauses 101 and 77 of the Regulation, shall cease to operate on and from 26 June 2023.

While this example combines an order (which is gazetted) and a direction (that the order has taken effect), its form suggests a distinction between these instruments, with an order being a public record of the decision appearing in the Gazette and the direction being a private communication served on the individual personally, in the form of what could be described as a letter. Granted, the terms of the enabling legislation here differ from those under the proposed s 4A of the Abortion Law Reform Amendment (Health Care Access) Bill 2025 (NSW).

A final example comes from a direction given to the Board of Sydney Water Corporation under section 20P of the State Owned Corporations Act 1989 (NSW). That section provides for written directions to be given as follows:

20P Power of portfolio Minister to give directions in public interest

(1) The portfolio Minister with the approval of the Treasurer may give the board of a statutory SOC a written direction in relation to the SOC and its subsidiaries if the portfolio Minister is satisfied that, because of exceptional circumstances, it is necessary to give the direction in the public interest.

(2) The board must ensure that the direction is carried out in relation to the SOC and must, as far as practicable, ensure that the direction is complied with in relation to its subsidiaries.

(3) Before giving a direction under this section, the portfolio Minister must–

(a) consult with the board, and

(…)

In the relevant document gazetted in the NSW Parliament, the Acting Minister for Water recorded that the direction had been given as follows:

Direction to the Board of Sydney Water Corporation under section 20P

Notice of reasons for giving the direction and why it is in the public interest

In my view it was necessary, on 21-12-2023, to give a direction to Sydney Water Corporation under section 20P of the State Owned Corporations Act 1989, requiring Sydney Water Corporation to cap the reasonable security it requires from a developer under section 74(1)(c) of the Sydney Water Act 1994, relating to the relevant costs for the delivery of stormwater services (…)

On balance, I think it fair to suggest that directions given under the proposed s 4A would or could have taken the form of private communications addressed to the management of the relevant public hospital, and that they may have been recorded as having been issued in the Gazette but possibly not gazetted as ‘directions’ or ‘orders’ themselves. In such a circumstance, the directions may be well described as letters. But certainly more important than this hypothesis is the question of whether the directions could or could not be subject to disallowance in parliament.

This matter recalls the more substantive debate that arose, during COVID-19, in the Kassam v Hazzard appeal¹⁰, as to the status of certain ministerial orders made under section 7 of the Public Health Act 2010 (NSW).¹¹ While the status of the ‘reasonable distance’ directions cannot be determined definitively (with s 4A having not been passed nor tested), it is notable that the direction made under s 20P of the State Owned Corporations Act 1989 (NSW), discussed above, is a disallowable instrument. If we assume that s 4A directions would have been disallowable too, then it bears noting that other members of Parliament would have had an opportunity to object to any directions made under that s 4A by the Minister of Health and to have brought a motion to vote on whether the directions should be allowed or not.

Having considered the form and status the directions might have taken under the proposed s 4A, it is probably time to return to the substance of that provision. As I postulated in my original written response to AAP FactCheck, it was most unlikely that a Ministerial direction issued under s 4A would have required any New South Wales faith-based hospital to ‘provide abortion services’. That was so for at least two reasons.

First, faith-based hospitals in New South Wales are surrounded by other public hospitals that either already provide abortions or could be directed to do so first (or instead) of the faith-based hospitals to ensure access. Second, the proposed Bill imposed a duty on the Minister not to ensure abortion services were provided by all public hospitals but, rather, to ensure that those services were available to residents within a reasonable distance of their homes. The Minister could have crafted directions to discharge this duty (to ensure the availability of abortions with a reasonable distance) in various ways other than requiring faith-based hospitals to provide abortions. For instance, a direction could have been issued to a faith-based hospital to participate in regional planning with other healthcare providers to map out service provision, thus confirming alternative pathways for patients in their catchment area were clearly established.

An additional point worth reiterating is that, under s 4A, the Health Minister would not have had an express power to enforce non-compliance with the directions. While the terms provided that compliance was mandatory, and presumably could be compelled in some way, the directions did not permit any specific penalties. Nor did it indicate that the defunding to faith-based hospitals — or orders to close them — could be initiated, as was suggested during the debate about the Bill. I will deal with why, in my opinion, these decisions could not be lawfully made below.

One reason the drafters of the Bill may not have provided a specific enforcement pathway was because they had recognised that the directions could be issued only to controlled entities within what might amount to the ‘sequelae’ of the executive branch of government: that is, to the Secretary of the NSW Ministry of Health or to a ‘public health organisation.’ In other words, the directions could not be issued to members of the public or to private enterprises. They are only allowed to be issued to regulated entities that serve the NSW government: ie, public hospitals.

In circumstances such as this, directions have been presumed to operate administratively and not through the courts. That is because the separation of powers would generally make courts reluctant to enforce a direction made by a Minister in respect of an agent or servant of government (ie, an executive direction issued to the executive). Of course, the court may still intervene for reasons unrelated to enforcement on judicial review (such as if the direction is ultra vires).

Relevant to this analysis is the classic social security case of Riddell.¹² That case concerned ministerial directions issued by the Minister of State for Social Security to the Secretary of the Department of Social Security. As Riddell illustrated, while courts are generally reluctant to directly compel an official’s adherence to a ministerial direction, they may yet scrutinise the legality and scope of any such directions. If any direction under s 4A was found to unlawfully circumscribe or improperly fetter a statutory entitlement given to the Secretary or a public health organisation, then the validity of those directions could justifiably be challenged and potentially overturned by a court. However, the court would be less likely to enforce mere compliance with such directions for reasons relating to the separation of powers. The courts generally avoid acting as an enforcement mechanism for intra-executive directives.

Superficially, it might be said that the court’s putative reluctance to arbitrate internal disputes within the executive gives credibility to the claim that faith-based hospitals could be ‘shut down’ by the Minister, precisely because courts typically refrain from resolving such ‘internal’ executive disputes and, therefore, ‘internal’ executive action — such as defunding a faith-based hospital — would be needed to resolve a dispute the courts will not resolve. However, to say nothing of the public health demerits of any move to shut-down a public hospital in New South Wales, there are strong arguments to rebut that conclusion.

The issue is that any decision to ‘shut down’, defund or otherwise manage the running of faith-based hospitals through the ALR Act would be likely invalid. That is because various provisions in the HS Act, which is the primary legislative instrument governing the way hospitals are controlled in New South Wales, provide affiliated health organisations (ie, faith-based public hospitals) clear statutory entitlements relevant to the running of and maintenance of their own operations, including very strong consultation and consent safeguards. As I noted in my original response to AAP FactCheck, section 65(2) of the HS Act, for instance, requires the Minister to consult with an affiliated health organisation (ie, a faith-based public hospital) before it determines (or varies) its role, function or activities:

65 Minister may determine role, functions and activities of affiliated health organisations

(1) The Minister may, from time to time, determine the role, functions and activities of any recognised establishment or recognised service of an affiliated health organisation and, for that purpose, give the organisation any necessary directions.

(2) Before making a determination under subsection (1), the Minister is to consult with the affiliated health organisation concerned having regard to the health care philosophy of the organisation.

(…)

Similarly, section 62 of the HS Act, particularly subsection (4), provides that an order cannot be made (and in this case the order must be made by the Governor of NSW, which increases its strictness from a ministerial order) that inserts or alters the name or services of an affiliated health organisation in schedule 3 (which lists such organisations) unless the organisation or its governing body consents to it:

62 Recognition of affiliated health organisations

(1) An organisation or institution whose name is included in column 1 of Schedule 3 is an affiliated health organisation in respect of any of its recognised establishments and recognised services.

(2) The Governor may, by order published on the NSW legislation website:

(a) amend column 1 of Schedule 3 by inserting the name of any organisation or institution (other than a local health district or statutory health corporation) that controls any hospital, health institution, health service or health support service

(…)

(4) An order cannot be made under this section:

(a) inserting or altering the name of an organisation or institution in column 1 of Schedule 3 unless the organisation or institution (or its governing body) consents to it, or

(b) inserting or altering a description of any hospital, health institution, health service or health support service under the control of an organisation or institution in column 2 of Schedule 3 unless the organisation or institution (or its governing body) consents to it.

(…)

Where a directive issued under the proposed s 4A purporting to change the role of a faith-based hospital, or change its status as an affiliated health organisation, it would almost certainly be liable to challenge on the basis that it was an invalid order. Indeed, even if a decision was taken to do something like this in another manner — unrelated to abortion legislation — it would subvert and undermine the statutory safeguards and protections given to faith-based hospitals under sections 65 and 62 of the HS Act. After all, these latter provisions are much more comprehensive than s 4A, and they include specific protections for faith-based hospitals as against any ministerial or executive action. In short, the HS Act would ‘speak over’ any direction under proposed s 4A.

But such an analysis is not only consistent with Riddell. It is also consistent with principles that have been developed about indirect inconsistency among state laws. In addition, according to well-established principle, section 4A could not permit the Minister to do indirectly (namely, shut down a faith-based hospital without consultation or consent) what the Minister could not lawfully do directly (eg, under the s 65 of the HS Act). And certainly the Minister could not do indirectly what the Governor cannot lawfully do directly under s 62 of the HS Act.¹³

At the end of the day, the above analysis is academic only. That is because the proposed section 4A was ultimately removed from the Bill. It is impossible to know now what interpretation of the section would have borne out. While there was certainly anxiety about the prospect of the provision heralding a fundamental ethical transformation in NSW, that anxiety was misplaced. In this regard, the next section will address how the debate led to the apparent combination (or conflation) of the ethics of abortion law reform and the ethics of the regulation of human embryonic stem cell research.

3. Research Involving Embryos in Australia

As already suggested, the public debate surrounding the Bill was characterised by confusing generalities. I was puzzled by claims that linked abortion law reform and the proposed blanket ban on research involving human embryonic stem cells (hESCs) in the United States.¹⁴ In the broad discussion of bioethics and health regulation, these two issues are sometimes linked. However, the implication that abortion and embryonic stem cells are directly linked — as though there is some clinical connection between them or overlap — is false.

The conflation of hESC research with abortion, particularly the apparent assumption that hESCs are or might be derived from aborted fetuses, could be very misleading, subverting the professional development of sound policy, ethical and legal reform. It is therefore important to examine and clarify the regulatory frameworks. In what follows, I will outline Australia’s stringent regulation of human embryonic stem cell (hESC) research; then, in Part 4, I will outline the distinct legal and ethical oversight of Assisted Reproductive Technology (ART) throughout Australia, from which procedures embryos used for research purposes are sourced (under licence); and later, in Part 5, I will examine the separate regulation applying to research involving fetal tissue obtained from abortion procedures.

Research Involving Human Embryos (and hESCs)

When human cloning (and human embryo cloning) became a real scientific prospect in the late 1990s, Australia took serious measures to develop a robust national legislative framework to prohibit certain uses of human embryos for research (such as embryo cloning) and to permit other uses on approval and under strict licensing conditions.

In 1998, the Australian Health Ethics Committee (AHEC) recommended that the Commonwealth adopt a uniform federal ban on human cloning but also that a regime be established to license limited research involving human embryos. The Committee acknowledged the ethical difficulties raised by embryo research. It likewise acknowledged the potential clinical benefits of such work. It ultimately recommended that research could be conducted on ‘pre-existing surplus assisted reproductive technology embryos’ as this would ‘ensure that Australia remains at the forefront of research which may lead to medical breakthroughs in the treatment of disease.’¹⁵ These recommendations followed reforms at the state level that had already prohibited human and embryo cloning.

The AHEC’s recommendations were reiterated in a 2001 federal parliamentary report known as the Andrews Report.¹⁶ And soon after the Andrews Report was proffered, legislation to implement the recommendations was tabled. However, when a proposed Bill for regulating embryo research was debated in the Commonwealth Parliament, it became apparent that, though there was unanimous support for prohibiting human cloning, divergent views were strongly held on the use of surplus ART embryos for research. As one member of Parliament noted,

There has been considerable debate in both houses of parliament on the complex ethical, moral and scientific questions raised by this legislation. Members of this chamber have so far spent approximately 38 hours debating both the Prohibition of Human Cloning Bill and the Research Involving Embryos Bill 2002. Twenty-four hours were spent on the original bill by the Community Affairs Legislation Committee, and the members of the Senate chamber spent 46 hours debating the two bills. The length and detail of the debate on the bills and the controversial and emotive issues raised reflect the importance of this debate.¹⁷

In recognition of the distinct issues raised by embryo research, the Bill was therefore divided into two. The first Bill concerned only the prohibition on embryo cloning, and was swiftly passed, while the other concerned the more controversial matter of embryo research. The research Bill was debated for an exceptionally long period in both Houses of Parliament. In the end, however, amended versions of both Bills passed through Parliament and were entered into force in 2003, establishing a national system of regulation.

Since that time, research involving hESCs has only been permitted where it uses so-called surplus ART embryos that would otherwise be disposed of and with the specific and clear consent of all parties.¹⁸ No such embryos are permitted to be used for research purposes beyond a period of 14 days — at which the point the primitive streak emerges. It is worth briefly exploring the background to the 14-day rules and describing what the ‘primitive streak’ is.

The 14-day rule

The primitive streak is a temporary structure that initiates gastrulation. Gastrulation is an important process in which cells detach from the epiblast and move towards the primitive streak structure so as to differentiate into the three germ layers of the developing embryo: the endoderm, mesoderm and ectoderm. Cells that have differentiated into these different germ layers will go on to migrate into specialised tissues, after which their developmental potential (potency) is restricted. These cells will become multipotent, which means they can differentiate into several cell types within a particular lineage: eg, blood stem cells in the mesoderm layer; or they may become unipotent, which means they can form only one cell type: eg, epidermal stem cells in the ectoderm layer. In short, cells within these germ layers maintain their differentiated lineage and do not revert to a more primitive state. They cannot (in vivo) ‘cross’ germ layer boundaries.

The primitive streak thus represents a point at which pluripotent cells (those cells that can differentiate into any other cell type across any of the germ layers) cease to exist, with all embryonic cells beginning to commit to specific lineages at that time. Gastrulation thus marks a period of complex development. But the primitive streak is also significant for other reasons. It is commonly understood as being closely associated with individuation and individuality because it is considered the point at which an embryo can no longer split in two so as to form identical twins.

An exchange during a senate committee hearing illustrates several important points about the adoption of the 14-day rule. It is also an interesting back-and-forth between two religious adherents: on one side, the Catholic Labor Senator Brian Harradine (‘BH’) and, on the other, Professor John William White AO CMG FAA FRS. White was the spokesperson on human cloning and stem cell research for the Australian Academy of Science, but he was also a founding member of the organisation known as the Institute for the Study of Christianity in an Age of Science and Technology in 1987, for which organisation he served as President from 1992 to 2006 (‘JW’):

BH: I will go to the vital issue of the legislation which says: ‘A person commits an offence if the person intentionally develops a human embryo outside the body of a woman for a period of more than 14 days, excluding any period when development is suspended.’ What is so special about 14 days?

JW: The matter was very much considered 20 years ago in connection with the—

BH: The Warnock thing, yes.

JW: Yes, the Warnock matter, but also I believe in this parliament and in other places, in discussion of this whole business of assisted fertility. All of that should be wired on to the discussion, as I think it was fairly thoroughly discussed at that time. What is more, I do not see that very much has changed except that there has been a considerable increase in knowledge about early embryology. In a very quick answer, in deference to the chair and to the senators, I will just say that much, although I could of course carry through with a discussion of it. I am familiar with the question because you asked it on 29 August and I have read the transcript from 29 August. I am aware of your concern about that matter and indeed the idea that it might be arbitrary—the idea of the primitive streak and so on. In some sense, that is true, but nevertheless a date has been fixed and a pragmatic arrangement for the treatment of early embryos has been arrived at both in law and in practice.

BH: So it is pragmatic and nothing to do with science?

JW: It is a point in science where a discernible, bilateral symmetry is apparent in the early embryo in the cluster of cells—the first sign of a nervous system and of right-handedness and left-handedness. That particular point was chosen by Warnock for that reason.

BH: Yes, but in respect of the development process, that was there at the beginning, wasn’t it? What is it 14 days from?

JW: Fourteen days from fertilisation in the fallopian tubes.

BH: Is it not a fact that at the time of conception our unique genetic endowment organises and guides the expression of our particular nature, its species and individual character? That happens from the time of the zygote.

JW: I do not wish to make a big digression, because I am sure that you want time.

BH: It is a very important question and a very important issue.

JW: It is a very good question and one which I think deserves reflection from the scientific point of view. It also deserves reflection from a moral, ethical and religious point of view.

BH: I am talking about the scientific.

JW: Speaking only from a scientific point of view, one of the things I have been most struck by was talking to Craig Venter, the person who decoded the human genome for the first time. He spoke to me at dinner about the so-called junk DNA. One of the most striking things scientifically that came from that conversation was this: you say that our unique genetic arrangement is determined by the genes at that time, but it turns out that the junk DNA appears to be some form of pause. While the genes are being read, some pause occurs and something happens—so environment comes into it. I was most struck by the fact. It seems to me a Lamarckian rather than a Darwinian argument about the way in which the gene was expressed. What I am beginning to suggest to you—and I think it is a matter of scientific debate and well worth while pursuing and thinking about—is that the extent of the effect of DNA as it is being expressed in the early embryo is something we do not understand properly.

BH: But the Senate Select Committee on Human Embryo Experimentation, adopted the usage of embryo’ in its 1985-86 report to mean: genetically new human life organised as a distinct entity oriented towards further development … Is that how you would see it?

JW: I think oriented towards further development’ is a key phrase.

BH: So it is a distinct human entity?

JW: Yes, I think I would agree with that.

BH: At the time?

…

JW: I think oriented towards development’ is the important matter.

BH: Yes, but internally oriented?

JW: That was what I was beginning to suggest may not be totally the case. BR: Are you seriously suggesting that, in some way or other, there is not a human entity in existence at that time, a human being existing at that time? JW: I am suggesting that, as you say, a human entity is there, certainly.

BR: So it is in existence, it is human; therefore, it is a human being. Is that right? JW: I am not sure I understand that declension. I said entity’

BH: I am talking about the human embryo, scientifically.

JW: And, scientifically, I think that it is certainly an entity.

BH: And it is a human being at that stage? You started your life as a human embryo —

JW: I hope I did; yes.

BH: … from fertilisation.

JW: I am distinguishing between being’ and ‘entity’ because —

BH: Why? We are talking about existence. Does the entity exist or doesn’t it? If it exists it is a being, unless I am confused about the English language.

JW: I do not think I can easily chop words with you, Senator. There are many overtones to the word being’ that I would build into it, and perhaps you would build different ones in. Therefore, I find it difficult to deconstruct what you mean by it and what I would mean by it. But I am quite happy to agree to entity’.

CHAIR : There are two other senators who want to ask questions. We are now getting over time.¹⁹

Despite the apparent meaningfulness of the fourteen-day mark in embryonic development, the parliamentary debate on the the joint embryo research and cloning Bill involved much criticism of the rule. For instance, one MP said the following:

Once the line is crossed, how will we refuse to allow embryos older than 14 days to be used in scientific research, when that 14-day limit is just an arbitrary limit set by legislators: it has no meaning, because a 14-day-old embryo is exactly the same as a one-day-old embryo and exactly the same as a three-month-old embryo? How long will it be before we are asked to cross the line to move to embryos older than 14 days—to 60 days or however many days? It is a meaningless and arbitrary figure. Once the line is crossed, how will the parliament continue to ban embryos created after 5 April 2002, which is simply an arbitrary figure with no basis in principle? What is the difference between an embryo created before 5 April and after 5 April? Nothing whatsoever, except a meeting of ministers, premiers and a Prime Minister at COAG which set that date as an arbitrary date. How long will it be before the parliament is asked to cross that line and ignore that arbitrary date when it has no basis in principle? The only way to ensure that these and other questions are resolved is to value each human life that is created in Australia and not cross that line.²⁰

However, another important reason for the 14-day rule was linked to the ART process itself. As the NHMRC noted in its evidence before the Senate Community Affairs Committee,

The prohibition on maintaining an embryo in vitro for longer than 14 days is based on scientific evidence, which indicates that beyond 14 days development in vitro, an embryo is unlikely to have the capacity to implant in a woman’s uterus.

In vivo, the second week of embryonic development is marked by continued blastocyst development and implantation. Rapid growth and differentiation of the extra-embryonic tissue leads to development of the placenta. During the second week the cavity within the blastocyst and the inner cell mass, consisting of embryonic stem cells that form the embryo, begin early differentiation. Implantation is necessary to ensure the viability of the embryo and has normally completed by the end of the second week (14 days).

If implantation occurs, this is shortly followed by the next phase embryonic development known as gastrulation. The term gastrulation describes the series of events that leads to the formation of the trilaminar (three layered) embryo and is characterised by the appearance of the primitive streak. Hence, guidelines for clinical practice in the application of ART require that embryos must be implanted, stored or allowed to succumb before the 14th day of their development.²¹

Research on embryos within the first fourteen days after fertilisation can only be approved under licences issued by the NHMRC’s Embryo Research Licensing Committee; and these licences impose strict conditions on the licensee. This framework, established by the Research Involving Human Embryos Act 2002 (Cth) and the Prohibition of Human Cloning for Reproduction Act 2002 (Cth), was designed to enable ethical research sensitive to community values.

4. The Regulation of Assisted Reproductive Technology in Australia

The journey of assisted reproductive technology (ART) into legal acceptance in Australia was not marked by a singular event but unfolded as a progressive series of state and territory legislative reforms. These were complemented by influential national guidelines. In the 1970s, Australia was at the vanguard of in-vitro fertilisation (IVF): the first pregnancy through assisted reproductive technology was achieved in Victoria in 1973; and the birth of Australia’s first so-called IVF baby occurred in Melbourne in 1980.²² These events drove state legislatures to regulate these procedures. Victoria was an international pioneer in enacting the Infertility (Medical Procedures) Act in 1984 (Vic). Proclaimed in 1988, the legislation was among the world’s first comprehensive Acts to govern the use of ART and human embryo research.

State law

Following Victoria’s lead, other Australian states began to enact legislative controls. South Australia enacted the Assisted Reproductive Treatment Act 1988 (SA); Western Australia enacted the Human Reproductive Technology Act 1991 (WA); and, later, New South Wales introduced the Assisted Reproductive Technology Act in 2007 (NSW). It was not until 2024, however, that the Queensland Parliament enacted the Assisted Reproductive Technology Act 2024 (Qld). Indeed, many of this Act’s provisions have still not yet commenced.

Across Australia, ART is regulated by State legislation. For clarity, here are the Acts, from oldest to newest, noting that Victoria has had two previous Acts):

• in South Australia, the Assisted Reproductive Treatment Act 1988 (SA);
• in Western Australia, the Human Reproductive Technology Act 1991 (WA);
• in NSW, the Assisted Reproductive Technology Act 2007 (NSW);
• in Victoria, the Assisted Reproductive Treatment Act 2008 (Vic);
• in the ACT, the Assisted Reproductive Technology Act 2024 (ACT); and,
• in Queensland, the Assisted Reproductive Technology Act 2024 (Qld).

While there are variations between these legislative enactments, each of them gives the regulator considerable powers to control ART providers in their state. Notably, however, the Northern Territory and Tasmania lack any specific legislation and are ‘self-regulated.’ Up until 2024, this was also the case for Queensland and the ACT. This, however, does not mean that there are no safeguards. As will be discussed below, clinics in the Northern Territory and Tasmania will still be required to hold licences and be accredited; and, for them (as for clinics in externally regulated states) any breaches of the NHMRC Guidelines would likely result in the cancelling of their ART licences.

The impetus for these legal frameworks arose from the rapid scientific advancements in reproductive technology and the subsequent ethical questions they raised. The responsibility for regulating ART has predominantly rested with individual states and territories; and this has led to some variations in legislation across the country. For constitutional reasons,²³ medical practices and procedures are almost always regulated state to state, which does lead to a patchwork of different rules (as is the case with abortion procedures).

There are some key points of disuniformity between the Acts. Regulatory enforcement is the responsibility of different agents and different kinds of agent: a chief executive in Queensland; the Minister for Health in South Australia; the Western Australian Reproductive Technology Council in Western Australia; and the Secretary of the Departments of Health in Victoria and New South Wales. (Victoria’s former regulator, the Victorian Assisted reproductive Technology Authority, or VARTA, was wound down in December 2024). There are also different restrictions on the number of families that can be created by different donors. In Queensland, 10 donor-related families can be created in Australia, whereas the ACT law specifies that only 5 donor families can be created in the ACT, while 10 can be created throughout Australia. New South Wales (section 27) specifies that an ART provider cannot provide ART treatment where it would result in the offspring of the donor being born to more than five women. There are other differences too. These relate to consent, specific regulatory mechanisms (eg, WA has a Code of practice while other states do not) and enforcement, among other things.

Recent errors

In recent months, the regulation of ART has been all over the news, with at least two high-profile ‘bungles’ resulting in the implantation of the wrong embryo into treatment recipients.²⁴ The Queensland case involved the wrongful implantation of an embryo (the product of, say, ‘X’ and ‘Y’) into a patient ‘Z’. Although the specific facts of the incident are not clear — and would be subject to the health privacy legislation — the basic outline appears to be as follows. The recipient Z reportedly gave birth to the child, nurtured and cared for that child for reportedly more than 12 months, before returning to the clinic in late 2023 with an intention to transfer her remaining embryos to another clinic. When the transfer or embryos was being arranged, it was reportedly discovered, then, that a ‘full stock’ of Z’s embryos remained in vitrification. It was at that time also realised that Z had been implanted with X and Y’s embryo, and that Z’s child was not genetically related to her.

The matter is now undergoing an independent review, commissioned by the clinic, Monash IVF, by Fiona McLeod SC. Whether the gestational parents of the child, or the genetic parents of the child, would be able to successfully sue for professional negligence may depend on how the damages claim is framed. While the Singapore Court of Appeal has recognised a head of damage called the ‘loss of genetic affinity’ where a gestational parent sued in similar circumstances, Australian courts have not recognised such a head of damage.²⁵ Indeed, following Cattanach v Melchior,²⁶ laws across the country, including in Queensland, were enacted to prevent courts from awarding damages for the costs ordinarily associated with rearing or maintaining a child — including where negligence (eg, failed sterilisation) had caused the birth of that child.²⁷

The second, more recent incident, in Victoria, involves a reportedly same-sex couple, X and Y. The treatment plan required that X be implanted with Y’s embryo; however, X was implanted with her own embryo. The implications of this error are unknown. However, depending on whether the donor of the sperm for X’s embryo was the same person as the donor for Y’s embryo (and whether different arrangements were in place if so), the repercussions could be significant. It could mean that the genetic profile of the child is very different; but it could also change the parental arrangements or agreements. It would potentially make all of the mandatory genetic counselling, required under the Victorian legislation, as well as under the RTAC COP, otiose and of no clinical value (undermining consent both at common law and in statutory terms). For instance, it could be supposed that at least three people have not consented to the specific procedure: X, Y and the donor.

Calls for reform to the state-based framework have been made; and these calls mirror the call for reform that was made in a report published in November 2024 titled Findings, Recommendations and Framework for an Australian 10 Year Fertility Roadmap (the ‘roadmap report’). The roadmap report was authored by former Commonwealth Health Minister and Honorary Professor at the University of Melbourne Greg Hunt and Dr Rachel Swift, General Manager Strategy, Innovation and Ventures at HCF, former Liberal candidate for Boothby (South Australia) and public health expert in communicable diseases (and formerly strategic adviser to the Special Representative of the Secretary General for the UN Mission for Ebola working in Liberia, Guinea and Sierra Leone). The law firm MinterEllison are also attributed as contributors.

The report was published and commissioned by the Fertility Society of Australia and New Zealand (FSANZ), which established the Reproductive Technology Accreditation Committee (RTAC) in 1987. The RTAC’s role is to accredit ART ‘units’ throughout Australia. To be clear, RTAC is the relevant accreditor of ART providers throughout Australia, and their role as the accreditor has been ratified by the legislative frameworks in each state, which incorporates RTAC’s accreditation system into their own regulatory regimes. For example, the state laws of all states with legislation make RTAC accreditation a prerequisite for a licence application to be made and approved in each state.

Similarly, due to the fact the definition of ‘ART Centre’ in the Research Involving Human Embryos Act 2002 (Cth) picks up the role of the RTAC, the RTAC operates as the ‘licensing’ and ‘accreditation’ body at a national level. This is explained pretty well in the RTAC Code of Practice for Assisted Reproductive Technology Units (Updated December 2024) (RTAC COP):

In Australia, the Research Involving Human Embryos Act 2002 defines an accredited ART centre as a ‘person or body accredited to carry out assisted reproductive technology by the Reproductive Technology Accreditation Committee of the Fertility Society of Australia and New Zealand’. Under this Act, a person commits an offence (imprisonment for 5 years), if the person ‘intentionally uses, outside the body of a person, a human embryo that is not an excess ART embryo; and the use is not for a purpose relating to the assisted reproductive technology treatment of a person carried out by an accredited ART centre’. As a result, it is currently an offence in Australian Commonwealth law to use human embryos in any way without RTAC licensing.

In all Australian States and Territories, compliance with the RTAC Code of Practice is mandatory
for Units involved in the treatment of patients using ART.

Despite the fact that RTAC is thus already the national and state accreditation body (and, as it calls itself, the licensing body), the FSANZ roadmap report recommends (recs 1 and 4) a uniform national fertility law and a robust RTAC Code of Practice to establish consistent, high-standard operating procedures for all clinics, including mandating stringent protocols for embryo identification, labelling, witnessing, tracking, and the embryo transfer process itself. The report also recommends an independent and strengthened RTAC (recs 7-10, 13) with enhanced auditing capabilities and enforcement powers (including issuing and varying licenses based on compliance) to ensure clinics adhere to these critical safety protocols designed to prevent mix-ups.

The report also suggests that the new Code of Practice (rec 17) would include clear criteria for patient support (like informed consent detailing procedures) and licensing, meaning clinics failing to implement robust systems to prevent errors could face repercussions. Of course, the detailed RTAC COP is already in place; and RTAC revised it as recently as December 2024. Moreover, legislation in Queensland and the ACT, only enacted last year, arms the state regulators with clear and strict powers of regulation — similar to those recommended in the RTAC roadmap report — such as powers to impose conditions, suspend clinics, and deregister them.

Accordingly, I have questioned whether, for a state like Victoria, where ART has been generally well-regulated since the 1980s, the creation of a national regulator would add anything of value. What would a Victorian version of a uniform law contain that it does not already contain that could prevent or respond to human errors? That said, for Tasmania and the Northern Territory, where there is no jurisdictional legislation regulating ART, a national framework could well improve the conduct of any ART providers in those jurisdictions (and there may be very few at present).

Recently, the federal health minister has said that Australia has essentially eight systems of regulation across the country’ because of the state-based approach. Tasmania and the Northern Territory, however, are unregulated, so these jurisdictions can be counted one. But the Health Minister also noted that there had been disclosure problems:

We know in the last full year there were dozens of breaches of the code of conduct, but I don’t know what as the federal health minister they were. They are not reported, they are not disclosed.

I assume that these undisclosed breaches related to breached of the RTAC COP (discussed below) (not a ‘Code of Conduct’). But the RTAC COP requires, under point 3.22, open disclosure of mistakes:

Australian ART Units must have a policy of open disclosure consistent with the Australian Open
Disclosure Framework from the Australian Commission on Safety and Quality in Health Care [ACSQHC]…

The ACSQHC open disclosure requirements are part of a clinical governance standard requiring certain actions, in this case action 1.11 (Incident management systems and open disclosure) and action 1.12 (open disclosure processes consistent with the open disclosure framework). The open disclosure framework (2014) is a comprehensive how-to guide for open disclosure practice, with flowcharts, definitions, and all that is needed to enable clinics to be aware of and implement open disclosure systems. If the RTAC COP requires ACSQHC-compliant open disclosure systems to be in place, and yet adverse events or incidents — which the Minister might be calling breaches of the RTAC Code of Practice — are going undisclosed, then there may be a problem with the nature of these breaches under the RTAC COP. Maybe the RTAC COP needs to ensure that any breach of the RTAC COP has to be subject to open disclosure — not just adverse events or incidents.

It appears that what the Health Minister calls breaches may instead be simply accreditation compliance fails: for example, an ART unit might not have an up to date consent plan or even an up-to-date open disclosure system. This does not mean that a patient has been involved in a ‘breach’ and that there has been the non-disclosure of an adverse event or error.

Nevertheless, as the National Cabinet Communique confirms, at the Health Ministers Meeting (HMM) in June, 2025,

Health Ministers discussed the safety and transparency of the assisted reproductive technology (ART) and in-vitro fertilisation (IVF) sector, following growing public concern. Ministers have requested Health Chief Executives undertake a rapid review of the regulatory and accreditation environment for the ART and IVF sectors and identify opportunities for improvement and action to be reported back within 3 months, including:

• a. Options for implementation of an independent accreditation body and process;
• b. Consideration of how existing state based regulatory regimes could be strengthened;
  and
• c. Consideration of whether a national regulatory approach would deliver benefit

Although more can and will be said about these recent reform efforts, there is more to the regulatory framework than simply FSANZ and the state laws.

The NHMRC Guidelines

In addition to the state legislation, the NHMRC has been instrumental in developing ethical guidelines for the use of ART in both clinical practice and research; and ART clinics are mandated to adhere to these NHMRC guidelines, regardless of the state law. The Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research 2017 (updated 2023) are founded on principles that emphasise respect for all involved, the paramount importance of the wellbeing of any person born, the minimisation of harm, recognition of biological and social ties, and the necessity of valid consent.²⁸

The guidelines address clinical procedures, including detailed requirements for information provision, counselling, consent, the use and donation of gametes and embryos, surrogacy, sex selection, preimplantation genetic testing, and fertility preservation (see Part B, pp 14–64). Additionally, Part C outlines ethical standards for research involving human gametes and embryos, aligning with national legislation like the RIHE Act and the Prohibition of Human Cloning for Reproduction Act 2002 (Cth) (see Part C, pp 65–78). A dedicated supplementary section (Part D) specifically addresses the ethical introduction and use of mitochondrial donation following the enactment of Maeve’s Law (see Part D, pp 79-94). These guidelines aim to ensure ART activities are conducted transparently, ethically, and in compliance with legal and accreditation standards, while being open to scrutiny and respecting privacy (see pp 11, 19).

RTAC Accreditation and the RTAC Code of Practice

I have already discussed RTAC accreditation. But some further background can be added. In 1987, the Fertility Society of Australia and New Zealand (FSANZ) established RTAC. Its purpose was to implement a national accreditation system for ART units across these jurisdictions and thus to create an important quality assurance framework. RTAC is an independent body of FSANZ, although its independence has sometimes been questioned, presumably because of the way FSANZ is run (ie, it includes professionals affiliated with the IVF industry).

RTAC ensures ART units meet minimum standards through its regularly revised RTAC COP — a mandatory Code that governs a wide range of assisted reproductive technologies (ARTs), including IVF, artificial insemination, and procedures involving donated gametes or embryos. Its stated aim is to continuously improve care quality with a focus on patient and offspring welfare, dignity, privacy, and the rights of children born via ART. Key areas of the Code include ensuring compliance with legal and ethical guidelines (like the NHMRC Guidelines), mandating qualified key personnel, ensuring protocols for robust patient and gamete identification, medication safety, strategies to minimise multiple pregnancies and Ovarian Hyperstimulation Syndrome (OHSS), comprehensive informed consent processes, adverse event management, data reporting, specific requirements for donor and surrogacy arrangements, infection control, and the implementation of quality management systems.

Conformity Assessment Bodies (CABs): The Auditors for RTAC

However, the accreditation process for RTAC accreditation does not involve, seemingly, any RTAC committee member or any FSANZ representative visiting the clinics. Instead, to receive RTAC certification and a licence, a new ART Unit must undergo a primary audit by an independent Certification Body, known as a Conformity Assessment Body, approved by the Joint Accreditation System of Australia and New Zealand (JAS-ANZ). The scheme in which a JAS-ANZ-approved CAB accredits an ART unit is called the RTAC Scheme. ART units in this scheme become accredited bodies.

All of the Monash IVF clinics in australia, for instance, appear to have been certified by Global-Mark Pty Ltd. As the CAB for Monash IVF, Global-Mark would have audited and then issued Monash IVF a certificate of compliance (or something similar) following an audit of an individual unit, with Monash IVF being its ‘client.’ To confirm the arrangement only requires visiting this JAS-ANZ webpage and searching for ‘Monash IVF’ in the ‘Organisation Name’ field. On the Global-Mark website, in a blog post of April 2020, Donna Close, Global-Mark Client Manager and auditor, wrote the following:

In 2019 the second largest provider of IVF services joined Global-Mark, now we have the three largest IVF providers in Australia as our clients. Global-Mark has issued 83 certificates under the domestic Code of Practice and 8 in New Zealand.

The current RTAC Scheme has been reviewed in 2019 and is awaiting JAZ-ANZ approval, this will be a very important step for the Code of Practice as it will allow Global-Mark to formally issue international certificates under the JAS-ANZ banner.

We have a tight knit team in RTAC, with Dr Adrianne Pope and Donna Close the primary Auditor/Technical Expert’s ably assisted in QMS and NZ8181 aspects of RTAC by Wendy Adams. We have three external Technical Expert’s for file reviews.

Auditing in non-english speaking countries is sometimes a challenge, however the staff in the Vietnamese clinics are so lovely, it makes it an absolute pleasure. They were very patient and accepted our findings with such a humble attitude for improvement. They also love photos at the end of the audit. Adrianne and I feel very fortunate to have these opportunities.

Another blog post makes clear that, during COVID-19 in 2020, all audits were postponed until 2021 and licences were automatically extended for 12 months.

As seen above, the legal and ethical frameworks surrounding ART in Australia have not remained static. However, there is a complex and layered array of regulatory agents involved in controlling the ART sector. Although this is not exhaustive, there is the national legislation (RIHE Act), the state legislation, the RTAC and its COP, and then the JAS-ANZ-accredited CABs, which apply the quality management systems (QMSs). These QMSs include:

• the National Association of Testing Authorities (NATA);
• the ISO (International Standards Organisation 9001:2000 quality management systems) requirements;
• and the ACSQHC framework (specifically the NSQHS Standards)

An ART clinic that adheres to the NSQHS Standards is supposed to have robust systems for patient identification (to prevent mix-ups of sperm, eggs, or embryos), clinical governance (clear lines of responsibility and accountability), medication safety, and infection prevention and control. When errors occur, then whether the auditors (CABs) that certified the NSQHS Standards were met, and reported to RTAC that they had been met for accreditation purposes, might be looked at.

In this context, it appears that the legislation of the states is more about responding to than preventing errors. And the states’ legislation has undergone periodic reviews. Victoria’s 1984 Act was succeeded by the Infertility Treatment Act 1995 (Vic) and later the Assisted Reproductive Treatment Act 2008 (Vic). These revisions addressed complex issues such as donor conception, surrogacy arrangements, access to information for individuals conceived via donation, and preimplantation genetic diagnosis.

At the same time, other legal instruments have been updated to account for these changes. Section 60H of the Family Law Act 1975 (Cth), for instance, was inserted in 2008 and became operative in 2009.²⁹ The section provides that: where a woman is married to or in a de facto relationship with another person; where both people consent to an ART procedure (‘artificial conception procedure’); and where and any other person providing genetic material also consents, then a child born of such an ART procedure is legally presumed to be a child of both the woman and the other intended parent.³⁰

In essence, the legalisation of ART in Australia was an evolutionary process that began in the early 1980s. It was propelled by pioneering medical achievements and shaped by a combination of state-driven legislative efforts, with Victoria taking a leading international role, and the establishment of national ethical guidelines and accreditation systems.

The conflation of surplus IVF embryos for research purposes and abortion services

Given the symbiotic relationship between ART and research involving human embryos, it is important to note that the YouTube video mentioned earlier appears to conflate the proposed reforms about abortion services addressed at the start of this post with the use of IVF embryos for clinical research. This is a very misleading conflation. No clinical research involving human embryos derived from an abortion procedure would be permitted under the Research Involving Human Embryos Act 2002 (Cth). By definition, human embryonic stem cells (hESCs) are derived from the inner cell mass of a blastocyst, which is a very early-stage embryo (typically 5-7 days after fertilisation).

In Australia, and generally worldwide where such research is permitted, these embryos are usually ‘surplus’ embryos created through Assisted Reproductive Technology (ART) procedures that are no longer needed for reproductive purposes and are donated for research with explicit consent (as required by the Research Involving Human Embryos Act 2002 (Cth). Tissues deriving from abortion procedures, or fetal tissue, comes from a fetus at a later stage of human development (typically from 8-9 weeks post-fertilisation onwards). Therefore, hESCs are not and cannot be derived from aborted fetal tissue.

Confusion as to the difference between hESCs and fetal tissue may arise for various reasons. Firstly, in the past, some hESC lines were cultured on what were called ‘feeder layers’ of other cells to help them grow and remain undifferentiated. While these feeder layers were often mouse embryonic fibroblasts, sometimes human fetal fibroblasts (which could have been derived from aborted fetal tissue at some point historically) were used. However, this does not mean that fetal tissue is the source of the hESCs themselves, and modern hESC culture predominantly uses feeder-free methods.

Secondly, it is conceivable that in some research projects, scientists might use both hESCs (derived from ART embryos) and fetal cells/tissues (derived from abortions) for comparative studies or to investigate interactions between different cell types during development. In such cases, fetal tissue would be used alongside or in conjunction with hESCs, but not as the source material for deriving the hESCs. However, this does not mean that research involving hESCs requires the use of fetal tissue derived from abortion procedures.

Thirdly, it is scientifically possible to take differentiated cells, including those from fetal tissue (whether from miscarriage or abortion), and reprogram them to become iPSCs. These iPSCs have properties similar to hESCs. However, these reprogrammed cells would be iPSCs — not hESCs. Research on iPSCs derived from fetal tissue would fall under the guidelines for fetal tissue research rather than the specific legislative framework for hESCs. Accordingly, it should be clear that research involving aborted fetal tissue is a distinct area of research from hESC research, though both involve ethical considerations related to early human life. I address the latter below.

5. Research involving Fetal Tissue from Abortion Procedures

The legislative scheme established to regulate human embryo research in Australia does not permit or facilitate research involving fetal tissue obtained from abortion procedures. However, the use of fetal tissue from abortion procedures for clinical research is not explicitly prohibited in the state human tissues legislation either.

Currently (June 2025) there is a review of Australian tissue legislation being conducted by the Australian Law Reform Commission (ALRC). Its terms of reference ask the ALRC to consider what reforms are necessary to harmonise and modernise human tissue laws. Nothing in the materials thus far produced by the ALRC indicate that fetal tissue will be considered in this review. Indeed, in the Issues Paper, published in May 2025, the ALRC confirmed it was

unlikely to focus on … [the] safety of cells, organs, and tissue (regulated by the Therapeutic Goods Administration); … human cloning and embryonic research; … the regulation of human gametes (sperm and egg cells) and embryos, except as they intersect with the HTAs …³¹

Given that tissues legislation does not specifically speak to abortion-derived fetal tissue, the regulatory instrument most relevant to any research involving pregnant women, the human fetus ex utero, and human fetal tissue following an abortion, is the NHMRC’s National Statement on Ethical Conduct in Human Research 2023 (updated with minor revisions in 2025) (‘the National Statement’). This is distinct from the NHMRC guidelines, discussed above, specifically regulating ART. Indeed, the National Statement is the research ethics ‘source of truth’ for all human research in Australia. Human Research Ethics Committees (HRECs) use this document to assess and approve (or reject) any proposed research program in Australian universities, as well as in the private research sector.

Unfortunately, non-compliance with the National Statement is not very easily enforced. Withdrawal of funding is one of the most obvious methods of penalising ethical breaches; however, if an ethical breach amounts to a privacy breach, then the matter could be subject to findings being made and fines being imposed by the Office of the Australian Information Commissioner (OAIC) under the Privacy Act 1988 (Cth). Similarly, if there is misuse of therapeutic goods, then relevant provisions under the Therapeutic Goods Act (Cth) could be used by the Secretary of the Department of Health (Commonwealth) to prosecute or take civil regulatory action, as appropriate, under that Act.

Chapter 4.1 of the National Statement defines the ‘fetus’ as the ‘developing human from fertilisation to delivery, regardless of whether it is alive or dead at delivery.’ It also defines ‘fetal tissue’ as materials including the membranes, placenta, and umbilical cord that contain the fetal genome and are considered part of the fetus before separation from the mother.

As indicated earlier, the National Statement’s guidelines do not apply to research on gametes or embryos derived from ART. The separate guidelines and legislation specified above apply to that research. However, all proposed research involving fetal tissue will be subject to mandatory review and approval by a Human Research Ethics Committee (HREC), except if it meets criteria for exemption. For research involving the pregnant woman and the fetus in utero, the Statement confirms that the paramount principle is that the wellbeing and care of both the woman and her fetus. These matters take precedence over any research considerations (see 4.1.1). If the pregnant participant is a young person, then the specific guidelines on children and young people in chapter 4.2 must be followed.

The National Statement contains a wide range of obligations relating to researchers using fetal tissue. To begin with, conducting non-therapeutic research that involves administering drugs or carrying out procedures on the woman or fetus, where there is a risk to the fetus, is ethically unacceptable (4.1.10). However, where research does not pose this risk, then a range of conditions are imposed on researchers. For instance, researchers must consider and discuss with the woman the risks and benefits to both herself and the fetus, including potential fetal stress and implications for the child who may be born (4.1.3). They must also discuss the possibility of providing access to counselling should be part of this discussion (4.1.4). The National Statement also requires researchers to ask the woman if she wishes to involve other individuals in her decisions about research participation (4.1.5).

Except for what is called therapeutic innovative therapy, the processes for providing research information and obtaining consent must be kept separate from clinical care (4.1.6). Research on the fetus in utero may be ethically acceptable if it promotes the life and health of the fetus, such as by providing information about fetal health (4.1.7). However, such research must be: designed to minimise fetal pain or distress; include monitoring for these signs; and allow for suspension or cessation if necessary (4.1.8). Any innovative therapy involving the fetus should be considered under ‘innovations in clinical practice’ (see 4.1.9, referring to 3.1.38).

Regarding research on the human fetus or fetal tissue after separation, the National Statement makes clear that a clear separation between the woman’s clinical care and the research activities must be maintained (4.1.11). If a treating health professional is also involved in the research, any conflict of interest must be managed according to item 5.4.3 of the National Statement (4.1.11). Importantly, in cases of intended pregnancy termination, the topic of contributing fetal tissue to research must not be raised until after the decision to terminate has been made, and consent processes must be distinctly separate from clinical care. For example, the researcher who seeks consent must not be the treating health professional unless specifically justified (4.1.11). Researchers must also demonstrate that no suitable alternatives exist for achieving the research aims without using the separated human fetus or fetal tissue (4.1.12). Moreover, there should be no trade in human fetal tissue (4.1.13). Those who conscientiously object to participating in such research should not be compelled to participate or disadvantaged because they have not participated (4.1.14). Moreover, the National Statement facilitates shared decision-making in requiring that the woman should be asked if she wishes to involve others in decisions concerning research on her separated fetus or its tissue (4.1.15).

The National Statement sets down many guidelines related specifically to abortion decision-making. If a fetus or fetal tissue becomes available due to termination, the process of approaching the woman, informing her, and seeking consent for research must be separate and distinct from her decision to terminate, and must not begin until that decision is made. It should also not compromise her freedom to change her decision about termination (4.1.16). Arrangements should be made for the woman to access counselling and support (4.1.17). The research design, including the timing and content of seeking consent, should not compromise the woman’s decisions about the timing and method of termination (4.1.18). The woman’s wishes and her physical, psychological, and emotional welfare should also inform both the decision to approach her about research and the manner in which information is provided and consent sought (4.1.19a, 4.1.19b).

In addition to standard disclosure requirements (2.2.2, 2.2.6), the woman must be informed that she should consider seeking consent from others (4.1.20a, referring to 4.1.5, 4.1.15), whether fetal tissues might be stored for later research (4.1.20b), her freedom to withdraw consent at any time (4.1.20c), any potential for commercial application of research outcomes, including cell line development (4.1.20d), that she will not be entitled to profit from commercial applications (4.1.20e), and whether fetal organs or derived stem cell lines will be exported (4.1.20f). A fetus delivered alive is considered a child and must receive appropriate care (4.1.21). Organs and tissues may be removed from a fetus delivered dead for research only if the conditions of separating care from research (4.1.11) and lack of alternatives (4.1.12) are met, and the woman (and any others she involves, see 4.1.15) has consented to removal and research (4.1.22a), the fetus is available through natural processes or lawful means (4.1.22b), and death has been determined by a registered medical practitioner uninvolved in the research (4.1.22c). The woman’s consent (and that of others she identifies) is also required if fetal cells are to be derived, stored, propagated, or used in human transplantation (4.1.23).

As already suggested, various State Acts regulating human tissue and anatomy across Australia explicitly exclude ‘fetal tissue’ from their definitions or do not expressly regulate it. This creates what has been identified as ‘lacunae’ (gaps) in the legal framework, meaning that the laws, regulating other forms of human tissue and anatomy donations do not apply to fetal tissue.³²

In the absence of a clear legal purpose relevant to — or prohibition of — fetal tissue in state law, the ethical considerations surrounding the use of fetal tissue, as expressed in the National Statement, become paramount. As already indicated, all research involving human biopecimens must be approved by a HREC, and any HREC convened to determine the ethics of a research proposal will apply the National Statement diligently.

In a 2024 study of fetal tissue research in Australia³³, the authors emphasised that informed consent is the central ethical concern, particularly for any future collections. That study surveyed Australian education-focused stakeholders and found that a clear majority (61.6%) expressed a perceived value in establishing new human fetal and embryological collections for research and education, provided those collections were obtained with proper informed consent of donors.

The authors also noted, however, that it was ‘unclear whether obstetricians can still donate fetal remains to anatomical institutions’ and that National Statement is ambiguous regarding who should provide consent for research involving fetal or embryo tissue. My hypothesis would be that any such donation would require the relevant HREC involved in the proposed research use to interpret and apply the National Statement’s principles to the proposed collection and the range of uses proposed.

The authors published a similar study in the same journal in 2025 relating to human fetal collections in medical archives, and advocated for clearer legislative inclusion of fetal tissue; they said there is a ‘clear need for guidelines and recommendations concerning the use of human fetal and embryological collections.’³⁴

Historical and International Regulation Fetal Tissue Research

The use of tissue derived from aborted human fetuses for clinical and biomedical research has a history dating back to the mid-twentieth century. Early scientific investigations in the 1930s and 1950s explored viral cultivation, including the development of the poliovirus, using fetal tissues. However, reflecting the fact that this research predated the Nuremberg Code and other major instruments relating to consent, including records of consent, the specific origin and viability details of the fetus from which these tissues were derived were not consistently or clearly recorded.³⁵ Several significant cell lines, which remain foundational in research and pharmaceutical production today, were established from fetuses that were consensually and electively aborted during the 1960s and 1970s. These include:

• the WI-38 cell line, derived from fetal lung tissue;³⁶
• the MRC-5 line, also derived from fetal lung tissue;³⁷
• the HEK293 human embryonic kidney cell line;³⁸ and
• the PER.C6 fetal retinal cell line.³⁹

These historical cell lines have been crucial for the development of vaccines against diseases such as rubella, rabies, and hepatitis A, as well as for basic biological research. Internationally, these cells have established a scientific infrastructure that, in certain fields, continued to utilise or seek new sources of human fetal tissue after those decades.⁴⁰

Internationally, the regulation of human fetal tissue research is inconsistent. The United States has a complex and extensively debated regulatory history. Regulatory considerations there began to emerge in the 1970s. ⁴¹ A significant development was the 1988 moratorium on federal funding for HFT transplantation research imposed during the Reagan administration.⁴² Subsequently, a National Institutes of Health (NIH) panel concluded that the use of such tissue was ethically acceptable under specific guidelines and the NIH Revitalization Act of 1993 lifted this moratorium, establishing federal legal parameters for NIH-funded fetal tissue research.

The NIH Revitalization Act mandated informed consent from women who donated tissue (separate from her consent for the abortion), stipulated the abortion procedure could not be altered solely to obtain the tissue, and made it unlawful to offer or accept ‘valuable consideration’ (payment beyond reasonable associated costs) for human fetal tissue. Despite these regulations, controversy has persisted, notably fueled by undercover videos released in 2015 that purported to show that human fetal tissue was being traded in the Planned Parenthood system. Those videos prompted Congressional investigations; however, the video makers were later charged, as a result of those investigations, for tampering with government records. Since then, further developments have occurred. In 2019, the US Department of Health and Human Services (HHS) announced it would discontinue internal NIH research projects involving fetal tissue derived from elective abortions and instituted an ethics advisory board review for new external grant applications proposing such research.⁴³

In the United Kingdom, the Human Tissue Act 2004 (UK) governs the use, storage, and disposal of human tissue. Unlike Australia, the UK legislation is a national statute.⁴⁴ While it does not detail the use of fetal or embryological donations as extensively as adult tissue, it provides exemptions for material from individuals who died more than 100 years ago or where the donor’s identity is unknown and unlikely to become known.⁴⁵ It also acknowledges that embryos outside the body are subject to separate regulation under the Human Fertilisation & Embryology Act 2008 (UK).⁴⁶ The overarching principle of informed consent remains an axiom within the regime.⁴⁷

As noted earlier, the direct regulation of fetal tissue for research in Australia is characterised by what some scholars term legislative ‘lacunae’ (gaps) when compared to more detailed frameworks in jurisdictions like the US.⁴⁸ Older studies in the area note that fetal tissue has been utilised in Australia for biomedical research from at least 1980, with the Diabetes Transplant Unit at the Prince of Wales Hospital, Sydney, having served as a major distribution centre for fetal tissue to medical researchers, with tissue obtained from therapeutically terminated pregnancies.⁴⁹ However, recent academic study of the uses and regulation of fetal tissue in Australia is notably scarce, with studies of the 1990s being the most detailed.⁵⁰

6. Conclusion

This long post has explored recent legislative amendments to abortion law in New South Wales, contextualising the reforms (and the process of reform) within the broader regulatory landscape governing three related but distinct areas of medical science and practice: research involving human embryos, assisted reproductive technology, and the use of fetal tissue in research. It has sought to clarify some of the key distinctions often overlooked or misunderstood in public and professional discourse, particularly the separation between abortion procedures and the sources of embryos for hESC research, and the different regulatory frameworks applicable to ART-derived embryos versus fetal tissue from abortion procedures.

1. See Nursing and Midwifery Board of Australia, Nurse Practitioner Standards for Practice (effective 1 March 2021) https://www.nursingmidwiferyboard.gov.au/codes-guidelines-statements/professional-standards/nurse-practitioner-standards-of-practice.aspx; Nursing and Midwifery Board of Australia, Midwife Standards for Practice (effective 1 October 2018) https://www.nursingmidwiferyboard.gov.au/Codes-Guidelines-Statements/Professional-standards/Midwife-standards-for-practice.aspx#; Nursing and Midwifery Board of Australia, Code of Conduct (Published 1 March 2018) https://www.nursingmidwiferyboard.gov.au/sitecore/content/Home/Resources/Code-of-conduct.aspx; International Council of Nurses, ICN Code of Ethics for Nurses (Revised 2021) https://www.icn.ch/sites/default/files/2023-06/ICN_Code-of-Ethics_EN_Web.pdf; International Confederation of Midwives, International Code of Ethics for Midwives (Updated 2023) https://internationalmidwives.org/resources/international-code-of-ethics-for-midwives/. ↩︎
2. See, eg, Nursing and Midwifery Board of Australia, Registered Nurse Standards for Practice (Standard, 1 June 2016) Standard 6 https://www.nursingmidwiferyboard.gov.au/codes-guidelines-statements/professional-standards/registered-nurse-standards-for-practice.aspx. ↩︎
3. See Standard for the Uniform Scheduling of Medicines and Poisons. See Therapeutic Goods (Poisons
   Standard—June 2024) Instrument 2024 (Cth); Therapeutic Goods Act 1989 (Cth) 52D(2)(b). ↩︎
4. See C Rudge and C Stewart, ‘Injecting Tighter Regulation: Implications of the TGA’s Clampdown on Cosmetic Injectables Advertising’ (2024) 31(3) Journal of Law and Medicine 464–482. https://pubmed.ncbi.nlm.nih.gov/39789678/. ↩︎
5. Narcyz Ghinea, ‘Aligning Legislation with Clinical Practice: Off-Label Prescribing under the Microscope’ (2024) 221(8) Medical Journal of Australia https://doi.org/10.5694/mja2.52439. ↩︎
6. The Royal Women’s Hospital, ‘Surgical abortion’ (Web Page, 26 October 2023) https://www.thewomens.org.au/health-information/unplanned-pregnancy/abortion/surgical-abortion. ↩︎
7. Agency for Clinical Innovation, Minimum Standards for Safe Procedural Sedation (Report No ACI/D14/2115, Agency for Clinical Innovation, June 2015) https://aci.health.nsw.gov.au/__data/assets/pdf_file/0006/218580/ACI-Minimum-standards-safe-procedural-sedation-project.PDF. ↩︎
8. It is not necessary to repeat the language or personal details of those criticisms here, but they involve describing my ‘interest’ in ‘the dehumanisation of human beings.’ See Joanna Howe, ‘AAP Fact Check Discredits Themselves With Last Minute Hit Piece’ (YouTube, The Dr Jo Show, 20 March 2025) https://youtu.be/Nt81K1ZTEas?si=IFigVI6AfoAnwkHM. ↩︎
9. Incidentally, this kind of analysis recalls discussion during COVID-19 as to whether certain ministerial orders under section 7 of the Public Health Act 2010 (NSW) were ‘statutory rules’ or not. The point arose in argument in Kassam v Hazzard; Henry v Hazzard [2021] NSWSC 1320 but was not grappled with there. However, in the appeal decision, Leeming JA said:
   _{In some respects, the impugned orders have a hybrid character. They are described by the President. They are not ‘statutory rules’ within the meaning of s 21 of the Interpretation Act 1987(NSW). That denies to them the statutory presumption of validity effected by s 45(1) of that statute, but also means that they are not subject to tabling and disallowance under Part 6. It is true that that reduces the scope for scrutiny, but counterbalancing that is the fact that the order must expire of its own force within 90 days; contrast most statutory rules (such as regulations) which are disallowable but will generally expire after five years: Subordinate Legislation Act 1989 (NSW), s 10(2). On the other hand, as a matter of substance, the orders are ‘legislative’ in the sense that they prescribe general norms of conduct, with real sanctions if breached which were applicable to thousands, indeed millions, of people. For what it is worth, they also appear on the NSW legislation website, prominently, on a page titled ‘COVID-related legislation.’}
   See Kassam v Hazzard; Henry v Hazzard [2021] NSWCA 299, [144] (Leeming JA). ↩︎
10. Kassam v Hazzard; Henry v Hazzard [2021] NSWCA 299. ↩︎
11. See note above. ↩︎
12. See Gail Riddell v The Secretary to the Department of Social Security [1993] FCA 261; (1993) 42 FCR 443. ↩︎
13. The High Court of Australia has affirmed the maxim ‘you cannot do indirectly what you are forbidden to do directly’ as an important guide to construing constitutional guarantees and prohibitions, indicating they are concerned with substance, not mere form: see Georgiadis v Australian & Overseas Telecommunications Corporation (1994) 179 CLR 297, 308 (Mason CJ, Deane and Gaudron JJ). While the maxim first applied in a constitutional context, the underlying logic applies forcefully in administrative law when interpreting statutory powers and limitations. For example, in The WorkChoices Case, it was said that ‘The true principle is that ‘it is not permissible to do indirectly what is prohibited directly’ (New South Wales v Commonwealth (2006) 229 CLR 1, 102 (Gleeson CJ, Gummow, Hayne, Heydon and Crennan JJ). Their Honours were in turn quoting (Gleeson CJ in Gleeson CJ in Pacific Coal Pty Ltd v Coal Refineries Pty Ltd (2000) 203 CLR 346 at 358. ↩︎
14. See comments made in Joanna Howe, ‘AAP Fact Check Discredits Themselves With Last Minute Hit Piece’ (YouTube, The Dr Jo Show, 20 March 2025) https://youtu.be/Nt81K1ZTEas?si=IFigVI6AfoAnwkHM. This criticism focused on a tweet I had published in 2024 concerning the ‘Project 2025’ report — a policy roadmap developed by the Heritage Foundation for a future United States administration. My tweet merely highlighted several proposals from the 2025 report relevant to health regulation: see https://x.com/chrisrudge/status/1810145841086365741. Notably, only one tweet (Tweet 3) was included in the criticism and exhibited on screen (and, funnily enough, it was not the tweet related to abortion). While each tweet was accompanied by screenshots, the complete thread (without screenshots) read as follows:
    _{[Tweet 1] A few snapshots from ‘Project 2025′ in my area of research. 1. In the name of deregulation, FDA oversight of lab-developed tests disappears… [Tweet 2] Mifepristone and other abortion drugs are disapproved and withdrawn. [Tweet 3] Research using human embryonic stem cells (hESCs) is prohibited. Yes, there are ethical considerations, but the blanket ban would set back regenerative medicine decades (centuries?).}
    To contextualise this tweet, three points are worth clarifying. First, the tweet was a direct response to proposals within the US-centric Project 2025 report and not a commentary on the current state of Australian law regarding hESCs, nor a prediction for those laws in Australia. Second, the phrasing of the impugned tweet — ‘Research using human embryonic stem cells (hESCs) is prohibited’ — employed a ‘present future’ tense, describing a potential future scenario under Project 2025 as if it were unfolding (eg, ‘Next year, the Olympics are in Paris’). It was not an assertion that hESC research is currently banned in Australia or even that it was in the US. And third, research involving hESCs in Australia is far from unregulated. On the contrary, it is governed by an extremely clear and strict system of regulation, in place since the early 2000s. My expressed concern that such a blanket ban ‘would set back regenerative medicine decades (centuries?)’ stems from a recognition of the significant potential of hESC research to deliver transformative health outcomes. The potential for positive outcomes was central to the rigorous ethical and parliamentary debates leading to its legalisation in Australia — debate, as can be seen above — involving many deeply committed religious parliamentarians and organisation representatives. ↩︎
15. See Stewart Smith, Human Cloning and Stem Cell Research (NSW Parliamentary Library Research Service, Briefing Paper No 9/02, 2002) https://www.parliament.nsw.gov.au/researchpapers/Documents/human-cloning-and-stem-cell-research/09-02.pdf. ↩︎
16. See House of Representatives Standing Committee on Legal and Constitutional Affairs, Human Cloning: Scientific, Ethical and Regulatory Aspects of Human Cloning and Stem Cell Research (Parliament of Australia, 2001) https://www.aph.gov.au/parliamentary_business/committees/house_of_representatives_committees?url=laca/humancloning/report.pdf. ↩︎
17. Commonwealth, Parliamentary Debates, House of Representatives, 11 December 2002, 10116 (Daryl Williams, Attorney-General) https://parlinfo.aph.gov.au/parlInfo/genpdf/chamber/hansardr/2002-12-11/0052/hansard_frag.pdf;fileType=application%2Fpdf. ↩︎
18. Legislation in Australian states regulate these processes in the context of artificial reproduction treatment providers: see, eg, Assisted Reproductive Technology Act 2007 (NSW) ss 20, 29; Assisted Reproductive Treatment Act 2008 (Vic) ss 22, 24, 26; Assisted Reproductive Treatment Act 1988 (SA) s 14; Human Reproductive Technology Act 1991 (WA) ss 3, 25. ↩︎
19. Commonwealth, Parliamentary Debates, Senate, Community Affairs Legislation Committee, 19 September 2002, 179-81 (Senator Brian Harradine and Professor John White) https://parlinfo.aph.gov.au/parlInfo/genpdf/chamber/hansardr/2002-12-11/0052/hansard_frag.pdf;fileType=application%2Fpdf. ↩︎
20. Commonwealth, House of Represntatives, Parliamentary Debates, 20 August 2002, 5264 (Christopher Pyne) https://parlinfo.aph.gov.au/parlInfo/download/chamber/hansardr/2002-08-20/toc_pdf/1873-5.pdf;fileType=application%2Fpdf#search=%22chamber/hansardr/2002-08-20/0081%22 ↩︎
21. See Commonwealth, Senate Standing Committee on Community Affairs, Provisions of the Research Involving Embryos and Prohibition of Human Cloning Bill 2002 (Report, October 2002) [4.43] https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/Completed_inquiries/2002-04/completed_inquiries_2002-04/report/c04. ↩︎
22. See generally Louise Johnson, ‘Regulation of Assisted Reproductive Treatment (ART) in Australia and Current Ethical Issues’ (2014) 140(Suppl 1) Indian Journal of Medical Research S9. ↩︎
23. Namely, that there is no clear and comprehensive power given to the Commonwealth to make laws about health in the Australian Constitution. ↩︎
24. See ‘Australian Woman Implanted by Embryo by Mistake’, News Hour, reported by Paul Henley, BBC World Service, 11 April 2025; ‘Monash IVF CEO Resigns after Second Embryo Bungle’, ABC News Radio, reported by Kate McKenna, ABC, 12 June 2025; ‘Case of IVF Mix-up Sits in Unchartered Legal Territory, Experts Warn’, Nine News, reported by Abbey Geran, Nine Network, 12 April 2025. ↩︎
25. See, eg, See Jordan English and Mohammud Jaamae Hafeez-Baig, ‘ACB v Thomson Medical Pte Ltd: Recovery of Upkeep Costs, Claims for Loss of Autonomy and Loss of Genetic Affinity: Fertile Ground for Development?’ (2018) 41(3) Melbourne University Law Review 1360, 1381. ↩︎
26. (2003) 215 CLR 1. ↩︎
27. See Justice and Other Legislation Amendment Bill 2003 (Qld); Civil Liability Act 2003 (Qld) ss 49A and 49B; Civil Liability Act 2002 (NSW) ss 70 and 71(2). ↩︎
28. NHMRC, National Statement (2023) 15. ↩︎
29. The section was inserted by the Family Law Amendment (De Facto Financial Matters and Other Measures) Act 2008 (Cth). ↩︎
30. However, as provided in s 60H(5) of the Family Law Act 1975 (Cth), the presumption may be rebutted if it is ‘proved, on the balance of probabilities, that the person did not consent’. ↩︎
31. Australian Law Reform Commission, Review of Human Tissue Laws (Issues Paper No 51, May 2025) https://www.alrc.gov.au/wp-content/uploads/2025/05/HT-issues-paper-2025.pdf ↩︎
32. See Joyce El-Haddad and Nalini Pather, ‘Macro and Micro Ethics in Fetal and Embryological Collections: Exploring the Paradigms of Informed Consent Among Australian Education-Focused Stakeholders’ (2024) 17(3) Anatomical Sciences Education 630 https://doi.org/10.1002/ase.2385. ↩︎
33. See El-Haddad and Pather, ‘Macro and Micro’ (2024). ↩︎
34. Joyce El-Haddad and Nalini Pather, ‘Developing an Ethical Framework for Informed Consent Using Human Fetal and Embryological Collections: An Australian Perspective’ (2025) 18(1) Anatomical Sciences Education 192 ↩︎
35. See Tara Sander Lee et al, ‘Human Fetal Tissue from Elective Abortions in Research and Medicine: Science, Ethics, and the Law’ (2020) 35(1-2) Issues in Law and Medicine 3, 7. ↩︎
36. See Kyle Christopher McKenna, ‘Use of Aborted Fetal Tissue in Vaccines and Medical Research Obscures the Value of All Human Life’ (2018) 85(1) The Linacre Quarterly 13, 14; Lee et al, ‘Human Fetal Tissue from Elective Abortions’, 21. ↩︎
37. Lee et al, ‘Human Fetal Tissue from Elective Abortions’, 21. ↩︎
38. McKenna, ‘Use of Aborted Fetal Tissue in Vaccines’, 15; Lee et al, ‘Human Fetal Tissue from Elective Abortions’, 23. ↩︎
39. Lee et al, ‘Human Fetal Tissue from Elective Abortions’, 22. ↩︎
40. Lee et al, ‘Human Fetal Tissue from Elective Abortions’, 21, 26. ↩︎
41. Meredith Wadman, ‘The Truth About Fetal Tissue Research’ (2015) 528 Nature 178, 180. ↩︎
42. See Kassirer and Angell, ‘The Use of Fetal Tissue in Research and Therapy’ (1992) 327(22) New England Journal of Medicine 1591; Lee et al, 7. ↩︎
43. Lee et al, ‘Human Fetal Tissue from Elective Abortions’, 12, 49. ↩︎
44. Human Tissue Act 2004 (UK) s 59. ↩︎
45. Human Tissue Act 2004 (UK) ss 14, 1(9), 7(1). ↩︎
46. Human Tissue Act 2004 (UK) s 14(2ZA). ↩︎
47. See, eg, Human Tissue Act 2004 (UK) ss 5, 27. ↩︎
48. See El-Haddad and Pather, ‘Macro and Micro’ (2024) 631, 633 ↩︎
49. See Bernard E Tuch et al, ‘Use of Human Fetal Tissue for Biomedical Research in Australia, 1994–2002’ (2003) 179(10) Medical Journal of Australia 547, 547. ↩︎
50. See, eg, Gail Morgan, ‘The Regulation of Fetal Tissue Transplantation’ (1991) 14(2) University of New South Wales Law Journal 283 https://www.unswlawjournal.unsw.edu.au/wp-content/uploads/2017/09/14-2-8.pdf; Pascal Kaszmba and Karen Dawson, ‘Can Fetal Tissue Transplantation Be Done Legally?’ (1990) 12(1) Sydney Law Review 362; Anita Stuhmcke, ‘The Legal Regulation of Fetal Tissue Transplantation’ (1996) 4(2) Journal of Law and Medicine 132 https://ssrn.com/abstract=2545139; G L Morgan, ‘Is There a Right to Fetal Tissue Transplantation?’ (1991) 10(1) University of Tasmania Law Review 129 https://www5.austlii.edu.au/au/journals/UTasLawRw/1991/3.pdf. ↩︎