Is there a need for more stringent IVF regulation in Australia?

Aside from the devastating emotional toll and impact it has on the families, the question arises: Is there is a need for tighter regulation of the lucrative IVF industry in Australia?

In its 2024 report, ‘Findings, Recommendations and Framework for an Australian 10 Year Fertility Roadmap’, the Fertility Society of Australia and New Zealand (FSANZ) recorded that in 2021 over 20,000 babies were born in Australia and New Zealand through IVF. It predicted that the number of births, achieved through IVF, will rise exponentially over the next decade.

The Australian and New Zealand Assisted Reproduction Database contains similar statistics. It is estimated that in Australia, one in eighteen children are born from IVF and one in 10 children are born to mothers 35 and older.

Reproductive health as a profitable industry

In Australia, the assisted reproductive technology industry is estimated to generate more than $800 million annually with many of the IVF clinics establishing themselves as household names.

The company at the centre of two recent incidents is one of the largest IVF clinics in Australia. As a publicly listed company, it has a duty to disclose incidents that occur in any of its clinics. Furthermore, its financial position is more transparent than other IVF clinics and providers and its annual reports show just how profitable the industry is.

According to its 2024 annual report, Monash IVF Group Limited (Monash IVF) made up 21.7 per cent of the market in Australia alone. Its total group revenue in 2024 was $255 million, up from $213.6 million in 2023.

There are different ART treatments available, but IVF remains the most well-known method. Despite the various treatment options, the cost of accessing IVF and other ART treatments remains out of reach for many families. In Australia, the average cost of undergoing IVF can range anywhere between $2000 to over $12,000 depending on the clinic and the treatment required.

Following a string of incidents this year, the spotlight has shifted to whether there is a need for a national legislative framework, tighter regulation or oversight of the industry.

In April this year, Monash IVF announced that the embryo of one of its patients was “incorrectly transferred” to another patient which resulted in the birth of a child. The incident occurred at its Brisbane clinic and after conducting a preliminary internal investigation, Monash concluded the incident was the product of “human error.”

In June, Monash announced that a further incident occurred at its Clayton laboratory whereby the patient’s own embryo was transferred to that patient instead of the embryo of the patient’s partner.

Following the incidents, Monash IVF announced that it will adopt interim additional verification processes and safeguards to “ensure patients and clinicians have every confidence in its processes.”

Importance of accreditation

Like most other industries providing professional services, ART providers must be accredited to provide treatment. Dr Christopher Rudge, lecturer at Sydney Law School and deputy director of Sydney Health Law at the University of Sydney, explains “[S]ince around 1987, a committee within the Fertility Society of Australia and New Zealand called the ‘Reproductive Technology Accreditation Committee’ (RTAC) has accredited providers … which has enabled them to be then recognised by state legislatures … as lawful providers,” he says.

Rudge explains that RTAC accredits providers and issues accreditation certificates which acts as a licence. Providers that are issued with licences are entitled to practice ART in Australia. State legislation recognising those accredited providers possess various powers to manage them. RTAC sets standards for ART through its Code of Practice which covers matters from quality management systems to compliance, personnel, information management, and ‘adverse event reporting.’ “So, you’ve got a bunch of ‘soft law’ kind of guidelines that the auditors apply when they’re looking at compliance with the code of practice. Those auditors send that information to RTAC and RTAC uses that to accredit the units,” he says.

Whilst the Code of Practice sets out a roadmap or guidelines for clinics, there is no central body or authority that enforces the code. Dr Rebekah McWhirter, senior lecturer in health and medical law in the College of Law at the Australian National University explains that “FSANZ as the peak professional body takes on that role with RTAC, their committee responsible for the auditing … there is a level of oversight, but it is a self-regulatory system,” she says.

McWhirter explains that when it comes to the process in the labs, there are usually a series of checks in place. For instance, for the identification of samples, there is usually a barcode and at least three points of identification, which is checked by multiple staff members.

Given the stringent guidelines in place, McWhirter does not believe it is the regulatory system that needs to be improved. “If you look at the things that have gone wrong recently, actually the regulatory system is not bad … it says all the right things and they’re doing the right things. …

“Cultural change probably is an important one. … [W]ith the incorrectly implanted embryos for example, that’s human error, right? It’s probably not that the standards were inadequate …,” she says.

While McWhirter does not think regulatory change would have prevented these issues, she believes changes are needed to address some of the inconsistencies that exist. “[A]lthough the NHMRC and the RTAC guidelines both apply across the country, they’re overridden by state legislation and the state legislation is obviously overridden by Commonwealth legislation … Any inconsistencies there get magnified in that way.

“[A]n example of that is, how long you can store embryos for. In some places, it’s like whatever the patient has consented to but then there are limits that are placed on the storage by legislation in some areas but not in other areas … complying with that is obviously more difficult if it’s inconsistent,” she says.

Differences in state legislation and penalties for when things go wrong

Rudge says Victoria has the most comprehensive regime because it has gone through multiple pieces of legislation since the 1980s. “[T]hey’ve built up a lot of legislative precedent and built on their pre-existing law thrice …

“[T]he ACT and Queensland got new law last year, and I reviewed the Queensland law when the first IVF incident happened in Queensland with the wrong embryo implantation and it looks very comprehensive … [although] it’s untested,” he says.

Penalties vary across states and territories, depending on whether  a corporation or individual is involved.

Rudge points to the Assisted Reproductive Treatment Act 2008 (VIC) (the Victorian Act). Penalties of up to 480 penalty units or four years imprisonment or both can apply if the clinic carries out assisted reproductive treatment without being satisfied that the requirements for consent have been satisfied.

The Victorian Act also sets out prohibitions on certain procedures, gender selection and using donated gametes to produce more than ten families. Penalties for breach of each of these sections can attract 240 penalty units or two years imprisonment or both.

In NSW, under the Assisted Reproductive Technology Act 2007 (NSW) (the NSW Act), an ART provider must not provide ART treatment to a woman using a gamete except with the permission or consent of the gamete provider and in a way that’s consistent with the gamete provider’s consent. Section 28 of the NSW Act expressly prohibits the creation of an embryo between ‘close’ family members. The maximum penalty is 1000 penalty units for a corporation or 400 penalty units or imprisonment for two years, or both.

While Victoria will allow the use of donated gametes to create up to ten families, in NSW the maximum number is five.

Although an argument can be made for a federal piece of legislation to address the inconsistencies across the states and territories, McWhirter says people can “underestimate the power of a good set of guidelines.

“I think if they’re well respected, they’re evidence-based and everyone adheres to them, because you can update them and make them relevant, they can be way more useful, because they actually address the issues that labs are facing,” she says.

She acknowledges that reproduction is an immensely personal thing.

“[T]o find out that the baby you’ve been carrying is genetically not yours or not who you thought it was, it’s kind of hard to even articulate what the harm is, but we also recognise that there’s been a fundamental loss of trust … [P]ublic trust in reproductive clinical services is really critical and I think if we lose that, the industry is going to collapse,” says McWhirter.

She points out that while these sorts of errors are rare, the repercussions are immense and it’s hard to remedy or compensate those affected in any way.

“[T]he law doesn’t give us very good tools for handling it when things go wrong …

“We sort of try and use property law … but property law is just so inadequate for something that is … [so] personal … and the same with consumer law. It almost seems like it’s trivalising the problem,” she says.

Rudge agrees there is a human element to these incidents. “[U]ltimately, the aim for all of this is to improve outcomes for people, health outcomes and life planning …,” he says.

While there may be pieces of legislation that can be argued and applied, where the implantation of the incorrect embryo has resulted in a child or a human life, he queries what the ‘damage’ is in that instance.

When it comes to the possible heads of damages, the answer may lie in learning from overseas jurisdictions. Rudge points to the Singapore Court of Appeal’s decision in ACB v Thomson Medical Pte Ltd [2017] 1 SLR 918. In that decision, a couple conceived a baby through IVF however it was not until the child was born that it was discovered that a stranger’s gamete had been used to fertilise the mother’s egg instead of her husband’s. The Court partially recognised the loss of genetic affinity as a head of damage and awarded the birth parents the upbringing costs of the child.

Rudge acknowledges that in Australia, there is no clear civil law remedy for patients where the wrong embryo is implanted. This “simply highlights the importance of the regulation system because there’s no clear avenue for civil litigation,” he says.