Time to end self-regulation of the Australian fertility industry

The Australian fertility industry has been rocked by several recent cases of embryo and sperm mix-ups. With a lack of transparency about what clinics do to prevent such errors recurring, trust and confidence in the industry and how it is regulated have been eroded.

The fertility industry has been self-regulating to date. But, as these cases show, a move to a system of independent accreditation of clinics against national standards is urgently needed.

Errors reported in the media

All three of the major fertility groups that own and operate clinics around the country have been involved in incidents in the past year.

At the Monash IVF group, it was revealed that an embryo belonging to another woman had mistakenly been transferred to a patient at a Brisbane-based clinic, with the patient giving birth to a child that was not genetically related to her or her partner (see BioNews 1285). At a Melbourne-based clinic, a woman's own embryo was transferred to her, instead of an embryo created with her female partner's egg as planned (see BioNews 1293).

Monash IVF group commissioned an independent investigation into the causes of these incidents, and the CEO has resigned. The company's decision to keep the findings from the investigation secret was slammed by our current health minister, the Hon Mark Butler, who stated that 'transparency is the foundation of trust' (see BioNews 1303).

At the Virtus Health group, Australia's largest fertility company, an ABC investigation revealed that a couple had signed a non-disclosure agreement after discovering that sperm from the wrong overseas donor had been used to conceive their child born in 2014 (see BioNews 1305). At the time of the incident, the scientific director of the clinic was also chair of the industry regulatory committee. An internal audit found that almost all the donor sperm provided to patients at this clinic was at high risk of potential mix-ups because there was no evidence that so-called 'double-witnessing' had been practised in the lab before 2020.

At Genea, sensitive patient information was accessed in a cyber attack executed by an international ransomware group (see BioNews 1279). Some of the patients affected are now considering a class action against the company.

These events raise significant questions about the adequacy and appropriateness of the current model of industry self-regulation. In response, state and federal health ministers commissioned a rapid review of the fertility sector in June. This review concluded that 'the current self-regulatory approach lacks the transparency and rigour that governments and the community expect, especially with the emergence of large private equity providers'.

So, how did we get here, and how can trust in the industry be restored?

Current state of Australia's fertility industry

Australia's fertility industry is booming. It was valued at USD 545 million in 2024 and is expected to grow by 3.5 percent per year over the next few years. In 2023, more than 100,000 treatment cycles were performed at Australian clinics, which equates to 18.7 cycles per 1000 women of reproductive age. Some of the most generous taxpayer-funded subsidies in the world for fertility treatments cover a significant proportion of their cost. Even so, 'out-of-pocket' costs for patients remain considerable.

While there are some small independent clinics, the bulk of fertility treatment is delivered by big companies which operate throughout the country, some of which are publicly listed, while others are owned by private equity. Studies on the impact of commercial influences on fertility treatment practice reveal concerns about the potential for conflicts of interest, the lack of industry regulation, and the need for regulatory reform to ensure patient wellbeing.

Fertility treatment regulation in Australia

To operate, clinics must be licensed by the Reproductive Technology Accreditation Committee (RTAC) and adhere to its code of practice. The RTAC is funded by the industry and run by an arm of the industry peak body, the Fertility Society of Australia and New Zealand (FSANZ).

Licensed clinics must also adhere to national ethical guidelines on the use of reproductive technology developed by the National Health and Medical Research Council (NHMRC). Further, six states or territories have legislation to regulate and monitor clinical practice. There are important differences between these state laws, including around access, the types and form of treatment offered, use of donor gametes, surrogacy and requirements to report adverse events and other data to state authorities.

There is no national regulation, and clinics have no reporting obligations to the federal government. Considering the recent reports of serious errors and the outcome of the rapid review into the industry, this may now change as state and federal health ministers have agreed that 'the Australian Commission on Safety and Quality in Health Care (ACSQHC) should provide independent accreditation for fertility services, against updated national standards.' They pledge that 'Work will commence immediately, and the new accreditation requirements will be in place by January 2027.'

There are no details yet on how this will be operationalised, but rather than reinventing the wheel, our governments should look to the UK's Human Fertilisation and Embryology Authority (HFEA) as a model.

Proposal for future-fit governance

We believe that consideration should be given to forming an independent statutory authority to regulate fertility treatment provision in accordance with national standards. The model organisation for this is HFEA. This national regulator would replace the various state regulatory bodies already in existence and bring consistency, transparency and efficiency to the fertility industry in Australia.
There are several significant advantages to having an independent national statutory authority.

First, it is essential for best practice care in Australia that inconsistencies in state legislation be removed. Health law – of which fertility legislation is a part – is constitutionally a state remit in Australia. A national legislative approach, therefore, requires either constitutional change, states referring their legislative power to the Commonwealth, or passing uniform mirroring legislation in all jurisdictions. Instituting a national statutory authority to work with states to bring their legislation into practical and principled alignment with each other would be more efficient and more likely to succeed.

Second, this would enable consistent and independent monitoring and compliance powers, rather than relying on a sub-committee of the industry peak body to enforce regulations upon the industry. Appropriate national requirements for reporting of adverse events such as those above, would enhance transparency.

Third, an independent authority would be able to improve consumer engagement in the fertility industry. It could do so through regularly engaging with relevant stakeholder groups, so their views and experiences are incorporated into industry standards that meet their needs. Increasing awareness of fertility and providing public education through independent information could be a core function. Acting as an independent source for consumer complaints and remediation would enhance accountability and trust.

In the words of health minister Butler, 'Ultimately, this is about restoring trust, accountability, and effective governance in a sector where mistakes carry irreversible consequences.'