Monash IVF CEO Michael Knaap has resigned^[1] after one of the company’s Melbourne clinics mistakenly transferred the wrong embryo^[2] to a patient. The patient wanted her partner’s embryo, but instead her own embryo was transferred.

It is the second time this year Monash IVF has made such an announcement. In April, the company revealed a clinic in Brisbane had mixed up^[3] two different couples’ embryos.

IVF is big business in Australia. When Monash IVF was listed on the stock exchange in 2014, it raised more than A$300 million^[4], with financial analysts noting the potential for massive profits, as “people will pay almost anything to have a baby”.

Total annual revenue in Australia from the IVF industry is more than $800 million^[5]. But what does the booming IVF industry mean for patients?

Strong regulation is crucial

In Australia, regulation of the IVF industry largely happens at the state and territory level^[6]. This leads to variation, such as restrictions on single women accessing IVF in Western Australia^[7], which other states do not have.

Victoria passed legislation^[8] in 2008, with a guiding principle to safeguard children born through assisted reproduction. However, until recently, Queensland largely relied on industry self-regulation^[9].

The Fertility Society of Australia and New Zealand, the peak body for reproductive medicine, has called for a national regulatory framework^[10] to address the current “patchwork^[11]” of legislation.

Commercialisation is not necessarily a bad thing for patients. It can lead to innovation^[12] that improves the chances of successfully having a baby.

However, clinicians^[13], ethicists^[14] and patients^[15] have raised concerns about the effects of commercialisation on the quality and cost of service provision in IVF.

With the rapid growth of the sector and high-profile incidents such as those at Monash IVF, stronger and more comprehensive regulation at the national level can help ensure quality and safety for patients.

High costs can lead to inequities in access

Most IVF in Australia occurs in private practice^[16], not the public system. While Medicare rebates are available, there is usually a significant out-of-pocket^[17] expense. This can range from a few hundred dollars to many thousands for each cycle. IVF can therefore be a big financial decision. Financial expense is one of the biggest barriers^[18], which leads to inequities in access between those who can afford it and those who can’t.

The costs stack up even more if you want non-essential “add-ons”, such as pre-implantation genetic testing, acupuncture, or embryo time-lapse imaging. A study in 2021 found 82% of women using IVF in Australia^[19] had used an add-on during their IVF treatment.

Many IVF clinics^[20] offer these add-ons, which are promoted as improving patient experience, or the chance of a successful birth. Add-ons are offered as a point of difference on the market^[21].

However, the evidence for these claims is often weak or non-existent. They also come with significant costs and can potentially take advantage of people’s hopes, if they are willing to pay “whatever it takes” to have a baby.

Read more: IVF add-ons: why you should be cautious of these expensive procedures if you're trying to conceive^[22]

Patients or customers?

Commercial providers in the IVF industry can help provide choice, particularly as it is difficult to get IVF in the public system.

However, when health care becomes a business, a risk is that the relationship between the patient and doctor can be affected: a patient seeking treatment becomes^[23] a “customer” buying a product.

The therapeutic relationship should be about^[24] enhancing patients’ health and wellbeing, relieving suffering, and promoting human flourishing.

When we talk about “choice^[25]” in medicine, we often think about ideas such as informed consent, autonomy and the best interests of the patient. However, if we think of patients as customers, “choice” may become more about being free to purchase what you want to.

The commercialisation of the sector can also increase the risk of over-servicing^[26], where financial incentives may shape medical decision-making.

This doesn’t necessarily mean clinics are making deliberate decisions or misleading patients for financial benefit. However, it can mean doing more IVF cycles^[27], even as success becomes increasingly unlikely.

We need to ensure doctors don’t feel pressure – directly or indirectly – to provide particular treatments just because a patient is willing to pay for it.

Medical professionals’ obligations

Doctors and other healthcare professionals have special responsibilities and moral obligations^[28] because of their role. They serve an essential human need in society because of their particular expertise in health and wellbeing. And they often have a monopoly on the essential services they offer.

Without patients’ trust^[29] that clinicians are being guided by medical reasons instead of financial ones, their special and privileged role to promote human flourishing can be undermined.

This special role is not necessarily incompatible with business. However, it is essential we allow doctors to maintain their focus on patient wellbeing. This is reflected in the doctors’ code of conduct^[30], which notes their “duty to make the care of patients their first concern”.

What happens next?

Much public and media discourse has framed the embryo mix-up primarily as a reputational^[31] and financial^[32] risk to Monash IVF – but it is about patients. It’s not (just) an error of corporate governance, it’s about the special trust that we as a society place in medical practice.

IVF is expensive, and can be tough both emotionally and physically. One of the ways we can ensure trust in IVF services is by moving towards consistent and improved regulation at the national level. This might include more uniform standards and policies around who is eligible for IVF.

IVF industry regulation is on the agenda^[33] for the federal and state health ministers tomorrow. While there is still much to be done, a review of the regulation and processes in this sector could help prevent more embryo mix-ups from happening in the future.

Read more: Why do women get 'reassurance scans' during pregnancy? And how can you spot a dodgy provider?^[34]

References

1. ^{^} has resigned (www.abc.net.au)
2. ^{^} mistakenly transferred the wrong embryo (www.abc.net.au)
3. ^{^} a clinic in Brisbane had mixed up (www.abc.net.au)
4. ^{^} it raised more than A$300 million (www.tandfonline.com)
5. ^{^} more than $800 million (www.ibisworld.com)
6. ^{^} state and territory level (theconversation.com)
7. ^{^} single women accessing IVF in Western Australia (www.abc.net.au)
8. ^{^} passed legislation (www.health.vic.gov.au)
9. ^{^} industry self-regulation (www.abc.net.au)
10. ^{^} called for a national regulatory framework (www.fertilitysociety.com.au)
11. ^{^} patchwork (thenightly.com.au)
12. ^{^} innovation (onlinelibrary.wiley.com)
13. ^{^} clinicians (www.bmj.com)
14. ^{^} ethicists (pubmed.ncbi.nlm.nih.gov)
15. ^{^} patients (www.abc.net.au)
16. ^{^} private practice (bmjopen.bmj.com)
17. ^{^} significant out-of-pocket (obgyn.onlinelibrary.wiley.com)
18. ^{^} one of the biggest barriers (www1.racgp.org.au)
19. ^{^} 82% of women using IVF in Australia (academic.oup.com)
20. ^{^} Many IVF clinics (obgyn.onlinelibrary.wiley.com)
21. ^{^} a point of difference on the market (onlinelibrary.wiley.com)
22. ^{^} IVF add-ons: why you should be cautious of these expensive procedures if you're trying to conceive (theconversation.com)
23. ^{^} becomes (www.sciencedirect.com)
24. ^{^} should be about (onlinelibrary.wiley.com)
25. ^{^} choice (www.tandfonline.com)
26. ^{^} over-servicing (www.bmj.com)
27. ^{^} more IVF cycles (www.tandfonline.com)
28. ^{^} special responsibilities and moral obligations (philpapers.org)
29. ^{^} Without patients’ trust (global.oup.com)
30. ^{^} doctors’ code of conduct (www.medicalboard.gov.au)
31. ^{^} reputational (www.theage.com.au)
32. ^{^} financial (www.afr.com)
33. ^{^} on the agenda (www.abc.net.au)
34. ^{^} Why do women get 'reassurance scans' during pregnancy? And how can you spot a dodgy provider? (theconversation.com)