Reports of several cases of embryo^[1] and sperm^[2] mix-ups have put the Australian fertility industry in the spotlight for all the wrong reasons.

These bungles have raised serious questions about the industry’s current model of self-regulation, and demonstrate a lack of transparency about how it handles complaints and misconduct. In response, the federal government commissioned a rapid review^[3] of the sector in June.

Last Friday, the report^[4] was quietly released. State, territory and federal health ministers had already committed^[5] to accepting all the review’s recommendations earlier in September. But we’ve only just learned the details of those recommendations.

So, what are they? And will they work? Here are the main takeaways.

What did the review look at?

The fertility industry is highly lucrative^[6], profit driven, fast growing and increasingly complex. So one of the review’s main questions was whether self-regulation is fit-for-purpose.

Currently, Australian fertility clinics must be accredited and licensed by the Reproductive Technology Accreditation Committee^[7] and adhere to its code of practice. But this body is funded by the industry and run by an arm of the industry peak body, the Fertility Society of Australia and New Zealand^[8].

The rapid review focused on accreditation and regulation in particular. It looked at:

• how an independent accreditation body and process could work
• how to strengthen existing state-based regulation.

Independent accreditation

The review recommends the existing Australian Commission on Safety and Quality in Health^[9] should be responsible for accrediting fertility clinics. This commission already oversees accreditation of hospitals and other health services.

The review also identified the need for clear, evidence-based standards for clinics and their staff, and a more effective auditing process to pick up when these are breached.

These new standards would align with existing rules that govern^[10] other health services. They would protect consumers with minimum standards for patient care, and include measures of clinics’ performance and guardrails for so-called “add-ons”. These are optional extra^[11] procedures or medications offered by fertility clinics, which can be costly and often lack evidence^[12] they work.

For those involved in delivering fertility care – such as nurses, counsellors, embryologists and doctors – the review recommends introducing minimum requirements for qualifications and ongoing professional development.

Better regulation

Rules for the fertility industry are state-based, and currently vary across states and territories. The review recommended the jurisdictions streamline:

• clinic registration and reporting requirements
• how they monitor compliance with regulation
• how they enforce the regulation.

This would require state and territories to work together so the same rules apply nationally. The review was vague on how this would be done.

Insights from people who use fertility services

The review team also consulted with 18 people who’ve used fertility services as patients, to get their perspectives on the health of the fertility industry.

Their insights suggest the sector has a lot of work to do to improve its relationship with patients.

Problems identified by consumers included:

• clinics advertising misleading success rates
• lack of transparency about cost
• incomplete and inconsistent information, hindering informed decisions
• inadequate counselling services
• providers being more focused on maximising profit than patient care
• complaints processes that are confusing and difficult to navigate.

So, the review recommended better support for people to use existing complaints processes. It also said complaints data should be shared between clinics, the accreditor, regulator and complaints handling bodies.

To help people make informed decisions about treatment, the review recommends adding content to the existing YourIVFSuccess^[13] website, which is funded by the federal government. The platform provides independent, personalised estimates of someone’s chance of success, based on their circumstances. The review said it should also provide treatment costs and evidence for add-ons.

What was missing

Consumers were very concerned about the lack of a national donor register. Currently, donors can exceed legislated family limits^[14] by donating in several jurisdictions. This means some donor-conceived people discover they have dozens of half-siblings^[15].

But the review kicked this problem down the road, recommending only that the Australian Law Reform Commission should be asked to review state-based donor legislation. This will likely take many years. In the meantime, donor-conceived people remain at risk.

The review also offered no suggestions for how to increase donor supply and reduce Australia’s reliance on overseas donor banks.

Nor did it address issues with clinics advertising to patients. Fertility clinics appear not to be subject to the same restrictions as individual doctors (who are banned from advertising services or products to patients). Similar rules for fertility clinics would ensure more balanced, evidence-based communication with patients.

We also believe making complaints and misconduct information public is essential to improve transparency – but the review didn’t mention this.

While it did consider the option of running public health campaigns about fertility care, this was explicitly not recommended, on the basis it’s too expensive.

This is another missed opportunity, since research shows knowledge about fertility^[16] in the community is low. Improving awareness can prevent infertility and reduce the need for treatments.

Will the proposed changes make a difference?

The recommendations will likely improve industry standards, transparency about performance, complaints processes, and accountability when things go wrong.

However, health ministers have provided very little information about when recommendations will be fully implemented. Their joint response^[17] says only that “the new accreditation requirements will be in place by January 2027”.

It’s still unclear:

• how the recommendations will be implemented
• who will be responsible
• where the money will come from for the new accreditation system
• how clinics that don’t meet standards will be dealt with.

Let’s hope for clear answers – and prompt reform.

References

1. ^{^} embryo (www.abc.net.au)
2. ^{^} sperm (www.abc.net.au)
3. ^{^} a rapid review (www.health.gov.au)
4. ^{^} the report (www.health.gov.au)
5. ^{^} had already committed (www.abc.net.au)
6. ^{^} highly lucrative (www.stellarmr.com)
7. ^{^} Reproductive Technology Accreditation Committee (www.fertilitysociety.com.au)
8. ^{^} Fertility Society of Australia and New Zealand (www.fertilitysociety.com.au)
9. ^{^} Australian Commission on Safety and Quality in Health (www.safetyandquality.gov.au)
10. ^{^} govern (www.safetyandquality.gov.au)
11. ^{^} optional extra (doi.org)
12. ^{^} lack evidence (doi.org)
13. ^{^} YourIVFSuccess (yourivfsuccess.com.au)
14. ^{^} exceed legislated family limits (www.abc.net.au)
15. ^{^} dozens of half-siblings (donorconceptionandbeyond.com.au)
16. ^{^} knowledge about fertility (doi.org)
17. ^{^} joint response (www.health.gov.au)