IVF is “big business” and experts are concerned about conflicts of interest between profit-making and helping families have children.Monash IVF’ssecond embryo bunglehas sparked renewed scrutiny on the IVF industry as a whole amid calls for national regulation.
On Friday, state and federal health ministers agreed to a three-month review of the need for a federal scheme.
Monash IVF’s chief executive officer, Michael Knapp,stepped down this weekafter the second mistake the company revealed this year.
In April, Monash IVF revealeda woman had given birth to a stranger’s childafter being implanted with the wrong embryo in a Queensland clinic. This week, it admitted that a womanhad been implanted with her own embryoinstead of her partner’s in a Victorian clinic.
The federal health minister, Mark Butler, saidIVF“delivers joy to thousands of families” but that some were losing confidence in the system.
“We need to deal with some of the gaps in regulations, some of the lack of transparency that I think we now know is in this sector,” he said.
Bioethicists and others have concerns that clinics are overselling the chances of a pregnancy, overselling extra IVF cycles, and overselling the benefits of nonessential “add-ons” such as acupuncture, with very little evidence of benefit.
In 2022, about 20,000 babies were born following IVF treatment. That year, about 109,000 cycles were performed. One in 16 babies born in Australia is conceived using IVF.
The chances of a birth drops rapidly depending on age. Thechances of a live birthfrom one cycle is 43% for women aged 30 to 34 years but just 11% for women aged 40 to 44.
While there are some public IVF facilities, most are private. Families can pay thousands per cycle out of pocket, after some rebates from Medicare and private health. The industry revenue for this year will be an estimated $810m.
Swinburne University bioethicist Dr Evie Kendal said IVF straddles the boundary between a consumer service and healthcare, a grey area where conflicts of interest can arise.
“As soon as there’s a financial incentive to provide these services or even upsell these services, there is a perverse incentive to not look at alternatives that may not require these services [such as lifestyle changes or ovulation tracking],” she said.
“So they jump to ‘let’s do IVF’.
“If the person suggesting that has any sort of financial incentive, then we can be very concerned about conflicts of interest, because obviously if there is a less invasive way for someone to achieve their family goals that align with their values, then obviously we would want to be focussing on that.”
She said IVF providers have helped a lot of people, but incidents such as the Monash IVF situation undermined public trust.
“People get very concerned, because for them this is not a consumer experience,” she said.
“It is a family-building experience.
“That child is not a product, that is a family member, so the service might be a product that’s traded, but the child absolutely isn’t.”
On Thursday, University of South Australia research fellow Hilary Bowman-Smart and Monash University bioethicist Craig Stanburywrote in the Conversationthat IVF is “big business”. Financial analysts have noted that “people will pay almost anything to have a baby”, they wrote.
And they pointed out that about eight in 10 women using IVF pay for “non-essential ‘add-ons’ such as pre-implantation genetic testing, acupuncture, or embryo time-lapse imaging” even though claims they help with pregnancy lack evidence.
There are more than 20 add-ons offered in Australia, University of Melbourne academics have found.
These optional extras can includesteroids,acupunctureandendometrial scratching.
For some of them, there is no evidence of benefit. Earlier research by the same team found about 77% of clinic websites make unsubstantiated claims and lack details about potential harms and costs.
They have developed anevidence-based websiteabout the optional extras.
While commercialisation might drive innovation, they wrote, it could also increase the risk of over-servicing, such as doing more cycles even though the chances of a pregnancy are dwindling.
Nationally consistent regulation could help by having more uniform standards and policies around who is eligible for IVF, they wrote.
On Friday, Victoria’s health minister, Mary-Anne Thomas, said state and territory departments would lead a three-month review to investigate options for a federally regulated IVF scheme and an independent IVF accreditation body.
Asked about the latest Monash IVF bungle, Thomas said “there may well be more errors we don’t know about” because of inadequate regulation.
The country’s patchwork of IVF regulation across jurisdictions will also be reviewed by health departments to ensure they are “fit- for-purpose” for safety and quality, she said.
Thomas said the key issue for her was accreditation for fertility care because providers were currently self-accredited by the Reproductive Technology Accreditation Committee.
“It simply doesn’t pass the pub test that the people that provide the service are also the ones that determine who provides the service,” Thomas said.
The Fertility Society of Australia and New Zealand (FSANZ) has called for a nationally consistent framework to strengthen oversight and trust, and an independent statutory accreditation body.
President Dr Petra Wale said FSANZ was committed to “ensuring transparency, accountability and patient-centred care across all fertility services, whether publicly or privately funded” and that many clinics were “global leaders in outcomes, safety and reporting standards”.
Safeguards include accreditation, ethical guidelines including requirements for evidence-based practice, patient consent and transparent communication, she said, and clinics are required to clearly explain the evidence behind any add-on treatments.
“Clinics must provide patients with information tailored to their individual circumstances, including the impact of age, health status and other factors on success rates,” Wale said.
Wale said commercial providers had driven innovation, attracted investment and contributed to improved success rates and access to cutting-edge treatments.