The Monash IVF chief executive, Michael Knaap, has resigned after the reproductive healthcare company’s second embryo transplant bungle.
In a statement to the ASX, Monash IVF said the board had accepted Knaap’s resignation as CEO and managing director.
This week Monash IVF admitted to a second bungled embryo implant, this time in a Victorian clinic. In an earlier error in April, Monash IVF revealed a woman had given birth to the child of an unrelated woman after an incorrect embryo transplant in Queensland.
Monash IVF said on Thursday it “acknowledges and respects [Knaap’s] decision”.
“Since his appointment in 2019, Michael has led the organisation through a period of significant growth and transformation, and we thank him for his years of dedicated service,” the company said.
Malik Jainudeen, Monash IVF’s chief financial officer and company secretary, will serve as acting chief executive.
Experts are calling for national regulation of the sector, something that the federal health minister, Mark Butler, said would be discussed on Friday when health ministers meet in Melbourne.
“These cases are just shocking, deeply distressing, and undermine confidence in the system,” Butler told ABC radio on Thursday.
“As governments, we’ve got a responsibility to see whether there are better levels of regulation that should be put in place, and to inject some confidence back into a system that delivers such joy to so many thousands of families every year.”
IVF is regulated by state and territory laws but a more consistent, federal approach is being urged.
Clinics must be licensed by the Reproductive Technology Accreditation Committee (RTAC), a subcommittee of the Fertility Society of Australia and New Zealand (FSANZ). That’s the unit that carries out audits, including on some assisted reproductive technology (ART) clinics internationally.
Clinics must also follow ethical guidelines from the National Health and Medical Research Council.
FSANZ said in a statement about the latest Monash IVF incident that Australia’s fertility care system was “among the safest, most transparent and tightly regulated in the world”.
Dr Petra Wale, the FSANZ president, said errors were “exceedingly rare” although “deeply difficult for those affected”.
FSANZ has called for a nationally consistent framework for ART, and an independent statutory authority to “strengthen oversight and trust”. It said that while the clinical standards in IVF clinics were nationally consistent, each state and territory had its own legislation.
Transitioning the RTAC to an independent statutory authority would strengthen the accreditation scheme with “the regulatory clarity and operational flexibility needed to uphold rigorous standards and respond swiftly to emerging risks”, it said, while a national approach to ART would “strengthen transparency, streamline governance, and enhance patient care across the country”.
The latest audit of Australian ART facilities found 172 non-conformance reports, but only one was “major”. Other countries audited, including New Zealand, had higher rates.
Prof Jeremy Thompson, a fertility researcher at the University of Adelaide and the co-founder and chief scientific officer at the IVF technology company Fertilis, said there was a global shortage of well-trained and experienced embryologists.
This means “levels of training and experience can vary”, Thompson said, in a stressful job where “skill and time management are critical for the best outcome”.
But he added: “Australia’s reputation as a leader in embryology training and technique auditing is beyond question.”
A University of New South Wales associate professor Kuldip Sidhu, co-founder and director of CK Cell Technologies, said more rigorous compliance was needed in the industry.
Embryologists are not registered under a national scheme, and doing this would “help in adding another layer of responsibility to check such mishappenings in the IVF industry”, he said.
Dr Evie Kendal, a senior lecturer in health promotion at Swinburne University of Technology, said more human intervention in reproduction brought increased potential for human error.
“Previous safeguards are clearly not up to the challenge of protecting clients against such incidents, and urgent ethical and policy guidance is needed to prevent such mistakes from occurring again,” she said.
On Tuesday Monash IVF told the ASX it would extend the review into the Queensland error and start a new investigation into the Victorian one.
Victoria’s health minister, Mary-Anne Thomas, confirmed the Victorian health regulator was also investigating. She said Monash IVF’s “clinical governance standards are not where they should be”. On Thursday, she said Monash IVF had “a lot of work to do to win back public trust and confidence”.
“They need a strong leadership team to do that,” she said.
“It is very clear that there needs to be greater national consistency to strengthen regulation of the fertility care providers across Australia.”
Thomas said she would advocate for “a strong and independent national accreditation and licensing scheme for fertility providers” at Friday’s meeting.
Monash IVF said on Tuesday that as well as the investigations it would put extra verification processes and patient confirmation safeguards in place “over and above normal practice and electronic witness systems, to ensure patients and clinicians have every confidence in its processes”.
– with additional reporting by Benita Kolovos
