Review of new Australian regulations and the implication for commercial stem cell clinics
Professor Megan Munsie and Dr Christopher Rudge joined colleagues Dr Narcyz Ghinea, and Professor Cameron Stewart from the University of Sydney to review the new regulatory framework, discussing the history behind the reforms and highlighting some of ambiguities that may arise in practice.
The Therapeutic Goods Administration recently introduced changes to how certain therapeutic products are regulated in Australia. Clinics, doctors and dentists must now meet strict standards when using a patient’s own cells and tissues in their treatment. While these regulatory reforms were designed to provide greater protection for patients at risk of being exploited by clinics selling unproven treatments, the impact on Australian medical and dental practices is yet to be established.
Deputy Director of the Centre for Stem Cell Systems Professor Megan Munsie and Centre member Dr Christopher Rudge joined colleagues Dr Narcyz Ghinea, and Professor Cameron Stewart from the University of Sydney to review the new regulatory framework. In their recent paper ‘Australian regulation of autologous human cell and tissue products: implications for commercial stem cell clinics’, published in Regenerative Medicine, the authors discuss the history behind the reforms and highlight some of ambiguities that may arise in practice.
Professor Megan Munsie, Dr Christopher Rudge, Dr Narcyz Ghinea, and Professor Cameron Stewart
They focus on the implications for commercial stem cell clinics. Such clinics have grown in number across Australia over the last decade and claim to be able to treat a myriad of conditions despite a lack of credible evidence that their approaches are effective or even safe.
The authors note that the ban on direct-to-consumer advertising combined with new manufacturing requirements should make it more difficult for stem cell clinics to offer unproven products outside of a hospital setting. Further, that the reforms should also incentivise stem cell clinics and hospitals to work together to conduct more robust clinical research into possible applications of stem cell-based medicine.
They warn however, that some clinics may be able to bypass the new advertising rules by employing various strategies. The authors also note that without greater coordination with other agencies, the reforms could also inadvertently result in stem cell clinics simply moving their practice under the patronage of, or in partnership with, hospitals.
“We welcome the new framework and the effort of TGA and the Australian government to protect patients as well as those in research and industry trying to develop safe and effective new treatments using stem cells,” said Professor Megan Munsie.
“While stem cell science offers great promise, we must still ensure that appropriate standards are met. It is also critical to communicate with the public about the likely therapeutic benefits of any medical innovation in parallel to the implementation of new regulation. ” she said.
“We must insist that robust evidence not just enthusiasm underpins medical innovation. Exploiting patients’ hopes and vulnerabilities, particularly for profit, is simply unacceptable,” Megan concluded.
Prof Megan Munsie