Australia’s burgeoning and unregulated stem cell industry will no longer be able to operate unchecked under reforms proposed by the TGA.
Concerns have been mounting over the proliferation of clinics advertising direct-to-public unproven treatments derived from a patient’s own stem cells claimed to treat a range of conditions including arthritis and Parkinson’s disease.
The evidence base is not borne out in the medical literature, but clinics have been able to offer the treatment – sometimes charging thousands of dollars – outside TGA regulation due to a regulatory “loophole” brought in via the excluded goods order legislation six years ago.
Calls to close the loophole intensified last year following a NSW coroner’s damning inquest into the death of a dementia patient who underwent a stem-cell procedure.
After two years and two rounds of consultation, the TGA this week proposed a multi-tiered system to regulate autologous stem cell products based on risk.
The toughest rules would apply to autologous stem cell and tissue that is more than minimally manipulated and intended for non-homologous use outside a hospital setting, which would fall under the Biologicals Regulatory Framework.
There would also be TGA regulation – with exemptions from some requirements – for treatments derived from minimally manipulated autologous stem cells intended for homologous use developed and provided outside a hospital setting by a doctor or dentist.
Autologous stem cell treatments manufactured and provided in a hospital by a doctor or dentist for a patient in their care will remain unregulated.
Under the proposal direct-to-consumer advertising would be banned, however services “that don’t mention specific products” could still be advertised.
“The approach will bring Australia into closer alignment with international regulation such as in the United States and the European Union,” the TGA said.
The regulatory model is the Australian Rheumatology Association’s preferred option, said president Professor Rachelle Buchbinder.
“One of the things we are concerned about is there isn’t high quality evidence these treatments are efficacious so they should not be offered outside a clinical trial.
“Some of these operators say that they’re doing a clinical trial but they’re not doing a high-quality trial, in terms of registering their protocol and having a control group.”
‘We want patients to be safe and not able to receive treatments that are very expensive and may not work”.
Clinical haematologist and pathologist Professor John Rasko, who has repeatedly called for closure of the regulatory loophole, said the announcement was a good start.
“This loophole has been an open sore in the otherwise beautiful regulatory environment Australia has and it’s taken years to start to put on a bandaid,” he told the limbic.
“For six years an unfortunate loophole has existed in the regulation of ‘autologous stem cell’ therapies that has allowed unscrupulous clinics to appear all over Australia.
They have taken advantage of the loophole to sell at exorbitant costs unproven liposuction-based procedures for any number of diseases.
“After two rounds of public consultation the recent announcement is a welcome indication that at least there is some movement towards protecting the public from snake oil salesmen.
“However the new regulations will still have to be drafted by the Office of Parliamentary Counsel and already there is mention of certain ‘exemptions’ to the new regulations which won’t commence for many months followed by a transition period.
“At this stage we have reason to be hopeful that the public will have further protections, but how much longer do they have to wait before millions of dollars are wasted on cell-based injections of no proven value and possible harm?”