Unscrupulous clinics offering unproven stem cell therapies will no longer be able to freely advertise direct to the public under new rules due to come into effect on July 1.
The new advertising rules will apply to all procedures provided outside a hospital setting that use autologous stem cells that are ‘more than minimally manipulated’ and to non-homologous use.
The changes to the TGA’s Biologicals Regulatory Framework were announced last October in response to calls to close a regulatory ‘loophole’ that has allowed commercial clinics to operate unchecked for years, charging thousands of dollars to treat conditions such as arthritis and Parkinson’s disease.
Under the new rules clinics can advertise services but may not mention particular treatments or specific cell or tissue-derived products.
“However, such information can be provided to patients as part of a consultation with the professional”, the new TGA guidance document states.
It cautions that medical and dental professionals need to assess whether the therapeutic good is appropriate and suitable for their patient before an autologous HCT product can be administered.
As part of the new rules clinics offering stem cell treatments will also be required to register products on the ARTG and report adverse events to the TGA.
References to colloquial names like ‘stem cells’ are also banned, with financial penalties for breaches up to $840,000 for individuals and $4.2 million for corporations.
Associate Professor Megan Munsie, deputy director of the Centre for Stem Cell Systems at the University of Melbourne, welcomed the clamp down on advertising, which she said will “hopefully” address “exploitative practices”.
“I think it’s quite explicit in the guidance document you can’t just have the ‘such and such stem cell clinic’ and then have a sanitised website but retain the name, but of course it will need to be policed and investigated,” she told the limbic.
But how individual businesses will interpret these rules remains to be seen.
“I think it will all have to be tested….I think we will see a change in (individual) websites and I hope we will see a change in practice but I also think we will have to keep a watching brief.
“We will definitely be sharing concerning practices we hear about with the TGA.”
The limbic sought comment from a stem cell clinic and the TGA, but had not received a response before deadline.