The ability of for-profit stem cell clinics to pitch unproven, risky stem cell offerings to patients may soon get much tougher in Australia.
The country’s Therapeutic Goods Administration (TGA), which has some similar responsibilities there as the FDA does here in the U.S., announced planned new reforms that’ll put stem cell clinics under more scrutiny and more thorough oversight. Hopefully it’ll in many ways provide patients with more protections.
While details remain to be determined, there are four major components to the TGA policy change, which should be implemented in early 2018:
- “Not permit direct advertising to consumers of autologous cell and tissue products, similar to the prohibition in Australia in the advertising of prescription medicines, but noting that services (that do not mention specific products) will still be permitted to be advertised.
- Exclude from regulation by the TGA only those autologous cell and tissue products that are manufactured and used in a hospital by a medical or dental practitioner, for a patient in the care of the same practitioner.
- Introduce regulation by the TGA, with exemptions from some requirements, for autologous cell and tissue products that are:
- minimally manipulated, and
- for homologous use only, and
- manufactured and used outside a hospital by a medical or dental practitioner,
- for a patient in the same practitioner’s care.
- Regulate under the Biologicals Regulatory Framework those autologous human cell and tissue products that are:
- manufactured and used outside an accredited hospital, and
- more than minimally manipulated, or
- for non-homologous use.”
In a helpful piece Professors Megan Munsie, Cameron Steward, and Ian Kerridge, detail this legal development, which is largely viewed as good news. Early in their piece, Munsie (who is also Deputy Director of the Centre for Stem Cell Systems and Head of Education, Ethics, Law & Community Awareness Unit, Stem Cells Australia, at University of Melbourne) and colleagues outline the potential impact:
“Regulation of stem cell treatments being offered outside hospitals will be increased. It will acknowledge the risks of these treatments, and advertising of certain treatments will be prohibited.
While more specific details are not yet available, it seems at last possible the most egregious practices of suburban stem cell clinics will be severely curtailed.”
With more than 60 stem cell clinics now, Australia has a growing problem in this area much like the U.S. and other countries where such clinics are mushrooming. Hopefully this new policy will have strong, positive impact in Australia. It’s unclear why dentists should be added into the mix of stem cell providers, although here in the US there are rumblings about other practitioners besides physicians more often getting into selling stem cells including chiropractors and less often dentists. Also, hopefully hospitals will not jump into offering unproven stem cells in Australia as apparently they’d be exempt from the new policy’s oversight.
In the U.S. the situation is mixed as the FDA under new Commissioner Scott Gottlieb has taken some strong, if preliminary action and California has a new state law mandating that clinics put up postings and inform patients about what they are getting into, but Texas has a new state law that, while not nearly as risky as it could have been prior to last-minute legislative changes, still is decidedly pro-clinic in some ways. A push for a national right-to-try law in the U.S. may also make things more complicated on the stem cell front.
Munsie and her coauthors see the new TGA policy as a positive step but more details are still needed and vigilance is required in this arena:
“The dangers here are clear. While regulatory reform is welcome, they will remain ineffective unless the TGA and other regulatory bodies have the will, power and resources to enforce them. And unless this happens – patients will continue to be harmed.
Selling stem cells has been a big business in Australia for too long. After two public consultations and much deliberation, we have some action. Researchers, health practitioners, patients and regulators have an interest in making sure the proposed changes to the regulations work.”
With potential positive steps such as the California law, the newly emboldened FDA, and this development with the TGA in Australia, much of the final outcome will depend on practical issues and enforcement on the ground of stem cell clinics. Actions need to back up the words from governmental agencies. In each case, there also remain potential loopholes through which stem cell clinics can try to operate and continue to siphon money from vulnerable patients even as they put these folks at risk by experimenting on them without governmental permission.