Who is looking after my interests? | Stem Cells Australia | Who is looking after my interests? | Stem Cells Australia

Who is looking after my interests?

Your current doctor is well placed to help you evaluate information and work out what is the right choice for you. There are also many different government agencies that protect the interests of patients.

Here is some more information about how to access help and who is responsible for what when it comes to stem cells in the clinic.

How are new treatments
developed?

What should I ask my doctor about stem cells?

As a general rule, your GP is a great place to start, while your specialist will have more in-depth knowledge of your condition and available treatment options.

Here are some questions that you may want to ask your Australian doctor. You can click to download and take the list along to your next appointment.

Download PDF

How are stem cell treatments regulated in Australia?

If a treatment is being provided in a hospital, the hospital will have their own checks and balances in place to make sure the health practitioner treating the patient is appropriately qualified and that the treatment is an accepted therapy. The use of bone marrow and cord blood stem cells at transplantation clinics will need to meet additional standards in order to be accredited.

Where the stem cell treatment is being offered outside a hospital or an accredited transplantation clinic, the Therapeutic Goods Administration (or TGA) now requires the doctor or dentist to meet strict standards to better protect Australians and visiting patients. Australian doctors, dentists and other healthcare providers are also required to meet professional standards.

Since 2019, all Australian doctors or dentists who provide stem cell treatment must meet new standards set down by the Therapeutic Goods Administration (TGA). This is the Australian government agency that regulates the use of prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and cell-based products, including those made from stem cells.

They are responsible for ensuring that therapeutic goods available in Australia are of an acceptable standard, with the aim of ensuring that Australian patients have access to therapeutic advances.

All doctors, dentists and other health practitioners treating patients in Australia are required to be registered by the Australian Health Practitioners Regulation Agency (AHPRA). The primary role of this authority is to protect the public and set standards and policies that all registered health practitioners must meet. Failure to register with AHPRA or to meet their standards can result is significant penalties.

Regulations around use of my own cells recently changed what does this mean?

The new standards have been designed to provide greater protection for patients and encourage more clinical research to determine what stem cell-based treatment work best, under what circumstances, and for what conditions.

In order to protect patients and the general public, a ban on the advertising of unproven cell therapies has also been introduced recently. Stem cell clinics and individual doctors and dentists who fail to meet the new requirements may face significant penalties.

Prior to these changes many private clinics were operating in Australia, claiming to use the patient’s own stem cells to treat a wide range of conditions but without any evidence of what they were selling worked or was even safe.

Unfortunately an Australian women died, others have suffered complications or been disappointed with the outcome following paying for what we now realise was unsubstantiated stem cell treatments. The new regulations will mean that patients can still access unproven or experimental stem cell treatments but it a way to lessen risk to them.

Patients will still be able to access less established or unproven stem cell treatments where:

Treatment is offered as part of a clinical trial (Note: You should not have to pay for a treatment that is part of a clinical trial and the trial should be registered on the ANZCTR)
Treatment occurs in a hospital following consultation with a specialist doctor and the cells are prepared at the hospital
Treatment in other settings where a doctor has used a special access pathway for people who are very sick or for whom established treatment options are unsuitable.
The cells are from the patient’s fat, blood or other tissue and are considered low risk as their preparation has been very limited, caused minimal disruption to the tissue and the cells are expected to perform a similar role that they usually do in the body. For example, transferring fat cells from one site to another with little or no disruption of the fat tissue.

For more information, visit the TGA's Stem cell treatments and regulation - a quick guide for consumers

Where can I report a problem or concern?

If you or someone you care for have experienced a complication following stem cell treatment, please first contact your GP or medical specialist as soon as possible to seek help.

If you are dissatisfied with the treatment you have receive or are concerned about a treatment that you or a patient have experienced or heard about, please consider sharing your experience through one or more of the following options listed.

By sharing your experience, you can bring attention to concerning practices and help us make sure that the interests and health of others are better protected.

Contact TGA online or via email to report side effects following stem cell treatment
Contact TGA online to report concerns about advertising of a therapeutic product
Contact AHPRA if you have concerns that the health practitioner is placing the public at risk, practicing in an unsafe way, or practising outside of their scope of practice (the boundaries a particular medical practitioner must work within)
Contact relevant health complaints or consumer protection organisations
You might also like to share your concerns with your GP or medical specialist.

Recommendation: If you do go ahead with an unproven stem cell treatment, it's important to keep in touch with your current Australian doctor. Making sure they are aware of what procedures you’re undertaking helps them to provide the best care for you. This is especially important if you suffer any side-effects or complications.

Who is looking after my interests?

Who is looking after my interests? | Stem Cells Australia | Who is looking after my interests? | Stem Cells Australia