News

New Australian laws to regulate clinical use of stem cells

26 October 2017
Changes to TGA regulation welcomed

Stem Cells Australia welcomes the announcement that the Australian Government will introduce regulatory changes to address the sale of unproven stem cell treatments, increasing safeguards to protect patients from harm and bringing Australia into alignment with international standards.

Stem cell research holds great promise for many suffering from incurable conditions. While a growing number of clinical trials are underway to evaluate possible approaches, safe and effective treatments for many conditions are yet to be identified.

Despite this lack of evidence, unproven stem cell treatments are already being marketed by clinics around the world, including in Australia. Often using the patient’s own cells, so called autologous stem cell’ therapies, many of these clinics are exploiting ambiguity in local regulations.

In a welcomed move, the Australian Government has announced changes will be made to ensure the Therapeutic Goods Administration (TGA) will have greater regulatory oversight of the manufacturing and clinical use of autologous cells and tissues of this area.

Commenting on the announced change that will take effect in early 2018, Program Leader of Stem Cells Australia Professor Melissa Little said, “We are very pleased to see these changes announced. This will bring our industry in line with regulations in place in many international jurisdictions and safeguard the vulnerable patient groups from unproven and potentially unsafe practices”.

Historically the use of the patient’s own cells had been seen as a medical practice and not regulated by the TGA. However, the breadth and complexity of what is on offer by Australian clinics places patients at risk and warrants additional safeguards.

The decision by the Australian Government follows an extensive two-phase public consultation process during 2015 and 2016.

Stem Cells Australia has long called for more stringent regulatory oversight to protect the Australian public and overseas visitors from harm, and to ensure genuine efforts to translate promising stem cell research into clinical benefit are not stymied.

We thank and acknowledge the contribution of our members to the reform process, particularly The University of Melbourne’s A/Prof Megan Munsie and former Program Leader Martin Pera, as well as our colleagues at the Australian Academy of Science, the National Stem Cell Foundation of Australia, Australasian Society for Stem Cell Research, International Society for Cellular Therapies and many community and patient advocacy groups.

With these reforms, we now have in place a regulatory framework to advance stem cell medicine in Australia.

Associate Professor Megan Munsie heads Stem Cell Australia's Education, Ethics, Law & Community Awareness Unit.

For more information:

Finally, unproven stem cell clinic practices might be curtailed, The Conversation 27 October 2017

Tighter rules for stem cell clinics on the horizon, The Limbic, 26 October 2017

Regulation of autologous cell and tissue products, TGA 24 October 2017

Click to read submissions made to 2015 and 2016 TGA public consultations