TGA to introduce new laws for use of stem cells

The stem cell community 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.

These changes will bring the stem cell 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 Centre for Stem Cell Systems 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 as well as our colleagues at Stem Cells Australia, 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.

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Megan Munsie