Therapeutic Products Act
This act is intended to replace the Medicines Act 1981 and the Dietary Supplements Regulations 1985 to provide for the comprehensive, risk-proportionate regulation of therapeutic products, such as medicines, medical devices, natural health products, and active pharmaceutical ingredients.
The bill had its third reading in the House and was passed on 19 July and assented on 26 July 2023, with regulations once they're established due to come into effect September 2026. However on 24 November 2023, an announcement was made by the new coalition government that it will repeal the Therapeutic Products Act 2023.
Our stance:
The passing of this act has implications for individuals and organisations operating within the natural health products industry. FxMed opposes the Therapeutic Products Act (TPA)
Bottom line:
Adopt an expansive approach rather than a restrictive one, maintain and enhance freedom of choice for practitioners and consumers. We are in support of the TPA being repealed in favour of a new stand-alone regulation and regulatory body for natural health products.
Since our original submission:
We have conducted an internal review and appended notes to indicate whether any of our suggested changes have been considered.
Summary of key objections:
- Natural Health Products (NHPs) should be regulated separately from the TPA which is a framework primarily designed for medicines, medical devices.
- Regulator should have sound knowledge of Naturopathy, Herbalism and should constitute an expert advisory board drawing upon the skill sets of various practitioner modalities.
- Blacklist ingredients rather than a whitelist approach. Ingredients or Products being sold safely in other countries like USA, EU, Australia etc should be allowed.
- Increase ingredient limits eg Vit B12, Vit D. Thought be given for natural healthcare practitioners to be able to access higher limits.
- Costs and fees must be kept equitable for low-volume products so that these products do not disappear from the market.
Watch FxMed’s 10-minute oral submission opposing the bill presented by our CEO, Amal Karl
