The Australian Government has introduced new regulations which will allow more sponsors of complementary healthcare products to use "Australian made" claims. The regulations are intended to deal with the "unintended" consequences of country of origin labelling reforms introduced following the release in 2018 of the ACCC's non-binding country of origin labelling for Complementary Medicine Healthcare Products – A Guide for Businesses and the Federal Court's decision in Nature's Care Manufactured Products Limited v Australian Made Campaign Limited (2018) FCA 1936.
The new regulations, which came into force in December 2019, apply to complementary medicines listed or registered on the Australian Register of Therapeutic Goods. The regulations make clear that if the last step in the process of manufacture of a dosage form of a complementary medicine
- occurs at a licensed premise in Australia; and
- is authorised by a licence to occur in relation to those medicines at those premises;
the medicine in question will be taken to have been "substantially transformed" for the purposes of the safe harbour defences for "made in" or "manufactured in" claims that are set out in section 255 of the Australian Consumer Law. In those cases a sponsor can therefore claim that the medicine in question was made in Australia or Australian made.
Importantly, some "last steps" have been expressly excluded, meaning that they will not, of themselves, be enough to amount to a substantial transformation on which a sponsor can rely to make the claim "Australian made". These include:
- covering in containers;
- storage (whether in packaging or not);
- testing; or
- release for supply.
As a result of the introduction of the new regulations the ACCC has withdrawn its earlier guidance, while Australian Made Campaign Limited, the not-for-profit public company responsible for licensing the Australian made logo:
has also withdrawn its earlier guidelines.
As part of the announcement of these changes, the Australian Government also foreshadowed further amendments to the Australian Competition and Consumer Act will be implemented in the second half of 2020. These amendments will require that Australian made claims based on this most recent regulatory change must display a bar chart that is a visual representation of the portion of Australian ingredients in the medicine in question.
If you have any questions in respect of these amendments or would like advice on the labelling of complementary medicines, please contact Clayton Utz.