FAQ - Regulation of homoeopathic products
Monday, 11 December 2017
The role of the Therapeutic Goods Administration (TGA) is to support therapeutic goods available for supply in Australia to be safe and fit for their intended purpose to protect the public health of consumers.
In Australia herbal products, vitamins, minerals and nutritional supplements, some aromatherapy products and certain homoeopathic products are regulated as complementary medicines under the Therapeutic Goods Act, 1989 by the TGA.
Currently in Australia, most homoeopathic medicines are considered to be of very low risk and are not required to be on the Australian Register of Therapeutic Goods, providing they comply with certain requirements.
On 24 October 2014 the Australian Government announced that there would be an expert panel review of the regulation of medicines and medical devices.
In September 2016, the Government agreed to most of the recommendations made by the Expert Panel. As part of this program of work, an initial public consultation has been conducted on the possible future regulation of a variety of low risk therapeutic goods, including homoeopathic products.
The options explored for all identified product types ranged from maintaining the regulation as it already is, to removal from the TGA’s regulatory framework altogether.
As part of the review recommendations the Government also agreed to enhance the regulatory framework for complementary medicines in a number of ways. These reforms will improve transparency for both industry and consumers and support consumer health decisions by increasing the amount of information that is available about the safe and effective use of complementary medicines.
National Health and Medical Research Council Homoeopathy Review
National Health and Medical Research Council (NHMRC) uses standardised, internationally-accepted methods and quality assurance processes to ensure that the evidence it utilises in developing advice has been identified, appraised and interpreted in an appropriate and transparent manner.
These standards were applied in conducting the Homoeopathy Review as well as the evaluation of a number of natural therapies as a part of the Department of Health’s Review of the Australian Government Rebate on Private Health Insurance (the Rebate) for Natural Therapies (the Review).
The approach to the Review, the evidence base and the final report are all detailed on NHMRC’s website at www.nhmrc.gov.au/health topics/complementary-medicines.
The Review of the Australian Government Rebate on Private Health Insurance for Natural Therapies
The Government has not made any decision to restrict private health insurers from offering benefits for complementary medicine.
The Review was overseen by the Department’s Chief Medical Officer, to determine if Natural Therapies should continue to attract the Rebate.
- The report of the Review was published on 16 November 2015. This report is on the Department’s website.
- Evidence on 17 natural therapies was assessed by the NHMRC, which contributed to the Review.
Natural therapies continue to be covered by the Rebate. Where natural therapies are covered by a private health insurance policy, the policy will continue to attract the Rebate.
The proportion of the rebate linked to natural therapy benefits within general treatment products is relatively very small. At this point, decisions on the coverage of natural therapies in private health insurance policies continues to be a commercial matter for each insurer.
The Government has established the Private Health Insurance Advisory Committee to provide advice on possible reforms to improve the value of private health insurance for consumers. The Committee is considering a range of issues, including product design for both hospital and general treatment insurance.
None of the natural therapies considered by the Review are listed on the Medicare Benefits Schedule (MBS). Therefore, these therapies do not attract Medicare rebates.