Regulation of Homoeopathic Products
The role of the Therapeutic Goods Administration (TGA) is to ensure that therapeutic goods available for supply in Australia are 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 (the Act) 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 (MMDR review). 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. Further public consultation will be conducted before any new regulatory arrangements are proposed by Government. People are able to keep up-to-date of the consultation process via the ‘open consultations’ link on the TGA website.
As part of the MMDR 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 (NHMRC) Homoeopathy Review
The 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 for Natural Therapies. The approach to the review, the evidence base and the final report are all detailed on NHMRC’s website.
The Review of the Australian Government Rebate on Private Health Insurance for Natural Therapies
A package of reforms to private health insurance was announced on 13 October 2017. This package includes changes to private health insurance cover for some natural therapies.
Cover for the following natural therapies will be removed from all private health insurance products: Alexander technique, aromatherapy, Bowen therapy, Buteyko, Feldenkrais, herbalism, homoeopathy, iridology, kinesiology, naturopathy, Pilates, reflexology, Rolfing, shiatsu, tai chi and yoga. Consumers can still choose to access these services, but they will not be able to claim benefits from their insurer. This change will take effect from 1 April 2019.
In 2015, the Natural Therapies Review Advisory Committee, chaired by the Commonwealth’s Chief Medical Officer and included members from the natural therapies industry, reported that ‘clear evidence could not be found’ for the effectiveness of the listed natural therapies.
Commonwealth health funding is typically only paid where a therapy has demonstrated clinical efficacy, and therefore the Government has decided to remove coverage for these services.
Consumers can still choose to access natural therapies, but these services will not be eligible for private health insurance rebates. It is important that practitioners note that some private health insurers provide access to gym services and other products as incentives under their insurance. Private health insurers will continue to be able to provide natural therapies as incentives which do not attract the private health insurance rebate.
The reforms include a number of other changes designed to make private health insurance simpler and more affordable. Further information about the package, including the removal of cover for natural therapies, is available on the Department’s website.