In response to recent calls to have Federal Senators disallow the Therapeutic Goods (Permissible Indications) Determination No 1 of 2018, the Australian Self Medication Industry (ASMI) would like to clarify some misinformation regarding the reforms and encourage Federal Senators to allow the legislative instrument to pass into law. Several concerns have been raised, and these will be addressed in turn.
A. No. Traditional medicines have always been an important part of the Australian complementary medicines framework and the availability of traditional indications is not new. These reforms will not increase the number or type of indications to which consumers are exposed, in fact the determination will restrict the indications available to ensure that industry is only referring to conditions and circumstances that have been assessed by the Therapeutic Goods Administration (TGA).
A. Traditional medicines are an important part of cultural practices and knowledge. Including these products on the ARTG enables culturally relevant products to be utilised by those that choose them, while ensuring that their manufacture and supply meets Australian standards for quality and safety. This gives consumers safe and regulated choices rather than relying on purchasing unregulated products from overseas.
A. No. The TGA has clear evidence requirements for complementary medicines, whether these are supported by scientific evidence, traditional evidence, or a combination of the two. Substantiation of traditional use indications requires evidence of a history of medicinal use of the ingredients or medicines that exceeds three generations (75 years) of use, and must be extensively recorded in internationally recognised evidence sources. While traditional indications are not always validated through scientific inquiry, they are not without evidence, and have important cultural uses that consumers seek and reflect cultural knowledge that should not be denigrated.
A. The introduction of this legislative instrument creates clear requirements for terminology for indications and will increase the clarity regarding the traditional paradigm and context of the product. An indication based on a traditional paradigm must be clearly disclosed on the label, and proposed reforms to the Therapeutic Goods Advertising Code requires the history of traditional use to be disclosed in the advertisement. For example, a traditionally supported product cannot claim ‘helps maintain heart health’ without clearly identifying the tradition on the label and in advertising, such as ‘traditionally used in Ayurvedic medicine to support heart health’ or ‘traditionally used in Western herbal medicine to support healthy heart function’.
A. The proposed educational statement should not be introduced as this legislation is already increasing transparency regarding traditional evidence on these products so that consumers are better informed. The proposed educational statement devalues the traditional knowledge that is important to many Australians, while also ignoring the fact that indications can be supported by both traditional and scientific evidence.
A. Yes, however this is already being introduced through other mechanisms and there is no need to disallow this legislative instrument to achieve this. Transition to the new labelling order is underway, with all medicines required to be compliant by 1st September 2020. This includes a requirement for homoeopathic products to display a prominent heading on the main label alerting consumers that it is a homoeopathic product.
A. If a mandatory statement on the product label of any therapeutic good is considered to be necessary it should be underpinned by the appropriate legislation, which would be the labelling order. Additionally, any statement should be evidence-based, respectful of cultural traditions, properly consulted and tested to ensure that it is accurate, not misleading and easily interpreted by consumers. The proposed statement does not meet any of these criteria and presents misinformation about the varied sources of data that can underpin complementary medicines, while the reforms package that is underway is designed to increase transparency for consumers.
A. No. Disallowance of this instrument would have far reaching impacts to Australian consumers as it will disrupt not only traditional medicines, but scientifically backed low risk medicines including supplements, sunscreens and over-the-counter medicines through the regulatory gap that the absence of this legislation would create.
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